Science.gov

Sample records for adolescent medicine trials

  1. Linkage to care for HIV-positive adolescents: A multi-site study of the Adolescent Medicine Trials Units of the Adolescent Trials Network

    PubMed Central

    Fortenberry, J. Dennis; Martinez, Jaime; Rudy, Bret J; Monte, Dina

    2012-01-01

    Purpose To understand linkage to care practices in sites providing clinical services for newly diagnosed HIV-positive adolescents. Methods Qualitative analysis of detailed interviews conducted with 28 personnel involved in linkage to care at 15 sites providing specialty care for HIV-positive adolescents. Results We showed that multiple models exist for linkage to care, and that both formal and informal community relationships are important for successful linkage to care. Stigma was seen as a universal issue, enhancing the importance of the balance of confidentiality and social support. Barriers to care such as mental health issues, substance use, and transportation are common. Conclusions We conclude that the complexity of linkage to care requires thought and planning as HIV testing is expanded to lower risk populations. PMID:23174464

  2. Psychopharmacology in adolescent medicine.

    PubMed

    Scharf, Michael A; Williams, Thomas P

    2006-02-01

    Psychopharmacology is a challenge for health care providers treating adolescents. A detailed and accurate assessment, including developmental issues relevant to adolescence in general and to the individual adolescent, guides clinicians in formulating thoughtful and effective treatment plans to meet the needs of each patient. Parents play an important role in providing family history regarding psychiatric diagnoses and the response to various drugs, in making decisions to initiate medication and to change a medication regimen, and in monitoring an adolescent's adherence to a prescribed regimen. The role of parents is especially important for younger patients. Following the biopsychosocial model, rarely should psychopharmacologic agents be used as the sole means to treat a psychiatric condition in adolescents. Pharmacologic agents described in this article are tools that have their effect in the biological domain of central neurotransmitters, but psychosocial interventions addressing the emotional and behavioral issues that are the indications for such medication are generally also required. The development of newer medications holds promise for more effective treatment of target symptoms with minimal side effects. PMID:16473299

  3. Society for Adolescent Health and Medicine

    MedlinePlus

    ... Media Use by Adolescents Mental Health Sexual & Reproductive Health Sports Medicine Substance Use Transition to Adult Care Related ... Puberty/Normal Development Eating Disorders and Nutrition LGBT Health Media Use by ... Medicine Substance Abuse Transition to Adult Care Clinical ...

  4. Clinical holistic medicine: holistic adolescent medicine.

    PubMed

    Ventegodt, Søren; Morad, Mohammed; Press, Joseph; Merrick, Joav; Shek, Daniel T L

    2004-08-04

    The holistic medical approach seems to be efficient and can also be used in adolescent medicine. Supporting the teenager to grow and develop is extremely important in order to prevent many of the problems they can carry into adulthood. The simple consciousness-based, holistic medicine--giving love, winning trust, giving holding, and getting permission to help the patient feel, understand, and let go of negative beliefs--is easy for the physician interested in this kind of practice and it requires little previous training for the physician to be able to care for his/her patient. A deeper insight into the principles of holistic treatment and a thorough understanding of our fellow human beings are making it work even better. Holistic medicine is not a miracle cure, but rather a means by which the empathic physician can support the patient in improving his/her future life in respect to quality of life, health, and functional capacity--through coaching the patient to work on him/herself in a hard and disciplined manner. When the patient is young, this work is so much easier. During our lifetime, we have several emotional traumas arranged in the subconscious mind with the smallest at the top, and it is normal for the person to work on a large number of traumatic events that have been processed to varying degrees. Some traumas have been acknowledged, some are still being explored by the person, and yet others are still preconscious, which can be seen for example in the form of muscle tension. Sometimes the young dysfunctional patient carries severe traumas of a violent or sexual nature, but the physician skilled in the holistic medical toolbox can help the patient on his/her way to an excellent quality of life, full self-expression, a love and sex life, and a realization of his/her talents--all that a young patient is typically dreaming about. Biomedicine is not necessary or even recommended when the physical or mental symptoms are caused by disturbances in the personal

  5. The Child and Adolescent Psychiatry Trials Network

    ERIC Educational Resources Information Center

    March, John S.; Silva, Susan G.; Compton, Scott; Anthony, Ginger; DeVeaugh-Geiss, Joseph; Califf, Robert; Krishnan, Ranga

    2004-01-01

    Objective: The current generation of clinical trials in pediatric psychiatry often fails to maximize clinical utility for practicing clinicians, thereby diluting its impact. Method: To attain maximum clinical relevance and acceptability, the Child and Adolescent Psychiatry Trials Network (CAPTN) will transport to pediatric psychiatry the practical…

  6. [Clinical trials with advanced therapy medicinal products].

    PubMed

    Schüssler-Lenz, M; Schneider, C K

    2010-01-01

    For advanced therapies, the same basic principles for assessment apply as for any other biotechnological medicinal product. Nevertheless, the extent of data for quality, safety, and efficacy can be highly specific. Until recently, advanced therapies were not uniformly regulated across Europe, e.g., tissue engineered products were regulated either as medicinal products or medical devices. Thus, for some products no data from clinical studies are available, e.g., for autologous chondrocyte products. The draft guideline on Good Clinical Practice for clinical trials with advanced therapies describes specific additional requirements, e.g., ensuring traceability. Most clinical studies with advanced therapies in Germany are still in early phase I or II trials with highly divergent types of products and clinical indications. The Committee for Advanced Therapies (CAT) at the European Medicines Agency (EMEA) has been established to meet the scientific and regulatory challenges with advanced therapies.

  7. Transitioning adolescents with HIV to adult care: Lessons learned from twelve adolescent medicine clinics

    PubMed Central

    Tanner, Amanda E.; Philbin, Morgan M.; DuVal, Anna; Ellen, Jonathan; Kapogiannis, Bill; Fortenberry, J. Dennis

    2016-01-01

    Purpose To maximize positive health outcomes for youth with HIV as they transition from youth to adult care, clinical staff need strategies and protocols to help youth maintain clinic engagement and medication adherence. Accordingly, this paper describe transition processes across twelve clinics within the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) to provide lessons learned and inform the development of transition protocols to improve health outcomes as youth shift from adolescent to adult HIV care. Design and Methods During a large multi-method Care Initiative program evaluation, three annual visits were completed at each site from 2010–2012 and conducted 174 semi-structured interviews with clinical and program staff (Baseline n=64, Year 1 n=56, Year 2=54). Results The results underscore the value of adhering to recent American Academy of Pediatrics (AAP) transition recommendations, including: developing formal transition protocols, preparing youth for transition, facilitating youth’s connection to the adult clinic, and identifying necessary strategies for transition evaluation. Conclusions Transitioning youth with HIV involves targeting individual-, provider-, and system-level factors. Acknowledging and addressing key barriers is essential for developing streamlined, comprehensive, and context-specific transition protocols. Practice Implications Adolescent and adult clinic involvement in transition is essential to reduce service fragmentation, provide coordinated and continuous care, and support individual and community level health. PMID:27133767

  8. Complementary and Alternative Medicine Cancer Clinical Trials

    MedlinePlus

    ... patients. Currently, what cancer clinical trials are the NCI and medical community sponsoring involving CAM modalities? Cancer CAM clinical trials are listed in NCI’s PDQ ® (Physician Data Query) computer database of clinical ...

  9. Music therapy and music medicine for children and adolescents.

    PubMed

    Yinger, Olivia Swedberg; Gooding, Lori

    2014-07-01

    This article summarizes the research on music therapy and music medicine for children and adolescents with diagnoses commonly treated by psychiatrists. Music therapy and music medicine are defined, effects of music on the brain are described, and music therapy research in psychiatric treatment is discussed. Music therapy research with specific child/adolescent populations is summarized, including disorders usually diagnosed in childhood, substance abuse, mood/anxiety disorders, and eating disorders. Clinical implications are listed, including suggestions for health care professionals seeking to use music medicine techniques. Strengths and weaknesses of music therapy treatment are discussed, as well as areas for future research.

  10. Music therapy and music medicine for children and adolescents.

    PubMed

    Yinger, Olivia Swedberg; Gooding, Lori

    2014-07-01

    This article summarizes the research on music therapy and music medicine for children and adolescents with diagnoses commonly treated by psychiatrists. Music therapy and music medicine are defined, effects of music on the brain are described, and music therapy research in psychiatric treatment is discussed. Music therapy research with specific child/adolescent populations is summarized, including disorders usually diagnosed in childhood, substance abuse, mood/anxiety disorders, and eating disorders. Clinical implications are listed, including suggestions for health care professionals seeking to use music medicine techniques. Strengths and weaknesses of music therapy treatment are discussed, as well as areas for future research. PMID:24975624

  11. Cognitive-Behavioral Psychotherapy for Anxiety and Depressive Disorders in Children and Adolescents: An Evidence-Based Medicine Review

    ERIC Educational Resources Information Center

    Compton, Scott N.; March, John S.; Brent, David; Albano, Anne Marie; Weersing, V. Robin; Curry, John

    2004-01-01

    Objective: To review the literature on the cognitive-behavioral treatment of children and adolescents with anxiety and depressive disorders within the conceptual framework of evidence-based medicine. Method: The psychiatric and psychological literature was systematically searched for controlled trials applying cognitive-behavioral treatment to…

  12. Herbal medicine, randomised controlled trials and global core competencies.

    PubMed

    Siegfried, Nandi Louise; Hughes, Gail

    2012-12-01

    Despite widespread use, few empirical data on the efficacy of traditional medicine are available. We conducted systematic reviews of eight widely used African medicines and identified only one plant, Pelargonium sidoides, which has been extensively studied (including in a Cochrane systematic review). To address the need for rigorous science to underpin traditional medicine claims, the South African Herbal Science and Medicine Institute at the University of Western Cape launched the Multi-disciplinary University Traditional Health Initiative (MUTHI) in 2011. The European Union-funded initiative aims to build sustainable research capacity on plants for better public health in Africa. A 2011 needs analysis of clinicians and scientists from 14 African countries confirmed a lack of clinical trial methodology, knowledge and experience. In response, MUTHI deliverables include annual clinical trial methodology workshops in host countries and development of e-learning modules. The initiative provides a unique opportunity for developing African capacity to discover new medicinal products. PMID:23498035

  13. Evaluation of an Intervention among Adolescents to Reduce Preventive Misconception in HIV Vaccine Clinical Trials

    PubMed Central

    Lally, Michelle; Goldsworthy, Richard; Sarr, Moussa; Kahn, Jessica; Brown, Larry; Peralta, Ligia; Zimet, Greg

    2014-01-01

    Purpose Placebo and randomization are important concepts that must be understood before youth can safely participate in HIV vaccine studies or other biomedical trials for HIV prevention. These concepts are central to the phenomenon of preventive misconception which may be associated with an increase in risk behavior among study participants related to mistaken beliefs. Persuasive messaging, traditionally used in the field of marketing, could enhance educational efforts associated with randomized clinical trials. Methods Two educational brochures were designed to increase knowledge about HIV vaccine clinical trials via 1 and 2-sided persuasive messaging. Through the Adolescent Medicine Trials Network, 120 youth were enrolled, administered a mock HIV vaccine trial consent, and then randomized to receive either no supplemental information or one of the two brochures. Results The 2-sided brochure group in which common clinical trial misconceptions were acknowledgedand then refuted had significantly higher scores on knowledge of randomization and interpretation of side effects than the consent-only control group, and willingness to participate in an HIV vaccine trial was not decreased with the use of this brochure. Conclusion Two sided persuasive messaging improves understanding of the concepts of randomization and placebo among youth who would consider participating in an HIV vaccine trial. Further evaluation of this approach should be considered for at-risk youth participating in an actual trial of a biomedical intervention for HIV prevention. PMID:24613097

  14. CATCH: Child and Adolescent Trial for Cardiovascular Health. [Multimedia.

    ERIC Educational Resources Information Center

    National Heart, Lung, and Blood Inst. (DHHS/NIH), Bethesda, MD.

    The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health has launched an initiative called the Cardiovascular Health Promotion Project to teach heart-healthy habits to children. One of the programs developed by this initiative, CATCH, the Child and Adolescent Trial for Cardiovascular Health, is the largest…

  15. Nuclear Medicine in Thyroid Diseases in Pediatric and Adolescent Patients

    PubMed Central

    Volkan-Salancı, Bilge; Özgen Kıratlı, Pınar

    2015-01-01

    Both benign and malignant diseases of the thyroid are rare in the pediatric and adolescent population, except congenital hypothyroidism. Nuclear medicine plays a major role, both in the diagnosis and therapy of thyroid pathologies. Use of radioactivity in pediatric population is strictly controlled due to possible side effects such as secondary cancers; therefore, management of pediatric patients requires detailed literature knowledge. This article aims to overview current algorithms in the management of thyroid diseases and use of radionuclide therapy in pediatric and adolescent population. PMID:26316469

  16. Overview of integrative medicine in child and adolescent psychiatry.

    PubMed

    Simkin, Deborah R; Popper, Charles W

    2013-07-01

    Complementary and alternative medicine (CAM) defies simple definition, because the distinction between CAM and conventional medicine is largely arbitrary and fluid. Despite inconclusive data on the efficacy and safety of many CAM treatments in child and adolescent psychiatry, there are enough data on certain treatments to provide guidance to clinicians and researchers. CAM treatments, as adjunctive therapy or monotherapy, can be clinically beneficial and sensible. The low stigma and cost-competitiveness of many CAM psychiatric treatments are highly attractive to children and parents. Physicians need to be knowledgeable about CAM treatments to provide clinically valid informed consent for some conventional treatments.

  17. The placebo effect and randomized trials: analysis of alternative medicine.

    PubMed

    Moyad, Mark A

    2002-02-01

    Randomized controlled trials are generally regarded as the gold standard of study designs to determine causality. The inclusion of a placebo group in these trials, when appropriate, is critical to access the efficacy of a drug or supplement. The placebo response itself has received some attention in the medical literature over the past fifty years. The recent increasing utilization of dietary supplements and herbal medications by patients makes it imperative to reevaluate the placebo response in conventional and alternative medicine. This article will review some of the negative and positive results from randomized trials utilizing dietary supplements (androstenedione, beta-carotene, CoQ10, garlic, soy, vitamin C and E...) for a number of non-urologic and urologic conditions, including cancer. PMID:12109341

  18. Risk of discontinuation of Advanced Therapy Medicinal Products clinical trials

    PubMed Central

    Hanna, Eve; Rémuzat, Cecile; Auquier, Pascal; Toumi, Mondher

    2016-01-01

    Objective Advanced therapy medicinal products (ATMPs) constitute a class of innovative products that encompasses gene therapy, somatic cell therapy, and tissue-engineered products (TEP). There is an increased investment of commercial and non-commercial sponsors in this field and a growing number of ATMPs randomized clinical trials (RCT) and patients enrolled in such trials. RCT generate data to prove the efficacy of a new therapy, but the discontinuation of RCTs wastes scarce resources. Our objective is to identify the number and characteristics of discontinued ATMPs trials in order to evaluate the rate of discontinuation. Methods We searched for ATMPs trials conducted between 1999 to June 2015 using three databases, which are Clinicaltrials.gov, the International Clinical Trials Registry Platform (ICTRP), and the EU Drug Regulating Authorities Clinical Trials (EudraCT). We selected the ATMPs trials after elimination of the duplicates. We identified the disease areas and the sponsors as commercial or non-commercial organizations. We classified ATMPs by type and trial status, that is, ongoing, completed, terminated, discontinued, and prematurely ended. Then, we calculated the rate of discontinuation. Results Between 1999 and June 2015, 143 withdrawn, terminated, or prematurely ended ATMPs clinical trials were identified. Between 1999 and June 2013, 474 ongoing and completed clinical trials were identified. Therefore, the rate of discontinuation of ATMPs trials is 23.18%, similar to that for non-ATMPs drugs in development. The probability of discontinuation is, respectively, 27.35, 16.28, and 16.34% for cell therapies, gene therapies, and TEP. The highest discontinuation rate is for oncology (43%), followed by cardiology (19.2%). It is almost the same for commercial and non-commercial sponsors; therefore, the discontinuation reason may not be financially driven. Conclusion No failure risk rate per development phase is available for ATMPs. The discontinuation rate may

  19. Migraine therapeutics in adolescents: a systematic analysis and historic perspectives of triptan trials in adolescents.

    PubMed

    Sun, Haihao; Bastings, Eric; Temeck, Jean; Smith, P Brian; Men, Angela; Tandon, Veneeta; Murphy, Dianne; Rodriguez, William

    2013-03-01

    OBJECTIVES To conduct a systematic review and analysis of trial data submitted to the US Food and Drug Administration (FDA) to identify possible causes for the failure of pediatric trials of triptans for treatment of migraines. DATA SOURCE The FDA website for drug information and published literature. STUDY SELECTION All pediatric efficacy and pharmacokinetics trial data of drugs used for abortive treatment of migraine submitted to the FDA from January 1, 1999, through December 31, 2011. MAIN OUTCOME MEASURES Patient demographic baseline characteristics, inclusion and exclusion criteria, trial designs, efficacy end points, and pharmacokinetic profiles were analyzed and compared across drug products. RESULTS We analyzed data for sumatriptan succinate nasal spray and zolmitriptan, eletriptan hydrobromide, almotriptan malate, and rizatriptan benzoate tablets. Seven efficacy trials had a randomized, double-blinded, placebo-controlled, parallel-group trial design. In 4 trials, patients were required to have a history of migraine attacks lasting at least 4 hours. High response rates for placebo were observed in all trials, with pain relief at 2 hours ranging from 53% to 57.5%. Nonrandomization of patients with an early placebo response design was used in the rizatriptan trial in 2011. Compared with the rizatriptan trial conducted in 1999, the 2011 rizatriptan trial reduced the placebo response rate by 6% for headache freedom at the 2-hour posttreatment end point owing to study design. The pharmacokinetic profiles between adolescents and adults were statistically similar. CONCLUSIONS High placebo response rates are consistent across all trials and may represent the principal challenge in pediatric trials of drugs for abortive treatment of migraine. Enrichment with selection of subjects with long-lasting migraine attacks is not sufficient to overcome high placebo response rates. Another enrichment strategy, the nonrandomization of patients with an early placebo response

  20. Migraine therapeutics in adolescents: a systematic analysis and historic perspectives of triptan trials in adolescents.

    PubMed

    Sun, Haihao; Bastings, Eric; Temeck, Jean; Smith, P Brian; Men, Angela; Tandon, Veneeta; Murphy, Dianne; Rodriguez, William

    2013-03-01

    OBJECTIVES To conduct a systematic review and analysis of trial data submitted to the US Food and Drug Administration (FDA) to identify possible causes for the failure of pediatric trials of triptans for treatment of migraines. DATA SOURCE The FDA website for drug information and published literature. STUDY SELECTION All pediatric efficacy and pharmacokinetics trial data of drugs used for abortive treatment of migraine submitted to the FDA from January 1, 1999, through December 31, 2011. MAIN OUTCOME MEASURES Patient demographic baseline characteristics, inclusion and exclusion criteria, trial designs, efficacy end points, and pharmacokinetic profiles were analyzed and compared across drug products. RESULTS We analyzed data for sumatriptan succinate nasal spray and zolmitriptan, eletriptan hydrobromide, almotriptan malate, and rizatriptan benzoate tablets. Seven efficacy trials had a randomized, double-blinded, placebo-controlled, parallel-group trial design. In 4 trials, patients were required to have a history of migraine attacks lasting at least 4 hours. High response rates for placebo were observed in all trials, with pain relief at 2 hours ranging from 53% to 57.5%. Nonrandomization of patients with an early placebo response design was used in the rizatriptan trial in 2011. Compared with the rizatriptan trial conducted in 1999, the 2011 rizatriptan trial reduced the placebo response rate by 6% for headache freedom at the 2-hour posttreatment end point owing to study design. The pharmacokinetic profiles between adolescents and adults were statistically similar. CONCLUSIONS High placebo response rates are consistent across all trials and may represent the principal challenge in pediatric trials of drugs for abortive treatment of migraine. Enrichment with selection of subjects with long-lasting migraine attacks is not sufficient to overcome high placebo response rates. Another enrichment strategy, the nonrandomization of patients with an early placebo response

  1. Evidence-based medicine: the design and interpretation of noninferiority clinical trials in veterinary medicine.

    PubMed

    Freise, K J; Lin, T-L; Fan, T M; Recta, V; Clark, T P

    2013-01-01

    Noninferiority trials are clinical studies designed to demonstrate that an investigational drug is at least as effective as an established treatment within a predetermined margin. They are conducted, in part, because of ethical concerns of administering a placebo to veterinary patients when an established effective treatment exists. The use of noninferiority trial designs has become more common in veterinary medicine with the increasing number of established veterinary therapeutics and the desire to eliminate potential pain or distress in a placebo-controlled study. Selecting the appropriate active control and an a priori noninferiority margin between the investigational and active control drug are unique and critical design factors for noninferiority studies. Without reliable historical knowledge of the disease response in the absence of treatment and of the response to the selected active control drug, proper design and interpretation of a noninferiority trial is not possible. Despite the appeal of conducting noninferiority trials to eliminate ethical concerns of placebo-controlled studies, there are real limitations and possible ethical conundrums associated with noninferiority trials. The consequences of incorrect study conclusions because of poor noninferiority trial design need careful attention. Alternative trial designs to typical noninferiority studies exist, but these too have limitations and must also be carefully considered.

  2. Proceedings: Persepectives on adolescent medicine: concepts and program design.

    PubMed

    Cohen, M I; Litt, R F; Schonberg, S K; Sheehy, A J; Daum, F; Hein, K

    1975-01-01

    The concepts and goals of a program in adolescent medicine should include development of a capability to focus on current health needs of youth in a variety of settings; to plan clinical services to meet those needs with the flexibility necessary to respond to changing future requirements; and to deliver service within such a context while simulataneously creating a milieu conducive to education and investigation into the very process and definition of adolescence. The Division of Adolescent Medicine at Montefiore Hospital and Medical Center was designed 7 years ago to fulfill these goals and consequently may serve others as a functional model for health care delivery to teenagers. The Division is comprised of: (1) a 37 bed in-patient unit; (2) a hospital-based ambulatory program including general diagnostic and follow-up services, as well as a speciality service capability in the areas of gynecology and family planning, cardiology, gastroenterology and nutrition; (3) primary care health services within teenage dentention and prison facilities; (4) addictive disease diagnostic and treatment programs; (5) school health programs from intermediate school through college levels, and (6) the division also performs supportive and consultative functions for a variety of community-based agencies. Within the programatic design approximately 70,000 adolescents have been served. The cornerstone of the educational and investigative efforts has been the concept that all the above six functional units are clinical laboratories and classrooms so that training and research activities are integral parts of each of the service areas. This program design is continually undergoing revision and refinement so as to remain ever-responsive to new and emerging problems to meet additional training demands and, most importantly, to permit and encourage creativity and growth patients and staff.

  3. Proceedings: Persepectives on adolescent medicine: concepts and program design.

    PubMed

    Cohen, M I; Litt, R F; Schonberg, S K; Sheehy, A J; Daum, F; Hein, K

    1975-01-01

    The concepts and goals of a program in adolescent medicine should include development of a capability to focus on current health needs of youth in a variety of settings; to plan clinical services to meet those needs with the flexibility necessary to respond to changing future requirements; and to deliver service within such a context while simulataneously creating a milieu conducive to education and investigation into the very process and definition of adolescence. The Division of Adolescent Medicine at Montefiore Hospital and Medical Center was designed 7 years ago to fulfill these goals and consequently may serve others as a functional model for health care delivery to teenagers. The Division is comprised of: (1) a 37 bed in-patient unit; (2) a hospital-based ambulatory program including general diagnostic and follow-up services, as well as a speciality service capability in the areas of gynecology and family planning, cardiology, gastroenterology and nutrition; (3) primary care health services within teenage dentention and prison facilities; (4) addictive disease diagnostic and treatment programs; (5) school health programs from intermediate school through college levels, and (6) the division also performs supportive and consultative functions for a variety of community-based agencies. Within the programatic design approximately 70,000 adolescents have been served. The cornerstone of the educational and investigative efforts has been the concept that all the above six functional units are clinical laboratories and classrooms so that training and research activities are integral parts of each of the service areas. This program design is continually undergoing revision and refinement so as to remain ever-responsive to new and emerging problems to meet additional training demands and, most importantly, to permit and encourage creativity and growth patients and staff. PMID:1065206

  4. Nuclear Medicine in Pediatric and Adolescent Tumors.

    PubMed

    Kiratli, Pınar Özgen; Tuncel, Murat; Bar-Sever, Zvi

    2016-07-01

    Nuclear medicine has an important role in the management of many cancers in pediatric age group with multiple imaging modalities and radiopharmaceuticals targeting various biological uptake mechanisms. 18-Flourodeoxyglucose is the radiotracer of choice especially in patients with sarcoma and lymphoma. (18)FDG-PET, for sarcoma and lymphomas, is proved to be superior to conventional imaging in staging and therapy response. Although studies are limited in pediatric population, (18)FDG-PET/CT has found its way through international guidelines. Limitations and strengths of PET imaging must be noticed before adapting PET imaging in clinical protocols. Established new response criteria using multiple parameters derived from (18)FDG-PET would increase the accuracy and repeatability of response evaluation. Current data suggest that I-123 metaiodobenzylguanidine (MIBG) remains the tracer of choice in the evaluation of neuroblastoma (NB) because of its high sensitivity, specificity, diagnostic accuracy, and prognostic value. It is valuable in determining the response to therapy, surveillance for disease recurrence, and in selecting patients for I-131 therapy. SPECT/CT improves the diagnostic accuracy and the interpretation confidence of MIBG scans. (18)FDG-PET/CT is an important complementary to MIBG imaging despite its lack of specificity to NB. It is valuable in cases of negative or inconclusive MIBG scans and when MIBG findings underestimate the disease status as determined from clinical and radiological findings. F-18 DOPA is promising tracer that reflects catecholamine metabolism and is both sensitive and specific. F-18 DOPA scintigraphy provides the advantages of PET/CT imaging with early and short imaging times, high spatial resolution, inherent morphologic correlation with CT, and quantitation. Regulatory and production issues currently limit the tracer's availability. PET/CT with Ga-68 DOTA appears to be useful in NB imaging and may have a unique role in selecting

  5. Cognitive Behavioral Treatment for Recurrent Binge Eating in Adolescent Girls: A Pilot Trial

    ERIC Educational Resources Information Center

    DeBar, Lynn L.; Wilson, G. Terence; Yarborough, Bobbi Jo; Burns, Beryl; Oyler, Barbara; Hildebrandt, Tom; Clarke, Gregory N.; Dickerson, John; Striegel, Ruth H.

    2013-01-01

    There is a need for treatment interventions to address the high prevalence of disordered eating throughout adolescence and early adulthood. We developed an adolescent-specific manualized CBT protocol to treat female adolescents with recurrent binge eating and tested its efficacy in a small, pilot randomized controlled trial. We present lessons…

  6. Promoting protective factors for young adolescents: ABCD Parenting Young Adolescents Program randomized controlled trial.

    PubMed

    Burke, Kylie; Brennan, Leah; Cann, Warren

    2012-10-01

    This study examined the efficacy of a program for parents of young adolescents combining behavioral family intervention with acceptance-based strategies. 180 parents were randomly allocated to a 6-session group ABCD Parenting Young Adolescent Program or wait-list condition. Completer analysis indicated parents in the intervention reported significantly higher adolescent prosocial behaviors (p = 0.020), lower conduct problems (p = 0.048) and total difficulties (p = 0.041). These parents also reported lower stress associated with adolescent moodiness (p = 0.032), parent life-restriction (p < 0.001), adult-relations (p < 0.001), social isolation (p = 0.012), incompetence/guilt (p < 0.001), lower stress in the parenting domain (p < 0.001) and lower overall stress (p = 0.003) relative to the control condition following the intervention period. No other statistically significant differences were evident (p < 0.05). Results of intention-to-treat analyses were similar. Greater reliable clinically significant change was also achieved for the intervention condition. Participants reported high satisfaction with all elements of the ABCD program. Results suggest the program may assist parents of young adolescents to promote or maintain protective factors in their families. Australian and New Zealand Clinical Trials Registry: ANZCTRN12609000194268. PMID:22677166

  7. The foundations of interdisciplinary fellowship training in adolescent medicine in the United States.

    PubMed

    Bravender, Terrill

    2016-08-01

    The field of adolescent medicine, having developed from the specialty of Pediatrics, encompasses a holistic and developmental approach from its very origin. While its foundations were in medicine, early leaders in the field emphasized the importance of mental health care as well as nutrition, public health, and social justice. As the specialty became further established in the US with the creation of an academic society, board certification and training program accreditation, the interdisciplinary nature of adolescent medicine practice and training became formalized. This formal recognition brought with it strict guidelines with regards training and board certification. Despite the often Byzantinian training requirements, an interdisciplinary approach forms the core of adolescent medicine practice, and the incorporation of interdisciplinary training is a necessity for graduate medical education programs in the field of adolescent medicine.

  8. Clinical trials with herbal medicinal products in children: a literature analysis.

    PubMed

    Marquardt, Peter; Kaft, Karin; Nieber, Karen

    2015-06-01

    Herbal medicinal products have been used since several decades for the health care of children. Nevertheless, well-controlled clinical studies with herbal medicinal products for children are rare. The authors' objective therefore was to evaluate clinical trials with herbal medicinal products in children, based on a literature search in PubMed and Web of Science. A total of 133 trials were identified. 90 studies were randomized, 32.2% were randomized and double-blinded. Most studies were performed in China, in the age group 6-12 years, and in children with respiratory diseases, most often herbal medicinal products with Hedera helix were tested. The analysis revealed that studies on herbal medicinal products were feasible in children. Although clinical trials have been found, this literature search have limitations and did not cover all studies performed. However, only few clinical trials of high quality were identified. Further studies therefore are urgently needed to support the good empirical findings. PMID:26183729

  9. Herbal Medicines for Treating Metabolic Syndrome: A Systematic Review of Randomized Controlled Trials.

    PubMed

    Jang, Soobin; Jang, Bo-Hyoung; Ko, Youme; Sasaki, Yui; Park, Jeong-Su; Hwang, Eui-Hyoung; Song, Yun-Kyung; Shin, Yong-Cheol; Ko, Seong-Gyu

    2016-01-01

    Objective. The aim of this systematic review is to evaluate the efficacy and safety of herbal medicines in the management of metabolic syndrome. Materials and Methods. On December 9, 2015, we searched PubMed, EMBASE, Cochrane Library, SCOPUS, AMED, CNKI, KoreaMed, KMBASE, OASIS, and J-STAGE with no restriction on language or published year. We selected randomized controlled trials that involved patients with metabolic syndrome being treated with herbal medicines as intervention. The main keywords were "Chinese herbal medicines", "metabolic syndrome", and "randomized controlled trials". Herbal substances which were not based on East Asian medical theory, combination therapy with western medicines, and concurrent diseases other than metabolic syndrome were excluded. The risk of bias was assessed by Cochrane's "Risk of Bias" tool. The protocol or review was registered in PROSPERO (an international prospective register of systematic reviews) (CRD42014006842). Results. From 1,098 articles, 12 RCTs were included in this review: five trials studied herbal medicines versus a placebo or no treatment, and seven trials studied herbal medicines versus western medicines. Herbal medicines were effective on decreasing waist circumference, blood glucose, blood lipids, and blood pressure. Conclusion. This study suggests the possibility that herbal medicines can be complementary and alternative medicines for metabolic syndrome. PMID:27413388

  10. [Insist on the nature of evidence-based medicine for the development of glaucoma clinical trial].

    PubMed

    Ge, Jian

    2015-02-01

    Evidence-based medicine (EBM) has markedly promoted the development of ophthalmology.Glaucoma clinical trials have been developed rapidly. Clinical trial papers have been tremendously increasing in the decade, but unhealthy tendency deviating from the nature of EBM---"conscientious, explicit and judicious" has come into notice by the medical society. It is the time to develop patient based medicine, combining with experience-based, experiment-based, ethics-based, economy-based medicine. Only face up to the fundamental problems can we avoid misleading clinicians and provide better health care of affordable, accessible, accountable medical service for patients. This is the intrinsic value of evidence-based medicine.

  11. Chinese herbal medicine for gout: a systematic review of randomized clinical trials.

    PubMed

    Li, Xin-Xue; Han, Mei; Wang, Yu-Yi; Liu, Jian-Ping

    2013-07-01

    Patients with gout referring to Chinese herbal medicine are not rare in China, and a great number of clinical trials on herbal medicine have been published. However, there has not been a systematic review to summarize the evidence of Chinese herbal medicine for gout. The aim of this study is to evaluate the evidence for the effectiveness and safety of Chinese herbal medicine for gout. We searched for randomized clinical trials on Chinese herbal medicine for gout till December 2012. Cochrane risk of bias tool was used to assess the methodological quality. RevMan 5.2 was used to synthesize the results. We included 57 trials involving 4,527 gout patients. The quality of trials was generally poor. No trial reported health-related quality of life in patients. There is not enough evidence showing that herbal medicine was statistically more effective than conventional medications in pain relief [mean difference (MD), -0.03; 95% confidence interval (CI), -0.06, 0.00], but herbal medicine combined with conventional medicines may have better effectiveness (MD, -0.33; 95% CI, -0.59, -0.07). Trials that reported function limitation relief found herbal medicine more effective than conventional medications (MD, -0.23; 95% CI, -0.32, -0.15). There was no evidence showing that herbal medicine prevents gout recurrence better. Twenty-five out of 41 trials, involving 23 different herbal prescriptions, found statistical significance in lowering serum uric acid level, and the overall effect from Chinese herbal medicine in inflammation relief is better than conventional therapies in 19 trials with 17 different prescriptions. The current data show that herbal medicine leads to fewer side reactions compared to conventional therapies [risk ratio (RR), 0.11; 95% CI, 0.08 to 0.15]. Chinese herbal medicine may have clinical effectiveness for functional recovery in patients with gout, and lead to a safe control of serum uric acid level and inflammation severity. Due to low quality of trials

  12. Webcam Delivery of the Camperdown Program for Adolescents Who Stutter: A Phase I Trial

    ERIC Educational Resources Information Center

    Carey, Brenda; O'Brian, Sue; Onslow, Mark; Packman, Ann; Menzies, Ross

    2012-01-01

    Purpose: This Phase I clinical trial explored the viability of webcam Internet delivery of the Camperdown Program for adolescents who stutter. Method and Procedure: Participants were 3 adolescents ages 13, 15, and 16 years, with moderate-severe stuttering. Each was treated with the Camperdown Program delivered by webcam with no clinic attendance.…

  13. Attachment-Based Family Therapy for Adolescents with Suicidal Ideation: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Diamond, Guy S.; Wintersteen, Matthew B.; Brown, Gregory K.; Diamond, Gary M.; Gallop, Robert; Shelef, Karni; Levy, Suzanne

    2010-01-01

    Objective: To evaluate whether Attachment-Based Family Therapy (ABFT) is more effective than Enhanced Usual Care (EUC) for reducing suicidal ideation and depressive symptoms in adolescents. Method: This was a randomized controlled trial of suicidal adolescents between the ages of 12 and 17, identified in primary care and emergency departments. Of…

  14. Webcam Delivery of the Camperdown Program for Adolescents Who Stutter: A Phase II Trial

    ERIC Educational Resources Information Center

    Carey, Brenda; O'Brian, Sue; Lowe, Robyn; Onslow, Mark

    2014-01-01

    Purpose: This Phase II clinical trial examined stuttering adolescents' responsiveness to the Webcam-delivered Camperdown Program. Method: Sixteen adolescents were treated by Webcam with no clinic attendance. Primary outcome was percentage of syllables stuttered (%SS). Secondary outcomes were number of sessions, weeks and hours to maintenance,…

  15. Treatment of Co-Occurring Substance Abuse and Suicidality among Adolescents: A Randomized Trial

    ERIC Educational Resources Information Center

    Esposito-Smythers, Christianne; Spirito, Anthony; Kahler, Christopher W.; Hunt, Jeffrey; Monti, Peter

    2011-01-01

    Objective: This study tested a cognitive-behavioral treatment protocol for adolescents with a co-occurring alcohol or other drug use disorder (AOD) and suicidality in a randomized clinical trial. Method: Forty adolescents (M[subscript age] = 15 years; 68% female, 89% White) and their families recruited from an inpatient psychiatric hospital were…

  16. Randomized Trial of a Broad Preventive Intervention for Mexican American Adolescents

    ERIC Educational Resources Information Center

    Gonzales, Nancy A.; Dumka, Larry E.; Millsap, Roger E.; Gottschall, Amanda; McClain, Darya B.; Wong, Jessie J.; German, Miguelina; Mauricio, Anne M.; Wheeler, Lorey; Carpentier, Francesca D.; Kim, Su Yeong

    2012-01-01

    Objective: This randomized trial of a family-focused preventive intervention for Mexican American (MA) adolescents evaluated intervention effects on adolescent substance use, internalizing and externalizing symptoms, and school discipline and grade records in 8th grade, 1 year after completion of the intervention. The study also examined…

  17. Psychopharmacological Treatment Options for Global Child and Adolescent Mental Health: The WHO Essential Medicines Lists

    ERIC Educational Resources Information Center

    Kutcher, Stan; Murphy, Andrea; Gardner, David

    2008-01-01

    The article examines the World Health Organization's Model List of Essential Medicines (EML) and suggests modification for appropriate psychopharmacological treatment of child- and adolescent-onset mental disorders. The EML enlists few of the psychotropic medicines that are useful for the treatment of young people thereby limiting the…

  18. Motivations and concerns about adolescent tuberculosis vaccine trial participation in rural Uganda: a qualitative study

    PubMed Central

    Buregyeya, Esther; Kulane, Asli; Kiguli, Juliet; Musoke, Phillipa; Mayanja, Harriet; Mitchell, Ellen Maeve Hanlon

    2015-01-01

    Introduction Research is being carried out to develop and test new potentially more effective tuberculosis vaccines. Among the vaccines being developed are those that target adolescents. This study explored the stakeholders’ perceptions about adolescent participation in a hypothetical tuberculosis vaccine trial in Ugandan adolescents. Methods Focus group discussions with adolescents, parents of infants and adolescents, and key informant interviews with community leaders and traditional healers were conducted. Results The majority of the respondents expressed potential willingness to allow their children participate in a tuberculosis vaccine trial. Main motivations for potential participation would be being able to learn about health-related issues. Hesitations included the notion that trial participation would distract the youths from their studies, fear of possible side effects of an investigational product, and potential for being sexually exploited by researchers. In addition, bad experiences from participation in previous research and doubts about the importance of research were mentioned. Suggested ways to motivate participation included: improved clarity on study purpose, risks, benefits and better scheduling of study procedures to minimize disruption to participants’ academic schedules. Conclusion Findings from this study suggest that the community is open to potential participation of adolescents in a tuberculosis vaccine trial. However, there is a need to communicate more effectively with the community about the purpose of the trial and its effects, including safety data, in a low-literacy, readily understood format. This raises a challenge to researchers, who cannot know all the potential effects of a trial product before it is tested. PMID:26834929

  19. [Defining trials of medicinal products according to the revised Dutch Medical Research in Human Subjects Act (WMO)].

    PubMed

    Vos, E J; Huitema, A D R

    2006-09-23

    The revised Dutch Medical Research in Human Subjects Act (WMO), which implements the European directive regarding 'good clinical practice in the conduct of clinical trials on medicinal products for human use' (2001/20/EC), became effective on March 1, 2006. The revision places additional requirements on trials of medicinal products. Whether a trial should be regarded as a trial of a medicinal product is therefore an important question. The law does not provide adequate guidance for the classification of trials in which biological samples are collected, e.g. for genomic, proteomic or pharmacokinetic studies, while a medicinal product is given for a registered indication. Classifying these types of trials as trials of medicinal products does not enhance the safety of the participants. Therefore, these studies should not be considered as trials of medicinal products to avoid the increased administrative burden required by the revised WMO.

  20. Randomised trials in context: practical problems and social aspects of evidence-based medicine and policy.

    PubMed

    Pearce, Warren; Raman, Sujatha; Turner, Andrew

    2015-01-01

    Randomised trials can provide excellent evidence of treatment benefit in medicine. Over the last 50 years, they have been cemented in the regulatory requirements for the approval of new treatments. Randomised trials make up a large and seemingly high-quality proportion of the medical evidence-base. However, it has also been acknowledged that a distorted evidence-base places a severe limitation on the practice of evidence-based medicine (EBM). We describe four important ways in which the evidence from randomised trials is limited or partial: the problem of applying results, the problem of bias in the conduct of randomised trials, the problem of conducting the wrong trials and the problem of conducting the right trials the wrong way. These problems are not intrinsic to the method of randomised trials or the EBM philosophy of evidence; nevertheless, they are genuine problems that undermine the evidence that randomised trials provide for decision-making and therefore undermine EBM in practice. Finally, we discuss the social dimensions of these problems and how they highlight the indispensable role of judgement when generating and using evidence for medicine. This is the paradox of randomised trial evidence: the trials open up expert judgment to scrutiny, but this scrutiny in turn requires further expertise. PMID:26341114

  1. Randomised trials in context: practical problems and social aspects of evidence-based medicine and policy.

    PubMed

    Pearce, Warren; Raman, Sujatha; Turner, Andrew

    2015-09-01

    Randomised trials can provide excellent evidence of treatment benefit in medicine. Over the last 50 years, they have been cemented in the regulatory requirements for the approval of new treatments. Randomised trials make up a large and seemingly high-quality proportion of the medical evidence-base. However, it has also been acknowledged that a distorted evidence-base places a severe limitation on the practice of evidence-based medicine (EBM). We describe four important ways in which the evidence from randomised trials is limited or partial: the problem of applying results, the problem of bias in the conduct of randomised trials, the problem of conducting the wrong trials and the problem of conducting the right trials the wrong way. These problems are not intrinsic to the method of randomised trials or the EBM philosophy of evidence; nevertheless, they are genuine problems that undermine the evidence that randomised trials provide for decision-making and therefore undermine EBM in practice. Finally, we discuss the social dimensions of these problems and how they highlight the indispensable role of judgement when generating and using evidence for medicine. This is the paradox of randomised trial evidence: the trials open up expert judgment to scrutiny, but this scrutiny in turn requires further expertise.

  2. [Features of Clinical Register of Chinese Medicine and Pharmacy Based on ClinicalTrials.gov. (USA)].

    PubMed

    Lu, Peng-fei; Liao, Xing; Xie, Yan-ming; Wang, Zhi-guo

    2015-11-01

    In recent 10 years, clinical trials of Chinese medicine and pharmacy (cMP) at clinicalTrials.gov.(USA) are gradually increasing. In order to analyze features of CMP clinical register, ClinicalTrials.gov register database were comprehensively retrieved in this study. Included clinical trials were input one item after another using EXCEL. A final of 348 CMP clinical trials were included. Results showed that China occupied the first place in CMP clinical register, followed by USA. CMP clinical trials, sponsored mainly by colleges/universities and hospitals, mostly covered interventional studies on evaluating safety/effectiveness of CMP. The proportions of studies, sponsored by mainland China and companies, recruitment trials and multi-center clinical trials in interventional trials were increasing. The proportions of studies sponsored by Hong Kong and Taiwan, research completed trials, unclear research status, phase III clinical trials, and published research trials in interventional trials were decreasing. Published ratios of CMP clinical trials were quite low. There were more missing types and higher proportions in trial register information.

  3. Herbal Medicines for Treating Metabolic Syndrome: A Systematic Review of Randomized Controlled Trials

    PubMed Central

    Ko, Youme; Sasaki, Yui; Hwang, Eui-Hyoung; Song, Yun-Kyung; Shin, Yong-Cheol

    2016-01-01

    Objective. The aim of this systematic review is to evaluate the efficacy and safety of herbal medicines in the management of metabolic syndrome. Materials and Methods. On December 9, 2015, we searched PubMed, EMBASE, Cochrane Library, SCOPUS, AMED, CNKI, KoreaMed, KMBASE, OASIS, and J-STAGE with no restriction on language or published year. We selected randomized controlled trials that involved patients with metabolic syndrome being treated with herbal medicines as intervention. The main keywords were “Chinese herbal medicines”, “metabolic syndrome”, and “randomized controlled trials”. Herbal substances which were not based on East Asian medical theory, combination therapy with western medicines, and concurrent diseases other than metabolic syndrome were excluded. The risk of bias was assessed by Cochrane's “Risk of Bias” tool. The protocol or review was registered in PROSPERO (an international prospective register of systematic reviews) (CRD42014006842). Results. From 1,098 articles, 12 RCTs were included in this review: five trials studied herbal medicines versus a placebo or no treatment, and seven trials studied herbal medicines versus western medicines. Herbal medicines were effective on decreasing waist circumference, blood glucose, blood lipids, and blood pressure. Conclusion. This study suggests the possibility that herbal medicines can be complementary and alternative medicines for metabolic syndrome. PMID:27413388

  4. Randomized Trial of a Broad Preventive Intervention for Mexican American Adolescents

    PubMed Central

    Gonzales, N.A.; Dumka, L.E.; Millsap, R.E.; Gottschall, A.; McClain, D.B.; Wong, J.J.; Germán, M.; Mauricio, A.M.; Wheeler, L.; Carpentier, F.D.; Kim, S.Y.

    2012-01-01

    Objective This randomized trial of a family-focused preventive intervention for Mexican American (MA) adolescents evaluated intervention effects on adolescent substance use, internalizing and externalizing symptoms, and school discipline and grade records in 8th grade, one year after completion of the intervention. The study also examined hypothesized mediators and moderators of intervention effects. Method Stratified by language of program delivery (English vs. Spanish), the trial included a sample of 516 MA adolescents (50.8% female; M =12.3 years, SD=.54) and at least one caregiver that were randomized to receive a low dosage control group workshop or the 9-week group intervention that included parenting, adolescent coping, and conjoint family sessions. Results Positive program effects were found on all five outcomes at one-year posttest, but varied depending on whether adolescents, parents, or teachers reported on the outcome. Intervention effects were mediated by posttest changes in effective parenting, adolescent coping efficacy, adolescent school engagement, and family cohesion. The majority of direct and mediated effects were moderated by language, with a larger number of significant effects for families that participated in Spanish. Intervention effects also were moderated by baseline levels of mediators and outcomes, with the majority showing stronger effects for families with poorer functioning at baseline. Conclusion Findings support the efficacy of the intervention to decrease multiple problem outcomes for MA adolescents, but also demonstrate differential effects for parents and adolescents receiving the intervention in Spanish vs. English, and depending on their baseline levels of functioning. PMID:22103956

  5. Preventing internalizing symptoms among Hispanic adolescents: a synthesis across Familias Unidas trials.

    PubMed

    Perrino, Tatiana; Pantin, Hilda; Prado, Guillermo; Huang, Shi; Brincks, Ahnalee; Howe, George; Beardslee, William; Sandler, Irwin; Brown, C Hendricks

    2014-12-01

    Studies document that there are efficacious interventions to prevent adolescent depression and internalizing symptoms, including several family-focused interventions. Questions remain about for whom interventions work (moderation) and by what mechanisms they work (mediation) to prevent internalizing symptoms. Unfortunately, single trials are often underpowered to address moderation and mediation, an issue addressed in this paper. This synthesis study combined individual-level, longitudinal data from 721 adolescents across 3 randomized clinical trials of Familias Unidas, a family-focused prevention intervention for Hispanic youth. Using integrative data analysis (IDA) methods applied to trials, the study examined intervention moderation and mediation effects on internalizing symptoms. Baseline internalizing symptoms were a significant moderator of the intervention's effects on internalizing symptoms, while baseline externalizing symptoms did not moderate intervention effects. Baseline parent-adolescent communication, a modifiable risk factor and hypothesized mechanism by which the intervention works, significantly moderated the intervention's effects. Specifically, the intervention was more efficacious in its impact on internalizing symptoms for youth with lower initial levels of parent-adolescent communication compared to those with higher communication levels. Moderated mediation analyses showed that parent-adolescent communication changes mediated the intervention's effects on internalizing symptoms, with stronger effects for those with poorer baseline communication. Results suggest a potential benefit of identifying youth risks prior to interventions, and targeting specific modifiable mediators that lead to reductions of internalizing problems of adolescents. Findings also highlight advantages of utilizing data from combined trials and IDA for examining intervention moderators and mediators.

  6. Regulation of Clinical Trials with Advanced Therapy Medicinal Products in Germany.

    PubMed

    Renner, Matthias; Anliker, Brigitte; Sanzenbacher, Ralf; Schuele, Silke

    2015-01-01

    In the European Union, clinical trials for Advanced Therapy Medicinal Products are regulated at the national level, in contrast to the situation for a Marketing Authorisation Application, in which a centralised procedure is foreseen for these medicinal products. Although based on a common understanding regarding the regulatory requirement to be fulfilled before conduct of a clinical trial with an Advanced Therapy Investigational Medicinal Product, the procedures and partly the scientific requirements for approval of a clinical trial application differ between the European Union Member States. This chapter will thus give an overview about the path to be followed for a clinical trial application and the subsequent approval process for an Advanced Therapy Investigational Medicinal Product in Germany and will describe the role of the stakeholders that are involved. In addition, important aspects of manufacturing, quality control and non-clinical testing of Advanced Therapy Medicinal Products in the clinical development phase are discussed. Finally, current and future approaches for harmonisation of clinical trial authorisation between European Union Member States are summarised.

  7. Adolescent and young adult medicine is a special and specific area of medical practice.

    PubMed

    Steinbeck, Kate; Towns, Susan; Bennett, David

    2014-06-01

    Adolescent and young adult medicine is a concept that has gained traction in the last decade or so. The medical literature has come primarily from oncology. Advances in neuroscience that document continuing brain development into the third decade, and research that shows risk behaviours associated with adolescence both remain and may increase in the third decade, have been two of the drivers in the conversation around linking these two age groups together as a medical practice group. A third driver of importance is transition care in chronic illness, where older adolescents and young adults continue to have difficulties making effective linkages with adult care. The case for specific training in adolescent and young adult medicine, including the developmental concepts behind it, the benefits of the delineation and the particular challenges in the Australian health-care system, are discussed. On balance, there is a strong case for managing the health issues of adolescents and young adults together. This scenario does not fit easily with the age demarcations that are in place in acute care facilities. However, this is less the case in community services and can work in focused private practice. Such a situation suggests that both paediatric and adult physicians might be interested in adolescent and young adult medicine training and practice.

  8. An Open Trial of Acceptance-based Separated Family Treatment (ASFT) for Adolescents with Anorexia Nervosa

    PubMed Central

    Timko, C. Alix; Zucker, Nancy L.; Herbert, James D.; Rodriguez, Daniel; Merwin, Rhonda M.

    2016-01-01

    Family based-treatments have the most empirical support in the treatment of adolescent anorexia nervosa; yet, a significant percentage of adolescents and their families do not respond to manualized family based treatment (FBT). The aim of this open trial was to conduct a preliminary evaluation of an innovative family-based approach to the treatment of anorexia: Acceptance-based Separated Family Treatment (ASFT). Treatment was grounded in Acceptance and Commitment Therapy (ACT), delivered in a separated format, and included an ACT-informed skills program. Adolescents (ages 12–18) with anorexia or sub-threshold anorexia and their families received 20 treatment sessions over 24 weeks. Outcome indices included eating disorder symptomatology reported by the parent and adolescent, percentage of expected body weight achieved, and changes in psychological acceptance/avoidance. Half of the adolescents (48.0%) met criteria for full remission at the end of treatment, 29.8% met criteria for partial remission, and 21.3% did not improve. Overall, adolescents had a significant reduction in eating disorder symptoms and reached expected body weight. Treatment resulted in changes in psychological acceptance in the expected direction for both parents and adolescents. This open trial provides preliminary evidence for the feasibility, acceptability, and efficacy of ASFT for adolescents with anorexia. Directions for future research are discussed. PMID:25898341

  9. Stem cell trials for cardiovascular medicine: ethical rationale.

    PubMed

    Niemansburg, Sophie L; Teraa, Martin; Hesam, Husna; van Delden, Johannes J M; Verhaar, Marianne C; Bredenoord, Annelien L

    2014-10-01

    Stem cell-based interventions provide new treatment prospects for many disease conditions, including cardiovascular disorders. Clinical trials are necessary to collect adequate evidence on (long-term) safety and efficacy of novel interventions such as stem cells, but the design and launch of clinical trials, from first-in-human studies to larger randomized controlled trials (RCTs), is scientifically and ethically challenging. Stem cells are different from traditional pharmaceuticals, surgical procedures, and medical devices in the following ways: the novelty and complexity of stem cells, the invasiveness of the procedures, and the novel aim of regeneration. These specifics, combined with the characteristics of the study population, will have an impact on the design and ethics of RCTs. The recently closed JUVENTAS trial will serve as an example to identify the (interwoven) scientific and ethical challenges in the design and launch of stem cell RCTs. The JUVENTAS trial has investigated the efficacy of autologous bone marrow cells in end-stage vascular patients, in a double-blind sham-controlled design. We first describe the choices, considerations, and experiences of the JUVENTAS team. Subsequently, we identify the main ethical and scientific challenges and discuss what is important to consider in the design of future stem cell RCTs: assessment of risks and benefits, the choice for outcome measures, the choice for the comparator, the appropriate selection of participants, and adequate informed consent. Additionally, the stem cell field is highly in the spotlight due to the (commercial) interests and expectations. This warrants a cautious pace of translation and scrupulous set up of clinical trials, as failures could put the field in a negative light. At the same time, knowledge from clinical trials is necessary for the field to progress. We conclude that in the scientifically and ethically challenging field of stem cell RCTs, researchers and clinicians have to

  10. Use of herbal medicinal products among children and adolescents in Germany

    PubMed Central

    2014-01-01

    Background Germany is a country with a high use of herbal medicinal products. Population-based data on the use of herbal medicinal products among children are lacking. The aim of this study is to investigate the prevalence, patterns and determinants of herbal medicine use among children and adolescents in Germany. Methods As data base served the German Health Interview and Examination Survey for Children and Adolescents (KiGGS), a representative population based survey conducted 2003–2006 by the Robert Koch Institute. 17,450 boys and girls aged 0–17 years provided information on drug use in the preceding seven days. Herbal medicinal products were defined according to the European and German drug laws. SPSS Complex Sample method was used to estimate prevalence rates and factors associated with herbal medicine use. Results The prevalence rate of herbal medicinal product use amounts to 5.8% (95% confidence interval 5.3-6.3%). Use of herbal medicine declines along with increasing age and shows no difference between boys and girls in younger age groups. Teenage girls are more likely to use herbal medicines than teenage boys. Two thirds of herbal medicines are used for the treatment of coughs and colds; nearly half of herbal medicines are prescribed by medical doctors. Determinants of herbal medicinal product use are younger age, residing in South Germany, having a poor health status, having no immigration background and coming from a higher social class family. Children’s and parents-related health behavior is not found to be associated with herbal medicine use after adjusting for social class. Conclusions Use of herbal medicinal products among children and adolescents between the ages of 0 and 17 years in Germany is widely spread and shows relatively higher rates compared to international data. This study provides a reference on the use of herbal medicinal products for policy-makers, health professionals and parents. Further studies are needed to investigate the

  11. The Goal Wheel: Adapting Navajo Philosophy and the Medicine Wheel to Work with Adolescents

    ERIC Educational Resources Information Center

    Garner, Holly; Bruce, Mary Alice; Stellern, John

    2011-01-01

    The purpose of this article is to describe a group counseling model that is based on the indigenous medicine wheel as well as Navajo philosophy by which to help troubled adolescents restore harmony and balance in their lives, through establishing goals and sequential steps to accomplish these goals. The authors call this model the Goal Wheel. A…

  12. Attitudes and Practices of Complementary and Alternative Medicine Among Adolescents in Saudi Arabia

    PubMed Central

    Musaiger, Abdulrahman O.; Abahussain, Nada A.

    2015-01-01

    The aim of this study was to investigate the attitudes and use of complementary and alternative medicine (CAM) among Saudi Arabian adolescents. A multistage stratified sampling method was used to select 736 adolescents (358 males, 378 females) aged 15–19 years from secondary schools. The study was carried out in Al-Khobar city, Eastern region of Saudi Arabia. The findings revealed that the use of CAM by adolescents in their lifetime ranged from 1.6% for acupuncture to 58.6% for honey treatment, with significant differences between genders, except in the use of dietary supplements, black cumin, and acupuncture therapies. Females were more likely to use CAM for treating abdominal pains, cold and flu, and cough than males (P < 0.000). Family members and friends (67.7%) were the main source of CAM usage, followed by television (10%), and Internet (8%). Religious and medicinal herb healers were the CAM healers most commonly visited by adolescents. Nearly 21–43% of adolescents had positive attitudes toward CAM, with some significant differences between males and females. It can be concluded that CAM is widely used by Saudi adolescents, but caution should be exercised for the safe usage of some CAM treatments. CAM should not be ignored; however there is an urgent need to establish regulations for CAM usage. PMID:25560362

  13. Chinese Patent Medicine Tongxinluo Capsule for Hypertension: A Systematic Review of Randomised Controlled Trials

    PubMed Central

    Wang, Jie; Xiong, Xingjiang; Liu, Wei

    2014-01-01

    Background. This study was intended to evaluate the efficacy and safety of Tongxinluo capsule for hypertension. Search Strategy. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, The PubMed, EMBASE, Chinese Bio-Medical Literature Database (CBM), Chinese National Knowledge Infrastructure (CNKI), Chinese Scientific Journal Database, and Wan-fang Data started from the first of database to October 28, 2013. No language restriction was applied. We included randomized clinical trials testing Tongxinluo capsule against western medicine, Tongxinluo capsule versus placebo, and Tongxinluo capsule combined with western medicine versus western medicine. Study selection, data extraction, quality assessment, and data analyses were conducted according to the Cochrane standards. Results. 25 trials with 1958 participants were included. The methodological quality of the included trials was evaluated as generally low. The blood pressure (BP) lowering effect of Tongxinluo capsule plus western medicine was significantly higher than that of western medicine (systolic blood pressure (SBP): −3.87, −5.32 to −2.41, P < 0.00001; and diastolic blood pressure (DBP): −2.72, −4.19 to −1.24, P = 0.0003). The BP also decreased significantly from baseline with Tongxinluo capsule than placebo (SBP: −9.40, −10.90 to −7.90, P < 0.00001; and DBP: −11.80, −12.40 to −11.20, P < 0.00001) or western medicine (SBP: −3.90, −4.93 to −2.87, P < 0.00001; and DBP: −3.70, −3.83 to −3.57, P < 0.00001). 12 trials reported adverse events without details. Conclusions. There is some but weak evidence about the effectiveness of TXL in treating patients with hypertension. PMID:24693319

  14. Lung-MAP Launches: First Precision Medicine Trial From National Clinical Trials Network

    Cancer.gov

    A unique public-private collaboration today announced the initiation of the Lung Cancer Master Protocol (Lung-MAP) trial, a multi-drug, multi-arm, biomarker-driven clinical trial for patients with advanced squamous cell lung cancer. Squamous cell carcinom

  15. Dialectical Behavior Therapy for Adolescents with Bipolar Disorder: Results from a Pilot Randomized Trial

    PubMed Central

    Fersch-Podrat, Rachael K.; Rivera, Maribel; Axelson, David A.; Merranko, John; Yu, Haifeng; Brent, David A.; Birmaher, Boris

    2015-01-01

    Abstract Objective: The purpose of this study was to conduct a pilot randomized trial of dialectical behavior therapy (DBT) versus psychosocial treatment as usual (TAU) for adolescents diagnosed with bipolar disorder (BP). Methods: We recruited participants 12–18 years of age with a primary BP diagnosis (I, II, or operationalized not otherwise specified [NOS] criteria) from a pediatric specialty clinic. Eligible patients were assigned using a 2:1 randomization structure to either DBT (n=14) or psychosocial TAU (n=6). All patients received medication management from a study-affiliated psychiatrist. DBT included 36 sessions (18 individual, 18 family skills training) over 1 year. TAU was an eclectic psychotherapy approach consisting of psychoeducational, supportive, and cognitive behavioral techniques. An independent evaluator, blind to treatment condition, assessed outcomes including affective symptoms, suicidal ideation and behavior, nonsuicidal self-injurious behavior, and emotional dysregulation, quarterly over 1 year. Results: Adolescents receiving DBT attended significantly more therapy sessions over 1 year than did adolescents receiving TAU, possibly reflecting greater engagement and retention; both treatments were rated as highly acceptable by adolescents and parents. As compared with adolescents receiving TAU, adolescents receiving DBT demonstrated significantly less severe depressive symptoms over follow-up, and were nearly three times more likely to demonstrate improvement in suicidal ideation. Models indicate a large effect size, for more weeks being euthymic, over follow-up among adolescents receiving DBT. Although there were no between-group differences in manic symptoms or emotional dysregulation with treatment, adolescents receiving DBT, but not those receiving TAU, evidenced improvement from pre- to posttreatment in both manic symptoms and emotional dysregulation. Conclusions: DBT may offer promise as an adjunct to pharmacotherapy in the treatment

  16. Chinese Herbal Medicine for Acute Mountain Sickness: A Systematic Review of Randomized Controlled Trials

    PubMed Central

    Wang, Jie; Xiong, Xingjiang; Xing, Yanwei; Liu, Zhen; Jiang, Wenrui; Huang, Junyi; Feng, Bo

    2013-01-01

    Objectives. We aimed to assess the current clinical evidence of Chinese herbal medicine for AMS. Methods. Seven electronic databases were searched until January 2013. We included randomized clinical trials testing Chinese herbal medicine against placebo, no drugs, Western drugs, or a combination of routine treatment drugs against routine treatment drugs. Study selection, data extraction, quality assessment, and data analyses were conducted according to Cochrane standards. Results. Nine randomized trials were included. The methodological quality of the included trials was evaluated as low. Two trials compared prescriptions of Chinese formula used alone with Western drugs. A meta-analysis showed a beneficial effect in decreasing the score of AMS (MD: −2.23 [−3.98, −0.49], P = 0.01). Only one trial compared prescriptions of Chinese formula used alone with no drugs. A meta-analysis showed a significant beneficial effect in decreasing the score of AMS (MD: −6.00 [−6.45, −5.55], P < 0.00001). Four trials compared Chinese formula used alone with placebo. A meta-analysis also showed a significant beneficial effect in decreasing the score of AMS (MD: −1.10 [−1.64, −0.55], P < 0.0001). Two trials compared the combination of Chinese formula plus routine treatment drugs with routine treatment drugs. A meta-analysis showed a beneficial effect in decreasing the score of AMS (MD: −5.99 [−11.11, −0.86], P = 0.02). Conclusions. No firm conclusion on the effectiveness and safety of Chinese herbal medicine for AMS can be made. More rigorous high-quality trials are required to generate a high level of evidence and to confirm the results. PMID:24454510

  17. Mindfulness-Based Stress Reduction for the Treatment of Adolescent Psychiatric Outpatients: A Randomized Clinical Trial

    ERIC Educational Resources Information Center

    Biegel, Gina M.; Brown, Kirk Warren; Shapiro, Shauna L.; Schubert, Christine M.

    2009-01-01

    Research has shown that mindfulness-based treatment interventions may be effective for a range of mental and physical health disorders in adult populations, but little is known about the effectiveness of such interventions for treating adolescent conditions. The present randomized clinical trial was designed to assess the effect of the…

  18. Escitalopram in the Treatment of Adolescent Depression: A Randomized Placebo-Controlled Multisite Trial

    ERIC Educational Resources Information Center

    Emslie, Graham J.; Ventura, Daniel; Korotzer, Andrew; Tourkodimitris, Stavros

    2009-01-01

    A randomized, double-blind, placebo-controlled trial that involves 312 male and female patients aged 12-17 reveal the effectiveness of escitalopram in the treatment of depressed adolescents. Eighty-three percent of the participants or 259 participants completed the 8 weeks therapy period.

  19. A Pilot Controlled Trial of Topiramate for Mania in Children and Adolescents with Bipolar Disorder.

    ERIC Educational Resources Information Center

    DelBello, Melissa P.; Findling, Robert L.; Kushner, Stuart; Wang, Daniel; Olson, William H.; Capece, Julie A.; Fazzio, Lydia; Rosenthal, Norman R.

    2005-01-01

    Objective: To assess the efficacy of topiramate monotherapy for acute mania in children and adolescents with bipolar disorder type 1. Method: This double-blind, placebo-controlled study was discontinued early when adult mania trials with topiramate failed to show efficacy. Efficacy end points included the Young Mania Rating Scale (YMRS), Brief…

  20. Randomized Trial of Anger Control Training for Adolescents with Tourette's Syndrome and Disruptive Behavior

    ERIC Educational Resources Information Center

    Sukhdolsky, Denis G.; Vitulano, Lawrence A.; Carroll, Deirdre H.; McGuire, Joseph; Leckman, James F.; Scahill, Lawrence

    2009-01-01

    A randomized trial to examine the efficacy of anger control training for treating adolescents with Tourette's syndrome and disruptive behavior reveals that those administered with the anger control training showed a decrease in their Disruptive Behavior Rating Scale score by 52 percent as compared with a decrease of 11 percent in the treatment as…

  1. Recruiting a Diverse Group of Middle School Girls into the Trial of Activity for Adolescent Girls

    ERIC Educational Resources Information Center

    Elder, John P.; Shuler, LaVerne; Moe, Stacey G.; Grieser, Mira; Pratt, Charlotte; Cameron, Sandra; Hingle, Melanie; Pickrel, Julie L.; Saksvig, Brit I.; Schachter, Kenneth; Greer, Susan; Bothwell, Elizabeth K. Guth

    2008-01-01

    Background: School-based study recruitment efforts are both time consuming and challenging. This paper highlights the recruitment strategies employed by the national, multisite Trial of Activity for Adolescent Girls (TAAG), a study designed to measure the effectiveness of an intervention to reduce the decline of physical activity levels among…

  2. A Multisite Psychotherapy and Medication Trial for Depressed Adolescents: Background and Benefits

    ERIC Educational Resources Information Center

    Kratochvil, Christopher J.; Simons, Anne; Vitiello, Benedetto; Walkup, John; Emslie, Graham; Rosenberg, David; March, John S.

    2005-01-01

    The Treatment for Adolescents With Depression Study (TADS) is an NIMH-supported multisite clinical trial that compares the effectiveness of a depression-specific cognitive behavioral therapy (CBT), medication management with fluoxetine (FLX), the combination of CBT and FLX (COMB), and medical management with pill placebo (PBO). TADS was…

  3. The role of Society for Adolescent Health and Medicine in training of health professionals.

    PubMed

    Ford, Carol A

    2016-08-01

    The Society for Adolescent Health and Medicine (SAHM) was created by health professionals committed to identifying and better addressing the health needs of adolescents and young adults, and this work has continued for nearly 50 years. The society initially focused primarily on clinical education, but has evolved to include educational activities providing clinical, research, policy, advocacy, and professional development content. Strategies have included high-quality annual meetings designed to meet the educational needs of its multi-disciplinary membership, publishing an internationally recognized journal, and developing strategic collaborations to advocate for legitimacy of the field and reform in health profession education. Historically, SAHM has been most successful at increasing specialized training in the United States among physicians, and primarily pediatricians, likely driven by the nuances of the development of adolescent medicine in this country. Successes are often linked to strategic collaborations with other professional organizations, and have been facilitated by federally funded initiatives to improve adolescent and young adult health. Recent efforts to improve professional training are focused on the use of technology, and SAHM is also currently exploring strategies to directly reach adolescents, young adults, and their parents. As the society becomes increasingly multidisciplinary and international, members have extraordinary opportunities to learn from each other, build upon lessons learned, and collaborate. Descriptions of the history of SAHM's training-focused efforts, selected highlights, and current priorities will be used to illustrate this long-standing commitment to the training of health professionals.

  4. Curcumin: from ancient medicine to current clinical trials.

    PubMed

    Hatcher, H; Planalp, R; Cho, J; Torti, F M; Torti, S V

    2008-06-01

    Curcumin is the active ingredient in the traditional herbal remedy and dietary spice turmeric (Curcuma longa). Curcumin has a surprisingly wide range of beneficial properties, including anti-inflammatory, antioxidant, chemopreventive and chemotherapeutic activity. The pleiotropic activities of curcumin derive from its complex chemistry as well as its ability to influence multiple signaling pathways, including survival pathways such as those regulated by NF-kappaB, Akt, and growth factors; cytoprotective pathways dependent on Nrf2; and metastatic and angiogenic pathways. Curcumin is a free radical scavenger and hydrogen donor, and exhibits both pro- and antioxidant activity. It also binds metals, particularly iron and copper, and can function as an iron chelator. Curcumin is remarkably non-toxic and exhibits limited bioavailability. Curcumin exhibits great promise as a therapeutic agent, and is currently in human clinical trials for a variety of conditions, including multiple myeloma, pancreatic cancer, myelodysplastic syndromes, colon cancer, psoriasis and Alzheimer's disease.

  5. Adverse environmental exposures in pregnancy: teratology in adolescent medicine practice.

    PubMed

    Seaver, Laurie H

    2002-06-01

    A teratogen is any drug, chemical, infectious or physical agent, or maternal disease or altered metabolic state that causes a structural or functional disability by acting on the embryo or fetus. Teratogens are responsible for approximately 10% of all human birth defects. Education of physicians caring for children and adolescents in the basic principles of teratology, the spectrum of human teratogens, and the recognition of associated anomalies is essential, because many maternal exposures and resultant fetal defects are completely preventable.

  6. Designs and challenges for personalized medicine studies in oncology: focus on the SHIVA trial.

    PubMed

    Le Tourneau, Christophe; Kamal, Maud; Trédan, Olivier; Delord, Jean-Pierre; Campone, Mario; Goncalves, Anthony; Isambert, Nicolas; Conroy, Thierry; Gentien, David; Vincent-Salomon, Anne; Pouliquen, Anne-Lise; Servant, Nicolas; Stern, Marc-Henri; Le Corroller, Anne-Gaëlle; Armanet, Sébastien; Rio Frio, Thomas; Paoletti, Xavier

    2012-12-01

    Personalized medicine is defined by the National Cancer Institute as "a form of medicine that uses information about a person's genes, proteins, and environment to prevent, diagnose, and treat disease." In oncology, the term "personalized medicine" arose with the emergence of molecularly targeted agents. The prescription of approved molecularly targeted agents to cancer patients currently relies on the primary tumor location and histological subtype. Predictive biomarkers of efficacy of these modern agents have been exclusively validated in specific tumor types. A major concern today is to determine whether the prescription of molecularly targeted therapies based on tumor molecular abnormalities, independently of primary tumor location and histology, would improve the outcome of cancer patients. This new paradigm requires prospective validation before being implemented in clinical practice. In this paper, we will first review different designs, including observational cohorts, as well as nonrandomized and randomized clinical trials, that have been recently proposed to evaluate the relevance of this approach, and further discuss their advantages and drawbacks. The design of the SHIVA trial, a randomized proof-of-concept phase II trial comparing therapy based on tumor molecular profiling versus conventional therapy in patients with refractory cancer will be detailed. Finally, we will discuss the multiple challenges associated with the implementation of personalized medicine in oncology, as well as perspectives for the future.

  7. INCANT: a transnational randomized trial of Multidimensional Family Therapy versus treatment as usual for adolescents with cannabis use disorder

    PubMed Central

    2010-01-01

    Background In 2003, the governments of Belgium, France, Germany, the Netherlands and Switzerland agreed that there was a need in Europe for a treatment programme for adolescents with cannabis use disorders and other behavioural problems. Based on an exhaustive literature review of evidence-based treatments and an international experts meeting, Multidimensional Family Therapy (MDFT) was selected for a pilot study first, which was successful, and then for a joint, transnational randomized controlled trial named INCANT (INternational CAnnabis Need for Treatment). Methods/design INCANT is a randomized controlled trial (RCT) with an open-label, parallel group design. This study compares MDFT with treatment as usual (TAU) at and across sites in Brussels, Berlin, Paris, The Hague and Geneva. Assessments are at baseline and at 3, 6, 9 and 12 months after randomization. A minimum of 450 cases in total is required; sites will recruit 60 cases each in Belgium and Switzerland, and a maximum of 120 each in France, Germany and the Netherlands. Eligible for INCANT are adolescents from 13 through 18 years of age with a cannabis use disorder (dependence or abuse), with at least one parent willing to take part in the treatment. Randomization is concealed to, and therefore beyond control by, the researcher/site requesting it. Randomization is stratified as to gender, age and level of cannabis consumption. Assessments focus on substance use; mental function; behavioural problems; and functioning regarding family, school, peers and leisure time. For outcome analyses, the study will use state of the art latent growth curve modelling techniques, including all randomized participants according to the intention-to-treat principle. INCANT has been approved by the appropriate ethical boards in Belgium, France, Germany, the Netherlands, Switzerland, and the University of Miami Miller School of Medicine. INCANT is funded by the (federal) Ministries of Health of Belgium, Germany, the

  8. Promoting Protective Factors for Young Adolescents: ABCD Parenting Young Adolescents Program Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Burke, Kylie; Brennan, Leah; Cann, Warren

    2012-01-01

    This study examined the efficacy of a program for parents of young adolescents combining behavioral family intervention with acceptance-based strategies. 180 parents were randomly allocated to a 6-session group ABCD Parenting Young Adolescent Program or wait-list condition. Completer analysis indicated parents in the intervention reported…

  9. Recommendations for promoting the health and well-being of lesbian, gay, bisexual, and transgender adolescents: a position paper of the Society for Adolescent Health and Medicine.

    PubMed

    2013-04-01

    Adolescent health care providers frequently care for patients who identify as lesbian, gay, bisexual, or transgendered (LGBT), or who may be struggling with or questioning their sexual orientation or gender identity. Whereas these youth have the same health concerns as their non-LGBT peers, LGBT teens may face additional challenges because of the complexity of the coming-out process, as well as societal discrimination and bias against sexual and gender minorities. The Society for Adolescent Health and Medicine encourages adolescent providers and researchers to incorporate the impact of these developmental processes (and understand the impacts of concurrent potential discrimination) when caring for LGBT adolescents. The Society for Adolescent Health and Medicine also encourages providers to help positively influence policy related to LGBT adolescents in schools, the foster care system, and the juvenile justice system, and within the family structure. Consistent with other medical organizations, the Society for Adolescent Health and Medicine rejects the mistaken notion that LGBT orientations are mental disorders, and opposes the use of any type of reparative therapy for LGBT adolescents. PMID:23521897

  10. Recommendations for promoting the health and well-being of lesbian, gay, bisexual, and transgender adolescents: a position paper of the Society for Adolescent Health and Medicine.

    PubMed

    2013-04-01

    Adolescent health care providers frequently care for patients who identify as lesbian, gay, bisexual, or transgendered (LGBT), or who may be struggling with or questioning their sexual orientation or gender identity. Whereas these youth have the same health concerns as their non-LGBT peers, LGBT teens may face additional challenges because of the complexity of the coming-out process, as well as societal discrimination and bias against sexual and gender minorities. The Society for Adolescent Health and Medicine encourages adolescent providers and researchers to incorporate the impact of these developmental processes (and understand the impacts of concurrent potential discrimination) when caring for LGBT adolescents. The Society for Adolescent Health and Medicine also encourages providers to help positively influence policy related to LGBT adolescents in schools, the foster care system, and the juvenile justice system, and within the family structure. Consistent with other medical organizations, the Society for Adolescent Health and Medicine rejects the mistaken notion that LGBT orientations are mental disorders, and opposes the use of any type of reparative therapy for LGBT adolescents.

  11. Indigenous Knowledge of Herbal Medicines among Adolescents in Amassoma, Bayelsa State, Nigeria

    PubMed Central

    Alade, Gideon O.; Okpako, Ese; Ajibesin, Kola’ K.; Omobuwajo, Olanrewaju R.

    2016-01-01

    Background: The use of herbal medicines in Nigeria is on the increase. Documented Population based data on the use of herbal medicinal products and indigenous knowledge among the younger generations are lacking in Nigeria and Africa at large. Aim: The aim of this study is to investigate the extent of use and general knowledge of herbal medicines among adolescents in the Niger Delta Region of Nigeria. Methods: The study covered a total of Two hundred and twenty-eight adolescents randomly selected in Senior Secondary Schools (SSS 1-3) in Amassoma using a semi structured questionnaire/Interview and informal conversation on the respondents. Findings: Nearly all (97%) the respondents have had contact with herbs. Less than 1% had contact with herbs through formal education (teachers/literatures). Stimulation of interest was majorly through parents (53%). Grandparents were the highest (46%) of custodian of indigenous knowledge. Parents were the next (39.7%). Only 39% of the respondents would prefer the use of herbal medicine to modern medicine. Fever was the main ailment mentioned followed by eye ailment and stomach ache. Vernonia amygdalina was the main plant for the treatment of fever. Conclusion: The study revealed that parents are the major custodians of knowledge being transferred to the younger generation and little or none is learnt from Schools. There is therefore the need to include the study of herbal medicines in School’s curricula especially at SS 2 and SS 3 since they are matured enough to appreciate the importance of Herbal medicine so as to prepare them for the promotion of herbal medicine in future and to preserve our indigenous knowledge. PMID:26234964

  12. The n-of-1 clinical trial: the ultimate strategy for individualizing medicine?

    PubMed Central

    Lillie, Elizabeth O; Patay, Bradley; Diamant, Joel; Issell, Brian; Topol, Eric J; Schork, Nicholas J

    2011-01-01

    N-of-1 or single subject clinical trials consider an individual patient as the sole unit of observation in a study investigating the efficacy or side-effect profiles of different interventions. The ultimate goal of an n-of-1 trial is to determine the optimal or best intervention for an individual patient using objective data-driven criteria. Such trials can leverage study design and statistical techniques associated with standard population-based clinical trials, including randomization, washout and crossover periods, as well as placebo controls. Despite their obvious appeal and wide use in educational settings, n-of-1 trials have been used sparingly in medical and general clinical settings. We briefly review the history, motivation and design of n-of-1 trials and emphasize the great utility of modern wireless medical monitoring devices in their execution. We ultimately argue that n-of-1 trials demand serious attention among the health research and clinical care communities given the contemporary focus on individualized medicine. PMID:21695041

  13. Parent-focused treatment for adolescent anorexia nervosa: a study protocol of a randomised controlled trial

    PubMed Central

    2014-01-01

    Background Family-based treatment is an efficacious outpatient intervention for medically stable adolescents with anorexia nervosa. Previous research suggests family-based treatment may be more effective for some families when parents and adolescents attend separate therapy sessions compared to conjoint sessions. Our service developed a novel separated model of family-based treatment, parent-focused treatment, and is undertaking a randomised controlled trial to compare parent-focused treatment to conjoint family-based treatment. Methods/Design This randomised controlled trial will recruit 100 adolescents aged 12–18 years with DSM-IV anorexia nervosa or eating disorder not otherwise specified (anorexia nervosa type). The trial commenced in 2010 and is expected to be completed in 2015. Participants are recruited from the Royal Children’s Hospital Eating Disorders Program, Melbourne, Australia. Following a multidisciplinary intake assessment, eligible families who provide written informed consent are randomly allocated to either parent-focused treatment or conjoint family-based treatment. In parent-focused treatment, the adolescent sees a clinical nurse consultant and the parents see a trained mental health clinician. In conjoint family-based treatment, the whole family attends sessions with the mental health clinician. Both groups receive 18 treatment sessions over 6 months and regular medical monitoring by a paediatrician. The primary outcome is remission at end of treatment and 6 and 12 month follow up, with remission defined as being ≥ 95% expected body weight and having an eating disorder symptom score within one standard deviation of community norms. The secondary outcomes include partial remission and changes in eating pathology, depressive symptoms and self-esteem. Moderating and mediating factors will also be explored. Discussion This will be first randomised controlled trial of a parent-focused model of family-based treatment of adolescent

  14. Olanzapine versus Placebo in Adolescents with Schizophrenia; a 6-Week, Randomized Double-Blind, Placebo-Controlled Trial

    ERIC Educational Resources Information Center

    Kryzhanovskaya, Ludmila; Schulz, Charles; McDougle, Christopher; Frazier, Jean; Dittman, Ralf; Robertson-Plouch, Carol; Bauer, Theresa; Xu, Wen; Wang, Wei; Carlson, Janice; Tohen, Mauricio

    2009-01-01

    The efficacy of olanzapine in treating schizophrenia was tested through a placebo-controlled trial involving one hundred seven inpatient and outpatients adolescents. Patients who took olanzapine experienced significant symptom improvement.

  15. The Acute Effect of Methylphenidate in Brazilian Male Children and Adolescents with ADHD: A Randomized Clinical Trial

    ERIC Educational Resources Information Center

    Szobot, C. M.; Ketzer, C.; Parente, M. A.; Biederman, J.; Rohde, L. A.

    2004-01-01

    Objective: To evaluate the acute efficacy of methylphenidate (MPH) in Brazilian male children and adolescents with ADHD. Method: In a 4-day, double-blind, placebo-controlled, randomized, fix dose escalating, parallel-group trial, 36 ADHD children and adolescents were allocated to two groups: MPH (n = 19) and placebo (n = 17). Participants were…

  16. The Treatment of Adolescent Suicide Attempters Study (TASA): Predictors of Suicidal Events in an Open Treatment Trial

    ERIC Educational Resources Information Center

    Brent, David A.; Greenhill, Laurence L.; Compton, Scott; Emslie, Graham; Wells, Karen; Walkup, John T.; Vitiello, Benedetto; Bukstein, Oscar; Stanley, Barbara; Posner, Kelly; Kennard, Betsy D.; Cwik, Mary F.; Wagner, Ann; Coffey, Barbara; March, John S.; Riddle, Mark; Goldstein, Tina; Curry, John; Barnett, Shannon; Capasso, Lisa; Zelazny, Jamie; Hughes, Jennifer; Shen, Sa; Gugga, S. Sonia; Turner, J. Blake

    2009-01-01

    Objective: To identify the predictors of suicidal events and attempts in adolescent suicide attempters with depression treated in an open treatment trial. Method: Adolescents who had made a recent suicide attempt and had unipolar depression (n =124) were either randomized (n = 22) or given a choice (n = 102) among three conditions. Two…

  17. Randomized Clinical Trial of Motivational Enhancement of Substance Use Treatment among Incarcerated Adolescents: Post-Release Condom Non-Use

    ERIC Educational Resources Information Center

    Rosengard, Cynthia; Stein, L. A. R.; Barnett, Nancy P.; Monti, Peter M.; Golembeske, Charles; Lebeau-Craven, Rebecca; Miranda, Robert

    2007-01-01

    Evaluated impact of motivational enhancement (ME) of substance abuse treatment compared to relaxation training (RT) on sex without condoms (overall and involving substance use) 3 months following release among incarcerated adolescents. This randomized clinical trial involved 114 incarcerated adolescents from the Northeast. Regression analyses…

  18. Effectiveness of Multidimensional Family Therapy with Higher Severity Substance-Abusing Adolescents: Report from Two Randomized Controlled Trials

    ERIC Educational Resources Information Center

    Henderson, Craig E.; Dakof, Gayle A.; Greenbaum, Paul E.; Liddle, Howard A.

    2010-01-01

    Objective: We used growth mixture modeling to examine heterogeneity in treatment response in a secondary analysis of 2 randomized controlled trials testing multidimensional family therapy (MDFT), an established evidence-based therapy for adolescent drug abuse and delinquency. Method: The first study compared 2 evidence-based adolescent substance…

  19. Comparing patterns of sexual risk among adolescent and young women in a mixed-method study in Tanzania: implications for adolescent participation in HIV prevention trials

    PubMed Central

    Tolley, Elizabeth E; Kaaya, Sylvia; Kaale, Anna; Minja, Anna; Bangapi, Doreen; Kalungura, Happy; Headley, Jennifer; Baumgartner, Joy Noel

    2014-01-01

    Introduction Despite the disproportionate impact of HIV on women, and adolescents in particular, those below age 18 years are underrepresented in HIV prevention trials due to ethical, safety and logistical concerns. This study examined and compared the sexual risk contexts of adolescent women aged 15–17 to young adult women aged 18–21 to determine whether adolescents exhibited similar risk profiles and the implications for their inclusion in future trials. Methods We conducted a two-phase, mixed-method study to assess the opportunities and challenges of recruiting and retaining adolescents (aged 15–17) versus young women (18–21) in Tanzania. Phase I, community formative research (CFR), used serial in-depth interviews with 11 adolescent and 12 young adult women from a range of sexual risk contexts in preparation for a mock clinical trial (MCT). For Phase II, 135 HIV-negative, non-pregnant adolescents and young women were enrolled into a six-month MCT to assess and compare differences in sexual and reproductive health (SRH) outcomes, including risky sexual behaviour, incident pregnancy, sexually transmitted infections (STIs), reproductive tract infections (RTIs) and HIV. Results In both research phases, adolescents appeared to be at similar, if not higher, risk than their young adult counterparts. Adolescents reported earlier sexual debut, and similar numbers of lifetime partners, pregnancy and STI/RTI rates, yet had lower perceived risk. Married women in the CFR appeared at particular risk but were less represented in the MCT. In addition, adolescents were less likely than their older counterparts to have accessed HIV testing, obtained gynaecological exams or used protective technologies. Conclusions Adolescent women under 18 are at risk of multiple negative SRH outcomes and they underuse preventive services. Their access to new technologies such as vaginal microbicides or pre-exposure prophylaxis (PrEP) may similarly be compromised unless greater effort is

  20. Syndrome Differentiation in Chinese Herbal Medicine for Irritable Bowel Syndrome: A Literature Review of Randomized Trials

    PubMed Central

    Li, Qing; Yang, Guo-Yan; Liu, Jian-Ping

    2013-01-01

    Traditional Chinese medicine (TCM) has been commonly used for irritable bowel syndrome (IBS). Syndrome differentiation is one of the important characteristics of TCM. To assess the application and basic characteristics of syndrome differentiation in randomized controlled trials (RCTs) of Chinese herbal medicine for IBS, we performed this paper. We conducted electronic searches in main Chinese and English databases till March 2012. A total of 735 RCTs involving 67,784 IBS participants were included. 224 (30.5%) studies applied syndrome differentiation. The major syndromes of IBS patients were the syndrome of liver stagnation and spleen deficiency (56.8%), spleen-stomach weakness (49.4%), spleen-kidney yang deficiency (48.1%), and cold and heat in complexity (29.6%). Herbal formulas were prescribed based on syndrome differentiation in 202 studies. Chinese patent medicine was more commonly used in studies that only enrolled patients with a specific syndrome. 15 studies compared the therapeutic effect among different syndromes, of which 6 studies showed that there were significant differences among different syndromes. The low use of TCM syndrome differentiation in randomized trials of Chinese herbal medicine for IBS results in the poor pertinence of treatment. TCM syndrome differentiation should be used in further studies at the stage of recruitment, treatment, and data analyses. PMID:23554827

  1. Building psychosocial assets and wellbeing among adolescent girls: A randomized controlled trial.

    PubMed

    Leventhal, Katherine Sachs; Gillham, Jane; DeMaria, Lisa; Andrew, Gracy; Peabody, John; Leventhal, Steve

    2015-12-01

    We conducted a randomized controlled trial of a 5-month resilience-based program (Girls First Resilience Curriculum or RC) among 2308 rural adolescent girls at 57 government schools in Bihar, India. Local women with at least a 10th grade education served as group facilitators. Girls receiving RC improved more (vs. controls) on emotional resilience, self-efficacy, social-emotional assets, psychological wellbeing, and social wellbeing. Effects were not detected on depression. There was a small, statistically significant negative effect on anxiety (though not likely clinically significant). Results suggest psychosocial assets and wellbeing can be improved for girls in high-poverty, rural schools through a brief school-day program. To our knowledge, this is one of the largest developing country trials of a resilience-based school-day curriculum for adolescents. PMID:26547145

  2. Building psychosocial assets and wellbeing among adolescent girls: A randomized controlled trial.

    PubMed

    Leventhal, Katherine Sachs; Gillham, Jane; DeMaria, Lisa; Andrew, Gracy; Peabody, John; Leventhal, Steve

    2015-12-01

    We conducted a randomized controlled trial of a 5-month resilience-based program (Girls First Resilience Curriculum or RC) among 2308 rural adolescent girls at 57 government schools in Bihar, India. Local women with at least a 10th grade education served as group facilitators. Girls receiving RC improved more (vs. controls) on emotional resilience, self-efficacy, social-emotional assets, psychological wellbeing, and social wellbeing. Effects were not detected on depression. There was a small, statistically significant negative effect on anxiety (though not likely clinically significant). Results suggest psychosocial assets and wellbeing can be improved for girls in high-poverty, rural schools through a brief school-day program. To our knowledge, this is one of the largest developing country trials of a resilience-based school-day curriculum for adolescents.

  3. Computerised cognitive behaviour therapy for depression in adolescents: study protocol for a feasibility randomised controlled trial

    PubMed Central

    Wright, Barry; Tindall, Lucy; Littlewood, Elizabeth; Adamson, Joy; Allgar, Victoria; Bennett, Sophie; Gilbody, Simon; Verduyn, Chrissie; Alderson-Day, Ben; Dyson, Lisa; Trépel, Dominic; Ali, Shehzad

    2014-01-01

    Introduction The 1 year prevalence of depression in adolescents is about 2%. Treatment with antidepressant medication is not recommended for initial treatment in young people due to concerns over high side effects, poor efficacy and addictive potential. Evidence suggests that cognitive behaviour therapy (CBT) is an effective treatment for depression and is currently one of the main treatment options recommended in adolescents. Given the affinity young people have with information technology they may be treated effectively, more widely and earlier in their illness evolution using computer-administered CBT (CCBT). Currently little is known about the clinical and resource implications of implementing CCBT within the National Health Service for adolescents with low mood/depression. We aim to establish the feasibility of running a fully powered randomised controlled trial (RCT). Methods and analysis Adolescents aged 12–18 with low mood/depression, (scoring ≥20 on the Mood and Feelings Questionnaire (MFQ)), will be approached to participate. Consenting participants will be randomised to either a CCBT programme (Stressbusters) or accessing selected websites providing information about low mood/depression. The primary outcome measure will be the Beck Depression Inventory (BDI). Participants will also complete generic health measures (EQ5D-Y, HUI2) and resource use questionnaires to examine the feasibility of cost-effectiveness analysis. Questionnaires will be completed at baseline, 4 and 12-month follow-ups. Progress and risk will be monitored via the MFQ administered at each treatment session. The acceptability of a CCBT programme to adolescents; and the willingness of clinicians to recruit participants and of participants to be randomised, recruitment rates, attrition rates and questionnaire completion rates will be collected for feasibility analysis. We will estimate ‘numbers needed’ to plan a fully powered RCT of clinical and cost-effectiveness. Ethics and

  4. Randomized controlled trials on complementary and traditional medicine in the korean literature.

    PubMed

    Kim, Chang-Kyu; Kim, Da-Hee; Lee, Myeong Soo; Kim, Jong-In; Wieland, L Susan; Shin, Byung-Cheul

    2014-01-01

    Objective. This study aimed to identify all of the features of complementary and alternative (CAM) randomized controlled trials (RCTs) in the Korean literature and then introduce English-speaking researchers to the bibliometric and risk of bias characteristics of this literature. Methods. Eleven electronic databases and sixteen Korean journals were searched to August 2013 for RCTs of CAM therapies. Key study characteristics were extracted and risk of bias was assessed using the Cochrane Collaboration's tool for assessing risk of bias. Results. Three hundred and sixty publications met our inclusion criteria. Complementary and traditional medicine RCTs in the Korean literature emerged in the mid-1990s and increased in the mid-2000s. The most common CAM interventions include acupuncture (59.4%) and herbal medicine (8.3%). The largest proportion of trials evaluated CAM for musculoskeletal conditions (20.7%). Adequate methods of randomization were reported in 41.7% of the RCTs, whereas only 8.3% reported adequate allocation concealment. A low proportion of trials reported participant blinding (34.2%) and outcome assessor blinding (22.5%). Conclusions. Korean CAM RCTs are typically omitted from systematic reviews resulting in the potential for language bias. This study will enable these trials of diverse quality to be identified and assessed for inclusion in future systematic reviews on CAM interventions.

  5. Sequential Multiple Assignment Randomized Trial (SMART) to Construct Weight Loss Interventions for African American Adolescents.

    PubMed

    Naar-King, Sylvie; Ellis, Deborah A; Idalski Carcone, April; Templin, Thomas; Jacques-Tiura, Angela J; Brogan Hartlieb, Kathryn; Cunningham, Phillippe; Jen, Kai-Lin Catherine

    2016-01-01

    The purpose of this study was to develop an adaptive behavioral treatment for African American adolescents with obesity. In a sequential multiple assignment randomized trial, 181 youth ages 12-16 years with primary obesity and their caregiver were first randomized to 3 months of home-based versus office-based delivery of motivational interviewing plus skills building. After 3 months, nonresponders to first phase treatment were rerandomized to continued home-based skills or contingency management. Primary outcome was percent overweight and hypothesized moderators were adolescent executive functioning and depression. There were no significant differences in primary outcome between home-based or office-based delivery or between continued home-based skills or contingency management for nonresponders to first-phase treatment. However, families receiving home-based treatment initially attended significantly more sessions in both phases of the trial, and families receiving contingency management attended more sessions in the second phase. Overall, participants demonstrated decreases in percent overweight over the course of the trial (3%), and adolescent executive functioning moderated this effect such that those with higher functioning lost more weight. More potent behavioral treatments to address the obesity epidemic are necessary, targeting new areas such as executive functioning. Delivering treatment in the home with contingency management may increase session attendance for this population.

  6. A Systematic Review of Randomized Controlled Trials on Oral Chinese Herbal Medicine for Prostate Cancer

    PubMed Central

    Li, Xun; Wang, Yuyi; Chen, Shiuan; Liu, Jian-ping

    2016-01-01

    Background Prostate cancer is the most common malignant tumor associated with male reproductive system. Objective The existing eligible randomized controlled trials (RCTs) were critically appraised for the safety and effectiveness of CHM for prostate cancer. Methods A literature search was conducted by using PubMed, CENTRAL, CNKI, CBM, VIP and Wanfang databases until August 2015. RCTs of CHM or CHM plus conventional medicine for prostate cancer patients were included. The primary outcomes appraised were survival time, time to progression and quality of life. The risk of bias assessment according to the Cochrane Handbook was used to evaluate the methodological quality of the included trials. Revman 5.3 software was used for data analyses. Risk ratio and mean difference (MD) with a 95% confidence interval (CI) were used as effect measures. Meta-analysis was to be used if sufficient trials without obvious clinical or statistical heterogeneity were available. Results A total of 17 RCTs involving 1224 participants were analyzed. One trial was about CHM comparing to no treatment. The remaining 16 trials used CHMs as adjunctive treatment for endocrine therapy. Due to the poor quality of methodologies of most trials, only limited evidence showed that a combination of CHM and endocrine therapy might be more effective in restraining the development of the disease (MD 10.37 months, 95%CI 9.10 to 11.63 months), increasing patients’ survival time (7–15 months) or improving patients’ performance status, when compared to endocrine therapy alone (Karnofsky performance scale average changed 15 scores between groups). No severe adverse event was reported related to CHM. Conclusion Due to the insufficient quality of trials that were analyzed, it is not appropriate to recommend any kind of CHMs in treating prostate cancer at the present time. Well-designed trials with high methodological quality are needed to validate the effect of CHMs for patients with prostate cancer. PMID

  7. Qualitative Treatment-Subgroup Interactions in a Randomized Clinical Trial of Treatments for Adolescents with ADHD: Exploring What Cognitive-Behavioral Treatment Works for Whom

    PubMed Central

    Geurts, Hilde M.; Prins, Pier J. M.; Van Mechelen, Iven; Van der Oord, Saskia

    2016-01-01

    Objective This study explored qualitative treatment-subgroup interactions within data of a RCT with two cognitive behavioral treatments (CBT) for adolescents with ADHD: a planning-focused (PML) and a solution-focused CBT (SFT). Qualitative interactions imply that which treatment is best differs across subgroups of patients, and are therefore most relevant for personalized medicine. Methods Adolescents with ADHD (N = 159) received either PML or SFT. Pre-, post- and three-month follow-up data were gathered on parent-rated ADHD symptoms and planning problems. Pretreatment characteristics were explored as potential qualitative moderators of pretest to follow-up treatment effects, using an innovative analyses technique (QUINT; Dusseldorp & Van Mechelen, 2014). In addition, qualitative treatment-subgroup interactions for the therapeutic changes from pre- to posttest and from post- to follow-up test were investigated. Results For the entire time span from pretest to follow-up only a quantitative interaction was found, while from posttest to follow-up qualitative interactions were found: Adolescents with less depressive symptoms but more anxiety symptoms showed more improvement when receiving PML than SFT, while for other adolescents the effects of PML and SFT were comparable. Discussion Whereas subgroups in both treatments followed different trajectories, no subgroup was found for which SFT outperformed PML in terms of the global change in symptoms from pretest to three months after treatment. This implies that, based on this exploratory study, there is no need for personalized treatment allocation with regard to the CBTs under study for adolescents with ADHD. However, for a subgroup with comorbid anxiety symptoms but low depression PML clearly appears the treatment of preference. Trial Registration Nederlands Trial Register NTR2142 PMID:26977602

  8. Efficacy of Adolescent Suicide Prevention E-Learning Modules for Gatekeepers: A Randomized Controlled Trial

    PubMed Central

    Gould, Madelyn S; Twisk, Jos WR; Kerkhof, Ad JFM; Koot, Hans M

    2016-01-01

    Background Face-to-face gatekeeper training can be an effective strategy in the enhancement of gatekeepers’ knowledge and self-efficacy in adolescent suicide prevention. However, barriers related to access (eg, time, resources) may hamper participation in face-to-face training sessions. The transition to a Web-based setting could address obstacles associated with face-to-face gatekeeper training. Although Web-based suicide prevention training targeting adolescents exists, so far no randomized controlled trials (RCTs) have been conducted to investigate their efficacy. Objective This RCT study investigated the efficacy of a Web-based adolescent suicide prevention program entitled Mental Health Online, which aimed to improve the knowledge and self-confidence of gatekeepers working with adolescents (12-20 years old). The program consisted of 8 short e-learning modules each capturing an important aspect of the process of early recognition, guidance, and referral of suicidal adolescents, alongside additional information on the topic of (adolescent) suicide prevention. Methods A total of 190 gatekeepers (ages 21 to 62 years) participated in this study and were randomized to either the experimental group or waitlist control group. The intervention was not masked. Participants from both groups completed 3 Web-based assessments (pretest, posttest, and 3-month follow-up). The outcome measures of this study were actual knowledge, and participants’ ratings of perceived knowledge and perceived self-confidence using questionnaires developed specifically for this study. Results The actual knowledge, perceived knowledge, and perceived self-confidence of gatekeepers in the experimental group improved significantly compared to those in the waitlist control group at posttest, and the effects remained significant at 3-month follow-up. The overall effect sizes were 0.76, 1.20, and 1.02, respectively, across assessments. Conclusions The findings of this study indicate that Web

  9. A Web-Based Adolescent Positive Psychology Program in Schools: Randomized Controlled Trial

    PubMed Central

    Manicavasagar, Vijaya; Batterham, Philip J; Miller, Leonie M; Talbot, Elizabeth; Lum, Alistair

    2015-01-01

    Background Adolescent mental health is characterized by relatively high rates of psychiatric disorders and low levels of help-seeking behaviors. Existing mental health programs aimed at addressing these issues in adolescents have repeated inconsistent results. Such programs have generally been based on techniques derived from cognitive behavioral therapy, which may not be ideally suited to early intervention among adolescent samples. Positive psychology, which seeks to improve well-being rather than alleviate psychological symptoms, offers an alternative approach. A previous community study of adolescents found that informal engagement in an online positive psychology program for up to 6 weeks yielded significant improvements in both well-being and depression symptoms. However, this approach had not been trialed among adolescents in a structured format and within a school setting. Objective This study examines the feasibility of an online school-based positive psychology program delivered in a structured format over a 6-week period utilizing a workbook to guide students through website content and interactive exercises. Methods Students from four high schools were randomly allocated by classroom to either the positive psychology condition, "Bite Back", or the control condition. The Bite Back condition consisted of positive psychology exercises and information, while the control condition used a series of non-psychology entertainment websites. Both interventions were delivered online for 6 hours over a period of 4-6 weeks during class time. Symptom measures and measures of well-being/flourishing and life satisfaction were administered at baseline and post intervention. Results Data were analyzed using multilevel linear modeling. Both conditions demonstrated reductions in depression, stress, and total symptom scores without any significant differences between the two conditions. Both the Bite Back and control conditions also demonstrated significant improvements in

  10. Brief Strategic Family Therapy versus Treatment as Usual: Results of a Multisite Randomized Trial for Substance Using Adolescents

    ERIC Educational Resources Information Center

    Robbins, Michael S.; Feaster, Daniel J.; Horigian, Viviana E.; Rohrbaugh, Michael; Shoham, Varda; Bachrach, Ken; Miller, Michael; Burlew, Kathleen A.; Hodgkins, Candy; Carrion, Ibis; Vandermark, Nancy; Schindler, Eric; Werstlein, Robert; Szapocznik, Jose

    2011-01-01

    Objective: To determine the effectiveness of brief strategic family therapy (BSFT; an evidence-based family therapy) compared to treatment as usual (TAU) as provided in community-based adolescent outpatient drug abuse programs. Method: A randomized effectiveness trial in the National Drug Abuse Treatment Clinical Trials Network compared BSFT to…

  11. Using Process Data to Explain Outcomes. An Illustration from the Child and Adolescent Trial for Cardiovascular Health (CATCH).

    ERIC Educational Resources Information Center

    McGraw, Sarah A.; And Others

    1996-01-01

    Data from the Child and Adolescent Trial for Cardiovascular Health, a school-based field trial, are used to illustrate the use of process evaluation for understanding study outcomes. Teacher characteristics and fidelity to the program model had direct and independent effects on student outcomes from the program. (SLD)

  12. Effectiveness guidance document (EGD) for Chinese medicine trials: a consensus document

    PubMed Central

    2014-01-01

    Background There is a need for more Comparative Effectiveness Research (CER) on Chinese medicine (CM) to inform clinical and policy decision-making. This document aims to provide consensus advice for the design of CER trials on CM for researchers. It broadly aims to ensure more adequate design and optimal use of resources in generating evidence for CM to inform stakeholder decision-making. Methods The Effectiveness Guidance Document (EGD) development was based on multiple consensus procedures (survey, written Delphi rounds, interactive consensus workshop, international expert review). To balance aspects of internal and external validity, multiple stakeholders, including patients, clinicians, researchers and payers were involved in creating this document. Results Recommendations were developed for “using available data” and “future clinical studies”. The recommendations for future trials focus on randomized trials and cover the following areas: designing CER studies, treatments, expertise and setting, outcomes, study design and statistical analyses, economic evaluation, and publication. Conclusion The present EGD provides the first systematic methodological guidance for future CER trials on CM and can be applied to single or multi-component treatments. While CONSORT statements provide guidelines for reporting studies, EGDs provide recommendations for the design of future studies and can contribute to a more strategic use of limited research resources, as well as greater consistency in trial design. PMID:24885146

  13. Effects of media campaign messages targeting parents on adolescent sexual beliefs: a randomized controlled trial with a national sample.

    PubMed

    Palen, Lori-Ann; Ashley, Olivia Silber; Gard, Jennifer C; Kan, Marni L; Davis, Kevin C; Evans, W Douglas

    2011-01-01

    Using a randomized controlled trial, this study evaluated the effects of media messages targeting parents on the sexual beliefs of 404 adolescents. The messages aimed to increase parent-child communication about waiting to initiate sexual activity. Compared with children of unexposed parents, children of parents exposed to media messages were more likely to believe that teen sexual activity is psychologically harmful. However, effects varied by parent and adolescent gender; treatment effects were only significant among adolescents whose opposite-sex parent was exposed. Parent exposure strengthened beliefs that teen sexual activity is physically harmful only among adolescents with at least 1 sexually active friend.

  14. Effects of media campaign messages targeting parents on adolescent sexual beliefs: a randomized controlled trial with a national sample.

    PubMed

    Palen, Lori-Ann; Ashley, Olivia Silber; Gard, Jennifer C; Kan, Marni L; Davis, Kevin C; Evans, W Douglas

    2011-01-01

    Using a randomized controlled trial, this study evaluated the effects of media messages targeting parents on the sexual beliefs of 404 adolescents. The messages aimed to increase parent-child communication about waiting to initiate sexual activity. Compared with children of unexposed parents, children of parents exposed to media messages were more likely to believe that teen sexual activity is psychologically harmful. However, effects varied by parent and adolescent gender; treatment effects were only significant among adolescents whose opposite-sex parent was exposed. Parent exposure strengthened beliefs that teen sexual activity is physically harmful only among adolescents with at least 1 sexually active friend. PMID:21135626

  15. A Pilot Whole Systems Clinical Trial of Traditional Chinese Medicine and Naturopathic Medicine for the Treatment of Temporomandibular Disorders

    PubMed Central

    Hammerschlag, Richard; Calabrese, Carlo; Mist, Scott; Aickin, Mikel; Sutherland, Elizabeth; Leben, Joseph; DeBAR, Lynn; Elder, Charles; Dworkin, Samuel F.

    2008-01-01

    Abstract Objectives To assess the feasibility and acceptability of studying whole systems of Traditional Chinese Medicine (TCM) and Naturopathic medicine (NM) in the treatment of temporomandibular disorders (TMD), and to determine whether there is indication to support further research. Design A pilot study using a randomized controlled clinical trial design of whole system TCM and NM versus state-of-the-art specialty care (SC). Setting/location Kaiser Permanente Northwest (KPNW), and practitioner offices in Portland, Oregon. Subjects One hundred and sixty (160) women 25–55 years of age attending a KPNW TMD specialty clinic. Interventions Whole system TCM and NM, and KPNW TMD clinic SC; the intervention protocols were designed to model the individually tailored type of community care offered in alternative medicine practices in Portland and in the KPNW TMD clinic, using protocols that enhanced similarities among practitioners within each system and permitted full descriptions of the treatments provided. Outcome measures TMD was ascertained using the Research Diagnostic Criteria/TMD; outcomes were self-reported worst and average facial pain and interference with activities (scaled 0–10 where 10 is worst). Results Of 948 consecutive eligible patients, 160 were randomized to one of three arms; 128 provided endpoint data. TCM and NM demonstrated significantly greater in-treatment reductions for worst facial pain compared to SC (adjusted regression analysis; higher negative values indicate greater improvement, = −1.11 ± 0.43, p = 0.010 and −1.02 ± 0.45, p = 0.025 for TCM and NM, respectively, compared to SC) and at 3 months post-treatment (−1.07 ± 0.51, p = 0.037 and −1.27 ± 0.54, p = 0.019 for TCM and NM versus SC, respectively). Additionally, TCM provided significantly greater decreases in average pain than SC; NM provided significantly greater decreases than SC or TCM in TMD-related psychosocial interference

  16. Personalised and Precision Medicine in Cancer Clinical Trials: Panacea for Progress or Pandora's Box?

    PubMed

    Lawler, Mark; Sullivan, Richard

    2015-01-01

    Cancer clinical trials have been one of the key foundations for significant advances in oncology. However, there is a clear recognition within the academic, care delivery and pharmaceutical/biotech communities that our current model of clinical trial discovery and development is no longer fit for purpose. Delivering transformative cancer care should increasingly be our mantra, rather than maintaining the status quo of, at best, the often miniscule incremental benefits that are observed with many current clinical trials. As we enter the era of precision medicine for personalised cancer care (precision and personalised medicine), it is important that we capture and utilise our greater understanding of the biology of disease to drive innovative approaches in clinical trial design and implementation that can lead to a step change in cancer care delivery. A number of advances have been practice changing (e.g. imatinib mesylate in chronic myeloid leukaemia, Herceptin in erb-B2-positive breast cancer), and increasingly we are seeing the promise of a number of newer approaches, particularly in diseases like lung cancer and melanoma. Targeting immune checkpoints has recently yielded some highly promising results. New algorithms that maximise the effectiveness of clinical trials, through for example a multi-stage, multi-arm type design are increasingly gaining traction. However, our enthusiasm for the undoubted advances that have been achieved are being tempered by a realisation that these new approaches may have significant cost implications. This article will address these competing issues, mainly from a European perspective, highlight the problems and challenges to healthcare systems and suggest potential solutions that will ensure that the cost/value rubicon is addressed in a way that allows stakeholders to work together to deliver optimal cost-effective cancer care, the benefits of which can be transferred directly to our patients.

  17. Counselling sessions increased duration of exclusive breastfeeding: a randomized clinical trial with adolescent mothers and grandmothers

    PubMed Central

    2014-01-01

    Background Considering that adolescent mothers may be more vulnerable to discontinuing exclusive breastfeeding (EBF) before 6 months and that their mothers may exert a negative influence on this practice, this study was conducted with the objective of evaluating the efficacy of breastfeeding counselling for adolescent mothers and their mothers in increasing EBF duration. Methods A clinical trial was performed in 323 adolescent mothers with newborns and their mothers randomized in four groups: (1) not living with mother, without intervention; (2) not living with mother, with intervention; (3) living with mother, without intervention, (4) living with mother, with intervention. The intervention consisted of five counselling sessions directed to mother and grandmother, in the maternity hospital and on follow-up. Information about feeding practices during the newborn’s first six months of life was collected monthly by telephone. Intervention’s efficacy was measured through Cox regression and comparison of exclusive breastfeeding medians and survival curves for the different groups. Results The intervention increased the duration of EBF by67 days for the group which included grandmothers (HR = 0.64; CI 95% = 0.46-0.90) and 46 days for the group which did not include grandmothers (HR = 0.52; CI 95% = 0.36-0.76). Conclusions Counselling sessions in the first four months of children’s lives proved to be effective in increasing EBF duration among adolescent mothers. Trial registration ClinicalTrials.gov NCT00910377. PMID:25033743

  18. Acceptance and Commitment Therapy for anxious children and adolescents: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Anxiety disorders affect approximately 10% to 20% of young people, can be enduring if left untreated, and have been associated with psychopathology in later life. Despite this, there is a paucity of empirical research to assist clinicians in determining appropriate treatment options. We describe a protocol for a randomized controlled trial in which we will examine the effectiveness of a group-based Acceptance and Commitment Therapy program for children and adolescents with a primary diagnosis of anxiety disorder. For the adolescent participants we will also evaluate the elements of the intervention that act as mechanisms for change. Methods/design We will recruit 150 young people (90 children and 60 adolescents) diagnosed with an anxiety disorder and their parent or caregiver. After completion of baseline assessment, participants will be randomized to one of three conditions (Acceptance and Commitment Therapy, Cognitive Behavior Therapy or waitlist control). Those in the Acceptance and Commitment Therapy and Cognitive Behavior Therapy groups will receive 10 × 1.5 hour weekly group-therapy sessions using a manualized treatment program, in accordance with the relevant therapy, to be delivered by psychologists. Controls will receive the Cognitive Behavior Therapy program after 10 weeks waitlisted. Repeated measures will be taken immediately post-therapy and at three months after therapy cessation. Discussion To the best of our knowledge, this study will be the largest trial of Acceptance and Commitment Therapy in the treatment of children and young people to date. It will provide comprehensive data on the use of Acceptance and Commitment Therapy for anxiety disorders and will offer evidence for mechanisms involved in the process of change. Furthermore, additional data will be obtained for the use of Cognitive Behavior Therapy in this population and this research will illustrate the comparative effectiveness of these two interventions, which are currently

  19. Qualitative systemic review of randomized controlled trials on complementary and alternative medicine treatments in fibromyalgia.

    PubMed

    Baranowsky, Julia; Klose, Petra; Musial, Frauke; Häuser, Winfried; Haeuser, Winfried; Dobos, Gustav; Langhorst, Jost

    2009-11-01

    The objectives of the study were identification, quality evaluation and summary of RCTs on complementary and alternative medicine as defined by the National Institute of Health with the exception of dietary and nutritional supplements. A computerized search of databases from 1990 (year of publication of the ACR criteria for fibromyalgia) to July 2007 was performed. The RCTs were assessed by a methodological quality score. A total of 23 RCTs issued from 1992 to 2007 on acupuncture, balneotherapy, thermotherapy, magnetic therapy, homeopathy, manual manipulation, mind-body medicine, diet therapy and music therapy were identified. The RCTs had an average group size of 25 with the number of groups ranging from two to four. The quality score assessment of the RCTs yielded a mean score of 51 out of 100. The average methodological quality of the identified studies was fairly low. Best evidence was found for balneotherapy/hydrotherapy in multiple studies. Positive results were also noted for homeopathy and mild infrared hyperthermia in 1 RCT in each field. Mindfulness meditation showed mostly positive results in two trials and acupuncture mixed results in multiple trials with a tendency toward positive results. Tendencies for improvement were furthermore noted in single trials of the Mesendieck system, connective tissue massage and to some degree for osteopathy and magnet therapy. No positive evidence could be identified for Qi Gong, biofeedback, and body awareness therapy.

  20. Web Intervention for Adolescents Affected by Disaster: Population-Based Randomized Controlled Trial

    PubMed Central

    Ruggiero, Kenneth J.; Price, Matthew; Adams, Zachary; Stauffacher, Kirstin; McCauley, Jenna; Danielson, Carla Kmett; Knapp, Rebecca; Hanson, Rochelle F.; Davidson, Tatiana M.; Amstadter, Ananda B.; Carpenter, Matthew J.; Saunders, Benjamin E.; Kilpatrick, Dean G.; Resnick, Heidi S.

    2015-01-01

    Objective To assess the efficacy of Bounce Back Now (BBN), a modular, web-based intervention for disaster-affected adolescents and their parents. Method A population-based randomized controlled trial used address-based sampling to enroll 2,000 adolescents and parents from communities affected by tornadoes in Joplin, MO, and Alabama. Data collection via baseline and follow-up semi-structured telephone interviews was completed between September 2011 and August 2013. All families were invited to access the BBN study web portal irrespective of mental health status at baseline. Families who accessed the web portal were assigned randomly to 3 groups: (1) BBN, which featured modules for adolescents and parents targeting adolescents’ mental health symptoms; (2) BBN plus additional modules targeting parents’ mental health symptoms; or (3) assessment only. The primary outcomes were adolescent symptoms of posttraumatic stress disorder (PTSD) and depression. Results Nearly 50% of families accessed the web portal. Intent-to-treat analyses revealed time × condition interactions for PTSD symptoms (B=−0.24, SE=0.08, p<.01) and depressive symptoms (B=−0.23, SE=0.09, p<.01). Post-hoc comparisons revealed fewer PTSD and depressive symptoms for adolescents in the experimental vs. control conditions at 12-month follow-up (PTSD: B=−0.36, SE=0.19, p=.06; depressive symptoms: B=−0.42, SE=0.19, p=0.03). A time × condition interaction also was found favoring the BBN vs. BBN + parent self-help condition for PTSD symptoms (B=0.30, SE=0.12, p=.02), but not depressive symptoms (B=0.12, SE=0.12, p=.33). Conclusion Results supported the feasibility and initial efficacy of BBN as a scalable disaster mental health intervention for adolescents. Technology-based solutions have tremendous potential value if found to reduce the mental health burden of disasters. PMID:26299292

  1. Precision Medicine for Molecularly Targeted Agents and Immunotherapies in Early-Phase Clinical Trials

    PubMed Central

    Lopez, Juanita; Harris, Sam; Roda, Desam; Yap, Timothy A

    2015-01-01

    Precision medicine in oncology promises the matching of genomic, molecular, and clinical data with underlying mechanisms of a range of novel anticancer therapeutics to develop more rational and effective antitumor strategies in a timely manner. However, despite the remarkable progress made in the understanding of novel drivers of different oncogenic processes, success rates for the approval of oncology drugs remain low with substantial fiscal consequences. In this article, we focus on how recent rapid innovations in technology have brought greater clarity to the biological and clinical complexities of different cancers and advanced the development of molecularly targeted agents and immunotherapies in clinical trials. We discuss the key challenges of identifying and validating predictive biomarkers of response and resistance using both tumor and surrogate tissues, as well as the hurdles associated with intratumor heterogeneity. Finally, we outline evolving strategies employed in early-phase trial designs that incorporate omics-based technologies. PMID:26609214

  2. Searching for Controlled Trials of Complementary and Alternative Medicine: A Comparison of 15 Databases

    PubMed Central

    Cogo, Elise; Sampson, Margaret; Ajiferuke, Isola; Manheimer, Eric; Campbell, Kaitryn; Daniel, Raymond; Moher, David

    2011-01-01

    This project aims to assess the utility of bibliographic databases beyond the three major ones (MEDLINE, EMBASE and Cochrane CENTRAL) for finding controlled trials of complementary and alternative medicine (CAM). Fifteen databases were searched to identify controlled clinical trials (CCTs) of CAM not also indexed in MEDLINE. Searches were conducted in May 2006 using the revised Cochrane highly sensitive search strategy (HSSS) and the PubMed CAM Subset. Yield of CAM trials per 100 records was determined, and databases were compared over a standardized period (2005). The Acudoc2 RCT, Acubriefs, Index to Chiropractic Literature (ICL) and Hom-Inform databases had the highest concentrations of non-MEDLINE records, with more than 100 non-MEDLINE records per 500. Other productive databases had ratios between 500 and 1500 records to 100 non-MEDLINE records—these were AMED, MANTIS, PsycINFO, CINAHL, Global Health and Alt HealthWatch. Five databases were found to be unproductive: AGRICOLA, CAIRSS, Datadiwan, Herb Research Foundation and IBIDS. Acudoc2 RCT yielded 100 CAM trials in the most recent 100 records screened. Acubriefs, AMED, Hom-Inform, MANTIS, PsycINFO and CINAHL had more than 25 CAM trials per 100 records screened. Global Health, ICL and Alt HealthWatch were below 25 in yield. There were 255 non-MEDLINE trials from eight databases in 2005, with only 10% indexed in more than one database. Yield varied greatly between databases; the most productive databases from both sampling methods were Acubriefs, Acudoc2 RCT, AMED and CINAHL. Low overlap between databases indicates comprehensive CAM literature searches will require multiple databases. PMID:19468052

  3. Participant selection for preventive Regenerative Medicine trials: ethical challenges of selecting individuals at risk.

    PubMed

    Niemansburg, Sophie L; Habets, Michelle G J L; Dhert, Wouter J A; van Delden, Johannes J M; Bredenoord, Annelien L

    2015-11-01

    The innovative field of Regenerative Medicine (RM) is expected to extend the possibilities of prevention or early treatment in healthcare. Increasingly, clinical trials will be developed for people at risk of disease to investigate these RM interventions. These individuals at risk are characterised by their susceptibility for developing clinically manifest disease in future due to the existence of degenerative abnormalities. So far, there has been little debate about the ethical appropriateness of including such individuals at risk in clinical trials. We discuss three main challenges of selecting this participant model for testing RM interventions: the challenge of achieving a proportional risk-benefit balance; complexities in the trial design in terms of follow-up and sample size; and the difficulty of obtaining informed consent due to the many uncertainties. We conclude that selecting the model is not ethically justifiable for first-in-man trials with RM interventions due to the high risks and uncertainties. However, the model can be ethically appropriate for testing the efficacy of RM interventions under the following conditions: interventions should be low risk; the degenerative abnormalities (and other risk factors) should be strongly related with disease within a short time frame; robust preclinical evidence of efficacy needs to be present; and the informed consent procedure should contain extra safeguards with regard to communication on uncertainties.

  4. A PARENT–ADOLESCENT INTERVENTION TO INCREASE SEXUAL RISK COMMUNICATION: RESULTS OF A RANDOMIZED CONTROLLED TRIAL

    PubMed Central

    Villarruel, Antonia M.; Cherry, Carol Loveland; Cabriales, Esther Gallegos; Ronis, David L.; Zhou, Yan

    2009-01-01

    This article reports results of a randomized controlled trial designed to test an intervention to increase parent–adolescent sexual risk communication among Mexican parents. Data were analyzed from parents (n = 791) randomly assigned to an HTV risk reduction or health promotion intervention. Measures were administered at pretest, posttest, and 6– and 12–month follow–ups. Generalized estimation equation (GEE) analysis indicates parents in the HIV risk reduction intervention reported significantly more general communication (p < .005), more sexual risk communication (p < .001) and more comfort with communication (p < .001) than parents in the control intervention. Behavioral, normative, and control beliefs significantly mediated the effect of the intervention on all communication outcomes. This study demonstrates the efficacy of an intervention to increase the quality and quantity of parent–adolescent communication related to general and sex–specific communication. PMID:18956979

  5. Cognitive Behavior Therapy for Generalized Social Anxiety Disorder in Adolescents: A Randomized Controlled Trial

    PubMed Central

    Herbert, James D.; Gaudiano, Brandon A.; Rheingold, Alyssa A.; Moitra, Ethan; Myers, Valerie H.; Dalrymple, Kristy L.; Brandsma, Lynn L.

    2010-01-01

    Early identification and treatment of social anxiety disorder (SAD) is critical to prevent development of a chronic course of symptoms, persistent functional impairment, and progressive psychiatric comorbidity. A small but growing literature supports the effectiveness of cognitive behavior therapy (CBT) for anxiety disorders, including SAD, in adolescence. The present randomized controlled trial evaluated the efficacy of group vs. individual CBT for adolescents with generalized SAD in relation to an educational/supportive psychotherapy that did not contain specific CBT elements. All three treatments were associated with significant reductions in symptoms and functional impairment, and in improved social skills. No differences between treatments emerged on measures of symptoms, but the CBT conditions demonstrated greater gains on behavioral measures. The implications of the findings are discussed. PMID:18653310

  6. Effects of Naltrexone on Adolescent Alcohol Cue Reactivity and Sensitivity: An Initial Randomized Trial

    PubMed Central

    Miranda, Robert; Ray, Lara; Blanchard, Alexander; Reynolds, Elizabeth K.; Monti, Peter M.; Chun, Thomas; Justus, Alicia; Swift, Robert M.; Tidey, Jennifer; Gwaltney, Chad J.; Ramirez, Jason

    2013-01-01

    Adolescent alcohol use is associated with myriad adverse consequences and contributes to the leading causes of mortality among youth. Despite the magnitude of this public health problem, evidenced-based treatment initiatives for alcohol use disorders in youth remain inadequate. Identifying promising pharmacological approaches may improve treatment options. Naltrexone is an opiate receptor antagonist that is efficacious for reducing drinking in adults by attenuating craving and the rewarding effects of alcohol. Implications of these findings for adolescents are unclear, however, given that randomized trials of naltrexone with youth are nonexistent. We conducted a randomized, double-blinded, placebo-controlled crossover study, comparing naltrexone (50 mg/daily) and placebo in 22 adolescent problem drinkers aged 15 – 19 years (M = 18.36, SD = 0.95; 12 females). The primary outcome measures were alcohol use, subjective responses to alcohol consumption, and alcohol-cue-elicited craving assessed in the natural environment using ecological momentary assessment methods, and craving and physiological reactivity assessed using standard alcohol cue reactivity procedures. Results showed that naltrexone reduced the likelihood of drinking and heavy drinking (p’s ≤ .03), blunted craving in the laboratory and in the natural environment (p’s ≤ .04), and altered subjective responses to alcohol consumption (p’s ≤ .01). Naltrexone was generally well tolerated by participants. This study provides the first experimentally controlled evidence that naltrexone reduces drinking and craving, and alters subjective responses to alcohol in a sample of adolescent problem drinkers, and suggests larger clinical trials with long-term follow ups are warranted. PMID:23489253

  7. Effects of a Brief Intervention for Reducing Violence and Alcohol Misuse Among Adolescents: A Randomized Trial

    PubMed Central

    Cunningham, Rebecca M.; Chermack, Stephen T.; Shope, Jean T.; Bingham, C. Raymond; Zimmerman, Marc A.; Blow, Frederic C.; Walton, Maureen A.

    2013-01-01

    Context The Emergency Department (ED) visit presents an opportunity to deliver brief interventions (BIs) to reduce violence and alcohol misuse among urban adolescents at risk for future injury. Objectives To determine the efficacy of BIs addressing violence and alcohol among adolescents presenting to an urban ED. Design, Setting, and Participants Patients (ages 14–18; 12 pm–11 pm; 7 days/week) at a Level 1 ED in Flint, MI, completed a computerized survey. Adolescents reporting past year alcohol use and aggression were enrolled in a randomized trial (SafERteens) which included: a computerized baseline assessment, randomization to a control group, or a 35-minute brief intervention delivered by a computer or therapist in the ED, and follow-up assessments at 3 and 6 months. Intervention Combining motivational interviewing with skills training, the BI for violence and alcohol included: review of goals, tailored feedback, decisional balance exercise, role plays, and referrals. Main Outcome Measures Self-report measures included peer aggression and violence, violence consequences, alcohol use, binge drinking, alcohol consequences. Results 3338 adolescents were screened (n=446, 12% refused): 1452 (43.5%) male; 1866 (55.9%) African-American. Of those, 829 (24.8%) screened positive for both alcohol and violence; 726 were randomized. As compared to the control, participants in the therapist intervention showed self-reported reductions in the occurrence of peer aggression (−34.3% therapist, −16.4% control; RR=0.74, CI=0.61–0.90), experience of peer violence (10.4% therapist, +4.7% control; RR=0.70, CI=0.52–0.95), and violence consequences (30.4% therapist, −13.0% control; RR=0.76, CI=0.64–0.90) at three months. At 6 months, participants in the therapist intervention showed self-reported reductions in peer aggression (−37.7% therapist, −28.4% control; RR=0.85, CI=0.68–1.06) and alcohol consequences (−32.2% therapist, −17.5% control; RR=0.56, CI=0.34

  8. Supplementation trials with calcium citrate malate: evidence in favor of increasing the calcium RDA during childhood and adolescence.

    PubMed

    Andon, M B; Lloyd, T; Matkovic, V

    1994-08-01

    The vast majority of peak adult bone mass is accumulated by the time longitudinal growth is complete. As peak bone mass is an important determinant of future fracture risk, the goal of the current calcium recommended dietary allowance during youth is to provide a calcium intake that allows individuals to reach their full genetic potential for acquiring skeletal mass. The advent of controlled trials of calcium supplementation and total body bone mass measurements in children and adolescents provide the first direct way of determining the amount of calcium necessary to achieve optimal skeletal accretion. These studies indicate that the current RDAs are insufficient to support optimal bone mass gain during growth and development. Based on the recent intervention trials, recommendations are made for an RDA of 1250 mg during childhood and 1450 mg during adolescence. These values are consistent with established calcium balance intake thresholds for growth during pre-adolescence and adolescence.

  9. Treatment of Co-Occurring Substance Abuse and Suicidality Among Adolescents: A Randomized Trial

    PubMed Central

    Esposito-Smythers, Christianne; Spirito, Anthony; Kahler, Christopher W.; Hunt, Jeffrey; Monti, Peter

    2011-01-01

    Objective The purpose of this study was to test a cognitive behavioral treatment protocol for adolescents with a co-occurring alcohol or other drug use disorder (AOD) and suicidality in a randomized clinical trial. Method Forty adolescents (Mage = 15; 68% females, 89% Caucasian) and their families recruited from an inpatient psychiatric hospital were randomly assigned to an integrated outpatient cognitive behavioral intervention for co-occurring AOD and suicidality (I-CBT) or enhanced treatment-as-usual (E-TAU). Primary measures include the Schedule for Affective Disorders and Schizophrenia for School-Aged Children, Suicide Ideation Questionnaire, Columbia Impairment Scale, Timeline Followback, Rutgers Alcohol Problem Index, and the Rutgers Marijuana Problem Index. Assessments were completed at pre-treatment as well as 3, 6, 12, and 18 months post-enrollment. Results Using intent-to-treat analyses, I-CBT was associated with significantly fewer heavy drinking days and days of marijuana use relative to E-TAU, but not drinking days. Those randomized to I-CBT in comparison to E-TAU also reported significantly less global impairment as well as fewer suicide attempts, inpatient psychiatric hospitalizations, emergency department visits, and arrests. Adolescents across groups showed equivalent reductions in suicidal ideation. Conclusions I-CBT for adolescents with co-occurring AOD and suicidality is associated with significant improvement in both substance use and suicidal behavior, as well as markedly decreased use of additional health services including inpatient psychiatric hospitalizations and emergency department visits. Further testing of integrated protocols for adolescent AOD and suicidality with larger and more diverse samples is warranted. PMID:22004303

  10. Efficacy and safety of Chinese herbal medicine for benign prostatic hyperplasia: systematic review of randomized controlled trials

    PubMed Central

    Ma, Chun Ho; Lin, Wai Ling; Lui, Sing Leung; Cai, Xun-Yuan; Wong, Vivian Taam; Ziea, Eric; Zhang, Zhang-Jin

    2013-01-01

    Chinese herbal medicine is commonly used as a treatment for benign prostatic hyperplasia (BPH), but its efficacy and safety remain to be examined. To compare the efficacy and adverse events of Chinese herbal medicine alone or used adjuvantly with Western medications for BPH. Two independent reviewers searched the major electronic databases for randomized controlled trials comparing Chinese herbal medicine, either in single or adjuvant use with Western medication, with placebo or Western medication. Relevant journals and grey literature were also hand-searched. The outcome measures included changes in urological symptoms, urodynamic measures, prostate volume and adverse events. The frequency of commonly used herbs was also identified. Out of 13 922 identified citations of publications, 31 studies were included. Eleven studies with a Jadad score ≥3 were selected for meta-analysis. Chinese herbal medicine was superior to Western medication in improving quality of life and reducing prostate volume. The frequency of adverse events in Chinese herbal medicine was similar to that of placebo and less than that of Western medication. The evidence is too weak to support the efficacy of Chinese herbal medicine for BPH due to the poor methodological quality and small number of trials included. The commonly used herbs identified here should provide insights for future clinical practice and research. Larger randomized controlled trials of better quality are needed to truly evaluate the efficacy of Chinese herbal medicine. PMID:23728585

  11. Comprehensive rehabilitation with integrative medicine for subacute stroke: A multicenter randomized controlled trial

    PubMed Central

    Fang, Jianqiao; Chen, Lifang; Ma, Ruijie; Keeler, Crystal Lynn; Shen, Laihua; Bao, Yehua; Xu, Shouyu

    2016-01-01

    To determine whether integrative medicine rehabilitation (IMR) that combines conventional rehabilitation (CR) with acupuncture and Chinese herbal medicine has better effects for subacute stroke than CR alone, we conducted a multicenter randomized controlled trial that involved three hospitals in China. Three hundred sixty patients with subacute stroke were randomized into IMR and CR groups. The primary outcome was the Modified Barthel Index (MBI). The secondary outcomes were the National Institutes of Health Stroke Scale (NIHSS), the Fugl-Meyer Assessment (FMA), the mini-mental state examination (MMSE), the Montreal Cognitive Assessment (MoCA), Hamilton’s Depression Scale (HAMD), and the Self-Rating Depression Scale (SDS). All variables were evaluated at week 0 (baseline), week 4 (half-way of intervention), week 8 (after treatment) and week 20 (follow-up). In comparison with the CR group, the IMR group had significantly better improvements (P < 0.01 or P < 0.05) in all the primary and secondary outcomes. There were also significantly better changes from baseline in theses outcomes in the IMR group than in the CR group (P < 0.01). A low incidence of adverse events with mild symptoms was observed in the IMR group. We conclude that conventional rehabilitation combined with integrative medicine is safe and more effective for subacute stroke rehabilitation. PMID:27174221

  12. Comprehensive rehabilitation with integrative medicine for subacute stroke: A multicenter randomized controlled trial.

    PubMed

    Fang, Jianqiao; Chen, Lifang; Ma, Ruijie; Keeler, Crystal Lynn; Shen, Laihua; Bao, Yehua; Xu, Shouyu

    2016-05-13

    To determine whether integrative medicine rehabilitation (IMR) that combines conventional rehabilitation (CR) with acupuncture and Chinese herbal medicine has better effects for subacute stroke than CR alone, we conducted a multicenter randomized controlled trial that involved three hospitals in China. Three hundred sixty patients with subacute stroke were randomized into IMR and CR groups. The primary outcome was the Modified Barthel Index (MBI). The secondary outcomes were the National Institutes of Health Stroke Scale (NIHSS), the Fugl-Meyer Assessment (FMA), the mini-mental state examination (MMSE), the Montreal Cognitive Assessment (MoCA), Hamilton's Depression Scale (HAMD), and the Self-Rating Depression Scale (SDS). All variables were evaluated at week 0 (baseline), week 4 (half-way of intervention), week 8 (after treatment) and week 20 (follow-up). In comparison with the CR group, the IMR group had significantly better improvements (P < 0.01 or P < 0.05) in all the primary and secondary outcomes. There were also significantly better changes from baseline in theses outcomes in the IMR group than in the CR group (P < 0.01). A low incidence of adverse events with mild symptoms was observed in the IMR group. We conclude that conventional rehabilitation combined with integrative medicine is safe and more effective for subacute stroke rehabilitation.

  13. Herbal Medicines for Parkinson's Disease: A Systematic Review of Randomized Controlled Trials

    PubMed Central

    Kim, Tae-Hun; Cho, Ki-Ho; Jung, Woo-Sang; Lee, Myeong Soo

    2012-01-01

    Objective We conducted systematic review to evaluate current evidence of herbal medicines (HMs) for Parkinson's disease (PD). Methods Along with hand searches, relevant literatures were located from the electronic databases including CENTRAL, MEDLINE, EMBASE, CINAHL, AMED, PsycInfo, CNKI, 7 Korean Medical Databases and J-East until August, 2010 without language and publication status. Randomized controlled trials (RCTs), quasi-randomized controlled trials and randomized crossover trials, which evaluate HMs for idiopathic PD were selected for this review. Two independent authors extracted data from the relevant literatures and any disagreement was solved by discussion. Results From the 3432 of relevant literatures, 64 were included. We failed to suggest overall estimates of treatment effects on PD because of the wide heterogeneity of used herbal recipes and study designs in the included studies. When compared with placebo, specific effects were not observed in favor of HMs definitely. Direct comparison with conventional drugs suggested that there was no evidence of better effect for HMs. Many studies compared combination therapy with single active drugs and combination therapy showed significant improvement in PD related outcomes and decrease in the dose of anti-Parkinson's drugs with low adverse events rate. Conclusion Currently, there is no conclusive evidence about the effectiveness and efficacy of HMs on PD. For establishing clinical evidence of HMs on PD, rigorous RCTs with sufficient statistical power should be promoted in future. PMID:22615738

  14. Adolescent depressive disorders and family based interventions in the family options multicenter evaluation: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background There is increasing community and government recognition of the magnitude and impact of adolescent depression. Family based interventions have significant potential to address known risk factors for adolescent depression and could be an effective way of engaging adolescents in treatment. The evidence for family based treatments of adolescent depression is not well developed. The objective of this clinical trial is to determine whether a family based intervention can reduce rates of unipolar depressive disorders in adolescents, improve family functioning and engage adolescents who are reluctant to access mental health services. Methods/Design The Family Options study will determine whether a manualized family based intervention designed to target both individual and family based factors in adolescent depression (BEST MOOD) will be more effective in reducing unipolar depressive disorders than an active (standard practice) control condition consisting of a parenting group using supportive techniques (PAST). The study is a multicenter effectiveness randomized controlled trial. Both interventions are delivered in group format over eight weekly sessions, of two hours per session. We will recruit 160 adolescents (12 to 18 years old) and their families, randomized equally to each treatment condition. Participants will be assessed at baseline, eight weeks and 20 weeks. Assessment of eligibility and primary outcome will be conducted using the KID-SCID structured clinical interview via adolescent and parent self-report. Assessments of family mental health, functioning and therapeutic processes will also be conducted. Data will be analyzed using Multilevel Mixed Modeling accounting for time x treatment effects and random effects for group and family characteristics. This trial is currently recruiting. Challenges in design and implementation to-date are discussed. These include diagnosis and differential diagnosis of mental disorders in the context of adolescent

  15. Systematic review of randomised controlled trials of over the counter cough medicines for acute cough in adults

    PubMed Central

    Schroeder, Knut; Fahey, Tom

    2002-01-01

    Objectives To determine whether over the counter cough medicines are effective for acute cough in adults. Design Systematic review of randomised controlled trials. Data sources Search of the Cochrane Acute Respiratory Infections Group specialised register, Cochrane Controlled Trials Register, Medline, Embase, and the UK Department of Health National Research Register in all languages. Included studies All randomised controlled trials that compared oral over the counter cough preparations with placebo in adults with acute cough due to upper respiratory tract infection in ambulatory settings and that had cough symptoms as an outcome. Results 15 trials involving 2166 participants met all the inclusion criteria. Antihistamines seemed to be no better than placebo. There was conflicting evidence on the effectiveness of antitussives, expectorants, antihistamine-decongestant combinations, and other drug combinations compared with placebo. Conclusion Over the counter cough medicines for acute cough cannot be recommended because there is no good evidence for their effectiveness. Even when trials had significant results, the effect sizes were small and of doubtful clinical relevance. Because of the small number of trials in each category, the results have to be interpreted cautiously. What is already know on this topicThe NHS encourages self treatment of acute self limiting illnessesOver the counter cough medicines are commonly used as first line treatment for acute coughWhat this study addsThere is little evidence for or against the effectiveness of over the counter cough medicinesAlthough cough medicines are generally well tolerated, they may be an unnecessary expenseRecommendation of over the counter cough medicines to patients is not justified by current evidence PMID:11834560

  16. A prospective, randomized trial of integrative medicine for women with ovarian cancer☆,☆☆

    PubMed Central

    Judson, Patricia L.; Dickson, Elizabeth L.; Argenta, Peter A.; Xiong, Yin; Geller, Melissa A.; Carson, Linda F.; Ghebre, Rahel; Jonson, Amy L.; Downs, Levi S.

    2012-01-01

    Objectives Despite increased use of integrative medicine in cancer therapy, little data exist on its efficacy. This prospective, randomized, pilot trial sought to evaluate the feasibility of combined modality integrative medicine (CM-IM) in women with ovarian cancer (OvCA) and evaluate its effects on quality of life (QoL), chemotherapy toxicity and immunologic profiles. Methods Women with newly diagnosed OvCA requiring chemotherapy were offered enrollment. Those randomized to the experimental arm received hypnosis, therapeutic massage and healing touch with each cycle of chemotherapy. The control arm received chemotherapy without CM-IM. All patients completed QoL questionnaires prior to cycles 1, 3 and 6, and 6-months after chemotherapy. Immunologic profiles were measured. Statistical analysis was based on intent-to-treat. Student’s t-test and Fischer’s exact-test were used to determine differences. Results Forty-three women enrolled. All women randomized to CM-IM were successfully treated. There were no statistical differences between the groups in age, stage, grade, histologic cell type, CA125 levels, or surgical cytoreductive status. There was no difference in overall QoL measurements. Re-hospitalization rates, treatment delays, anti-emetic use, and infection rates were similar. Immunologic profiles revealed no difference between arms for WBC or salivary IgA levels. Women receiving CM-IM had consistently higher levels of CD4, CD8 and NK cells, although this did not reach statistical significance. Conclusions Prospective clinical evaluation of integrative medicine for women with gynecologic malignancy is feasible. This first, pilot study of CM-IM in gynecologic oncology demonstrated no improvement in QoL or chemotherapy toxicity. Integrative medicine-associated improvements in immunologic profiles warrant further investigation. PMID:21864886

  17. Methylphenidate for attention-deficit/hyperactivity disorder in children and adolescents: Cochrane systematic review with meta-analyses and trial sequential analyses of randomised clinical trials

    PubMed Central

    Krogh, Helle B; Ramstad, Erica; Moreira-Maia, Carlos R; Holmskov, Mathilde; Skoog, Maria; Nilausen, Trine Danvad; Magnusson, Frederik L; Zwi, Morris; Gillies, Donna; Rosendal, Susanne; Groth, Camilla; Rasmussen, Kirsten Buch; Gauci, Dorothy; Kirubakaran, Richard; Forsbøl, Bente; Simonsen, Erik; Gluud, Christian

    2015-01-01

    Study question Is methylphenidate beneficial or harmful for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents? Methods Electronic databases were searched up to February 2015 for parallel and crossover randomised clinical trials comparing methylphenidate with placebo or no intervention in children and adolescents with ADHD. Meta-analyses and trial sequential analyses (TSA) were conducted. Quality was assessed using GRADE. Teachers, parents, and observers rated ADHD symptoms and general behaviour. Study answer and limitations The analyses included 38 parallel group trials (n=5111, median treatment duration 49 days) and 147 crossover trials (n=7134, 14 days). The average age across all studies was 9.7 years. The analysis suggested a beneficial effect of methylphenidate on teacher rated symptoms in 19 parallel group trials (standardised mean difference (SMD) −0.77, n=1698), corresponding to a mean difference of −9.6 points on the ADHD rating scale. There was no evidence that methylphenidate was associated with an increase in serious adverse events (risk ratio 0.98, nine trials, n=1532; TSA adjusted intervention effect RR 0.91). Methylphenidate was associated with an increased risk of non-serious adverse events (1.29, 21 trials, n=3132; TSA adjusted RR 1.29). Teacher rated general behaviour seemed to improve with methylphenidate (SMD −0.87, five trials, n=668) A change of 7 points on the child health questionnaire (CHQ) has been deemed a minimal clinically relevant difference. The change reported in a meta-analysis of three trials corresponds to a mean difference of 8.0 points on the CHQ (range 0-100 points), which suggests that methylphenidate may improve parent reported quality of life (SMD 0.61, three trials, n=514). 96.8% of trials were considered high risk of bias trials according to the Cochrane guidelines. All outcomes were assessed very low quality according to GRADE. What this study adds The results suggest that

  18. A Clustered Randomized Controlled Trial of the Positive Prevention PLUS Adolescent Pregnancy Prevention Program

    PubMed Central

    2016-01-01

    Objectives. To determine the impact of Positive Prevention PLUS, a school-based adolescent pregnancy prevention program on delaying sexual intercourse, birth control use, and pregnancy. Methods. I randomly assigned a diverse sample of ninth grade students in 21 suburban public high schools in California into treatment (n = 2483) and control (n = 1784) groups that participated in a clustered randomized controlled trial. Between October 2013 and May 2014, participants completed baseline and 6-month follow-up surveys regarding sexual behavior and pregnancy. Participants in the treatment group were offered Positive Prevention PLUS, an 11-lesson adolescent pregnancy prevention program. Results. The program had statistically significant impacts on delaying sexual intercourse and increasing the use of birth control. However, I detected no program effect on pregnancy rates at 6-month follow-up. Conclusions. The Positive Prevention PLUS program demonstrated positive impacts on adolescent sexual behavior. This suggests that programs that focus on having students practice risk reduction skills may delay sexual activity and increase birth control use. PMID:27689502

  19. Weekend Schoolyard Accessibility, Physical Activity, and Obesity: The Trial of Activity in Adolescent Girls (TAAG) Study

    PubMed Central

    Scott, Molly M; Cohen, Deborah A; Evenson, Kelly R; Elder, John; Catellier, Diane; Ashwood, J. Scott; Overton, Adrian

    2007-01-01

    Objectives To assess the accessibility and suitability of schools as recreational sites and to determine whether they are associated with young adolescent girls’ weekend metabolic equivalent-weighted moderate-to-vigorous (MW-MVPA) physical activity and body mass index (BMI). Methods We drew a half-mile (0.805 km) radius around the residences of participants in Trial of Activity for Adolescent Girls (n=1556) in Maryland, South Carolina, Minnesota, Louisiana, California, and Arizona. We visited all schools and parks within the defined distance and documented their amenities and accessibility on Saturdays in Spring 2003. Staff gathered data on each girls’ height and weight and used accelerometers to record weekend MW-MVPA. Results Schools represented 44% of potential neighborhood sites for physical activity. However, a third of schools were inaccessible on the Saturday we visited. Neighborhoods with locked schools were primarily non-white, older, more densely populated, and of lower socioeconomic status. Though there was no relationship between school accessibility on Saturdays and weekend MW-MVPA, the number of locked schools was associated with significantly higher BMI. Conclusions The lack of relationship between MW-MVPA and school accessibility may imply that young adolescent girls do not identify schools as recreational resources. However, due to the association between BMI and locked schools, efforts to stem the obesity epidemic should include making schools more accessible. PMID:17292958

  20. Understanding Adolescent Nonresponsiveness to Text Messages: Lessons from the DepoText Trial.

    PubMed

    Irons, Mallory; Tomaszewski, Kathy; Muñoz Buchanan, Cara R; Trent, Maria

    2015-06-01

    Urban adolescents face economic, social, and behavioral challenges in adhering to long-term contraceptive use. Use of text messaging reminders has the potential to increase adherence to family planning appointments and to educate patients about safe sexual health practices; however, nonresponsiveness to messages is difficult to interpret and may jeopardize programmatic success. We aimed to understand why adolescent girls enrolled in a randomized, controlled pilot trial (DepoText) designed to increase attendance at family planning visits were periodically nonresponsive to text messages through conducting structured interviews with participants whose text reply rates were less than 100 % during the trial period. Qualitative and quantitative data were collected and classified using descriptive data analysis. Reasons for nonresponsiveness, barriers to continuous cell phone coverage, cell phone plan characteristics, and attitudes toward the DepoText program were the primary endpoints of interest. Most participants (78%) attributed instances of nonresponsiveness to being away from the phone or due to a personal conflict such as school or work. Service interruption due to bill nonpayment (44%), phone loss (28%), and cell phone number change (28%) were significant barriers to continuous coverage during the trial period, and many respondents indicated that the downturn in the economy made it more difficult to maintain their cell phone plan. Almost a third reported having to choose between cell phone and other payments, but the vast majority (88%) considered their cell phone a "need" rather than a "want." Participants universally expressed satisfaction with the text messaging program and reported feeling more connected to the clinic (96%) through the messages serving as reminders (64%), encouragement to assume personal responsibility for their health care (12%), and enhanced personal connection with the clinic staff (4%). Our study suggests that a text messaging program can

  1. Bioinformatics for precision medicine in oncology: principles and application to the SHIVA clinical trial

    PubMed Central

    Servant, Nicolas; Roméjon, Julien; Gestraud, Pierre; La Rosa, Philippe; Lucotte, Georges; Lair, Séverine; Bernard, Virginie; Zeitouni, Bruno; Coffin, Fanny; Jules-Clément, Gérôme; Yvon, Florent; Lermine, Alban; Poullet, Patrick; Liva, Stéphane; Pook, Stuart; Popova, Tatiana; Barette, Camille; Prud’homme, François; Dick, Jean-Gabriel; Kamal, Maud; Le Tourneau, Christophe; Barillot, Emmanuel; Hupé, Philippe

    2014-01-01

    Precision medicine (PM) requires the delivery of individually adapted medical care based on the genetic characteristics of each patient and his/her tumor. The last decade witnessed the development of high-throughput technologies such as microarrays and next-generation sequencing which paved the way to PM in the field of oncology. While the cost of these technologies decreases, we are facing an exponential increase in the amount of data produced. Our ability to use this information in daily practice relies strongly on the availability of an efficient bioinformatics system that assists in the translation of knowledge from the bench towards molecular targeting and diagnosis. Clinical trials and routine diagnoses constitute different approaches, both requiring a strong bioinformatics environment capable of (i) warranting the integration and the traceability of data, (ii) ensuring the correct processing and analyses of genomic data, and (iii) applying well-defined and reproducible procedures for workflow management and decision-making. To address the issues, a seamless information system was developed at Institut Curie which facilitates the data integration and tracks in real-time the processing of individual samples. Moreover, computational pipelines were developed to identify reliably genomic alterations and mutations from the molecular profiles of each patient. After a rigorous quality control, a meaningful report is delivered to the clinicians and biologists for the therapeutic decision. The complete bioinformatics environment and the key points of its implementation are presented in the context of the SHIVA clinical trial, a multicentric randomized phase II trial comparing targeted therapy based on tumor molecular profiling versus conventional therapy in patients with refractory cancer. The numerous challenges faced in practice during the setting up and the conduct of this trial are discussed as an illustration of PM application. PMID:24910641

  2. Development and evaluation of a web-based assent for adolescents considering an HIV vaccine trial.

    PubMed

    Blake, Diane R; Lemay, Celeste A; Maranda, Louise S; Fortenberry, J Dennis; Kearney, Margaret H; Mazor, Kathleen M

    2015-01-01

    HIV vaccine trials with minors will likely require parental permission and informed assent from adolescents. For this to be a valid process, the information needs to be presented in a manner that promotes adolescent comprehension. Previous studies suggest that adolescent comprehension of assent is often insufficient. We developed an interactive web-based assent that included interspersed quiz questions for a hypothetical HIV vaccine trial. Efficacy of the web-based assent was compared to a standard paper assent with and without interspersed questions. One hundred twenty teen participants, ages 15-17 years, from five community organizations were randomized to self-administered web-based assent (n=60) or investigator-administered paper assent with (n=29) or without (n=31) interspersed quiz questions. After reviewing the assent, participants completed a 27-item comprehension test. Comprehension scores were compared between groups. The mean number of correctly answered questions were 21.2 for the full paper group and 21.1 for the web-based group (t118=-0.08, p=0.94). Scores were 20.2 for the paper without interspersed questions sub-group and 22.1 for the paper with interspersed questions sub-group (t58=1.96, p=0.055). Participants in the web-based group performed as well on the comprehension test as those in the paper group, and those in the paper with questions sub-group performed better than those in the paper without questions sub-group, suggesting that interspersed quiz questions may improve understanding of a traditional paper assent. The minimal investigator time and standardized administration of the web-based assent as well as ability to tailor the assent discussion to topics identified by incorrect comprehension test responses are advantages worthy of further investigation.

  3. Development and Evaluation of a Web-based Assent for Adolescents Considering an HIV Vaccine Trial

    PubMed Central

    Blake, Diane R.; Lemay, Celeste A.; Maranda, Louise S.; Fortenberry, J. Dennis; Kearney, Margaret H.; Mazor, Kathleen M.

    2015-01-01

    HIV vaccine trials with minors will likely require parental permission and informed assent from adolescents. For this to be a valid process, the information needs to be presented in a manner that promotes adolescent comprehension. Previous studies suggest that adolescent comprehension of assent is often insufficient. We developed an interactive web-based assent that included interspersed quiz questions for a hypothetical HIV vaccine trial. Efficacy of the web-based assent was compared to a standard paper assent with and without interspersed questions. One hundred twenty teen participants, ages 15-17 years, from 5 community organizations were randomized to self-administered web-based assent (n=60) or investigator-administered paper assent with (n=29) or without (n=31) interspersed quiz questions. After reviewing the assent, participants completed a 27 item comprehension test. Comprehension scores were compared between groups. The mean number of correctly answered questions were 21.2 for the full paper group and 21.1 for the web-based group (t(118)=-0.08, p=0.94). Scores were 20.2 for the paper without interspersed questions sub-group and 22.1 for the paper with interspersed questions sub-group (t(58)=1.96, p=0.055). Participants in the web-based group performed as well on the comprehension test as those in the paper group, and those in the paper with questions sub-group performed better than those in the paper without questions sub-group, suggesting that interspersed quiz questions may improve understanding of a traditional paper assent. The minimal investigator time and standardized administration of the web-based assent as well as ability to tailor the assent discussion to topics identified by incorrect comprehension test responses are advantages worthy of further investigation. PMID:25803694

  4. Intervention Effects on Adolescent Physical Activity in the Multicomponent SPACE Study: A Cluster Randomized Controlled Trial

    PubMed Central

    Toftager, Mette; Christiansen, Lars B.; Ersbøll, Annette K.; Kristensen, Peter L.; Due, Pernille; Troelsen, Jens

    2014-01-01

    Background Multicomponent school-based interventions have the potential to reduce the age-related decline in adolescents' physical activity (PA), yet there is not consistent evidence to guide non-curricular and school environment interventions. The aim of this study was to assess the effectiveness of a multicomponent environmental school-based intervention, designed to reduce the age-related decline in PA among adolescents. Methods A cluster randomized controlled trial was conducted with 7 intervention and 7 control schools. Baseline measurements were carried out in spring 2010 with 2 years of follow-up. A total of 1,348 students (11–13 years, in grade 5 and 6) enrolled in the study at baseline. The 14 schools included in the study were located in the Region of Southern Denmark. The intervention consisted of organizational and physical changes in the school environment with a total of 11 intervention components. The primary outcome measure was overall PA (cpm, counts per minute) and was supported by analyses of time spent in MVPA, and time spent sedentary. Furthermore, a secondary outcome measure was PA in school time and during recess. PA was measured using accelerometer (Actigraph GT3X). Results A total of 797 students completed the trial and had valid accelerometer data. No significant difference was found for overall PA with an adjusted difference of −19.1 cpm (95% CI: −93, 53) or for school time activity with an adjusted difference of 6 cpm (95% CI: −73, 85). A sensitivity analysis revealed a positive significant intervention effect of PA in recess with an adjusted difference of 95 cpm. Conclusions No evidence was found of the overall effect of a non-curricular multicomponent school-based intervention on PA among Danish adolescents. The intervention was positively associated with PA during school time and recess, however, with small estimates. Lack of effect on overall PA could be due to both program theory and different degrees of implementation

  5. Does Interpersonal Psychotherapy improve clinical care for adolescents with depression attending a rural child and adolescent mental health service? Study protocol for a cluster randomised feasibility trial

    PubMed Central

    Bearsley-Smith, Cate; Browne, Mark Oakley; Sellick, Ken; Villanueva, Elmer V; Chesters, Janice; Francis, Karen; Reddy, Prasuna

    2007-01-01

    Background Depression amongst adolescents is a costly societal problem. Little research documents the effectiveness of public mental health services in mapping this problem. Further, it is not clear whether usual care in such services can be improved via clinician training in a relevant evidence based intervention. One such intervention, found to be effective and easily learned amongst novice clinicians, is Interpersonal Psychotherapy (IPT). The study described in the current paper has two main objectives. First, it aims to investigate the impact on clinical care of implementing Interpersonal Psychotherapy for Adolescents for the treatment of adolescent depression within a rural mental health service compared with Treatment as Usual (TAU). The second objective is to record the process and challenges (i.e. feasibility, acceptability, sustainability) associated with implementing and evaluating an evidence-based intervention within a community service. This paper outlines the study rationale and design for this community based research trial. Methods/design The study involves a cluster randomisation trial to be conducted within a Child and Adolescent Mental Health Service in rural Australia. All clinicians in the service will be invited to participate. Participating clinicians will be randomised via block design at each of four sites to (a) training and delivery of IPT, or (b) TAU. The primary measure of impact on care will be a clinically significant change in depressive symptomatology, with secondary outcomes involving treatment satisfaction and changes in other symptomatology. Participating adolescents with significant depressive symptomatology, aged 12 to 18 years, will complete assessment measures at Weeks 0, 12 and 24 of treatment. They will also complete a depression inventory once a month during that period. This study aims to recruit 60 adolescent participants and their parent/guardian/s. A power analysis is not indicated as an intra-class correlation

  6. Text Message Delivered Peer Network Counseling for Adolescent Smokers: A Randomized Controlled Trial.

    PubMed

    Mason, Michael; Mennis, Jeremy; Way, Thomas; Zaharakis, Nikola; Campbell, Leah Floyd; Benotsch, Eric G; Keyser-Marcus, Lori; King, Laura

    2016-10-01

    Although adolescent tobacco use has declined in the last 10 years, African American high school seniors' past 30-day use has increased by 12 %, and as they age they are more likely to report lifetime use of tobacco. Very few urban youth are enrolled in evidenced-based smoking prevention and cessation programming. Therefore, we tested a text messaging smoking cessation intervention designed to engage urban youth through an automated texting program utilizing motivational interviewing-based peer network counseling. We recruited 200 adolescents (90.5 % African American) into a randomized controlled trial that delivered either the experimental intervention of 30 personalized motivational interviewing-based peer network counseling messages, or the attention control intervention, consisting of text messages covering general (non-smoking related) health habits. All adolescents were provided smart phones for the study and were assessed at baseline, and at 1, 3, and 6 months post intervention. Utilizing repeated measures general linear models we examined the effects of the intervention while controlling for race, gender, age, presence of a smoker in the home, and mental health counseling. At 6 months, participants in the experimental condition significantly decreased the number of days they smoked cigarettes and the number of cigarettes they smoked per day; they significantly increased their intentions not to smoke in the future; and significantly increased peer social support among girls. For boys, participants in the experimental condition significantly reduced the number of close friends in their networks who smoke daily compared to those in the control condition. Effect sizes ranged from small to large. These results provide encouraging evidence of the efficacy of text messaging interventions to reduce smoking among adolescents and our intervention holds promise as a large-scale public health preventive intervention platform.

  7. Behavioral effects of neurofeedback in adolescents with ADHD: a randomized controlled trial.

    PubMed

    Bink, Marleen; van Nieuwenhuizen, Chijs; Popma, Arne; Bongers, Ilja L; van Boxtel, Geert J M

    2015-09-01

    Neurofeedback has been proposed as a potentially effective intervention for reducing Attention Deficit Hyperactivity Disorder (ADHD) symptoms. However, it remains unclear whether neurofeedback is of additional value to treatment as usual (TAU) for adolescents with clinical ADHD symptoms. Using a multicenter parallel-randomized controlled trial design, adolescents with ADHD symptoms were randomized to receive either a combination of TAU and neurofeedback (NFB + TAU, n = 45) or TAU-only (n = 26). Randomization was computer generated and stratified for age group (ages 12 through 16, 16 through 20, 20 through 24). Neurofeedback treatment consisted of approximately 37 sessions of theta/sensorimotor rhythm (SMR)-training on the vertex (Cz). Primary behavioral outcome measures included the ADHD-rating scale, Youth Self Report, and Child Behavior Checklist all assessed pre- and post-intervention. Behavioral problems decreased equally for both groups with medium to large effect sizes, range of partial η2 = 0.08-0.31, p < 0.05. Hence, the combination of NFB + TAU was not more effective than TAU-only on the behavioral outcome measures. In addition, reported adverse effects were similar for both groups. On behavioral outcome measures, the combination of neurofeedback and TAU was as effective as TAU-only for adolescents with ADHD symptoms. Considering the absence of additional behavioral effects in the current study, in combination with the limited knowledge of specific treatment effects, it is questionable whether theta/SMR neurofeedback for adolescents with ADHD and comorbid disorders in clinical practice should be used. Further research is warranted to investigate possible working mechanisms and (long-term) specific treatment effects of neurofeedback.

  8. Can homeopaths detect homeopathic medicines by dowsing? A randomized, double-blind, placebo-controlled trial

    PubMed Central

    McCarney, R; Fisher, P; Spink, F; Flint, G; van Haselen, R

    2002-01-01

    Dowsing is a method of problem-solving that uses a motor automatism, amplified through a pendulum or similar device. In a homeopathic context, it is used as an aid to prescribing and as a tool to identify miasm or toxin load. A randomized double-blind trial was conducted to determine whether six dowsing homeopaths were able to distinguish between Bryonia in a 12c potency and placebo by use of dowsing alone. The homeopathic medicine Bryonia was correctly identified in 48.1% of bottle pairs (n=156; 95% confidence interval 40.2%, 56.0%; P=0.689). These results, wholly negative, add to doubts whether dowsing in this context can yield objective information. PMID:11934908

  9. Can homeopaths detect homeopathic medicines by dowsing? A randomized, double-blind, placebo-controlled trial.

    PubMed

    McCarney, R; Fisher, P; Spink, F; Flint, G; van Haselen, R

    2002-04-01

    Dowsing is a method of problem-solving that uses a motor automatism, amplified through a pendulum or similar device. In a homeopathic context, it is used as an aid to prescribing and as a tool to identify miasm or toxin load. A randomized double-blind trial was conducted to determine whether six dowsing homeopaths were able to distinguish between Bryonia in a 12c potency and placebo by use of dowsing alone. The homeopathic medicine Bryonia was correctly identified in 48.1% of bottle pairs (n=156; 95% confidence interval 40.2%, 56.0%; P=0.689). These results, wholly negative, add to doubts whether dowsing in this context can yield objective information. PMID:11934908

  10. School-Based Health Center Model Within the Military Health System: The Role of the Adolescent Medicine Physician.

    PubMed

    Greene, Jeffery P; Dawson, Rachel

    2016-09-01

    Adolescents are less motivated to seek medical care for various reasons. Within the military health care system, access barriers, although less encountered, can still be a burden not only to the adolescent, but also the school system. This article describes the development of a school-based health center within a school district on a military installation. The school clinic was created by adolescent medicine specialists to maximize access to care. Students of adolescent age utilized the clinic for evaluation of acute and chronic conditions, preventative services, preparticipation evaluation, and other general complaints. After receiving signed consent forms, 30% of students were eligible for health care. There was minimal cost to initiate the service. Development of school-based health center programs at other military installations could potentially improve the status of the military health system during a time of high stress among military dependents. PMID:27612351

  11. A regulatory perspective of clinical trial applications for biological products with particular emphasis on Advanced Therapy Medicinal Products (ATMPs).

    PubMed

    Jones, David R; McBlane, James W; McNaughton, Graham; Rajakumaraswamy, Nishanthan; Wydenbach, Kirsty

    2013-08-01

    The safety of trial subjects is the tenet that guides the regulatory assessment of a Clinical Trial Authorization application and applies equally to trials involving small molecules and those with biological/biotechnological products, including Advanced Therapy Medicinal Products. The objective of a regulator is to ensure that the potential risk faced by a trial subject is outweighed by the potential benefit to them from taking part in the trial. The focus of the application review is to assess whether risks have been identified and appropriate steps taken to alleviate these as much as possible. Other factors are also taken into account during a review, such as regulatory requirements, and emerging non-clinical and clinical data from other trials on the same or similar products. This paper examines the regulatory review process of a Clinical Trial Authorization application from the perspectives of Quality, Non-Clinical and Clinical Regulatory Assessors at the Medicines and Healthcare products Regulatory Agency. It should be noted that each perspective has highlighted specific issues from their individual competence and that these can be different between the disciplines.

  12. Chinese Herbal Medicine for Aspirin Resistance: A Systematic Review of Randomized Controlled Trials

    PubMed Central

    Liu, Ai-ju; Li, Hui-qin; Li, Ji-huang; Wang, Yuan-yuan; Chen, Dong; Wang, Yan

    2014-01-01

    Aspirin resistance (AR) is a prevalent phenomenon and leads to significant clinical consequences, but the current evidence for effective interventional strategy is insufficient. The objective of this systematic review is thus to assess the efficacy and safety of Chinese herbal medicine (CHM) for AR. A systematical literature search was conducted in 6 databases until December 2012 to identify randomized controlled trials (RCTs) of CHM for AR. As a result, sixteen RCTs with a total of 1011 subjects were identified, suggesting that the interests of the medical profession and the public in the use of CHM for AR have grown considerably in the recent years. Tongxinluo capsule and Danshen-based prescriptions were the most frequently used herbal prescriptions, while danshen root, milkvetch root, Leech, and Rosewood were the most frequently used single herbs. Despite the apparent reported positive findings, it is premature to determine the efficacy and safety of CHM for the treatment of AR due to poor methodological quality and insufficient safety data. However, CHMs appeared to be well tolerated in all included studies. Thus, CHM as a promising candidate is worthy of improvement and development for further clinical AR trials. Large sample-size and well-designed rigorous RCTs are needed. PMID:24701247

  13. Randomized Trial Outcomes of a TTM-Tailored Condom Use and Smoking Intervention in Urban Adolescent Females

    ERIC Educational Resources Information Center

    Redding, Colleen A.; Prochaska, James O.; Armstrong, Kay; Rossi, Joseph S.; Hoeppner, Bettina B.; Sun, Xiaowu; Kobayashi, Hisanori; Yin, Hui-Qing; Coviello, Donna; Evers, Kerry; Velicer, Wayne F.

    2015-01-01

    Smoking and sexual risk behaviors in urban adolescent females are prevalent and problematic. Family planning clinics reach those who are at most risk. This randomized effectiveness trial evaluated a transtheoretical model (TTM)-tailored intervention to increase condom use and decrease smoking. At baseline, a total of 828 14- to 17-year-old females…

  14. A Randomized Controlled Trial of Pemoline for Attention-Deficit-hyperactivity Disorder in Substance-Abusing Adolescents

    ERIC Educational Resources Information Center

    Riggs, Paula D.; Hall, Shannon K.; Mikulich-Gilbertson, Susan K.; Lohman, Michelle; Kayser, Ashley

    2004-01-01

    Objective: In adolescents with substance use disorder (SUD), comorbid attention-deficit/hyperactivity disorder (ADHD) is associated with greater severity of substance abuse, conduct problems, and worse treatment outcomes. Although many controlled trials have established the efficacy of psychostimulants, including pemoline, for ADHD in children and…

  15. Randomized, Controlled Trial of Atomoxetine for Attention-Deficit/Hyperactivity Disorder in Adolescents with Substance Use Disorder

    ERIC Educational Resources Information Center

    Thurstone, Christian; Riggs, Paula D.; Salomonsen-Sautel, Stacy; Mikulich-Gilbertson, Susan K.

    2010-01-01

    Objective: To evaluate the effect of atomoxetine hydrochloride versus placebo on attention-deficit/hyperactivity disorder (ADHD) and substance use disorder (SUD) in adolescents receiving motivational interviewing/cognitive behavioral therapy (MI/CBT) for SUD. Method: This single-site, randomized, controlled trial was conducted between December…

  16. Randomized, Controlled Trial of Behavioral Family Systems Therapy for Diabetes: Maintenance and Generalization of Effects on Parent-Adolescent Communication

    ERIC Educational Resources Information Center

    Wysocki, Tim; Harris, Michael A.; Buckloh, Lisa M.; Mertlich, Deborah; Lochrie, Amanda Sobel; Taylor, Alexandra; Sadler, Michelle; White, Neil H.

    2008-01-01

    We report a randomized trial of a revised Behavioral Family Systems Therapy for Diabetes (BFST-D) intervention. Families of 104 adolescents with diabetes were randomized to standard care (SC) or to 6 months of an educational support group (ES) or BFST-D. Family communication and problem-solving skills were assessed at 0, 6, 12, and 18 months by…

  17. Guanfacine Extended Release in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder: A Placebo-Controlled Trial

    ERIC Educational Resources Information Center

    Sallee, Floyd R.; McGough, James; Wigal, Tim; Donahue, Jessica; Lyne, Andrew; Biederman, Joseph

    2009-01-01

    A double-blind, 9-week, randomized trial was done to compare the efficacy of guanfacine extended release (GXR) with a placebo in treating children and adolescents with attention-deficit/hyperactivity disorders (ADHD). Results find a significant reduction in ADHD from baseline to endpoint for all daily doses of GXR which were measured at 1-, 2-,…

  18. The YouthMood Project: A Cluster Randomized Controlled Trial of an Online Cognitive Behavioral Program with Adolescents

    ERIC Educational Resources Information Center

    Calear, Alison L.; Christensen, Helen; Mackinnon, Andrew; Griffiths, Kathleen M.; O'Kearney, Richard

    2009-01-01

    The aim in the current study was to investigate the effectiveness of an online, self-directed cognitive-behavioral therapy program (MoodGYM) in preventing and reducing the symptoms of anxiety and depression in an adolescent school-based population. A cluster randomized controlled trial was conducted with 30 schools (N = 1,477) from across…

  19. Using and teaching evidence-based medicine: the Duke University child and adolescent psychiatry model.

    PubMed

    March, John S; Chrisman, Allan; Breland-Noble, Alfiee; Clouse, Kelly; D'Alli, Richard; Egger, Helen; Gammon, Pat; Gazzola, Marta; Lin, Anne; Mauro, Christian; Rana, Aasim; Ravi, Himabindu; Srirama, Madhanika; Su, Hansen; Thrall, Grace; van de Velde, Polly

    2005-04-01

    Evidence-based medicine (EBM) is defined as a set of processes that facilitate the conscientious, explicit, and judicious integration of individual clinical expertise with the best available external clinical evidence from systematic research in making decisions about the care of individual patients. EBM focuses not only on grading the strength of the evidence but also on the processes and tools that are necessary for clinicians to continually upgrade their knowledge and skills for those problems encountered in daily practice. This article, authored by members of the Duke Pediatric Psychiatry EBM Seminar Team, (1) describes EBM as applied to the training of child and adolescent psychiatrists in the Division of Child and Adolescent Psychiatry, Department of Psychiatry at Duke University Medical Center; (2) presents a simplified discussion of EBM as a technology for training and patient care; (3) discusses the basic principles and procedures for teaching EBM in the setting of a multidisciplinary training program; and (4) briefly mentions two training and research initiatives that are furthered by incorporating EBM.

  20. Availability and affordability of new medicines in Latin American countries where pivotal clinical trials were conducted

    PubMed Central

    Ugalde, Antonio

    2015-01-01

    Abstract Objective To assess whether new pharmaceutical products approved by the United States Food and Drug Administration (FDA) in 2011 and 2012 were registered, commercialized and sold at affordable prices in the Latin American countries where they were tested. Methods We obtained a list of new molecular entities (new pharmaceutical products) approved by the FDA in 2011 and 2012. FDA medical reviews indicated the countries where pivotal clinical trials had been conducted. The registration status of the products was obtained from pharmaceutical registers; pharmaceutical companies confirmed their availability in national markets and local pricing observatories provided the price of medicines in retail pharmacies. Affordability was assessed as the cost of a course of treatment as a proportion of monthly income. Information on safety and efficacy was gathered from independent drug bulletins. Findings Of an expected 114 registrations, if the 33 products had been registered in all the countries where tested, only 68 (60%) were completed. Eight products were registered and commercialized in all countries but 10 had not been registered in any of the countries. With one exception, products for which we obtained pricing information (n = 18) cost more than the monthly minimum wage in all countries and 12 products cost at least five times the monthly minimum wage. Conclusion Many pharmaceutical products tested in Latin America are unavailable and/or unaffordable to most of the population. Ethical review committees should consider the local affordability and therapeutic relevance of new products as additional criteria for the approval of clinical trials. Finally, clinical trials have opportunity costs that need to be assessed. PMID:26600609

  1. [Randomized controlled trial on the promotion of healthy lifestyles among adolescents in the orthodontic setting: study protocol].

    PubMed

    La Torre, G; Rossini, G; Saulle, R; Mannocci, A; Di Thiene, D; Mauro, V; Barbato, E

    2013-01-01

    Many studies have shown that the bad lifestyles are the major factors thought to influence susceptibility to many diseases in our society and often these habits during the adolescence begin. The aim of the study was to evaluate the health promotion intervention effect in an orthodontic adolescent sample, in particular: deterring adolescents from smoking; discourage the use and abuse of alcoholic beverages; encourage the adherence to the Mediterranean style diet. A blinded randomized controlled trial will be performed. The participants will be adolescents aged 10 to 14 years that will receive a medical examination in the Complex Unit of Orthodontics. The sample will be followed for three years. The collected evidence would be a scientific support for decisions in public health, in order to increase the health of the young generations.

  2. Interventions to reduce unintended pregnancies among adolescents: systematic review of randomised controlled trials

    PubMed Central

    DiCenso, Alba; Guyatt, Gordon; Willan, A; Griffith, L

    2002-01-01

    Objective To review the effectiveness of primary prevention strategies aimed at delaying sexual intercourse, improving use of birth control, and reducing incidence of unintended pregnancy in adolescents. Data sources 12 electronic bibliographic databases, 10 key journals, citations of relevant articles, and contact with authors. Study selection 26 trials described in 22 published and unpublished reports that randomised adolescents to an intervention or a control group (alternate intervention or nothing). Data extraction Two independent reviewers assessed methodological quality and abstracted data. Data synthesis The interventions did not delay initiation of sexual intercourse in young women (pooled odds ratio 1.12; 95% confidence interval 0.96 to 1.30) or young men (0.99; 0.84 to 1.16); did not improve use of birth control by young women at every intercourse (0.95; 0.69 to 1.30) or at last intercourse (1.05; 0.50 to 2.19) or by young men at every intercourse (0.90; 0.70 to 1.16) or at last intercourse (1.25; 0.99 to 1.59); and did not reduce pregnancy rates in young women (1.04; 0.78 to 1.40). Four abstinence programmes and one school based sex education programme were associated with an increase in number of pregnancies among partners of young male participants (1.54; 1.03 to 2.29). There were significantly fewer pregnancies in young women who received a multifaceted programme (0.41; 0.20 to 0.83), though baseline differences in this study favoured the intervention. Conclusions Primary prevention strategies evaluated to date do not delay the initiation of sexual intercourse, improve use of birth control among young men and women, or reduce the number of pregnancies in young women. What is already known on this topicUnintended pregnancies among adolescents pose a considerable problem for the young parents, the child, and societyWhat this study addsPrimary prevention strategies evaluated to date do not delay the initiation of sexual intercourse or improve use of

  3. Is the European pediatric medicine regulation working for children and adolescents with cancer?

    PubMed

    Vassal, Gilles; Geoerger, Birgit; Morland, Bruce

    2013-03-15

    The European Pediatric Medicine Regulation was launched in 2007 to provide better medicines for children. Five years later, the number of new anticancer drugs in early development in the pediatric population remains low, and most children with cancer are still largely denied access to innovative drugs in Europe, as compared with the United States. We analyzed individual pediatric investigation plan (PIP) and waiver decisions for oncology drugs and all oncology drugs that have been approved for marketing authorization since 2007 in Europe. Among the 45 approved PIPs, 33% concern leukemias and lymphomas, 29% solid tumors, 13% brain tumors, and 20% a drug for supportive care. No specific PIP exists for life-threatening diseases such as high-risk neuroblastoma, whereas there are several PIPs in extremely rare malignancies in children and adolescents such as gastrointestinal stromal tumor, melanoma, thyroid cancer, and chronic myeloid leukemia. This paradoxical situation is due to approval of a PIP being driven by the adult indication. Twenty-six of 28 authorized new oncology drugs have a potentially relevant mechanism of action for pediatric malignancies, but 50% have been waived because the adult condition does not occur in children. The most striking example is crizotinib. Implementation of the pediatric regulation should no longer be driven by the adult indication but should be guided instead by the biology of pediatric tumors and the mechanism of action of a drug. This change will be achievable through voluntary PIPs submitted by Pharma or revocation of the oncology class waiver list.

  4. The adolescence of AI in medicine: will the field come of age in the '90s?

    PubMed

    Shortliffe, E H

    1993-04-01

    Artificial intelligence in medicine (AIM) has reached a period of adolescence in which interactions with the outside world are not only natural but mandatory. Although the basic research topics in AIM may be those of artificial intelligence, the applied issues touch more generally on the broad field of medical informatics. To the extent that AIM research is driven by performance goals for biomedicine, AIM is simply one component within a wide range of research and development activities. Furthermore, an adequate appraisal of AIM research requires an understanding of the research motivations, the complexity of the problems, and a suitable definition of the criteria for judging the field's success. Effective fielding of AIM systems will be dependent on the development of integrated environments for communication and computing that allow merging of knowledge-based tools with other patient data-management and information-retrieval applications. The creation of this kind of infrastructure will require vision and resources from leaders who realize that the practice of medicine is inherently an information-management task and that biomedicine must make the same kind of coordinated commitment to computing technologies as have other segments of our society in which the importance of information management is well understood.

  5. Interpersonal and Social Rhythm Therapy for Adolescents with Bipolar Disorder: Treatment Development and Results from an Open Trial

    PubMed Central

    Hlastala, Stefanie A.; Kotler, Julie S.; McClellan, Jon M.; McCauley, Elizabeth A.

    2010-01-01

    Background In adolescents and adults, bipolar disorder (BD) is associated with significant morbidity, mortality, and impairment in psychosocial and occupational functioning. IPSRT is an empirically-supported adjunctive psychotherapy for adults with bipolar disorder which has been shown to help delay relapse, speed recovery from a bipolar depressive episode, and increase occupational and psychosocial functioning in adults with BD. The current study is designed to describe the adolescent-specific developmental adaptations made to IPSRT (i.e., IPSRT-A) and to report the results from an open trial of IPSRT-A with 12 adolescents with a bipolar spectrum disorder. Method Interpersonal and Social Rhythm Therapy was adapted to be developmentally-relevant to adolescents with bipolar disorder. Twelve adolescents (mean age 16.5 ± 1.3 years) diagnosed with a bipolar spectrum disorder participated in 16–18 sessions of adjunctive IPSRT-A over 20 weeks. Manic, depressive, and general symptoms and global functioning were measured at baseline, monthly during treatment, and at post-treatment. Adolescent satisfaction with treatment was also measured. Results Feasibility and acceptability of IPSRT-A were high; 11/12 participants completed treatment, 97% of sessions were attended, and adolescent-rated satisfaction scores were high. IPSRT-A participants experienced significant decreases in manic, depressive and general psychiatric symptoms over the 20 weeks of treatment. Participants’ global functioning increased significantly as well. Effect sizes ranged from medium-large to large. Conclusions IPSRT-A appears to be a promising adjunctive treatment for adolescents with bipolar disorder. A current randomized controlled trial is underway to examine effects of adjunctive IPSRT-A on psychiatric symptoms and psychosocial functioning. PMID:20186968

  6. A Randomized Controlled Trial to Test the Effectiveness of an Immersive 3D Video Game for Anxiety Prevention among Adolescents.

    PubMed

    Scholten, Hanneke; Malmberg, Monique; Lobel, Adam; Engels, Rutger C M E; Granic, Isabela

    2016-01-01

    Adolescent anxiety is debilitating, the most frequently diagnosed adolescent mental health problem, and leads to substantial long-term problems. A randomized controlled trial (n = 138) was conducted to test the effectiveness of a biofeedback video game (Dojo) for adolescents with elevated levels of anxiety. Adolescents (11-15 years old) were randomly assigned to play Dojo or a control game (Rayman 2: The Great Escape). Initial screening for anxiety was done on 1,347 adolescents in five high schools; only adolescents who scored above the "at-risk" cut-off on the Spence Children Anxiety Survey were eligible. Adolescents' anxiety levels were assessed at pre-test, post-test, and at three month follow-up to examine the extent to which playing Dojo decreased adolescents' anxiety. The present study revealed equal improvements in anxiety symptoms in both conditions at follow-up and no differences between Dojo and the closely matched control game condition. Latent growth curve models did reveal a steeper decrease of personalized anxiety symptoms (not of total anxiety symptoms) in the Dojo condition compared to the control condition. Moderation analyses did not show any differences in outcomes between boys and girls nor did age differentiate outcomes. The present results are of importance for prevention science, as this was the first full-scale randomized controlled trial testing indicated prevention effects of a video game aimed at reducing anxiety. Future research should carefully consider the choice of control condition and outcome measurements, address the potentially high impact of participants' expectations, and take critical design issues into consideration, such as individual- versus group-based intervention and contamination issues. PMID:26816292

  7. A Randomized Controlled Trial to Test the Effectiveness of an Immersive 3D Video Game for Anxiety Prevention among Adolescents.

    PubMed

    Scholten, Hanneke; Malmberg, Monique; Lobel, Adam; Engels, Rutger C M E; Granic, Isabela

    2016-01-01

    Adolescent anxiety is debilitating, the most frequently diagnosed adolescent mental health problem, and leads to substantial long-term problems. A randomized controlled trial (n = 138) was conducted to test the effectiveness of a biofeedback video game (Dojo) for adolescents with elevated levels of anxiety. Adolescents (11-15 years old) were randomly assigned to play Dojo or a control game (Rayman 2: The Great Escape). Initial screening for anxiety was done on 1,347 adolescents in five high schools; only adolescents who scored above the "at-risk" cut-off on the Spence Children Anxiety Survey were eligible. Adolescents' anxiety levels were assessed at pre-test, post-test, and at three month follow-up to examine the extent to which playing Dojo decreased adolescents' anxiety. The present study revealed equal improvements in anxiety symptoms in both conditions at follow-up and no differences between Dojo and the closely matched control game condition. Latent growth curve models did reveal a steeper decrease of personalized anxiety symptoms (not of total anxiety symptoms) in the Dojo condition compared to the control condition. Moderation analyses did not show any differences in outcomes between boys and girls nor did age differentiate outcomes. The present results are of importance for prevention science, as this was the first full-scale randomized controlled trial testing indicated prevention effects of a video game aimed at reducing anxiety. Future research should carefully consider the choice of control condition and outcome measurements, address the potentially high impact of participants' expectations, and take critical design issues into consideration, such as individual- versus group-based intervention and contamination issues.

  8. Educational Effectiveness of an HIV Pretest Video for Adolescents: A Randomized Controlled Trial

    PubMed Central

    Cowan, Ethan; Nickerson, Jillian; Mathew, Sheba; Fettig, Jade; Rosenberg, Michael; Brusalis, Christopher; Chou, Katherine; Leider, Jason; Bauman, Laurie

    2011-01-01

    OBJECTIVE: The goal of this study was to compare the effectiveness of a youth-friendly HIV video with in-person counseling in conveying HIV knowledge and obtaining consent for HIV testing among adolescent patients of an urban emergency department. METHODS: A 2-armed, randomized controlled trial was conducted on a convenience sample of 200 stable, sexually active people aged 15 to 21 years in an urban emergency department. Participants in both the in-person counseling group and the video intervention group completed preintervention and postintervention HIV knowledge measures. HIV knowledge was the primary outcome measure, and consent for HIV testing was the secondary outcome. Characteristics associated with voluntary HIV testing were identified. RESULTS: Of 333 eligible people, 200 agreed to participate. There was no difference in preintervention HIV knowledge scores between groups. Mean postintervention knowledge scores differed significantly between the video (78.5% correct) and the counselor (66.3% correct) (P < 0.01) groups. Overall, 51% of the video group accepted HIV testing compared with 22% in the control group (P < .01). Watching the video (OR: 3.6 [95% CI: 1.8–7.2]), being female (OR: 2.1 [95% CI: 1.0–4.2]), engaging in oral sex (OR: 2.8 [95% CI: 1.4–5.9]), and being older than 18 years (OR: 3.8 [95% CI: 1.8–7.8]) were all positively associated with testing. CONCLUSIONS: A youth-friendly HIV educational video improved adolescents' HIV knowledge and increased their participation in HIV testing more than in-person counseling. video-based HIV counseling can perform as well or better than in-person counseling for adolescents in the ED. PMID:21482613

  9. A Randomized Trial of the Effect of Centralized Reminder/Recall on Immunizations and Preventive Care Visits for Adolescents

    PubMed Central

    Szilagyi, Peter G.; Albertin, Christina; Humiston, Sharon G.; Rand, Cynthia M.; Schaffer, Stanley; Brill, Howard; Stankaitis, Joseph; Yo, Byung-Kwang; Blumkin, Aaron; Stokley, Shannon

    2015-01-01

    Objective To assess the impact of a managed care-based patient reminder/recall system on immunization rates and preventive care visits among low-income adolescents. Methods We conducted a randomized controlled trial between December 2009 and December 2010 that assigned adolescents aged 11–17 years to one of three groups: mailed letter, telephone reminders, or control. Publicly insured youths (n = 4, 115) were identified in 37 participating primary care practices. The main outcome measures were immunization rates for routine vaccines (meningococcus, pertussis, HPV) and preventive visit rates at study end. Results Intervention and control groups were similar at baseline for demographics, immunization rates, and preventive visits. Among adolescents who were behind at the start, immunization rates at study end increased by 21% for mailed (P < .01 vs control), 17% for telephone (P < .05), and 13% for control groups. The proportion of adolescents with a preventive visit (within 12 months) was: mailed (65%; P <.01), telephone (63%; P <.05), and controls (59%). The number needed to treat for an additional fully vaccinated adolescent was 14 for mailed and 25 for telephone reminders; for an additional preventive visit, it was 17 and 29. The intervention cost $18.78 (mailed) or $16.68 (phone) per adolescent per year to deliver. The cost per additional adolescent fully vaccinated was $463.99 for mailed and $714.98 for telephone; the cost per additional adolescent receiving a preventive visit was $324.75 and $487.03. Conclusions Managed care-based mail or telephone reminder/recall improved adolescent immunizations and preventive visits, with modest costs and modest impact. PMID:23510607

  10. Chinese herbal medicine for obesity: a randomized, double-blinded, multicenter, prospective trial.

    PubMed

    Zhou, Qiang; Chang, Bai; Chen, Xin-Yan; Zhou, Shui-Ping; Zhen, Zhong; Zhang, Lan-Lan; Sun, Xin; Zhou, Yuan; Xie, Wan-Qing; Liu, Hong-Fang; Xu, Yuan; Kong, Yi; Zhou, Li-Bo; Lian, Feng-Mei; Tong, Xiao-Lin

    2014-01-01

    Obesity is a serious medical problem worldwide. As a holistic therapy, traditional Chinese medicine (TCM) may have a potential in obesity management. In this controlled trial, we evaluated the safety and effectiveness of xin-ju-xiao-gao-fang (XJXGF), a TCM herbal formulation, in 140 obese subjects over a 24-week period. The XJXGF formula mainly consists of rhubarb, coptis, semen cassia, and citrus aurantium. Subjects with body mass index (BMI) 28-40 kg/m(2) were recruited at 5 centers in China. We assessed the changes in subjects' body weight, its related parameters, and the reduction of insulin resistance (IR) after administration of XJXGF formula or low-dose XJXGF (10% of the XJXGF formula, as control). After 24-week treatment, among participants in the XJXGF formula group and low-dose XJXGF group, the mean ± SE changes in the body weight were -3.58 ± 0.48 and -1.91 ± 0.38 kg, respectively (p < 0.01). The changes in the IR-index of two groups were -2.65 ± 1.04 and -1.58 ± 1.3, respectively (p < 0 .05). There were no serious adverse events reported during the 24-week trial. Participants reported 7 minor adverse events, 4 in the XJXGF formula group and 3 in the low-dose XJXGF group (p = 0.578). Future studies are needed to investigate the clinical utility of this TCM formulation in the treatment of obese subjects. PMID:25406653

  11. A Pilot Randomized Trial of Text-Messaging for Symptom Awareness and Diabetes Knowledge in Adolescents With Type 1 Diabetes

    PubMed Central

    Han, Yi; Faulkner, Melissa Spezia; Fritz, Heather; Fadoju, Doris; Muir, Andrew; Abowd, Gregory D.; Head, Lauren; Arriaga, Rosa I.

    2015-01-01

    Adolescents with type 1 diabetes typically receive clinical care every 3 months. Between visits, diabetes-related issues may not be frequently reflected, learned, and documented by the patients, limiting their self-awareness and knowledge about their condition. We designed a text-messaging system to help resolve this problem. In a pilot, randomized controlled trial with 30 adolescents, we examined the effect of text messages about symptom awareness and diabetes knowledge on glucose control and quality of life. The intervention group that received more text messages between visits had significant improvements in quality of life. PMID:25720675

  12. A randomized trial of transdermal and oral estrogen therapy in adolescent girls with hypogonadism

    PubMed Central

    2014-01-01

    Background Adolescent females with ovarian failure require estrogen therapy for induction of puberty and other important physiologic effects. Currently, health care providers have varying practices without evidence-based standards, thus investigating potential differences between oral and transdermal preparations is essential. The purpose of this study was to compare the differential effects of treatment with oral conjugated equine estrogen (OCEE), oral 17β estradiol (OBE), or transdermal 17β estradiol (TBE) on biochemical profiles and feminization in girls with ovarian failure. Study design 20 prepubertal adolescent females with ovarian failure, ages 12–18 years, were randomized to OCEE (n = 8), OBE (n = 7), or TBE (n = 5) for 24 months. Estrogen replacement was initiated at a low dose (0.15 mg OCEE, 0.25 mg OBE, or 0.0125 mg TBE) and doubled every 6 months to a maximum dose of 0.625 mg/d OCEE, 1 mg/d OBE, or 0.05 mg/d TBE. At 18 months, micronized progesterone was added to induce menstrual cycles. Biochemical markers including sex hormones, inflammatory markers, liver enzymes, coagulation factors, and lipids were obtained at baseline and 6 month intervals. Differences in levels of treatment parameters between the groups were evaluated with one-way analysis of variance (ANOVA). The effect of progesterone on biochemical markers was evaluated with the paired t-test. Results Mean (±SE) estradiol levels at maximum estrogen dose (18 months) were higher in the TBE group (53 ± 19 pg/mL) compared to OCEE (14 ± 5 pg/mL) and OBE (12 ± 5 pg/mL) (p ≤ 0.01). The TBE and OBE groups had more effective feminization (100% Tanner 3 breast stage at 18 months). There were no statistical differences in other biochemical markers between treatment groups at 18 months or after the introduction of progesterone. Conclusions Treatment with transdermal 17β estradiol resulted in higher estradiol levels and more effective feminization

  13. Complementary and alternative medicine use in adolescents with inflammatory bowel disease and juvenile idiopathic arthritis

    PubMed Central

    2014-01-01

    Background The use of complementary alternative medicine (CAM) is potentially prevalent among paediatric patients with chronic diseases but with variable rates among different age groups, diseases and countries. There are no recent reports on CAM use among paediatric patients with inflammatory bowel disease (IBD) and juvenile idiopathic arthritis (JIA) in Europe. We hypothesized that CAM use associates with a more severe disease in paediatric IBD and JIA. Methods A cross-sectional questionnaire study among adolescent outpatients with IBD and JIA addressing the frequency and type of CAM use during the past year. The patients were recruited at the Children’s Hospital, University of Helsinki, Finland. Results Of the 147 respondents, 97 had IBD (Crohn’s disease: n = 46; median age 15.5, disease duration 3.4 years) and 50 had JIA (median age 13.8, disease duration 6.9 years). During the past 12 months, 48% regularly used CAM while 81% reported occasional CAM use. Compared to patients with JIA, the use of CAM in IBD patients tended to be more frequent. The most commonly used CAM included probiotics, multivitamins, and mineral and trace element supplements. Self-imposed dietary restrictions were common, involving 27.6% of the non-CAM users but 64.8% of all CAM users. Disease activity was associated with CAM use in JIA but not in IBD. Conclusions CAM use is frequent among adolescents with IBD and JIA and associates with self-imposed dietary restrictions. Reassuringly, adherence to disease modifying drugs is good in young CAM users. In JIA, patients with active disease used more frequently CAM than patients with inactive disease. As CAM use is frequent, physicians should familiarise themselves with the basic concepts of CAM. The potential pharmacological interaction or the toxicity of certain CAM products warrants awareness and hence physicians should actively ask their patients about CAM use. PMID:24708564

  14. Randomized Controlled Trial of Therapeutic Horseback Riding in Children and Adolescents With Autism Spectrum Disorder

    PubMed Central

    Gabriels, Robin L.; Pan, Zhaoxing; Dechant, Briar; Agnew, John A.; Brim, Natalie; Mesibov, Gary

    2015-01-01

    Objective This study expands previous equine-assisted intervention research by evaluating the effectiveness of therapeutic horseback riding (THR) on self-regulation, socialization, communication, adaptive, and motor behaviors in children with autism spectrum disorder (ASD). Method Participants with ASD (ages 6–16 years; N=127) were stratified by nonverbal IQ standard scores (≤ 85 or > 85) and randomized to one of two groups for 10 weeks: THR intervention or a barn activity (BA) control group without horses that employed similar methods. The fidelity of the THR intervention was monitored. Participants were evaluated within one month pre- and post-intervention by raters blind to intervention conditions and unblinded caregiver questionnaires. During the intervention, caregivers rated participants’ behaviors weekly. Results Intent-to-treat analysis conducted on the 116 participants who completed a baseline assessment (THR n = 58; BA control n = 58) revealed significant improvements in the THR group compared to the control on measures of irritability (primary outcome) (p=.002; effect size [ES]=.50) and hyperactivity (p=.001; ES=0.53), beginning by week five of the intervention. Significant improvements in the THR group were also observed on a measure of social cognition (p=.05, ES=.41) and social communication (p=.003; ES =.63), along with the total number of words (p=.01; ES=.54) and new words (p=.01; ES=.54) spoken during a standardized language sample. Sensitivity analyses adjusting for age, IQ, and per-protocol analyses produced consistent results. Conclusion This is the first large-scale randomized, controlled trial demonstrating efficacy of THR for the ASD population, and findings are consistent with previous equine-assisted intervention studies. Clinical trial registration information Trial of Therapeutic Horseback Riding in Children and Adolescents With Autism Spectrum Disorder; http://clinicaltrials.gov/; NCT02301195. PMID:26088658

  15. Nurse-Led Medicines' Monitoring for Patients with Dementia in Care Homes: A Pragmatic Cohort Stepped Wedge Cluster Randomised Trial

    PubMed Central

    Jordan, Susan; Gabe-Walters, Marie Ellenor; Watkins, Alan; Humphreys, Ioan; Newson, Louise; Snelgrove, Sherrill; Dennis, Michael S

    2015-01-01

    Background People with dementia are susceptible to adverse drug reactions (ADRs). However, they are not always closely monitored for potential problems relating to their medicines: structured nurse-led ADR Profiles have the potential to address this care gap. We aimed to assess the number and nature of clinical problems identified and addressed and changes in prescribing following introduction of nurse-led medicines’ monitoring. Design Pragmatic cohort stepped-wedge cluster Randomised Controlled Trial (RCT) of structured nurse-led medicines’ monitoring versus usual care. Setting Five UK private sector care homes Participants 41 service users, taking at least one antipsychotic, antidepressant or anti-epileptic medicine. Intervention Nurses completed the West Wales ADR (WWADR) Profile for Mental Health Medicines with each participant according to trial step. Outcomes Problems addressed and changes in medicines prescribed. Data Collection and Analysis Information was collected from participants’ notes before randomisation and after each of five monthly trial steps. The impact of the Profile on problems found, actions taken and reduction in mental health medicines was explored in multivariate analyses, accounting for data collection step and site. Results Five of 10 sites and 43 of 49 service users approached participated. Profile administration increased the number of problems addressed from a mean of 6.02 [SD 2.92] to 9.86 [4.48], effect size 3.84, 95% CI 2.57–4.11, P <0.001. For example, pain was more likely to be treated (adjusted Odds Ratio [aOR] 3.84, 1.78–8.30), and more patients attended dentists and opticians (aOR 52.76 [11.80–235.90] and 5.12 [1.45–18.03] respectively). Profile use was associated with reduction in mental health medicines (aOR 4.45, 1.15–17.22). Conclusion The WWADR Profile for Mental Health Medicines can improve the quality and safety of care, and warrants further investigation as a strategy to mitigate the known adverse

  16. The Practice of Korean Medicine: An Overview of Clinical Trials in Acupuncture

    PubMed Central

    2005-01-01

    Acupuncture, one of the Oriental medical therapeutic techniques that can be traced back at least 2500 years, is growing in popularity all over the world. Korea has continued to develop its own unique tradition of medicine throughout its long history, and has formed different types of acupuncture methods. The purpose of this review is to summarize clinical case studies in acupuncture and related therapies, such as acupressure, electric acupuncture, auricular acupuncture and moxibustion in Korea. A survey of Korean journals revealed that a total of 124 studies were published from 1983 to 2001. Results obtained from the survey showed that most clinical studies using acupuncture, electric acupuncture, moxibustion and other traditional therapies could alleviate a relatively broad range of medical problems. However, it should be emphasized that almost all clinical case studies published in various local journals did not follow the ‘good clinical practice’ with respect to regulatory aspects. Since they were not conducted using the randomized double-blinded controls with a large sample size, all the results should be considered as therapeutic indications. This review is an attempt to show the scope of acupuncture in our country and the kind of diseases, after many years of clinical experience, that were deemed valid targets for clinical trials. PMID:16136212

  17. Effectiveness of Chinese herbal medicine in treating liver fibrosis: a systematic review and meta-analysis of randomized controlled trials

    PubMed Central

    2012-01-01

    Background The studies on the effectiveness of Chinese herbal medicines (CHM) in treating liver fibrosis (LF) were not consistent. This study aims to systematically review the effectiveness of CHM on treating LF patients. Methods Databases including MEDLINE, AMED, EMBASE, The Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, TCMOnline, Chinese Biomedical Literature Database, and Chinese Medical Current Contents were searched up to March 2011. Randomized controlled trials (RCTs) involving LF patients receiving CHM, Western medicine, combined CHM and Western medicine compared with placebo, Western medicine or no intervention were included. LF markers including serum hyaluronic acid (HA), laminin (LN), procollagen type III (PC-III), type IV collagen (IV-C), matrix metalloproteinase (MMP), and tissue inhibitors of metalloproteinase (TIMP) were measured as primary outcomes. Liver biochemistry, including alanine aminotransferase (ALT) and aspartarte aminotransferase (AST), and improvement of related clinical symptoms were measured as secondary outcomes. Risk of bias of allocation sequence, allocation concealment, blinding, incomplete outcome data, selective outcome reporting, and other biases were assessed. Results Twenty-three RCTs with 2123 participants were analyzed in subgroups of types of comparison and study quality. Fifteen studies were graded as good quality. CHM alone and combined with Western medicine showed significant improvements in HA, LN, PC-III and IV-C compared with Western medicine alone. However, there were no significant differences observed between CHM and placebo treatments. Conclusion The current inconclusive results in determining the effectiveness of CHM treatment on LF, due to the poor methodological quality and high heterogeneity of the studies, suggests that large RCTs using standardized Chinese medicine syndrome diagnosis and CHM formulae with longer follow-up are required for further evaluation. PMID

  18. Alterations in left ventricular, left atrial, and right ventricular structure and function to cardiovascular risk factors in adolescents with type 2 diabetes participating in the TODAY clinical trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Data on cardiovascular disease (CVD) risk in adolescents with type 2 diabetes (T2D) are limited. Echocardiography was performed in the last year of the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) clinical trial (median 4.5 yr from diagnosis of T2D, average age 18 yr), incl...

  19. Effectiveness of treatment approaches for children and adolescents with reading disabilities: a meta-analysis of randomized controlled trials.

    PubMed

    Galuschka, Katharina; Ise, Elena; Krick, Kathrin; Schulte-Körne, Gerd

    2014-01-01

    Children and adolescents with reading disabilities experience a significant impairment in the acquisition of reading and spelling skills. Given the emotional and academic consequences for children with persistent reading disorders, evidence-based interventions are critically needed. The present meta-analysis extracts the results of all available randomized controlled trials. The aims were to determine the effectiveness of different treatment approaches and the impact of various factors on the efficacy of interventions. The literature search for published randomized-controlled trials comprised an electronic search in the databases ERIC, PsycINFO, PubMed, and Cochrane, and an examination of bibliographical references. To check for unpublished trials, we searched the websites clinicaltrials.com and ProQuest, and contacted experts in the field. Twenty-two randomized controlled trials with a total of 49 comparisons of experimental and control groups could be included. The comparisons evaluated five reading fluency trainings, three phonemic awareness instructions, three reading comprehension trainings, 29 phonics instructions, three auditory trainings, two medical treatments, and four interventions with coloured overlays or lenses. One trial evaluated the effectiveness of sunflower therapy and another investigated the effectiveness of motor exercises. The results revealed that phonics instruction is not only the most frequently investigated treatment approach, but also the only approach whose efficacy on reading and spelling performance in children and adolescents with reading disabilities is statistically confirmed. The mean effect sizes of the remaining treatment approaches did not reach statistical significance. The present meta-analysis demonstrates that severe reading and spelling difficulties can be ameliorated with appropriate treatment. In order to be better able to provide evidence-based interventions to children and adolescent with reading disabilities

  20. Effectiveness of treatment approaches for children and adolescents with reading disabilities: a meta-analysis of randomized controlled trials.

    PubMed

    Galuschka, Katharina; Ise, Elena; Krick, Kathrin; Schulte-Körne, Gerd

    2014-01-01

    Children and adolescents with reading disabilities experience a significant impairment in the acquisition of reading and spelling skills. Given the emotional and academic consequences for children with persistent reading disorders, evidence-based interventions are critically needed. The present meta-analysis extracts the results of all available randomized controlled trials. The aims were to determine the effectiveness of different treatment approaches and the impact of various factors on the efficacy of interventions. The literature search for published randomized-controlled trials comprised an electronic search in the databases ERIC, PsycINFO, PubMed, and Cochrane, and an examination of bibliographical references. To check for unpublished trials, we searched the websites clinicaltrials.com and ProQuest, and contacted experts in the field. Twenty-two randomized controlled trials with a total of 49 comparisons of experimental and control groups could be included. The comparisons evaluated five reading fluency trainings, three phonemic awareness instructions, three reading comprehension trainings, 29 phonics instructions, three auditory trainings, two medical treatments, and four interventions with coloured overlays or lenses. One trial evaluated the effectiveness of sunflower therapy and another investigated the effectiveness of motor exercises. The results revealed that phonics instruction is not only the most frequently investigated treatment approach, but also the only approach whose efficacy on reading and spelling performance in children and adolescents with reading disabilities is statistically confirmed. The mean effect sizes of the remaining treatment approaches did not reach statistical significance. The present meta-analysis demonstrates that severe reading and spelling difficulties can be ameliorated with appropriate treatment. In order to be better able to provide evidence-based interventions to children and adolescent with reading disabilities

  1. Use of Rorschach tests at the Nuremberg war crimes trial: A forgotten chapter in history of medicine.

    PubMed

    Dimsdale, Joel E

    2015-06-01

    Seventy years ago, psychiatrists and psychologists had unusual access to the Nazi leaders awaiting trial by the International Military Tribunal in Nuremberg. Early leaders in the field of psychosomatic medicine were instrumental in facilitating these interviews as well as arranging for the administration of psychological testing with the Rorschach inkblot test. These observations were kept under wraps for decades and there remains controversy even now about what these Rorschachs revealed-demonic psychopaths or just morally corrupt individuals. PMID:25896214

  2. Use of Rorschach tests at the Nuremberg war crimes trial: A forgotten chapter in history of medicine.

    PubMed

    Dimsdale, Joel E

    2015-06-01

    Seventy years ago, psychiatrists and psychologists had unusual access to the Nazi leaders awaiting trial by the International Military Tribunal in Nuremberg. Early leaders in the field of psychosomatic medicine were instrumental in facilitating these interviews as well as arranging for the administration of psychological testing with the Rorschach inkblot test. These observations were kept under wraps for decades and there remains controversy even now about what these Rorschachs revealed-demonic psychopaths or just morally corrupt individuals.

  3. Exercise and BMI in Overweight and Obese Children and Adolescents: A Systematic Review and Trial Sequential Meta-Analysis

    PubMed Central

    Kelley, George A.; Kelley, Kristi S.; Pate, Russell R.

    2015-01-01

    Objective. Determine the effects of exercise on body mass index (BMI in kg·m−2) among overweight and obese children and adolescents. Methods. Trial sequential meta-analysis of randomized controlled exercise intervention trials ≥ 4 weeks and published up to November 11, 2014. Results. Of the 5,436 citations screened, 20 studies representing 971 boys and girls were included. Average length, frequency, and duration of training were 13 weeks, 3 times per week, for 46 minutes per session. Overall, random-effects models showed that exercise decreased BMI by 3.6% (mean: −1.08; 95% CI: −0.52 to −1.64; Q = 231.4; p < 0.001; I2 = 90.9%; 95% CI: 87.6% to 93.4%; D2 = 91.5%). Trial sequential meta-analysis showed that changes in BMI crossed the monitoring boundary for a type 1 error in 2010, remaining stable thereafter. The number needed to treat was 5 while the percentile improvement was 26.9. It was estimated that approximately 2.5 million overweight and obese children in the US and 22.0 million overweight and obese children worldwide could reduce their BMI by participating in a regular exercise program. Overall quality of evidence was rated as moderate. Conclusions. Exercise is associated with improvements in BMI among overweight and obese children and adolescents. This trial is registered with PROSPERO Trial Registration #CRD42015017586. PMID:26579538

  4. Short-term psychotherapeutic treatment in adolescents engaging in non-suicidal self-injury: a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Worldwide, prevalence rates of adolescent non-suicidal self-injury (NSSI) range between 13 and 45%. In Germany, lifetime prevalence of NSSI is around 25% in non-clinical samples, and the one-year prevalence for repetitive NSSI is 4%. NSSI is present in the context of several axis I and II disorders (for example, affective disorders or borderline personality disorder); however, preliminary evidence suggests that it would be justified to consider NSSI as its own diagnostic category. Despite the large impact of this behavior, there is still a lack of evidence-based, specific, and effective manualized treatment approaches for adolescents with NSSI. Methods/Design The study is designed as a randomized controlled trial (RCT) to test the effectiveness of a new cognitive-behavioral treatment manual for self-harming adolescents - the ‘Cutting-Down-Programme’ (CDP). A total of 80 adolescents aged between 12 and 17 years from a region in Southern Germany who have engaged in repetitive NSSI (≥5 incidents) in the last 6 months will be randomized into a treatment group (CDP) or a control group that will receive treatment as usual (TAU). The adolescents will be assessed by means of structured interviews and questionnaires at three time points (before treatment, directly after treatment and six months after treatment). Primary outcome criterion is a significant reduction (or remission) in the frequency of NSSI. Secondary outcome criteria are depressivity as well as general well-being and self-worth. Additionally, comorbid psychiatric disorders and childhood adversity will be evaluated as predictors of therapeutic outcome. Discussion Recently, a pilot study in the United Kingdom showed significant reductions in self-harming behavior, depressive symptoms and trait anxiety. This is the first RCT to test the effectiveness of a short-term psychotherapeutic intervention in outpatients engaging in NSSI. Trial registration The study is registered in the German Clinical

  5. Improving health-related fitness in adolescents: the CrossFit Teens™ randomised controlled trial.

    PubMed

    Eather, Narelle; Morgan, Philip James; Lubans, David Revalds

    2016-01-01

    The aim of this study was to evaluate the preliminary efficacy and feasibility of the CrossFit Teens™ resistance training programme for improving health-related fitness and resistance training skill competency in adolescents. This assessor-blinded randomised controlled trial was conducted in one secondary school in the Hunter Region, Australia, from July to September 2013. Ninety-six (96) students (age = 15.4 (.5) years, 51.5% female) were randomised into intervention (n = 51) or control (n = 45) conditions for 8-weeks (60 min twice per week). Waist circumference, body mass index (BMI), BMI-Z score (primary outcomes), cardiorespiratory fitness (shuttle run test), muscular fitness (standing jump, push-up, handgrip, curl-up test), flexibility (sit and reach) and resistance training skill competency were measured at baseline and immediate post-intervention. Feasibility measures of recruitment, retention, adherence and satisfaction were assessed. Significant group-by-time intervention effects were found for waist circumference [-3.1 cm, P < 0.001], BMI [-1.38 kg · m(‒)(2), P < 0.001], BMI-Z [-0.5 z-scores, P < 0.001], sit and reach [+3.0 cm, P < 0.001], standing jump [+0.1 m, P = 0.021] and shuttle run [+10.3 laps, P = 0.019]. Retention rate was 82.3%. All programme sessions were delivered and participants' mean satisfaction scores ranged from 4.2 to 4.6 out of 5. The findings demonstrate that CrossFit Teens™ is a feasible and efficacious programme for improving health-related fitness in adolescents.

  6. Improving health-related fitness in adolescents: the CrossFit Teens™ randomised controlled trial.

    PubMed

    Eather, Narelle; Morgan, Philip James; Lubans, David Revalds

    2016-01-01

    The aim of this study was to evaluate the preliminary efficacy and feasibility of the CrossFit Teens™ resistance training programme for improving health-related fitness and resistance training skill competency in adolescents. This assessor-blinded randomised controlled trial was conducted in one secondary school in the Hunter Region, Australia, from July to September 2013. Ninety-six (96) students (age = 15.4 (.5) years, 51.5% female) were randomised into intervention (n = 51) or control (n = 45) conditions for 8-weeks (60 min twice per week). Waist circumference, body mass index (BMI), BMI-Z score (primary outcomes), cardiorespiratory fitness (shuttle run test), muscular fitness (standing jump, push-up, handgrip, curl-up test), flexibility (sit and reach) and resistance training skill competency were measured at baseline and immediate post-intervention. Feasibility measures of recruitment, retention, adherence and satisfaction were assessed. Significant group-by-time intervention effects were found for waist circumference [-3.1 cm, P < 0.001], BMI [-1.38 kg · m(‒)(2), P < 0.001], BMI-Z [-0.5 z-scores, P < 0.001], sit and reach [+3.0 cm, P < 0.001], standing jump [+0.1 m, P = 0.021] and shuttle run [+10.3 laps, P = 0.019]. Retention rate was 82.3%. All programme sessions were delivered and participants' mean satisfaction scores ranged from 4.2 to 4.6 out of 5. The findings demonstrate that CrossFit Teens™ is a feasible and efficacious programme for improving health-related fitness in adolescents. PMID:25972203

  7. Indispensable value of clinical trials in the modernization of traditional Chinese medicine: 12 years' experience at CUHK and future perspectives.

    PubMed

    Liang, Willmann; Yew, David T; Hon, Kam Lun; Wong, Chun Kwok; Kwok, Timothy C Y; Leung, Ping Chung

    2014-01-01

    The last decade has seen a wealth of information reporting the beneficial effects of Chinese herbal medicines. While a lot more studies were done using in vitro and in vivo research platforms, much fewer investigations were conducted according to evidence-based requirements in clinical settings. The Institute of Chinese Medicine at the Chinese University of Hong Kong (CUHK) has had the opportunity to collaborate with clinicians over the years to initiate and conduct dozens of clinical trials investigating and verifying the therapeutic values of Chinese herbs in selected disease conditions. Of the many disorders, we chose to focus on those that are known for their difficulties achieving perfect results with conventional treatment methods. Examples include non-healing ulcers, allergic conditions, degenerative diseases and cancer. Protective effects of the herbs in such chronic diseases as coronary artery disease and osteoporosis were also part of our focus. Even in healthy individuals and those recovering from chemotherapy, Chinese herbs could help with the immune system and were studied in our clinical trials as well. This paper aims to highlight the important findings from these clinical studies while at the same time, stressing the indispensable value of clinical trials in modernizing the use of Chinese herbs in present-day medicine.

  8. A Randomized Controlled Trial to Test the Effectiveness of an Immersive 3D Video Game for Anxiety Prevention among Adolescents

    PubMed Central

    Scholten, Hanneke; Malmberg, Monique; Lobel, Adam; Engels, Rutger C. M. E.; Granic, Isabela

    2016-01-01

    Adolescent anxiety is debilitating, the most frequently diagnosed adolescent mental health problem, and leads to substantial long-term problems. A randomized controlled trial (n = 138) was conducted to test the effectiveness of a biofeedback video game (Dojo) for adolescents with elevated levels of anxiety. Adolescents (11–15 years old) were randomly assigned to play Dojo or a control game (Rayman 2: The Great Escape). Initial screening for anxiety was done on 1,347 adolescents in five high schools; only adolescents who scored above the “at-risk” cut-off on the Spence Children Anxiety Survey were eligible. Adolescents’ anxiety levels were assessed at pre-test, post-test, and at three month follow-up to examine the extent to which playing Dojo decreased adolescents’ anxiety. The present study revealed equal improvements in anxiety symptoms in both conditions at follow-up and no differences between Dojo and the closely matched control game condition. Latent growth curve models did reveal a steeper decrease of personalized anxiety symptoms (not of total anxiety symptoms) in the Dojo condition compared to the control condition. Moderation analyses did not show any differences in outcomes between boys and girls nor did age differentiate outcomes. The present results are of importance for prevention science, as this was the first full-scale randomized controlled trial testing indicated prevention effects of a video game aimed at reducing anxiety. Future research should carefully consider the choice of control condition and outcome measurements, address the potentially high impact of participants’ expectations, and take critical design issues into consideration, such as individual- versus group-based intervention and contamination issues. PMID:26816292

  9. Early intervention for adolescents with Patellofemoral Pain Syndrome - a pragmatic cluster randomised controlled trial

    PubMed Central

    2012-01-01

    Background Self-reported knee pain is highly prevalent among adolescents. As much as 50% of the non-specific knee pain may be attributed to Patellofemoral Pain Syndrome (PFPS). In the short term, exercise therapy appears to have a better effect than patient education consisting of written information and general advice on exercise or compared with placebo treatment. But the long-term effect of exercise therapy compared with patient education is conflicting. The purpose of this study is to examine the short- and long-term effectiveness of patient education compared with patient education and multimodal physiotherapy applied at a very early stage of the condition among adolescents. Methods/Design This study is a single blind pragmatic cluster randomised controlled trial. Four upper secondary schools have been invited to participate in the study (approximately 2500 students, aged 15-19 years). Students are asked to answer an online questionnaire regarding musculoskeletal pain. The students who report knee pain are contacted by telephone and offered a clinical examination by a rheumatologist. Subjects who fit the inclusion criteria and are diagnosed with PFPS are invited to participate in the study. A minimum of 102 students with PFPS are then cluster-randomised into two intervention groups based on which school they attend. Both intervention groups receive written information and education. In addition to patient education, one group receives multimodal physiotherapy consisting primarily of neuromuscular training of the muscles around the foot, knee and hip and home exercises. The students with PFPS fill out self-reported questionnaires at baseline, 3, 6, 12 and 24 months after inclusion in the study. The primary outcome measure is perception of recovery measured on a 7-point Likert scale ranging from "completely recovered" to "worse than ever" at 12 months. Discussion This study is designed to investigate the effectiveness of patient education compared with patient

  10. Regulatory acceptance of animal models of disease to support clinical trials of medicines and advanced therapy medicinal products.

    PubMed

    Cavagnaro, Joy; Silva Lima, Beatriz

    2015-07-15

    The utility of animal models of disease for assessing the safety of novel therapeutic modalities has become an increasingly important topic of discussion as research and development efforts focus on improving the predictive value of animal studies to support accelerated clinical development. Medicines are approved for marketing based upon a determination that their benefits outweigh foreseeable risks in specific indications, specific populations, and at specific dosages and regimens. No medicine is 100% safe. A medicine is less safe if the actual risks are greater than the predicted risks. The purpose of preclinical safety assessment is to understand the potential risks to aid clinical decision-making. Ideally preclinical studies should identify potential adverse effects and design clinical studies that will minimize their occurrence. Most regulatory documents delineate the utilization of conventional "normal" animal species to evaluate the safety risk of new medicines (i.e., new chemical entities and new biological entities). Animal models of human disease are commonly utilized to gain insight into the pathogenesis of disease and to evaluate efficacy but less frequently utilized in preclinical safety assessment. An understanding of the limitations of the animal disease models together with a better understanding of the disease and how toxicity may be impacted by the disease condition should allow for a better prediction of risk in the intended patient population. Importantly, regulatory authorities are becoming more willing to accept and even recommend data from experimental animal disease models that combine efficacy and safety to support clinical development.

  11. Regulatory acceptance of animal models of disease to support clinical trials of medicines and advanced therapy medicinal products.

    PubMed

    Cavagnaro, Joy; Silva Lima, Beatriz

    2015-07-15

    The utility of animal models of disease for assessing the safety of novel therapeutic modalities has become an increasingly important topic of discussion as research and development efforts focus on improving the predictive value of animal studies to support accelerated clinical development. Medicines are approved for marketing based upon a determination that their benefits outweigh foreseeable risks in specific indications, specific populations, and at specific dosages and regimens. No medicine is 100% safe. A medicine is less safe if the actual risks are greater than the predicted risks. The purpose of preclinical safety assessment is to understand the potential risks to aid clinical decision-making. Ideally preclinical studies should identify potential adverse effects and design clinical studies that will minimize their occurrence. Most regulatory documents delineate the utilization of conventional "normal" animal species to evaluate the safety risk of new medicines (i.e., new chemical entities and new biological entities). Animal models of human disease are commonly utilized to gain insight into the pathogenesis of disease and to evaluate efficacy but less frequently utilized in preclinical safety assessment. An understanding of the limitations of the animal disease models together with a better understanding of the disease and how toxicity may be impacted by the disease condition should allow for a better prediction of risk in the intended patient population. Importantly, regulatory authorities are becoming more willing to accept and even recommend data from experimental animal disease models that combine efficacy and safety to support clinical development. PMID:25814257

  12. Endorsement for improving the quality of reports on randomized controlled trials of traditional medicine journals in Korea: a systematic review.

    PubMed

    Choi, Jiae; Jun, Ji Hee; Kang, Byoung Kab; Kim, Kun Hyung; Lee, Myeong Soo

    2014-11-05

    The aim of this study was to assess the endorsement of reporting guidelines in Korean traditional medicine (TM) journals by reviewing their instructions to authors. We examined the instructions to authors in all of the TM journals published in Korea to assess the appropriate use of reporting guidelines for research studies. The randomized controlled trials (RCTs) published after 2010 in journals that endorsed reporting guidelines were obtained. The reporting quality was assessed using the following guidelines: the 38-item Consolidated Standards of Reporting Trials (CONSORT) statement for non-pharmacological trials (NPT); the 17-item Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) statement, instead of the 5-item CONSORT for acupuncture trials; and the 22-item CONSORT extensions for herbal medicine trials. The overall item score was calculated and expressed as a proportion.One journal that endorsed reporting guidelines was identified. Twenty-nine RCTs published in this journal after 2010 met the selection criteria. General editorial policies such as those of the International Committee of Medical Journal Editors (ICMJE) were endorsed by 15 journals. In each of the CONSORT-NPT articles, 21.6 to 56.8% of the items were reported, with an average of 11.3 items (29.7%) being reported. In the 24 RCTs (24/29, 82.8%) appraised using the STRICTA items, an average of 10.6 items (62.5%) were addressed, with a range of 41.2 to 100%. For the herbal intervention reporting, 17 items (77.27%) were reported. In the RCT studies before and after the endorsement of CONSORT and STRICTA guidelines by each journal, all of the STRICTA items had significant improvement, whereas the CONSORT-NPT items improved without statistical significance.The endorsement of reporting guidelines is limited in the TM journals in Korea. Authors should adhere to the reporting guidelines, and editorial departments should refer authors to the various reporting guidelines to

  13. The Relationship Between Parental Stress and Postpartum Depression Among Adolescent Mothers Enrolled in a Randomized Controlled Prevention Trial

    PubMed Central

    Phipps, Maureen G.; Triche, Elizabeth W.; Zlotnick, Caron

    2015-01-01

    Given the high co-occurrence of depression and parental stress among adolescent mothers, we evaluated the relationship between parental stress and postpartum depression among primiparous adolescent mothers. We conducted an observational analysis among a cohort of 106 adolescent mothers at 289 postpartum visits who were enrolled in a randomized controlled trial to prevent postpartum depression. Parental stress was measured using the Parenting Stress Index, short form. The Structured Clinical Interview for DSM-IV Childhood Diagnoses was administered to assess for postpartum depression; subthreshold depression was assessed using the Children's Depression Rating Scale, revised version. Generalized estimating equations were utilized to assess the relationship of parental stress on postpartum depression during the first 6 months postpartum. We present adjusted odds ratios (AOR) controlling for study arm, age, born in the United States, prior history of depression, and number of study visits. The median age was 16 years, 53 % were Latina, and 16 % reported a past history of depression. Nineteen adolescents (19 %) were diagnosed with postpartum depression and 25 % experienced high levels of parental stress through 6 months postpartum. Adolescent mothers who reported higher levels of parental stress were at significantly increased risk for postpartum depression [AOR 1.06 (95 % CI 1.04–1.09); p < 0.0001]. High levels of parental stress predicted subsequent postpartum depression when assessing parental stress at visits prior to a depression diagnosis to determine whether we could establish a temporal association [AOR 1.06 (95 % CI 1.02– 1.09); p < 0.01]. Parental stress was also a risk factor for subthreshold depression [AOR 1.04 (95 % CI 1.01– 1.07); p < 0.01]. Parental stress was a significant risk factor for developing both postpartum depression as well as subthreshold depression among adolescent mothers. Interventions that target a reduction in parental stress may

  14. The relationship between parental stress and postpartum depression among adolescent mothers enrolled in a randomized controlled prevention trial.

    PubMed

    Venkatesh, Kartik K; Phipps, Maureen G; Triche, Elizabeth W; Zlotnick, Caron

    2014-08-01

    Given the high co-occurrence of depression and parental stress among adolescent mothers, we evaluated the relationship between parental stress and postpartum depression among primiparous adolescent mothers. We conducted an observational analysis among a cohort of 106 adolescent mothers at 289 postpartum visits who were enrolled in a randomized controlled trial to prevent postpartum depression. Parental stress was measured using the Parenting Stress Index, short form. The Structured Clinical Interview for DSM-IV Childhood Diagnoses was administered to assess for postpartum depression; subthreshold depression was assessed using the Children's Depression Rating Scale, revised version. Generalized estimating equations were utilized to assess the relationship of parental stress on postpartum depression during the first 6 months postpartum. We present adjusted odds ratios (AOR) controlling for study arm, age, born in the United States, prior history of depression, and number of study visits. The median age was 16 years, 53% were Latina, and 16% reported a past history of depression. Nineteen adolescents (19%) were diagnosed with postpartum depression and 25% experienced high levels of parental stress through 6 months postpartum. Adolescent mothers who reported higher levels of parental stress were at significantly increased risk for postpartum depression [AOR 1.06 (95% CI 1.04-1.09); p < 0.0001]. High levels of parental stress predicted subsequent postpartum depression when assessing parental stress at visits prior to a depression diagnosis to determine whether we could establish a temporal association [AOR 1.06 (95% CI 1.02-1.09); p < 0.01]. Parental stress was also a risk factor for subthreshold depression [AOR 1.04 (95% CI 1.01-1.07); p < 0.01]. Parental stress was a significant risk factor for developing both postpartum depression as well as subthreshold depression among adolescent mothers. Interventions that target a reduction in parental stress may lead to less

  15. Recruiting a Diverse Group of Middle School Girls Into the Trial of Activity for Adolescent Girls

    PubMed Central

    Elder, John P.; Shuler, LaVerne; Moe, Stacey G.; Grieser, Mira; Pratt, Charlotte; Cameron, Sandra; Hingle, Melanie; Pickrel, Julie L.; Saksvig, Brit I.; Schachter, Kenneth; Greer, Susan; Bothwell, Elizabeth K. Guth

    2009-01-01

    BACKGROUND School-based study recruitment efforts are both time consuming and challenging. This paper highlights the recruitment strategies employed by the national, multisite Trial of Activity for Adolescent Girls (TAAG), a study designed to measure the effectiveness of an intervention to reduce the decline of physical activity levels among middle school—aged girls. TAAG provided a unique opportunity to recruit large cohorts of randomly sampled girls within 36 diverse middle schools across the United States. METHODS Key elements of the formative planning, coordination, and design of TAAG’s recruitment efforts included flexibility, tailoring, and the use of incentives. Various barriers, including a natural disaster, political tension, and district regulations, were encountered throughout the recruitment process, but coordinated strategies and frequent communication between the 6 TAAG sites were helpful in tailoring the recruitment process at the 36 intervention and control schools. RESULTS Progressively refined recruitment strategies and specific attention to the target audience of middle school girls resulted in overall study recruitment rates of 80%, 85%, and 89%, for the baseline, posttest, and follow-up period, respectively. DISCUSSION The steady increase in recruitment rates over time is attributed to an emphasis on successful strategies and a willingness to modify less successful methods. Open and consistent communication, an increasingly coordinated recruitment strategy, interactive recruitment presentations, and participant incentives resulted in an effective recruitment campaign. PMID:18808471

  16. Reducing sexual victimization among adolescent girls: a randomized controlled pilot trial of my voice, my choice.

    PubMed

    Rowe, Lorelei Simpson; Jouriles, Ernest N; McDonald, Renee

    2015-05-01

    Despite extensive efforts to develop and implement programs to prevent sexual violence, few programs have empirically-demonstrated efficacy. The primary exceptions are programs that emphasize risk-reduction skills; yet even these programs are not consistently effective. This study seeks to add to the literature by evaluating the effects of My Voice, My Choice (MVMC), a 90-minute assertive resistance training program that emphasizes skill practice in an immersive virtual environment (IVE). We hypothesized that MVMC would reduce male-to-female sexual victimization among adolescent girls over a 3-month follow-up period. We also examined whether these results would generalize to other forms of male-to-female relationship violence and to girls' psychological distress. Eighty-three female students from an urban public high school were randomized to MVMC (n=47) or to a wait-list control condition (n=36); 78 provided data over the 3-month follow-up period. Participants assigned to MVMC were less likely than control participants to report sexual victimization during the follow-up period. Our results also suggest that MVMC reduced risk for psychological victimization and for psychological distress among participants with greater prior victimization at baseline. The promising results of this pilot trial suggest that MVMC may help girls evade male-to-female relationship violence. PMID:25892168

  17. Brief motivational intervention for adolescents treated in emergency departments for acute alcohol intoxication – a randomized-controlled trial

    PubMed Central

    2014-01-01

    Background Alcohol misuse among youth is a major public health concern and numbers of adolescents admitted to the emergency department for acute alcoholic intoxication in Germany are recently growing. The emergency setting offers an opportunity to reach at-risk alcohol consuming adolescents and provide brief interventions in a potential “teachable moment”. However, studies on brief interventions targeting adolescents in emergency care are scarce and little is known about their effectiveness when delivered immediately following hospitalization for acute alcohol intoxication. In this protocol we present the HaLT-Hamburg trial evaluating a brief motivational intervention for adolescents treated in the emergency department after an episode of acute alcoholic intoxication. Methods The trial design is a parallel two-arm cluster randomized-controlled trial with follow-up assessment after 3 and 6 months. N = 312 participants aged 17 years and younger will be recruited Fridays to Sundays in 6 pediatric clinics over a period of 30 months. Intervention condition is a manual-based brief motivational intervention with a telephone booster after 6 weeks and a manual-guided intervention for caregivers which will be compared to treatment as usual. Primary outcomes are reduction in binge drinking episodes, quantity of alcohol use on a typical drinking day and alcohol-related problems. Secondary outcome is further treatment seeking. Linear mixed models adjusted for baseline differences will be conducted according to intention-to-treat (ITT) and completers (per-protocol) principles to examine intervention effects. We also examine quantitative and qualitative process data on feasibility, intervention delivery, implementation and receipt from intervention providers, receivers and regular emergency department staff. Discussion The study has a number of strengths. First, a rigorous evaluation of HaLT-Hamburg is timely because variations of the HaLT project are widely used in

  18. Acetyl-L-Carnitine as an Adjunctive Therapy in the Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents: A Placebo-Controlled Trial

    ERIC Educational Resources Information Center

    Abbasi, Seyed-Hesameddin; Heidari, Shahram; Mohammadi, Mohammad-Reza; Tabrizi, Mina; Ghaleiha, Ali; Akhondzadeh, Shahin

    2011-01-01

    The objective of this study was to test whether a previous observed Acetyl-L-carnitine (ALC) treatment effect could be repeated in an ALC adjunctive therapy treatment trial of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents. This was a six-week, randomized clinical trial undertaken in an outpatient child and adolescent…

  19. Predicting hypothetical willingness to participate (WTP) in a future phase III HIV vaccine trial among high-risk adolescents.

    PubMed

    Giocos, Georgina; Kagee, Ashraf; Swartz, Leslie

    2008-11-01

    The present study sought to determine whether the Theory of Planned Behaviour predicted stated hypothetical willingness to participate (WTP) in future Phase III HIV vaccine trials among South African adolescents. Hierarchical logistic regression analyses showed that The Theory of Planned Behaviour (TPB) significantly predicted WTP. Of all the predictors, Subjective norms significantly predicted WTP (OR = 1.19, 95% C.I. = 1.06-1.34). A stepwise logistic regression analysis revealed that Subjective Norms (OR = 1.19, 95% C.I. = 1.07-1.34) and Attitude towards participation in an HIV vaccine trial (OR = 1.32, 95% C.I. = 1.00-1.74) were significant predictors of WTP. The addition of Knowledge of HIV vaccines and HIV vaccine trials, Perceived self-risk of HIV infection, Health-promoting behaviours and Attitudes towards HIV/AIDS yielded non-significant results. These findings provide support for the Theory of Reasoned Action (TRA) and suggest that psychosocial factors may play an important role in WTP in Phase III HIV vaccine trials among adolescents.

  20. Normative Feedback and Adolescent Readiness to Change: A Small Randomized Trial

    ERIC Educational Resources Information Center

    Smith, Douglas C.; Davis, Jordan P.; Ureche, Daniel J.; Tabb, Karen M.

    2015-01-01

    For adolescents with substance use problems, it is unknown whether the provision of normative feedback is a necessary active ingredient in motivational interviewing (MI). This study investigated the impact of normative feedback on adolescents' readiness to change and perceptions of MI quality. Adolescents referred for substance use disorder (SUD)…

  1. A Randomized Controlled Trial of Online versus Clinic-Based CBT for Adolescent Anxiety

    ERIC Educational Resources Information Center

    Spence, Susan H.; Donovan, Caroline L.; March, Sonja; Gamble, Amanda; Anderson, Renee E.; Prosser, Samantha; Kenardy, Justin

    2011-01-01

    Objective: The study examined the relative efficacy of online (NET) versus clinic (CLIN) delivery of cognitive behavior therapy (CBT) in the treatment of anxiety disorders in adolescents. Method: Participants included 115 clinically anxious adolescents aged 12 to 18 years and their parent(s). Adolescents were randomly assigned to NET, CLIN, or…

  2. Mentalization-Based Treatment for Self-Harm in Adolescents: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Rossouw, Trudie I.; Fonagy, Peter

    2012-01-01

    Objective: We examined whether mentalization-based treatment for adolescents (MBT-A) is more effective than treatment as usual (TAU) for adolescents who self-harm. Method: A total of 80 adolescents (85% female) consecutively presenting to mental health services with self-harm and comorbid depression were randomly allocated to either MBT-A or TAU.…

  3. Prolonged Exposure versus Dynamic Therapy for Adolescent PTSD: A Pilot Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Gilboa-Schechtman, Eva; Foa, Edna B.; Shafran, Naama; Aderka, Idan M.; Powers, Mark B.; Rachamim, Lilach; Rosenbach, Lea; Yadin, Elna; Apter, Alan

    2010-01-01

    Objective: To examine the efficacy and maintenance of developmentally adapted prolonged exposure therapy for adolescents (PE-A) compared with active control time-limited dynamic therapy (TLDP-A) for decreasing posttraumatic and depressive symptoms in adolescent victims of single-event traumas. Method: Thirty-eight adolescents (12 to 18 years old)…

  4. Telephone Cognitive-Behavioral Therapy for Adolescents With Obsessive-Compulsive Disorder: A Randomized Controlled Non-inferiority Trial

    PubMed Central

    Turner, Cynthia M.; Mataix-Cols, David; Lovell, Karina; Krebs, Georgina; Lang, Katie; Byford, Sarah; Heyman, Isobel

    2014-01-01

    Objective Many adolescents with obsessive-compulsive disorder (OCD) do not have access to evidence-based treatment. A randomized controlled non-inferiority trial was conducted in a specialist OCD clinic to evaluate the effectiveness of telephone cognitive-behavioral therapy (TCBT) for adolescents with OCD compared to standard clinic-based, face-to-face CBT. Method Seventy-two adolescents, aged 11 through 18 years with primary OCD, and their parents were randomized to receive specialist TCBT or CBT. The intervention provided differed only in the method of treatment delivery. All participants received up to 14 sessions of CBT, incorporating exposure with response prevention (E/RP), provided by experienced therapists. The primary outcome measure was the Children’s Yale–Brown Obsessive-Compulsive Scale (CY-BOCS). Blind assessor ratings were obtained at midtreatment, posttreatment, 3-month, 6-month, and 12-month follow-up. Results Intent-to-treat analyses indicated that TCBT was not inferior to face-to-face CBT at posttreatment, 3-month, and 6-month follow-up. At 12-month follow-up, there were no significant between-group differences on the CY-BOCS, but the confidence intervals exceeded the non-inferiority threshold. All secondary measures confirmed non-inferiority at all assessment points. Improvements made during treatment were maintained through to 12-month follow-up. Participants in each condition reported high levels of satisfaction with the intervention received. Conclusion TCBT is an effective treatment and is not inferior to standard clinic-based CBT, at least in the midterm. This approach provides a means of making a specialized treatment more accessible to many adolescents with OCD. Clinical trial registration information–Evaluation of telephone-administered cognitive-behaviour therapy (CBT) for young people with obsessive-compulsive disorder (OCD); http://www.controlled-trials.com; ISRCTN27070832. PMID:25457928

  5. Brief Strategic Family Therapy Versus Treatment as Usual: Results of a Multisite Randomized Trial for Substance Using Adolescents

    PubMed Central

    Robbins, Michael S.; Feaster, Daniel J.; Horigian, Viviana E.; Rohrbaugh, Michael; Shoham, Varda; Bachrach, Ken; Miller, Michael; Burlew, Kathleen A.; Hodgkins, Candy; Carrion, Ibis; Vandermark, Nancy; Schindler, Eric; Werstlein, Robert; Szapocznik, José

    2012-01-01

    Objective To determine the effectiveness of brief strategic family therapy (BSFT; an evidence-based family therapy) compared to treatment as usual (TAU) as provided in community-based adolescent outpatient drug abuse programs. Method A randomized effectiveness trial in the National Drug Abuse Treatment Clinical Trials Network compared BSFT to TAU with a multiethnic sample of adolescents (213 Hispanic, 148 White, and 110 Black) referred for drug abuse treatment at 8 community treatment agencies nationwide. Randomization encompassed both adolescents’ families (n = 480) and the agency therapists (n = 49) who provided either TAU or BSFT services. The primary outcome was adolescent drug use, assessed monthly via adolescent self-report and urinalysis for up to 1 year post randomization. Secondary outcomes included treatment engagement (≥2 sessions), retention (≥8 sessions), and participants’ reports of family functioning 4, 8, and 12 months following randomization. Results No overall differences between conditions were observed in the trajectories of self-reports of adolescent drug use. However, the median number of days of self-reported drug use was significantly higher, χ2(1) = 5.40, p < .02, in TAU (Mdn = 3.5, interquartile range [IQR] = 11) than BSFT (Mdn = 2, IQR = 9) at the final observation point. BSFT was significantly more effective than TAU in engaging, χ2(1) = 11.33, p < .001, and retaining, χ2(1) = 5.66, p < .02, family members in treatment and in improving parent reports of family functioning, χ2(2) = 9.10, p < .011. Conclusions We discuss challenges in treatment implementation in community settings and provide recommendations for further research. PMID:21967492

  6. Effect of a multimodality natural medicine program on carotid atherosclerosis in older subjects: a pilot trial of Maharishi Vedic Medicine.

    PubMed

    Fields, Jeremy Z; Walton, Kenneth G; Schneider, Robert H; Nidich, Sanford; Pomerantz, Rhoda; Suchdev, Parmi; Castillo-Richmond, Amparo; Payne, Kathleen; Clark, Elizabeth T; Rainforth, Maxwell

    2002-04-15

    Although the onset and progression of coronary heart disease (CHD) involve multiple risk factors, few intervention studies have attempted to modify these factors simultaneously. This pilot study tested the effect of a multimodality intervention involving dietary, exercise, herbal food supplement, and stress reduction approaches from a traditional system of natural medicine, Maharishi Vedic Medicine (MVM). The primary outcome measure was carotid intima-media thickness (IMT), a noninvasive measure of peripheral atherosclerosis and surrogate measure of coronary atherosclerosis. Comparison groups included modern medicine (conventional dietary, exercise, and multivitamin approaches) and usual care (no added intervention). Of 57 healthy seniors (mean age 74 years) randomized to the 3 treatment groups, 46 completed IMT post-testing. Carotid IMT was determined by B-mode ultrasound before and after 1 year of treatment. IMT decreased in a larger fraction of MVM subjects (16 of 20) than in the modern (5 of 9) and usual care (7 of 14) groups combined (i.e., 12 of 23; odds ratio 3.7, p = 0.05). For subjects with multiple CHD risk factors ("high-risk" subjects, n = 15), IMT decreased more in the MVM (-0.32 +/- 0.23 mm, mean +/- SD) than in the usual care (+0.022 +/- 0.085; p = 0.009) or modern (-0.082 +/- 0.095, p = 0.10) groups. Within-group reductions in IMT were significant for all MVM subjects (-0.15 +/- 0.21, n = 20, p = 0.004) and for high-risk MVM subjects (n = 6, p = 0.01). These results show that this multimodality traditional approach can attenuate atherosclerosis in older subjects, particularly those with marked CHD risk.

  7. Effects of Qishe Pill, a compound traditional Chinese herbal medicine, on cervical radiculopathy: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Neck pain is a common symptom in most patients suffering from cervical radiculopathy. However, some conservative treatments are limited by their modest effectiveness. On the other hand, surgical intervention for cervical disc disorders is indicated when symptoms are refractory to conservative treatments and neurological symptoms are progressive. Many patients use complementary and alternative medicine, including traditional Chinese medicine, to address their symptoms. The purpose of the present study is to examine the efficacy and safety of Qishe Pill, a compound traditional Chinese herbal medicine, for neck pain in patients with cervical radiculopathy. Methods/design A multicenter, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of the Qishe Pill is proposed. The study will include 240 patients from five sites across China and diagnosed with cervical radiculopathy, according to the following inclusion criteria: age 18 to 65 with pain or stiffness in the neck for at least 2 weeks (neck disability index score 25 or more) and accompanying arm pain that radiates distally from the elbow. Qualified participants will be randomly allocated into two groups: Qishe Pill group and placebo group. The prescription of the trial medications (Qishe Pill/placebo) are 3.75 g each twice a day for 28 consecutive days. The primary outcome is pain severity. Secondary outcomes are functional status, patient satisfaction, and adverse events as reported in the trial. Discussion Qishe Pill is composed of processed Radix Astragali, Muscone, Szechuan Lovage Rhizome, Radix Stephaniae Tetrandrae, Ovientvine, and Calculus Bovis Artifactus. According to modern research and preparation standards, Qishe Pill is developed to improve on the various symptoms of cervical radiculopathy, especially for neck pain. As it has a potential benefit in treating patients with neck pain, we designed a double-blind, prospective, randomized-controlled trial and

  8. Chinese medicine combined with calcipotriol betamethasone and calcipotriol ointment for Psoriasis vulgaris (CMCBCOP): study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Psoriasis causes worldwide concern because of its high-prevalence, as well as its harmful, and incurable characteristics. Topical therapy is a conventional treatment for psoriasis vulgaris. Chinese medicine (CM) has been commonly used in an integrative way for psoriasis patients for many years. Some CM therapies have shown therapeutic effects for psoriasis vulgaris (PV), including relieving symptoms and improving quality of life, and may reduce the relapse rate. However, explicit evidence has not yet been obtained. The purpose of the present trial is to examine the efficacy and safety of the YXBCM01 granule, a compound Chinese herbal medicine, with a combination of topical therapy for PV patients. Methods/Design Using an add-on design, the trial is to evaluate whether the YXBCM01 granule combined topical therapy is more effective than topical therapy alone for the treatment of PV. The study design is a double-blind, parallel, randomized controlled trial comparing the YXBCM01 granule (5.5 g twice daily) to a placebo. The duration of treatment is 12 weeks. A total of 600 participants will be randomly allocated into two groups, YXBCM01 granule group and placebo group, from 11 general or dermatological hospitals in China. Topical use of calcipotriol betamethasone for the first 4 weeks and calcipotriol ointment for the remaining 8 weeks will be the same standard therapy for the two groups. Patients will be enrolled if they have a clinical diagnosis of PV, a psoriasis area severe index (PASI) of more than 10 or body surface area (BSA) of more than 10%, but PASI of less than 30 and BSA of less than 30%, are aged between 18 and 65-years-old, and provide signed informed consent. The primary outcome, relapse rate, is based on PASI assessed blindly during the treatment. Secondary outcomes include: (i) relapse time interval, (ii) time to onset, (iii) rebound rate, (iv) PASI score, (v) cumulative consumption of medicine, (vi) the dermatology quality life index

  9. The evolution of phase I trials in cancer medicine: a critical review of the last decade.

    PubMed

    Tolcher, Anthony W

    2011-12-01

    The advent of targeted therapies, combined with an unsustainable rate of failure in oncology drug development, has resulted in a number of new approaches to clinical trials. Early clinical trials are no exception, with efforts to improve the eventual success rate of late stage trials through evolving phase I trial methodologies, the addition of extensive pharmacodynamic studies, and early adoption of patient selection strategies. Unfortunately, some of these new approaches have met with mixed results. Furthermore, no clear metrics are available to determine whether these designs are more successful than previous strategies. This review examines the evolution of phase I trials and draws upon several examples of strategies that have been successful as well as those that have not, and outlines a pragmatic approach to phase I trials as our understanding of the molecular biology of individual malignancies emerges. PMID:22059910

  10. A Randomized Depression Prevention Trial Comparing Interpersonal Psychotherapy--Adolescent Skills Training to Group Counseling in Schools.

    PubMed

    Young, Jami F; Benas, Jessica S; Schueler, Christie M; Gallop, Robert; Gillham, Jane E; Mufson, Laura

    2016-04-01

    Given the rise in depression disorders in adolescence, it is important to develop and study depression prevention programs for this age group. The current study examined the efficacy of Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST), a group prevention program for adolescent depression, in comparison to group programs that are typically delivered in school settings. In this indicated prevention trial, 186 adolescents with elevated depression symptoms were randomized to receive IPT-AST delivered by research staff or group counseling (GC) delivered by school counselors. Hierarchical linear modeling examined differences in rates of change in depressive symptoms and overall functioning from baseline to the 6-month follow-up assessment. Cox regression compared rates of depression diagnoses. Adolescents in IPT-AST showed significantly greater improvements in self-reported depressive symptoms and evaluator-rated overall functioning than GC adolescents from baseline to the 6-month follow-up. However, there were no significant differences between the two conditions in onset of depression diagnoses. Although both intervention conditions demonstrated significant improvements in depressive symptoms and overall functioning, results indicate that IPT-AST has modest benefits over groups run by school counselors which were matched on frequency and duration of sessions. In particular, IPT-AST outperformed GC in reduction of depressive symptoms and improvements in overall functioning. These findings point to the clinical utility of this depression prevention program, at least in the short-term. Additional follow-up is needed to determine the long-term effects of IPT-AST, relative to GC, particularly in preventing depression onset.

  11. A randomized controlled trial of a brief motivational enhancement for non-treatment-seeking adolescent cannabis users.

    PubMed

    de Gee, Elisabeth A; Verdurmen, Jacqueline E E; Bransen, Els; de Jonge, Jannet M; Schippers, Gerard M

    2014-09-01

    Evidence for negative effects of early-onset cannabis use has led to a need for effective interventions targeting adolescent cannabis users. A randomized controlled trial of an Australian two-session intervention based on motivational interviewing (the ACCU, or Weed-Check in Dutch) was replicated in a larger Dutch sample of 119 non-treatment-seeking adolescent cannabis users. Outcome measures at the 3-month follow-up were quantity and frequency of cannabis use, symptoms of dependence, stage of change, and psychosocial functioning. Changes in all measures were in the expected direction, yet not significant. In moderation analyses, heavier cannabis users at baseline receiving the Weed-Check had greater reductions in cannabis use than those in the control condition. These results suggest that the Weed-Check might be beneficial for heavier cannabis-using adolescents. Further research is needed to confirm these results in a sample of adolescent heavy cannabis users and to examine the relationship between MI skills of prevention workers and outcome.

  12. Improving Short-Term Sun Safety Practices among Adolescent Survivors of Childhood Cancer: A Randomized Controlled Efficacy Trial

    PubMed Central

    Mays, Darren; Black, Jessica Donze; Mosher, Revonda B.; Shad, Aziza T.; Tercyak, Kenneth P.

    2012-01-01

    Introduction Skin cancer is one of the most common secondary neoplasms among childhood cancer survivors. However, little evidence exists for effective interventions to promote sun safety behaviors within this population. Methods This small-scale randomized controlled trial examined the efficacy of the Survivor Health and Resilience Education (SHARE) Program intervention, a multiple health behavior change intervention designed to increase sun safety practices among adolescent survivors of childhood cancer. Adolescent survivors of childhood cancer (11-21 years) were randomly allocated to a group-based behavioral intervention (n = 38) or wait-list control (n = 37). Self-reported sun safety behaviors were assessed using a valid, 8-item scale at baseline and 1-month post-intervention. Results Controlling for baseline sun safety, gender, and seasonal influences, intervention participants reported significantly more sun safety practices (e.g., using sunscreen, reapplying sunscreen regularly) at 1-month post-intervention than control participants (B = 2.64, 95% CI = 1.02, 4.27, p = 0.002). Conclusions The results suggest that SHARE was efficacious in producing improvements in short-term self-reported sun safety practices among adolescent survivors of childhood cancer. Future research is needed to build upon this work by incorporating objective measures of sun safety behaviors and examining intervention durability. Implications for Cancer Survivors Behavioral interventions addressing lifestyle factors, including sun safety behaviors, among adolescent survivors of childhood cancer should be integrated into long-term care to reduce the risk for secondary malignancies and diseases. PMID:21359690

  13. 1-year follow-up of neurofeedback treatment in adolescents with attention-deficit hyperactivity disorder: randomised controlled trial

    PubMed Central

    Bongers, Ilja L.; Popma, Arne; Janssen, Tieme W.P.; van Nieuwenhuizen, Chijs

    2016-01-01

    Background Estimates of the effectiveness of neurofeedback as a treatment for attention-deficit hyperactivity disorder (ADHD) are mixed. Aims To investigate the long-term additional effects of neurofeedback (NFB) compared with treatment as usual (TAU) for adolescents with ADHD. Method Using a multicentre parallel-randomised controlled trial design, 60 adolescents with a DSM-IV-TR diagnosis of ADHD receiving NFB+TAU (n=41) or TAU (n=19) were followed up. Neurofeedback treatment consisted of approximately 37 sessions of theta/sensorimotor rhythm (SMR)-training on the vertex (Cz). Outcome measures included behavioural self-reports and neurocognitive measures. Allocation to the conditions was unmasked. Results At 1-year follow-up, inattention as reported by adolescents was decreased (range ηp2=0.23–0.36, P<0.01) and performance on neurocognitive tasks was faster (range ηp2=0.20–0.67, P<0.005) irrespective of treatment group. Conclusions Overall, NFB+TAU was as effective as TAU. Given the absence of robust additional effects of neurofeedback in the current study, results do not support the use of theta/SMR neurofeedback as a treatment for adolescents with ADHD and comorbid disorders in clinical practice. Declaration of interest None. Copyright and usage © The Royal College of Psychiatrists 2016. This is an open access article distributed under the terms of the Creative Commons Non-Commercial, No Derivatives (CC BY-NC-ND) licence. PMID:27703763

  14. A randomized controlled trial of a brief motivational enhancement for non-treatment-seeking adolescent cannabis users.

    PubMed

    de Gee, Elisabeth A; Verdurmen, Jacqueline E E; Bransen, Els; de Jonge, Jannet M; Schippers, Gerard M

    2014-09-01

    Evidence for negative effects of early-onset cannabis use has led to a need for effective interventions targeting adolescent cannabis users. A randomized controlled trial of an Australian two-session intervention based on motivational interviewing (the ACCU, or Weed-Check in Dutch) was replicated in a larger Dutch sample of 119 non-treatment-seeking adolescent cannabis users. Outcome measures at the 3-month follow-up were quantity and frequency of cannabis use, symptoms of dependence, stage of change, and psychosocial functioning. Changes in all measures were in the expected direction, yet not significant. In moderation analyses, heavier cannabis users at baseline receiving the Weed-Check had greater reductions in cannabis use than those in the control condition. These results suggest that the Weed-Check might be beneficial for heavier cannabis-using adolescents. Further research is needed to confirm these results in a sample of adolescent heavy cannabis users and to examine the relationship between MI skills of prevention workers and outcome. PMID:24969735

  15. Medicines

    MedlinePlus

    ... better. In the United States, the Food and Drug Administration is in charge of assuring the safety ... prescription and over-the-counter medicines. Even safe drugs can cause unwanted side effects or interactions with ...

  16. A randomized trial of the Positive Thoughts and Action program for depression among early adolescents.

    PubMed

    McCarty, Carolyn A; Violette, Heather D; Duong, Mylien T; Cruz, Rick A; McCauley, Elizabeth

    2013-01-01

    This study was conducted to compare the outcomes of a group-based cognitive-behavioral preventive intervention (Positive Thoughts and Actions [PTA]) tailored to youth in middle school with a brief, individually administered supportive intervention (Individual Support Program [ISP]). A randomized, controlled trial was conducted with 120 early adolescents (72 girls, 48 boys; age = 11-15 years) who had elevated depressive symptoms and were selected from a school-based population. Measures of internalizing problems, externalizing problems, personal adjustment, school problems, and interpersonal relations were obtained from parents, youth, and/or teachers at preintervention (Time 1) and postintervention (Time 2, 5-7 months after preintervention). General linear model repeated measures analyses yielded a significant Group × Time interaction on youth-reported, but not parent-reported, depressive symptoms and internalizing symptoms. Youth in the PTA group showed greater decreases following intervention compared to youth who received ISP, yielding effect sizes (Cohen's d) of 0.36 for depressive symptoms, 95% CI [-.02, .73], and 0.44, 95% CI [.05, .82], for internalizing symptoms. PTA youth also showed improvements in their personal adjustment (sense of inadequacy, self-esteem), and parent-reported social skills, but no differences emerged between groups for externalizing symptoms, school problems, or interpersonal relationships. Cognitive-behavioral preventive interventions in which youth engage in personal goal-setting and practice social-emotional skills, such as PTA, may be beneficial for the reduction of depressive symptoms over and above general support and empathy. PMID:23560384

  17. Promoting Physical Activity in Middle School Girls: Trial of Activity for Adolescent Girls

    PubMed Central

    Webber, Larry S.; Catellier, Diane J.; Lytle, Leslie A.; Murray, David M.; Pratt, Charlotte A.; Young, Deborah R.; Elder, John P.; Lohman, Timothy G.; Stevens, June; Jobe, Jared B.; Pate, Russell R.

    2008-01-01

    Background Physical activity is important for weight control and good health; however, activity levels decline in the adolescent years, particularly in girls. Design Group randomized controlled trial Setting/participants Middle school girls with English-speaking skills and no conditions to prevent participation in physical activity in 36 schools in six geographically diverse areas of the United States. Random, cross-sectional samples were drawn within schools: 6th graders in 2003 (n=1721) and 8th graders in 2005 (n=3504) and 2006 (n=3502). Intervention A 2-year study-directed intervention (fall 2003 to spring 2005) targeted schools, community agencies, and girls to increase opportunities, support, and incentives for increased physical activity. Components included programs linking schools and community agencies, physical education, health education, and social marketing. A third-year intervention used school and community personnel to direct intervention activities. Main outcome measures The primary outcome, daily MET-weighted minutes of moderate-to-vigorous physical activity (MET-weighted MVPA), was assessed using accelerometry. Percent body fat was assessed using anthropometry. Results After the staff-directed intervention (pre-stated primary outcome), there were no differences (mean= −0.4, 95% CI= CI= −8.2 to 7.4) in adjusted MET-weighted MVPA between 8th-grade girls in schools assigned to intervention or control. Following the Program Champion–directed intervention, girls in intervention schools were more physically active than girls in control schools (mean difference 10.9 MET-weighted minutes of MVPA, 95% CI=0.52–21.2). This difference is about 1.6 minutes of daily MVPA or 80 kcal per week. There were no differences in fitness or percent body fat at either 8th-grade timepoint. Conclusion A school-based, community-linked intervention modestly improved physical activity in girls. PMID:18312804

  18. Meal replacements in the treatment of adolescent obesity: a randomized controlled trial.

    PubMed

    Berkowitz, Robert I; Wadden, Thomas A; Gehrman, Christine A; Bishop-Gilyard, Chanelle T; Moore, Reneé H; Womble, Leslie G; Cronquist, Joanna L; Trumpikas, Natalie L; Levitt Katz, Lorraine E; Xanthopoulos, Melissa S

    2011-06-01

    Use of meal replacements (MRs) in lifestyle modification programs (LMPs) for obese adults significantly increases weight loss, compared with prescription of an isocaloric conventional diet (CD). This 12-month randomized trial examined 113 obese adolescents (mean ± s.d. age of 15.0 ± 1.3 years and BMI of 37.1 ± 5.1 kg/m2) who were assigned to a LMP, combined with meal plans of 1300-1500 kcal/day of CD (self-selected foods) or MR (three SlimFast shakes, one prepackaged meal, five vegetable/fruit servings). After month 4 (phase 1), participants originally treated with MR were unmasked to their phase 2 (months 5-12) random assignment: continued use of MR (i.e., MR+MR) or transitioned to CD (i.e., MR+CD). Participants initially treated with CD in phase 1, continued with CD (i.e., CD). All three groups were treated for an additional 8 months (phase 2). Regression models were used to evaluate percentage change in BMI from baseline to month 4 (phase 1), months 5-12 (phase 2), and baseline to month 12. At month 4, participants assigned to MR (N = 65) achieved a mean (±s.e.) 6.3 ± 0.6% reduction in BMI, compared to a significantly (P = 0.01) smaller 3.8 ± 0.8% for CD participants (N = 37). In phase 2, BMI increased significantly (P < 0.001) in all three conditions, resulting in no significant (P = 0.39) differences between groups in percentage change in BMI at month 12. Across groups, mean reduction in BMI from baseline to month 12 was 3.4 ± 0.7% (P < 0.01). Use of MR significantly improved short-term weight loss, compared with CD, but its continued use did not improve maintenance of lost weight.

  19. Randomized clinical trial of musical distraction with and without headphones for adolescents' immunization pain.

    PubMed

    Kristjánsdóttir, Ólöf; Kristjánsdóttir, Guðrún

    2011-03-01

    Distraction has shown to be a helpful pain intervention for children; however, few investigations have studied the effectiveness of this method with adolescents. The aim of this study was to evaluate the usefulness of an easy and practical musical distraction in reducing adolescents' immunization pain. Furthermore, to examine whether musical distraction techniques (with or without headphones) used influenced the pain outcome. Hundred and eighteen 14-year-old adolescents, scheduled for polio immunization, participated. Adolescents were randomly assigned to one of three research groups; musical distraction with headphones (n=38), musical distraction without headphones (n=41) and standard care control (n=39). Results showed adolescents receiving musical distraction were less likely to report pain compared to the control group, controlling for covariates. Comparing musical distraction techniques, eliminating headphone emerged as a significant predictor of no pain. Results suggest that an easy and practical musical distraction intervention, implemented without headphones, can give some pain relief to adolescents during routine vaccination.

  20. Using genetically informed, randomized prevention trials to test etiological hypotheses about child and adolescent drug use and psychopathology.

    PubMed

    Brody, Gene H; Beach, Steven R H; Hill, Karl G; Howe, George W; Prado, Guillermo; Fullerton, Stephanie M

    2013-10-01

    In this essay, we describe a new era of public health research in which prevention science principles are combined with genomic science to produce gene × intervention (G × I) research. We note the roles of behavioral and molecular genetics in risk and protective mechanisms for drug use and psychopathology among children and adolescents, and the results of first-generation genetically informed prevention trials are reviewed. We also consider the need for second-generation research that focuses on G × I effects on mediators or intermediate processes. This research can be used to further understanding of etiological processes, to identify individual differences in children's and adolescents' responses to risk, and to increase the precision of prevention programs. We note the caveats about using genetic data to select intervention participants.

  1. Early Signs of Atherogenesis in Adolescents in a Havana Family Medicine Catchment Area.

    PubMed

    Valdés, Wendy; Díaz-Perera, Georgia; Espinosa, Tania M

    2015-10-01

    INTRODUCTION Atherosclerosis is the common underlying cause of cardiovascular diseases; the leading cause of morbidity and mortality globally. It is a major contributor to disability and poorer quality of life and is costly to health systems, individuals, families and society. Early signs of atherogenesis are manifestations of atherosclerosis and known atherogenic risk factors occurring at young ages and detectable by health professionals. Early detection of such signs in children and adolescents enables actions to prevent short- and long-term complications. OBJECTIVE Detect early signs of atherogenesis in adolescents in Family Doctor-and-Nurse Office No. 13 of the Raúl Gómez García Polyclinic in Havana's 10 de Octubre Municipality. METHODS An observational, cross-sectional descriptive study was conducted: the universe consisted of 110 adolescents and, once exclusion criteria were applied, the sample was made up of 96 adolescents in the office's geographical catchment area. Variables included sociodemographic data; measurements from physical and anthropometric examinations (weight, height, body mass index, waist circumference, blood pressure, presence of acanthosis nigricans); maternal history of diabetes mellitus and hypertension, smoking during pregnancy; birth weight and duration of exclusive breastfeeding; lifestyle (physical activity, dietary habits by frequency of consumption of fruits and vegetables, salt intake, and smoking); and a history of atherogenic risk factors and atherosclerotic diseases (hypertension, diabetes mellitus, heart disease, cerebrovascular disease, peripheral arterial disease and chronic kidney disease) in adolescents and their families. The number of early signs of atherogenesis was determined. Descriptive statistics and a chi-square test, with significance threshold set at p = 0.05, were used to examine differences by sex and age. RESULTS A total of 62.5% of participating adolescents were female and the same percent of the total

  2. Why do – or don’t – patients with urinary tract infection participate in a clinical trial? A qualitative study in German family medicine

    PubMed Central

    Bleidorn, Jutta; Bucak, Sermin; Gágyor, Ildikó; Hummers-Pradier, Eva; Dierks, Marie-Luise

    2015-01-01

    family medicine, the following key issues should be considered: emphasizing patients’ personal benefit, featuring patient relevant trial topics, providing a maximum of safety, keeping effort by trial procedures comfortable. PMID:26512232

  3. Randomized trial of epidural injections for spinal stenosis published in the New England Journal of Medicine: further confusion without clarification.

    PubMed

    Manchikanti, Laxmaiah; Candido, Kenneth D; Kaye, Alan D; Boswell, Mark V; Benyamin, Ramsin M; Falco, Frank J E; Gharibo, Christopher G; Hirsch, Joshua A

    2014-01-01

    Randomized controlled trials are considered the hallmark of evidence-based medicine. This conveys the idea that up-to-date evidence applied consistently in clinical practice, in combination with clinicians' individual expertise and patients own preference/expectations are enjoined to achieve the best possible outcome. Since its inception in 1990s, evidence-based medicine has evolved in conjunction with numerous changes in the healthcare environment. However, the benefits of evidence-based medicine have not materialized for spinal pain including surgical interventions. Consequently, the debate continues on the efficacy and medical necessity of multiple interventions provided in managing spinal pain. Friedly et al published a randomized controlled trial of epidural glucocorticoid injections for spinal stenosis in the July 2014 edition of the highly prestigious New England Journal of Medicine. This was accompanied by an editorial from Andersson. This manuscript provided significant sensationalism for the media and confusion for the spine community. This randomized trial of epidural glucocorticoid injections for spinal stenosis and accompanying editorial concluded that epidural injections of glucocorticoids plus lidocaine offered minimal or no short-term benefit as compared with epidural injections of lidocaine alone, with the editorial emphasizing proceeding directly to surgical intervention. In addition media statements by the authors also emphasized the idea that exercise or surgery might be better options for patients suffereing from narrowing of the spinal canal. The interventional pain management community believes that there are severe limitations to this study, manuscript, and accompanying editorial. The design, inclusion criteria, outcomes assessment, analysis of data and interpretation, and conclusions of this trial point to the fact that this highly sophisticated and much publicized randomized trial may not be appropriate and lead to misinformation. The

  4. Randomized Controlled Trial of Osmotic-Release Methylphenidate with CBT in Adolescents with ADHD and Substance Use Disorders

    PubMed Central

    Riggs, Paula D.; Winhusen, Theresa; Davies, Robert D.; Leimberger, Jeffrey D.; Mikulich-Gilbertson, Susan; Klein, Constance; Macdonald, Marilyn; Lohman, Michelle; Bailey, Genie L.; Haynes, Louise; Jaffee, William B.; Hodgkins, Candace; Whitmore, Elizabeth; Trello-Rishel, Kathlene; Tamm, Leanne; Acosta, Michelle C.; Royer-Malvestuto, Charlotte; Subramaniam, Geetha; Fishman, Marc; Holmes, Beverly W.; Kaye, Mary Elyse; Vargo, Mark A.; Woody, George E.; Nunes, Edward V.; Liu, David

    2011-01-01

    Objective To evaluate the efficacy and safety of osmotic-release methylphenidate (OROS-MPH) compared to placebo for attention deficit hyperactivity disorder (ADHD) and impact on substance treatment outcomes in adolescents concurrently receiving cognitive behavioral therapy (CBT) for substance use disorders (SUD). Method 16-week randomized controlled multi-site trial of OROS-MPH + CBT versus placebo + CBT in 303 adolescents (aged 13-18), meeting DSM-IV diagnostic criteria for ADHD and SUD. Primary outcomes: (1) ADHD- clinician-administered ADHD Rating Scale (ADHD-RS), adolescent informant; (2) Substance- adolescent reported days of use in the past 28 days. Secondary outcome measures included parent ADHD-RS and weekly urine drug screens (UDS). Results There were no group differences on reduction in ADHD-RS scores (OROS-MPH: −19.2, 95% confidence interval [CI], −17.1 to −21.2; placebo,−21.2, 95% CI, −19.1 to −23.2) or reduction in days of substance use (OROS-MPH: −5.7 days, 95% CI, 4.0-7.4; placebo: −5.2 days, 95% CI, 3.5-7.0). Some secondary outcomes favored OROS-MPH including lower parent ADHD-RS scores at 8 (mean difference [md]=4.4, 95% CI, 0.8-7.9) and 16 weeks (md=6.9; 95% CI, 2.9-10.9) and more negative UDS in OROS-MPH (mean=3.8) compared to placebo (mean=2.8; P=0.04). Conclusions OROS-MPH did not show greater efficacy than placebo for ADHD or on reduction in substance use in adolescents concurrently receiving individual CBT for co-occurring SUD. However, OROS-MPH was relatively well tolerated and was associated with modestly greater clinical improvement on some secondary ADHD and substance outcome measures. PMID:21871372

  5. The clinical effectiveness of cognitive behavior therapy and an alternative medicine approach in reducing symptoms of depression in adolescents.

    PubMed

    Charkhandeh, Mansoureh; Talib, Mansor Abu; Hunt, Caroline Jane

    2016-05-30

    The main aim of the study was to investigate the effectiveness of two psychotherapeutic approaches, cognitive behavioral therapy (CBT) and a complementary medicine method Reiki, in reducing depression scores in adolescents. We recruited 188 adolescent patients who were 12-17 years old. Participants were randomly assigned to CBT, Reiki or wait-list. Depression scores were assessed before and after the 12 week interventions or wait-list. CBT showed a significantly greater decrease in Child Depression Inventory (CDI) scores across treatment than both Reiki (p<.001) and the wait-list control (p<.001). Reiki also showed greater decreases in CDI scores across treatment relative to the wait-list control condition (p=.031). The analyses indicated a significant interaction between gender, condition and change in CDI scores, such that male participants showed a smaller treatment effect for Reiki than did female participants. Both CBT and Reiki were effective in reducing the symptoms of depression over the treatment period, with effect for CBT greater than Reiki. These findings highlight the importance of early intervention for treatment of depression using both cognitive and complementary medicine approaches. However, research that tests complementary therapies over a follow-up period and against a placebo treatment is required.

  6. Motivational Enhancement Therapy for Adolescent Marijuana Users: A Preliminary Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Walker, Denise D.; Roffman, Roger A.; Stephens, Robert S.; Wakana, Kim; Berghuis, James

    2006-01-01

    This study's aims were (a) to investigate the feasibility of a school-based motivational enhancement therapy (MET) intervention in voluntarily attracting adolescents who smoke marijuana regularly but who are not seeking formal treatment and (b) to evaluate the efficacy of the intervention in reducing marijuana use. Ninety-seven adolescents who had…

  7. Preventing Adolescent Social Anxiety and Depression and Reducing Peer Victimization: Intervention Development and Open Trial

    ERIC Educational Resources Information Center

    La Greca, Annette M.; Ehrenreich-May, Jill; Mufson, Laura; Chan, Sherilynn

    2016-01-01

    Background: Social anxiety disorder (SAD) and depression are common among adolescents, frequently comorbid, and resistant to change. Prevention programs for adolescent SAD are scant, and depression prevention programs do not fully address peer-risk factors. One critical peer-risk factor for SAD and depression is peer victimization. We describe the…

  8. Treatment for Adolescents Following a Suicide Attempt: Results of a Pilot Trial.

    ERIC Educational Resources Information Center

    Donaldson, Deidre; Spirito, Anthony; Esposito-Smythers, Christianne

    2005-01-01

    Objective: To compare the efficacy of a skills-based treatment protocol to a supportive relationship therapy for adolescents after a suicide attempt. Method: Thirty-nine adolescents (12-17 years old) and parents who presented to a general pediatric emergency department or inpatient unit of a child psychiatric hospital after a suicide attempt were…

  9. Emotion Regulation Training for Adolescents with Borderline Personality Disorder Traits: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Schuppert, H. Marieke; Timmerman, Marieke E.; Bloo, Josephine; van Gemert, Tonny G.; Wiersema, Herman M.; Minderaa, Ruud B.; Emmelkamp, Paul M. G.; Nauta, Maaike H.

    2012-01-01

    Objective: To evaluate the effectiveness of Emotion Regulation Training (ERT), a 17-session weekly group training for adolescents with borderline personality disorder (BPD) symptoms. Method: One hundred nine adolescents with borderline traits (73% meeting the full criteria for BPD) were randomized to treatment as usual only (TAU) or ERT + TAU.…

  10. Strength and Agility Training in Adolescents with Down Syndrome: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Lin, Hsiu-Ching; Wuang, Yee-Pay

    2012-01-01

    The purpose of this study was to investigate the effects of a proposed strength and agility training program of adolescents with Down syndrome. Ninety-two adolescents were recruited and evenly randomized to two intervention groups (exercise group vs. control group). The mean age for the exercise and the control group was 10.6 plus or minus 3.2 and…

  11. NIH announces the launch of 3 integrated precision medicine trials: ALCHEMIST

    Cancer.gov

    The Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials, or ALCHEMIST, will identify early-stage lung cancer patients with tumors that harbor certain uncommon genetic changes and evaluate whether drug treatments targeted against

  12. Enhancing Adolescent and Young Adult Oncology Research Within the National Clinical Trials Network: Rationale, Progress, and Emerging Strategies.

    PubMed

    Weiss, Aaron R; Nichols, Craig R; Freyer, David R

    2015-10-01

    Adolescent and Young Adult Oncology (AYAO, including patients 15-39 years of age) is an emerging discipline in the field of cancer treatment and research. Poorer survival outcomes for this population and characteristic age-related challenges in care have called attention to the need for increased AYAO research. This chapter outlines pressing questions and reviews recent progress in AYAO research within the current organizational structure of the federal clinical trials enterprise, emphasizing how the United States National Cancer Institute's National Clinical Trials Network (NCTN) has created novel opportunities for collaborative AYAO research among the pediatric and adult NCTN groups. Potential strategies for expanding AYAO research, both within the NCTN and with other partners in the federal and advocacy domains are identified. PMID:26433555

  13. Effect of Combination of Chinese Herbal Medicine versus Western Medicine on Mortality in Patients after Cardiopulmonary Resuscitation: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Guo, Wenxiu; Lu, Xiaoguang; Wang, Dalong; Chen, Tuo; Fan, Zhiwei; Song, Yi

    2016-01-01

    Introduction. Although Chinese herbal medicine (CHM) treatment combined with conventional western therapy has been widely used and reported in many clinical trials in China, there is uncertainty about the efficacy of this combination in the treatment of patients after cardiopulmonary resuscitation (CPR). This systematic review aimed to assess whether the risk of mortality has decreased comparing the combination of CHM treatment with conventional western therapy. Methods. To identify relevant studies, the literature search was conducted in Medline, Embase, the Cochrane Library, CBM, CNKI, VIP, and Wanfang database. We included all randomized controlled trials (RCTs) that compared outcomes of patients after CPR taking combination of CHM treatment with those taking just conventional western therapy. Results. This meta-analysis showed that patients randomly assigned to combined CHM treatment group had a statistically significant 23% reduction in mortality compared with those randomly assigned to conventional western therapy group (RR: 0.77; 95% CI: 0.70–0.84). Conclusions. This meta-analysis provides evidence suggesting that a combined CHM therapy is associated with a decreased risk of mortality compared with conventional western therapy in patients after CPR. Further studies are needed to provide more evidence to prove or refute our conclusion and identify reasons for the reduction of mortality. PMID:26952966

  14. Effect of Combination of Chinese Herbal Medicine versus Western Medicine on Mortality in Patients after Cardiopulmonary Resuscitation: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

    PubMed

    Guo, Wenxiu; Lu, Xiaoguang; Wang, Dalong; Chen, Tuo; Fan, Zhiwei; Song, Yi

    2016-01-01

    Introduction. Although Chinese herbal medicine (CHM) treatment combined with conventional western therapy has been widely used and reported in many clinical trials in China, there is uncertainty about the efficacy of this combination in the treatment of patients after cardiopulmonary resuscitation (CPR). This systematic review aimed to assess whether the risk of mortality has decreased comparing the combination of CHM treatment with conventional western therapy. Methods. To identify relevant studies, the literature search was conducted in Medline, Embase, the Cochrane Library, CBM, CNKI, VIP, and Wanfang database. We included all randomized controlled trials (RCTs) that compared outcomes of patients after CPR taking combination of CHM treatment with those taking just conventional western therapy. Results. This meta-analysis showed that patients randomly assigned to combined CHM treatment group had a statistically significant 23% reduction in mortality compared with those randomly assigned to conventional western therapy group (RR: 0.77; 95% CI: 0.70-0.84). Conclusions. This meta-analysis provides evidence suggesting that a combined CHM therapy is associated with a decreased risk of mortality compared with conventional western therapy in patients after CPR. Further studies are needed to provide more evidence to prove or refute our conclusion and identify reasons for the reduction of mortality.

  15. [Academic discussion of adverse reaction of clinical trials of new traditional Chinese medicines and relevant influencing factors].

    PubMed

    Wang, Wen-ping; Yu, Ming; Wang, Li; Jiang, Xi-ren; Li, Xiao-bin; Wang, Hua-wei; Cao, Ying; Liu, Kai; Huang, Lu-qi

    2015-01-01

    Data of clinical trial projects involved by clinical trial institutions certified by the State Food and Drug Administration from 2002 to November 2012 were collected to summarize adverse reactions in project summary/statistical reports, analyze the rate of adverse reactions of clinical trials of new traditional Chinese medicines and relevant influencing factors, and increase the awareness of the safety of new traditional Chinese medicines. A total of 73 050 cases in 209 projects of 14 specialties were collected, including 49 689 cases in the new traditional Chinese medicine group and 271 adverse reaction cases, with an incidence rate of adverse reactions at 0.55%. The adverse reaction rate in 3 months < middle long course ≤ 6 months was the highest (1.04%), whereas that in short course ≤ half a month was the lowest (0.48%). The adverse reaction was closely related with the route of administration, 1.28% for topical > 0.63% for injection > 0.50% for oral. In the administration of only the test drug, the adverse reaction rate of patches was the highest (2.68%), whereas that of aerosols and suppositories was lowest (0). In the combined administration of the test drug and the simulation agent, the adverse reaction rate of external test patch + capsule was the highest (3.38%), whereas that of capsule + oral liquid, pills + granules, tablets + oral liquid, tablets + pills, tablet + capsule was the lowest (0). In the administration of only the test drug, the adverse reaction rate was 0.47%; In the combined administration with simulation agent (drug volume increase), the adverse reaction rate was 0.74%. Different doses caused adverse reaction different rates; The adverse reaction rate of drugs with whole-course dose between 1 100-1 200 g was the highest (3.36%), that for whole-course doses of 500-600, 900-1 000, 1 400-1 500, 1 600-1 700, 1 800-1 900 g was the lowest (0). In conclusion, the adverse reaction rate of new traditional Chinese medicines was still up to 0

  16. Antipsychotic treatment for children and adolescents with schizophrenia spectrum disorders: protocol for a network meta-analysis of randomised trials

    PubMed Central

    Pagsberg, A K; Tarp, S; Glintborg, D; Stenstrøm, A D; Fink-Jensen, A; Correll, C U; Christensen, R

    2014-01-01

    Introduction Antipsychotic treatment in early-onset schizophrenia (EOS) lacks a rich evidence base, and efforts to rank different drugs concerning their efficacy have not proven any particular drug superior. In contrast to the literature regarding adult-onset schizophrenia (AOS), comparative effectiveness studies in children and adolescents are limited in number and size, and only a few meta-analyses based on conventional methodologies have been conducted. Methods and analyses We will conduct a network meta-analysis of all randomised controlled trials (RCTs) that evaluate antipsychotic therapies for EOS to determine which compounds are efficacious, and to determine the relative efficacy and safety of these treatments when compared in a network meta-analysis. Unlike a contrast-based (standard) meta-analysis approach, an arm-based network meta-analysis enables statistical inference from combining both direct and indirect comparisons within an empirical Bayes framework. We will acquire eligible studies through a systematic search of MEDLINE, the Cochrane Central Registry of Controlled Trials, Clinicaltrials.gov and Centre for Reviews and Dissemination databases. Eligible studies should randomly allocate children and adolescents presenting with schizophrenia or a related non-affective psychotic condition to an intervention group or to a control group. Two reviewers will—independently and in duplicate—screen titles and abstracts, complete full text reviews to determine eligibility, and subsequently perform data abstraction and assess risk of bias of eligible trials. We will conduct meta-analyses to establish the effect of all reported therapies on patient-relevant efficacy and safety outcomes when possible. Ethics and dissemination No formal ethical procedures regarding informed consent are required as no primary data collection is undertaken. The review will help facilitate evidence-based management, identify key areas for future research, and provide a framework

  17. Effect of oriental medicine music therapy on patients with Hwa-byung: a study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Hwa-byung, a Korean culture-bound syndrome with both psychological and somatic symptoms, is also known as ‘anger syndrome’. It includes various physical symptoms including anxiety, a feeling of overheating, a sensation of pressure on the chest, heart palpitations, respiratory stuffiness, insomnia, and anxiety. Methods/design The proposed study is a single-center, double-blind, randomized, controlled trial with two parallel arms: an oriental medicine music therapy (OMMT) group and a control music therapy (CMT) group. In total, 48 patients will be enrolled into the trial. The first visit will be the screening visit. At baseline (visit 2), all participants fulfilling both the inclusion and the exclusion criteria will be split and randomly divided into two equal groups: the OMMT and the CMT (n = 24 each). Each group will receive treatment sessions over the course of 4 weeks, twice per week, for eight sessions in total. The primary outcome is the State-Trait Anxiety Inventory (STAI), and the secondary outcomes are the Hwa-byung scale (H-scale), the Center for Epidemiologic Studies Depression Scale (CES-D), the Hwa-byung visual analogue scale (H-VAS) for primary symptoms, the World Health Organization Quality of Life scale, brief version (WHOQOL-BREF), and levels of salivary cortisol. Patients will be asked to complete questionnaires at the baseline visit (visit 2), after the last treatment session (visit 9), and at 4 weeks after the end of all trial sessions (visit 10). From the baseline (visit 2) through the follow-up (visit 10), the entire process will take a total of 53 days. Discussion This proposed study targets patients with Hwa-byung, especially those who have exhibited symptoms of anxiety. Therefore, the primary outcome is set to measure the level of anxiety. OMMT is music therapy combined with traditional Korean medicinal theories. Unlike previously reported music therapies, for which patients simply listen to music passively, in OMMT, patients

  18. Herbal medicine (Gyejibongneyong-hwan) for treating primary dysmenorrhoea: a protocol for a systematic review of randomised controlled trials

    PubMed Central

    Lee, Ju Ah; Park, Sunju; Jung, Jeeyoun; Jun, Ji Hee; Choi, Jiae

    2016-01-01

    Introduction Gyejibongneyong-hwan (GBH), also known as Guizhi Fuling formula, and is widely used for uterine fibroids in East Asian countries. Many clinical trials assessing the efficacy and safety of GBH formula for the treatment of dysmenorrhoea have been reported. This review will assess the clinical evidence for and against the use of GBH formula as a treatment for dysmenorrhoea. It will also discuss the proposed mechanism(s) that could link herbal medicine to improvements in dysmenorrhoea. Methods and analysis Fourteen databases will be searched until September 2016. We will include randomised controlled trials (RCTs) examining GBH decoctions for any type of dysmenorrhoea. All RCTs of decoctions or modified decoctions will be included. The methodological qualities of the RCTs will be assessed using the Cochrane Collaboration tool for assessing risk of bias. Ethics and dissemination This systematic review will be published in a peer-reviewed journal. The review will also be disseminated electronically and in print. It will be updated to inform and guide healthcare practices. Trial registration number CRD42015023419. PMID:27683510

  19. Nanoparticle-Based Medicines: A Review of FDA-Approved Materials and Clinical Trials to Date.

    PubMed

    Bobo, Daniel; Robinson, Kye J; Islam, Jiaul; Thurecht, Kristofer J; Corrie, Simon R

    2016-10-01

    In this review we provide an up to date snapshot of nanomedicines either currently approved by the US FDA, or in the FDA clinical trials process. We define nanomedicines as therapeutic or imaging agents which comprise a nanoparticle in order to control the biodistribution, enhance the efficacy, or otherwise reduce toxicity of a drug or biologic. We identified 51 FDA-approved nanomedicines that met this definition and 77 products in clinical trials, with ~40% of trials listed in clinicaltrials.gov started in 2014 or 2015. While FDA approved materials are heavily weighted to polymeric, liposomal, and nanocrystal formulations, there is a trend towards the development of more complex materials comprising micelles, protein-based NPs, and also the emergence of a variety of inorganic and metallic particles in clinical trials. We then provide an overview of the different material categories represented in our search, highlighting nanomedicines that have either been recently approved, or are already in clinical trials. We conclude with some comments on future perspectives for nanomedicines, which we expect to include more actively-targeted materials, multi-functional materials ("theranostics") and more complicated materials that blur the boundaries of traditional material categories. A key challenge for researchers, industry, and regulators is how to classify new materials and what additional testing (e.g. safety and toxicity) is required before products become available. PMID:27299311

  20. Suicide Attempts and Nonsuicidal Self-Injury in the Treatment of Resistant Depression in Adolescents: Findings from the TORDIA Trial

    PubMed Central

    Asarnow, Joan Rosenbaum; Porta, Giovanna; Spirito, Anthony; Emslie, Graham; Clarke, Greg; Wagner, Karen Dineen; Vitiello, Benedetto; Keller, Martin; Birmaher, Boris; McCracken, James; Mayes, Taryn; Berk, Michele; Brent, David A.

    2011-01-01

    Objective To evaluate the clinical and prognostic significance of suicide attempts (SAs) and non-suicidal self-injury (NSSI) in adolescents with treatment-resistant depression. Method Depressed adolescents who did not improve with an adequate SSRI trial (N=334) were randomized to a medication switch (SSRI or venlafaxine) with or without cognitive-behavior therapy. NSSI and SAs were assessed at baseline and throughout the 24-week treatment period. Results 47.4% of youths reported a history of self-injurious behavior at baseline: 23.8% NSS-alone, 14% NSSI+SAs, 9.5% SAs-alone. The 24-week incidence rates of SAs and NSSI were 7% and 11%, respectively; these rates were highest among youths with NSSI+SAs at baseline. NSSI history predicted both incident SAs (HR= 5.28, 95% CI: 1.80–15.47, z= 3.04, p=.002) and incident NSSI (HR= 7.31, z= 4.19, 95% CI: 2.88–18.54, p<.001) through week-24, and was a stronger predictor of future attempts than a history of SAs (HR= 1.92, 95% CI: z = 2.29, p=.13). In the most parsimonious model predicting to time to incident SAs, baseline NSSI history and hopelessness were significant predictors, adjusting for treatment effects. Parallel analyses predicting time to incident NSSI through week-24, identified baseline NSSI history and physical and/or sexual abuse history as significant predictors. Conclusions NSSI is a common problem among youths with treatment resistant depression and a significant predictor of future SAs and NSSI, underscoring the critical need for strategies that target the prevention of both NSSI and suicidal behavior. Clinical Trial Registration Information Treatment of SSRI-Resistant Depression in Adolescents (TORDIA). URL: http://www.clinicaltrials.gov. Unique Identifier: NCT00018902. PMID:21784297

  1. Intervention with Substance Abusing Runaway Adolescents and their Families: Results of a Randomized Clinical Trial

    PubMed Central

    Slesnick, Natasha; Erdem, Gizem; Bartle-Haring, Suzanne; Brigham, Gregory S.

    2013-01-01

    Objectives To examine the efficacy of three theoretically distinct interventions among substance-abusing runaway adolescents and to explore individual differences in trajectories of change. Methods Adolescents (N=179) between the ages of 12–17 were recruited from a runaway shelter in a Midwestern city. The sample included 94 females (52.5%) and 85 males (47.5%), the majority of the adolescents were African American (n= 118, 65.9%). Adolescents were randomly assigned to the Community Reinforcement Approach (CRA, n = 57), Motivational Interviewing (MI, n = 61), or Ecologically-Based Family Therapy (EBFT, n = 61). Substance use was assessed at baseline, 3, 6, 9, 12, 18, and 24 months via Form 90 and urine screens. Results Hierarchical linear modeling revealed statistically significant improvement in frequency of substance use among runaways in all three treatment groups with a slight increase at post-treatment. Latent trajectory profile analysis explored individual differences in change trajectories and yielded a 3 class model. The majority of adolescents (n = 136, 76%) showed reductions in substance use over time with a slight increase at follow-up (Class 1: Decreasing). Twenty-four (13.4%) adolescents had shown high levels of substance use over time with patterns of increase and decrease (Class 2: Fluctuating high users), and 19 (10.6%) decreased but returned to baseline levels by two years post-baseline (Class 3: U shaped). Few differences among treatment conditions were noted; within the “decreasing” group, adolescents in MI treatment showed a quicker decline in their substance use but a faster relapse compared to those receiving EBFT. Conclusions These findings suggest that CRA, EBFT and MI are viable treatments for runaway substance-abusing adolescents. PMID:23895088

  2. Evidence of Chinese herbal medicine Duhuo Jisheng decoction for knee osteoarthritis: a systematic review of randomised clinical trials

    PubMed Central

    Zhang, Wenming; Wang, Shangquan; Zhang, Ranxing; Zhang, Yuanyuan; Li, Xinjian; Lin, Yanping; Wei, Xu

    2016-01-01

    Objectives Duhuo Jisheng decoction (DJD) is considered beneficial for controlling knee osteoarthritis (KOA)-related symptoms in some Asian countries. This review compiles the evidence from randomised clinical trials and quantifies the effects of DJD on KOA. Designs 7 online databases were investigated up to 12 October 2015. Randomised clinical trials investigating treatment of KOA for which DJD was used either as a monotherapy or in combination with conventional therapy compared to no intervention, placebo or conventional therapy, were included. The outcomes included the evaluation of functional activities, pain and adverse effect. The risk of bias was evaluated using the Cochrane Collaboration tool. The estimated mean difference (MD) and SMD was within a 95% CI with respect to interstudy heterogeneity. Results 12 studies with 982 participants were identified. The quality presented a high risk of bias. Meta-analysis found that DJD combined with glucosamine (MD 4.20 (1.72 to 6.69); p<0.001) or DJD plus meloxicam and glucosamine (MD 3.48 (1.59 to 5.37); p<0.001) had a more significant effect in improving Western Ontario and McMaster Universities Arthritis Index (total WOMAC scores). Also, meta-analysis presented more remarkable pain improvement when DJD plus sodium hyaluronate injection (MD 0.89 (0.26 to 1.53); p=0.006) was used. These studies demonstrated that active treatment of DJD in combination should be practiced for at least 4 weeks. Information on the safety of DJD or comprehensive therapies was insufficient in few studies. Conclusions DJD combined with Western medicine or sodium hyaluronate injection appears to have benefits for KOA. However, the effectiveness and safety of DJD is uncertain because of the limited number of trials and low methodological quality. Therefore, practitioners should be cautious when applying DJD in daily practice. Future clinical trials should be well designed; more research is needed. PMID:26729379

  3. The COPE healthy lifestyles TEEN randomized controlled trial with culturally diverse high school adolescents: baseline characteristics and methods.

    PubMed

    Melnyk, Bernadette Mazurek; Kelly, Stephanie; Jacobson, Diana; Belyea, Michael; Shaibi, Gabriel; Small, Leigh; O'Haver, Judith; Marsiglia, Flavio Francisco

    2013-09-01

    Obesity and mental health disorders remain significant public health problems in adolescents. Substantial health disparities exist with minority youth experiencing higher rates of these problems. Schools are an outstanding venue to provide teens with skills needed to improve their physical and mental health, and academic performance. In this paper, the authors describe the design, intervention, methods and baseline data for a randomized controlled trial with 779 culturally diverse high-school adolescents in the southwest United States. Aims for this prevention study include testing the efficacy of the COPE TEEN program versus an attention control program on the adolescents' healthy lifestyle behaviors, Body Mass Index (BMI) and BMI%, mental health, social skills and academic performance immediately following the intervention programs, and at six and 12 months post interventions. Baseline findings indicate that greater than 40% of the sample is either overweight (n = 148, 19.00%) or obese (n = 182, 23.36%). The predominant ethnicity represented is Hispanic (n = 526, 67.52%). At baseline, 15.79% (n = 123) of the students had above average scores on the Beck Youth Inventory Depression subscale indicating mildly (n = 52, 6.68%), moderately (n = 47, 6.03%), or extremely (n = 24, 3.08%) elevated scores (see Table 1). Anxiety scores were slightly higher with 21.56% (n = 168) reporting responses suggesting mildly (n = 81, 10.40%), moderately (n = 58, 7.45%) or extremely (n = 29, 3.72%) elevated scores. If the efficacy of the COPE TEEN program is supported, it will offer schools a curriculum that can be easily incorporated into high school health courses to improve adolescent healthy lifestyle behaviors, psychosocial outcomes and academic performance.

  4. Disclosure of HSV-2 Serological Test Results in the Context of an Adolescent HIV Prevention Trial in Kenya

    PubMed Central

    Hallfors, Denise Dion; Cho, Hyunsan; Mbai, Isabella; Millimo, Benson; Atieno, Carolyne; Okumu, David; Luseno, Winnie; Hartman, Shane; Halpern, Carolyn T.; Hobbs, Marcia M.

    2015-01-01

    Objectives HSV-2 biomarkers are often used in adolescent sub-Saharan HIV prevention studies, but evaluations of test performance and disclosure outcomes are rare in the published literature. Therefore, we investigated the proportion of ELISA-positive and indeterminant samples confirmed by Western blot (WB); the psychosocial response to disclosure; and whether reports of sexual behavior and HSV-2 symptoms are consistent with WB confirmatory results among adolescent orphans in Kenya. Methods In 2011, 837 Kenyan orphan youth in grades 7 and 8 enrolled in an HIV prevention clinical trial with HSV-2 biomarker outcomes. We used a modified algorithm for the Kalon HSV-2 ELISA to improve specificity; positive and indeterminate results were WB-tested. We developed culturally sensitive protocols for disclosing positive results and documented psychosocial responses, reports of sexual contact, and HSV-2 symptoms. Results 28 adolescents (3.3%) were identified as HSV-2 seropositive; 6 as indeterminate. Of these, 22 positive and all indeterminants were WB-tested; 20 and 5, respectively, were confirmed positive. Most youth reported moderate brief stress after disclosure; 22% reported longer and more severe distress. Boys were more likely to be in the latter category. Self-reported virginity was highly inconsistent with WB confirmed positives. Conclusions The higher than manufacturer cut-off for Kalon ELISA modestly reduced the rate of false positive test results but also increased false negatives. Investigators should consider the risk-benefit ratio in deciding whether or not to disclose HSV-2 results to adolescent participants under specific field conditions. PMID:26139208

  5. Effects of a brief school-based media literacy intervention on digital media use in adolescents: cluster randomized controlled trial.

    PubMed

    Walther, Birte; Hanewinkel, Reiner; Morgenstern, Matthis

    2014-09-01

    The aim of this study was to evaluate the effects of a four-session school-based media literacy curriculum on adolescent computer gaming and Internet use behavior. The study comprised a cluster randomized controlled trial with three assessments (baseline, posttest, and 12-month follow-up). At baseline, a total of 2,303 sixth and seventh grade adolescents from 27 secondary schools were assessed. Of these, 1,843 (80%) could be reached at all three assessments (Mage=12.0 years; SD=0.83). Students of the intervention group received the media literacy program Vernetzte www.Welten ("Connected www.Worlds ") implemented by trained teachers during class time. The control group attended regular class. Main outcome measures were adolescents' computer gaming and Internet use: days per month, hours per day, and addictive use patterns. Parental media monitoring and rules at home were assessed as secondary outcomes. Results of multilevel growth-curve models revealed a significant intervention effect in terms of a lower increase in self-reported gaming frequency (β = -1.10 [95% CI -2.06, -0.13]), gaming time (β = -0.27 [95% CI -0.40, -0.14]), and proportion of excessive gamers (AOR=0.21 [95% CI 0.08, 0.57]) in the intervention group. There were also significant group-time interactions for the addictive gaming scale (β=-0.08 [95% CI -0.12, -0.04]), and the Internet Addiction Scale (β = -0.06 [95% CI -0.10, -0.01]). No effect was found for days and hours of Internet use or parental media behavior. The study shows that the program Vernetzte www.Welten can influence adolescents' media use behavior. Future research should address mediating and moderating variables of program effects.

  6. Effects of a brief school-based media literacy intervention on digital media use in adolescents: cluster randomized controlled trial.

    PubMed

    Walther, Birte; Hanewinkel, Reiner; Morgenstern, Matthis

    2014-09-01

    The aim of this study was to evaluate the effects of a four-session school-based media literacy curriculum on adolescent computer gaming and Internet use behavior. The study comprised a cluster randomized controlled trial with three assessments (baseline, posttest, and 12-month follow-up). At baseline, a total of 2,303 sixth and seventh grade adolescents from 27 secondary schools were assessed. Of these, 1,843 (80%) could be reached at all three assessments (Mage=12.0 years; SD=0.83). Students of the intervention group received the media literacy program Vernetzte www.Welten ("Connected www.Worlds ") implemented by trained teachers during class time. The control group attended regular class. Main outcome measures were adolescents' computer gaming and Internet use: days per month, hours per day, and addictive use patterns. Parental media monitoring and rules at home were assessed as secondary outcomes. Results of multilevel growth-curve models revealed a significant intervention effect in terms of a lower increase in self-reported gaming frequency (β = -1.10 [95% CI -2.06, -0.13]), gaming time (β = -0.27 [95% CI -0.40, -0.14]), and proportion of excessive gamers (AOR=0.21 [95% CI 0.08, 0.57]) in the intervention group. There were also significant group-time interactions for the addictive gaming scale (β=-0.08 [95% CI -0.12, -0.04]), and the Internet Addiction Scale (β = -0.06 [95% CI -0.10, -0.01]). No effect was found for days and hours of Internet use or parental media behavior. The study shows that the program Vernetzte www.Welten can influence adolescents' media use behavior. Future research should address mediating and moderating variables of program effects. PMID:25126888

  7. A school intervention for mental health literacy in adolescents: effects of a non-randomized cluster controlled trial

    PubMed Central

    2013-01-01

    Background “Mental health for everyone” is a school program for mental health literacy and prevention aimed at secondary schools (13–15 yrs). The main aim was to investigate whether mental health literacy, could be improved by a 3-days universal education programme by: a) improving naming of symptom profiles of mental disorder, b) reducing prejudiced beliefs, and c) improving knowledge about where to seek help for mental health problems. A secondary aim was to investigate whether adolescent sex and age influenced the above mentioned variables. A third aim was to investigate whether prejudiced beliefs influenced knowledge about available help. Method This non-randomized cluster controlled trial included 1070 adolescents (53.9% boys, M age14 yrs) from three schools in a Norwegian town. One school (n = 520) received the intervention, and two schools (n = 550) formed the control group. Pre-test and follow-up were three months apart. Linear mixed models and generalized estimating equations models were employed for analysis. Results Mental health literacy improved contingent on the intervention, and there was a shift towards suggesting primary health care as a place to seek help. Those with more prejudiced beleifs did not suggest places to seek help for mental health problems. Generally, girls and older adolescents recognized symptom profiles better and had lower levels of prejudiced beliefs. Conclusions A low cost general school program may improve mental health literacy in adolescents. Gender specific programs and attention to the age and maturity of the students should be considered when mental health literacy programmes are designed and tried out. Prejudice should be addressed before imparting information about mental health issues. PMID:24053381

  8. Chinese herbal medicine Guizhi Fuling Formula for treatment of uterine fibroids: a systematic review of randomised clinical trials

    PubMed Central

    2014-01-01

    Background Guizhi Fuling Formula is widely applied for uterine fibroids in China. Many clinical trials are reported. This study assessed the efficacy and safety of Guizhi Fuling Formula for the treatment of uterine fibroids. Methods PubMed, Cochrane CENTRAL, EMBASE, and four Chinese databases were searched through May 2013. We included randomised controlled trials (RCTs) that tested Guizhi Fuling Formula for uterine fibroids, compared with no intervention, placebo, pharmaceutical medication, or other Chinese patent medicines approved by the State Food and Drug Administration of China. Authors extracted data and assessed the quality independently. We applied RevMan 5.2.0 software to analyse data of included randomised trials. Results A total of 38 RCTs involving 3816 participants were identified. The methodological quality of the included trials was generally poor. Meta-analyses demonstrated that Guizhi Fuling Formula plus mifepristone were more effective than mifepristone alone in reducing the volume of fibroids (in total volume of multiple fibroids, MD −19.41 cm3, 95% CI −28.68 to −10.14; in average volume of multiple fibroids, MD −1.00 cm3, 95% CI −1.23 to −0.76; in average volume of maximum fibroids, MD −3.35 cm3, 95% CI −4.84 to −1.87, I2 = 93%, random effects model). Guizhi Fuling Formula significantly improved symptoms of dysmenorrhea either when it was used alone (RR 2.27, 95% CI 1.04 to 4.97) or in combination with mifepristone (RR 2.35, 95% CI 1.15 to 4.82). No serious adverse events were reported. Conclusions Guizhi Fuling Formula appears to have additional benefit based on mifepristone treatment in reducing volume of fibroids. However, due to high risk of bias of the trials, we could not draw confirmative conclusions on its benefit. Future clinical trials should be well-designed and avoid the issues that are identified in this study. PMID:24383676

  9. Protocol for: Sheffield Obesity Trial (SHOT): A randomised controlled trial of exercise therapy and mental health outcomes in obese adolescents [ISRCNT83888112

    PubMed Central

    Daley, Amanda J; Copeland, Robert J; Wright, Neil P; Wales, Jerry KH

    2005-01-01

    Background While obesity is known to have many physiological consequences, the psychopathology of this condition has not featured prominently in the literature. Cross-sectional studies have indicated that obese children have increased odds of experiencing poor quality of life and mental health. However, very limited trial evidence has examined the efficacy of exercise therapy for enhancing mental health outcomes in obese children, and the Sheffield Obesity Trial (SHOT) will provide evidence of the efficacy of supervised exercise therapy in obese young people aged 11–16 years versus usual care and an attention-control intervention. Method/design SHOT is a randomised controlled trial where obese young people are randomised to receive; (1) exercise therapy, (2) attention-control intervention (involving body-conditioning exercises and games that do not involve aerobic activity), or (3) usual care. The exercise therapy and attention-control sessions will take place three times per week for eight weeks and a six-week home programme will follow this. Ninety adolescents aged between 11–16 years referred from a children's hospital for evaluation of obesity or via community advertisements will need to complete the study. Participants will be recruited according to the following criteria: (1) clinically obese and aged 11–16 years (Body Mass Index Centile > 98th UK standard) (2) no medical condition that would restrict ability to be active three times per week for eight weeks and (3) not diagnosed with insulin dependent diabetes or receiving oral steroids. Assessments of outcomes will take place at baseline, as well as four (intervention midpoint) and eight weeks (end of intervention) from baseline. Participants will be reassessed on outcome measures five and seven months from baseline. The primary endpoint is physical self-perceptions. Secondary outcomes include physical activity, self-perceptions, depression, affect, aerobic fitness and BMI. PMID:16259624

  10. Regulatory requirements for clinical trial and marketing authorisation application for cell-based medicinal products.

    PubMed

    Salmikangas, P; Flory, E; Reinhardt, J; Hinz, T; Maciulaitis, R

    2010-01-01

    The new era of regenerative medicine has led to rapid development of new innovative therapies especially for diseases and tissue/organ defects for which traditional therapies and medicinal products have not provided satisfactory outcome. Although the clinical use and developments of cell-based medicinal products (CBMPs) could be witnessed already for a decade, robust scientific and regulatory provisions for these products have only recently been enacted. The new Regulation for Advanced Therapies (EC) 1394/2007 together with the revised Annex I, Part IV of Directive 2001/83/EC provides the new legal framework for CBMPs. The wide variety of cell-based products and the foreseen limitations (small sample sizes, short shelf life) vs. particular risks (microbiological purity, variability, immunogenicity, tumourigenicity) associated with CBMPs have called for a flexible, case-by-case regulatory approach for these products. Consequently, a risk-based approach has been developed to allow definition of the amount of scientific data needed for a Marketing Authorisation Application (MAA) of each CBMP. The article provides further insight into the initial risk evaluation, as well as to the quality, non-clinical, and clinical requirements of CBMPs. Special somatic cell therapies designed for active immunotherapy are also addressed. PMID:19940964

  11. Regulatory requirements for clinical trial and marketing authorisation application for cell-based medicinal products.

    PubMed

    Salmikangas, P; Flory, E; Reinhardt, J; Hinz, T; Maciulaitis, R

    2010-01-01

    The new era of regenerative medicine has led to rapid development of new innovative therapies especially for diseases and tissue/organ defects for which traditional therapies and medicinal products have not provided satisfactory outcome. Although the clinical use and developments of cell-based medicinal products (CBMPs) could be witnessed already for a decade, robust scientific and regulatory provisions for these products have only recently been enacted. The new Regulation for Advanced Therapies (EC) 1394/2007 together with the revised Annex I, Part IV of Directive 2001/83/EC provides the new legal framework for CBMPs. The wide variety of cell-based products and the foreseen limitations (small sample sizes, short shelf life) vs. particular risks (microbiological purity, variability, immunogenicity, tumourigenicity) associated with CBMPs have called for a flexible, case-by-case regulatory approach for these products. Consequently, a risk-based approach has been developed to allow definition of the amount of scientific data needed for a Marketing Authorisation Application (MAA) of each CBMP. The article provides further insight into the initial risk evaluation, as well as to the quality, non-clinical, and clinical requirements of CBMPs. Special somatic cell therapies designed for active immunotherapy are also addressed.

  12. Racial and Ethnic Profiles of Complementary and Alternative Medicine Use Among Young Adults in the United States: Findings From the National Longitudinal Study of Adolescent Health.

    PubMed

    Upchurch, Dawn M; Wexler Rainisch, Bethany K

    2012-10-01

    This study describes complementary and alternative medicine use among a national sample of young adults, with an emphasis on characterizing racial and ethnic differences, highlighting variation across subgroups of Hispanics. The authors examined young adults ages 18 to 27 years (n = 14 128) from wave III (2001-2002) of the National Longitudinal Study of Adolescent Health. Prevalence estimates and logistic regression results were weighted and adjusted for complex sample design. The study examined recent complementary and alternative medicine use in the past 12 months, recent use for each of 15 specific complementary and alternative medicine modalities, and the 5 most commonly used modalities (herbs, massage, chiropractic, relaxation, and vitamins). Results showed that 29% of young adults aged 18 to 27 years recently used complementary and alternative medicine. Prevalence was highest among Cuban Americans (42%) and lowest among blacks (22%). Young adults used a diversity of complementary and alternative medicine modalities and there were substantial differences in use across racial and ethnic groups.

  13. [Medicinal glaucoma therapy. What can we learn from large randomized clinical trials?].

    PubMed

    Jünemann, A G M; Huchzermeyer, C; Rejdak, R

    2013-12-01

    The prospective multicenter randomized controlled clinical trials (RCTs) Ocular Hypertension Glaucoma Treatment Study (OHTS), Early Manifest Glaucoma Trial (EMGT), Advanced Glaucoma Intervention Study (AGIS), Collaborative Initial Glaucoma Treatment Study (CITGS) and Collaborative Normal Tension Glaucoma Study (CNGTS) are often named as landmarks for glaucoma management as the results of these studies provided the evidence for numerous therapeutic decisions in clinical practice. The studies confirmed the consensus that reduction of intraocular pressure reduces the risk of glaucoma progression covering the whole spectrum of glaucoma from ocular hypertension to advanced glaucoma. Furthermore, the identification of new risk factors allows a higher precision of assessment of the risk of progression. The RCTs achieved the main goal of high level of evidence, thus making progress in the understanding of glaucoma and its treatment and bridging consensus-based and evidence-based decisions. However, the implementation of the results into clinical practice needs adequate and accurate interpretation of the results.

  14. The Effect of Metformin on Adolescents with Type 1 Diabetes: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    2016-01-01

    Background. The effect of metformin in combination with insulin in adolescents with type 1 diabetes (T1DM) is controversial. Methods and Results. The PubMed and EMBASE online databases were searched. Five double-blind randomized controlled trials (RCTs) that included 301 adolescents with T1DM were identified. Metformin plus insulin was associated with reduced hemoglobin A1C levels, total daily insulin dosage, body mass index (BMI), and body weight. However, the subgroup analysis demonstrated that HbA1c levels were not significantly changed in overweight/obese adolescents and were significantly reduced in the general patients. On the contrary, BMI and body weight were significantly reduced in overweight/obese adolescents but not in the general patients. Metformin was associated with higher incidence of adverse events. Conclusions. Among adolescents with T1DM, administering adjunctive metformin therapy in addition to insulin was associated with improved HbA1c levels, total daily insulin dosage, BMI, and body weight. However, there may be differences in the effects of this regimen between overweight/obese and nonobese adolescents. The risk of an adverse event may be increased with metformin treatment. These results provide strong evidence supporting future high-quality, large-sample trials. PMID:27478438

  15. A prospective trial for laparoscopic adjustable gastric banding in morbidly obese adolescents: an interim report of weight loss, metabolic and quality of life outcomes.

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The outcome of patients completing 12 months of follow-up in a prospective longitudinal trial of the safety/efficacy of laparoscopic adjustable gastric banding (LAGB), for morbidly obese adolescents aged 14 to 17 years using a Food and Drug Administration Institutional Device Exemption for the use o...

  16. A Randomised Controlled Treatment Trial of Two Forms of Family Therapy in Adolescent Anorexia Nervosa: A Five-Year Follow-Up

    ERIC Educational Resources Information Center

    Eisler, Ivan; Simic, Mima; Russell, Gerald F. M.; Dare, Christopher

    2007-01-01

    Background: There is growing evidence that family therapy is an effective treatment for adolescent anorexia nervosa. This study aimed to ascertain the long-term impact of two forms of outpatient family intervention previously evaluated in a randomised controlled trial (RCT). Method: A five-year follow-up was conducted on a cohort of 40 patients…

  17. Cost-Effectiveness of Classroom-Based Cognitive Behaviour Therapy in Reducing Symptoms of Depression in Adolescents: A Trial-Based Analysis

    ERIC Educational Resources Information Center

    Anderson, Rob; Ukoumunne, Obioha C.; Sayal, Kapil; Phillips, Rhiannon; Taylor, John A.; Spears, Melissa; Araya, Ricardo; Lewis, Glyn; Millings, Abigail; Montgomery, Alan A.; Stallard, Paul

    2014-01-01

    Background: A substantial minority of adolescents suffer from depression and it is associated with increased risk of suicide, social and educational impairment, and mental health problems in adulthood. A recently conducted randomized controlled trial in England evaluated the effectiveness of a manualized universally delivered age-appropriate CBT…

  18. Measuring the Plasticity of Social Approach: A Randomized Controlled Trial of the Effects of the PEERS Intervention on EEG Asymmetry in Adolescents with Autism Spectrum Disorders

    ERIC Educational Resources Information Center

    Van Hecke, Amy Vaughan; Stevens, Sheryl; Carson, Audrey M.; Karst, Jeffrey S.; Dolan, Bridget; Schohl, Kirsten; McKindles, Ryan J.; Remmel, Rheanna; Brockman, Scott

    2015-01-01

    This study examined whether the Program for the Education and Enrichment of Relational Skills ("PEERS: Social skills for teenagers with developmental and autism spectrum disorders: The PEERS treatment manual," Routledge, New York, 2010a) affected neural function, via EEG asymmetry, in a randomized controlled trial of adolescents with…

  19. Sources of Site Differences in the Efficacy of a Multisite Clinical Trial: The Treatment of SSRI-Resistant Depression in Adolescents

    ERIC Educational Resources Information Center

    Spirito, Anthony; Abebe, Kaleab Z.; Iyengar, Satish; Brent, David; Vitiello, Benedetto; Clarke, Gregory; Wagner, Karen Dineen; Asarnow, Joan; Emslie, Graham; Keller, Martin

    2009-01-01

    Site differences in treatment outcomes are not often highlighted when the results of multisite randomized clinical trials (MRCTs) are reported. The primary analyses of a 6-site MRCT, the Treatment of SSRI-Resistant Depression in Adolescents (TORDIA) study, showed substantial variation by site in the performance of a medication-only condition and a…

  20. Influencing Antecedents of Adolescent Risk-Taking Behaviour in Elementary School: Results of a 4-Year Quasi-Experimental Controlled Trial

    ERIC Educational Resources Information Center

    Maruska, K.; Morgenstern, M.; Isensee, B.; Hanewinkel, R.

    2010-01-01

    Effects of the life skills programme "Eigenstandig werden" (Becoming independent) on life skills and on identified antecedents of adolescent health risk behaviour, childhood internalizing and externalizing behaviour were tested in an elementary school setting. A quasi-experimental controlled trial with five repeated measures was conducted.…

  1. Can attention control conditions have detrimental effects in behavioral medicine randomized trials?

    PubMed Central

    Pagoto, Sherry; McDermott, Mary M.; Reed, George; Greenland, Philip; Mazor, Kathy M.; Ockene, Judith K.; Whited, Matt; Schneider, Kristin; Appelhans, Brad; Leung, Kathy; Merriam, Philip; Ockene, Ira

    2012-01-01

    Objective Attention control conditions are used to balance nonspecific attention in randomized trials of behavioral interventions. Very little guidance is available in the literature about which behavioral interventions and outcomes merit an attention control. The primary aim of the present paper is to demonstrate a scenario in which use of attention control in a behavioral randomized trial was unnecessary and possibly detrimental. Methods Exploratory analyses were performed in a randomized controlled trial that tested whether a patient-centered telephone counseling (PC) intervention reduced low-density lipoprotein cholesterol (LDL-C) levels in 355 participants with peripheral arterial disease (PAD), compared to attention control (AC) and usual care (UC) conditions. The PC intervention was designed to activate participants to ask their physician for lipid-lowering medication and/or increase dose intensity, increase medication adherence, and reduce fat intake. The AC condition involved attention-matched phone-delivered health education, and the UC condition consisted of an educational pamphlet. Results At 12-month follow-up, mean LDL-C changes were −11.1, and −6.8 mg/dl in the UC and AC conditions, respectively (p=.17). The proportion of participants who increased use or dose intensity of medication was significantly lower in AC than UC, 17.5% versus 30.5% (p=0.03). No significant difference between AC and UC were observed on other outcomes. Conclusions The AC had significantly worse medication outcomes and there was no indication of a therapeutic effect on other endpoints. Implications for use of attention control in behavioral randomized trials are discussed. PMID:23197844

  2. Chinese Herbal Medicines for the Treatment of Type A H1N1 Influenza: A Systematic Review of Randomized Controlled Trials

    PubMed Central

    Chen, Wei; Lim, Chi Eung Danforn; Kang, Hong-Jun; Liu, Jianping

    2011-01-01

    Background Chinese herbs are thought to be effective for type A H1N1 influenza. Series of Chinese herbs have been authorized recommended by the Chinese government, and until now a number of clinical trials of Chinese herbs for H1N1 influenza have been conducted. However, there is no critically appraised evidence such as systematic reviews or meta-analyses on potential benefits and harms of medicinal herbs for H1N1 influenza to justify their clinical use and their recommendation. Methods and Findings CENTRAL, MEDLINE, EMBASE, CBM, CNKI, VIP, China Important Conference Papers Database, China Dissertation Database, and online clinical trial registry websites were searched for published and unpublished randomized controlled trials (RCTs) of Chinese herbs for H1N1 influenza till 31 August, 2011. A total of 26 RCTs were identified and reviewed. Most of the RCTs were of high risk of bias with flawed study design and poor methodological quality. The combination of several Chinese herbal medicines with or without oseltamivir demonstrated positive effect on fever resolution, relief of symptoms, and global effectiveness rate compared to oseltamivir alone. However, only one herbal medicine showed positive effect on viral shedding. Most of the trials did not report adverse events, and the safety of herbal medicines is still uncertain. Conclusions Some Chinese herbal medicines demonstrated potential positive effect for 2009 type A H1N1 influenza; however, due to the lack of placebo controlled trial and lack of repeated test of the intervention, we could not draw confirmative conclusions on the beneficial effect of Chinese herbs for H1N1 influenza. More rigorous trials are warranted to support their clinical use. PMID:22164232

  3. Lessons from writing sessions: a school-based randomized trial with adolescent orphans in Rwanda

    PubMed Central

    Unterhitzenberger, Johanna; Rosner, Rita

    2014-01-01

    Background Treatments for adolescents affected by long-term loss in low- and middle-income countries are lacking. As school-based interventions are cost-efficient and easy to disseminate, an evaluation of this treatment setting for adolescents is worthwhile. Objective Examining the effect of a school-based unstructured emotional writing intervention (sensu Pennebaker, group 1) about the loss of a parent to reduce adaptation problems to loss, compared to writing about a hobby (group 2), and non-writing (group 3). Method We randomly assigned 14–18-year-old Rwandan orphans to one of the three conditions (n=23 per condition). Before and after the intervention, subjects completed the Prolonged Grief Questionnaire for Adolescents and the Mini International Neuropsychiatric Interview for Children and Adolescents, Part A, on depression as self-report measures of long-term effects of early parental loss. Results Repeated measures analyses of variance showed no differential effect for any of the three conditions but revealed a significant effect of time at posttest regarding grief severity. Reduction of grief symptoms was significantly higher in subjects with elevated grief. Depressive symptoms showed no significant change from pre- to posttest in the emotional writing condition, whereas they significantly decreased in the control condition. Conclusions Results imply that unstructured, brief emotional writing might not be indicated in adolescents affected by early parental loss who show severe and long-term distress; a more structured approach seems recommendable. PMID:25537814

  4. Chinese Herbal Medicine for Postpartum Depression: A Systematic Review of Randomized Controlled Trials

    PubMed Central

    Li, Yongle; Chen, Zijie; Yu, Ning; Yao, Keyu; Che, Yiwen; Xi, Yupeng

    2016-01-01

    Background. Postpartum depression (PPD) does great harm to women following childbirth. The aim of this study was to conduct a systematic review of the literature to assess the efficacy and safety of CHM for the treatment of PPD. Methods. Published or ongoing registered trials were searched for from the inception of the various databases to December 31, 2015. Data extraction and methodology assessment were conducted independently by two researchers. RevMan 5.3 software was used to analyze the data. Results. Forty-seven registered clinical trials (RCTs) were identified and reviewed. The results showed CHM alone or in combination with routine treatments could reduce HAMD score, EPDS score, incidence of adverse events, TESS, and SERS. CHM combined with routine treatment was more effective in increasing serum estradiol levels and reducing progesterone levels than routine treatment alone. Meanwhile, pooled data revealed that MRLQS combined with routine treatments or MRLQS plus MSHS combined with routine treatments were more effective than other therapeutic methods in TCM. MRLQS plus MSHS alone was found to be an effective alternative when compared to routine treatments. Conclusions. This review suggested that CHM was safe and effective in the treatment of PPD. However, this could not be proven conclusively. To ensure evidence-based clinical practice, more rigorously designed trials are warranted. PMID:27774110

  5. School Nurses on the Front Lines of Medicine: An Adolescent Female Student with Severe Abdominal Pain.

    PubMed

    Olympia, Robert P; Brady, Jodi

    2016-09-01

    Abdominal pain is a common chief complaint encountered by school nurses. This article explains the etiology of abdominal pain in children and adolescents, describes the office assessment, and delineates life-threatening conditions associated with severe abdominal pain that may prompt the school nurse to transfer the student to a local emergency department. PMID:27470683

  6. Neural Systems Underlying Motivated Behavior in Adolescence: Implications for Preventive Medicine

    PubMed Central

    Richards, Jessica M.; Plate, Rista C.; Ernst, Monique

    2012-01-01

    Objective Although a time of increased independence and autonomy, adolescence is also a time of vulnerabilities, through increased risk-taking and the emergence of psychopathology. Neurodevelopmental changes during this period may provide a neurobiological basis for this normative rise in deleterious behaviors. Thus, the objective of this review was to identify neurodevelopmental processes underlying the emergence of risk-taking and psychopathology in adolescence, and discuss implications of these findings for prevention. Method This article reviews literature examining developmental and contextual factors influencing neural functioning in systems mediating threat, reward, and cognitive control. This literature is discussed from the perspective of the Triadic Neural Systems Model of motivated behavior. Results Neuroimaging research suggests that neurodevelopmental and contextual factors both contribute to a shift in the functional equilibrium among the Triadic nodes. This equilibrium shift may contribute to negative outcomes of adolescent behavior. Most importantly, the balance of this equilibrium and its sensitivity to social and appetitive contexts may be exploited to facilitate prevention of deleterious outcomes. Conclusion Understanding developmental and contextual factors that influence functioning in motivational neural circuits can inform research on adolescent risk-taking, and may provide targets for novel preventions, for example through the use of incentives to reduce deleterious outcomes. PMID:22198622

  7. Effects of exercise intensity and nutrition advice on myocardial function in obese children and adolescents: a multicentre randomised controlled trial study protocol

    PubMed Central

    Dias, Katrin A; Coombes, Jeff S; Green, Daniel J; Gomersall, Sjaan R; Keating, Shelley E; Tjonna, Arnt Erik; Hollekim-Strand, Siri Marte; Hosseini, Mansoureh Sadat; Ro, Torstein Baade; Haram, Margrete; Huuse, Else Marie; Davies, Peter S W; Cain, Peter A; Leong, Gary M; Ingul, Charlotte B

    2016-01-01

    Introduction The prevalence of paediatric obesity is increasing, and with it, lifestyle-related diseases in children and adolescents. High-intensity interval training (HIIT) has recently been explored as an alternate to traditional moderate-intensity continuous training (MICT) in adults with chronic disease and has been shown to induce a rapid reversal of subclinical disease markers in obese children and adolescents. The primary aim of this study is to compare the effects of HIIT with MICT on myocardial function in obese children and adolescents. Methods and analysis Multicentre randomised controlled trial of 100 obese children and adolescents in the cities of Trondheim (Norway) and Brisbane (Australia). The trial will examine the efficacy of HIIT to improve cardiometabolic outcomes in obese children and adolescents. Participants will be randomised to (1) HIIT and nutrition advice, (2) MICT and nutrition advice or (3) nutrition advice. Participants will partake in supervised exercise training and/or nutrition sessions for 3 months. Measurements for study end points will occur at baseline, 3 months (postintervention) and 12 months (follow-up). The primary end point is myocardial function (peak systolic tissue velocity). Secondary end points include vascular function (flow-mediated dilation assessment), quantity of visceral and subcutaneous adipose tissue, myocardial structure and function, body composition, cardiorespiratory fitness, autonomic function, blood biochemistry, physical activity and nutrition. Lean, healthy children and adolescents will complete measurements for all study end points at one time point for comparative cross-sectional analyses. Ethics and dissemination This randomised controlled trial will generate substantial information regarding the effects of exercise intensity on paediatric obesity, specifically the cardiometabolic health of this at-risk population. It is expected that communication of results will allow for the development of

  8. Clinical efficacy and safety of Chinese herbal medicine for Wilson's disease: a systematic review of 9 randomized controlled trials.

    PubMed

    Wang, Yan; Xie, Cheng-long; Fu, Deng-lei; Lu, Lin; Lin, Yan; Dong, Qi-qian; Wang, Xiao-tong; Zheng, Guo-qing

    2012-06-01

    Wilson's disease is an autosomal recessive disorder of copper metabolism. Despite being treatable, there is no universally accepted treatment regimen. Currently, various Chinese herbal medicines (CHMs) are widely used in the treatment of Wilson's disease in China, but there is a lack of reliable scientific evidence for the effectiveness of such therapies. The objective of this systematic review is to assess the clinical efficacy and safety of CHM as an alternative or/and adjuvant therapy for Wilson's disease. A systematic literature search in different medical databases was performed to identify randomized controlled trials comparing CHM as monotherapy or CHM as adjuvant therapy with western conventional medical therapy in the treatment of Wilson's disease. A total of 687 participants were included in nine eligible studies. The main findings are that CHM as monotherapy or adjuvant therapy for Wilson's disease may be able to improve the clinical symptoms, to promote the urinary copper excretion, to ameliorate liver function and/or liver cirrhosis, and has fewer adverse effects in comparison with western conventional medication. Furthermore, CHM generally appeared to be safe and well tolerated in patients with Wilson's disease. However, the evidence presented in this review are insufficient to warrant a clinical recommendation due to the generally low methodological quality of the included studies. In conclusion, CHM seems to be beneficial and safe for Wilson's disease, but high-quality evidences are still needed to further evaluate this therapy. Therefore, additional well-designed, randomized, placebo-controlled clinical trials are needed.

  9. Herbal medicine (Danggui Shaoyao San) for treating primary dysmenorrhea: A systematic review and meta-analysis of randomized controlled trials.

    PubMed

    Lee, Hye Won; Jun, Ji Hee; Kil, Ki-Jung; Ko, Byong-Seob; Lee, Choong Hwan; Lee, Myeong Soo

    2016-03-01

    Danggui Shaoyao San (DSS), a traditional herbal prescription, has long been used to treat menopause-related symptoms, including dysmenorrhea. We conducted a systematic review of randomized controlled trials to evaluate the efficacy of DSS for dysmenorrhea. We searched the following electronic databases through October 2015: PubMed; EMBASE; the Cochrane Library; AMED; five Korean databases (KoreaMed, DBPIA, OASIS, RISS, and KISS); three Chinese databases (CNKI, Wan Fang Database, and VIP), and one Japanese database (CiNii). The Cochrane criteria were used to assess the risk of bias for the individual studies. All randomized clinical trials (RCTs) of DSS or modified DSS were included. Data from all articles were extracted by two independent reviewers. Meta-analysis was used to pool the data. A total of 746 potentially relevant studies were identified, and four RCTs met our inclusion criteria. All of the included RCTs had a high risk of bias across their domains. Three RCTs showed favourable effects of DSS on response rate compared with conventional medicine, and a meta-analysis showed that DSS had superior effects compared to analgesics (RR: 1.31, 95%CI, 1.06-1.63, I(2)=73%). One RCT showed a beneficial effect of DSS on pain compared with placebo control. Our systematic review and meta-analysis provided suggestive evidence of the superiority of DSS over analgesics or placebo for dysmenorrhea. The quality of evidence for this finding was low to moderate because of a high risk of bias. PMID:26857875

  10. Lab Plays Central Role in Groundbreaking National Clinical Trial in Precision Medicine | Poster

    Cancer.gov

    The Molecular Characterization Laboratory lies at the heart of an ambitious new approach for testing cancer drugs that will use the newest tools of precision medicine to select the best treatment for individual patients based on the genetic makeup of their tumors. The protocol, called NCI-Molecular Analysis for Therapy Choice (NCI-MATCH), will start with tumor biopsies from as many as 3,000 patients to see if they have genetic defects for which a targeted cancer drug is available. Cancers will be treated based on their genetic profiles rather than by their location in the body, which is the conventional approach.

  11. Medical Students' and Tutors' Experiences of Directed and Self-Directed Learning Programs in Evidence-Based Medicine: A Qualitative Evaluation Accompanying a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Bradley, Peter; Oterholt, Christina; Nordheim, Lena; Bjorndal, Arild

    2005-01-01

    This qualitative study aims to interpret the results of a randomized controlled trial comparing two educational programs (directed learning and self-directed learning) in evidence-based medicine (EBM) for medical students at the University of Oslo from 2002 to 2003. There is currently very little comparative educational research in this field. In…

  12. Complementary therapies for labour and birth study: a randomised controlled trial of antenatal integrative medicine for pain management in labour

    PubMed Central

    Levett, Kate M; Smith, C A; Bensoussan, A; Dahlen, H G

    2016-01-01

    Objective To evaluate the effect of an antenatal integrative medicine education programme in addition to usual care for nulliparous women on intrapartum epidural use. Design Open-label, assessor blind, randomised controlled trial. Setting 2 public hospitals in Sydney, Australia. Population 176 nulliparous women with low-risk pregnancies, attending hospital-based antenatal clinics. Methods and intervention The Complementary Therapies for Labour and Birth protocol, based on the She Births and acupressure for labour and birth courses, incorporated 6 evidence-based complementary medicine techniques: acupressure, visualisation and relaxation, breathing, massage, yoga techniques, and facilitated partner support. Randomisation occurred at 24–36 weeks’ gestation, and participants attended a 2-day antenatal education programme plus standard care, or standard care alone. Main outcome measures Rate of analgesic epidural use. Secondary: onset of labour, augmentation, mode of birth, newborn outcomes. Results There was a significant difference in epidural use between the 2 groups: study group (23.9%) standard care (68.7%; risk ratio (RR) 0.37 (95% CI 0.25 to 0.55), p≤0.001). The study group participants reported a reduced rate of augmentation (RR=0.54 (95% CI 0.38 to 0.77), p<0.0001); caesarean section (RR=0.52 (95% CI 0.31 to 0.87), p=0.017); length of second stage (mean difference=−0.32 (95% CI −0.64 to 0.002), p=0.05); any perineal trauma (0.88 (95% CI 0.78 to 0.98), p=0.02) and resuscitation of the newborn (RR=0.47 (95% CI 0.25 to 0.87), p≤0.015). There were no statistically significant differences found in spontaneous onset of labour, pethidine use, rate of postpartum haemorrhage, major perineal trauma (third and fourth degree tears/episiotomy), or admission to special care nursery/neonatal intensive care unit (p=0.25). Conclusions The Complementary Therapies for Labour and Birth study protocol significantly reduced epidural use and caesarean section. This

  13. Smoked medicinal cannabis for neuropathic pain in HIV: a randomized, crossover clinical trial.

    PubMed

    Ellis, Ronald J; Toperoff, Will; Vaida, Florin; van den Brande, Geoffrey; Gonzales, James; Gouaux, Ben; Bentley, Heather; Atkinson, J Hampton

    2009-02-01

    Despite management with opioids and other pain modifying therapies, neuropathic pain continues to reduce the quality of life and daily functioning in HIV-infected individuals. Cannabinoid receptors in the central and peripheral nervous systems have been shown to modulate pain perception. We conducted a clinical trial to assess the impact of smoked cannabis on neuropathic pain in HIV. This was a phase II, double-blind, placebo-controlled, crossover trial of analgesia with smoked cannabis in HIV-associated distal sensory predominant polyneuropathy (DSPN). Eligible subjects had neuropathic pain refractory to at least two previous analgesic classes; they continued on their prestudy analgesic regimens throughout the trial. Regulatory considerations dictated that subjects smoke under direct observation in a hospital setting. Treatments were placebo and active cannabis ranging in potency between 1 and 8% Delta-9-tetrahydrocannabinol, four times daily for 5 consecutive days during each of 2 treatment weeks, separated by a 2-week washout. The primary outcome was change in pain intensity as measured by the Descriptor Differential Scale (DDS) from a pretreatment baseline to the end of each treatment week. Secondary measures included assessments of mood and daily functioning. Of 127 volunteers screened, 34 eligible subjects enrolled and 28 completed both cannabis and placebo treatments. Among the completers, pain relief was greater with cannabis than placebo (median difference in DDS pain intensity change, 3.3 points, effect size=0.60; p=0.016). The proportions of subjects achieving at least 30% pain relief with cannabis versus placebo were 0.46 (95%CI 0.28, 0.65) and 0.18 (0.03, 0.32). Mood and daily functioning improved to a similar extent during both treatment periods. Although most side effects were mild and self-limited, two subjects experienced treatment-limiting toxicities. Smoked cannabis was generally well tolerated and effective when added to concomitant analgesic

  14. Smoked medicinal cannabis for neuropathic pain in HIV: a randomized, crossover clinical trial.

    PubMed

    Ellis, Ronald J; Toperoff, Will; Vaida, Florin; van den Brande, Geoffrey; Gonzales, James; Gouaux, Ben; Bentley, Heather; Atkinson, J Hampton

    2009-02-01

    Despite management with opioids and other pain modifying therapies, neuropathic pain continues to reduce the quality of life and daily functioning in HIV-infected individuals. Cannabinoid receptors in the central and peripheral nervous systems have been shown to modulate pain perception. We conducted a clinical trial to assess the impact of smoked cannabis on neuropathic pain in HIV. This was a phase II, double-blind, placebo-controlled, crossover trial of analgesia with smoked cannabis in HIV-associated distal sensory predominant polyneuropathy (DSPN). Eligible subjects had neuropathic pain refractory to at least two previous analgesic classes; they continued on their prestudy analgesic regimens throughout the trial. Regulatory considerations dictated that subjects smoke under direct observation in a hospital setting. Treatments were placebo and active cannabis ranging in potency between 1 and 8% Delta-9-tetrahydrocannabinol, four times daily for 5 consecutive days during each of 2 treatment weeks, separated by a 2-week washout. The primary outcome was change in pain intensity as measured by the Descriptor Differential Scale (DDS) from a pretreatment baseline to the end of each treatment week. Secondary measures included assessments of mood and daily functioning. Of 127 volunteers screened, 34 eligible subjects enrolled and 28 completed both cannabis and placebo treatments. Among the completers, pain relief was greater with cannabis than placebo (median difference in DDS pain intensity change, 3.3 points, effect size=0.60; p=0.016). The proportions of subjects achieving at least 30% pain relief with cannabis versus placebo were 0.46 (95%CI 0.28, 0.65) and 0.18 (0.03, 0.32). Mood and daily functioning improved to a similar extent during both treatment periods. Although most side effects were mild and self-limited, two subjects experienced treatment-limiting toxicities. Smoked cannabis was generally well tolerated and effective when added to concomitant analgesic

  15. We Never Thought This Would Happen: Transitioning Care of Adolescents with Perinatally-Acquired HIV Infection from Pediatrics to Internal Medicine

    PubMed Central

    Vijayan, Tara; Benin, Andrea L.; Wagner, Krystn; Romano, Sostena; Andiman, Warren A.

    2009-01-01

    Purpose Transitioning the medical care of children with perinatally-acquired HIV from pediatric care to internal medicine practices has become increasingly important as newer therapies prolong survival. The study aims to describe challenges to caring for these adolescents and the potential barriers to transitioning them to internal medicine-based care. Methods Qualitative study in which data were gathered from open-ended interviews conducted from November 2005-April 2006 with 18 adolescents with HIV, 15 of their principal guardians, and 9 pediatric health care providers from the Yale Pediatric AIDS Care Program, New Haven, Connecticut. Results Issues of stigma played a prominent role in both the challenges to care and barriers to transitioning care. Challenges to care were: (1) poor adherence to medication regimens; (2) adolescent sexuality; and (3) disorganized social environments. Potential barriers to transitioning care were: (1) families’ negative perceptions of and experiences with stigma of HIV disease--which undermined the desire to meet new providers; (2) perceived and actual lack of autonomy-- pediatric providers feared that staff in adult clinics would demand a level of independence that adolescents did not have; and (3) difficulty letting-go of relationships-- adolescents, guardians, and providers described a familial relationship and expressed anxiety about terminating their relationships. Conclusion Understanding these challenges and barriers can inform both pediatric and adult HIV care providers and enable them to create successful transition programs, with the goal of improving retention and follow-up to care. PMID:20024697

  16. Precision Medicine in NCI’s National Clinical Trials Network: Progress and Lessons Learned

    Cancer.gov

    NCI’s Jeff Abrams, M.D., Acting Director for Clinical Research in the Division of Cancer Treatment and Diagnosis (DCTD) and Associate Director of the Cancer Therapy Evaluation Program (CTEP) and Nita Seibel, M.D., Head of the Pediatric Solid Tumor Therapeutics in the Clinical Investigations Branch of CTEP, DCTD will host a Google Hangout on Air. The discussion will be moderated by Andrea Denicoff, R.N., N.P, Head, NCTN Clinical Trials Operations in the Investigational Drug Branch of CTEP, DCTD.

  17. Acellular approaches for regenerative medicine: on the verge of clinical trials with extracellular membrane vesicles?

    PubMed

    Fuster-Matanzo, Almudena; Gessler, Florian; Leonardi, Tommaso; Iraci, Nunzio; Pluchino, Stefano

    2015-01-01

    Extracellular vesicles (EVs) are a heterogeneous population of naturally occurring secreted small vesicles, with distinct biophysical properties and different functions both in physiology and under pathological conditions. In recent years, a number of studies have demonstrated that EVs might hold remarkable potential in regenerative medicine by acting as therapeutically promising nanodrugs. Understanding their final impact on the biology of specific target cells as well as clarification of their overall therapeutic impact remains a matter of intense debate. Here we review the key principles of EVs in physiological and pathological conditions with a specific highlight on the most recently described mechanisms regulating some of the EV-mediated effects. First, we describe the current debates and the upcoming research on EVs as potential novel therapeutics in regenerative medicine, either as unmodified agents or as functionalized small carriers for targeted drug delivery. Moreover, we address a number of safety aspects and regulatory limitations related to the novel nature of EV-mediated therapeutic applications. Despite the emerging possibilities of EV treatments, these issues need to be overcome in order to allow their safe and successful application in future explorative clinical studies. PMID:26631254

  18. Supplemental Reading Strategy Instruction for Adolescents: A Randomized Trial and Follow-up Study

    ERIC Educational Resources Information Center

    Cantrell, Susan Chambers; Almasi, Janice F.; Rintamaa, Margaret; Carter, Janis C.

    2016-01-01

    In this study, the authors examine the impact of a yearlong supplemental reading course involving daily instruction in the learning strategies curriculum on lower achieving adolescent students' reading achievement and motivation. Using a multiple-cohort randomized treatment-control group design over 4 years, they compared achievement and…

  19. Open-Label, Prospective Trial of Olanzapine in Adolescents with Subaverage Intelligence and Disruptive Behavioral Disorders

    ERIC Educational Resources Information Center

    Handen, Benjamin L.; Hardan, Antonio Y.

    2006-01-01

    Objective: Olanzapine, an atypical antipsychotic, has been shown to be efficacious for treatment of psychotic and mood disorders in adults. This prospective, open-label study was conducted to examine the safety and usefulness of olanzapine in treating disruptive behavior disorders in adolescents with subaverage intelligence. Method: Sixteen…

  20. Fluoxetine in Treatment of Adolescent Patients with Autism: A Longitudinal Open Trial.

    ERIC Educational Resources Information Center

    Fatemi, S. Hossein; Realmuto, George M.; Khan, Lubna; Thuras, Paul

    1998-01-01

    Retrospective chart reviews of seven adolescents and young adults (ages 9-20) with autistic disorder treated with fluoxetine alone or in combination with other medications were performed. Side effects included initial appetite suppression, vivid dreams, and hyperactivity. Improvement was seen in irritability, lethargy, sterotypy, and inappropriate…

  1. Plasticity of Decision-Making Abilities Among Maltreated Adolescents: Evidence From a Random Controlled Trial

    PubMed Central

    Weller, Joshua A.; Leve, Leslie D.; Kim, Hyoun K.; Bhimji, Jabeene; Fisher, Philip A.

    2014-01-01

    Childhood maltreatment has lasting negative effects throughout the lifespan. Early intervention research has demonstrated that these effects can be remediated through skill-based, family-centered interventions. However, less is known about plasticity during adolescence, and whether interventions are effective many years after children experience maltreatment. This study investigated this question by examining adolescent girls’ ability to make advantageous decisions in the face of risk using a validated decision-making task; performance on this task has been associated with key neural regions involved in affective processing and executive functioning. Maltreated foster girls (n = 92), randomly assigned at age 11 to either an intervention designed to prevent risk-taking behaviors or services as usual (SAU), and non-maltreated age and SES-matched girls living with their biological parent(s) (n = 80), completed a decision-making task (at age 15–17) that assessed risk-taking and sensitivity to expected value, an index of advantageous decision-making. Girls in the SAU condition demonstrated the greatest decision-making difficulties, primarily for risks to avoid losses. In the SAU group, frequency of neglect was related to greater difficulties in this area. Girls in the intervention condition with less neglect performed similarly to non-maltreated peers. This research suggests that early maltreatment may impact decision-making abilities into adolescence and that enriched environments during early adolescence provide a window of plasticity that may ameliorate these negative effects. PMID:25997770

  2. A Randomized Controlled Trial of the "Cool Teens" CD-ROM Computerized Program for Adolescent Anxiety

    ERIC Educational Resources Information Center

    Wuthrich, Viviana M.; Rapee, Ronald M.; Cunningham, Michael J.; Lyneham, Heidi J.; Hudson, Jennifer L.; Schniering, Carolyn A.

    2012-01-01

    Objective: Computerized cognitive behavioral interventions for anxiety disorders in adults have been shown to be efficacious, but limited data are available on the use of computerized interventions with young persons. Adolescents in particular are difficult to engage in treatment and may be especially suited to computerized technologies. This…

  3. A Controlled Trial of Working Memory Training for Children and Adolescents with ADHD

    ERIC Educational Resources Information Center

    Beck, Steven J.; Hanson, Christine A.; Puffenberger, Synthia S.; Benninger, Kristen L.; Benninger, William B.

    2010-01-01

    This study assessed the efficacy of a 5-week, intensive working memory training program for 52 children and adolescents (ages 7-17) who had Attention-Deficit/Hyperactivity Disorder (ADHD) and other comorbid diagnoses. This study provided a treatment replication since the waitlist control group also completed training and was included in the…

  4. A School-Based Program for Overweight and Obese Adolescents: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Pbert, Lori; Druker, Susan; Barton, Bruce; Schneider, Kristin L.; Olendzki, Barbara; Gapinski, Mary A.; Kurtz, Stephen; Osganian, Stavroula

    2016-01-01

    Background: Given the dramatic increase in adolescent overweight and obesity, models are needed for implementing weight management treatment through readily accessible venues. We evaluated the acceptability and efficacy of a school-based intervention consisting of school nurse-delivered counseling and an afterschool exercise program in improving…

  5. Dialectical Behavior Therapy for Adolescents with Bipolar Disorder: A 1-Year Open Trial

    ERIC Educational Resources Information Center

    Goldstein, Tina R.; Axelson, David A.; Birmaher, Boris; Brent, David A.

    2007-01-01

    Objective: To describe an adapted version of dialectical behavior therapy for adolescents with bipolar disorder. Method: The dialectical behavior therapy intervention is delivered over 1 year and consists of two modalities: family skills training (conducted with individual family units) and individual therapy. The acute treatment period (6 months)…

  6. The COPE healthy lifestyles TEEN randomized controlled trial with culturally diverse high school adolescents: Baseline characteristics and methods

    PubMed Central

    Melnyk, Bernadette Mazurek; Kelly, Stephanie; Jacobson, Diana; Belyea, Michael; Shaibi, Gabriel; Small, Leigh; O’Haver, Judith; Marsiglia, Flavio Francisco

    2014-01-01

    Obesity and mental health disorders remain significant public health problems in adolescents. Substantial health disparities exist with minority youth experiencing higher rates of these problems. Schools are an outstanding venue to provide teens with skills needed to improve their physical and mental health, and academic performance. In this paper, the authors describe the design, intervention, methods and baseline data for a randomized controlled trial with 779 culturally diverse high-school adolescents in the southwest United States. Aims for this prevention study include testing the efficacy of the COPE TEEN program versus an attention control program on the adolescents’ healthy lifestyle behaviors, Body Mass Index (BMI) and BMI%, mental health, social skills and academic performance immediately following the intervention programs, and at six and 12 months post interventions. Baseline findings indicate that greater than 40% of the sample is either overweight (n = 148, 19.00%) or obese (n = 182, 23.36%). The predominant ethnicity represented is Hispanic (n = 526, 67.52%). At baseline, 15.79%(n = 123) of the students had above average scores on the Beck Youth Inventory Depression subscale indicating mildly (n = 52, 6.68%), moderately (n = 47, 6.03%), or extremely (n = 24, 3.08%) elevated scores (see 1). Anxiety scores were slightly higher with 21.56% (n = 168) reporting responses suggesting mildly (n = 81, 10.40%), moderately (n = 58, 7.45%) or extremely (n = 29, 3.72%) elevated scores. If the efficacy of the COPE TEEN program is supported, it will offer schools a curriculum that can be easily incorporated into high school health courses to improve adolescent healthy lifestyle behaviors, psychosocial outcomes and academic performance. PMID:23748156

  7. Internet-delivered cognitive-behavioral treatment for adolescents with chronic pain and their parents: a randomized controlled multicenter trial.

    PubMed

    Palermo, Tonya M; Law, Emily F; Fales, Jessica; Bromberg, Maggie H; Jessen-Fiddick, Tricia; Tai, Gabrielle

    2016-01-01

    Internet-delivered interventions are emerging as a strategy to address barriers to care for individuals with chronic pain. This is the first large multicenter randomized controlled trial of Internet-delivered cognitive-behavioral therapy (CBT) for pediatric chronic pain. Participants included were 273 adolescents (205 females and 68 males), aged 11 to 17 years with mixed chronic pain conditions and their parents, who were randomly assigned in a parallel-group design to Internet-delivered CBT (n = 138) or Internet-delivered Education (n = 135). Assessments were completed before treatment, immediately after treatment, and at 6-month follow-up. All data collection and procedures took place online. The primary analysis used linear growth models. Results demonstrated significantly greater reduction on the primary outcome of activity limitations from baseline to 6-month follow-up for Internet CBT compared with Internet education (b = -1.13, P = 0.03). On secondary outcomes, significant beneficial effects of Internet CBT were found on sleep quality (b = 0.14, P = 0.04), on reducing parent miscarried helping (b = -2.66, P = 0.007) and protective behaviors (b = -0.19, P = 0.001), and on treatment satisfaction (P values < 0.05). On exploratory outcomes, benefits of Internet CBT were found for parent-perceived impact (ie, reductions in depression, anxiety, self-blame about their adolescent's pain, and improvement in parent behavioral responses to pain). In conclusion, our Internet-delivered CBT intervention produced a number of beneficial effects on adolescent and parent outcomes, and could ultimately lead to wide dissemination of evidence-based psychological pain treatment for youth and their families.

  8. Randomized trial outcomes of a TTM-tailored condom use and smoking intervention in urban adolescent females

    PubMed Central

    Redding, Colleen A.; Prochaska, James O.; Armstrong, Kay; Rossi, Joseph S.; Hoeppner, Bettina B.; Sun, Xiaowu; Kobayashi, Hisanori; Yin, Hui-Qing; Coviello, Donna; Evers, Kerry; Velicer, Wayne F.

    2015-01-01

    Smoking and sexual risk behaviors in urban adolescent females are prevalent and problematic. Family planning clinics reach those who are at most risk. This randomized effectiveness trial evaluated a transtheoretical model (TTM)-tailored intervention to increase condom use and decrease smoking. At baseline, a total of 828 14- to 17-year-old females were recruited and randomized within four urban family planning clinics. Participants received TTM or standard care (SC) computerized feedback and stage-targeted or SC counseling at baseline, 3, 6 and 9 months. Blinded follow-up telephone surveys were conducted at 12 and 18 months. Analyses revealed significantly more consistent condom use in the TTM compared with the SC group at 6 and 12, but not at 18 months. In baseline consistent condom users (40%), significantly less relapse was found in the TTM compared with the SC group at 6 and 12, but not at 18 months. No significant effects for smoking prevention or cessation were found, although cessation rates matched those found previously. This TTM-tailored intervention demonstrated effectiveness for increasing consistent condom use at 6 and 12 months, but not at 18 months, in urban adolescent females. This intervention, if replicated, could be disseminated to promote consistent condom use and additional health behaviors in youth at risk. PMID:24794584

  9. The effects of a comprehensive community trial on cardiometabolic risk factors in adolescents: Isfahan Healthy Heart Program

    PubMed Central

    Kelishadi, Roya; Mohammadifard, Noushin; Sarrazadegan, Nizal; Nouri, Fatemeh; Pashmi, Rezvan; Bahonar, Ahmad; Heidari, Hossein; Asgary, Sedigheh; Boshtam, Maryam; Mardani, Alireza

    2012-01-01

    BACKGROUND: This study aimed to assess the effects of a 6-year-long community-participatory program including school-based interventions on mean values and prevalence of cardiometabolic risk factors among adolescents. METHODS: The interventions of this community trial, conducted from 2000 to 2007 in Iran, targeted the whole population (of nearly two millions) living in two cities considered as the intervention area (IA) in comparison with a reference area (RA). Data from surveys conducted before and after interventions was used to compare the differences between the secondary school students of the IA and RA. RESULTS: The prevalence of hypercholesterolemia and hypertriglyceridemia declined significantly in girls and boys in the IA (P < 0.01). The prevalence of high LDL-C decreased significantly in the girls in the RA (P = 0.002). Among both sexes in the IA, the prevalence of low HDL-C increased significantly (P < 0.001), whereas it decreased in the girls and boys in the RA (P = 0.04). Although in the IA, the prevalence of overweight and obesity decreased significantly in girls (P = 0.001), it increased in boys (P = 0.001) as well as in the girls of the RA (P = 0.01). CONCLUSION: By performing school-based interventions, our study was successful, at least in part, in controlling some cardiometabolic risk factors in adolescents. Such modifications may have long-term impacts on non-communicable diseases prevention in adulthood. PMID:23205053

  10. Updated clinical evidence of Chinese herbal medicine for insomnia: a systematic review and meta-analysis of randomized controlled trials.

    PubMed

    Ni, Xiaojia; Shergis, Johannah Linda; Guo, Xinfeng; Zhang, Anthony Lin; Li, Yan; Lu, Chuanjian; Xue, Charlie Changli

    2015-12-01

    This systematic review is to evaluate the efficacy and safety of Chinese herbal medicine (CHM) for people with insomnia. Randomized controlled trials (RCTs) investigating oral CHM alone or in combination with conventional therapies for primary insomnia were identified by searching English and Chinese publications and databases of clinical trial registration. Risk of bias was assessed according to the Cochrane Handbook 5.1. Meta-analysis was conducted using RevMan 5.2.4. Seventy-nine trials (7886 participants) were finally included in the review, and 76 were included in the meta-analysis. Twenty-seven trials reported the methods of random sequence generation, and five of them used the allocation concealment. Blinding of participants and personnel were used in 10 studies. The main meta-analysis showed that CHM alone was more effective than placebo by reducing scores of Pittsburgh Sleep Quality Index (mean difference, MD: -3.06, 95% confidence interval, CI: -5.14 to -0.98, I(2) = 97%) and benzodiazepine drugs (BZDs) (MD: -1.94, 95% CI: -2.45 to -1.43, I(2) = 96%). The effect was also seen when CHM was combined with BZDs compared with placebo plus BZDs (MD: -1.88, 95% CI: -2.78 to -0.97, I(2) = 0%) or cognitive and behavioral therapy (MD: -3.80, 95% CI: -4.91 to -2.68, I(2) = 68%) alone. There was no significant difference between CHM and placebo regarding the frequency of adverse events (relative risk, RR: 1.65, 95% CI: 0.67-4.10, I(2) = 0). Overall, oral CHM used as a monotherapy or as an adjunct to conventional therapies appears safe, and it may improve subjective sleep in people with insomnia. However, the typical effect of CHM for insomnia cannot be determined due to heterogeneity. Further study focusing on individual CHM formula for insomnia is needed. The development of a comparable placebo is also needed to improve the successful blinding in RCTs.

  11. Two-year outcomes of an adjunctive telephone coaching and electronic contact intervention for adolescent weight-loss maintenance: the Loozit randomized controlled trial.

    PubMed

    Nguyen, B; Shrewsbury, V A; O'Connor, J; Steinbeck, K S; Hill, A J; Shah, S; Kohn, M R; Torvaldsen, S; Baur, L A

    2013-03-01

    This paper reports the final 24-month outcomes of a randomized controlled trial evaluating the effect of additional therapeutic contact (ATC) as an adjunct to a community-based weight-management program for overweight and obese 13-16-year-olds. ATC involved telephone coaching or short-message-service and/or email communication once per fortnight. Adolescents were randomized to receive the Loozit group program-a two-phase behavioral lifestyle intervention with (n=73), or without (n=78), ATC in Phase 2. Adolescents/parents separately attended seven weekly group sessions (Phase 1), followed by quarterly adolescent sessions (Phase 2). Assessor-blinded, 24-month changes in anthropometry and metabolic health included primary outcomes body mass index (BMI) z-score and waist:height ratio (WHtR). Secondary outcomes were self-reported psychosocial and lifestyle changes. By 24 months, 17 adolescents had formally withdrawn. Relative to the Loozit program alone, ATC largely had no impact on outcomes. Secondary pre-post assessment of the Loozit group program showed mean (95% CI) reductions in BMI z-score (-0.13 (-0.20, -0.06)) and WHtR (-0.02 (-0.03, -0.01)) in both arms, with several metabolic and psychosocial improvements. Adjunctive ATC did not provide further benefits to the Loozit group program. We recommend that further work is needed to optimize technological support for adolescents in weight-loss maintenance. Australian New Zealand Clinical Trials Registry Number ACTRNO12606000175572.

  12. Re-Visit to the School Nurse and Adolescents' Medicine Use

    ERIC Educational Resources Information Center

    Borup, Ina K.; Andersen, Anette; Holstein, Bjorn E.

    2011-01-01

    Objective: To examine if students who re-visit the school nurse use medicines differently than other students when exposed to aches and psychological problems. Methods: The study includes all 11-, 13- and 15-year-old students from a random sample of schools in Denmark, response rate 87 per cent, n = 5,205. The data collection followed the…

  13. Normative Feedback and Adolescent Readiness to Change: A Small Randomized Trial

    PubMed Central

    Smith, Douglas C.; Davis, Jordan P.; Ureche, Daniel J.; Tabb, Karen M.

    2015-01-01

    For adolescents with substance use problems, it is unknown whether the provision of normative feedback is a necessary active ingredient in motivational interviewing (MI). This study investigated the impact of normative feedback on adolescents’ readiness to change and perceptions of MI quality. Adolescents referred for substance use disorder (SUD) assessments were randomized to MI with normative feedback (NF; MI + NF, n = 26) or MI only (MI, n = 22). There were no significant differences between the MI + NF or MI conditions with reference to changes in readiness, and although not significant, there was a decline in readiness for the overall sample. Treatment satisfaction and ratings of MI quality were generally high with no between-group differences. Post hoc analyses revealed a nonsignificant trend where race interacted with treatment condition. Larger replication studies are needed to further study the effects of NF and potential NF by participant characteristic interactions. PMID:26877622

  14. Quetiapine versus aripiprazole in children and adolescents with psychosis - protocol for the randomised, blinded clinical Tolerability and Efficacy of Antipsychotics (TEA) trial

    PubMed Central

    2014-01-01

    Background The evidence for choices between antipsychotics for children and adolescents with schizophrenia and other psychotic disorders is limited. The main objective of the Tolerability and Efficacy of Antipsychotics (TEA) trial is to compare the benefits and harms of quetiapine versus aripiprazole in children and adolescents with psychosis in order to inform rational, effective and safe treatment selections. Methods/Design The TEA trial is a Danish investigator-initiated, independently funded, multi-centre, randomised, blinded clinical trial. Based on sample size estimation, 112 patients aged 12-17 years with psychosis, antipsychotic-naïve or treated for a limited period are, 1:1 randomised to a 12- week, double-blind intervention with quetiapine versus aripiprazole. Effects on psychopathology, cognition, health-related quality of life, and adverse events are assessed 2, 4, and 12 weeks after randomisation. The primary outcome is change in the positive symptom score of the Positive and Negative Syndrome Scale. The recruitment period is 2010-2014. Discussion Antipsychotics are currently the only available pharmacologic treatments for psychotic disorders. However, information about head-to-head differences in efficacy and tolerability of antipsychotics are scarce in children and adolescents. The TEA trial aims at expanding the evidence base for the use of antipsychotics in early onset psychosis in order to inform more rational treatment decisions in this vulnerable population. Here, we account for the trial design, address methodological challenges, and discuss the estimation of sample size. Trial registration ClinicalTrials.gov: NCT01119014 PMID:25015535

  15. Aripiprazole versus risperidone for treating children and adolescents with tic disorder: a randomized double blind clinical trial.

    PubMed

    Ghanizadeh, Ahmad; Haghighi, Alireza

    2014-10-01

    There are some uncontrolled studies about the efficacy and safety of both aripiprazole and risperidone for treating tic disorder. Moreover, the efficacy of these medications has never been compared. This is the first double blind randomized clinical trial comparing the safety and efficacy of aripiprazole and risperidone for treating patients with tic disorder. Sixty children and adolescents with tic disorder were randomly allocated into one of the two groups to receive either aripiprazole or risperidone for 2 months. The primary outcome measure was the score of Yale Global Tic Severity Scale. In addition, health related quality of life and adverse events were assessed. Both aripiprazole and risperidone decreased the Yale Global Tic Severity Scale score during this trial. Moreover, both medications increased the health related quality of life score. Both aripiprazole and risperidone were tolerated well. Aripiprazole [3.22 (1.9) mg/day] decreased tic score as much as risperidone [0.6 (0.2) mg/day]. Their adverse effects and their effects on health related quality of life were comparable. However, risperidone increased the patients' social functioning more than aripiprazole in short term.

  16. Brief intervention in substance-use among adolescent psychiatric patients: a randomized controlled trial.

    PubMed

    Goti, Javier; Diaz, Rosa; Serrano, Lourdes; Gonzalez, Laura; Calvo, Rosa; Gual, Antoni; Castro, Josefina

    2010-06-01

    Objective of the study is to assess the efficacy of a brief motivational enhancement intervention in adolescents referred to psychiatric treatment who reported substance-use. In a sample of adolescents (n = 237) consecutively admitted to a psychiatry department, 143 were identified as users. Subjects were randomly allocated to one of two groups: an experimental group that received a brief intervention aimed at increasing their awareness of the risks of substance-use, or a control group. All subjects received standard treatment according to the primary diagnosis. Structured questionnaires assessing knowledge, problems, perception of risks and intention of use of psychoactive substances were administered upon admission and 1 month later. Fifty-nine subjects entered the experimental group and 44 the control group. No significant differences between the two groups were identified in socio-demographic features or substance-use. Non-parametric analyses showed a significant increase across time in overall knowledge about drugs and perception of risk in the experimental group (P < 0.05). A significant increase in overall knowledge in the experimental group compared to controls was found (P < 0.05). No differences were observed for other variables such as intention of use or perception of risk. Brief intervention in adolescents entering psychiatric treatment led to a significant change in overall knowledge about psychoactive substances but not in other variables related to use. Our results point to the need of more intensive interventions.

  17. A trial of d-cycloserine to treat the social deficit in older adolescents and young adults with autism spectrum disorders.

    PubMed

    Urbano, Maria; Okwara, Leonore; Manser, Paul; Hartmann, Kathrin; Deutsch, Stephen I

    2015-01-01

    Autism spectrum disorders are difficult for older adolescents and young adults as impaired social communication affects the transition to adult life. d-Cycloserine, a partial glycine agonist at the N-methyl-d-aspartic acid receptor, was tested in a double-blind randomized trial in 20 older adolescents and young adults with autism spectrum disorders using two dosing strategies (50 mg daily versus 50 mg weekly) for 8 weeks with a 2-week follow-up after discontinuation. d-Cycloserine caused statistically and clinically significant improvement with no differentiation between dosing strategies on the Social Responsiveness Scale and the Aberrant Behavior Checklist before and after d-cycloserine administration.

  18. Efficacy of Cognitive Behavioral Therapy for Insomnia in Adolescents: A Randomized Controlled Trial with Internet Therapy, Group Therapy and A Waiting List Condition

    PubMed Central

    de Bruin, Eduard J.; Bögels, Susan M.; Oort, Frans J.; Meijer, Anne Marie

    2015-01-01

    Study Objectives: To investigate the efficacy of cognitive behavioral therapy for insomnia (CBTI) in adolescents. Design: A randomized controlled trial of CBTI in group therapy (GT), guided internet therapy (IT), and a waiting list (WL), with assessments at baseline, directly after treatment (post-test), and at 2 months follow-up. Setting: Diagnostic interviews were held at the laboratory of the Research Institute of Child Development and Education at the University of Amsterdam. Treatment for GT occurred at the mental health care center UvAMinds in Amsterdam, the Netherlands. Participants: One hundred sixteen adolescents (mean age = 15.6 y, SD = 1.6 y, 25% males) meeting DSM-IV criteria for insomnia, were randomized to IT, GT, or WL. Interventions: CBTI of 6 weekly sessions, consisted of psychoeducation, sleep hygiene, restriction of time in bed, stimulus control, cognitive therapy, and relaxation techniques. GT was conducted in groups of 6 to 8 adolescents, guided by 2 trained sleep therapists. IT was applied through an online guided self-help website with programmed instructions and written feedback from a trained sleep therapist. Measurements and Results: Sleep was measured with actigraphy and sleep logs for 7 consecutive days. Symptoms of insomnia and chronic sleep reduction were measured with questionnaires. Results showed that adolescents in both IT and GT, compared to WL, improved significantly on sleep efficiency, sleep onset latency, wake after sleep onset, and total sleep time at post-test, and improvements were maintained at follow-up. Most of these improvements were found in both objective and subjective measures. Furthermore, insomnia complaints and symptoms of chronic sleep reduction also decreased significantly in both treatment conditions compared to WL. Effect sizes for improvements ranged from medium to large. A greater proportion of participants from the treatment conditions showed high end-state functioning and clinically significant

  19. Cannabis, pain, and sleep: lessons from therapeutic clinical trials of Sativex, a cannabis-based medicine.

    PubMed

    Russo, Ethan B; Guy, Geoffrey W; Robson, Philip J

    2007-08-01

    Cannabis sativa L. has been utilized for treatment of pain and sleep disorders since ancient times. This review examines modern studies on effects of Delta9-tetrahydrocannabinol (THC) and cannabidiol (CBD) on sleep. It goes on to report new information on the effects on sleep in the context of medical treatment of neuropathic pain and symptoms of multiple sclerosis, employing standardized oromucosal cannabis-based medicines containing primarily THC, CBD, or a 1 : 1 combination of the two (Sativex). Sleep-laboratory results indicate a mild activating effect of CBD, and slight residual sedation with THC-predominant extracts. Experience to date with Sativex in numerous Phase I-III studies in 2000 subjects with 1000 patient years of exposure demonstrate marked improvement in subjective sleep parameters in patients with a wide variety of pain conditions including multiple sclerosis, peripheral neuropathic pain, intractable cancer pain, and rheumatoid arthritis, with an acceptable adverse event profile. No tolerance to the benefit of Sativex on pain or sleep, nor need for dosage increases have been noted in safety extension studies of up to four years, wherein 40-50% of subjects attained good or very good sleep quality, a key source of disability in chronic pain syndromes that may contribute to patients' quality of life. PMID:17712817

  20. Randomized controlled trial of cannabis-based medicine in spasticity caused by multiple sclerosis.

    PubMed

    Collin, C; Davies, P; Mutiboko, I K; Ratcliffe, S

    2007-03-01

    Symptoms relating to spasticity are common in multiple sclerosis (MS) and can be difficult to treat. We have investigated the efficacy, safety and tolerability of a standardized oromucosal whole plant cannabis-based medicine (CBM) containing delta-9 tetrahydrocannabinol (THC) and cannabidiol (CBD), upon spasticity in MS. A total of 189 subjects with definite MS and spasticity were randomized to receive daily doses of active preparation (n = 124) or placebo (n = 65) in a double blind study over 6 weeks. The primary endpoint was the change in a daily subject-recorded Numerical Rating Scale of spasticity. Secondary endpoints included a measure of spasticity (Ashworth Score) and a subjective measure of spasm. The primary efficacy analysis on the intention to treat (ITT) population (n = 184) showed the active preparation to be significantly superior (P = 0.048). Secondary efficacy measures were all in favour of active preparation but did not achieve statistical significance. The responder analysis favoured active preparation, 40% of subjects achieved >30% benefit (P = 0.014). Eight withdrawals were attributed to adverse events (AEs); six were on active preparation and two on placebo. We conclude that this CBM may represent a useful new agent for treatment of the symptomatic relief of spasticity in MS. PMID:17355549

  1. How evidence-based medicine is failing due to biased trials and selective publication.

    PubMed

    Every-Palmer, Susanna; Howick, Jeremy

    2014-12-01

    Evidence-based medicine (EBM) was announced in the early 1990s as a 'new paradigm' for improving patient care. Yet there is currently little evidence that EBM has achieved its aim. Since its introduction, health care costs have increased while there remains a lack of high-quality evidence suggesting EBM has resulted in substantial population-level health gains. In this paper we suggest that EBM's potential for improving patients' health care has been thwarted by bias in the choice of hypotheses tested, manipulation of study design and selective publication. Evidence for these flaws is clearest in industry-funded studies. We argue EBM's indiscriminate acceptance of industry-generated 'evidence' is akin to letting politicians count their own votes. Given that most intervention studies are industry funded, this is a serious problem for the overall evidence base. Clinical decisions based on such evidence are likely to be misinformed, with patients given less effective, harmful or more expensive treatments. More investment in independent research is urgently required. Independent bodies, informed democratically, need to set research priorities. We also propose that evidence rating schemes are formally modified so research with conflict of interest bias is explicitly downgraded in value.

  2. Promoting Physical Activity in Low-Active Adolescents via Facebook: A Pilot Randomized Controlled Trial to Test Feasibility

    PubMed Central

    2014-01-01

    Background The World Wide Web is an effective method for delivering health behavior programs, yet major limitations remain (eg, cost of development, time and resource requirements, limited interactivity). Social media, however, has the potential to deliver highly customizable and socially interactive behavioral interventions with fewer constraints. Thus, the evaluation of social media as a means to influence health behaviors is warranted. Objective The objective of this trial was to examine and demonstrate the feasibility of using an established social networking platform (ie, Facebook) to deliver an 8 week physical activity intervention to a sample of low-active adolescents (N=21; estimated marginal mean age 13.48 years). Methods Participants were randomized to either an experimental (ie, Behavioral) or attentional control (ie, Informational) condition. Both conditions received access to a restricted-access, study-specific Facebook group where the group’s administrator made two daily wall posts containing youth-based physical activity information and resources. Primary outcomes included physical activity as assessed by accelerometry and self-report. Interactions and main effects were examined, as well as mean differences in effect sizes. Results Analyses revealed significant improvements over time on subjectively reported weekly leisure-time physical activity (F 1,18=8.426, P=.009, η2 = .319). However, there was no interaction between time and condition (F 1,18=0.002, P=.968, η2 = .000). There were no significant time or interaction effects among the objectively measured physical activity variables. Examination of effect sizes revealed moderate-to-large changes in physical activity outcomes. Conclusions Results provide initial support for the feasibility of delivery of a physical activity intervention to low-active adolescents via social media. Whether by employing behavioral interventions via social media can result in statistically meaningful changes in

  3. Exploring effective core drug patterns in primary insomnia treatment with Chinese herbal medicine: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Chinese herbal medicine is one of the most popular Chinese medicine (CM) therapies for primary insomnia. One of the important characteristics of CM is that different Chinese clinicians give different prescriptions even for the same patient. However, there must be some fixed drug patterns in every clinician’s prescriptions. This study aims to screen the effective core drug patterns in primary insomnia treatment of three prestigious Chinese clinicians. Methods/design A triple-blind, randomized, placebo-controlled, parallel-group clinical trial will be performed. Three clinicians will diagnose and treat every eligible patient individually and independently, producing three prescriptions from three clinicians for every patient. Patients will equally be randomized to one of four groups – medical group A, medical group B, medical group C, or placebo group – and observed for efficacy of treatment. The sample will include primary insomnia patients meeting DSM IV-TR criteria, Spiegel scale score >18, and age 18 to 65 years. A sequential design is employed. Interim analysis will be conducted when between 80 and 160 patients complete the study. The interim study could be stopped and treated as final if a statistically significant difference between treatment and placebo groups can be obtained and core effective drug patterns can be determined. Otherwise, the study continues until the maximum sample size reaches 300. Treatment of the CM group is one of three Chinese clinicians’ prescriptions, who provide independently prescriptions based on their own CM theory and the patient’s disease condition. Assessment will be by sleep diary and Pittsburgh sleep quality index, and CM symptoms and signs will be measured. Primary outcome is total sleep time. Assessment will be carried out at the washout period, weeks 1, 2, 3, and 4 and 4th week after the end of treatment. Effectiveness analysis will be per intent to treat. A multi-dimension association rule and scale

  4. Prospective Molecular Profiling of Canine Cancers Provides a Clinically Relevant Comparative Model for Evaluating Personalized Medicine (PMed) Trials

    PubMed Central

    Mazcko, Christina; Cherba, David; Hendricks, William; Lana, Susan; Ehrhart, E. J.; Charles, Brad; Fehling, Heather; Kumar, Leena; Vail, David; Henson, Michael; Childress, Michael; Kitchell, Barbara; Kingsley, Christopher; Kim, Seungchan; Neff, Mark; Davis, Barbara

    2014-01-01

    Background Molecularly-guided trials (i.e. PMed) now seek to aid clinical decision-making by matching cancer targets with therapeutic options. Progress has been hampered by the lack of cancer models that account for individual-to-individual heterogeneity within and across cancer types. Naturally occurring cancers in pet animals are heterogeneous and thus provide an opportunity to answer questions about these PMed strategies and optimize translation to human patients. In order to realize this opportunity, it is now necessary to demonstrate the feasibility of conducting molecularly-guided analysis of tumors from dogs with naturally occurring cancer in a clinically relevant setting. Methodology A proof-of-concept study was conducted by the Comparative Oncology Trials Consortium (COTC) to determine if tumor collection, prospective molecular profiling, and PMed report generation within 1 week was feasible in dogs. Thirty-one dogs with cancers of varying histologies were enrolled. Twenty-four of 31 samples (77%) successfully met all predefined QA/QC criteria and were analyzed via Affymetrix gene expression profiling. A subsequent bioinformatics workflow transformed genomic data into a personalized drug report. Average turnaround from biopsy to report generation was 116 hours (4.8 days). Unsupervised clustering of canine tumor expression data clustered by cancer type, but supervised clustering of tumors based on the personalized drug report clustered by drug class rather than cancer type. Conclusions Collection and turnaround of high quality canine tumor samples, centralized pathology, analyte generation, array hybridization, and bioinformatic analyses matching gene expression to therapeutic options is achievable in a practical clinical window (<1 week). Clustering data show robust signatures by cancer type but also showed patient-to-patient heterogeneity in drug predictions. This lends further support to the inclusion of a heterogeneous population of dogs with cancer

  5. Consultation for Disordered Puberty: What Do Adolescent Medicine Patients Teach Us?

    PubMed

    Michaud, Pierre-André; Ambresin, Anne-Emmanuelle

    2016-01-01

    The period of adolescence is not only marked by important growth and pubertal events, but is also characterized by important psychosocial changes driven by a search for autonomy and the construction of one's identity. It can thus be easily understood that puberty disorders interfere heavily with these process, requiring from the endocrinologist not only medical knowledge, but also a great deal of emotional and psychological skills. They must progressively move from an educational approach that heavily involves the parents to one of shared information and decision making that places the young patient at the center of the therapeutic process. This can be achieved in several ways: respecting the affective and cognitive development of the adolescent; securing his privacy and (if requested by him) confidentiality; exploring his self-image and self-esteem and adapting the therapeutic process to the patient's expectations; reviewing the teenager's lifestyle, including the issue of sexuality and sexual behavior, and involving him in any therapeutic choice that has to be made, even if it does not match with the parents' expectations. The skills required for this respectful and holistic follow-up often exceed the abilities of any physician; it is thus suggested that a team approach involving a clinical nurse and/or a psychologist and/or social worker(s) be set up whenever possible. PMID:26680583

  6. Consultation for Disordered Puberty: What Do Adolescent Medicine Patients Teach Us?

    PubMed

    Michaud, Pierre-André; Ambresin, Anne-Emmanuelle

    2016-01-01

    The period of adolescence is not only marked by important growth and pubertal events, but is also characterized by important psychosocial changes driven by a search for autonomy and the construction of one's identity. It can thus be easily understood that puberty disorders interfere heavily with these process, requiring from the endocrinologist not only medical knowledge, but also a great deal of emotional and psychological skills. They must progressively move from an educational approach that heavily involves the parents to one of shared information and decision making that places the young patient at the center of the therapeutic process. This can be achieved in several ways: respecting the affective and cognitive development of the adolescent; securing his privacy and (if requested by him) confidentiality; exploring his self-image and self-esteem and adapting the therapeutic process to the patient's expectations; reviewing the teenager's lifestyle, including the issue of sexuality and sexual behavior, and involving him in any therapeutic choice that has to be made, even if it does not match with the parents' expectations. The skills required for this respectful and holistic follow-up often exceed the abilities of any physician; it is thus suggested that a team approach involving a clinical nurse and/or a psychologist and/or social worker(s) be set up whenever possible.

  7. Herbal medicine (Shaofu Zhuyu decoction) for treating primary dysmenorrhea: A systematic review of randomized clinical trials.

    PubMed

    Lee, Hoyoung; Choi, Tae-Young; Myung, Chang-Seon; Lee, Ju Ah; Lee, Myeong Soo

    2016-04-01

    Shaofu Zhuyu decoction (SFZY) or Sobokchugeo-tang, a traditional herbal formula, is used as a treatment for primary dysmenorrhea. We searched four English, seven Korean, three Chinese, and one Japanese database from inception through January 2016 without a language restriction. All randomized controlled trials (RCTs) of SFZY or modified SFZY (MSFZY) were included. Data extraction and risk of bias assessments were performed by two independent reviewers. A total of 51 potentially relevant studies were identified, and 9 RCTs met our inclusion criteria. Seven RCTs tested the effects of SFZY or modified SFZY in treating dysmenorrhea. Three RCTs showed superior effects of (M)SFZY on the response rate, while the other three RCTs failed to do so (n=531, RR: 1.17, 95% CI: 1.09 to 1.26, P<0.0001, I(2)=0%). Three RCTs showed favorable effects of MSFZY for pain reduction compared with conventional drugs (n=340, SMD: -1.39, 95% CI: -2.23 to -0.55, P=0.01). Two RCTs examined the effects of modified SFZY plus conventional drugs and conventional drugs alone. The meta-analysis showed favorable effects of MSFZY (n=206; RR, 1.12; 95% CI 1.08 to 1.36; P=0.0009, I(2)=0%). Our systemic review and meta-analysis provide suggestive evidence of the superiority of SFZY over conventional drugs for treating primary dysmenorrhea. However, the level of evidence is low because of a high risk of bias. PMID:26921931

  8. Randomised clinical trial of snus versus medicinal nicotine among smokers interested in product switching

    PubMed Central

    Hatsukami, Dorothy K; Severson, Herbert; Anderson, Amanda; Vogel, Rachael Isaksson; Jensen, Joni; Broadbent, Berry; Murphy, Sharon E; Carmella, Steven; Hecht, Stephen S

    2016-01-01

    Background An essential component of evaluating potential modified risk tobacco products is to determine how consumers use the product and resulting effects on biomarkers of toxicant exposure. Study design Cigarette smokers (n=391) recruited in Minnesota and Oregon were randomised to either snus or 4 mg nicotine gum for 12 weeks. Participants were instructed to completely switch from cigarettes to these products. Urine samples were collected to analyse for carcinogenic tobacco-specific nitrosamine metabolites (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and N′-nitrosonornicotine and their glucuronides) and nicotine metabolites (total cotinine and nicotine equivalents) levels. Results Of the 391 participants randomised, 52.9% were male, the mean±SD age was 43.9±12.5 years, baseline number of cigarettes/day was 18.0±6.5 and Fagerstrom Test for Nicotine Dependence score was 5.1±2.0. The mean±SD number of snus pouches used/week at week 6 prior to tapering was 39.1±24.0 and nicotine gum pieces used was 37.6±26.3. Dual use of cigarettes and these products were observed in 52.9% and 58.2% of those assigned to snus and nicotine gum, respectively, at week 12. The end of treatment biochemically verified (carbon monoxide, CO <6 ppm) 7-day avoidance of cigarettes was 21.9% in the snus group and 24.6% in the nicotine gum group. Toxicant exposure in the nicotine gum group was significantly less when compared to snus. Conclusions Snus performed similarly to nicotine gum in cigarette smokers who were interested in completely switching to these products, but was associated with less satisfaction and greater toxicant exposure than nicotine gum. Trial registration number NCT: 00710034. PMID:25991608

  9. Effects of Academic Vocabulary Instruction for Linguistically Diverse Adolescents: Evidence from a Randomized Field Trial

    ERIC Educational Resources Information Center

    Lesaux, Nonie K.; Kieffer, Michael J.; Kelley, Joan G.; Harris, Julie Russ

    2014-01-01

    We conducted a randomized field trial to test an academic vocabulary intervention designed to bolster the language and literacy skills of linguistically diverse sixth-grade students (N = 2,082; n = 1,469 from a home where English is not the primary language), many demonstrating low achievement, enrolled in 14 urban middle schools. The 20-week…

  10. Randomized Trials on Consider This, a Tailored, Internet-Delivered Smoking Prevention Program for Adolescents

    ERIC Educational Resources Information Center

    Buller, David B.; Borland, Ron; Woodall, W. Gill; Hall, John R.; Hines, Joan M.; Burris-Woodall, Patricia; Cutter, Gary R.; Miller, Caroline; Balmford, James; Starling, Randall; Ax, Bryan; Saba, Laura

    2008-01-01

    The Internet may be an effective medium for delivering smoking prevention to children. Consider This, an Internet-based program, was hypothesized to reduce expectations concerning smoking and smoking prevalence. Group-randomized pretest-posttest controlled trials were conducted in Australia (n = 2,077) and the United States (n = 1,234) in schools…

  11. Reduction of overweight and eating disorder symptoms via the Internet in adolescents: A randomized controlled trial

    PubMed Central

    Doyle, Angela Celio; Goldschmidt, Andrea; Huang, Christina; Winzelberg, Andrew J.; Taylor, C. Barr; Wilfley, Denise E.

    2008-01-01

    Purpose Overweight in adolescence is a significant problem which is associated with body dissatisfaction and eating disorder (ED) behaviors. Cost-effective methods for early intervention of obesity and prevention of ED are important due to the refractory nature of both. This multisite RCT evaluated an Internet-delivered program targeting weight loss and ED attitudes/behaviors in adolescents. Methods Eighty overweight 12-17-year olds completed Student Bodies 2 (SB2), a 16-week cognitive-behavioral program, or usual care (UC). Results BMI z-scores were reduced in the SB2 group compared to the UC group from baseline (BL) to post-intervention (p=.027; ηp2=.08). The SB2 group maintained this reduction in BMI-z at 4-month follow-up, but significant differences were not observed due to improvement in the UC group. The SB2 group evidenced greater increases in dietary restraint at post (p=.016) and less improvement on shape concerns at follow-up (p=.044), however, these differences were not clinically significant. No other statistically significant differences were noted between groups on ED attitudes/behaviors. SB2 participants reported using healthy eating- and physical activity-related skills more frequently than UC participants at post (p=.001) and follow-up (p=.012). Conclusions Findings suggest that an Internet-delivered intervention yielded a modest reduction in weight status that continued four months following treatment and that ED attitudes/behaviors were not significantly improved. Group differences on weight loss were not sustained at 4-month follow-up due to parallel improvements in the groups. Future studies are needed to improve program adherence and to further explore the efficacy of Internet-delivery of weight control programs for adolescents. PMID:18639791

  12. Tobacco Cessation Treatment for Alaska Native Adolescents: Group Randomized Pilot Trial

    PubMed Central

    2014-01-01

    Introduction: Tobacco cessation treatments have not been evaluated among Alaska Native (AN) adolescents. This pilot study evaluated the feasibility and the potential efficacy of a targeted cessation intervention for AN youth using a group randomized design. Methods: Eight villages in western Alaska were randomly assigned to receive the intervention (n = 4 villages) or a delayed treatment control condition (written materials only; n = 4 villages). Ten adolescents aged 12–17 years were targeted from each village with a planned enrollment of 80. The intervention was held over a weekend, and youth traveled from their villages to quit tobacco use with other teens. The intervention comprised 8hr of group-based counseling. Talking circles, personal stories from elders, and recreational activities were included to enhance cultural acceptability and participation. Newsletters were mailed weekly for 5-weeks postprogram. Assessments were conducted at baseline, week 6 (end-of-treatment), and 6 months. Self-reported tobacco abstinence was confirmed with salivary cotinine. Results: Recruitment targets were met in the intervention (41 enrolled) but not in control villages (27 enrolled). All intervention participants attended the weekend program. Retention was high; 98% of intervention and 86% of control participants completed 6-month follow-up. The 7-day point-prevalence self-reported tobacco abstinence rates for intervention and control participants were 10% (4/41) and 0% (0/27) at both week 6 and 6 months (p = .15). Only 1 adolescent in the intervention condition was biochemically confirmed abstinent at week 6 and none at 6 months. Conclusion: The intensive individual-focused intervention used in this study was feasible but not effective for tobacco cessation among AN youth. Alternative approaches are warranted. PMID:24532352

  13. Chinese Herbal Medicine for Myelosuppression Induced by Chemotherapy or Radiotherapy: A Systematic Review of Randomized Controlled Trials

    PubMed Central

    Jia, Youji; Du, Huihui; Yao, Min; Cui, Xuejun; Shi, Qi; Wang, Yongjun; Yang, Yanping

    2015-01-01

    Background. Myelosuppression is one of the major side effects of chemo- and radiotherapy in cancer patients and there are no effective interventions to prevent it currently. Chinese herbal medicine (CHM) may be helpful due to its multidrug targets. Objectives. This study was designed to evaluate effectiveness of CHM on preventing patients from experiencing myelosuppression by chemo- or radiotherapy. Search Methods. Randomized controlled trials (RCTs) were retrieved from seven different databases from the date of database creation to April 2014. We assessed all included studies using Cochrane Handbook for Systematic Reviews of Interventions 5.1.0 and performed statistical analysis using RevMan 5.2.1. Results. Eight RCTs were included (818 patients). Pooled data showed that increase of white blood cells (WBCs) is higher with CHM plus chemotherapy/radiotherapy than with chemotherapy/radiotherapy only. Both CHM compared to placebo and CHM combined with chemotherapy/radiotherapy compared to chemotherapy/radiotherapy lacked significant differences in the peripheral platelets, red blood cells (RBCs), and hemoglobin changes. Conclusions. Our results demonstrated that CHM significantly protected peripheral blood WBCs from a decrease caused by chemotherapy or radiotherapy. There were no significant protective effects on peripheral RBCs, hemoglobin, or platelets, which may be related to low quality and small sample of included studies. PMID:25802542

  14. Trials of large group teaching in Malaysian private universities: a cross sectional study of teaching medicine and other disciplines

    PubMed Central

    2011-01-01

    Background This is a pilot cross sectional study using both quantitative and qualitative approach towards tutors teaching large classes in private universities in the Klang Valley (comprising Kuala Lumpur, its suburbs, adjoining towns in the State of Selangor) and the State of Negeri Sembilan, Malaysia. The general aim of this study is to determine the difficulties faced by tutors when teaching large group of students and to outline appropriate recommendations in overcoming them. Findings Thirty-two academics from six private universities from different faculties such as Medical Sciences, Business, Information Technology, and Engineering disciplines participated in this study. SPSS software was used to analyse the data. The results in general indicate that the conventional instructor-student approach has its shortcoming and requires changes. Interestingly, tutors from Medicine and IT less often faced difficulties and had positive experience in teaching large group of students. Conclusion However several suggestions were proposed to overcome these difficulties ranging from breaking into smaller classes, adopting innovative teaching, use of interactive learning methods incorporating interactive assessment and creative technology which enhanced students learning. Furthermore the study provides insights on the trials of large group teaching which are clearly identified to help tutors realise its impact on teaching. The suggestions to overcome these difficulties and to maximize student learning can serve as a guideline for tutors who face these challenges. PMID:21902839

  15. Circadian rhythm sleep disorders in adolescents: clinical trials of combined treatments based on chronobiology.

    PubMed

    Okawa, M; Uchiyama, M; Ozaki, S; Shibui, K; Ichikawa, H

    1998-10-01

    Delayed sleep phase syndrome (DSPS) and non-24-h sleep-wake rhythm are circadian rhythm sleep disorders that are common in adolescents. Most patients have difficulty adjusting to school life, poor class attendance or refuse to go to school. Since a treatment has not been established, the present paper is presented to propose a strategy for treating circadian rhythm sleep disorders in adolescents, based on our clinical studies. Twenty subjects (12 males and eight females, mean age 16.2+/-1.7 years) participated in the study. The onset of sleep disorder occurred between the ages of 11 and 17. The most common factors affecting the onset of disorders were changes in social environment. The subjects kept a sleep-log for the periods before and during treatments. The treatments were based on chronobiology: resetting the daily life schedule, chronotherapy, regulation of the lighting environment, methylcobalamin, and/or melatonin. Bright light exposure was successful in 10 patients, of whom four were treated with methylcobalamin. Melatonin treatment was successful in two patients (one with and one without chronotherapy). Thirteen of the 20 patients were successfully, treated with therapies based on chronobiology. After consideration of these results, a step-by-step procedure of combined treatments for the circadian rhythm sleep disorders is proposed.

  16. Recruitment of Minority Adolescents and Young Adults into Randomised Clinical Trials: Testing the Design of the Technology Enhanced Community Health Nursing (TECH-N) Pelvic Inflammatory Disease Trial

    PubMed Central

    Trent, Maria; Chung, Shang-en; Gaydos, Charlotte; Frick, Kevin D.; Anders, Jennifer; Huettner, Steven; Rothman, Richard; Butz, Arlene

    2016-01-01

    Purpose Pelvic inflammatory disease (PID) disproportionately affects adolescent and young adult (AYA) women and can negatively influence reproductive health trajectories. Few randomized controlled trials (RCTs) have focused on strategies to improve outpatient adherence or to reduce reproductive morbidity in this population. This paper describes the research methods and preliminary effectiveness of recruitment, retention, and intervention strategies employed in a novel RCT designed to test a technology-enhanced community-health nursing (TECH-N) intervention among urban AYA with PID. Methods AYA women aged 13–25 years were recruited during acute PID visits in outpatient clinics and emergency departments (ED) to participate in this IRB-approved trial. Participants completed an audio-computerized self-interview (ACASI), provided vaginal specimens, and were randomized to standard treatment or the intervention. Intervention participants received text-messaging support for 30 days and a community health nurse (CHN) interventionist performed a home visit with clinical assessment within 5 days after enrollment. All patients received a full course of medications and completed research visits at 14-days (adherence), 30 days and 90 days with by an outreach worker. STI testing performed at the 30-and 90-day visits. Exploratory analyses using descriptive statistics were conducted to examine recruitment, retention, and follow-up data to test the overall design of the intervention. Results In the first 48 months, 64% of 463 patients were eligible for the study and 81.2% of 293 eligible patients were recruited for the study (63.3%); 238 (81.2%) of eligible patients were enrolled. Most participants were African American (95.6%) with a mean age of 18.6 (2.3). Ninety-four percent of individuals assigned to the TECH-N intervention completed the nursing visits. All completed visits have been within the 5-day window and over 90% of patients in both arms have been retained over the 3

  17. Recruitment of Minority Adolescents and Young Adults into Randomised Clinical Trials: Testing the Design of the Technology Enhanced Community Health Nursing (TECH-N) Pelvic Inflammatory Disease Trial

    PubMed Central

    Trent, Maria; Chung, Shang-en; Gaydos, Charlotte; Frick, Kevin D.; Anders, Jennifer; Huettner, Steven; Rothman, Richard; Butz, Arlene

    2016-01-01

    Purpose Pelvic inflammatory disease (PID) disproportionately affects adolescent and young adult (AYA) women and can negatively influence reproductive health trajectories. Few randomized controlled trials (RCTs) have focused on strategies to improve outpatient adherence or to reduce reproductive morbidity in this population. This paper describes the research methods and preliminary effectiveness of recruitment, retention, and intervention strategies employed in a novel RCT designed to test a technology-enhanced community-health nursing (TECH-N) intervention among urban AYA with PID. Methods AYA women aged 13–25 years were recruited during acute PID visits in outpatient clinics and emergency departments (ED) to participate in this IRB-approved trial. Participants completed an audio-computerized self-interview (ACASI), provided vaginal specimens, and were randomized to standard treatment or the intervention. Intervention participants received text-messaging support for 30 days and a community health nurse (CHN) interventionist performed a home visit with clinical assessment within 5 days after enrollment. All patients received a full course of medications and completed research visits at 14-days (adherence), 30 days and 90 days with by an outreach worker. STI testing performed at the 30-and 90-day visits. Exploratory analyses using descriptive statistics were conducted to examine recruitment, retention, and follow-up data to test the overall design of the intervention. Results In the first 48 months, 64% of 463 patients were eligible for the study and 81.2% of 293 eligible patients were recruited for the study (63.3%); 238 (81.2%) of eligible patients were enrolled. Most participants were African American (95.6%) with a mean age of 18.6 (2.3). Ninety-four percent of individuals assigned to the TECH-N intervention completed the nursing visits. All completed visits have been within the 5-day window and over 90% of patients in both arms have been retained over the 3

  18. Family-Focused Treatment for Adolescents and Young Adults at High Risk for Psychosis: Results of a Randomized Trial

    PubMed Central

    Miklowitz, David J.; O’Brien, Mary P.; Schlosser, Danielle A.; Addington, Jean; Candan, Kristin A.; Marshall, Catherine; Domingues, Isabel; Walsh, Barbara C.; Zinberg, Jamie L.; De Silva, Sandra D.; Friedman-Yakoobian, Michelle; Cannon, Tyrone D.

    2014-01-01

    Objective Longitudinal studies have begun to clarify the phenotypic characteristics of adolescents and young adults at clinical high risk for psychosis. This 8-site randomized trial examined whether a 6-month program of family psychoeducation was effective in reducing the severity of attenuated positive and negative psychotic symptoms and enhancing functioning among individuals at high risk. Method Adolescents and young adults (mean 17.4±4.1 years) with attenuated positive psychotic symptoms, brief and intermittent psychosis, or genetic risk with functional deterioration were randomly assigned to 18 sessions of family-focused therapy for individuals at clinical high risk (FFT-CHR) in 6 months or 3 sessions of family psychoeducation (enhanced care, or EC). FFT-CHR included psychoeducation about early signs of psychosis, stress management, communication training, and problem-solving skills training, whereas EC focused on symptom prevention. Independent evaluators assessed participants at baseline and 6 months on positive and negative symptoms and social-role functioning. Results Of 129 participants, 102 (79.1%) were followed at 6 months. Participants in FFT-CHR showed greater improvements in attenuated positive symptoms over 6 months than participants in EC (F[1,97]=5.49, P=.02). Negative symptoms improved independently of psychosocial treatments. Changes in psychosocial functioning depended on age: participants over 19 years showed more role improvement in FFT-CHR, whereas participants between 16 and 19 years showed more role improvement in EC. The results were independent of concurrent pharmacotherapy. Conclusion Interventions that focus on improving family relationships may have prophylactic efficacy in individuals at high risk for psychosis. Future studies should examine the specificity of effects of family intervention compared to individual therapy of the same duration and frequency. PMID:25062592

  19. Moderators of two Indicated Cognitive-Behavioral Depression Prevention Approaches for Adolescents in a School-Based Effectiveness Trial

    PubMed Central

    Brière, Frédéric N.; Rohde, Paul; Shaw, Heather; Stice, Eric

    2014-01-01

    Objective Our aim was to identify moderators of the effects of a cognitive behavioral group-based prevention program (CB group) and CB bibliotherapy, relative to an educational brochure control condition and to one another, in a school-based effectiveness randomized controlled prevention trial. Method 378 adolescents (M age = 15.5, 68% female) with elevated depressive symptoms were randomized in one of three conditions and were assessed at pretest, posttest, and 6-month follow-up. We tested the moderating effect of three individual (Baseline Depressive Symptoms, Negative Attributional Style, Substance Use), three environmental (Negative Life Events, Parental Support, Peer Support), and two sociodemographic (Sex, Age) characteristics. Results Baseline Depressive Symptoms interacted with Condition and Time. Decomposition indicated that elevated baseline depressive symptoms amplified the effect of CB bibliotherapy at posttest (but not 6-month follow-up) relative to the control condition, but did not modify the effect of CB group relative to the control condition or relative to bibliotherapy. Specifically, CB bibliotherapy resulted in lower posttest depressive symptoms than the control condition in individuals with elevated, but not average or low baseline symptoms. We found no interaction effect for other putative moderators. Conclusions Our findings suggest that bibliotherapy is effective only in participants who have elevated depressive symptoms at baseline. The fact that no study variable moderated the effects of CB group, which had a significant main effect in reducing depressive symptoms relative to the control condition, suggests that this indicated prevention intervention is effective for a wide range of adolescents. PMID:24418653

  20. A Trial of D-Cycloserine to Treat Stereotypies in Older Adolescents and Young Adults With Autism Spectrum Disorder

    PubMed Central

    Urbano, Maria; Okwara, Leonore; Manser, Paul; Hartmann, Kathrin; Herndon, Amy; Deutsch, Stephen I.

    2015-01-01

    Objectives Autism spectrum disorders (ASDs) have core impairments in social communication as well as the presence of repetitive, stereotypic behaviors and restricted interests. Older adolescents and young adults are particularly impacted by these deficits. Preclinical data implicate glutamatergic dysfunction in the pathophysiology of ASDs. D-Cycloserine (DCS), a partial glycineB agonist at the N-methyl-D-aspartic acid receptor site, has been shown to improve sociability in mouse models and a small human study. The sensitivity of the obligatory glycineB co-agonist binding site may change with daily administration of DCS as a result of agonist-induced desensitization. The efficacy of a “pulsed” once-weekly administration versus “daily” administration of DCS was compared. Methods Males and females, ages 14 to 25 years, with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision diagnosis of an ASD were enrolled in a double-blind, randomized 10-week trial consisting of 8 weeks of active drug with either weekly or daily administration of 50 mg of DCS followed by a 2-week follow-up visit. Results For the purposes of this study, no statistical or clinical differences existed between the 2 dosage groups on the Aberrant Behavior Checklist subscale 3, which measures stereotypies/repetitive movements. When combining groups, a statistically significant decrease of 37% was found from baseline to week 8 when study drug was completed using a linear mixed effects model (P = 0.003). Conclusions D-Cycloserine was shown to be effective in improving stereotypic symptoms in older adolescents and young adults with ASDs measured by the Aberrant Behavior Checklist subscale 3. In addition, DCS was safe and well tolerated. PMID:24824660

  1. Comparing group-based acceptance and commitment therapy (ACT) with enhanced usual care for adolescents with functional somatic syndromes: a study protocol for a randomised trial

    PubMed Central

    Kallesøe, Karen Hansen; Schröder, Andreas; Wicksell, Rikard K; Fink, Per; Ørnbøl, Eva; Rask, Charlotte Ulrikka

    2016-01-01

    Introduction Functional somatic syndromes (FSS) are common in adolescents, characterised by severe disability and reduced quality of life. Behavioural treatments such as acceptance and commitment therapy (ACT) has shown promising results in children and adolescents with FSS, but has focused on specific syndromes such as functional pain. The current study will compare the efficacy of group-based ACT with that of enhanced usual care (EUC) in adolescents with a range of FSS operationalised by the unifying construct of multiorgan bodily distress syndrome (BDS). Methods and analysis A total of 120 adolescents aged 15–19 and diagnosed with multiorgan BDS, of at least 12 months duration, will be assessed and randomised to either: (1) EUC: a manualised consultation with a child and adolescent psychiatrist and individualised treatment plan or (2) manualised ACT-based group therapy plus EUC. The ACT programme consists of 9 modules (ie, 27 hours) and 1 follow-up meeting (3 hours). The primary outcome is physical health, assessed by an Short Form Health Survey (SF-36) aggregate score 12 months after randomisation. Secondary outcomes include self-reported symptom severity, symptom interference, depression and anxiety, illness worry, perceived stress and global improvement; as well as objective physical activity and bodily stress response measured by heart rate variability, hair cortisol and inflammatory biomarkers. Process measures are illness perception, illness-related behaviour and psychological flexibility. Ethics and dissemination The study is conducted in accordance with Helsinki Declaration II. Approval has been obtained from the Science Ethics Committee of the Central Denmark Region and the Danish Data Protection. The results will be sought to be published according to the CONSORT statement in peer-reviewed journals. Discussion This is one of the first larger randomised clinical trials evaluating the effect of a group-based intervention for adolescents with a

  2. Seeds of prevention: the impact on health behaviors of young adolescent girls in Uttar Pradesh, India, a cluster randomized control trial.

    PubMed

    Kapadia-Kundu, Nandita; Storey, Douglas; Safi, Basil; Trivedi, Geetali; Tupe, Rama; Narayana, G

    2014-11-01

    Of the world's 1.2 billion adolescents (10-19 years), India is home to the largest number globally, about 243 million. However not much is known about the health of young adolescent girls (11-14 years) in India who enter puberty with substantial nutritional and health deficits. Identifying early adolescence as a "gateway" moment, the Saloni pilot study is arandomized control trial (RCT) to improve nutrition, hygiene and reproductive health behaviors in 30 schools in rural Uttar Pradesh (UP), India. A prevention model that includes Sadharanikaran, an ancient Indian theory of communication, guided the development of the intervention. The Saloni strategy includes a 10 session in-school intervention based on compassion, self efficacy, emotional well being, peer and parental support, packaged in the form of short, easy-to-use instructional modules. A diary designed to engage adolescent girls is provided to each girl. The cluster RCT was conducted from January 2010 to October 2011 with adolescent girls (11-14 years of age) in Hardoi district. The trial is a two-level, nested RCT with the unit of randomization being the block with 15 schools in the intervention arm and 15 schools in the control arm. A sample of 1200 girls was randomly selected. The intervention had a significant impact on more than 13 preventive health behaviors. About 65 percent girls in the intervention group had adopted 13 or more health behaviors at end line compared 4.5 percent in the control group at end line and 5 percent at baseline. Behavioral impact was demonstrated in all three areas of nutrition, hygiene and reproductive health. The study provides evidence that early adolescence is indeed a "gateway moment" to build nutritional and health reserves. PMID:25254614

  3. Active video games as a tool to prevent excessive weight gain in adolescents: rationale, design and methods of a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Excessive body weight, low physical activity and excessive sedentary time in youth are major public health concerns. A new generation of video games, the ones that require physical activity to play the games –i.e. active games- may be a promising alternative to traditional non-active games to promote physical activity and reduce sedentary behaviors in youth. The aim of this manuscript is to describe the design of a study evaluating the effects of a family oriented active game intervention, incorporating several motivational elements, on anthropometrics and health behaviors in adolescents. Methods/Design The study is a randomized controlled trial (RCT), with non-active gaming adolescents aged 12 – 16 years old randomly allocated to a ten month intervention (receiving active games, as well as an encouragement to play) or a waiting-list control group (receiving active games after the intervention period). Primary outcomes are adolescents’ measured BMI-SDS (SDS = adjusted for mean standard deviation score), waist circumference-SDS, hip circumference and sum of skinfolds. Secondary outcomes are adolescents’ self-reported time spent playing active and non-active games, other sedentary activities and consumption of sugar-sweetened beverages. In addition, a process evaluation is conducted, assessing the sustainability of the active games, enjoyment, perceived competence, perceived barriers for active game play, game context, injuries from active game play, activity replacement and intention to continue playing the active games. Discussion This is the first adequately powered RCT including normal weight adolescents, evaluating a reasonably long period of provision of and exposure to active games. Next, strong elements are the incorporating motivational elements for active game play and a comprehensive process evaluation. This trial will provide evidence regarding the potential contribution of active games in prevention of excessive weight gain in

  4. Omega-3/Omega-6 Fatty Acids for Attention Deficit Hyperactivity Disorder: A Randomized Placebo-Controlled Trial in Children and Adolescents

    ERIC Educational Resources Information Center

    Johnson, Mats; Ostlund, Sven; Fransson, Gunnar; Kadesjo, Bjorn; Gillberg, Christopher

    2009-01-01

    Objective: The aim of the study was to assess omega 3/6 fatty acids (eye q) in attention deficit hyperactivity disorder (ADHD). Method: The study included a randomized, 3-month, omega 3/6 placebo-controlled, one-way crossover trial with 75 children and adolescents (8-18 years), followed by 3 months with omega 3/6 for all. Investigator-rated ADHD…

  5. Efficacy of an HIV/STI sexual risk-reduction intervention for African American adolescent girls in juvenile detention centers: a randomized controlled trial.

    PubMed

    DiClemente, Ralph J; Davis, Teaniese L; Swartzendruber, Andrea; Fasula, Amy M; Boyce, Lorin; Gelaude, Deborah; Gray, Simone C; Hardin, James; Rose, Eve; Carry, Monique; Sales, Jessica M; Brown, Jennifer L; Staples-Horne, Michelle

    2014-01-01

    Few HIV/STI interventions exist for African American adolescent girls in juvenile detention. The objective was to evaluate the efficacy of an intervention to reduce incident STIs, improve HIV-preventive behaviors, and enhance psychosocial outcomes. We conducted a randomized controlled trial among African American adolescent girls (13-17 years, N = 188) in juvenile detention from March 2011 to May 2012. Assessments occurred at baseline and 3- and 6-months post-randomization and included: audio computer-assisted self-interview, condom skills assessment, and self-collected vaginal swab to detect Chlamydia and gonorrhea. The Imara intervention included three individual-level sessions and four phone sessions; expedited partner therapy was offered to STI-positive adolescents. The comparison group received the usual care provided by the detention center: STI testing, treatment, and counseling. At the 6-month assessment (3-months post-intervention), Imara participants reported higher condom use self-efficacy (p < 0.001), HIV/STI knowledge (p < 0.001), and condom use skills (p < 0.001) compared to control participants. No significant differences were observed between trial conditions in incident Chlamydia or gonorrhea infections, condom use, or number of vaginal sex partners. Imara for detained African American adolescent girls can improve condom use skills and psychosocial outcomes; however, a critical need for interventions to reduce sexual risk remains. PMID:25190056

  6. Expert opinion and controversies in sports and musculoskeletal medicine: the diagnosis and treatment of spondylolysis in adolescent athletes.

    PubMed

    Standaert, Christopher J; Herring, Stanley A

    2007-04-01

    Although spondylolysis is relatively common in adolescent athletes, there are substantial disagreements in the literature concerning the best methods for diagnosing and treating the condition. Controversy particularly arises regarding the optimal use of available imaging modalities in the diagnosis of athletes with suspected pars defects and the extent of activity restriction or brace use required for appropriate treatment. Because there have been no controlled trials on the treatment of spondylolysis and only a very limited number of studies addressing potential imaging strategies, it is difficult to develop true evidence-based guidelines for this condition. Given the current state of the literature, it is our impression that nuclear imaging with single photon emission computed tomography followed by computed tomography, with a limited role for plain radiography, remains the standard for appropriately diagnosing a symptomatic pars lesion. Treatment hinges on activity restriction for an amount of time adequate to allow for symptom resolution and, when possible, potential bony healing followed by a progressive sport-specific rehabilitation program. The biomechanic effects of brace use in this population are not well understood, but there may be some detrimental effects to the use of a brace and there currently is no evidence that the routine use of a rigid brace results in any significant improvement in radiographic or functional outcome. PMID:17398258

  7. Interdisciplinary therapy changes superoxide dismutase activity and adiponectin in obese adolescents: a randomised controlled trial.

    PubMed

    Nunes, João Elias Dias; Cunha, Heitor Santos; Freitas, Zulmária Rezende; Nogueira, Ana Maria Caixeta; Dâmaso, Ana Raimunda; Espindola, Foued Salmen; Cheik, Nadia Carla

    2016-01-01

    The objective of this study is to evaluate the effect of interdisciplinary therapy in the parameters of the oxidative stress and the anti-inflammatory responses of obese adolescents. We selected 57 participants, who were randomly divided into 2 groups: interdisciplinary therapy group and a control group. After 6 months of intervention, 17 participants of the interdisciplinary therapy group and 8 of the control group returned for re-evaluation. The interdisciplinary therapy group participated in a treatment with 4 weekly sessions of exercise, a weekly group therapy session and a weekly nutritional education session. Blood parameters of oxidative stress and anti-inflammatory response were evaluated. The results demonstrated that there were significant increases in the interdisciplinary therapy group for superoxide dismutase activity (6.56 ± 3.22 to 11.40 ± 7.49) and ferric-reducing antioxidant potential concentration (532.91 ± 106.48 to 573.25 ± 112.57), although adiponectin levels did not reduce (40.9 ± 29.34 to 49.05 ± 41.22). A significant decrease in nitrite levels was also found (14.23 ± 8.48 to 11.45 ± 6.05). In the control group, significant reduction was found in adiponectin (31.56 ± 18.88 to 18.01 ± 11.66). This study suggests that interdisciplinary therapy for 6 months was effective in improving the anti-inflammatory responses and the antioxidant defences in obese adolescents. PMID:26367325

  8. Amplitude variability over trials in hemodynamic responses in adolescents with ADHD: The role of the anterior default mode network and the non-specific role of the striatum.

    PubMed

    Sørensen, L; Eichele, T; van Wageningen, H; Plessen, K J; Stevens, M C

    2016-01-01

    It has been suggested that intra-individual variability (IIV) in performance on attention and other cognitive tasks might be a cognitive endophenotype in individuals with ADHD. Despite robust IIV findings in behavioral data, only sparse data exist on how what type of brain dysfunction underlies variable response times. In this study, we asked whether ADHD IIV in reaction time on a commonly-used test of attention might be related to variation in hemodynamic responses (HRs) observed trial-to-trial. Based on previous studies linking IIV to regions within the "default mode" network (DMN), we predicted that adolescents with ADHD would have higher HR variability in the DMN compared with controls, and this in turn would be related to behavioral IIV. We also explored the influence of social anxiety on HR variability in ADHD as means to test whether higher arousal associated with high trait anxiety would affect the neural abnormalities. We assessed single-trial variability of HRs, estimated from fMRI event-related responses elicited during an auditory oddball paradigm in adolescents with ADHD and healthy controls (11-18 years old; N = 46). Adolescents with ADHD had higher HR variability compared with controls in anterior regions of the DMN. This effect was specific to ADHD and not associated with traits of age, IQ and anxiety. However, an ADHD effect of higher HR variability also appeared in a basal ganglia network, but for these brain regions the relationships of HR variability and social anxiety levels were more complex. Performance IIV correlated significantly with variability of HRs in both networks. These results suggest that assessment of trial-to-trial HR variability in ADHD provides information beyond that detectable through analysis of behavioral data and average brain activation levels, revealing specific neural correlates of a possible ADHD IIV endophenotype. PMID:27622136

  9. Protocol for the New Medicine Service Study: a randomized controlled trial and economic evaluation with qualitative appraisal comparing the effectiveness and cost effectiveness of the New Medicine Service in community pharmacies in England

    PubMed Central

    2013-01-01

    Background Medication non-adherence is considered an important cause of morbidity and mortality in primary care. This study aims to determine the effectiveness, cost effectiveness and acceptability of a complex intervention delivered by community pharmacists, the New Medicine Service (NMS), compared with current practice in reducing non-adherence to, and problems with, newly prescribed medicines for chronic conditions. Methods/design Research subject group: patients aged 14 years and above presenting in a community pharmacy for a newly prescribed medicine for asthma/chronic obstructive pulmonary disease (COPD); hypertension; type 2 diabetes or anticoagulant/antiplatelet agents in two geographical regions in England. Design: parallel group patient-level pragmatic randomized controlled trial. Interventions: patients randomized to either: (i) current practice; or (ii) NMS intervention comprising pharmacist-delivered support for a newly prescribed medicine. Primary outcomes: proportion of adherent patients at six, ten and 26 weeks from the date of presenting their prescriptions at the pharmacy; cost effectiveness of the intervention versus current practice at 10 weeks and 26 weeks; in-depth qualitative understanding of the operationalization of NMS in pharmacies. Secondary outcomes: impact of NMS on: patients’ understanding of their medicines, pharmacovigilance, interprofessional and patient-professional relationships and experiences of service users and stakeholders. Economic analysis: Trial-based economic analysis (cost per extra adherent patient) and long-term modeling of costs and health effects (cost per quality-adjusted-life-year) will be conducted from the perspective of National Health Service (NHS) England, comparing NMS with current practice. Qualitative analysis: a qualitative study of NMS implementation in different community settings, how organizational influences affect NMS delivery, patterns of NMS consultations and experiences of professionals and

  10. Adolescent psychotherapy for addiction medicine: From brain development to neurocognitive treatment mechanisms.

    PubMed

    Thayer, Rachel E; Feldstein Ewing, Sarah W

    2016-01-01

    Effectively treating addiction is a challenge among any population, and treatment for adolescents may be particularly challenging in the context of ongoing neurodevelopment, which may alter the brain's initial response to substances as well as its response to treatment. One way to improve treatment outcomes for youth is to use a translational perspective that explicitly connects cognitive and neurodevelopmental fields with the field of behavioral therapies. This integrative approach is a potential first step to inform the correspondence between the neurocognitive and behavioral fields in youth addiction. This chapter seeks to provide context for neurocognitive treatment studies by first discussing recent structural and functional neuroimaging studies showing associations with substance use or behavioral addictions. Several regions of interest are then proposed that appear to also be associated with addiction treatment across multiple studies, namely, the accumbens/striatum, precuneus, insula, anterior cingulate cortex, and dorsolateral prefrontal cortex. This research suggests that reward, self-reflective, and executive control areas might be especially relevant in youth behavioral treatment response, and preliminary evidence suggests that existing treatments may encourage neurocognitive changes in these areas. PMID:26822364

  11. Use of electronic healthcare records in large-scale simple randomized trials at the point of care for the documentation of value-based medicine.

    PubMed

    van Staa, T-P; Klungel, O; Smeeth, L

    2014-06-01

    A solid foundation of evidence of the effects of an intervention is a prerequisite of evidence-based medicine. The best source of such evidence is considered to be randomized trials, which are able to avoid confounding. However, they may not always estimate effectiveness in clinical practice. Databases that collate anonymized electronic health records (EHRs) from different clinical centres have been widely used for many years in observational studies. Randomized point-of-care trials have been initiated recently to recruit and follow patients using the data from EHR databases. In this review, we describe how EHR databases can be used for conducting large-scale simple trials and discuss the advantages and disadvantages of their use.

  12. Building Resilience After School for Early Adolescents in Urban Poverty: Open Trial of Leaders @ Play.

    PubMed

    Frazier, Stacy L; Dinizulu, Sonya Mathies; Rusch, Dana; Boustani, Maya M; Mehta, Tara G; Reitz, Kristin

    2015-11-01

    Leaders @ Play is a park after-school program for urban middle school youth designed to leverage recreational activities for social emotional learning. Mental health and park staff co-facilitated sports and games to teach and practice problem solving, emotion regulation, and effective communication. Additional practice occurred during multi-family groups and summer internships as junior camp counselors. We examined feasibility and promise via an open trial (n = 3 parks, 46 youth, 100 % African American, 100 % low-income, 59 % female, M = 13.09 years old). Improvements in social skills and reductions in problem behaviors lend support to after school programs as a space for mental health promotion. PMID:25425012

  13. Cinnarizine versus Topiramate in Prophylaxis of Migraines among Children and Adolescents: A Randomized, Double-Blind Clinical Trial

    PubMed Central

    ASHRAFI, Mahmoud Reza; NAJAFI, Zeinab; SHAFIEI, Masih; HEIDARI, Kazem; TOGHA, Mansoureh

    2014-01-01

    Objective Migraines, a common health problem in children and adolescents, still do not have an FDA approved preventive treatment for patients under the age of 18 years. This study compares and contrasts the efficacy and safety of cinnarizine and topiramate in preventing pediatric migraines. Materials & Methods In this randomized, double-blind clinical trial 44 migrainous (from 4–15 years of age) were equally allocated to receive cinnarizine or topiramate. The primary efficacy measure was monthly migraine frequency. Secondary efficacy measures were monthly migraine intensity and ≥ 50% responder rate. Efficacy measures were recorded at the baseline and at 4, 8, and 12 weeks of treatment. Results During the double-blind phase of the study, monthly migraine frequency and intensity were significantly decreased in both the cinnarizine and topiramate groups when compared to the baseline. However, at the end of the study, the cinnarizine group exhibits a significant decrease from the baseline in the mean monthly migraine intensity when compared to the topiramate group (4.7 vs. 3, respectively; 95% CI = -0.8 to -3.2). Conclusion No significant difference between cinnarizine and topiramate was found for the prevention of pediatric migraines. Both treatments were well tolerated. PMID:25657766

  14. The In Vivo Adherence Intervention For at Risk Adolescents With Asthma: Report of a Randomized Pilot Trial

    PubMed Central

    D'Amico, Elizabeth J.; Varni, James W.; Munafo, Jennifer K.; Britto, Maria T.; Kercsmar, Carolyn M.; Drotar, Dennis; King, Eileen C.; Darbie, Lynn

    2012-01-01

    Objective Low-income and minority adolescents are at high risk for poor asthma outcomes, due in part to adherence. We tested acceptability, feasibility, and effect sizes of an adherence intervention for low socioeconomic status (SES) minority youth with moderate- and severe-persistent asthma. Design and Methods Single-site randomized pilot trial: intervention (n = 12; asthma education, motivational interviewing, problem-solving skills training, 1 month cell-phone with tailored text messaging) versus control (n = 14; asthma education; cell-phone without tailored messaging). Calculated effect-sizes of relative change from baseline (1 and 3 months). Results Intervention was judged acceptable and feasible by participants. Participants (12–18 years, mean = 15.1, SD = 1.67) were 76.9% African-American, 80.7% public/no insurance. At 1 and 3 months, asthma symptoms (Cohen's d's = 0.40, 0.96) and HRQOL (PedsQL™; Cohen's d's = 0.23, 1.25) had clinically meaningful medium to large effect sizes. Conclusions This intervention appears promising for at-risk youth with moderate- and severe-persistent asthma. PMID:22167121

  15. Assessment of the Reporting Quality of Randomized Controlled Trials on the Treatment of Diabetes Mellitus with Traditional Chinese Medicine: A Systematic Review

    PubMed Central

    Wang, Ping; Xu, Qin; Sun, Qi; Fan, Fang-fang; Guo, Xue-rui; Guo, Fei

    2013-01-01

    Background After the publication of the CONSORT 2010 statement, few studies have been conducted to assess the reporting quality of randomized clinical trials (RCTs) on treatment of diabetes mellitus with Traditional Chinese Medicine (TCM) published in Chinese journals. Objective To investigate the current situation of the reporting quality of RCTs in leading medical journals in China with the CONSORT 2010 statement as criteria. Methods The China National Knowledge Infrastructure (CNKI) electronic database was searched for RCTs on the treatment of diabetes mellitus with TCM published in the Journal of Traditional Chinese Medicine, Chinese Journal of Integrated Traditional & Western Medicine, and the China Journal of Chinese Materia Medica from January to December 2011. We excluded trials reported as “animal studies”, “in vitro studies”, “case studies”, or “systematic reviews”. The CONSORT checklist was applied by two independent raters to evaluate the reporting quality of all eligible trials after discussing and comprehending the items thoroughly. Each item in the checklist was graded as either “yes” or “no” depending on whether it had been reported by the authors. Results We identified 27 RCTs. According to the 37 items in the CONSORT checklist, the average reporting percentage was 45.0%, in which the average reporting percentage for the “title and abstract”, the “introduction”, the “methods”, the “results”, the “discussion” and the “other information” was 33.3%, 88.9%, 36.4%, 54.4%, 71.6% and 14.8%, respectively. In the Journal of Traditional Chinese Medicine, Chinese Journal of Integrated Traditional & Western Medicine, and the China Journal of Chinese Materia Medica the average reporting percentage was 42.2%, 56.8%, and 46.0%, respectively. Conclusions The reporting quality of RCTs in these three journals was insufficient to allow readers to assess the validity of the trials. We recommend that editors require

  16. Rehabilitation for the management of knee osteoarthritis using comprehensive traditional Chinese medicine in community health centers: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background It is becoming increasingly necessary for community health centers to make rehabilitation services available to patients with osteoarthritis of the knee. However, for a number of reasons, including a lack of expertise, the small size of community health centers and the availability of only simple medical equipment, conventional rehabilitation therapy has not been widely used in China. Consequently, most patients with knee osteoarthritis seek treatment in high-grade hospitals. However, many patients cannot manage the techniques that they were taught in the hospital. Methods such as acupuncture, tuina, Chinese medical herb fumigation-washing and t’ai chi are easy to do and have been reported to have curative effects in those with knee osteoarthritis. To date, there have been no randomized controlled trials validating comprehensive traditional Chinese medicine for the rehabilitation of knee osteoarthritis in a community health center. Furthermore, there is no standard rehabilitation protocol using traditional Chinese medicine for knee osteoarthritis. The aim of the current study is to develop a comprehensive rehabilitation protocol using traditional Chinese medicine for the management of knee osteoarthritis in a community health center. Method/design This will be a randomized controlled clinical trial with blinded assessment. There will be a 4-week intervention utilizing rehabilitation protocols from traditional Chinese medicine and conventional therapy. Follow-up will be conducted for a period of 12 weeks. A total of 722 participants with knee osteoarthritis will be recruited. Participants will be randomly divided into two groups: experimental and control. Primary outcomes will include range of motion, girth measurement, the visual analogue scale, and results from the manual muscle, six-minute walking and stair-climbing tests. Secondary outcomes will include average daily consumption of pain medication, ability to perform daily tasks and health

  17. Chinese Medicinal Herbs in the Treatment of Upper Airway Cough Syndrome: A Systematic Review of Randomized, Controlled Trials.

    PubMed

    Jiang, Hongli; Liu, Wei; Li, Guanhong; Fan, Tao; Mao, Bing

    2016-03-01

    Context • Upper airway cough syndrome (UACS), previously called postnasal drip syndrome (PNDS), has been considered universally to be one of the most common causes of chronic cough. As an important part of complementary and alternative therapy, traditional Chinese medicine (TCM) has found an exact curative therapy for chronic cough through clinical practice for thousands of years. Objective • The aim of the current review was to investigate systematically the beneficial and adverse effects of Chinese medicinal herbs (CMH) in the treatment of UACS. Design • The research team performed searches in 11 main databases from respective inception to October 31, 2015, supplemented with manual retrieval of other data. Only randomized, controlled trials (RCTs) reporting on the effectiveness of CMH in patients with UACS were included. Descriptive and quantitative data on the studies' designs, population demographics, interventions, outcomes, and methodological quality were extracted and tabulated. Methodological quality was assessed using the Cochrane risk-of-bias system and the quality of the evidence was evaluated using the Grades of Recommendation Assessment, Development, and Evaluation (GRADE) system. Participants • The reviewed studies included 1355 participants-720 in the CMH groups and 635 in the control groups-of both genders, from various professional and ethnic groups, and with a wide range of ages. They all had a duration of cough symptoms of longer than 8 wk and a clinical diagnosis of chronic cough induced by UACS that was supported by appropriate physical findings. Outcome Measures • The primary outcomes included (1) TCM recovery rate and (2) TCM cough symptom score. TCM's curative effect was calculated as the cumulative percentage of the symptom-score reduction (PSSR), estimated between baseline and postintervention. The cough symptom scores were graded according to the Chinese Criteria Guiding Principle of Clinical Research on New Drugs of TCM, with

  18. The 24-h Energy Intake of Obese Adolescents Is Spontaneously Reduced after Intensive Exercise: A Randomized Controlled Trial in Calorimetric Chambers

    PubMed Central

    Thivel, David; Isacco, Laurie; Montaurier, Christophe; Boirie, Yves

    2012-01-01

    Background Physical exercise can modify subsequent energy intake and appetite and may thus be of particular interest in terms of obesity treatment. However, it is still unclear whether an intensive bout of exercise can affect the energy consumption of obese children and adolescents. Objective To compare the impact of high vs. moderate intensity exercises on subsequent 24-h energy intake, macronutrient preferences, appetite sensations, energy expenditure and balance in obese adolescent. Design This randomized cross-over trial involves 15 obese adolescent boys who were asked to randomly complete three 24-h sessions in a metabolic chamber, each separated by at least 7 days: (1) sedentary (SED); (2) Low-Intensity Exercise (LIE) (40% maximal oxygen uptake, VO2max); (3) High-Intensity Exercise (HIE) (75%VO2max). Results Despite unchanged appetite sensations, 24-h total energy intake following HIE was 6–11% lower compared to LIE and SED (p<0.05), whereas no differences appeared between SED and LIE. Energy intake at lunch was 9.4% and 8.4% lower after HIE compared to SED and LIE, respectively (p<0.05). At dinner time, it was 20.5% and 19.7% lower after HIE compared to SED and LIE, respectively (p<0.01). 24-h energy expenditure was not significantly altered. Thus, the 24-h energy balance was significantly reduced during HIE compared to SED and LIE (p<0.01), whereas those of SED and LIE did not differ. Conclusions In obese adolescent boys, HIE has a beneficial impact on 24-h energy balance, mainly due to the spontaneous decrease in energy intake during lunch and dinner following the exercise bout. Prescribing high-intensity exercises to promote weight loss may therefore provide effective results without affecting appetite sensations and, as a result, food frustrations. Trial Registration ClinicalTrial.gov NCT01036360 PMID:22272251

  19. A randomized controlled trial to increase information, motivation, and behavioral skills in Ugandan adolescents

    PubMed Central

    Ybarra, Michele L.; Korchmaros, Josephine D.; Prescott, Tonya L.; Birungi, Ruth

    2015-01-01

    Background One in twenty-five Ugandan adolescents is HIV positive. Purpose Examine the impact of an Internet-based HIV prevention program on Information-Motivation-Behavior Skills Model-related constructs. Methods Three hundred and sixty-six sexually experienced and inexperienced students 12-18+ years-old in Mbarara, Uganda were randomly assigned to: the five-lesson CyberSenga program or treatment-as-usual. Half of the intervention participants were further randomized to a booster session. Assessments were collected at three and six months post-baseline. Results Participants’ HIV-related information improved over time at a greater rate for the intervention groups compared to the control group. Motivation for condom use changed to a greater degree over time for the intervention group – especially those in the intervention+booster group - compared to the control group. Behavioral skills for condom use, and motivation and behavioral skills for abstinence were statistically similar over time for both groups. Conclusions CyberSenga improves HIV preventive information and motivation to use condoms. PMID:25633626

  20. Effectiveness of a drinking-motive-tailored emergency-room intervention among adolescents admitted to hospital due to acute alcohol intoxication - A randomized controlled trial.

    PubMed

    Wurdak, Mara; Wolstein, Jörg; Kuntsche, Emmanuel

    2016-06-01

    The aim of this study is to develop and test the effectiveness of a drinking-motive-tailored intervention for adolescents hospitalized due to alcohol intoxication in eight cities in Germany between December 2011 and May 2012 against a similar, non-motive-tailored intervention. In a randomized controlled trial, 254 adolescents received a psychosocial intervention plus motive-tailored (intervention group; IG) or general exercises (control group; CG). Adolescents in the IG received exercises in accordance with their drinking motives as indicated at baseline (e.g. alternative ways of spending leisure time or dealing with stress). Exercises for the CG contained alcohol-related information in general (e.g. legal issues). The data of 81 adolescents (age: M = 15.6, SD = 1.0; 42.0% female) who participated in both the baseline and the follow-up were compared using ANOVA with repeated measurements and effect sizes (available case analyses). Adolescents reported lower alcohol use at the four-week follow-up independently of the kind of intervention. Significant interaction effects between time and IG were found for girls in terms of drinking frequency (F = 7.770, p < 0.01) and binge drinking (F = 7.0005, p < 0.05) but not for boys. For the former, the proportional reductions and corresponding effect sizes of drinking frequency (d = - 1.18), binge drinking (d = - 1.61) and drunkenness (d = - 2.87) were much higher than the .8 threshold for large effects. Conducting psychosocial interventions in a motive-tailored way appears more effective for girls admitted to hospital due to alcohol intoxication than without motive-tailoring. Further research is required to address the specific needs of boys in such interventions. (German Clinical Trials Register, DRKS ID: DRKS00005588).

  1. Effectiveness of a drinking-motive-tailored emergency-room intervention among adolescents admitted to hospital due to acute alcohol intoxication — A randomized controlled trial

    PubMed Central

    Wurdak, Mara; Wolstein, Jörg; Kuntsche, Emmanuel

    2015-01-01

    The aim of this study is to develop and test the effectiveness of a drinking-motive-tailored intervention for adolescents hospitalized due to alcohol intoxication in eight cities in Germany between December 2011 and May 2012 against a similar, non-motive-tailored intervention. In a randomized controlled trial, 254 adolescents received a psychosocial intervention plus motive-tailored (intervention group; IG) or general exercises (control group; CG). Adolescents in the IG received exercises in accordance with their drinking motives as indicated at baseline (e.g. alternative ways of spending leisure time or dealing with stress). Exercises for the CG contained alcohol-related information in general (e.g. legal issues). The data of 81 adolescents (age: M = 15.6, SD = 1.0; 42.0% female) who participated in both the baseline and the follow-up were compared using ANOVA with repeated measurements and effect sizes (available case analyses). Adolescents reported lower alcohol use at the four-week follow-up independently of the kind of intervention. Significant interaction effects between time and IG were found for girls in terms of drinking frequency (F = 7.770, p < 0.01) and binge drinking (F = 7.0005, p < 0.05) but not for boys. For the former, the proportional reductions and corresponding effect sizes of drinking frequency (d = − 1.18), binge drinking (d = − 1.61) and drunkenness (d = − 2.87) were much higher than the .8 threshold for large effects. Conducting psychosocial interventions in a motive-tailored way appears more effective for girls admitted to hospital due to alcohol intoxication than without motive-tailoring. Further research is required to address the specific needs of boys in such interventions. (German Clinical Trials Register, DRKS ID: DRKS00005588). PMID:26844193

  2. Randomized trials on consider this, a tailored, internet-delivered smoking prevention program for adolescents.

    PubMed

    Buller, David B; Borland, Ron; Woodall, W Gill; Hall, John R; Hines, Joan M; Burris-Woodall, Patricia; Cutter, Gary R; Miller, Caroline; Balmford, James; Starling, Randall; Ax, Bryan; Saba, Laura

    2008-04-01

    The Internet may be an effective medium for delivering smoking prevention to children. Consider This, an Internet-based program, was hypothesized to reduce expectations concerning smoking and smoking prevalence. Group-randomized pretest-posttest controlled trials were conducted in Australia (n = 2,077) and the United States (n = 1,234) in schools containing Grades 6 through 9. Australian children using Consider This reported reduced 30-day smoking prevalence. This reduction was mediated by decreased subjective norms. The amount of program exposure was low in many classes, but program use displayed a dose-response relationship with reduced smoking prevalence. American children only reported lower expectations for smoking in the future. Intervening to prevent smoking is a challenge, and this data suggest small benefits from an Internet-based program that are unlikely to be of practical significance unless increased by improved implementation. Implementation remains the major challenge to delivering interventions via the Internet, both for health educators and researchers.

  3. Semi-individualised Chinese medicine treatment as an adjuvant management for diabetic nephropathy: a pilot add-on, randomised, controlled, multicentre, open-label pragmatic clinical trial

    PubMed Central

    Chan, Kam Wa; Ip, Tai Pang; Kwong, Alfred Siu Kei; Lui, Sing Leung; Chan, Gary Chi Wang; Cowling, Benjamin John; Yiu, Wai Han; Wong, Dickson Wai Leong; Liu, Yang; Feng, Yibin; Tan, Kathryn Choon Beng; Chan, Loretta Yuk Yee; Leung, Joseph Chi Kam; Lai, Kar Neng; Tang, Sydney Chi Wai

    2016-01-01

    Introduction Diabetes mellitus and diabetic nephropathy (DN) are prevalent and costly to manage. DN is the leading cause of end-stage kidney disease. Conventional therapy blocking the renin–angiotensin system has only achieved limited effect in preserving renal function. Recent observational data show that the use of Chinese medicine (CM), a major form of traditional medicine used extensively in Asia, could reduce the risk of end-stage kidney disease. However, existing clinical practice guidelines are weakly evidence-based and the effect of CM remains unclear. This trial explores the effect of an existing integrative Chinese–Western medicine protocol for the management of DN. Objective To optimise parameters and assess the feasibility for a subsequent phase III randomised controlled trial through preliminary evaluation on the effect of an adjuvant semi-individualised CM treatment protocol on patients with type 2 diabetes with stages 2–3 chronic kidney disease and macroalbuminuria. Methods and analysis This is an assessor-blind, add-on, randomised, controlled, parallel, multicentre, open-label pilot pragmatic clinical trial. 148 patients diagnosed with DN will be recruited and randomised 1:1 to a 48-week additional semi-individualised CM treatment programme or standard medical care. Primary end points are the changes in estimated glomerular filtration rate and spot urine albumin-to-creatinine ratio between baseline and treatment end point. Secondary end points include fasting blood glucose, glycated haemoglobin, brain natriuretic peptide, fasting insulin, C peptide, fibroblast growth factor 23, urinary monocyte chemotactic protein-1, cystatin C, nephrin, transforming growth factor-β1 and vascular endothelial growth factor. Adverse events are monitored through self-completed questionnaire and clinical visits. Outcomes will be analysed by regression models. Enrolment started in July 2015. Ethics and registration This protocol is approved by the Institutional

  4. Effectiveness of a complex intervention in reducing the prevalence of smoking among adolescents: study design of a cluster-randomized controlled trial

    PubMed Central

    2014-01-01

    Background The likelihood of an adolescent taking up smoking may be influenced by his or her society, school and family. Thus, changes in the immediate environment may alter a young person’s perception of smoking. Methods/Design The proposed multi-center, cluster-randomized controlled trial will be stratified by the baseline prevalence of smoking in schools. Municipalities with fewer than 100,000 inhabitants will be randomly assigned to a control or intervention group. One secondary school will be randomly selected from each municipality. These schools will be randomized to two groups: the students of one will receive any existing educational course regarding smoking, while those of the other school will receive a four-year, class-based curriculum intervention (22 classroom lessons) aimed at reinforcing a smoke-free school policy and encouraging smoking cessation in parents, pupils, and teachers. The intervention will also include annual meetings with parents and efforts to empower adolescents to change the smoking-related attitudes and behaviors in their homes, classrooms and communities. We will enroll children aged 12-13 years as they enter secondary school during two consecutive school years (to obtain sufficient enrolled subjects). We will follow them for five years, until two years after they leave secondary school. All external evaluators and analysts will be blinded to school allocation. The aim of this study is to analyze the effectiveness of a complex intervention in reducing the prevalence of smoking in the third year of compulsory secondary education (ESO) and two years after secondary school, when the participants are 14-15 and 17-18 years old, respectively. Discussion Most interventions aimed at preventing smoking among adolescents yield little to no positive long-term effects. This clinical trial will analyze the effectiveness of a complex intervention aimed at reducing the incidence and prevalence of smoking in this vulnerable age group. Trial

  5. Improving adolescent mental health and resilience through a resilience-based intervention in schools: study protocol for a randomised controlled trial

    PubMed Central

    2014-01-01

    Background Research investigating the effectiveness of universal interventions to reduce the risk of mental health problems remains limited. Schools are a promising setting within which adolescents can receive interventions aimed at promoting their mental health. The aim of this study is to assess the effectiveness of a resilience-based prevention-focused intervention in reducing the risk of mental health problems among adolescents attending secondary school in socio-economically disadvantaged areas. Methods/design A cluster randomised control trial will be conducted, with schools as the unit of randomisation. Initially, 32 secondary schools will be randomly allocated to a control or intervention group (12 control and 20 intervention). An intervention focused on improving student internal and external resilience factors will be implemented in intervention schools. A survey of students in Grade 7 in both intervention and control schools will be conducted (baseline) and repeated three years later when the students are in Grade 10. The Strengths and Difficulties Questionnaire will be used to measure the risk of mental health problems. At follow-up, the risk of mental health problems will be compared between Grade 10 students in intervention and control schools to determine intervention effectiveness. Discussion The study presents an opportunity to determine the effectiveness of a comprehensive resilience-based intervention in reducing the risk of mental health problems in adolescents attending secondary schools. The outcomes of the trial are of importance to youth, schools, mental health clinicians and policymakers. Trial registration Australian New Zealand Clinical Trials Registry, ACTRN12611000606987, registered 14 June 2011. PMID:25037455

  6. A Randomized Controlled Trial of Guided Self-Change with Minority Adolescents

    PubMed Central

    Wagner, Eric F.; Hospital, Michelle M.; Graziano, Juliette N.; Gil, Andrés G.; Morris, Staci L.

    2014-01-01

    Objective Adolescent substance use and abuse is a pressing public health problem, and is strongly related to interpersonal aggression. Such problems disproportionately impact minority youth, who have limited access to evidence-based interventions such as ecological family therapies, brief motivational interventions (BMI), and cognitive behavioral therapies (CBT). With a predominantly minority sample, our objective was to rigorously evaluate the efficacy of a school-based BMI/CBT, Guided Self-Change (GSC), for addressing substance use and aggressive behavior. Method We conducted a school-based RCT with 514 high school students (mean age 16.24 years, 41% female, 80% minority) reporting using substances and perpetrating aggression. We used structural equation modeling to compare participants randomly assigned to receive GSC or standard care (SC; education/assessment/referral-only), at post-treatment, and 3- and 6-months post-treatment, on alcohol use, drug use, and interpersonal aggression outcomes as assessed by the Timeline Follow-Back. Results Compared with SC participants, GSC participants showed significant reductions (p < .05) in total number of alcohol use days (Cohen’s d =0.45 at post-treatment, and 0.20 at 3-months post-treatment), drug use days (Cohen’s d =0.22 at post-treatment, and 0.20 at 3-months post-treatment), and aggressive behavior incidents (Cohen’s d =0.23 at post-treatment). Moreover, treatment effects did not vary by gender or ethnicity. Conclusions With minority youth experiencing mild to moderate problems with substance use and aggressive behavior, GSC holds promise as an early intervention approach that can be implemented with success in schools. PMID:24841864

  7. OBESITY AND DYSLIPIDEMIA IN BEHAVIORALLY HIV-INFECTED YOUNG WOMEN: ADOLESCENT TRIALS NETWORK (ATN) STUDY 021

    PubMed Central

    Mulligan, Kathleen; Harris, D. Robert; Monte, Dina; Stoszek, Sonia; Emmanuel, Patricia; Hardin, Dana S.; Kapogiannis, Bill G.; Worrell, Carol; Meyer, William A.; Sleasman, John; Wilson, Craig M.

    2009-01-01

    Background The goal of this study was to determine the nature and prevalence of abnormalities in lipids, glucose metabolism, and body composition in behaviorally HIV-infected young women and their relationship to different classes of antiretroviral therapy (ART) regimens. Methods We conducted a cross-sectional multicenter study in behaviorally infected women ages 12-24 years (HIVpos; N=173) and seronegative controls (HIVneg; N=61). HIVpos women were categorized as ART-naïve (N=85), on a non-nucleoside reverse transcriptase inhibitor-containing regimen (NNRTI; N=33), on a protease inhibitor-containing regimen (PI; N=36), or on a non-NNRTI/non-PI containing regimen (N=19). Measurements included fasting lipids; glucose and insulin before and 2 hours after an oral glucose challenge; high-sensitivity C-reactive protein (hsCRP); anthropometry; fat distribution (dual energy X-ray absorptiometry); and ART and medical histories. Race-adjusted results were compared across groups and within HIVpos groups. Results The median age was 20 (range 14-24) years. 77% of HIVpos were African American, 35% smoked cigarettes, and 32% reported exercising regularly. More than 40% had a BMI ≥25 kg/m2. Triglycerides; total, HDL, and non-HDL cholesterol; and hsCRP differed significantly among groups, with higher levels most common among those on ART. Indices of glucose metabolism did not differ among groups. In general, cholesterol, hsCRP, and indices of glucose metabolism worsened as BMI increased. Conclusions Obesity, dyslipidemia, and inflammation were prominent in HIV-infected adolescent women and, coupled with other risk factors, may accelerate the lifetime risk of cardiovascular disease and other adverse events. These results underscore the need for a multifaceted approach to addressing risk reduction in this population. PMID:19947855

  8. A Longitudinal Study of the Effects of Instrumental and Emotional Social Support on Physical Activity in Underserved Adolescents in the ACT Trial

    PubMed Central

    Siceloff, E. Rebekah; Wilson, Dawn K.; Van Horn, Lee

    2014-01-01

    Background Few previous studies have examined the influence of instrumental and emotional social support on physical activity (PA) longitudinally in underserved adolescents. Purpose This longitudinal study was a secondary analysis of the Active by Choice Today (ACT) trial examining whether instrumental social support predicts increases in PA in underserved adolescents, above and beyond emotional social support provided by family or peers. Methods Students in 6th grade (N=1422, 73% African American, 54% female, Mage=11 years) in the ACT trial participated. At baseline and 19 weeks, previously validated measures of social support (family instrumental, family emotional, and peer emotional) were completed and moderate-to-vigorous PA (MVPA) was assessed using 7-day accelerometry estimates. Results A mixed ANCOVA demonstrated that baseline (p=.02) and change in family instrumental support (p=.01), but not emotional support from family or peers, predicted increases in MVPA across a 19-week period. Conclusions Future interventions in underserved adolescents should enhance opportunities for instrumental support for PA. PMID:24327135

  9. Acetyl-L-carnitine as an adjunctive therapy in the treatment of attention-deficit/hyperactivity disorder in children and adolescents: a placebo-controlled trial.

    PubMed

    Abbasi, Seyed-Hesameddin; Heidari, Shahram; Mohammadi, Mohammad-Reza; Tabrizi, Mina; Ghaleiha, Ali; Akhondzadeh, Shahin

    2011-06-01

    The objective of this study was to test whether a previous observed Acetyl-L-carnitine (ALC) treatment effect could be repeated in an ALC adjunctive therapy treatment trial of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents. This was a six-week, randomized clinical trial undertaken in an outpatient child and adolescent clinic. Subjects included 40 outpatients (28 boys and 12 girls) between the ages of 7-13 who met the DSM-IV-TR diagnostic criteria for ADHD. All study subjects were randomly assigned to receive treatment using capsules of ALC doses ranging from 500 to 1,500 mg/day depending on the weight of the child plus methylphenidate at a dose of 20-30 mg/day depending on weight or Placebo plus methylphenidate at a dose of 20-30 mg/day depending on weight. The principal measure of outcome was the Teacher and Parent attention deficit/hyperactivity disorder Rating Scale- IV. No difference was observed between the two groups on the Parent and Teacher Rating Scale scores (df = 1; F = 0.10; P = 0.74 and df = 1; F = 0.22; P = 0.63 respectively). Side effects consisting of headache and irritability were observed more frequently in the methylphenidate plus placebo group. The results of this study do not support the application of ALC as an adjunctive therapy to methylphenidate in children and adolescents with ADHD. PMID:21336630

  10. Assessment of the Reporting Quality of Placebo-controlled Randomized Trials on the Treatment of Type 2 Diabetes With Traditional Chinese Medicine in Mainland China

    PubMed Central

    Zhao, Xiyan; Zhen, Zhong; Guo, Jing; Zhao, Tianyu; Ye, Ru; Guo, Yu; Chen, Hongdong; Lian, Fengmei; Tong, Xiaolin

    2016-01-01

    Abstract Placebo-controlled randomized trials are often used to evaluate the absolute effect of new treatments and are considered gold standard for clinical trials. No studies, however, have yet been conducted evaluating the reporting quality of placebo-controlled randomized trials. The current study aims to assess the reporting quality of placebo-controlled randomized trials on treatment of diabetes with Traditional Chinese Medicine (TCM) in Mainland China and to provide recommendations for improvements. China National Knowledge Infrastructure database, Wanfang database, China Biology Medicine database, and VIP database were searched for placebo-controlled randomized trials on treatment of diabetes with TCM. Review, animal experiment, and randomized controlled trials without placebo control were excluded. According to Consolidated Standards of Reporting Trials (CONSORT) 2010 checklists items, each item was given a yes or no depending on whether it was reported or not. A total of 68 articles were included. The reporting percentage in each article ranged from 24.3% to 73%, and 30.9% articles reported more than 50% of the items. Seven of the 37 items were reported more than 90% of the items, whereas 7 items were not mentioned at all. The average reporting for “title and abstract,” “introduction,” “methods,” “results,” “discussion,” and “other information” was 43.4%, 78.7%, 40.1%, 49.9%, 71.1%, and 17.2%, respectively. The percentage of each section had increased after 2010. In addition, the reporting of multiple study centers, funding, placebo species, informed consent forms, and ethical approvals were 14.7%, 50%, 36.85%, 33.8%, and 4.4%, respectively. Although a scoring system was created according to the CONSORT 2010 checklist, it was not designed as an assessment tool. According to CONSORT 2010, the reporting quality of placebo-controlled randomized trials on the treatment of diabetes with TCM improved after 2010. Future improvements

  11. Efficacy of Chinese Herbal Medicine for Diarrhea-Predominant Irritable Bowel Syndrome: A Meta-Analysis of Randomized, Double-Blind, Placebo-Controlled Trials

    PubMed Central

    Liu, Shan; Su, Xiao-Lan; Wang, Zi-Song; Li, Yi-Jie; Yang, Yang; Hou, Li-Wei; Wang, Qing-Guo; Wei, Ru-Han; Yang, Jian-Qin

    2016-01-01

    Objective. To explore the efficacy of Chinese herbal medicine in treating diarrhea-predominant irritable bowel syndrome (D-IBS). Methods. Four English and four Chinese databases were searched through November, 2015. Randomized, double-blind and placebo-controlled trials were selected. Data extraction and quality evaluation were performed by two authors independently. RevMan 5.2.0 software was applied to analyze the data of included trials. Results. A total of 14 trials involving 1551 patients were included. Meta-analysis demonstrated superior global symptom improvement (RR = 1.62; 95% CI 1.31, 2.00; P < 0.00001; number needed to treat = 3.6), abdominal pain improvement (RR = 1.95; 95% CI 1.61, 2.35; P < 0.00001), diarrhea improvement (RR = 1.87; 95% CI 1.60, 2.20; P < 0.00001), pain threshold assessment (MD = 54.53; 95% CI 38.76, 70.30; P < 0.00001), and lower IBS Symptom Severity Score (SMD = −1.01; 95% CI −1.72, −0.30; P = 0.005), when compared with placebo, while for defecation threshold assessment, quality of life, and adverse events, no differences were found between treatment groups and controlled groups. Conclusion. This meta-analysis shows that Chinese herbal medicine is an effective and safe treatment for D-IBS. However, due to the small sample size and high heterogeneity, further studies are required. PMID:27547226

  12. Efficacy of Chinese Herbal Medicine for Diarrhea-Predominant Irritable Bowel Syndrome: A Meta-Analysis of Randomized, Double-Blind, Placebo-Controlled Trials.

    PubMed

    Zhu, Jia-Jie; Liu, Shan; Su, Xiao-Lan; Wang, Zi-Song; Guo, Yu; Li, Yi-Jie; Yang, Yang; Hou, Li-Wei; Wang, Qing-Guo; Wei, Ru-Han; Yang, Jian-Qin; Wei, Wei

    2016-01-01

    Objective. To explore the efficacy of Chinese herbal medicine in treating diarrhea-predominant irritable bowel syndrome (D-IBS). Methods. Four English and four Chinese databases were searched through November, 2015. Randomized, double-blind and placebo-controlled trials were selected. Data extraction and quality evaluation were performed by two authors independently. RevMan 5.2.0 software was applied to analyze the data of included trials. Results. A total of 14 trials involving 1551 patients were included. Meta-analysis demonstrated superior global symptom improvement (RR = 1.62; 95% CI 1.31, 2.00; P < 0.00001; number needed to treat = 3.6), abdominal pain improvement (RR = 1.95; 95% CI 1.61, 2.35; P < 0.00001), diarrhea improvement (RR = 1.87; 95% CI 1.60, 2.20; P < 0.00001), pain threshold assessment (MD = 54.53; 95% CI 38.76, 70.30; P < 0.00001), and lower IBS Symptom Severity Score (SMD = -1.01; 95% CI -1.72, -0.30; P = 0.005), when compared with placebo, while for defecation threshold assessment, quality of life, and adverse events, no differences were found between treatment groups and controlled groups. Conclusion. This meta-analysis shows that Chinese herbal medicine is an effective and safe treatment for D-IBS. However, due to the small sample size and high heterogeneity, further studies are required. PMID:27547226

  13. Healthy Futures Program and Adolescent Sexual Behaviors in 3 Massachusetts Cities: A Randomized Controlled Trial

    PubMed Central

    Chow, Wendy; Doré, Katelyn F.; O’Brien, Michael J.; Heitz, Elizabeth R.; Millock, Rebecca R.

    2016-01-01

    Objectives. We evaluated the impact of the 3-year Healthy Futures program on reducing sexual behaviors among middle school students. Methods. Fifteen public middle schools in Haverhill, Lowell, and Lynn, Massachusetts, participated in this longitudinal school-cluster randomized controlled trial (2011–2015), which included 1344 boys and girls. We collected student survey data at baseline, immediately after each Nu-CULTURE curriculum (classroom component of Healthy Futures) in the sixth, seventh, and eighth grades, and at a 1-year follow-up in the ninth grade (cohort 1 students only). Results. Healthy Futures did not reduce the overall prevalence of eighth-grade students who reported ever having vaginal sex. In the eighth-grade follow-up, fewer girls in the treatment group than in the control group reported ever having vaginal sex (P = .04), and fewer Hispanic treatment students than Hispanic control students reported ever having vaginal sex (P = .002). Conclusions. There was some evidence of delaying sexual initiation by the end of Nu-CULTURE, for girls and Hispanics, but not for boys. Future research should focus on improving implementation of the supplemental components intended to foster interpersonal and environmental protective factors associated with sustained delays in sexual activity. PMID:27689476

  14. Adolescents' impressions of antismoking media literacy education: qualitative results from a randomized controlled trial.

    PubMed

    Primack, Brian A; Fine, Danielle; Yang, Christopher K; Wickett, Dustin; Zickmund, Susan

    2009-08-01

    Although media literacy represents an innovative venue for school-based antismoking programming, studies have not systematically compared student impressions of these and traditional programs. This study utilized data from a randomized trial comparing these two types of programs. After each program, students responded to three open-ended questions related to their assigned curriculum. Two coders, blinded to student assignments, independently coded these data. Coders had strong inter-rater agreement (kappa = 0.77). Our primary measures were spontaneously noted overall assessment, enjoyment/interest and the likelihood of changing smoking behavior. Of the 531 participants, 255 (48.0%) were randomized to the intervention (media literacy) group. Intervention participants had more net positive responses [rate ratio (RR) = 1.27, 95% confidence interval (CI) = 1.05, 1.54], more responses rating the program as compelling (RR = 1.63, 95% CI = 1.16, 2.29) and fewer responses rating the program as non-compelling (RR = 0.62, 95% CI = 0.39, 0.97). However, the intervention group was not more likely to suggest that the curriculum was likely to change behavior positively (RR = 0.57, 95% CI = 0.30, 1.06). Findings suggest that although media literacy provides a compelling format for the delivery of anti-tobacco programming, integration of components of traditional programming may help media literacy programs achieve maximal efficacy.

  15. Phase 2 Trial of Pemetrexed in Children and Adolescents with Refractory Solid Tumors: a Children’s Oncology Group Study

    PubMed Central

    Warwick, Anne B.; Malempati, Suman; Krailo, Mark; Melemed, Allen; Gorlick, Richard; Ames, Matthew M.; Safgren, Stephanie L.; Adamson, Peter C.; Blaney, Susan M.

    2012-01-01

    Background Pemetrexed is a multi-targeted antifolate that inhibits key enzymes involved in nucleotide biosynthesis. We performed a phase 2 trial of pemetrexed in children with refractory or recurrent solid tumors, including CNS tumors, to estimate the response rate and further define its toxicity profile. Procedure Pemetrexed, at a dose of 1910 mg/m2, was administered as a 10-minute intravenous infusion every 21 days. Patients also received vitamin B12, daily multivitamin supplementation, and dexamethasone. A two-stage design (10 + 10) was employed in each of the following disease strata: osteosarcoma, Ewing sarcoma/peripheral primitive neuroectodermal tumor (PNET), rhabdomyosarcoma, neuroblastoma, ependymoma, medulloblastoma/supratentorial PNET, and non-brainstem high-grade glioma. Results Seventy-two eligible subjects (39 males) were enrolled. Median age was 11 years (range 3–23). Sixty-eight were evaluable for response. The median number of cycles administered was 2 (range 1–13). No complete or partial responses were observed. Stable disease, for a median of 5 (range 4–13) cycles, was observed in 5 patients (ependymoma, Ewing sarcoma, medulloblastoma, neuroblastoma, osteosarcoma; n=1 each). Neutropenia (44%), anemia (35%), and elevated alanine transaminase (35%) attributable to pemetrexed were the most commonly recurring toxicities observed in patients receiving multiple cycles. Other toxicities attributed to pemetrexed occurring in ≥10% of cycles included thrombocytopenia (30%), fatigue (18%), nausea (14), hyperglycemia (13%), rash (11%), vomiting (13%), and hypophosphatemia (11%). Conclusions Pemetrexed, administered as an intravenous infusion every 21 days, was tolerable in children and adolescents with refractory solid tumors, including CNS tumors, but did not show evidence of objective anti-tumor activity in the childhood tumors studied. PMID:22745043

  16. Self-monitoring Using Mobile Phones in the Early Stages of Adolescent Depression: Randomized Controlled Trial

    PubMed Central

    Reid, Sophie Caroline; Crooke, Alexander Hew Dale; Khor, Angela; Hearps, Stephen John Charles; Jorm, Anthony Francis; Sanci, Lena; Patton, George

    2012-01-01

    ) using Mplus to test the indirect effect of the intervention on depressive symptoms via the mediator ESA, and calculated 95% bias-corrected bootstrapping confidence intervals (CIs). Results Of the 163 participants assessed for eligibility, 118 were randomly assigned and 114 were included in analyses (68 in the intervention group and 46 in the comparison group). A parallel process LGCM estimated the indirect effect of the intervention on depressive symptoms via ESA and was shown to be statistically significant based on the 95% bias-corrected bootstrapping CIs not containing zero (–6.366 to –0.029). The proportion of the maximum possible indirect effect estimated was κ2 =.54 (95% CI .426–.640). Conclusions This study supported the hypothesis that self-monitoring increases ESA, which in turn decreases depressive symptoms for young people with mild or more depressive symptoms. Mobile phone self-monitoring programs are ideally suited to first-step intervention programs for depression in the stepped-care approach, particularly when ESA is targeted as a mediating factor. Trial Registration ClinicalTrials.gov NCT00794222; http://clinicaltrials.gov/ct2/show/NCT00794222 (Archived by WebCite at http://www.webcitation.org/65lldW34k) PMID:22732135

  17. Effect of the peels of two Citrus fruits on endothelium function in adolescents with excess weight: A triple-masked randomized trial

    PubMed Central

    Hashemi, Mohammad; Khosravi, Elham; Ghannadi, Alireza; Hashemipour, Mahin; Kelishadi, Roya

    2015-01-01

    Background: Obesity induces endothelial dysfunction even in the pediatric age group. The possible protective effects of fruits and herbal products on the endothelial dysfunction of obese children remain to be determined. This study aims to investigate the effects of lemon and sour orange peels on endothelial function of adolescents with excess weight. Materials and Methods: This triple-masked, randomized placebo-controlled trial was conducted for 1-month among 90 overweight and obese participants, aged 6-18 years. They were randomly assigned into three groups of equal number receiving daily oral capsules containing lemon or sour orange powder or placebo. Flow-mediated dilatation (FMD) was compared between three groups by using analysis of covariance. Results: Overall, 30 participants in the lemon group, 27 in the sour orange group and 29 in the control group completed the trial. After the trial, mean FMD was significantly (P < 0.001) higher in the lemon group (11.99 ± 4.05) and in the sour orange group (12.79 ± 5.47) than in the placebo group (6.45 ± 2.79). FMD percent change was 145.02 ± 24.34 in the lemon group, 142.04 ± 16.11 in the sour orange group, and 46.73 ± 5.16 in controls (P < 0.001). Conclusion: This trial showed that consumption of extracts of lemon and sour orange peels, which contain plenty amounts of antioxidants, flavonoids, pectin, and vitamin C, might have significant benefits on endothelial function in children and adolescents with excess weight. Trial registry code: IRCT201311201434N10. PMID:26664417

  18. Effects of a Web-Based Computer-Tailored Game to Reduce Binge Drinking Among Dutch Adolescents: A Cluster Randomized Controlled Trial

    PubMed Central

    Crutzen, Rik; Mercken, Liesbeth; Candel, Math; de Vries, Hein

    2016-01-01

    Background Binge drinking among Dutch adolescents is among the highest in Europe. Few interventions so far have focused on adolescents aged 15 to 19 years. Because binge drinking increases significantly during those years, it is important to develop binge drinking prevention programs for this group. Web-based computer-tailored interventions can be an effective tool for reducing this behavior in adolescents. Embedding the computer-tailored intervention in a serious game may make it more attractive to adolescents. Objective The aim was to assess whether a Web-based computer-tailored intervention is effective in reducing binge drinking in Dutch adolescents aged 15 to 19 years. Secondary outcomes were reduction in excessive drinking and overall consumption during the previous week. Personal characteristics associated with program adherence were also investigated. Methods A cluster randomized controlled trial was conducted among 34 Dutch schools. Each school was randomized into either an experimental (n=1622) or a control (n=1027) condition. Baseline assessment took place in January and February 2014. At baseline, demographic variables and alcohol use were assessed. Follow-up assessment of alcohol use took place 4 months later (May and June 2014). After the baseline assessment, participants in the experimental condition started with the intervention consisting of a game about alcohol in which computer-tailored feedback regarding motivational characteristics was embedded. Participants in the control condition only received the baseline questionnaire. Both groups received the 4-month follow-up questionnaire. Effects of the intervention were assessed using logistic regression mixed models analyses for binge and excessive drinking and linear regression mixed models analyses for weekly consumption. Factors associated with intervention adherence in the experimental condition were explored by means of a linear regression model. Results In total, 2649 adolescents participated

  19. Clinical Efficacy and Safety of Chinese Herbal Medicine Auxiliary Therapy for Childhood Cough Variant Asthma: A Systematic Review and Meta-analysis of 20 Randomized Controlled Trials.

    PubMed

    Song, Ping; Zeng, Lingfeng; Liang, Zhaohui; Wang, Qi; Ou, Aihua

    2016-01-01

    This study aimed to evaluate the efficacy and safety of Chinese herbal medicine auxiliary therapy (CHMAT) in treating childhood cough variant asthma (CVA). A systematic literature review was conducted on RCTs that compared CHMAT, i.e., Chinese herbal medicine (CHM) plus pharmacotherapy (PT), versus the same PT alone in the treatment of CVA. All included trials were assessed for quality and risk bias and analyzed according to the criteria of the Cochrane Handbook based on the Review Manager 5.3 software program. Twenty studies were identified and the CHMAT group had a positive effect on the total effective rate and a lower recurrence rate compared with the control group. CHMAT may have positive effects on CVA, leading to better improvement in disorders of cough and asthma and less adverse effects. However, the methodology and reporting quality of current studies are generally low. Further studies should include larger sample sizes with a strict design to confirm these findings. PMID:27522988

  20. Preventing Obesity Among Adolescent Girls: One-Year Outcomes of the Nutrition and Enjoyable Activity for Teen Girls (NEAT Girls) Cluster Randomized Controlled Trial.

    PubMed

    Lubans, David R; Morgan, Philip J; Okely, Anthony D; Dewar, Deborah; Collins, Clare E; Batterham, Marijka; Callister, Robin; Plotnikoff, Ronald C

    2012-09-01

    OBJECTIVE To evaluate the impact of a 12-month multicomponent school-based obesity prevention program, Nutrition and Enjoyable Activity for Teen Girls among adolescent girls. DESIGN Group randomized controlled trial with 12-month follow-up. SETTING Twelve secondary schools in low-income communities in the Hunter and Central Coast regions of New South Wales, Australia. PARTICIPANTS Three hundred fifty-seven adolescent girls aged 12 to 14 years. INTERVENTION A multicomponent school-based intervention program tailored for adolescent girls. The intervention was based on social cognitive theory and included teacher professional development, enhanced school sport sessions, interactive seminars, nutrition workshops, lunch-time physical activity sessions, handbooks and pedometers for self-monitoring, parent newsletters, and text messaging for social support. MAIN OUTCOME MEASURES Body mass index (BMI, calculated as weight in kilograms divided by height in meters squared), BMI z score, body fat percentage, physical activity, screen time, dietary intake, and self-esteem. RESULTS After 12 months, changes in BMI (adjusted mean difference, -0.19; 95% CI, -0.70 to 0.33), BMI z score (mean, -0.08; 95% CI, -0.20 to 0.04), and body fat percentage (mean, -1.09; 95% CI, -2.88 to 0.70) were in favor of the intervention, but they were not statistically different from those in the control group. Changes in screen time were statistically significant (mean, -30.67 min/d; 95% CI, -62.43 to -1.06), but there were no group by time effects for physical activity, dietary behavior, or self-esteem. CONCLUSIONS A school-based intervention tailored for adolescent girls from schools located in low-income communities did not significantly reduce BMI gain. However, changes in body composition were of a magnitude similar to previous studies and may be associated with clinically important health outcomes. TRIAL REGISTRATION anzctr.org.au Identifier: 12610000330044. PMID:22566517

  1. Collaborative Care for Older Adults with low back pain by family medicine physicians and doctors of chiropractic (COCOA): study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Low back pain is a prevalent and debilitating condition that affects the health and quality of life of older adults. Older people often consult primary care physicians about back pain, with many also receiving concurrent care from complementary and alternative medicine providers, most commonly doctors of chiropractic. However, a collaborative model of treatment coordination between these two provider groups has yet to be tested. The primary aim of the Collaborative Care for Older Adults Clinical Trial is to develop and evaluate the clinical effectiveness and feasibility of a patient-centered, collaborative care model with family medicine physicians and doctors of chiropractic for the treatment of low back pain in older adults. Methods/design This pragmatic, pilot randomized controlled trial will enroll 120 participants, age 65 years or older with subacute or chronic low back pain lasting at least one month, from a community-based sample in the Quad-Cities, Iowa/Illinois, USA. Eligible participants are allocated in a 1:1:1 ratio to receive 12 weeks of medical care, concurrent medical and chiropractic care, or collaborative medical and chiropractic care. Primary outcomes are self-rated back pain and disability. Secondary outcomes include general and functional health status, symptom bothersomeness, expectations for treatment effectiveness and improvement, fear avoidance behaviors, depression, anxiety, satisfaction, medication use and health care utilization. Treatment safety and adverse events also are monitored. Participant-rated outcome measures are collected via self-reported questionnaires and computer-assisted telephone interviews at baseline, and at 4, 8, 12, 24, 36 and 52 weeks post-randomization. Provider-rated expectations for treatment effectiveness and participant improvement also are evaluated. Process outcomes are assessed through qualitative interviews with study participants and research clinicians, chart audits of progress notes and content

  2. Psychological treatments for depression in pre-adolescent children (12 years and younger): systematic review and meta-analysis of randomised controlled trials.

    PubMed

    Forti-Buratti, M Azul; Saikia, Rupalim; Wilkinson, Esther L; Ramchandani, Paul G

    2016-10-01

    The objective of this study was to evaluate the efficacy of psychological treatments for depression in pre-adolescent children, a disorder affecting 1-2 % of children in this age range. A systematic review of studies of psychological interventions to treat depressive disorder in pre-adolescent children (aged up to 12-years-old) was carried out. The primary outcome was level of depressive symptoms. Studies were found using Medline, PsycINFO, EMBASE and Web of Knowledge databases and selected on several criteria. Only randomised controlled trials were included. Where individual studies covered a broader age range (usually including adolescents up to age 18 years), authors of those studies were contacted and requested to provide individual patient level data for those aged 12 years and younger. 2822 abstracts were reviewed, and from these 124 full text articles were reviewed, yielding 7 studies for which we were able to access appropriate data for this review. 5 of these studies evaluated cognitive behaviour therapy (CBT). Combined results from these studies suggest that there is a lack of evidence that CBT is better than no treatment [standard mean difference -0.342 (95 % confidence interval -0.961, 0.278)], although the number of participants included in the trials was relatively small. The evidence for efficacy of family therapy and psychodynamic therapy is even more limited. The very limited number of participants in randomised controlled trials means that there is inconclusive evidence for the psychological treatment of depression in children aged 12 years and below. Given the prevalence and significant impact of this disorder, there is an urgent need to establish the effectiveness or otherwise of psychological intervention.

  3. Proposed trial: safety and efficacy of resveratrol for the treatment of non-alcoholic fatty liver disease (NAFLD) and associated insulin resistance in adolescents who are overweight or obese adolescents - rationale and protocol.

    PubMed

    Wicklow, Brandy; Wittmeier, Kristy; T' Jong, Geert W; McGavock, Jonathon; Robert, Marni; Duhamel, Todd; Dolinsky, Vernon W

    2015-10-01

    Non-alcoholic fatty liver (NAFL) disease (NAFLD) affects 30% of overweight adolescents and increases the risk of type 2 diabetes mellitus (T2D). Resveratrol is a naturally occurring compound with potential to reverse NAFL and its associated insulin resistance in adults. The use of resveratrol to reduce risk for T2D through its effect on NAFL has not been examined to date in youth. This paper provides a literature review and protocol for a 30 day proof of principle trial of resveratrol in a population of adolescents at risk for T2D. This randomized double-blind controlled trial is designed with the primary objective of evaluating a twice daily supplementation of 75 mg of resveratrol for safety and tolerability in overweight and obese adolescent subjects (13 to <18 years of age) with NAFL. Secondary objectives are to determine the effect size of the intervention on hepatic steatosis and whole body insulin sensitivity. Adolescents in the intervention arm (n = 10) will receive oral supplementation of resveratrol 75 mg twice daily (with breakfast and dinner) for a total daily dose of 150 mg for the duration of 30 days. The comparison group (n = 10) will receive a placebo twice daily for 30 days. Both cases and controls will receive a standardized lifestyle intervention program. Subjects in both groups will be followed for an additional 30 days post intervention for total study duration of approximately 60 days. Primary outcome measures include a primary side effect profile determined by participant interview, a side effect profile determined by serum biochemistry and vital signs. Secondary outcome measures include an oral glucose tolerance test, liver and cardiac fat content measured by magnetic resonance spectroscopy, anthropometric measures of overweight/obesity, inflammatory markers, and cardiac function and morphology measured with ultrasonography. Additional outcome measures include serum concentrations of resveratrol, compliance to protocol, physical activity, and

  4. Proposed trial: safety and efficacy of resveratrol for the treatment of non-alcoholic fatty liver disease (NAFLD) and associated insulin resistance in adolescents who are overweight or obese adolescents - rationale and protocol.

    PubMed

    Wicklow, Brandy; Wittmeier, Kristy; T' Jong, Geert W; McGavock, Jonathon; Robert, Marni; Duhamel, Todd; Dolinsky, Vernon W

    2015-10-01

    Non-alcoholic fatty liver (NAFL) disease (NAFLD) affects 30% of overweight adolescents and increases the risk of type 2 diabetes mellitus (T2D). Resveratrol is a naturally occurring compound with potential to reverse NAFL and its associated insulin resistance in adults. The use of resveratrol to reduce risk for T2D through its effect on NAFL has not been examined to date in youth. This paper provides a literature review and protocol for a 30 day proof of principle trial of resveratrol in a population of adolescents at risk for T2D. This randomized double-blind controlled trial is designed with the primary objective of evaluating a twice daily supplementation of 75 mg of resveratrol for safety and tolerability in overweight and obese adolescent subjects (13 to <18 years of age) with NAFL. Secondary objectives are to determine the effect size of the intervention on hepatic steatosis and whole body insulin sensitivity. Adolescents in the intervention arm (n = 10) will receive oral supplementation of resveratrol 75 mg twice daily (with breakfast and dinner) for a total daily dose of 150 mg for the duration of 30 days. The comparison group (n = 10) will receive a placebo twice daily for 30 days. Both cases and controls will receive a standardized lifestyle intervention program. Subjects in both groups will be followed for an additional 30 days post intervention for total study duration of approximately 60 days. Primary outcome measures include a primary side effect profile determined by participant interview, a side effect profile determined by serum biochemistry and vital signs. Secondary outcome measures include an oral glucose tolerance test, liver and cardiac fat content measured by magnetic resonance spectroscopy, anthropometric measures of overweight/obesity, inflammatory markers, and cardiac function and morphology measured with ultrasonography. Additional outcome measures include serum concentrations of resveratrol, compliance to protocol, physical activity, and

  5. A clustered randomised trial examining the effect of social marketing and community mobilisation on the age of uptake and levels of alcohol consumption by Australian adolescents

    PubMed Central

    Rowland, Bosco; Toumbourou, John Winston; Osborn, Amber; Smith, Rachel; Hall, Jessica Kate; Kremer, Peter; Kelly, Adrian B; Williams, Joanne; Leslie, Eva

    2013-01-01

    Introduction Throughout the world, alcohol consumption is common among adolescents. Adolescent alcohol use and misuse have prognostic significance for several adverse long-term outcomes, including alcohol problems, alcohol dependence, school disengagement and illicit drug use. The aim of this study was to evaluate whether randomisation to a community mobilisation and social marketing intervention reduces the proportion of adolescents who initiate alcohol use before the Australian legal age of 18, and the frequency and amount of underage adolescent alcohol consumption. Method and analysis The study comprises 14 communities matched with 14 non-contiguous communities on socioeconomic status (SES), location and size. One of each pair was randomly allocated to the intervention. Baseline levels of adolescent alcohol use were estimated through school surveys initiated in 2006 (N=8500). Community mobilisation and social marketing interventions were initiated in 2011 to reduce underage alcohol supply and demand. The setting is communities in three Australian states (Victoria, Queensland and Western Australia). Students (N=2576) will complete school surveys in year 8 in 2013 (average age 12). Primary outcomes: (1) lifetime initiation and (2) monthly frequency of alcohol use. Reports of social marketing and family and community alcohol supply sources will also be assessed. Point estimates with 95% CIs will be compared for student alcohol use in intervention and control communities. Changes from 2006 to 2013 will be examined; multilevel modelling will assess whether random assignment of communities to the intervention reduced 2013 alcohol use, after accounting for community level differences. Analyses will also assess whether exposure to social marketing activities increased the intervention target of reducing alcohol supply by parents and community members. Trial registration ACTRN12612000384853. PMID:23355674

  6. Using Culturally Sensitive Media Messages to Reduce HIV-associated Sexual Behavior in High-risk African-American Adolescents: Results from a Randomized Trial

    PubMed Central

    Sznitman, Sharon; Vanable, Peter A.; Carey, Michael P.; Hennessy, Michael; Brown, Larry K.; Valois, Robert F.; Stanton, Bonita F.; Salazar, Laura F.; DiClemente, Ralph; Farber, Naomi; Romer, Daniel

    2010-01-01

    Purpose To test the long-term effects of a mass media intervention that used culturally and developmentally appropriate messages to enhance HIV-preventive beliefs and behavior of high-risk African-American adolescents. Methods Television and radio messages were delivered over three years in two cities (Syracuse, NY and Macon, GA) that were randomly selected within each of two regionally matched city pairs with the other cities (Providence, RI and Columbia, SC) serving as controls. African American adolescents ages 14 to 17 (N = 1710), recruited in the four cities over a 16-month period, completed audio computer-assisted self-interviews at recruitment and again at 3, 6, 12 and 18-months post-recruitment to assess the long-term effects of the media program. To identify the unique effects of the media intervention, youth who completed at least one follow-up and who did not test positive for any of three sexually transmitted infections at recruitment or at 6 and 12-month follow-up were retained for analysis (N=1346). Results The media intervention reached virtually all of the adolescents in the trial and produced a range of effects including improved normative condom-use negotiation expectancies and increased sex refusal self-efficacy. Most importantly, older adolescents (ages 16-17) exposed to the media program exhibited a less risky age trajectory of unprotected sex than those in the non-media cities. Conclusions Culturally tailored mass media messages delivered consistently over time have the potential to reach a large audience of high-risk adolescents, to support changes in HIV-preventive beliefs, and to reduce HIV-associated risk behaviors among older youth. PMID:21856515

  7. The Youth-Nominated Support Team-Version II for Suicidal Adolescents: A Randomized Controlled Intervention Trial

    ERIC Educational Resources Information Center

    King, Cheryl A.; Klaus, Nicole; Kramer, Anne; Venkataraman, Sanjeev; Quinlan, Paul; Gillespie, Brenda

    2009-01-01

    The purpose of this study was to examine the efficacy of the Youth-Nominated Support Team-Version II (YST-II) for suicidal adolescents, an intervention based on social support and health behavior models, which was designed to supplement standard treatments. Psychiatrically hospitalized and suicidal adolescents, 13-17 years of age, were randomly…

  8. Multidimensional Family Therapy for Young Adolescent Substance Abuse: Twelve-Month Outcomes of a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Liddle, Howard A.; Rowe, Cynthia L.; Dakof, Gayle A.; Henderson, Craig E.; Greenbaum, Paul E.

    2009-01-01

    Research has established the dangers of early onset substance use for young adolescents and its links to a host of developmental problems. Because critical developmental detours can begin or be exacerbated during early adolescence, specialized interventions that target known risk and protective factors in this period are needed. This controlled…

  9. Computeen: A Randomized Trial of a Preventive Computer and Psychosocial Skills Curriculum for At-Risk Adolescents

    ERIC Educational Resources Information Center

    Lang, Jason M.; Waterman, Jill; Baker, Bruce L.

    2009-01-01

    Computeen, a preventive technology and psychosocial skills development program for at-risk adolescents, was designed to improve computer skills, self-esteem, and school attitudes, and reduce behavior problems, by combining elements of community-based and empirically supported prevention programs. Fifty-five mostly Latino adolescents from 12 to 16…

  10. Randomized Trial of Group Interventions to Reduce HIV/STD Risk and Change Theoretical Mediators among Detained Adolescents

    ERIC Educational Resources Information Center

    Schmiege, Sarah J.; Broaddus, Michelle R.; Levin, Michael; Bryan, Angela D.

    2009-01-01

    Criminally involved adolescents engage in high levels of risky sexual behavior and alcohol use, and alcohol use may contribute to lack of condom use. Detained adolescents (n = 484) were randomized to (1) a theory-based sexual risk reduction intervention (GPI), (2) the GPI condition with a group-based alcohol risk reduction motivational enhancement…

  11. Prevention of Depressive Symptoms in Adolescents: A Randomized Trial of Cognitive-Behavioral and Interpersonal Prevention Programs

    ERIC Educational Resources Information Center

    Horowitz, Jason L.; Garber, Judy; Ciesla, Jeffrey A.; Young, Jami F.; Mufson, Laura

    2007-01-01

    This study evaluated the efficacy of 2 programs for preventing depressive symptoms in adolescents. Participants were 380 high school students randomly assigned to a cognitive-behavioral program (CB), an interpersonal psychotherapy-adolescent skills training program (IPT-AST), or a no-intervention control. The interventions involved eight 90-min…

  12. Increasing Access to Mental Health Care With Breathe, an Internet-Based Program for Anxious Adolescents: Study Protocol for a Pilot Randomized Controlled Trial

    PubMed Central

    Wozney, Lori; Bagnell, Alexa; Fitzpatrick, Eleanor; Curtis, Sarah; Jabbour, Mona; Johnson, David; Rosychuk, Rhonda J; Young, Michael; Ohinmaa, Arto; Joyce, Anthony; McGrath, Patrick

    2016-01-01

    Background There is a demand to make first-line treatments, including cognitive behavioural therapy (CBT) for adolescent anxiety disorders, more widely available. Internet-based CBT is proposed to circumvent access and availability barriers and reduce health care system costs. Recent reviews suggest more evidence is needed to establish the treatment effects of Internet-based CBT in children and adolescents and to determine related economic impacts. Objective This pilot trial aims to collect the necessary data to inform the planning of a full-scale RCT to test the effectiveness of the Internet-based CBT program Breathe (Being Real, Easing Anxiety: Tools Helping Electronically). Methods We are conducting a 27-month, 2-arm parallel-group, pilot randomized controlled trial (RCT). Outcomes will inform the planning of a full-scale RCT aimed to test the effectiveness of Internet-based CBT with a population of adolescents with moderate to mild anxiety problems. In the pilot RCT we will: (1) define a minimal clinically important difference (MCID) for the primary outcome measure (total anxiety score using the Multidimensional Anxiety Scale for Children); (2) determine a sample size for the full-scale RCT; (3) estimate recruitment and retention rates; (4) measure intervention acceptability to inform critical intervention changes; (5) determine the use of co-interventions; and (6) conduct a cost-consequence analysis to inform a cost-effectiveness analysis in the full-scale RCT. Adolescents aged 13-17 years seeking care for an anxiety complaint from a participating emergency department, mobile or school-based crisis team, or primary care clinic are being screened for interest and eligibility. Enrolled adolescents are being randomly allocated to either 8 weeks of Internet-based CBT with limited telephone and e-mail support, or a control group with access to a static webpage listing anxiety resources. Adolescents are randomly assigned using a computer generated allocation

  13. Clinical Trial Participation and Time to Treatment Among Adolescents and Young Adults With Cancer: Does Age at Diagnosis or Insurance Make a Difference?

    PubMed Central

    Parsons, Helen M.; Harlan, Linda C.; Seibel, Nita L.; Stevens, Jennifer L.; Keegan, Theresa H.M.

    2011-01-01

    Purpose Because adolescent and young adult (AYA) patients with cancer have experienced variable improvement in survival over the past two decades, enhancing the quality and timeliness of cancer care in this population has emerged as a priority area. To identify current trends in AYA care, we examined patterns of clinical trial participation, time to treatment, and provider characteristics in a population-based sample of AYA patients with cancer. Methods Using the National Cancer Institute Patterns of Care Study, we used multivariate logistic regression to evaluate demographic and provider characteristics associated with clinical trial enrollment and time to treatment among 1,358 AYA patients with cancer (age 15 to 39 years) identified through the Surveillance, Epidemiology, and End Results Program. Results In our study, 14% of patients age 15 to 39 years had enrolled onto a clinical trial; participation varied by type of cancer, with the highest participation in those diagnosed with acute lymphoblastic leukemia (37%) and sarcoma (32%). Multivariate analyses demonstrated that uninsured, older patients and those treated by nonpediatric oncologists were less likely to enroll onto clinical trials. Median time from pathologic confirmation to first treatment was 3 days, but this varied by race/ethnicity and cancer site. In multivariate analyses, advanced cancer stage and outpatient treatment alone were associated with longer time from pathologic confirmation to treatment. Conclusion Our study identified factors associated with low clinical trial participation in AYA patients with cancer. These findings support the continued need to improve access to clinical trials and innovative treatments for this population, which may ultimately translate into improved survival. PMID:21931022

  14. Effect of School-Based Home-Collaborative Lifestyle Education on Reducing Subjective Psychosomatic Symptoms in Adolescents: A Cluster Randomised Controlled Trial

    PubMed Central

    Watanabe, Junko; Watanabe, Mariko; Yamaoka, Kazue; Adachi, Misa; Nemoto, Asuka; Tango, Toshiro

    2016-01-01

    In this study, we aimed to assess the effectiveness of a school-based home-collaborative lifestyle education program for adolescents (PADOK) in reducing poor subjective psychosomatic symptoms (SPS). The study was designed as a two-armed parallel cluster randomised controlled trial and the study population comprised adolescent students (aged 12–14 years, n = 1,565) who were recruited from 19 middle schools in Japan. The PADOK intervention or usual school programme was provided in schools to all eligible participants. The primary outcome was the SPS score at 6 months, while secondary outcomes included lifestyle factors, BMI, and dietary intakes. Analyses were undertaken on an intention to treat (ITT) basis accounting for the clustered design. Nineteen schools were randomised to the PADOK group (10 schools) and control group (9 schools). The numbers of students used for analysis were 1,509 for ITT and 1,420 (94.1%) for PPS. At 6 months, the crude mean change from baseline of the SPS scores by ITT analysis showed a significantly greater reduction in the PADOK group compared to that in the control group (−0.95, 95% CI −1.70 to −0.20, P = 0.016), while those for baseline-adjusted and multivariate-adjusted values showed similar directionality but were not significant (P = 0.063 and P = 0.130). The results indicated that the PADOK program may improve poor SPS scores among adolescents. PMID:27780251

  15. Effects of psyllium on LDL-cholesterol concentrations in Brazilian children and adolescents: a randomised, placebo-controlled, parallel clinical trial.

    PubMed

    Ribas, Simone Augusta; Cunha, Diana Barbosa; Sichieri, Rosely; Santana da Silva, Luiz Carlos

    2015-01-14

    The present study investigated the LDL-cholesterol (LDL-C)-lowering effects of psyllium in Brazilian dyslipidaemic children and adolescents. A total of fifty-one individuals (6-19 years) with mild-to-moderate hypercholesterolaemia were evaluated by conducting a randomised, double-blind, placebo-controlled, parallel clinical trial. Over an 8-week trial period, the participants were randomly allocated to one of two groups (control: n 25 and psyllium: n 26) using a computer-generated random number sequence. Fasting blood samples, dietary records and anthropometric data were collected. Both groups were treated with the National Cholesterol Education Program Step 2 diet for 6 weeks before randomisation. After this run-in period, a daily supplement of 7·0 g psyllium was given to the intervention group, while an equivalent amount of cellulose was given to the control group. Statistically significant changes between the control and intervention groups over time were observed for total cholesterol (7·7%; - 0·39 mmol/l; P= 0·003) and LDL-C (10·7%; - 0·36 mmol/l; P= 0·01). None of the participants reported any aversion to the smell, taste, appearance or texture of psyllium. No serious adverse effects were reported during the study. In addition to causing a significant reduction in LDL-C concentrations, psyllium therapy was found to be both safe and acceptable for the treatment of hypercholesterolaemic children and adolescents.

  16. A randomised placebo-exercise controlled trial of Kung Fu training for improvements in body composition in overweight/obese adolescents: the “Martial Fitness” study

    PubMed Central

    Tsang, Tracey W.; Kohn, Michael; Chow, Chin Moi; Singh, M Fiatarone

    2009-01-01

    The purpose of the study was to investigate if Chinese martial arts (Kung Fu, KF) might be effective for improving body composition, as well as being an appealing form of physical activity for inexperienced, sedentary, overweight/obese adolescents. Twenty subjects (age: 13.3 ± 1.8 y; BMI percentile: 98.6(86.5 - 99.8); 60% girls) were randomly-assigned to the supervised KF or placebo (Tai Chi, TC) control group 3 d.wk-1 for 6 months. We assessed body composition, including total and regional fat and lean mass, total and regional bone mineral density (BMD), percent lean and fat mass, body mass index and waist circumference, at baseline and after 6 months of training using anthropometry and dual-energy X-ray absorptiometry (DXA). Habitual physical activity and dietary intake were recorded as covariates via self-report at each time-point. As expected due to natural growth, significant increases in height, weight, total and lumbar BMD, and lean mass were seen in the cohort over time, with a trend for increased whole body fat mass, with no difference between groups. By contrast, percent fat and android fat mass via DXA did not increase in either group over time. The absence of a similar expected increase in central adiposity over 6 months could indicate a positive effect of participation in both programs on the metabolically critical abdominal adiposity in this cohort. Further research in this area is warranted to determine ways to increase uptake and compliance, and to see if longer-term martial arts training not only maintains, but improves abdominal fat mass and related metabolic health indices in overweight/ obese adolescents. Key points Participation in our martial arts trial attenuated the increases in body fat mass expected due to growth in our overweight/obese adolescent group. All subjects allocated to the Kung Fu intervention were satisfied with their Kung Fu training, in contrast to our placebo-exercise (Tai Chi) subjects, suggesting that this form of

  17. A randomised placebo-exercise controlled trial of Kung Fu training for improvements in body composition in overweight/obese adolescents: the "Martial Fitness" study.

    PubMed

    Tsang, Tracey W; Kohn, Michael; Chow, Chin Moi; Singh, M Fiatarone

    2009-01-01

    The purpose of the study was to investigate if Chinese martial arts (Kung Fu, KF) might be effective for improving body composition, as well as being an appealing form of physical activity for inexperienced, sedentary, overweight/obese adolescents. Twenty subjects (age: 13.3 ± 1.8 y; BMI percentile: 98.6(86.5 - 99.8); 60% girls) were randomly-assigned to the supervised KF or placebo (Tai Chi, TC) control group 3 d.wk(-1) for 6 months. We assessed body composition, including total and regional fat and lean mass, total and regional bone mineral density (BMD), percent lean and fat mass, body mass index and waist circumference, at baseline and after 6 months of training using anthropometry and dual-energy X-ray absorptiometry (DXA). Habitual physical activity and dietary intake were recorded as covariates via self-report at each time-point. As expected due to natural growth, significant increases in height, weight, total and lumbar BMD, and lean mass were seen in the cohort over time, with a trend for increased whole body fat mass, with no difference between groups. By contrast, percent fat and android fat mass via DXA did not increase in either group over time. The absence of a similar expected increase in central adiposity over 6 months could indicate a positive effect of participation in both programs on the metabolically critical abdominal adiposity in this cohort. Further research in this area is warranted to determine ways to increase uptake and compliance, and to see if longer-term martial arts training not only maintains, but improves abdominal fat mass and related metabolic health indices in overweight/ obese adolescents. Key pointsParticipation in our martial arts trial attenuated the increases in body fat mass expected due to growth in our overweight/obese adolescent group.All subjects allocated to the Kung Fu intervention were satisfied with their Kung Fu training, in contrast to our placebo-exercise (Tai Chi) subjects, suggesting that this form of

  18. Comparative efficacy, acceptability, and tolerability of dexmethylphenidate versus placebo in child and adolescent ADHD: a meta-analysis of randomized controlled trials

    PubMed Central

    Maneeton, Narong; Maneeton, Benchalak; Woottiluk, Pakapan; Suttajit, Sirijit; Likhitsathian, Surinporn; Charnsil, Chawanun; Srisurapanont, Manit

    2015-01-01

    Background The efficacy of dexmethylphenidate (d-MPH) has been proven in the treatment of children and adolescents with attention-deficit hyperactivity disorder (ADHD). Objective The aim of this systematic review is to determine the efficacy, acceptability, and tolerability of d-MPH in child and adolescent ADHD. Methods The searches of SCOPUS, MEDLINE, CINAHL, and Cochrane Controlled Trials Register were performed in February 2015. All randomized controlled trials of d-MPH versus placebo that were performed in children and adolescents with ADHD up to 18 years of age were included in the study. The efficacy was measured by using the pooled mean-endpoint or mean-changed scores of ADHD rating scales and the response rate. Acceptability and tolerability were measured by using the pooled rates of overall discontinuation and discontinuation due to adverse events, respectively. Results A total of 1,124 children and adolescents diagnosed as having ADHD were included in this review. In a laboratory school setting, the pooled mean-change and mean-endpoint scores in the d-MPH-treated group were significantly greater than those of the placebo-treated group with standardized mean difference (95% confidence interval [CI]) of −1.20 (−1.73, −0.67), I2=95%. Additionally, the pooled mean-changed scores of the ADHD rating scales for teachers and parents in the d-MPH-treated group were significantly greater than that of the placebo-treated group with weighted mean difference (95% CI) of −13.01 (−15.97, −10.05), I2=0% and (95% CI) of −12.99 (−15.57, −10.42), I2=0%, respectively. The pooled response rate in the d-MPH-treated groups had a significance higher than that of the placebo-treated group. The rates of pooled overall discontinuation and discontinuation due to adverse events between the two groups were not significantly different. Conclusion Based on the findings in this review, it can be concluded that d-MPH medication is efficacious and tolerable in child and

  19. Effect of Combining Therapy with Traditional Chinese Medicine-Based Psychotherapy and Herbal Medicines in Women with Menopausal Syndrome: A Randomized Controlled Clinical Trial

    PubMed Central

    Yang, Hongyan; Yang, Jing; Wen, Zehuai; Zha, Qinglin; Nie, Guangning; Huang, Xuchun; Zhang, Chunlin; Lu, Aiping; Jiang, Miao; Wang, Xiaoyun

    2012-01-01

    This multicenter, randomized, controlled clinical study was designed to address the effectiveness of combined traditional-Chinese-medicine- (TCM-) based psychotherapy and Chinese herbal medicine (CHM) in the treatment of menopausal syndrome. Altogether 424 eligible women diagnosed as menopausal syndrome and categorized as Kidney-Yin/Kidney-Yang deficiency pattern in TCM were randomly assigned into 4 groups and accepted TCM-based psychotherapy (PSY), CHM, PSY + CHM, or placebo therapies, respectively, for 12 weeks, and another 12 weeks were taken as the followup. Kupperman Index (KI) and the Menopause-Specific Quality of Life (MENQOL) with its four subscales (vasomotor, physical, psychosocial, and sexual) were employed for efficacy assessment. Results showed that 400 participants completed 12-week treatment, of which 380 finished the record of KI and MENQOF at week 24. The average adjusted number of KI score decreased between baseline and 12 weeks in all groups. Statistically significant differences were detected in the average adjusted change between the PSY + CHM group and placebo at overall time points (P < 0.05). No severe adverse events occurred in each group and no significant differences were indicated between any of the three groups and placebo in adverse event proportion. We concluded that TCM psychotherapy combined with CHM has a favorable outcome in treating menopausal syndrome. PMID:23304198

  20. Effectiveness of a Web-Based Screening and Fully Automated Brief Motivational Intervention for Adolescent Substance Use: A Randomized Controlled Trial

    PubMed Central

    Elgán, Tobias H; De Paepe, Nina; Tønnesen, Hanne; Csémy, Ladislav; Thomasius, Rainer

    2016-01-01

    Background Mid-to-late adolescence is a critical period for initiation of alcohol and drug problems, which can be reduced by targeted brief motivational interventions. Web-based brief interventions have advantages in terms of acceptability and accessibility and have shown significant reductions of substance use among college students. However, the evidence is sparse among adolescents with at-risk use of alcohol and other drugs. Objective This study evaluated the effectiveness of a targeted and fully automated Web-based brief motivational intervention with no face-to-face components on substance use among adolescents screened for at-risk substance use in four European countries. Methods In an open-access, purely Web-based randomized controlled trial, a convenience sample of adolescents aged 16-18 years from Sweden, Germany, Belgium, and the Czech Republic was recruited using online and offline methods and screened online for at-risk substance use using the CRAFFT (Car, Relax, Alone, Forget, Friends, Trouble) screening instrument. Participants were randomized to a single session brief motivational intervention group or an assessment-only control group but not blinded. Primary outcome was differences in past month drinking measured by a self-reported AUDIT-C-based index score for drinking frequency, quantity, and frequency of binge drinking with measures collected online at baseline and after 3 months. Secondary outcomes were the AUDIT-C-based separate drinking indicators, illegal drug use, and polydrug use. All outcome analyses were conducted with and without Expectation Maximization (EM) imputation of missing follow-up data. Results In total, 2673 adolescents were screened and 1449 (54.2%) participants were randomized to the intervention or control group. After 3 months, 211 adolescents (14.5%) provided follow-up data. Compared to the control group, results from linear mixed models revealed significant reductions in self-reported past-month drinking in favor of the

  1. Exercise and BMI z-score in overweight and obese children and adolescents: protocol for a systematic review and network meta-analysis of randomised trials

    PubMed Central

    Kelley, George A; Kelley, Kristi S

    2016-01-01

    Introduction While overweight and obesity in children and adolescents is a major global health problem, the effects of exercise on overweight and obesity in children and adolescents are not well established despite numerous studies on this topic. The purpose of this study is to use the network meta-analytic approach to determine the effects of exercise (aerobic, strength training or both) on body mass index (BMI) z-score in overweight and obese children and adolescents. Methods and analysis Randomised exercise intervention trials >4 weeks, published in any language between 1 January 1990 and 31 September 2015, and which include direct and/or indirect evidence, will be included. Studies will be retrieved by searching 6 electronic databases, cross-referencing and expert review. Dual abstraction of data will occur. The primary outcome will be changes in BMI z-score while the secondary outcome will be changes in body weight in kilograms (kg). Risk of bias will be assessed using the Cochrane risk of bias assessment instrument while confidence in the cumulative evidence will be assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) instrument for network meta-analysis. Network meta-analysis will be performed using multivariate random-effects meta-regression models. The surface under the cumulative ranking curve will be used to provide a hierarchy of exercise treatments (aerobic, strength training or both). Dissemination The results of this study will be presented at a professional conference and published in a peer-reviewed journal. Trial registration number CRD42015026377. PMID:27084289

  2. Group Therapy for Repeated Deliberate Self-Harm in Adolescents: Failure of Replication of a Randomized Trial

    ERIC Educational Resources Information Center

    Hazell, Philip L.; Martin, Graham; McGill, Katherine; Kay, Tracey; Wood, Alison; Trainor, Gemma; Harrington, Richard

    2009-01-01

    A study revealing the superiority of group therapy to routine care in preventing the recurrence of self-harming behavior among adolescents is unsuccessfully replicated. The study's findings contradicted those of the original study.

  3. The SHAZ! Project: Results from a Pilot Randomized Trial of a Structural Intervention to Prevent HIV among Adolescent Women in Zimbabwe

    PubMed Central

    Dunbar, Megan S.; Kang Dufour, Mi-Suk; Lambdin, Barrot; Mudekunye-Mahaka, Imelda; Nhamo, Definate; Padian, Nancy S.

    2014-01-01

    Adolescent females in Zimbabwe are at high risk for HIV acquisition. Shaping the Health of Adolescents in Zimbabwe (SHAZ!) was a randomized controlled trial of a combined intervention package including life-skills and health education, vocational training, micro-grants and social supports compared to life-skills and health education alone. SHAZ! was originally envisioned as a larger effectiveness trial, however, the intervention was scaled back due to contextual and economic conditions in the country at the time. SHAZ! enrolled 315 participants randomly assigned to study arm within blocks of 50 participants (158 intervention and 157 control). The intervention arm participants showed statistically significant differences from the control arm participants for several outcomes during the two years of follow up including; reduced food insecurity [IOR = 0.83 vs. COR = 0.68, p-0.02], and having their own income [IOR = 2.05 vs. COR = 1.67, p = 0.02]. Additionally, within the Intervention arm there was a lower risk of transactional sex [IOR = 0.64, 95% CI (0.50, 0.83)], and a higher likelihood of using a condom with their current partner [IOR = 1.79, 95% CI (1.23, 2.62)] over time compared to baseline. There was also evidence of fewer unintended pregnancies among intervention participants [HR = 0.61, 95% CI (0.37, 1.01)], although this relationship achieved only marginal statistical significance. Several important challenges in this study included the coordination with vocational training programs, the political and economic instability of the area at the time of the study, and the difficulty in creating a true standard of care control arm. Overall the results of the SHAZ! study suggest important potential for HIV prevention intervention packages that include vocational training and micro-grants, and lessons for further economic livelihoods interventions with adolescent females. Further work is needed to refine the intervention model, and

  4. An Independent Randomized Clinical Trial of Multisystemic Therapy with Non-Court-Referred Adolescents with Serious Conduct Problems

    PubMed Central

    Weiss, Bahr; Han, Susan; Harris, Vicki; Catron, Tom; Ngo, Victoria K.; Caron, Annalise; Gallop, Robert; Guth, Carol

    2013-01-01

    Objective Adolescent conduct problems exact serious social as well as personal costs, and effective treatments are essential. One of the most widely disseminated and effective programs for the treatment of serious conduct problems in adolescents is Multisystemic Therapy (MST). However, most evaluations of MST have involved the developers of MST. The purpose of the present study was to conduct an independent evaluation of MST, with non-court-referred adolescents with conduct problems. Method Participants were 164 adolescents aged 11 to 18 years who were recruited from self-contained behavior intervention classrooms in public schools. Adolescents and their families were randomly assigned to receive MST or services as usual. Outcome measures assessed conduct problems, school functioning, and court records of criminal behavior. Participants were followed for 18 months after baseline using parent, adolescent, and teacher reports; arrest data were collected for 2.5 years post-baseline. Results Two of four primary outcome measures focused on externalizing problems showed significant treatment effects favoring MST. Several secondary and intervention targets pertaining to family functioning and parent psychopathology showed positive effects of MST, and no negative effects were identified. Conclusions Results provide some further support for the effectiveness of MST, although smaller effect sizes than previous studies also suggest the complexity of successful dissemination, particularly to non-court-referred populations. PMID:23937347

  5. Lumbar manipulation and exercise for the treatment of acute low back pain in adolescents: a randomized controlled trial

    PubMed Central

    Selhorst, Brittany

    2015-01-01

    Objectives Low back pain (LBP) is a common condition in adolescents. Although much has been written about the efficacy of lumbar manipulation for adults with LBP, little is known about its effectiveness in adolescents. This study had two primary aims: (1) to assess the efficacy of adding lumbar manipulation to an exercise program in adolescents with acute (<90 days) LBP and (2) to report and assess any adverse reactions associated with lumbar manipulation noted in this study. Methods Patients were randomly assigned to receive lumbar manipulation or sham manipulation. All patients performed 4 weeks of physical therapy exercise. Pain, patient-specific functional scale (PSFS), and global rating of change (GROC) scores were measured at evaluation, 1 week, 4 weeks, and 6 months. Relative risk was calculated for adverse reactions noted. Results We recruited 35 consecutive patients with acute LBP. One patient was excluded after being diagnosed with a spondylolysis, 34 patients remained for analysis. Both groups experienced significant improvement over time in all measures. There were no differences between groups for pain, PSFS, or GROC scores. No increased risk of adverse reaction from lumbar manipulation was noted. Discussion The addition of lumbar manipulation to exercise did not benefit adolescents with acute LBP. There was not an increased risk of an adverse reaction noted in this study from lumbar manipulation performed on adolescents. Further research needs to be done to identify factors that predict positive outcomes following lumbar manipulation in adolescents. PMID:26917941

  6. Randomized controlled trial of motivational enhancement therapy with nontreatment-seeking adolescent cannabis users: a further test of the teen marijuana check-up.

    PubMed

    Walker, Denise D; Stephens, Robert; Roffman, Roger; Demarce, Josephine; Lozano, Brian; Towe, Sheri; Berg, Belinda

    2011-09-01

    Cannabis use adversely affects adolescents and interventions that are attractive to adolescents are needed. This trial compared the effects of a brief motivational intervention for cannabis use with a brief educational feedback control and a no-assessment control. Participants were randomized into one of three treatment conditions: Motivational Enhancement Therapy (MET), Educational Feedback Control (EFC), or Delayed Feedback Control (DFC). Those who were assigned to MET and EFC were administered a computerized baseline assessment immediately following randomization and completed assessments at the 3- and 12-month follow-up periods. Participants in the DFC condition were not assessed until the 3-month follow-up. Following the completion of treatment sessions, all participants were offered up to four optional individual treatment sessions aimed at cessation of cannabis use. The research was conducted in high schools in Seattle, Washington. The participant s included 310 self-referred adolescents who smoked cannabis regularly. The main outcome measures included days of cannabis use, associated negative consequences, and engagement in additional treatment. At the 3-month follow-up, participants in both the MET and EFC conditions reported significantly fewer days of cannabis use and negative consequences compared to those in the DFC. The frequency of cannabis use was less in MET relative to EFC at 3 months, but it did not translate to differences in negative consequences. Reductions in use and problems were sustained at 12 months, but there were no differences between MET and EFC interventions. Engagement in additional treatment was minimal and did not differ by condition. Brief interventions can attract adolescent cannabis users and have positive impacts on them, but the mechanisms of the effects are yet to be identified.

  7. The Efficacy of Two Adolescent Substance Abuse Treatments and the Impact of Comorbid Depression: Results of a Small Randomized Controlled Trial

    PubMed Central

    Santisteban, Daniel A.; Mena, Maite P.; Muir, Joan; McCabe, Brian E.; Abalo, Clara; Cummings, Amanda M.

    2016-01-01

    Objective The purpose of this randomized trial was to investigate the efficacy of two behavioral treatments focusing on different change mechanisms in ameliorating a borderline personality disorder constellation of behaviors and substance use in adolescents referred by juvenile diversion programs. Methods Forty adolescents 14 to 17 years of age and meeting DSM IV criteria for borderline personality disorder and substance use disorders were randomized to Integrative Borderline Personality Disorder-Oriented Adolescent Family Therapy (I-BAFT) or Individual Drug Counseling (IDC). This design allowed a comparison of two manualized interventions, one family-based and one individually-oriented. Profiles of clinical change were used to detect impact and to estimate treatment effect sizes. Results Primary analyses showed that both interventions had a clinically significant impact on borderline personality disorder behaviors 12 months after baseline but with no differential treatment effects. The impact on substance use was more complex. Subgroup analyses revealed that adolescents with depression had significantly more severe profiles of borderline personality disorder and substance use. These youth were the only group to show reductions in substance use, but only if they received the I-BAFT intervention. Study data also documented the high dosage of intensive residential treatment needed by this population. Conclusions and Implications for Practice Results highlight the intensive treatment needs of juvenile justice involved youth with co-occurring substance use and borderline personality disorder including depression, the hybrid outpatient and residential treatment often required by this population, and the promise of a family oriented approach particularly for youth with severe symptoms and co-occurring depression. PMID:25799306

  8. The Impact of a Low Glycemic Index Diet on Inflammatory Markers and Serum Adiponectin Concentration in Adolescent Overweight and Obese Girls: A Randomized Clinical Trial.

    PubMed

    Rouhani, M H; Kelishadi, R; Hashemipour, M; Esmaillzadeh, A; Surkan, P J; Keshavarz, A; Azadbakht, L

    2016-04-01

    Although the effects of dietary glycemic index (GI) on insulin resistance are well documented in adults, the complex interaction among glucose intolerance, inflammatory markers, and adipokine concentration has not been well studied, especially among adolescents. We investigated the effect of a low glycemic index (LGI) diet on insulin concentration, fasting blood sugar (FBS), inflammatory markers, and serum adiponectin concentration among healthy obese/overweight adolescent females. In this parallel randomized clinical trial, 2 different diets, an LGI diet and a healthy nutritional recommendation diet (HNRD) with similar macronutrient composition were prescribed to 50 obese and overweight adolescent girls with the same pubertal status. Biochemical markers FBS, serum insulin concentration, high sensitivity C-reactive protein (hs-CRP), interleukin 6 (IL-6), and adiponectin were measured before and after a 10 week intervention. Using an intention-to-treat analysis, data from 50 subjects were analyzed. According to a dietary assessment, GI in the LGI group was 43.22±0.54. While the mean for FBS, serum insulin concentration, the homeostasis model assessment (HOMA), the quantitative insulin sensitivity check index (QUICKI), and adiponectin concentration did not differ significantly within each group, the average hs-CRP and IL-6 decreased significantly in the LGI diet group after the 10 week intervention (p=0.009 and p=0.001; respectively). Comparing percent changes, we found a marginally significant decrease in hs-CRP in the LGI group compared with the HNRD group after adjusting for confounders. Compliance with an LGI diet may have favorable effect on inflammation among overweight and obese adolescent girls. PMID:27065462

  9. A Randomized Controlled Trial of Two Different Macronutrient Profiles on Weight, Body Composition and Metabolic Parameters in Obese Adolescents Seeking Weight Loss

    PubMed Central

    Jensen, Diane E.; Daniels, Lynne; Davies, Peter S. W.; Barrett, Paula; Blumfield, Michelle L.

    2016-01-01

    Objective Adolescent obesity is difficult to treat and the optimal dietary pattern, particularly in relation to macronutrient composition, remains controversial. This study tested the effect of two structured diets with differing macronutrient composition versus control, on weight, body composition and metabolic parameters in obese adolescents. Design A randomized controlled trial conducted in a children’s hospital. Methods Eighty seven obese youth (means: age 13.6 years, BMI z-score 2.2, waist: height ratio 0.65, 69% female) completed a psychological preparedness program and were then randomized to a short term ‘structured modified carbohydrate’ (SMC, 35% carbohydrate; 30% protein; 35% fat, n = 37) or a ‘structured low fat’ (SLF, 55% carbohydrate; 20% protein; 25% fat, n = 36) or a wait listed control group (n = 14). Anthropometric, body composition and biochemical parameters were measured at randomization and after 12 weeks, and analyzed under the intention to treat principle using analysis of variance models. Results After 12 weeks, data was collected from 79 (91%) participants. BMI z-scores were significantly lower in both intervention groups compared to control after adjusting for baseline values, SLF vs. control, mean difference = -0.13 (95%CI = -0.18, -0.07), P<0.001; SMC vs. control, -0.14 (-0.19, -0.09), P<0.001, but there was no difference between the two intervention diet groups: SLF vs. SMC, 0.00 (-0.05, 0.04), P = 0.83. Conclusions Both dietary patterns resulted in similar changes in weight, body composition and metabolic improvements compared to control. The use of a structured eating system which allows flexibility but limited choices can assist in weight change and the rigid application of a low fat eating pattern is not exclusive in its efficacy. Trial Registration International Clinical Trials Registry ISRCTN49438757 PMID:27022913

  10. Evaluation of effect of low-level laser therapy on adolescents with temporomandibular disorder: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background A number of problems involving the temporomandibular joint (TMJ) and associated structures can lead to temporomandibular disorder (TMD). The aim of the proposed study is to assess the effect of low-level laser therapy on occlusal contacts, mandibular movements, electromyography activity in the muscles of mastication and pain in adolescents with TMD. Methods/Design A randomized, controlled, double-blind, clinical trial will be carried out involving 85 male and female adolescents between 15 and 18 years of age. The research diagnostic criteria for TMD will be used to assess all individuals who agree to participate. All participants will be submitted to a clinical examination and electromyographic analysis of the masseter muscles and anterior bundle of the temporal muscles bilaterally, to determine TMD. Based on the clinical findings, the participants will be classified as having or not having TMD. Those with TMD will be divided into four groups, three of which will receive low-level laser therapy and one of which will receive a placebo treatment. The treatments will involve the TMJ region alone, the masseter and temporal muscles alone, or both these regions together. The data will be submitted to descriptive statistical analysis. The chi-square test and Fisher’s exact test will be used to determine associations among the categorical variables. The Student’s t test and analysis of variance will be used for the comparison of mean electromyographic signals. Pearson’s correlation coefficients will be calculated for the analysis of correlations among the continuous variables. Trial registration The protocol for this study has been submitted to Clinical Trials – registration number (NCT01846000). PMID:23876095

  11. The Nutrition and Enjoyable Activity for Teen Girls (NEAT girls) randomized controlled trial for adolescent girls from disadvantaged secondary schools: rationale, study protocol, and baseline results

    PubMed Central

    2010-01-01

    Background Child and adolescent obesity predisposes individuals to an increased risk of morbidity and mortality from a range of lifestyle diseases. Although there is some evidence to suggest that rates of pediatric obesity have leveled off in recent years, this has not been the case among youth from low socioeconomic backgrounds. The purpose of this paper is to report the rationale, study design and baseline findings of a school-based obesity prevention program for low-active adolescent girls from disadvantaged secondary schools. Methods/Design The Nutrition and Enjoyable Activity for Teen Girls (NEAT Girls) intervention will be evaluated using a group randomized controlled trial. NEAT Girls is a 12-month multi-component school-based intervention developed in reference to Social Cognitive Theory and includes enhanced school sport sessions, interactive seminars, nutrition workshops, lunch-time physical activity (PA) sessions, PA and nutrition handbooks, parent newsletters, pedometers for self-monitoring and text messaging for social support. The following variables were assessed at baseline and will be completed again at 12- and 24-months: adiposity, objectively measured PA, muscular fitness, time spent in sedentary behaviors, dietary intake, PA and nutrition social-cognitive mediators, physical self-perception and global self-esteem. Statistical analyses will follow intention-to-treat principles and hypothesized mediators of PA and nutrition behavior change will be explored. Discussion NEAT Girls is an innovative intervention targeting low-active girls using evidence-based behavior change strategies and nutrition and PA messages and has the potential to prevent unhealthy weight gain and reduce the decline in physical activity and poor dietary habits associated with low socio-economic status. Few studies have reported the long-term effects of school-based obesity prevention programs and the current study has the potential to make an important contribution to the

  12. Effectiveness of a School-Based Physical Activity Intervention on Cognitive Performance in Danish Adolescents: LCoMotion—Learning, Cognition and Motion – A Cluster Randomized Controlled Trial

    PubMed Central

    Domazet, Sidsel Louise; Froberg, Karsten; Hillman, Charles H.; Andersen, Lars Bo; Bugge, Anna

    2016-01-01

    Background Physical activity is associated not only with health-related parameters, but also with cognitive and academic performance. However, no large scale school-based physical activity interventions have investigated effects on cognitive performance in adolescents. The aim of this study was to describe the effectiveness of a school-based physical activity intervention in enhancing cognitive performance in 12–14 years old adolescents. Methods A 20 week cluster randomized controlled trial was conducted including seven intervention and seven control schools. A total of 632 students (mean (SD) age: 12.9 (0.6) years) completed the trial with baseline and follow-up data on primary or secondary outcomes (74% of randomized subjects). The intervention targeted physical activity during academic subjects, recess, school transportation and leisure-time. Cognitive performance was assessed using an executive functions test of inhibition (flanker task) with the primary outcomes being accuracy and reaction time on congruent and incongruent trials. Secondary outcomes included mathematics performance, physical activity levels, body-mass index, waist-circumference and cardiorespiratory fitness. Results No significant difference in change, comparing the intervention group to the control group, was observed on the primary outcomes (p’s>0.05) or mathematics skills (p>0.05). An intervention effect was found for cardiorespiratory fitness in girls (21 meters (95% CI: 4.4–38.6) and body-mass index in boys (-0.22 kg/m2 (95% CI: -0.39–0.05). Contrary to our predictions, a significantly larger change in interference control for reaction time was found in favor of the control group (5.0 milliseconds (95% CI: 0–9). Baseline to mid-intervention changes in physical activity levels did not differ significantly between groups (all p’s>0.05). Conclusions No evidence was found for effectiveness of a 20-week multi-faceted school-based physical activity intervention for enhancing

  13. An embedded longitudinal multi-faceted qualitative evaluation of a complex cluster randomized controlled trial aiming to reduce clinically important errors in medicines management in general practice

    PubMed Central

    2012-01-01

    Background There is a need to shed light on the pathways through which complex interventions mediate their effects in order to enable critical reflection on their transferability. We sought to explore and understand key stakeholder accounts of the acceptability, likely impact and strategies for optimizing and rolling-out a successful pharmacist-led information technology-enabled (PINCER) intervention, which substantially reduced the risk of clinically important errors in medicines management in primary care. Methods Data were collected at two geographical locations in central England through a combination of one-to-one longitudinal semi-structured telephone interviews (one at the beginning of the trial and another when the trial was well underway), relevant documents, and focus group discussions following delivery of the PINCER intervention. Participants included PINCER pharmacists, general practice staff, researchers involved in the running of the trial, and primary care trust staff. PINCER pharmacists were interviewed at three different time-points during the delivery of the PINCER intervention. Analysis was thematic with diffusion of innovation theory providing a theoretical framework. Results We conducted 52 semi-structured telephone interviews and six focus group discussions with 30 additional participants. In addition, documentary data were collected from six pharmacist diaries, along with notes from four meetings of the PINCER pharmacists and feedback meetings from 34 practices. Key findings that helped to explain the success of the PINCER intervention included the perceived importance of focusing on prescribing errors to all stakeholders, and the credibility and appropriateness of a pharmacist-led intervention to address these shortcomings. Central to this was the face-to-face contact and relationship building between pharmacists and a range of practice staff, and pharmacists’ explicitly designated role as a change agent. However, important concerns were

  14. The Youth-Nominated Support Team for Suicidal Adolescents – Version II: A Randomized Controlled Intervention Trial

    PubMed Central

    King, Cheryl A.; Klaus, Nicole; Kramer, Anne; Venkataraman, Sanjeev; Quinlan, Paul; Gillespie, Brenda

    2010-01-01

    The purpose of this study was to examine the efficacy of the Youth-Nominated Support Team – Version II (YST-II) for suicidal adolescents, an intervention based on social support and health behavior models, which was designed to supplement standard treatments. Psychiatrically hospitalized and suicidal adolescents, ages 13 to 17 years, were randomly assigned to treatment-as-usual (TAU) plus YST-II (n = 223) or TAU only (n = 225). YST-II provided tailored psychoeducation to youth-nominated adults in addition to weekly check-ins for three months following hospitalization. In turn, these adults had regular supportive contact with adolescents. Adolescents assigned to TAU+YST-II had an average of 3.43 (SD = .83) nominated adults. Measures included the Suicidal Ideation Questionnaire-JR (SIQ-JR), Children's Depression Rating Scale-Revised (CDRS-R), Beck Hopelessness Scale (BHS), and Child and Adolescent Functional Assessment Scale (CAFAS). YST-II had very limited positive effects, which were moderated by history of multiple suicide attempts, and no negative effects. It resulted in more rapid decreases in suicidal ideation (SIQ-JR) for multiple suicide attempters during the initial 6 weeks after hospitalization (small – moderate effect size). For non-multiple attempters, it was associated with greater declines in functional impairment (CAFAS) at 3- and 12-months (small effect sizes). YST-II had no effects on suicide attempts, and no enduring effects on SIQ-JR scores. PMID:19803568

  15. Developmentally adapted cognitive processing therapy for adolescents and young adults with PTSD symptoms after physical and sexual abuse: study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Although childhood sexual and/or physical abuse (CSA/CPA) is known to have severe psychopathological consequences, there is little evidence on psychotherapeutic interventions for adolescents and young adults suffering from post-traumatic stress disorder (PTSD). Equally sparse are data on moderators of treatment response on PTSD-related epigenetic changes, health care costs and loss of productivity, alterations in cognitive processing, and on how successful interventions affect all of these factors. Early treatment may prevent later (co)morbidity. In this paper, we present a study protocol for the evaluation of a newly developed psychotherapeutic manual for PTSD after CSA/CPA in adolescents and young adults – the Developmentally Adapted Cognitive Processing Therapy (D-CPT). Methods/design In a multicenter randomized controlled trial (RCT) D-CPT is compared to treatment as usual (TAU). A sample of 90 adolescent outpatients aged 14 to 21 years will be randomized to one of these conditions. Four assessments will be carried out at baseline, at end of treatment, and 3 and 6 months after end of therapy. Each time, patients will be assessed via clinical interviews and a wide range of questionnaires. In addition to PTSD symptoms and comorbidities, we will evaluate moderators of treatment response, epigenetic profiles, direct and indirect costs of this disorder, and neurophysiological processing of threat cues in PTSD and their respective changes in the course of these two treatments (D-CPT and TAU). Discussion The study will provide new insights in the understudied field of PTSD in adolescents and young adults. A newly developed intervention will be evaluated in this therapeutically underserved population. Results will provide data on treatment efficacy, direct and indirect treatment costs, as well as on associations of treatment outcome and PTSD intensity both to epigenetic profiles and to the neurobiological processing of threat cues. Besides, they will

  16. Improving mood with psychoanalytic and cognitive therapies (IMPACT): a pragmatic effectiveness superiority trial to investigate whether specialised psychological treatment reduces the risk for relapse in adolescents with moderate to severe unipolar depression: study protocol for a randomised controlled trial

    PubMed Central

    2011-01-01

    Background Up to 70% of adolescents with moderate to severe unipolar major depression respond to psychological treatment plus Fluoxetine (20-50 mg) with symptom reduction and improved social function reported by 24 weeks after beginning treatment. Around 20% of non responders appear treatment resistant and 30% of responders relapse within 2 years. The specific efficacy of different psychological therapies and the moderators and mediators that influence risk for relapse are unclear. The cost-effectiveness and safety of psychological treatments remain poorly evaluated. Methods/Design Improving Mood with Psychoanalytic and Cognitive Therapies, the IMPACT Study, will determine whether Cognitive Behavioural Therapy or Short Term Psychoanalytic Therapy is superior in reducing relapse compared with Specialist Clinical Care. The study is a multicentre pragmatic effectiveness superiority randomised clinical trial: Cognitive Behavioural Therapy consists of 20 sessions over 30 weeks, Short Term Psychoanalytic Psychotherapy 30 sessions over 30 weeks and Specialist Clinical Care 12 sessions over 20 weeks. We will recruit 540 patients with 180 randomised to each arm. Patients will be reassessed at 6, 12, 36, 52 and 86 weeks. Methodological aspects of the study are systematic recruitment, explicit inclusion criteria, reliability checks of assessments with control for rater shift, research assessors independent of treatment team and blind to randomization, analysis by intention to treat, data management using remote data entry, measures of quality assurance, advanced statistical analysis, manualised treatment protocols, checks of adherence and competence of therapists and assessment of cost-effectiveness. We will also determine whether time to recovery and/or relapse are moderated by variations in brain structure and function and selected genetic and hormone biomarkers taken at entry. Discussion The objective of this clinical trial is to determine whether there are specific

  17. A school-based intervention to promote physical activity among adolescent girls: Rationale, design, and baseline data from the Girls in Sport group randomised controlled trial

    PubMed Central

    2011-01-01

    Background Physical activity levels decline markedly among girls during adolescence. School-based interventions that are multi-component in nature, simultaneously targeting curricular, school environment and policy, and community links, are a promising approach for promoting physical activity. This report describes the rationale, design and baseline data from the Girls in Sport group randomised trial, which aims to prevent the decline in moderate-to-vigorous intensity physical activity (MVPA) among adolescent girls. Methods/Design A community-based participatory research approach and action learning framework are used with measurements at baseline and 18-month follow-up. Within each intervention school, a committee develops an action plan aimed at meeting the primary objective (preventing the decline in accelerometer-derived MVPA). Academic partners and the State Department of Education and Training act as critical friends. Control schools continue with their usual school programming. 24 schools were matched then randomized into intervention (n = 12) and control (n = 12) groups. A total of 1518 girls (771 intervention and 747 control) completed baseline assessments (86% response rate). Useable accelerometer data (≥10 hrs/day on at least 3 days) were obtained from 79% of this sample (n = 1199). Randomisation resulted in no differences between intervention and control groups on any of the outcomes. The mean age (SE) of the sample was 13.6 (± 0.02) years and they spent less than 5% of their waking hours in MVPA (4.85 ± 0.06). Discussion Girls in Sport will test the effectiveness of schools working towards the same goal, but developing individual, targeted interventions that bring about changes in curriculum, school environment and policy, and community links. By using community-based participatory research and an action learning framework in a secondary school setting, it aims to add to the body of literature on effective school-based interventions through

  18. Effects of a Behavioral Sleep Medicine Intervention on Trauma Symptoms in Adolescents Recently Treated for Substance Abuse

    ERIC Educational Resources Information Center

    Stevens, Sally; Haynes, Patricia L.; Ruiz, Bridget; Bootzin, Richard R.

    2007-01-01

    This study tested whether improvement in sleep by an integrative, behavioral sleep intervention was associated with improvement in traumatic stress (TS) symptoms in a sample of 20 adolescents who were recently treated for substance abuse. Sleep was measured throughout the intervention via daily sleep diaries, and traumatic stress symptoms were…

  19. Evaluating the evidence for evidence-based medicine: are randomized clinical trials less flawed than other forms of peer-reviewed medical research?

    PubMed

    Steen, R Grant; Dager, Stephen R

    2013-09-01

    Evidence-based medicine considers randomized clinical trials (RCTs) to be the strongest form of evidence for clinical decision making. To test the hypothesis that RCTs have fewer methodological flaws than non-RCTs, limitations of 17,591 RCTs and 39,029 non-RCTs were characterized. Panels of experts assembled to write meta-analyses evaluated this literature to determine which articles should be included in 316 meta-analytic reviews. Overall, 38.7% of RCTs evaluated were excluded from review for an identified flaw. Commonly identified flaws in RCTs were as follows: insufficient data provided to evaluate the study (9.6% of 17,591 RCTs); inadequate randomization (9.0%); inadequate blinding (4.9%); and duplicative publication (4.4%). Overall, 20.2% of all published medical research has an identified methodological flaw, with RCTs having as many limitations as non-RCTs.

  20. International Youth Justice Systems: Promoting Youth Development and Alternative Approaches: A Position Paper of the Society for Adolescent Health and Medicine.

    PubMed

    2016-10-01

    Youth incarceration is an international public health concern among developed and developing countries. Worldwide, youth are held in incarceration, detention, and other secure settings that are inappropriate for their age and developmental stages, jeopardizing their prosocial development, and reintegration into society. Youth incarceration lacks evidence and cost-effectiveness. The well-being of youth is a key indicator of the welfare of families, communities, and society at large; therefore, the Society for Adolescent Health and Medicine (SAHM) supports a paradigm shift in the role of the justice system as it relates to treatment of youth. SAHM recommends justice systems focus greater attention and resources on identifying and reducing the antecedents of high-risk and criminal behaviors, recognizing the rights and freedom of young persons, and prioritizing the well-being of youth over punitive measures that may harm and disrupt healthy adolescent development. SAHM supports the following positions: (1) incarceration is a last option for selected offenders who have committed the most serious violent crimes and are unable to remain safely in the community; (2) youth justice policies, programs, and practices affecting youth be evidence based and trauma informed; (3) youth justice policies, programs, and practices must incorporate research and ongoing program evaluation; (4) youth justice policies shall protect the privacy and dignity of children younger than 18 years; and (5) health care professionals and media will promote positive portrayals of youth in healthy relationships within their communities and reduce representations and images of youth that are negative, violent, deviant, and threatening.

  1. International Youth Justice Systems: Promoting Youth Development and Alternative Approaches: A Position Paper of the Society for Adolescent Health and Medicine.

    PubMed

    2016-10-01

    Youth incarceration is an international public health concern among developed and developing countries. Worldwide, youth are held in incarceration, detention, and other secure settings that are inappropriate for their age and developmental stages, jeopardizing their prosocial development, and reintegration into society. Youth incarceration lacks evidence and cost-effectiveness. The well-being of youth is a key indicator of the welfare of families, communities, and society at large; therefore, the Society for Adolescent Health and Medicine (SAHM) supports a paradigm shift in the role of the justice system as it relates to treatment of youth. SAHM recommends justice systems focus greater attention and resources on identifying and reducing the antecedents of high-risk and criminal behaviors, recognizing the rights and freedom of young persons, and prioritizing the well-being of youth over punitive measures that may harm and disrupt healthy adolescent development. SAHM supports the following positions: (1) incarceration is a last option for selected offenders who have committed the most serious violent crimes and are unable to remain safely in the community; (2) youth justice policies, programs, and practices affecting youth be evidence based and trauma informed; (3) youth justice policies, programs, and practices must incorporate research and ongoing program evaluation; (4) youth justice policies shall protect the privacy and dignity of children younger than 18 years; and (5) health care professionals and media will promote positive portrayals of youth in healthy relationships within their communities and reduce representations and images of youth that are negative, violent, deviant, and threatening. PMID:27664466

  2. Estimates of Intraclass Correlation Coefficients from Longitudinal Group-Randomized Trials of Adolescent HIV/STI/Pregnancy Prevention Programs

    ERIC Educational Resources Information Center

    Glassman, Jill R.; Potter, Susan C.; Baumler, Elizabeth R.; Coyle, Karin K.

    2015-01-01

    Introduction: Group-randomized trials (GRTs) are one of the most rigorous methods for evaluating the effectiveness of group-based health risk prevention programs. Efficiently designing GRTs with a sample size that is sufficient for meeting the trial's power and precision goals while not wasting resources exceeding them requires estimates of the…

  3. An Effectiveness Trial of a Dissonance-Based Eating Disorder Prevention Program for High-Risk Adolescent Girls

    ERIC Educational Resources Information Center

    Stice, Eric; Rohde, Paul; Gau, Jeff; Shaw, Heather

    2009-01-01

    Efficacy trials indicate that an eating disorder prevention program involving dissonance-inducing activities that decrease thin-ideal internalization reduces risk for current and future eating pathology, yet it is unclear whether this program produces effects under real-world conditions. The present effectiveness trial tested whether this program…

  4. Liuwei Dihuang Pills Enhance the Effect of Western Medicine in Treating Diabetic Nephropathy: A Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Lin, Lan; Wang, Qiuhong; Yi, Yongxin; Wang, Shihan; Qiu, Zonglin

    2016-01-01

    Objectives. To assess the effectiveness and adverse effects of adding Liuwei Dihuang Pills (LDP) to Western medicine for treating diabetic nephropathy. Methods. Studies were retrieved from seven electronic databases, including PubMed, Embase, The Cochrane Library, CBM, CNKI, Chinese Scientific Journal Database (VIP), and Wanfang Data until November 2015. Study selection, data extraction, quality assessment, and data analyses were conducted according to Cochrane standards. Meta-analysis was performed on the overall therapeutic efficacy of hyperglycemia and renal functions, and the study also analyzed adverse events. Results. A total of 1,275 patients from 18 studies were included. The methodological quality of these included trials was generally low. We found that adding LDP can lower patients' FBG (MD: −0.36 [−0.46, −0.25], P < 0.00001), PBG (MD: −1.10 [−1.35, −0.85], P < 0.00001), and HbA1c (MD: −0.14 [−0.49, 0.21], P = 0.43). There were also improvements in lowering patients' BUN (MD: −0.67 [−0.89, −0.45], P < 0.00001), SCr (MD: −0.96 [−1.53, −0.39], P < 0.00001), 24 h UTP (SMD: −1.26 [−2.38, −0.15], P < 0.00001), UAER (MD: −26.18 [−27.51, −24.85], P < 0.00001), and UmAlb (SMD: −1.72 [−2.67, −0.77], P < 0.00001). Conclusion. There is encouraging evidence that adding LDP to Western medicine might improve treatment outcomes of diabetic nephropathy, including hyperglycemia and renal functions. However, the evidence remains weak. More rigorous high-quality trials are warranted to substantiate or refute the results. PMID:26997962

  5. Liuwei Dihuang Pills Enhance the Effect of Western Medicine in Treating Diabetic Nephropathy: A Meta-Analysis of Randomized Controlled Trials.

    PubMed

    Lin, Lan; Wang, Qiuhong; Yi, Yongxin; Wang, Shihan; Qiu, Zonglin

    2016-01-01

    Objectives. To assess the effectiveness and adverse effects of adding Liuwei Dihuang Pills (LDP) to Western medicine for treating diabetic nephropathy. Methods. Studies were retrieved from seven electronic databases, including PubMed, Embase, The Cochrane Library, CBM, CNKI, Chinese Scientific Journal Database (VIP), and Wanfang Data until November 2015. Study selection, data extraction, quality assessment, and data analyses were conducted according to Cochrane standards. Meta-analysis was performed on the overall therapeutic efficacy of hyperglycemia and renal functions, and the study also analyzed adverse events. Results. A total of 1,275 patients from 18 studies were included. The methodological quality of these included trials was generally low. We found that adding LDP can lower patients' FBG (MD: -0.36 [-0.46, -0.25], P < 0.00001), PBG (MD: -1.10 [-1.35, -0.85], P < 0.00001), and HbA1c (MD: -0.14 [-0.49, 0.21], P = 0.43). There were also improvements in lowering patients' BUN (MD: -0.67 [-0.89, -0.45], P < 0.00001), SCr (MD: -0.96 [-1.53, -0.39], P < 0.00001), 24 h UTP (SMD: -1.26 [-2.38, -0.15], P < 0.00001), UAER (MD: -26.18 [-27.51, -24.85], P < 0.00001), and UmAlb (SMD: -1.72 [-2.67, -0.77], P < 0.00001). Conclusion. There is encouraging evidence that adding LDP to Western medicine might improve treatment outcomes of diabetic nephropathy, including hyperglycemia and renal functions. However, the evidence remains weak. More rigorous high-quality trials are warranted to substantiate or refute the results.

  6. Performance of research ethics committees in Spain. A prospective study of 100 applications for clinical trial protocols on medicines.

    PubMed Central

    Dal-Ré, R; Espada, J; Ortega, R

    1999-01-01

    OBJECTIVES: To review the characteristics and performance of research ethics committees in Spain in the evaluation of multicentre clinical trial drug protocols. DESIGN: A prospective study of 100 applications. SETTING: Forty-one committees reviewing clinical trial protocols, involving 50 hospitals in 25 cities. MAIN MEASURES: Protocol-related features, characteristics of research ethics committees and evaluation dynamics. RESULTS: The 100 applications involved 15 protocols (of which 12 were multinational) with 12 drugs. Committees met monthly (except one). They had a mean number of 12 members, requested a mean of six complete dossiers and nine additional copies of the protocol with a mean deadline of 14 days before the meeting. All applications were approved except three (two of the three were open-label long-term safety trials rejected by the same committee), which were approved by the other committees involved. The mean time from submission to approval was 64 days. The mean time from submission to arrival of the approval document at our offices was 85 days. Twenty-five committees raised queries for 38 of the 97 finally approved applications. Impact of evaluation fee, number of members, queries raised and experience of committees on timings were not statistically significant. CONCLUSION: Obtaining ethical approval is time-consuming. There is much diversity in the research ethics committees' performance. A remarkable delay (> 20 days) exists between the decision and the arrival of the written approval, suggesting administrative or organisational problems. PMID:10390685

  7. Long-term treatment with metformin in obese, insulin-resistant adolescents: results of a randomized double-blinded placebo-controlled trial

    PubMed Central

    van der Aa, M P; Elst, M A J; van de Garde, E M W; van Mil, E G A H; Knibbe, C A J; van der Vorst, M M J

    2016-01-01

    Background: As adolescents with obesity and insulin resistance may be refractory to lifestyle intervention therapy alone, additional off-label metformin therapy is often used. In this study, the long-term efficacy and safety of metformin versus placebo in adolescents with obesity and insulin resistance is studied. Methods: In a randomized placebo-controlled double-blinded trial, 62 adolescents with obesity aged 10–16 years old with insulin resistance received 2000 mg of metformin or placebo daily and physical training twice weekly over 18 months. Primary end points were change in body mass index (BMI) and insulin resistance measured by the Homeostasis Model Assessment for Insulin Resistance (HOMA-IR). Secondary end points were safety and tolerability of metformin. Other end points were body fat percentage and HbA1c. Results: Forty-two participants completed the 18-month study (66% girls, median age 13 (12–15) years, BMI 30.0 (28.3 to 35.0) kg m−2 and HOMA-IR 4.08 (2.40 to 5.88)). Median ΔBMI was +0.2 (−2.9 to 1.3) kg m−2 (metformin) versus +1.2 (−0.3 to 2.4) kg m−2 (placebo) (P=0.015). No significant difference was observed for HOMA-IR. No serious adverse events were reported. Median change in fat percentage was −3.1 (−4.8 to 0.3) versus −0.8 (−3.2 to 1.6)% (P=0.150), in fat mass −0.2 (−5.2 to 2.1) versus +2.0 (1.2–6.4) kg (P=0.007), in fat-free mass +2.0 (−0.1 to 4.0) versus +4.5 (1.3 to 11.6) kg (P=0.047) and in ΔHbA1c +1.0 (−1.0 to 2.3) versus +3.0 (0.0 to 5.0) mmol mol−1 (P=0.020) (metformin versus placebo). Conclusions: Long-term treatment with metformin in adolescents with obesity and insulin resistance results in stabilization of BMI and improved body composition compared with placebo. Therefore, metformin may be useful as an additional therapy in combination with lifestyle intervention in adolescents with obesity and insulin resistance. PMID:27571249

  8. Comparison between Chinese Herbal Medicines and Conventional Therapy in the Treatment of Severe Hand, Foot, and Mouth Disease: A Randomized Controlled Trial.

    PubMed

    Li, Xiuhui; Zhang, Xi; Ding, Jianbo; Xu, Yi; Wei, Dan; Tian, Yimei; Chen, Wei; Huang, Jihan; Wen, Tao; Li, Shuangjie

    2014-01-01

    Background. This study was made to evaluate the efficacy of Chinese herbal medicines, Reduning injection, and a traditional Chinese medicine (TCM) granule, in patients with severe hand, foot, and mouth disease (HFMD) by conducting a prospective, controlled, and randomized trial. Methods. 355 severe HFMD patients were randomly assigned to receive conventional therapy alone, Reduning injection plus conventional therapy, or TCM enema plus conventional therapy for 7-10 days. Results. There was no significant difference in the incidence of major complications between the groups. Median time to fever clearance was 20 hours (95% CI: 6.0-25.0) for conventional therapy recipients, 18 hours (95% CI: 4.0-24.0) for Reduning combination-treated patients, and 6 hours (95% CI: 4.0-16.0) for TCM combination-treated patients. Only the difference in time to fever clearance between TCM combination group and conventional group reached statistical significance (P = 0.048). Reduning combination group showed a significant reduction in sedative administration compared with conventional therapy group (P = 0.008). No HFMD-related death and no important adverse events were observed. Conclusions. Reduning injection plus conventional therapy significantly reduced the concomitant use of sedatives, which may help decrease HFMD-related neurologic complications in children. TCM effectively reduced time to fever clearance and may become a complementary therapy for relieving the symptoms of severe HFMD. PMID:24719639

  9. Comparison between Chinese Herbal Medicines and Conventional Therapy in the Treatment of Severe Hand, Foot, and Mouth Disease: A Randomized Controlled Trial

    PubMed Central

    Li, Xiuhui; Zhang, Xi; Ding, Jianbo; Xu, Yi; Wei, Dan; Tian, Yimei; Chen, Wei; Huang, Jihan; Li, Shuangjie

    2014-01-01

    Background. This study was made to evaluate the efficacy of Chinese herbal medicines, Reduning injection, and a traditional Chinese medicine (TCM) granule, in patients with severe hand, foot, and mouth disease (HFMD) by conducting a prospective, controlled, and randomized trial. Methods. 355 severe HFMD patients were randomly assigned to receive conventional therapy alone, Reduning injection plus conventional therapy, or TCM enema plus conventional therapy for 7–10 days. Results. There was no significant difference in the incidence of major complications between the groups. Median time to fever clearance was 20 hours (95% CI: 6.0–25.0) for conventional therapy recipients, 18 hours (95% CI: 4.0–24.0) for Reduning combination-treated patients, and 6 hours (95% CI: 4.0–16.0) for TCM combination-treated patients. Only the difference in time to fever clearance between TCM combination group and conventional group reached statistical significance (P = 0.048). Reduning combination group showed a significant reduction in sedative administration compared with conventional therapy group (P = 0.008). No HFMD-related death and no important adverse events were observed. Conclusions. Reduning injection plus conventional therapy significantly reduced the concomitant use of sedatives, which may help decrease HFMD-related neurologic complications in children. TCM effectively reduced time to fever clearance and may become a complementary therapy for relieving the symptoms of severe HFMD. PMID:24719639

  10. Chinese Medicines as an Adjuvant Therapy for Unresectable Hepatocellular Carcinoma during Transarterial Chemoembolization: A Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Wang, Xuanbin; Yuen, Man-Fung; Ziea, Tat-chi; Tong, Yao; Wong, Vivian Taam; Feng, Yibin

    2013-01-01

    Objective. To conduct a comprehensive PRISMA-compliant systematic review and meta-analysis to evaluate the efficacy and safety of Chinese medicines (CMs) as an adjuvant therapy for unresectable HCC during transarterial chemoembolization (TACE). Methods. Main databases were searched up to October 2012 for randomized controlled trials (RCTs) evaluating the effects of CMs plus TACE on unresectable HCC compared with TACE alone. References of relevant reviews and eligible studies were also assessed. Risk ratios with 95% confidence intervals and mean difference were calculated. Heterogeneity and publication bias were examined. Results. Sixty-seven trials (N = 5,211) were included in the meta-analysis. Sensitivity analysis and random-effects model were performed for assessing significant heterogeneity. CMs plus TACE showed beneficial effects on tumor response, survival at 6, 12, 18, 24, and 36 months, quality of life, and TACE toxicity reduction compared with TACE alone. Conclusion. The results show that the use of CMs may increase the efficacy and reduce the toxicity of TACE in treating patients with unresectable HCC. These findings suggest that CMs could be considered as an adjuvant therapy for unresectable HCC patients during TACE. Larger-scale RCTs using standard methods and long-term follow-up are warranted to confirm these findings. PMID:23956773

  11. The challenge to bring personalized cancer medicine from clinical trials into routine clinical practice: the case of the Institut Gustave Roussy.

    PubMed

    Arnedos, Monica; André, Fabrice; Farace, Françoise; Lacroix, Ludovic; Besse, Benjamin; Robert, Caroline; Soria, Jean Charles; Eggermont, Alexander M M

    2012-04-01

    Research with high throughput technologies has propitiated the segmentation of different types of tumors into very small subgroups characterized by the presence of very rare molecular alterations. The identification of these subgroups and the apparition of new agents targeting these infrequent alterations are already affecting the way in which clinical trials are being conducted with an increased need to identify those patients harboring specific molecular alterations. In this review we describe some of the currently ongoing and future studies at the Institut Gustave Roussy that aim for the identification of potential therapeutic targets for cancer patients with the incorporation of high throughput technologies into daily practice including aCGH, next generation sequencing and the creation of a software that allows for target identification specific for each tumor. The initial intention is to enrich clinical trials with cancer patients carrying certain molecular alterations in order to increase the possibility of demonstrating benefit from a targeted agent. Mid and long term aims are to facilitate and speed up the process of drug development as well as to implement the concept of personalized medicine. PMID:22483534

  12. Drug delivery trends in clinical trials and translational medicine: growth in biologic molecule development and impact on rheumatoid arthritis, Crohn's disease, and colitis.

    PubMed

    Ho, Rodney J Y; Chien, Jenny Y

    2012-08-01

    There are 94,709 clinical trials across 179 countries. Approximately half (47,467) are related to the three categories within the scope of the free online resource "Drug Delivery Trends in Clinical Trials and Translational Medicine," which are (1) drug delivery technology and systems, (2) biological molecule platforms, and (3) pharmacokinetic and pharmacodynamic interactions. In this commentary, trends in biological molecule platforms and their impacts are discussed. The sales of top 15 biologic drugs have reached over $63 billion in 2010. In the past 10 years, major pharmaceutical companies have acquired biological molecule platforms and have become integrated biopharmaceutical companies, highlighting the role of biotechnology in driving new therapeutic product development. The top three products--Remicade, Enbrel, and Humira--indicated for arthritis and colitis and targeted to tumor necrosis factor-alpha (TNF-α), each generated over $6 billion in annual sales. In addition to TNF-α, biologic candidates targeted to other inflammatory molecules are in clinical development, partly driven by commercial interests and medical need. Although clinical experience indicates that all the anti-TNF-α molecular platforms are effective for rheumatoid arthritis, Crohn's disease, and colitis, whether the new agents can provide additional relief or cures remains to be seen.

  13. Effectiveness of an additional individualized multi-component complementary medicine treatment on health-related quality of life in breast cancer patients: a pragmatic randomized trial.

    PubMed

    Witt, Claudia M; Außerer, Oskar; Baier, Susanne; Heidegger, Herbert; Icke, Katja; Mayr, Oswald; Mitterer, Manfred; Roll, Stephanie; Spizzo, Gilbert; Scherer, Arthur; Thuile, Christian; Wieser, Anton; Schützler, Lena

    2015-01-01

    The aim of this study was to evaluate the effectiveness of an additional, individualized, multi-component complementary medicine treatment offered to breast cancer patients at the Merano Hospital (South Tyrol) on health-related quality of life compared to patients receiving usual care only. A randomized pragmatic trial with two parallel arms was performed. Women with confirmed diagnoses of breast cancer were randomized (stratified by usual care treatment) to receive individualized complementary medicine (CM group) or usual care alone (usual care group). Both groups were allowed to use conventional treatment for breast cancer. Primary endpoint was the breast cancer-related quality of life FACT-B score at 6 months. For statistical analysis, we used analysis of covariance (with factors treatment, stratum, and baseline FACT-B score) and imputed missing FACT-B scores at 6 months with regression-based multiple imputation. A total of 275 patients were randomized between April 2011 and March 2012 to the CM group (n = 136, 56.3 ± 10.9 years of age) or the usual care group (n = 139, 56.0 ± 11.0). After 6 months from randomization, adjusted means for health-related quality of life were higher in the CM group (FACT-B score 107.9; 95 % CI 104.1-111.7) compared to the usual care group (102.2; 98.5-105.9) with an adjusted FACT-B score difference between groups of 5.7 (2.6-8.7, p < 0.001). Thus, an additional individualized and complex complementary medicine intervention improved quality of life of breast cancer patients compared to usual care alone. Further studies evaluating specific effects of treatment components should follow to optimize the treatment of breast cancer patients.

  14. A New Ethical Challenge for Institutional Review Boards (IRBs)/Ethics Committees (ECs) in the Assessment of Pediatric Clinical Trials

    PubMed Central

    Rose, Klaus; Kummer, Hans

    2015-01-01

    Both the US and EU have introduced pediatric pharmaceutical legislation to facilitate clinical trials in children and development of better medicines for children. The first concerns were published in 2014 that the European Medicines Agency (EMA)’s Pediatric Committee (PDCO) may be over-enthusiastic and has compelled questionable pediatric clinical trials from pharmaceutical companies. Numerous clinical trials are mandated in rare conditions for which not enough patients exist for even one trial. Furthermore, where these trials are mandated in adolescent patients, the legal age limit of the 18th birthday is confused with a medical age limit and can result in separate clinical trials in adolescent patients that neither make medical nor scientific sense nor will ever recruit enough patients for a meaningful outcome. To confirm our concerns we searched the registry clinicaltrials.gov and found examples for PDCO-triggered unethical trials. We conclude that such trials should not be accepted by institutional review boards (IRBs)/ethics committees (ECs) and that clinical trials resulting from negotiations with EMA’s PDCO need extra careful scrutiny by IRBs/ECs in order to prevent unethical studies and damage to pediatric research and unnecessary risks to pediatric patients. PMID:27417359

  15. A New Ethical Challenge for Institutional Review Boards (IRBs)/Ethics Committees (ECs) in the Assessment of Pediatric Clinical Trials.

    PubMed

    Rose, Klaus; Kummer, Hans

    2015-05-28

    Both the US and EU have introduced pediatric pharmaceutical legislation to facilitate clinical trials in children and development of better medicines for children. The first concerns were published in 2014 that the European Medicines Agency (EMA)'s Pediatric Committee (PDCO) may be over-enthusiastic and has compelled questionable pediatric clinical trials from pharmaceutical companies. Numerous clinical trials are mandated in rare conditions for which not enough patients exist for even one trial. Furthermore, where these trials are mandated in adolescent patients, the legal age limit of the 18th birthday is confused with a medical age limit and can result in separate clinical trials in adolescent patients that neither make medical nor scientific sense nor will ever recruit enough patients for a meaningful outcome. To confirm our concerns we searched the registry clinicaltrials.gov and found examples for PDCO-triggered unethical trials. We conclude that such trials should not be accepted by institutional review boards (IRBs)/ethics committees (ECs) and that clinical trials resulting from negotiations with EMA's PDCO need extra careful scrutiny by IRBs/ECs in order to prevent unethical studies and damage to pediatric research and unnecessary risks to pediatric patients.

  16. MEMO—A Mobile Phone Depression Prevention Intervention for Adolescents: Development Process and Postprogram Findings on Acceptability From a Randomized Controlled Trial

    PubMed Central

    Merry, Sally; Stasiak, Karolina; McDowell, Heather; Doherty, Iain; Shepherd, Matthew; Dorey, Enid; Parag, Varsha; Ameratunga, Shanthi; Rodgers, Anthony

    2012-01-01

    Background Prevention of the onset of depression in adolescence may prevent social dysfunction, teenage pregnancy, substance abuse, suicide, and mental health conditions in adulthood. New technologies allow delivery of prevention programs scalable to large and disparate populations. Objective To develop and test the novel mobile phone delivery of a depression prevention intervention for adolescents. We describe the development of the intervention and the results of participants’ self-reported satisfaction with the intervention. Methods The intervention was developed from 15 key messages derived from cognitive behavioral therapy (CBT). The program was fully automated and delivered in 2 mobile phone messages/day for 9 weeks, with a mixture of text, video, and cartoon messages and a mobile website. Delivery modalities were guided by social cognitive theory and marketing principles. The intervention was compared with an attention control program of the same number and types of messages on different topics. A double-blind randomized controlled trial was undertaken in high schools in Auckland, New Zealand, from June 2009 to April 2011. Results A total of 1348 students (13–17 years of age) volunteered to participate at group sessions in schools, and 855 were eventually randomly assigned to groups. Of these, 835 (97.7%) self-completed follow-up questionnaires at postprogram interviews on satisfaction, perceived usefulness, and adherence to the intervention. Over three-quarters of participants viewed at least half of the messages and 90.7% (379/418) in the intervention group reported they would refer the program to a friend. Intervention group participants said the intervention helped them to be more positive (279/418, 66.7%) and to get rid of negative thoughts (210/418, 50.2%)—significantly higher than proportions in the control group. Conclusions Key messages from CBT can be delivered by mobile phone, and young people report that these are helpful. Change in

  17. Treatment of Adolescent Marijuana Abuse: A Randomized Clinical Trial. Presentation 1: Structure of the Cannabis Youth Treatment Study.

    ERIC Educational Resources Information Center

    Titus, Janet C.; Dennis, Michael L.; Diamond, Guy; Godley, Susan H.; Babor, Thomas; Donaldson, Jean; Herrell, James; Tims, Frank; Webb, Charles

    The Cannabis Youth Treatment (CYT) study is a multi-site randomized field experiment examining five outpatient treatment protocols for adolescents who abuse or are dependent on marijuana. The purpose of the CYT project is twofold: (a) to test the relative clinical effectiveness and cost-effectiveness of five promising interventions targeted at…

  18. Five Randomized Trials to Assess the Effectiveness of Adolescent Literacy Interventions: Realities of Design and Implementation and Influences on Impact

    ERIC Educational Resources Information Center

    Sprague, Kim; Hamilton, Jennifer; Coffey, Deb; Loadman, William; Faddis, Bonnie

    2009-01-01

    Rigorous research provides information that will allow other schools and districts to select interventions that have a scientifically based track record of effectiveness. All Striving Reader grants include the mandate to evaluate literacy intervention(s) targeted to adolescents who are reading significantly below grade level. Although all studies…

  19. Internet-Delivered Targeted Group Intervention for Body Dissatisfaction and Disordered Eating in Adolescent Girls: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Heinicke, Brooke E.; Paxton, Susan J.; McLean, Sian A.; Wertheim, Eleanor H.

    2007-01-01

    This study evaluated a targeted intervention designed to alleviate body image and eating problems in adolescent girls that was delivered over the internet so as to increase access to the program. The program consisted of six, 90-minute weekly small group, synchronous on-line sessions and was facilitated by a therapist and manual. Participants were…

  20. Open Trial of Family-Based Treatment for Full and Partial Anorexia Nervosa in Adolescence: Evidence of Successful Dissemination

    ERIC Educational Resources Information Center

    Loeb, Katharine L.; Walsh, B. Timothy; Lock, James; Le Grange, Daniel; Jones, Jennifer; Marcus, Sue; Weaver, James; Dobrow, Ilyse

    2007-01-01

    Objective: There is a paucity of evidence-based interventions for anorexia nervosa (AN). An innovative family-based treatment (FBT), developed at the Maudsley Hospital and recently put in manual form, has shown great promise for adolescents with AN. Unlike traditional treatment approaches, which promote sustained autonomy around food, FBT…

  1. A randomised control trial of physical activity in a perceived environment on self-esteem and mood in UK adolescents.

    PubMed

    Wood, Carly; Angus, Caroline; Pretty, Jules; Sandercock, Gavin; Barton, Jo

    2013-01-01

    This study assessed whether exercising whilst viewing natural or built scenes affected self-esteem (SE) and mood in adolescents. Twenty-five adolescents participated in three exercise tests on consecutive days. A graded exercise test established the work rate equivalent to 50% heart rate reserve for use in subsequent constant load tests (CLTs). Participants undertook two 15-min CLTs in random order viewing scenes of either natural or built environments. Participants completed Rosenberg's SE scale and the adolescent profile of mood states questionnaire pre- and post-exercise. There was a significant main effect for SE (F(1) = 6.10; P < 0.05) and mood (F(6) = 5.29; P < 0.001) due to exercise, but no effect of viewing different environmental scenes (P > 0.05). Short bouts of moderate physical activity can have a positive impact on SE and mood in adolescents. Future research should incorporate field studies to examine the psychological effects of contact with real environments. PMID:23075427

  2. Evaluation of a Group Cognitive-Behavioral Depression Prevention Program for Young Adolescents: A Randomized Effectiveness Trial

    ERIC Educational Resources Information Center

    Gillham, Jane E.; Reivich, Karen J.; Brunwasser, Steven M.; Freres, Derek R.; Chajon, Norma D.; Kash-MacDonald, V. Megan; Chaplin, Tara M.; Abenavoli, Rachel M.; Matlin, Samantha L.; Gallop, Robert J.; Seligman, Martin E. P.

    2012-01-01

    Depression is a common psychological problem in adolescence. Recent research suggests that group cognitive-behavioral interventions can reduce and prevent symptoms of depression in youth. Few studies have tested the effectiveness of such interventions when delivered by school teachers and counselors (as opposed to research team staff). We…

  3. Effectiveness of a School-Based Group Psychotherapy Program for War-Exposed Adolescents: A Randomized Control Trial

    ERIC Educational Resources Information Center

    Layne, Christopher M.; Saltzman, William R.; Poppleton, Landon; Burlingame, Gary M.; Pasalic, Alma; Durakovic, Elvira; Music, Mirjana; Campara, Nihada; Dapo, Nermin; Arslanagic, Berina; Steinberg, Alan M.; Pynoos, Robert S.

    2008-01-01

    The study assesses the comparative efficacy of a classroom-based psycho-education and skills intervention and a school-based trauma- and grief-focused group treatment of a three-tiered mental health program for adolescents exposed to severe war-trauma, traumatic bereavement, and postwar adversity. The two-tier approach, combined with…

  4. The Prevention of Depression and Anxiety in a Sample of High-Risk Adolescents: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Dobson, Keith S.; Hopkins, Jamie Ahnberg; Fata, Ladan; Scherrer, Martin; Allan, Lauren C.

    2010-01-01

    This study investigated the efficacy of cognitive behavioural therapy (CBT) techniques in preventing depression and anxiety in a group of adolescent high school students with elevated risk for developing emotional disorders. Students were screened using a measure of depression severity and clinical interview. Following screening procedures,…

  5. Randomized Clinical Trial of the Efficacy of Bupropion Combined with Nicotine Patch in the Treatment of Adolescent Smokers

    ERIC Educational Resources Information Center

    Killen, Joel D.; Robinson, Thomas N.; Ammerman, Seth; Hayward, Chris; Rogers, Jayna; Stone, Christi; Samuels, Deanne; Levin, Sara K.; Green, Sarah

    2004-01-01

    Adolescent smokers (N = 211) were randomized to 1 of 2 groups: (a) nicotine patch plus bupropion SR (sustained release; 150 mg per day) or (b) nicotine patch plus placebo. Group skills training sessions were conducted each week by research staff. Abstinence rates at Weeks 10 and 26 were as follows: (a) patch plus bupropion, 23% and 8%, (b) patch…

  6. Cognitive Behavioral Therapy for Early Adolescents with Autism Spectrum Disorders and Clinical Anxiety: A Randomized, Controlled Trial

    PubMed Central

    Wood, Jeffrey J.; Ehrenreich-May, Jill; Alessandri, Michael; Fujii, Cori; Renno, Patricia; Laugeson, Elizabeth; Piacentini, John C.; De Nadai, Alessandro S.; Arnold, Elysse; Lewin, Adam B.; Murphy, Tanya K.; Storch, Eric A.

    2014-01-01

    Background Clinically elevated anxiety is a common, impairing feature of autism spectrum disorders (ASD). A modular CBT program designed for preteens with ASD, Behavioral Interventions for Anxiety in Children with Autism (BIACA; Wood et al., 2009), was enhanced and modified to address the developmental needs of early adolescents with ASD and clinical anxiety. Method Thirty-three adolescents (11–15 years old) were randomly assigned to 16 sessions of CBT or an equivalent waitlist period. The CBT model emphasized exposure, challenging irrational beliefs, and behavioral supports provided by caregivers, as well as numerous ASD-specific treatment elements. Independent evaluators, parents, and adolescents rated symptom severity at baseline and post-treatment/post-waitlist. Results In intent-to-treat analyses, the CBT group outperformed the waitlist group on independent evaluators’ ratings of anxiety severity on the Pediatric Anxiety Rating Scale (PARS) and 79% of the CBT group met Clinical Global Impressions-Improvement scale criteria for positive treatment response at posttreatment, as compared to only 28.6% of the waitlist group. Group differences were not found for diagnostic remission or questionnaire measures of anxiety. However, parent-report data indicated that there was a positive treatment effect of CBT on autism symptom severity. Conclusions The CBT manual under investigation, enhanced for early adolescents with ASD, yielded meaningful treatment effects on the primary outcome measure (PARS), although additional developmental modifications to the manual are likely warranted. Future studies examining this protocol relative to an active control are needed. PMID:25526831

  7. Cognitive behavioral therapy for early adolescents with autism spectrum disorders and clinical anxiety: a randomized, controlled trial.

    PubMed

    Wood, Jeffrey J; Ehrenreich-May, Jill; Alessandri, Michael; Fujii, Cori; Renno, Patricia; Laugeson, Elizabeth; Piacentini, John C; De Nadai, Alessandro S; Arnold, Elysse; Lewin, Adam B; Murphy, Tanya K; Storch, Eric A

    2015-01-01

    Clinically elevated anxiety is a common, impairing feature of autism spectrum disorders (ASD). A modular CBT program designed for preteens with ASD, Behavioral Interventions for Anxiety in Children with Autism (BIACA; Wood et al., 2009) was enhanced and modified to address the developmental needs of early adolescents with ASD and clinical anxiety. Thirty-three adolescents (11-15 years old) were randomly assigned to 16 sessions of CBT or an equivalent waitlist period. The CBT model emphasized exposure, challenging irrational beliefs, and behavioral supports provided by caregivers, as well as numerous ASD-specific treatment elements. Independent evaluators, parents, and adolescents rated symptom severity at baseline and posttreatment/postwaitlist. In intent-to-treat analyses, the CBT group outperformed the waitlist group on independent evaluators' ratings of anxiety severity on the Pediatric Anxiety Rating Scale (PARS) and 79% of the CBT group met Clinical Global Impressions-Improvement scale criteria for positive treatment response at posttreatment, as compared to only 28.6% of the waitlist group. Group differences were not found for diagnostic remission or questionnaire measures of anxiety. However, parent-report data indicated that there was a positive treatment effect of CBT on autism symptom severity. The CBT manual under investigation, enhanced for early adolescents with ASD, yielded meaningful treatment effects on the primary outcome measure (PARS), although additional developmental modifications to the manual are likely warranted. Future studies examining this protocol relative to an active control are needed.

  8. Cognitive behavioral therapy for early adolescents with autism spectrum disorders and clinical anxiety: a randomized, controlled trial.

    PubMed

    Wood, Jeffrey J; Ehrenreich-May, Jill; Alessandri, Michael; Fujii, Cori; Renno, Patricia; Laugeson, Elizabeth; Piacentini, John C; De Nadai, Alessandro S; Arnold, Elysse; Lewin, Adam B; Murphy, Tanya K; Storch, Eric A

    2015-01-01

    Clinically elevated anxiety is a common, impairing feature of autism spectrum disorders (ASD). A modular CBT program designed for preteens with ASD, Behavioral Interventions for Anxiety in Children with Autism (BIACA; Wood et al., 2009) was enhanced and modified to address the developmental needs of early adolescents with ASD and clinical anxiety. Thirty-three adolescents (11-15 years old) were randomly assigned to 16 sessions of CBT or an equivalent waitlist period. The CBT model emphasized exposure, challenging irrational beliefs, and behavioral supports provided by caregivers, as well as numerous ASD-specific treatment elements. Independent evaluators, parents, and adolescents rated symptom severity at baseline and posttreatment/postwaitlist. In intent-to-treat analyses, the CBT group outperformed the waitlist group on independent evaluators' ratings of anxiety severity on the Pediatric Anxiety Rating Scale (PARS) and 79% of the CBT group met Clinical Global Impressions-Improvement scale criteria for positive treatment response at posttreatment, as compared to only 28.6% of the waitlist group. Group differences were not found for diagnostic remission or questionnaire measures of anxiety. However, parent-report data indicated that there was a positive treatment effect of CBT on autism symptom severity. The CBT manual under investigation, enhanced for early adolescents with ASD, yielded meaningful treatment effects on the primary outcome measure (PARS), although additional developmental modifications to the manual are likely warranted. Future studies examining this protocol relative to an active control are needed. PMID:25526831

  9. Low bone mass in behaviorally HIV-infected young men on antiretroviral therapy: adolescent trials network (ATN) study 021B

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Peak bone mass is achieved in adolescence/early adulthood and is the key determinant of bone mass in adulthood. We evaluated the association of bone mass with HIV infection and antiretroviral therapy (ART) during this critical period among behaviorally HIV infected young men and seronegative control...

  10. Multisystemic Therapy for Adolescents with Poorly Controlled Type I Diabetes: Stability of Treatment Effects in a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Ellis, Deborah A.; Templin, Thomas; Naar-King, Sylvie; Frey, Maureen A.; Cunningham, Phillippe B.; Podolski, Cheryl-Lynn; Cakan, Nedim

    2007-01-01

    The primary purpose of the present study was to determine whether multisystemic therapy (MST), an intensive, home-based psychotherapy, improved regimen adherence, metabolic control, and rates of hospitalization for diabetic ketoacidosis (DKA) among adolescents with chronically poorly controlled Type 1 diabetes 6 months after the completion of…

  11. [Transition of adolescents with the exstrophy-epispadias complex to adult medicine: influence of long-term outcome results on management].

    PubMed

    Ebert, A-K; Reutter, H; Neissner, C; Rösch, W

    2012-11-01

    Today, young individuals with rare congenital anomalies as the Exstrophy-Epispadias-Complex (EEC) are mostly monitored interdisciplinary with a high standard of care and enthusiasm during childhood. However, when growing up through adolescence to adulthood adequate care-givers are not available at the moment in adult medicine in Germany and a concrete transition process has yet not been established. Over the past years, we put much effort in systematic evaluation of long-term outcome after reconstruction of the EEC in the newborn period to further improve outcome results. Beside predictive parameters for continence and long-term bladder function, genital function and fertility, as well as postoperative pelvic floor morphology and gynecological outcome, orthopedic results and psychosexual and psychosocial development in EEC were of major interest. As a consequence we currently develop a German-wide follow-up concept in EEC patients regarding age- and gender specific outcome issues. Long-term observations of the EEC outcome however, underline the unrestricted importance of careful long-term follow-up of all EEC patients, as well as the necessity of close cooperation of pediatric urologist, pediatric surgeons, urologists, orthopedic surgeons, gynecologists, andrologists, psychologists and urotherapists from early childhood and the need of knowledge transfer and hopefully a successful transition of the EEC individuals to general medicine.

  12. Four-year analysis of cardiovascular disease risk factors, depression symptoms, and antidepressant medicine use in the Look AHEAD (Action for Health in Diabetes) clinical trial of weight loss in diabetes

    Technology Transfer Automated Retrieval System (TEKTRAN)

    OBJECTIVE To study the association of depressive symptoms or antidepressant medicine (ADM) use with subsequent cardiovascular disease (CVD) risk factor status in the Look AHEAD (Action for Health in Diabetes) trial of weight loss in type 2 diabetes. RESEARCH DESIGN AND METHODS Participants (n = 5,1...

  13. School‐based brief psycho‐educational intervention to raise adolescent cancer awareness and address barriers to medical help‐seeking about cancer: a cluster randomised controlled trial

    PubMed Central

    Stoddart, Iona; Forbat, Liz; Neal, Richard D.; O'Carroll, Ronan E.; Haw, Sally; Rauchhaus, Petra; Kyle, Richard G.

    2015-01-01

    Abstract Objectives Raising cancer awareness and addressing barriers to help‐seeking may improve early diagnosis. The aim was to assess whether a psycho‐educational intervention increased adolescents' cancer awareness and addressed help‐seeking barriers. Methods This was a cluster randomised controlled trial involving 2173 adolescents in 20 schools. The intervention was a 50‐min presentation delivered by a member of Teenage Cancer Trust's (UK charity) education team. Schools were stratified by deprivation and roll size and randomly allocated to intervention/control conditions within these strata. Outcome measures were the number of cancer warning signs and cancer risk factors recognised, help‐seeking barriers endorsed and cancer communication. Communication self‐efficacy and intervention fidelity were also assessed. Results Regression models showed significant differences in the number of cancer warning signs and risk factors recognised between intervention and control groups. In intervention schools, the greatest increases in recognition of cancer warning signs at 6‐month follow‐up were for unexplained weight loss (from 44.2% to 62.0%) and change in the appearance of a mole (from 46.3% to 70.7%), up by 17.8% and 24.4%, respectively. Greatest increases in recognition of cancer risk factors were for getting sunburnt more than once as a child (from 41.0% to 57.6%) and being overweight (from 42.7% to 55.5%), up by 16.6% and 12.8%, respectively. Regression models showed that adolescents in intervention schools were 2.7 times more likely to discuss cancer at 2‐week follow‐up compared with the control group. No differences in endorsement of barriers to help‐seeking were observed. Conclusions School‐based brief psycho‐educational interventions are easy to deliver, require little resource and improve cancer awareness. © 2015 The Authors. Psycho‐Oncology published by John Wiley & Sons Ltd. PMID:26502987

  14. A randomized trial of a peer resistance skill building game for Hispanic early adolescent girls: Impact and feasibility of DRAMA-RAMA™

    PubMed Central

    Norris, Anne E.; Hughes, Charles; Hecht, Michael; Peragallo, Nilda; Nickerson, David

    2015-01-01

    BACKGROUND Research suggests that adolescents can use peer resistance skills to avoid being pressured into risky behavior, such as early sexual behavior. Avatar-based Virtual Reality (AVR) technology offers a novel way to build these skills. OBJECTIVES Study aims were to: evaluate the feasibility of an AVR peer resistance skill building game (DRAMA-RAMA™); explore the impact of game play on peer resistance self-efficacy; and assess how positively the game was perceived. METHOD 45 low income early adolescent Hispanic girls were randomly assigned to either the intervention (DRAMA-RAMA™) or comparison game (Wii Dancing with the Stars™ [Wii DWTS™]) condition. All participants were offered a 5 session curriculum that included peer resistance skill content before playing their respective game for 15 minutes, once a week, for two weeks. Participants completed electronic surveys assessing demographics, peer resistance self-efficacy, and sexual behavior at baseline, after game play, and at 2 months. They also completed a paper-pencil game experience questionnaire immediately after playing their game. Data were analyzed using descriptive statistics, chi-square, and analyses of covariance. RESULTS The separate analyses of covariance showed a significant game effect at post-test for the peer resistance self-efficacy measure (F = 4.21, p < 0.05), but not at follow-up (F = 0.01, p = 0.92). DRAMA-RAMA™ was rated as positively as the Wii DWTS™ (p ≥ .26). DISCUSSION This randomized control trial provides initial support for the hypothesis that playing an AVR technology game can strengthen peer resistance skills, and early adolescent Hispanic girls will have a positive response to this game. PMID:23150043

  15. A randomized field trial for the primary prevention of osteoporosis among adolescent females: Comparison of two methods, mother centered and daughter centered

    PubMed Central

    Ansari, Hourieh; Farajzadegan, Ziba; Hajigholami, Ali; Paknahad, Zamzam

    2014-01-01

    Background: Osteoporosis is a serious public health. Since the majority of bone mass occurs during adolescence, primary prevention is important. Probably mother's participation in health education interventions leads to promote health behaviors in children. Aims: To assess a lifestyle modification intervention focused on mothers and students has an impact on osteoporosis preventive behaviors in adolescent girls. Materials and Methods: It is a randomized field trial in female high schools. 210 girls aged between 11 and 15 were randomly selected. Students in groups A and C and mothers in group B were selected Through the sampling frame. Our lifestyle modification was based on group based education in the public girls’ high schools. Subjects in the intervention groups participated in three educational sessions. Students’ osteoporosis preventive behaviors were measured by using a lifestyle questionnaire consisting of items assessing nutrition, physical activity and sun exposure. Repeated measure ANOVA at baseline, 4 week, 2 months and 6 months and were used to analyze the data. Results: After 1 month, diet and sun exposure scores increased significantly (P < 0.001) but it was higher in group B compared with group A. (About diet P < 0.001 and sun exposure = 0. 001). After 6 months, diet and sun exposure status in the group A approximately decreased to baseline, while in group B, diet components were significantly different compared to baseline (P < 0.001). There was no change in physical activity. Conclusion: Osteoporosis prevention intervention of adolescent can be effective when parents or girls participate in training sessions, but education is associated with better outcomes when focused on mothers. PMID:25422660

  16. An exploratory randomized controlled trial of a novel high-school-based smoking cessation intervention for adolescent smokers using abstinence-contingent incentives and cognitive behavioral therapy

    PubMed Central

    Krishnan-Sarin, Suchitra; Cavallo, Dana A.; Cooney, Judith L.; Schepis, Ty S.; Kong, Grace; Liss, Thomas B.; Liss, Amanda K.; McMahon, Thomas J.; Nich, Charla; Babuscio, Theresa; Rounsaville, Bruce J.; Carroll, Kathleen M.

    2013-01-01

    Background There are few effective smoking cessation interventions for adolescent smokers. We developed a novel intervention to motivate tobacco use behavior change by 1) enhancing desire to quit through the use of abstinence-contingent incentives (CM), 2) increasing cessation skills through the use of cognitive behavioral therapy (CBT), and 3) removing cessation barriers through delivery within high schools. Methods An exploratory four-week, randomized controlled trial was conducted in Connecticut high schools to dismantle the independent and combined effects of CM and CBT; smokers received CM alone, CBT alone, or CM+CBT. Participants included 82 adolescent smokers seeking smoking cessation treatment. The primary outcome was seven-day end-of-treatment (EOT) point prevalence (PP) abstinence, determined using self-reports confirmed using urine cotinine levels. Secondary outcomes included one-day EOT PP abstinence and cigarette use during treatment and follow up. Results Among participants who initiated treatment (n=72), group differences in seven-day EOT-PP abstinence were observed (χ2=10.48, p<0.01) with higher abstinence in the CM+CBT (36.7%) and CM (36.3%) conditions when compared with CBT (0%). One-day EOT-PP abstinence evidenced similar effects (χ2= 10·39, p<0·01; CM+CBT: 43%, CM: 43%, CBT: 4·3%). Survival analyses indicated differences in time to first cigarette during treatment (χ2=8·73, p =·003; CBT: Day 3, CM: Day 9, CM+CBT: Day 20). At one-and three-month follow ups, while no differences were observed, the CM alone group had the slowest increase in cigarette use. Conclusions High-school, incentive-based smoking cessation interventions produce high rates of short-term abstinence among adolescent smokers; adding cognitive behavioral therapy does not appear to further enhance outcomes. PMID:23523130

  17. Will the EU Clinical Trials Regulation Support the Innovative Industry in Bringing New Medicines Faster to Patients?

    PubMed

    Atzor, Sabine; Gokhale, Surendra; Doherty, Michael

    2013-04-01

    A perspective from the innovative industry is provided in this article about the long awaited legal proposal for a Clinical Trial Regulation ("Proposal"), adopted in July 2012. With this Proposal, the European Commission reacted to a call by all stakeholders for more harmonization and streamlining of the provisions for conducting clinical trials in the EU. Discrepant approaches between Member States, a failure to respect legal timelines, and a lack of formal coordination mechanisms within and between Member States have resulted in an increased workload for the industry and contributed to a decline in Europe's attractiveness as a place to carry out research and development. The Proposal introduces a concept whereby the sponsor makes a single submission of the clinical trial application dossier to an EU portal, which is followed by a single assessment based on cooperation between Member States. A possibility for the sponsor to choose a 'reporting Member State' to take the lead on key aspects of the assessment is expected to support excellence building and work sharing of Competent Authorities in the EU. The Proposal respects the fact that certain aspects need to be reviewed nationally. The new process aims to lead to a single decision per clinical trial per concerned Member State. The rules are built on the principle of strict adherence to timelines for authorization. The timelines are ambitious but at the same time competitive, as the process builds in mechanisms that strengthen compliance. The rules have been designed to encourage sponsors to file complete submission packages, since any substantial modification to a trial would lead to delays in its commencement. Sponsors need to streamline their internal processes accordingly. In the end, streamlining is an effort that needs to be accepted by all parties involved. The Proposal does not detail how Member States organize the involvement of different bodies, such as Competent Authorities and Ethics Committees

  18. The group-based social skills training SOSTA-FRA in children and adolescents with high functioning autism spectrum disorder - study protocol of the randomised, multi-centre controlled SOSTA - net trial

    PubMed Central

    2013-01-01

    Background Group-based social skills training (SST) has repeatedly been recommended as treatment of choice in high-functioning autism spectrum disorder (HFASD). To date, no sufficiently powered randomised controlled trial has been performed to establish efficacy and safety of SST in children and adolescents with HFASD. In this randomised, multi-centre, controlled trial with 220 children and adolescents with HFASD it is hypothesized, that add-on group-based SST using the 12 weeks manualised SOSTA–FRA program will result in improved social responsiveness (measured by the parent rated social responsiveness scale, SRS) compared to treatment as usual (TAU). It is further expected, that parent and self reported anxiety and depressive symptoms will decline and pro-social behaviour will increase in the treatment group. A neurophysiological study in the Frankfurt HFASD subgroup will be performed pre- and post treatment to assess changes in neural function induced by SST versus TAU. Methods/design The SOSTA – net trial is designed as a prospective, randomised, multi-centre, controlled trial with two parallel groups. The primary outcome is change in SRS score directly after the intervention and at 3 months follow-up. Several secondary outcome measures are also obtained. The target sample consists of 220 individuals with ASD, included at the six study centres. Discussion This study is currently one of the largest trials on SST in children and adolescents with HFASD worldwide. Compared to recent randomised controlled studies, our study shows several advantages with regard to in- and exclusion criteria, study methods, and the therapeutic approach chosen, which can be easily implemented in non-university-based clinical settings. Trial registration ISRCTN94863788 – SOSTA – net: Group-based social skills training in children and adolescents with high functioning autism spectrum disorder. PMID:23289935

  19. Effect of Structured and Unstructured Physical Activity Training on Cognitive Functions in Adolescents – A Randomized Control Trial

    PubMed Central

    Subramanian, Senthil Kumar; Arunachalam, Vinayathan; Radhakrishnan, Krishnakumar; Ramamurthy, Sarah

    2015-01-01

    Background Regular physical activity in children and adolescents promotes not only their physical health but also improves their cognition. Paper and pencil Neurocognitive tests (NCT) are commonly used to assess the various cognitive domains of a person and can be used as simple tests to assess improvements, if any, in the cognitive abilities of growing adolescents who practice regular physical activity. Aim To study the effect of six months of structured and unstructured physical activity on cognitive functions in adolescents. Materials and Methods We recruited 439 healthy adolescent volunteers in the age group of 12 to 17 years (boys 250, girls 189) from a residential school (Jawahar Navodaya Vidyalaya, Pondicherry). The following paper and pencil neuropsychological cognitive tests were administered: Two Target Letter Cancellation test, Trail Making test A and B, Ruff Figural Fluency test (RFFT). These participants were then divided into Structured Physical Activity (SPA: n=219; boys 117, girls 102) and Unstructured Physical Activity (USPA: n=220; boys 119, girls 101) groups based on age and gender block randomization method. Six-month intervention was successfully completed by 347 participants only (SPA group: n= 136; boys 77, girls 59; USPA group: n = 139; boys 75, girls 64) and the tests were repeated. Statistical Analysis The data were recorded and statistically analysed by per-protocol analysis method, using the Statistical Package for Social Sciences (SPSS), version 19. Results After six months of intervention, both SPA and USPA group participants showed significant improvements in all the tested neurocognitive parameters. On inter-group comparison, participants in SPA group showed significantly better improvements. Conclusion Physical activity training in adolescents is more beneficial when structured as per WHO guidelines, probably due to higher cognitive loading. PMID:26675059

  20. Hebiatric psychosomatic medicine.

    PubMed

    Knobel, M

    1979-01-01

    Adolescent disease should not be considered as something similar to infantile pathology or adult sicknesses. Special consideration must be given to the adolescent as such, taking into account the characteristics of adolescents as described in the 'Normal Adolescence Syndrome'. Symptom formation follows the same pattern as described elsewhere for children, adolescents and adults, but with very special differences in this stage of human development. Hysterical, hypochondriacal and psychotic types of psychosomatic illnesses can be described with the qualification of 'adolescent type'. Hebiatric medicine must be the specialized approach to illnesses in this developmental stage and must define its study object: the adolescent. Interviewing, clinical examination, diagnosis treatment and prognosis are of a specialized kind and the psychosomatic approach is also different. There are some more typical hebiatric pathologies that must be considered properly. PMID:482531

  1. Chinese Herbal Medicine and Fluorouracil-Based Chemotherapy for Colorectal Cancer: A Quality-Adjusted Meta-Analysis of Randomized Controlled Trials.

    PubMed

    McCulloch, Michael; Ly, Helen; Broffman, Michael; See, Caylie; Clemons, Jen; Chang, Raymond

    2016-09-01

    Background Chinese herbal medicines reportedly increase efficacy and minimize toxicity of chemotherapy; however, little attention has been paid to how poor study quality can bias outcomes. Methods We systematically searched MEDLINE, TCMLARS, EMBASE, and Cochrane Library for randomized controlled trials of Chinese herbal medicines combined with fluorouracil-based chemotherapy compared with the same chemotherapy alone. We screened for eligibility, extracted data, and pooled data with random-effects meta-analysis. Outcome measures were survival, toxicity, tumor response, performance status, quality of life, and Cochrane Risk of Bias (ROB) criteria to critically evaluate the quality of reporting in the randomized trials included in the meta-analysis. Results We found 36 potentially eligible studies, with only 3 (those with low ROB) qualifying for meta-analysis. Two reported chemotherapy-related diarrhea reduced by 57% (relative risk [RR] = 0.43; 95% CI = 0.19-1.01; I(2) test for variation in RR due to heterogeneity = 0.0%), with nonsignificant results. Two reported white blood cell toxicity reduced by 66% (RR = 0.34; 95% CI = 0.16-0.72; I(2) test for variation in RR due to heterogeneity = 0.0%), with statistically significant results. Stratifying analysis by studies with high versus low ROB, we found substantial overestimation of benefit: Studies with high ROB overestimated by nearly 2-fold reduction of platelet toxicity by Chinese herbal medicines (RR = 0.35, 95% CI = 0.15-0.84 vs RR = 0.65, 95% CI = 0.11-3.92). Studies with high ROB overestimated by nearly 2-fold reduction of vomiting toxicity (RR = 0.45, 95% CI = 0.33-0.61 vs RR = 0.87, 95% CI = 0.48-1.58). And, studies with high ROB overestimated by 21% the reduction in diarrhea toxicity (RR = 0.34, 95% CI = 0.20-0.58 vs RR = 0.43, 95% CI = 0.19-1.01). Studies with high ROB also overestimated by 16% improvement in tumor response (RR = 1.39, 95% CI = 1.18-1.63 vs RR = 1.20; 95% CI = 0.81-1.79). Not accounting for

  2. Cognitive-behavioural health-promotion intervention increases fruit and vegetable consumption and physical activity among South African adolescents: a cluster-randomised controlled trial.

    PubMed

    Jemmott, John B; Jemmott, Loretta S; O'Leary, Ann; Ngwane, Zolani; Icard, Larry; Bellamy, Scarlett; Jones, Shasta; Landis, J Richard; Heeren, G Anita; Tyler, Joanne C; Makiwane, Monde B

    2011-02-01

    Rates of chronic diseases are high among Black South Africans but few studies have tested cognitive-behavioural health-promotion interventions to reduce this problem. We tested the efficacy of such an intervention among adolescents in a cluster-randomised controlled trial. We randomly selected 9 of 17 matched pairs of schools and randomised one school in each pair to the cognitive-behavioural health-promotion intervention designed to encourage health-related behaviours and the other to a human immunodeficiency virus (HIV)/sexually transmitted disease (STD) risk-reduction intervention that served as the control. Interventions were based on social cognitive theory, the theory of planned behaviour and qualitative data from the target population. Data collectors, blind to participants' intervention, administered confidential assessments at baseline and 3, 6 and 12 months post-intervention. Primary outcomes were fruit and vegetable consumption and physical activity. Participants were 1057 grade 6 learners (mean age = 12.4 years), with 96.7% retained at 12-month follow-up. Generalised estimating equations revealed that averaged over the follow-ups, a greater percentage of health-promotion intervention participants than HIV/STD control participants met 5-a-Day fruit and vegetable and physical activity guidelines. The intervention also increased health-promotion knowledge, attitude and intention, but did not decrease substance use or substance-use attitude and intention. The findings suggest that theory based and contextually appropriate interventions may increase health behaviours among young adolescents in sub-Saharan Africa.

  3. Alpha-Lipoic Acid and Antioxidant Diet Help to Improve Endothelial Dysfunction in Adolescents with Type 1 Diabetes: A Pilot Trial.

    PubMed

    Scaramuzza, Andrea; Giani, Elisa; Redaelli, Francesca; Ungheri, Saverio; Macedoni, Maddalena; Giudici, Valentina; Bosetti, Alessandra; Ferrari, Matteo; Zuccotti, Gian Vincenzo

    2015-01-01

    After evaluating the prevalence of early endothelial dysfunction, as measured by means of reactive hyperemia in adolescents with type 1 diabetes, we started a 6-month, double-blind, randomized trial to test the efficacy of an antioxidant diet (± alpha-lipoic acid supplementation) to improve endothelial dysfunction. Seventy-one children and adolescents, ages 17 ± 3.9 yrs, with type 1 diabetes since 9.5 ± 5.3 yrs, using intensified insulin therapy, were randomized into 3 arms: (a) antioxidant diet 10.000 ORAC + alpha-lipoic acid; (b) antioxidant diet 10.000 ORAC + placebo; (c) controls. BMI, blood pressure, fasting lipid profile, HbA1c, insulin requirement, dietary habits, and body composition were determined in each patient. An antioxidant diet significantly improved endothelial dysfunction when supplemented with alpha-lipoic acid, unlike diet with placebo or controls. A significant reduction in bolus insulin was also observed. We speculate that alpha-lipoic acid might have an antioxidant effect in pediatric diabetes patients by reducing insulin.

  4. 12 month changes in dietary intake of adolescent girls attending schools in low-income communities following the NEAT Girls cluster randomized controlled trial.

    PubMed

    Collins, Clare E; Dewar, Deborah L; Schumacher, Tracy L; Finn, Tara; Morgan, Philip J; Lubans, David R

    2014-02-01

    Poor dietary habits and obesity are more prevalent in lower socio-economic status (SES) communities. The NEAT Girls cluster randomized controlled trial was a school-based obesity prevention program targeting adolescent girls in low SES schools in NSW, Australia. The aim was to evaluate the 12-month impact of key nutrition program messages on dietary intake and food behaviors. Diet was assessed using a validated semi-quantitative food frequency questionnaire (FFQ). Individual foods were categorized into nutrient-dense or energy-dense, nutrient-poor food groups and the percentage contribution to total energy intake calculated. Participants were aged 13.2±0.5years (n=330). There were no statistically significant group-by-time effects for dietary intake or food related behaviors, with 12-month trends suggesting more intervention group girls had improved water intakes (59% consuming⩽three glasses per day to 54% at 12 months vs. 50% to 61% in controls, p=0.052), with a greater proportion consuming < one sweetened beverage per day (24-41% vs. 34-37% in controls, p=0.057). Further research including more intensive nutrition intervention strategies are required to evaluate whether dietary intake in adolescent girls attending schools in low SES communities can be optimized.

  5. Alpha-Lipoic Acid and Antioxidant Diet Help to Improve Endothelial Dysfunction in Adolescents with Type 1 Diabetes: A Pilot Trial

    PubMed Central

    Scaramuzza, Andrea; Giani, Elisa; Redaelli, Francesca; Ungheri, Saverio; Macedoni, Maddalena; Giudici, Valentina; Bosetti, Alessandra; Ferrari, Matteo; Zuccotti, Gian Vincenzo

    2015-01-01

    After evaluating the prevalence of early endothelial dysfunction, as measured by means of reactive hyperemia in adolescents with type 1 diabetes, we started a 6-month, double-blind, randomized trial to test the efficacy of an antioxidant diet (± alpha-lipoic acid supplementation) to improve endothelial dysfunction. Seventy-one children and adolescents, ages 17 ± 3.9 yrs, with type 1 diabetes since 9.5 ± 5.3 yrs, using intensified insulin therapy, were randomized into 3 arms: (a) antioxidant diet 10.000 ORAC + alpha-lipoic acid; (b) antioxidant diet 10.000 ORAC + placebo; (c) controls. BMI, blood pressure, fasting lipid profile, HbA1c, insulin requirement, dietary habits, and body composition were determined in each patient. An antioxidant diet significantly improved endothelial dysfunction when supplemented with alpha-lipoic acid, unlike diet with placebo or controls. A significant reduction in bolus insulin was also observed. We speculate that alpha-lipoic acid might have an antioxidant effect in pediatric diabetes patients by reducing insulin. PMID:26171398

  6. A cluster randomized controlled trial to evaluate the effectiveness of the clinically integrated RHL evidence -based medicine course

    PubMed Central

    2010-01-01

    Background and objectives Evidence-based health care requires clinicians to engage with use of evidence in decision-making at the workplace. A learner-centred, problem-based course that integrates e-learning in the clinical setting has been developed for application in obstetrics and gynaecology units. The course content uses the WHO reproductive health library (RHL) as the resource for systematic reviews. This project aims to evaluate a clinically integrated teaching programme for incorporation of evidence provided through the WHO RHL. The hypothesis is that the RHL-EBM (clinically integrated e-learning) course will improve participants' knowledge, skills and attitudes, as well as institutional practice and educational environment, as compared to the use of standard postgraduate educational resources for EBM teaching that are not clinically integrated. Methods The study will be a multicentre, cluster randomized controlled trial, carried out in seven countries (Argentina, Brazil, Democratic Republic of Congo, India, Philippines, South Africa, Thailand), involving 50-60 obstetrics and gynaecology teaching units. The trial will be carried out on postgraduate trainees in the first two years of their training. In the intervention group, trainees will receive the RHL-EBM course. The course consists of five modules, each comprising self-directed e-learning components and clinically related activities, assignments and assessments, coordinated between the facilitator and the postgraduate trainee. The course will take about 12 weeks, with assessments taking place pre-course and 4 weeks post-course. In the control group, trainees will receive electronic, self-directed EBM-teaching materials. All data collection will be online. The primary outcome measures are gain in EBM knowledge, change in attitudes towards EBM and competencies in EBM measured by multiple choice questions (MCQs) and a skills-assessing questionniare administered eletronically. These questions have been

  7. Clinical trials of medicines in neonates: the influence of ethical and practical issues on design and conduct

    PubMed Central

    Turner, Mark A

    2015-01-01

    In the past, there has been a perception that ethical and practical problems limit the opportunities for research in neonates. This perception is no longer appropriate. It is now clear that research about the medicines used in neonates is an ethical requirement. It is possible to conduct high quality research in neonates if the research team adapt to the characteristics of this population. Good practice involves respecting the specific needs of newborn babies and their families by adopting relevant approaches to study design, recruitment, pharmacokinetic studies and safety assessment. Neonatal units have a unique culture that requires careful development in a research setting. Clinical investigators need to recognize the clinical and ethical imperative to conduct rigorous research. Industry needs to engage with neonatal networks early in the process of drug development, preferably before contacting regulatory agencies. Follow-up over 3–5 years is essential for the evaluation of medicines in neonates and explicit funding for this is required for the assessment of the benefit and risk of treatments given to sick newborn babies. The views of parents must be central to the development of studies and the research agenda. Ethical and practical problems are no longer barriers to research in neonates. The current challenges are to disseminate good practice and maximize capacity in order to meet the need for research among newborn babies. PMID:25041601

  8. Cognitive-Behavioral Treatment versus an Active Control for Children and Adolescents with Anxiety Disorders: A Randomized Trial

    ERIC Educational Resources Information Center

    Hudson, Jennifer L.; Rapee, Ronald M.; Deveney, Charise; Schniering, Carolyn A.; Lyneham, Heidi J.; Bavopoulos, Nataly

    2009-01-01

    Specific delivery of cognitive-behavioral skills is more effective in treating childhood anxiety compared to treatment that contains only nonspecific therapy factors. The findings are based on a randomized trial involving 112 children aged 7-16 years.

  9. Is Marijuana Medicine?

    MedlinePlus

    ... Publications » DrugFacts » Is Marijuana Medicine? DrugFacts: Is Marijuana Medicine? Email Facebook Twitter Revised July 2015 What is ... isn’t the marijuana plant an FDA-approved medicine? The FDA requires carefully conducted studies (clinical trials) ...

  10. GMP facilities for manufacturing of advanced therapy medicinal products for clinical trials: an overview for clinical researchers.

    PubMed

    Alici, Evren; Blomberg, Pontus

    2010-12-01

    To be able to produce advanced therapy medicinal products, compliance with regulatory standards while maintaining flexibility is mandatory. For this purpose, careful planning is vital in the design or upgrade of a facility. Similarly, extensive foresight is elemental to anticipate upcoming needs and requirements. Failing this may lead to the facility's in-ability to meet the demands. In this chapter we aimed to outline the current issues with regards to the European Union Directives (EUD) and the proposal for Advanced Therapies, which are of importance to cellular and gene therapy facilities in Europe. This chapter is an attempt to elucidate what the minimum requirements for GMP facilities for cell and gene therapy products are and what is considered necessary to comply with the regulations in Europe.

  11. NCI and the Precision Medicine Initiative®

    Cancer.gov

    NCI's activities related to precision medicine focuses on new and expanded precision medicine clinical trials; mechanisms to overcome drug resistance to cancer treatments; and developing a shared digital repository of precision medicine trials data.

  12. Evaluation of a group cognitive-behavioral depression prevention program for young adolescents: A randomized effectiveness trial

    PubMed Central

    Gillham, Jane E.; Reivich, Karen J.; Brunwasser, Steven M.; Freres, Derek R.; Chajon, Norma D.; Megan Kash-MacDonald, V.; Chaplin, Tara M.; Abenavoli, Rachel M.; Matlin, Samantha L.; Gallop, Robert J.; Seligman, Martin E.P.

    2015-01-01

    Objective Depression is a common psychological problem in adolescence. Recent research suggests that group cognitive-behavioral interventions can reduce and prevent symptoms of depression in youth. Few studies have tested the effectiveness of such interventions when delivered by school teachers and counselors (as opposed to research team staff). Method We evaluated the effectiveness of the Penn Resiliency Program for adolescents (PRP-A), a school-based group intervention that targets cognitive behavioral risk factors for depression. We randomly assigned 408 middle school students (ages 10-15) to one of three conditions: PRP-A, PRP-AP (in which adolescents participated in PRP-A and parents were invited to attend a parent intervention component), or a school-as-usual control. Adolescents completed measures of depression and anxiety symptoms, cognitive style, and coping at baseline, immediately after the intervention, and at 6-month follow-up. Results PRP-A reduced depression symptoms relative to the school as usual control. Baseline levels of hopelessness moderated intervention effects. Among participants with average and high levels of hopelessness, PRP (A and AP) significantly improved depression symptoms, anxiety symptoms, hopelessness, and active coping relative to control. Among participants with low baseline hopelessness, we found no intervention effects. PRP-AP was not more effective than PRP-A alone. We found no intervention effects on clinical levels of depression or anxiety. Conclusion These findings suggest that cognitive-behavioral interventions can be beneficial when delivered by school teachers and counselors. These interventions may be most helpful to students with elevated hopelessness. PMID:22889296

  13. THE BIG PICTURE ON SMALL MEDICINE: THE STATE OF NANOMEDICINE PRODUCTS APPROVED FOR USE OR IN CLINICAL TRIALS

    PubMed Central

    Etheridge, Michael L.; Campbell, Stephen A.; Erdman, Arthur G.; Haynes, Christy L.; Wolf, Susan M.; McCullough, Jeffrey

    2015-01-01

    Developments in nanomedicine are expected to provide solutions to many of modern medicine’s unsolved problems, so it is no surprise that literature is flush with articles discussing the subject. However, existing reviews tend to focus on specific sectors of nanomedicine or take a very forward looking stance and fail to provide a complete perspective on the current landscape. This article provides a more comprehensive and contemporary inventory of nanomedicine products. A keyword search of literature, clinical trial registries, and the Web, yielded 247 nanomedicine products that are approved or in various stages of clinical study. Specific information on each was gathered, so the overall field could be described based on various dimensions, including: FDA classification, approval status, nanoscale size, treated condition, nanostructure, and others. In addition to documenting the large number of nanomedicine products already in human use, this study indentifies some interesting trends forecasting the future of nanomedicine. PMID:22684017

  14. Managed Activity Graded Exercise iN Teenagers and pre-Adolescents (MAGENTA) feasibility randomised controlled trial: study protocol

    PubMed Central

    Brigden, Amberly; Beasant, Lucy; Hollingworth, William; Metcalfe, Chris; Gaunt, Daisy; Mills, Nicola; Jago, Russell; Crawley, Esther

    2016-01-01

    Introduction Paediatric chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME) is a relatively common and disabling condition, yet there is a limited evidence base for treatment. There is good evidence that graded exercise therapy is moderately effective in adults with CFS/ME, but there is little evidence for the effectiveness, cost-effectiveness, acceptability or best method of delivery for paediatric CFS/ME. This study aims to investigate the acceptability and feasibility of carrying out a multicentre randomised controlled trial investigating the effectiveness of graded exercise therapy compared with activity management for children/teenagers who are mildly or moderately affected with CFS/ME. Methods and analysis 100 paediatric patients (8–17 years) with CFS/ME will be recruited from 3 specialist UK National Health Service (NHS) CFS/ME services (Bath, Cambridge and Newcastle). Patients will be randomised (1:1) to receive either graded exercise therapy or activity management. Feasibility analysis will include the number of young people eligible, approached and consented to the trial; attrition rate and treatment adherence; questionnaire and accelerometer completion rates. Integrated qualitative methods will ascertain perceptions of feasibility and acceptability of recruitment, randomisation and the interventions. All adverse events will be monitored to assess the safety of the trial. Ethics and dissemination The trial has received ethical approval from the National Research Ethics Service (South West—Frenchay 15/SW/0124). Trial registration number ISRCTN23962803; Pre-results. PMID:27377634

  15. An Internet-Based Intervention to Promote Alcohol-Related Attitudinal and Behavioral Change Among Adolescents: Protocol of a Cluster Randomized Controlled Trial

    PubMed Central

    Chan, Ko-Ling; Chow, Chun-Bong; Lam, Tai-Hing; Ho, Sai-Yin; Wong, Wilfred Hing-Sang; Wong, Margaret Fung-Yee

    2016-01-01

    Background Underage drinking is a prevalent risk behavior and common public health problem. Research shows that alcohol abuse not only affects the quality of life of drinkers themselves. The problems resulting from underage drinking pose substantial costs to society as well. The proposed study will address underage drinking with the use of an Internet campaign, which is a cost-effective way of tackling the problem. Objective The aims of this study are to test the effectiveness of an online quiz competition in changing adolescents’ alcohol-related attitudes and behavior and to explore the feasibility of using Internet viral marketing to reach a significant number of adolescents. Methods The study will constitute a cluster randomized controlled trial for 20 secondary schools (6720 Grade 7-9 students). Schools will be randomized to intervention or control arm with equal likelihood. Students in intervention schools will be invited to take part in the Internet campaign, whereas those in control schools will receive relevant promotional leaflets. Results Alcohol-related attitude and behavior will be the primary outcome measures. The results of the proposed study will provide evidence on the efficacy of an Internet intervention in modifying adolescents’ attitudes and behavior and guide further investigation into the prevention of and intervention in such risk behaviors as underage drinking. The project was funded July 2015, enrollment started September 2015, and results are expected July 2017. Conclusions With the Internet increasingly being recognized as a practical and cost-effective platform for health information delivery, the proposed Internet-based intervention is expected to be more effective in altering adolescents’ alcohol-related attitudes and behaviors than traditional health promotion. ClinicalTrial ClinicalTrials.gov NCT02450344; https://clinicaltrials.gov/ct2/show/NCT02450344 (Archived by WebCite at http://www.webcitation.org/6heB2zMBD) PMID:27252072

  16. Can Chinese Herbal Medicine Adjunctive Therapy Improve Outcomes of Senile Vascular Dementia? Systematic Review with Meta-analysis of Clinical Trials.

    PubMed

    Zeng, Lingfeng; Zou, Yuanping; Kong, Lingshuo; Wang, Ningsheng; Wang, Qi; Wang, Lu; Cao, Ye; Wang, Kezhu; Chen, Yunbo; Mi, Suiqing; Zhao, Wei; Wu, Haitao; Cheng, Shuyi; Xu, Weihua; Liang, Weixiong

    2015-12-01

    Many publications have reported the growing application of complementary and alternative medicine, particularly the use of Chinese herbal medicine (CHM) in combination with routine pharmacotherapy (RP) for senile vascular dementia (SVD), but its efficacy remains largely unexplored. The purpose of this study is to evaluate the efficacy of CHM adjunctive therapy (CHMAT), which is CHM combined with RP, in the treatment of SVD. Publications in seven electronic databases were searched extensively, and 27 trials with a total of 1961 patients were included for analysis. Compared with RP alone, CHMAT significantly increased the effective rate [odds ratio (OR) 2.98, 95% confidence interval (CI) 2.30, 3.86]. In addition, CHMAT showed benefits in detailed subgroups of the Mini-Mental State Exam (MMSE) score from time of onset to 4 weeks (WMD 3.01, 95% CI 2.15, 3.87), 8 weeks (weighted mean difference (WMD) 2.30, 95% CI 1.28, 3.32), 12 weeks (WMD 2.93, 95% CI 2.17, 3.69), and 24 weeks (WMD 3.25, 95% CI 2.61, 3.88), and in the activity of daily living scale score from time of onset to 4 weeks (WMD -4.64, 95% CI -6.12, -3.17), 8 weeks (WMD -4.30, 95% CI -6.04, -2.56), 12 weeks (WMD -3.89, 95% CI -4.68, -3.09), and 24 weeks (WMD -4.04, 95% CI -6.51, -1.57). Moreover, CHMAT had positive effects on changes in the Hasegawa dementia scale, National Institutes of Health Stroke Scale, Clinical Dementia Rating, and Montreal Cognitive Assessment scores, as well as blood fat levels (total cholesterol, triglyceride, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and apolipoprotein E), platelet aggregation rate (1-min platelet aggregation rate, 5-min platelet aggregation rate, and maximal platelet aggregation rate), and blood rheology (whole-blood viscosity and hematocrit). No serious or frequently occurring adverse effects were reported. Weaknesses of methodological quality in most trials were assessed using the Cochrane risk of bias tool, while

  17. Can Chinese Herbal Medicine Adjunctive Therapy Improve Outcomes of Senile Vascular Dementia? Systematic Review with Meta-analysis of Clinical Trials.

    PubMed

    Zeng, Lingfeng; Zou, Yuanping; Kong, Lingshuo; Wang, Ningsheng; Wang, Qi; Wang, Lu; Cao, Ye; Wang, Kezhu; Chen, Yunbo; Mi, Suiqing; Zhao, Wei; Wu, Haitao; Cheng, Shuyi; Xu, Weihua; Liang, Weixiong

    2015-12-01

    Many publications have reported the growing application of complementary and alternative medicine, particularly the use of Chinese herbal medicine (CHM) in combination with routine pharmacotherapy (RP) for senile vascular dementia (SVD), but its efficacy remains largely unexplored. The purpose of this study is to evaluate the efficacy of CHM adjunctive therapy (CHMAT), which is CHM combined with RP, in the treatment of SVD. Publications in seven electronic databases were searched extensively, and 27 trials with a total of 1961 patients were included for analysis. Compared with RP alone, CHMAT significantly increased the effective rate [odds ratio (OR) 2.98, 95% confidence interval (CI) 2.30, 3.86]. In addition, CHMAT showed benefits in detailed subgroups of the Mini-Mental State Exam (MMSE) score from time of onset to 4 weeks (WMD 3.01, 95% CI 2.15, 3.87), 8 weeks (weighted mean difference (WMD) 2.30, 95% CI 1.28, 3.32), 12 weeks (WMD 2.93, 95% CI 2.17, 3.69), and 24 weeks (WMD 3.25, 95% CI 2.61, 3.88), and in the activity of daily living scale score from time of onset to 4 weeks (WMD -4.64, 95% CI -6.12, -3.17), 8 weeks (WMD -4.30, 95% CI -6.04, -2.56), 12 weeks (WMD -3.89, 95% CI -4.68, -3.09), and 24 weeks (WMD -4.04, 95% CI -6.51, -1.57). Moreover, CHMAT had positive effects on changes in the Hasegawa dementia scale, National Institutes of Health Stroke Scale, Clinical Dementia Rating, and Montreal Cognitive Assessment scores, as well as blood fat levels (total cholesterol, triglyceride, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and apolipoprotein E), platelet aggregation rate (1-min platelet aggregation rate, 5-min platelet aggregation rate, and maximal platelet aggregation rate), and blood rheology (whole-blood viscosity and hematocrit). No serious or frequently occurring adverse effects were reported. Weaknesses of methodological quality in most trials were assessed using the Cochrane risk of bias tool, while

  18. Relative Cost-Effectiveness of Treatments for Adolescent Depression: 36-Week Results from the TADS Randomized Trial

    ERIC Educational Resources Information Center

    Domino, Marisa Elena; Foster, E. Michael; Vitiello, Benedetto; Kratochvil, Christopher J.; Burns, Barbara J.; Silva, Susan G.; Reinecke, Mark A.; March, John S.

    2009-01-01

    Randomized controlled trials that involve 327 participants aged 12 to 18 who were diagnosed with major depression were given either fluoxetine alone, cognitive-behavioral therapy, or a combination of both. Cost-effectiveness acceptability curves suggest that combination treatment is highly likely to be the most cost-effective treatment than…

  19. Effects of aerobic training, resistance training, or both on cardiorespiratory and musculoskeletal fitness in adolescents with obesity: the HEARTY trial.

    PubMed

    Alberga, Angela S; Prud'homme, Denis; Sigal, Ronald J; Goldfield, Gary S; Hadjiyannakis, Stasia; Phillips, Penny; Malcolm, Janine; Ma, Jinhui; Doucette, Steve; Gougeon, Rejeanne; Wells, George A; Kenny, Glen P

    2016-03-01

    The purpose of this study was to examine the effects of aerobic, resistance, and combined exercise training on cardiorespiratory and musculoskeletal fitness in postpubertal adolescents with obesity. After a 4-week supervised moderate-intensity exercise run-in, 304 adolescents aged 14-18 years with body mass index ≥85th percentile were randomized to 4 groups for 22 weeks of aerobic training, resistance training, combined training, or a nonexercising control. All participants received dietary counselling with a maximum daily energy deficit of 250 kcal. Cardiorespiratory fitness (peak oxygen consumption) was measured by indirect calorimetry using a graded treadmill exercise test. Musculoskeletal fitness was measured using the 2003 Canadian Physical Activity Fitness and Lifestyle Appraisal tests (hand grip, push-ups, partial curl-ups, sit and reach, and vertical jump). Muscular strength was assessed using an 8-repetition maximum test on the bench press, seated row, and leg press machines. A greater increase in peak oxygen consumption in the aerobic exercise group (30.6 ± 0.6 to 33.4 ± 0.7 mLO2/kg/min) was measured relative to the control group (30.6 ± 0.5 to 30.9 ± 0.7 mLO2/kg/min) (p = 0.002). Similarly, the number of partial curl-ups increased in the aerobic group (19 ± 1 to 23 ± 1) while no differences were measured in the control group (19 ± 1 to 20 ± 1) (p = 0.015). Increases in muscular strength and number of push-ups were greatest in the resistance group versus the control and combined groups versus the aerobic group (p < 0.05). In conclusion, aerobic training had the strongest effect on cardiorespiratory fitness, while resistance and combined training improved both muscular strength and endurance more than control and aerobic training alone, respectively, in adolescents with obesity.

  20. Engaging adolescent girls from linguistically diverse and low income backgrounds in school sport: a pilot randomised controlled trial.

    PubMed

    Dudley, Dean A; Okely, Anthony D; Pearson, Philip; Peat, Jennifer

    2010-03-01

    The purpose of this study was to determine the feasibility, acceptability, and potential efficacy of a school-based physical activity program delivered during school sport time among adolescent girls from low income predominately linguistically diverse backgrounds in New South Wales, Australia. Using a 3-month, 2-arm, parallel-group pilot RCT design, 38 adolescent girls (Year 11) were recruited to participate in the program and randomised into intervention (n=17) or control groups (n=21). The intervention program aimed to increase physical activity by improving enjoyment, physical self-perception and perceived competence. Baseline and follow-up (12 weeks) assessments included enjoyment of physical activity, physical self-perception, and objectively measured physical activity during school sport sessions. Process data were collected through observations of lessons, attendance records, and interviews with participants and staff. Recruitment (63%) and retention (68%) goals were less than anticipated but similar to other studies. Participation was higher for the intervention (72%) than the control (60%) group and the intervention group reported high levels of satisfaction with the program. At follow-up, girls in the intervention group, compared with the control group, showed greater improvement in their enjoyment of physical activity during school sport (adjusted mean difference=3.8, 95% Confidence Interval [CI] -2.4, 10.1; Cohen's d=0.42 standard deviation units) and body image (adjusted difference mean=1.0, 95% CI -0.4, 2.3; d=0.50). There was a smaller decline in participation in physical activity during school sport (adjusted mean=13.6, 95% CI -21.8, 48.9; d=0.24). This study highlights major barriers confronting adolescent girls' participation in school sport. Some of these include teacher attitudes and support, activities and programming, purpose and distinction, and student input. Negotiating these barriers and overcoming them in a school setting appears

  1. Depressed Adolescents Treated with Exercise (DATE): A pilot randomized controlled trial to test feasibility and establish preliminary effect sizes

    PubMed Central

    Hughes, Carroll W.; Barnes, Shauna; Barnes, Conrad; DeFina, Laura F.; Nakonezny, Paul; Emslie, Graham J.

    2013-01-01

    The Depressed Adolescents Treated with Exercise (DATE) study evaluated a standardized aerobic exercise protocol to treat nonmedicated adolescents that met DSM-IV-TR criteria for major depressive disorder. From an initial screen of 90 individuals, 30 adolescents aged 12-18 years were randomized to either vigorous exercise (EXER) (>12 kg/kcal/week [KKW]) or a control stretching (STRETCH) activity (< 4 KKW) for 12 weeks. The primary outcome measure was the blinded clinician rating of the Children's Depression Rating Scale – Revised (CDRS-R) to assess depression severity and Actical (KKW) accelerometry 24hr/7days a week to assess energy expenditure and adherence. Follow-up evaluations occurred at weeks 26 and 52. The EXER group averaged 77% adherence and the STRETCH group 81% for meeting weekly target goals for the 12 week intervention based on weekly sessions completed and meeting KKW requirements. There was a significant increase in overall weekly KKW expenditures (p < .001) for both groups with the EXER group doubling the STRETCH group in weekly energy expenditure. Depressive symptoms were significantly reduced from baseline for both groups with the EXER group improving more rapidly than STRETCH after six weeks (p < .016) and nine weeks (p < .001). Both groups continued to improve such that there were no group differences after 12 weeks (p = .07). By week 12, the exercise group had a 100% response rate (86% remission), whereas the stretch group response rate was 67% (50% remission) (p = .02). Both groups had improvements in multiple areas of psychosocial functioning related to school and relationships with parents and peers. Anthropometry reflected decreased waist, hip and thigh measurements (p = .02), more so for females than males (p = .05), but there were no weight changes for either gender. The EXER group sustained 100% remission at week 26 and 52. The STRETCH group had 80% response and 70% remission rates at week 26 and by week 52 only one had not fully

  2. Assessment of the Reporting Quality of Placebo-controlled Randomized Trials on the Treatment of Type 2 Diabetes With Traditional Chinese Medicine in Mainland China: A PRISMA-Compliant Systematic Review.

    PubMed

    Zhao, Xiyan; Zhen, Zhong; Guo, Jing; Zhao, Tianyu; Ye, Ru; Guo, Yu; Chen, Hongdong; Lian, Fengmei; Tong, Xiaolin

    2016-01-01

    Placebo-controlled randomized trials are often used to evaluate the absolute effect of new treatments and are considered gold standard for clinical trials. No studies, however, have yet been conducted evaluating the reporting quality of placebo-controlled randomized trials. The current study aims to assess the reporting quality of placebo-controlled randomized trials on treatment of diabetes with Traditional Chinese Medicine (TCM) in Mainland China and to provide recommendations for improvements.China National Knowledge Infrastructure database, Wanfang database, China Biology Medicine database, and VIP database were searched for placebo-controlled randomized trials on treatment of diabetes with TCM. Review, animal experiment, and randomized controlled trials without placebo control were excluded. According to Consolidated Standards of Reporting Trials (CONSORT) 2010 checklists items, each item was given a yes or no depending on whether it was reported or not.A total of 68 articles were included. The reporting percentage in each article ranged from 24.3% to 73%, and 30.9% articles reported more than 50% of the items. Seven of the 37 items were reported more than 90% of the items, whereas 7 items were not mentioned at all. The average reporting for "title and abstract," "introduction," "methods," "results," "discussion," and "other information" was 43.4%, 78.7%, 40.1%, 49.9%, 71.1%, and 17.2%, respectively. The percentage of each section had increased after 2010. In addition, the reporting of multiple study centers, funding, placebo species, informed consent forms, and ethical approvals were 14.7%, 50%, 36.85%, 33.8%, and 4.4%, respectively.Although a scoring system was created according to the CONSORT 2010 checklist, it was not designed as an assessment tool. According to CONSORT 2010, the reporting quality of placebo-controlled randomized trials on the treatment of diabetes with TCM improved after 2010. Future improvements, however, are still needed, particularly

  3. Laboratory and field trial of developing medicinal local Thai plant products against four species of mosquito vectors.

    PubMed

    Trongtokit, Yuwadee; Rongsriyam, Yupha; Komalamisra, Narumon; Krisadaphong, Panvipa; Apiwathnasorn, Chamnarn

    2004-06-01

    Oils of Syzygium aromaticum (clove) and Zanthoxylum limonella (makaen), widely used essential oils for dental caries or flavoring of food in Thailand, were prepared as 10 experimental repellent products in gel or cream form against Aedes aegypti, Culex quinquefasciatus, and Anopheles dirus under laboratory conditions, using the human-arm-in-cage method. Two products that gave the longest-lasting complete protection were selected to examine their repellency against a variety of mosquito species under field conditions. In laboratory tests, 0.1 g of each product was applied to 3x10 cm of exposed area on a volunteer's forearm, while in field trials, 1.0 g was applied to each volunteer's leg (from knee to ankle). In the laboratory, the gel dosage form contained 20% clove oil (Gel B) or 10% clove plus 10% makaen oil mixture (Gel E) were promising plant-based repellents against three mosquito species and gave significantly longer complete protection times of 4-5 hours than all other developing products. Therefore, their efficacy in the field was evaluated. Under field conditions, Gel E showed complete protection for 4 hours and gave 95.7% repellency after 5 hours application, whereas Gel B and 20% deet (di-methyl benzamide) provided only 86.8 and 82.7% repellency after treatment, respectively against Ae. aegypti, daytime-biting mosquitos. For nighttime-biting, the 3 repellents under development yielded equally excellent (average 97.1%) repellency for 5 hours against the predominant Cx. quinquefasciatus and Mansonia uniformis, but they gave 89.0% repellency against Cx. tritaeniorhynchus and Cx. gelidus. This finding demonstrated the effectiveness of Gel B and Gel E products for possible use by low-income rural communities against various mosquito species. PMID:15691131

  4. Medicinal clays improve the endurance of loaded inspiratory muscles in COPD: a randomized clinical trial of nonpharmacological treatment

    PubMed Central

    Baldi, Simonetta; Pinna, Gian Domenico; Bruschi, Claudio; Caldara, Fabrizio; Maestri, Roberto; Dacosto, Elena; Rezzani, Antonella; Popovich, Ermanno; Bellinzona, Ezio; Crotti, Paola; Montemartini, Silvia; Fracchia, Claudio

    2015-01-01

    Background Inspiratory resistive breathing (IRB) challenges affect respiratory muscle endurance in healthy individuals, which is considered to be an interleukin 6 (IL-6)–dependent mechanism. Whether nonpharmacological thermal therapies promote the endurance of loaded inspiratory muscles in chronic obstructive pulmonary disease (COPD) is unclear. The objectives of this study were to compare the effects of two thermal interventions on endurance time (ET) and plasma IL-6 concentration following an IRB challenge. Methods This study was a randomized, parallel-group, unblinded clinical trial in a single-center setting. Forty-two patients (aged 42–76 years) suffering from mild to severe COPD participated in this study. Both groups completed 12 sessions of the mud bath therapy (MBT) (n=22) or leisure thermal activity (LTA) (n=19) in a thermal spa center in Italy. Pre- and postintervention spirometry, maximum inspiratory pressure, and plasma mediators were obtained and ET and endurance oxygen expenditure (VO2Endur) were measured following IRB challenge at 40% of maximum inspiratory pressure. Results There was no difference in ΔIL-6 between the intervention groups. But, IRB challenge increased cytokine IL-6 plasma levels systematically. The effect size was small. A statistically significant treatment by IRB challenge effect existed in ET, which significantly increased in the MBT group (P=0.003). In analysis of covariance treatment by IRB challenge analysis with LnVO2Endur as the dependent variable, ΔIL-6 after intervention predicted LnVO2Endur in the MBT group, but not in the LTA group. Adverse events occurred in two individuals in the MBT group, but they were mainly transient. One patient in the LTA group dropped out. Conclusion MBT model improves ET upon a moderate IRB challenge, indicating the occurrence of a training effect. The LnVO2Endur/ΔIL-6 suggests a physiologic adaptive mechanism in respiratory muscles of COPD patients allocated to treatment. Both thermal

  5. Utilization of Western and Traditional Korean Medicine for Children and Adolescents with Mental Disorders: a Nationwide Population-based Study from 2010 to 2012.

    PubMed

    Kim, Su Jin; Kim, Bongseog; Lee, Young Sik; Bahn, Geon Ho

    2016-05-01

    When in need of medical treatment, Korean citizens have a choice of practitioners of western medicine (WM) or Traditional Korean Medicine (TKM). However, the two branches frequently conflict with one another, particularly with regard to mental disorders. This study was designed to compare the utilization of WM and TKM, focusing on child/adolescent patients with mental disorders. We analyzed F-code (Mental and behavioral disorders) claims from the Korean Health Insurance Review and Assessment Service, including data from 0-18-year-old patients from 2010 to 2012. Slightly more men than women utilized WM, while TKM use was almost evenly balanced. WM claims increased with advancing age, whereas utilization of TKM was common for the 0-6 age group. In WM and TKM, the total number of claims relying on the National Health Insurance Service (NHIS) was 331,154 (92.78%) and 73,282 (97.85%), respectively, and the number of claims relying on medical aid was 25,753 (7.22%) and 1,610 (2.15%), respectively. The most frequent F-coded claim in WM was F90 (Hyperkinetic disorders), with 64,088 claims (17.96%), and that in TKM was F45 (Somatoform disorders), with 28,852 claims (38.52%). The prevalence of a single disorder without comorbidities was 168,764 (47.29%) in WM and 52,615 (70.25%) in TKM. From these data, we conclude that WM takes prevalence over TKM in cases of attention deficit/hyperactivity disorder (ADHD), as well as in psychological problems such as depression and anxiety. On the other hand, patients utilizing TKM more commonly present with physical health problems including somatoform problems, sleep, and eating disorders. PMID:27134500

  6. Utilization of Western and Traditional Korean Medicine for Children and Adolescents with Mental Disorders: a Nationwide Population-based Study from 2010 to 2012

    PubMed Central

    2016-01-01

    When in need of medical treatment, Korean citizens have a choice of practitioners of western medicine (WM) or Traditional Korean Medicine (TKM). However, the two branches frequently conflict with one another, particularly with regard to mental disorders. This study was designed to compare the utilization of WM and TKM, focusing on child/adolescent patients with mental disorders. We analyzed F-code (Mental and behavioral disorders) claims from the Korean Health Insurance Review and Assessment Service, including data from 0–18-year-old patients from 2010 to 2012. Slightly more men than women utilized WM, while TKM use was almost evenly balanced. WM claims increased with advancing age, whereas utilization of TKM was common for the 0-6 age group. In WM and TKM, the total number of claims relying on the National Health Insurance Service (NHIS) was 331,154 (92.78%) and 73,282 (97.85%), respectively, and the number of claims relying on medical aid was 25,753 (7.22%) and 1,610 (2.15%), respectively. The most frequent F-coded claim in WM was F90 (Hyperkinetic disorders), with 64,088 claims (17.96%), and that in TKM was F45 (Somatoform disorders), with 28,852 claims (38.52%). The prevalence of a single disorder without comorbidities was 168,764 (47.29%) in WM and 52,615 (70.25%) in TKM. From these data, we conclude that WM takes prevalence over TKM in cases of attention deficit/hyperactivity disorder (ADHD), as well as in psychological problems such as depression and anxiety. On the other hand, patients utilizing TKM more commonly present with physical health problems including somatoform problems, sleep, and eating disorders. PMID:27134500

  7. Utilization of Western and Traditional Korean Medicine for Children and Adolescents with Mental Disorders: a Nationwide Population-based Study from 2010 to 2012.

    PubMed

    Kim, Su Jin; Kim, Bongseog; Lee, Young Sik; Bahn, Geon Ho

    2016-05-01

    When in need of medical treatment, Korean citizens have a choice of practitioners of western medicine (WM) or Traditional Korean Medicine (TKM). However, the two branches frequently conflict with one another, particularly with regard to mental disorders. This study was designed to compare the utilization of WM and TKM, focusing on child/adolescent patients with mental disorders. We analyzed F-code (Mental and behavioral disorders) claims from the Korean Health Insurance Review and Assessment Service, including data from 0-18-year-old patients from 2010 to 2012. Slightly more men than women utilized WM, while TKM use was almost evenly balanced. WM claims increased with advancing age, whereas utilization of TKM was common for the 0-6 age group. In WM and TKM, the total number of claims relying on the National Health Insurance Service (NHIS) was 331,154 (92.78%) and 73,282 (97.85%), respectively, and the number of claims relying on medical aid was 25,753 (7.22%) and 1,610 (2.15%), respectively. The most frequent F-coded claim in WM was F90 (Hyperkinetic disorders), with 64,088 claims (17.96%), and that in TKM was F45 (Somatoform disorders), with 28,852 claims (38.52%). The prevalence of a single disorder without comorbidities was 168,764 (47.29%) in WM and 52,615 (70.25%) in TKM. From these data, we conclude that WM takes prevalence over TKM in cases of attention deficit/hyperactivity disorder (ADHD), as well as in psychological problems such as depression and anxiety. On the other hand, patients utilizing TKM more commonly present with physical health problems including somatoform problems, sleep, and eating disorders.

  8. Interventions to Reduce Sexual Risk for HIV in Adolescents: A Meta-Analysis of Trials, 1985–2008

    PubMed Central

    Johnson, Blair T.; Scott-Sheldon, Lori A. J.; Huedo-Medina, Tania B.; Carey, Michael P.

    2014-01-01

    Objective To provide an updated review of the efficacy of behavioral interventions to reduce sexual risk of HIV among adolescents. Data Sources We searched electronic databases, leading public health journals, and the document depository held by the Synthesis of HIV/AIDS Risk Reduction Project. Studies that fulfilled the selection criteria and were available as of December 31, 2008 were included. Study Selection Studies were included if they investigated any behavioral intervention advocating sexual risk reduction for HIV prevention, sampled adolescents (age range, 11–19 years), measured a behavioral outcome relevant to sexual risk, and provided sufficient information to calculate effect sizes. Data from 98 interventions (N = 51,240 participants) were derived from 67 studies, dividing for qualitatively different interventions and gender when reports permitted it. Main Exposure Educational, psychosocial, or behavioral interventions to reduce sexual risk. Main Outcome Measures Condom use, sexual frequency, condom use skills, interpersonal communication skills, condom acquisition, and incident STIs. Results Relative to controls, interventions succeeded at reducing incident STIs, increasing condom use, reducing or delaying penetrative sex, and increasing skills to negotiate safer sex and to acquire prophylactic protection. Initial risk reduction varied depending on sample and intervention characteristics but did not decay over time. Conclusions Comprehensive behavioral interventions reduce risky sexual behavior and prevent transmission of STIs. Interventions are most successful when administered in larger doses. PMID:21199984

  9. Outcomes of a 1-year randomized controlled trial to evaluate a behavioral ‘stepped-down’ weight loss intervention for adolescent patients with obesity

    PubMed Central

    Norman, G.; Huang, J.; Davila, E. P.; Kolodziejczyk, J. K.; Carlson, J.; Covin, J. R.; Gootschalk, M.; Patrick, K.

    2015-01-01

    Summary Background Stepped-care approaches to weight loss have shown some success among adults. A ‘stepped-down’ version of the stepped-care approach to adolescent weight loss has never been evaluated. Objectives We conducted a one-year randomized controlled trial to compare a stepped-down weight loss intervention versus enhanced usual care (EUC). Methods Study participants were obese adolescents age 11–13 (N = 106, 51% girls, and 82% Hispanic) recruited from primary care clinics in San Diego, California. The stepped-down intervention was delivered through clinician and health educator counseling (in-person and by phone) and mailed content. The intervention consisted of four-month ‘steps’ beginning with the most intensive contact followed by reduced contact if treatment goals were met. The EUC group received an initial physician visit, one session with a health counselor, and monthly mailed materials. Body mass index (BMI kg/m2) was measured at baseline, 4, 8, and 12 months. Mixed-model regression analyses were stratified by sex. Results Results indicated a clinically significant treatment effect for boys on BMI (p < 0.001) but not girls. No between group differences were found for adiposity and biometric outcomes. Only 13% of intervention participants succeeded in stepping down from step 1 to step 2 or step 3. Conclusions A stepped-down approach to weight loss showed some evidence of efficacy for weight loss in boys but not girls. The findings suggest the program as designed was not intensive enough to result in weight loss in this population segment. PMID:25702630

  10. Biomarkers of kidney integrity in children and adolescents with dental amalgam mercury exposure: findings from the Casa Pia children's amalgam trial.

    PubMed

    Woods, James S; Martin, Michael D; Leroux, Brian G; DeRouen, Timothy A; Bernardo, Mario F; Luis, Henrique S; Leitão, Jorge G; Kushleika, John V; Rue, Tessa C; Korpak, Anna M

    2008-11-01

    Mercury is toxic to the kidney, and dental amalgam is a source of mercury exposure. Few studies have evaluated the effects of dental amalgam on kidney function in a longitudinal context in children. Here, we evaluated urinary concentrations of glutathione S-transferases (GSTs) alpha and pi as biomarkers of renal proximal and distal tubular integrity, respectively, and albumin as a biomarker of glomerular integrity in children and adolescents 8-18 years of age over a 7-year course of dental amalgam treatment. Five hundred seven children, 8-12 years of age at baseline, participated in a clinical trial to evaluate the neurobehavioral and renal effects of dental amalgam in children. Subjects were randomized to either dental amalgam or resin composite treatments. Urinary GSTs alpha and pi, albumin, and creatinine concentrations were measured at baseline and annually in all subjects. Results were evaluated using linear regression analysis. GST-alpha concentrations were similar between treatment groups and in each sex and race (white vs. non-white) group in each follow-up year. GST-pi levels tended upward over the course of follow-up by four- to six-fold. This increase was seen in all groups irrespective of the treatment, race, or gender. Females had GST-pi levels approximately twice those of males at all ages. Albumin concentrations were constant throughout the follow-up period and did not differ by treatment, although females had 39% higher albumin levels than males. Additionally, we found no significant effects of amalgam treatment on the proportion of children with microalbuminuria (>30 mg/g creatinine). These findings are relevant within the context of children's health risk assessment as relates to the safety of mercury exposure from dental amalgam on kidney function. These data also provide normative values for sensitive indices of renal functional integrity that may serve in the evaluation of children and adolescents with renal disorders.

  11. Trajectories of change during a randomized controlled trial of internet-delivered psychological treatment for adolescent chronic pain: how does change in pain and function relate?

    PubMed

    Palermo, Tonya M; Law, Emily F; Zhou, Chuan; Holley, Amy Lewandowski; Logan, Deirdre; Tai, Gabrielle

    2015-04-01

    Although pain and function improve at immediate posttreatment for youth receiving cognitive behavioral therapy for chronic pain, limited data are available to understand changes that youth make during psychological treatment. We sought to characterize distinct trajectory patterns of change in pain and function to understand the temporal association of these changes during internet-delivered cognitive behavioral therapy (CBT). Weekly repeated assessments of pain and function were conducted during 8 weeks of treatment among 135 adolescents, aged 11 to 17 years, with chronic pain who were randomized to the cognitive behavioral intervention arm of an ongoing trial of internet-delivered CBT (Web-based management of adolescent pain; Web-MAP2). Using random-effects growth mixture models, we characterized pain and functional disability trajectories finding distinct trajectory groups indicating patterns of both linear and quadratic effects. Trajectories of change showed that some patients' pain and functional disability were improving, others worsened or changed minimally. Paired t tests compared the within-subject relative change rate in pain and function demonstrating similar change range for pain and function during the treatment period. There was no support for improvements in either pain or function to precede changes in the other domain. Findings may be useful in informing future studies of psychosocial treatments for pediatric chronic pain to consider how to target treatment strategies to distinct patient response profiles. This may lead to the development of intervention strategies that can both more effectively target children's pain and function during treatment and lead to sustained changes after treatment.

  12. Biomarkers of kidney integrity in children and adolescents with dental amalgam mercury exposure: Findings from the Casa Pia children's amalgam trial

    SciTech Connect

    Woods, James S. Martin, Michael D.; Leroux, Brian G.; DeRouen, Timothy A.; Bernardo, Mario F.; Luis, Henrique S.; Leitao, Jorge G.; Kushleika, John V.; Rue, Tessa C.; Korpak, Anna M.

    2008-11-15

    Mercury is toxic to the kidney, and dental amalgam is a source of mercury exposure. Few studies have evaluated the effects of dental amalgam on kidney function in a longitudinal context in children. Here, we evaluated urinary concentrations of glutathione S-transferases (GSTs) {alpha} and {pi} as biomarkers of renal proximal and distal tubular integrity, respectively, and albumin as a biomarker of glomerular integrity in children and adolescents 8-18 years of age over a 7-year course of dental amalgam treatment. Five hundred seven children, 8-12 years of age at baseline, participated in a clinical trial to evaluate the neurobehavioral and renal effects of dental amalgam in children. Subjects were randomized to either dental amalgam or resin composite treatments. Urinary GSTs {alpha} and {pi}, albumin, and creatinine concentrations were measured at baseline and annually in all subjects. Results were evaluated using linear regression analysis. GST-{alpha} concentrations were similar between treatment groups and in each sex and race (white vs. non-white) group in each follow-up year. GST-{pi} levels tended upward over the course of follow-up by four- to six-fold. This increase was seen in all groups irrespective of the treatment, race, or gender. Females had GST-{pi} levels approximately twice those of males at all ages. Albumin concentrations were constant throughout the follow-up period and did not differ by treatment, although females had 39% higher albumin levels than males. Additionally, we found no significant effects of amalgam treatment on the proportion of children with microalbuminuria (>30 mg/g creatinine). These findings are relevant within the context of children's health risk assessment as relates to the safety of mercury exposure from dental amalgam on kidney function. These data also provide normative values for sensitive indices of renal functional integrity that may serve in the evaluation of children and adolescents with renal disorders.

  13. Effectiveness Trial of an Indicated Cognitive-Behavioral Group Adolescent Depression Prevention Program versus Bibliotherapy and Brochure Control at 1- and 2-Year Follow-Up

    PubMed Central

    Rohde, Paul; Stice, Eric; Shaw, Heather; Gau, Jeff M.

    2015-01-01

    Objective Evaluate the longterm effects of a brief group cognitive-behavioral (CB) adolescent depression indicated prevention program through 2-year follow-up, relative to CB bibliotherapy and brochure control, when high school personnel recruited students and delivered the program. Method 378 adolescents (M age = 15.5, SD = 1.2; 68% female, 72% White) with elevated self-assessed depressive symptoms who were randomized to CB group, CB bibliotherapy, or educational brochure control were assessed at pre, post, 6-, 12-, 18-, and 24-month follow-up. Results By 2 years post-intervention, CB group participants showed significantly lower major depressive disorder (MDD) onset versus CB bibliotherapy (10% vs. 25%, respectively; HR = 2.48, p = .006), but the incidence difference relative to brochure controls (17%) was nonsignificant; MDD incidence for bibliotherapy and brochure controls did not differ. Although CB group participants showed lower depressive symptoms at post versus brochure controls, there were no effects for this outcome or for social adjustment or substance use over 2-year follow-up. Moderator analyses suggested that participants with higher baseline depressive symptoms showed greater longterm symptom reductions in the CB group intervention versus bibliotherapy. Conclusions The evidence that a brief CB group intervention delivered by real-world providers significantly reduced MDD onset versus CB bibliotherapy is potentially encouraging. However, the lack of MDD prevention effects relative to brochure control and lack of longterm symptom effects (though consistent with results from other depression prevention trials), suggest that the delivery of CB group should be refined to strengthen its effectiveness. PMID:25894666

  14. Efficacy and Safety of a Chinese Herbal Medicine Formula (RCM-104) in the Management of Simple Obesity: A Randomized, Placebo-Controlled Clinical Trial

    PubMed Central

    Lenon, George Binh; Li, Kang Xiao; Chang, Yung-Hsien; Yang, Angela Weihong; Da Costa, Clifford; Li, Chun Guang; Cohen, Marc; Mann, Neil; Xue, Charlie C. L.

    2012-01-01

    Objective. This study was to evaluate the efficacy and safety of a Chinese herbal medicine formula (RCM-104) for the management of simple obesity. Method. Obese subjects aged between 18 and 60 years were selected for 12-week, double-blind, randomized, placebo-controlled trial. Subjects were randomly assigned to take 4 capsules of either the RCM-104 formula (n = 59) or placebo (n = 58), 3 times daily for 12 weeks. Measures of BW, BMI and WC, HC, WHR and BF composition were assessed at baseline and once every four weeks during the 12 week treatment period. Results. Of the 117 subjects randomised, 92 were included in the ITT analysis. The weight, BMI and BF in RCM-104 group were reduced by 1.5 kg, 0.6 kg/m2 and 0.9% and those in the placebo group were increased by 0.5 kg, 0.2 kg/m2 and 0.1% respectively. There were significant differences in BW and BMI (P < 0.05) between the two groups. Eleven items of the WLQOQ were significantly improved in the RCM-104 group while only 2 items were significantly improved in the placebo group. Adverse events were minor in both groups. Conclusion. RCM-104 treatment appears to be well tolerated and beneficial in reducing BW and BMI in obese subjects. PMID:22550541

  15. Additive Effect of Qidan Dihuang Grain, a Traditional Chinese Medicine, and Angiotensin Receptor Blockers on Albuminuria Levels in Patients with Diabetic Nephropathy: A Randomized, Parallel-Controlled Trial

    PubMed Central

    Xiang, Lei; Jiang, Pingping; Zhou, Lin; Sun, Xiaomin; Bi, Jianlu; Cui, Lijuan; Nie, Xiaoli; Luo, Ren; Liu, Yanyan

    2016-01-01

    Albuminuria is characteristic of early-stage diabetic nephropathy (DN). The conventional treatments with angiotensin receptor blockers (ARB) are unable to prevent the development of albuminuria in normotensive individuals with type 2 diabetes mellitus (T2DM). Purpose. The present study aimed to evaluate the effect of ARB combined with a Chinese formula Qidan Dihuang grain (QDDHG) in improving albuminuria and Traditional Chinese Medicine Symptom (TCMS) scores in normotensive individuals with T2DM. Methods. Eligible patients were randomized to the treatment group and the control group. Results. Compared with baseline (week 0), both treatment and control groups markedly improved the 24-hour albuminuria, total proteinuria (TPU), and urinary albumin to creatinine ratio (A/C) at 4, 8, and 12 weeks. Between treatment and the control group, the levels of albuminuria in the treatment group were significantly lower than in the control group at 8 and 12 weeks (p < 0.05). In addition, treatment group markedly decreased the scores of TCMS after treatment. Conclusion. This trial suggests that QDDHG combined with ARB administration decreases the levels of albuminuria and the scores for TCMS in normotensive individuals with T2DM. PMID:27375762

  16. Clinical trials in children

    PubMed Central

    Joseph, Pathma D; Craig, Jonathan C; Caldwell, Patrina HY

    2015-01-01

    Safety and efficacy data on many medicines used in children are surprisingly scarce. As a result children are sometimes given ineffective medicines or medicines with unknown harmful side effects. Better and more relevant clinical trials in children are needed to increase our knowledge of the effects of medicines and to prevent the delayed or non-use of beneficial therapies. Clinical trials provide reliable evidence of treatment effects by rigorous controlled testing of interventions on human subjects. Paediatric trials are more challenging to conduct than trials in adults because of the paucity of funding, uniqueness of children and particular ethical concerns. Although current regulations and initiatives are improving the scope, quantity and quality of trials in children, there are still deficiencies that need to be addressed to accelerate radically equitable access to evidence-based therapies in children. PMID:24325152

  17. Tolerability, Safety, and Benefits of Risperidone in Children and Adolescents with Autism: 21-Month Follow-up After 8-Week Placebo-Controlled Trial

    PubMed Central

    Rettiganti, Mallikarjuna; Nagaraja, Haikady N.; Hollway, Jill A.; McCracken, James; McDougle, Christopher J.; Tierney, Elaine; Scahill, Lawrence; Arnold, L. Eugene; Hellings, Jessica; Posey, David J.; Swiezy, Naomi B.; Ghuman, Jaswinder; Grados, Marco; Shah, Bhavik; Vitiello, Benedetto

    2015-01-01

    Abstract Objective: Risperidone has demonstrated efficacy for acute (8 week) and intermediate length (6 month) management of severe irritability and aggression in children and adolescents with autism. Less is known about the long-term effects of risperidone exposure in this population. We examined the tolerability, safety, and therapeutic benefit of risperidone exposure over a 1–2 year follow-up period. Methods: In a naturalistic study, 84 children and adolescents 5–17 years of age (from an original sample of 101) were assessed an average of 21.4 months after initial entry into a placebo-controlled 8 week trial of risperidone for children and adolescents with autism and severe irritability. They were assessed at baseline and at follow-up on safety and tolerability measures (blood, urinalysis, electrocardiogram [ECG], medical history, vital signs, neurological symptoms, other adverse events), developmental measures (adaptive behavior, intelligence quotient [IQ]), and standardized rating instruments. Treatment over the follow-up period, after completion of protocol participation, was uncontrolled. Statistical analyses assessed outcome over time with or without prolonged risperidone therapy. Results: Two-thirds of the 84 subjects continued to receive risperidone (mean 2.47 mg/day, S.D. 1.29 mg). At follow-up, risperidone was associated with more enuresis, more excessive appetite, and more weight gain, but not more adverse neurological effects. No clinically significant events were noted on blood counts, chemistries, urinalysis, ECG, or interim medical history. Regardless of drug condition at follow-up, there was considerable improvement in maladaptive behavior compared with baseline, including core symptoms associated with autism. Height and weight gains were elevated with risperidone. Social skills on Vineland Adaptive Behavior Scale (VABS) improved with risperidone. Parent-rated Aberrant Behavior Checklist (ABC) Irritability subscale scores were reduced in

  18. The SAFETY Program: a treatment-development trial of a cognitive-behavioral family treatment for adolescent suicide attempters.

    PubMed

    Asarnow, Joan Rosenbaum; Berk, Michele; Hughes, Jennifer L; Anderson, Nicholas L

    2015-01-01

    The purpose of this article is to describe feasibility, safety, and outcome results from a treatment development trial of the SAFETY Program, a brief intervention designed for integration with emergency services for suicide-attempting youths. Suicide-attempting youths, ages 11 to 18, were enrolled in a 12-week trial of the SAFETY Program, a cognitive-behavioral family intervention designed to increase safety and reduce suicide attempt (SA) risk (N = 35). Rooted in a social-ecological cognitive-behavioral model, treatment sessions included individual youth and parent session-components, with different therapists assigned to youths and parents, and family session-components to practice skills identified as critical in the pathway for preventing repeat SAs in individual youths. Outcomes were evaluated at baseline, 3-month, and 6-month follow-ups. At the 3-month posttreatment assessment, there were statistically significant improvements on measures of suicidal behavior, hopelessness, youth and parent depression, and youth social adjustment. There was one reported SA by 3 months and another by 6 months, yielding cumulative attempt rates of 3% and 6% at 3 and 6 months, respectively. Treatment satisfaction was high. Suicide-attempting youths are at high risk for repeat attempts and continuing mental health problems. Results support the value of a randomized controlled trial to further evaluate the SAFETY intervention. Extension of treatment effects to parent depression and youth social adjustment are consistent with our strong family focus and social-ecological model of behavior change.

  19. Effects of sixty six adolescent tobacco use cessation trials and seventeen prospective studies of self-initiated quitting

    PubMed Central

    Sussman, S

    2003-01-01

    This paper provides a review of the last two and a half decades of research in adolescent and young-adult tobacco use cessation. A total of 66 tobacco cessation intervention studies – targeted or population – are reviewed. In addition, an exhaustive review is completed of adolescent self-initiated tobacco use cessation, involving 17 prospective survey studies. Average reach and retention across the intervention studies was 61% and 78%, respectively, and was higher when whole natural units were treated (e.g., classrooms), than when units created specifically for the program were treated (e.g., school-based clinics). The mean quit-rate at a three to 12-month average follow-up among the program conditions was 12%, compared to approximately 7% across control groups. A comparison of intervention theories revealed that motivation enhancement (19%) and contingency-based reinforcement (16%) programs showed higher quit-rates than the overall intervention cessation mean. Regarding modalities (channels) of change, classroom-based programs showed the highest quit rates (17%). Computer-based (expert system) programs also showed promise (13% quit-rate), as did school-based clinics (12%). There was a fair amount of missing data and wide variation on how data points were measured in the programs' evaluations. Also, there were relatively few direct comparisons of program and control groups. Thus, it would be difficult to conduct a formal meta-analysis on the cessation programs. Still, these data suggest that use of adolescent tobacco use cessation interventions double quit rates on the average. In the 17 self-initiated quitting survey studies, key predictors of quitting were living in a social milieu that is composed of fewer smokers, less pharmacological or psychological dependence on smoking, anti-tobacco beliefs (e.g., that society should step in to place controls on smoking) and feeling relatively hopeful about life. Key variables relevant to the quitting process may

  20. Effects of sixty six adolescent tobacco use cessation trials and seventeen prospective studies of self-initiated