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Sample records for adolescent medicine trials

  1. Clinical trials and gender medicine.

    PubMed

    Cassese, Mariarita; Zuber, Veronica

    2011-01-01

    Women use more medicines than men because they fall ill more often and suffer more from chronic diseases, but also because women pay more attention to their health and have more consciousness and care about themselves. Although medicines can have different effects on women and men, women still represent a small percentage in the first phases of trials (22%) which are essential to verify drugs dosage, side effects, and safety. Even though women are more present in trials, studies results are not presented with a gender approach. This situation is due to educational, social, ethical and economical factors. The scientific research must increase feminine presence in clinical trials in order to be equal and correct, and all the key stakeholder should be involved in this process. We still have a long way to cover and it doesn't concern only women but also children and old people. The aim is to have a medicine not only illness-focused but patient-focused: a medicine able to take into consideration all the patient characteristics and so to produce a really personalized therapy. What above described is part of the reasons why in 2005 was founded the National Observatory for Women's Health (Osservatorio Nazionale sulla Salute della Donna, ONDa) which promotes a gender health awareness and culture in Italy, at all the levels of the civil and scientific society.

  2. Clinical trials for predictive medicine.

    PubMed

    Simon, Richard

    2012-11-10

    Developments in biotechnology and genomics are providing a biological basis for the heterogeneity of clinical course and response to treatment that have long been apparent to clinicians. The ability to molecularly characterize human diseases presents new opportunities to develop more effective treatments and new challenges for the design and analysis of clinical trials. In oncology, treatment of broad populations with regimens that benefit a minority of patients is less economically sustainable with expensive molecularly targeted therapeutics. The established molecular heterogeneity of human diseases requires the development of new paradigms for the design and analysis of randomized clinical trials as a reliable basis for predictive medicine. We review prospective designs for the development of new therapeutics and predictive biomarkers to inform their use. We cover designs for a wide range of settings. At one extreme is the development of a new drug with a single candidate biomarker and strong biological evidence that marker negative patients are unlikely to benefit from the new drug. At the other extreme are Phase III clinical trials involving both genome-wide discovery of a predictive classifier and internal validation of that classifier. We have outlined a prediction-based approach to the analysis of randomized clinical trials that both preserves the Type I error and provides a reliable internally validated basis for predicting which patients are most likely or unlikely to benefit from the new regimen.

  3. Adolescent medicine with a 100 year perspective.

    PubMed

    Hardoff, Daniel; Eisenstein, Evelyn

    2004-01-01

    Adolescent medicine was born out of scientific advances from a wide variety of disciplines, changes in societal mores and the explosion of technology that occurred during the 20th century. The past 100 years of clinical practice and research have provided a wealth of information that has improved our understanding of the biologic and physical development of adolescents as well as the epidemiology of high-risk adolescent behaviors. The present challenge for all providers of health care to adolescents is to continue to examine the effect of these high-risk behaviors and develop mechanisms to address and limit the impact of these behaviors, just as the scientists and practitioners of the 20th century made great strides in treatment and cure of medical illnesses. With a broad base of scientific knowledge, formalization into an academic field and strong government and organizational support adolescent medicine are energized by these factors and can only envision continued growth in this important field of medicine.

  4. 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…

  5. Ethical reflections of gender equality and equity in adolescence medicine.

    PubMed

    Tozzo, P; Caenazzo, L

    2015-01-01

    Gender differences, in both clinical and research environment, exist also in a particular category of patients, adolescents, who constitute a vulnerable group with respect to healthcare decisions. In clinical context, the main ethical issues that may be identified within gender medicine for adolescent patients are related to the information given to the patient and its parents, the adolescent's capacity of understanding considering his/her maturity, vulnerability and autonomy, the consent to medical treatment in relation to the different possible approaches to their different efficacy and possible side effects. Also, with regard to the research context, ethical issues may arise from the participation of female minors in clinical trials. Ethical concerns may also arise in the field of resource allocation in health policies, such as the equitable distribution and access to resources, considering the young age of the subjects involved. A bioethical reflection, which takes into account not only the differences biologically and epidemiologically relevant, but also the main determinants of health in adolescence, might find a role in structured education for diversity and gender equity. Given the magnitude of the problem, to encourage the pursuit of gender equity in health and, in some situations, also to promote the full recognition of the right to health of women are some of the most effective and direct ways to reduce inequalities and to ensure a rational and efficient use of available resources, including through a bioethical reflection on the topic. The Authors show the necessity to differentiate the various aspects of gender differences in adolescence medicine, providing arguments in support of the fact that interventions for health prevention and promotion should be modulated in relation to the gender of the recipients, emphasizing the most important aspects for each group of individuals. This approach could implement personalized medicine, even and especially

  6. A patient with autism and severe depression: medical and ethical challenges for an adolescent medicine unit.

    PubMed

    Skinner, S Rachel; Ng, Cindy; McDonald, Ann; Walters, Tamara

    2005-10-17

    An adolescent with autism and intellectual disability presented with severe depression related to menstruation. Because of the complex medical, psychiatric and ethical issues involved, her care was coordinated by a hospital-based adolescent medicine unit. After trials of other therapies over an extended period and interdisciplinary and intersectoral case conferencing, it was decided that hysterectomy was the most appropriate management. This case highlights the complexity of adolescent health care in a tertiary hospital, the importance of intersectoral cooperation between hospital and community, and the integral role of interdisciplinary care of adolescent patients with chronic conditions.

  7. Recruitment and Retention of Patients into Emergency Medicine Clinical Trials

    PubMed Central

    Cofield, Stacey; Conwit, Robin; Barsan, William; Quinn, James

    2010-01-01

    The emergency medicine and pre-hospital environments are unlike any other clinical environments and require special consideration to allow the successful implementation of clinical trials. This article reviews the specific issues involved in Emergency Medicine Clinical Trials (EMCT), and provides strategies from emergency medicine and non-emergency medicine trials to maximize recruitment and retention. While the evidence supporting some of these strategies is deficient, addressing recruitment and retention issues with specific strategies will help researchers deal with these issues in their funding applications and in turn develop the necessary infrastructure to participate in emergency medicine clinical trials. PMID:21040112

  8. [Placebo control and clinical trial of Chinese medicine].

    PubMed

    Wu, Jing

    2010-10-01

    World Health Organization aims to develop safe, effective and practical traditional medicine. Traditional Chinese medicine (TCM) and other complementary and alternative medicine are being recognized in the whole world nowadays. However, the definite effect of Chinese medicine is still in need of scientific research proof. Placebo control is of equal importance to active control and blank control in clinical trial of TCM. This article briefly reviewed the importance of placebo control and commented on its present situation in clinical trial of TCM. This article also brought up the preliminary proposals of placebo application in TCM clinical trial. We should emphasize scientific placebo preparation and good design of placebo-controlled trial, which are directed by International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. A good clinical trial project will avoid unnecessary wastes and provide safe and effective treatment for people.

  9. Placebos used in clinical trials for Chinese herbal medicine.

    PubMed

    Qi, Guan D; We, Ding A; Chung, Leung P; Fai, Cheng K

    2008-06-01

    One of the important components in randomized Controlled Trial (RCT) is blinding. The gold standard of clinical trials is to achieve a double blind design. However, only a small number of randomized controlled trials in traditional Chinese medicine have been reported, most of them are of poor quality in methodology including placebo preparation and verification. The purpose of the article is to review the validity of placebo used in blinded clinical trials for Chinese herbal medicine (CHM) in recent years and related patents. We searched the Wanfang Database (total of 827 Chinese journals of medicine and/or pharmacy, from 1999 to 2005) and 598 full-length articles related to placebo clinical trials were found. 77 placebo blinded clinical trials for Chinese medicine were extracted by manual search from the 598 articles. After reviewing the 77 full-length articles, we found that nearly half of the clinical trials did not pay attention to the physical quality of the testing drug and placebo and whether they were of comparable physical quality. The rest provided very limited placebo information so that blinding assurance could not be assumed. Only 2 articles (2.6%) specifically validated the comparability between the testing drug and the placebo. Researchers in Chinese medicine commonly ignored the quality of the placebo in comparison to the test drug. This may be causing bias in the clinical trials. Quality specifications and evaluation of the placebo should deserve special attention to reduce bias in randomized controlled trials in TCM study.

  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.

  11. Adolescent Participation in HPV Vaccine Clinical Trials: Are Parents Willing?

    PubMed

    Erves, Jennifer Cunningham; Mayo-Gamble, Tilicia L; Hull, Pamela C; Duke, Lauren; Miller, Stephania T

    2017-03-21

    Approximately one-quarter of human papillomavirus (HPV) infections are acquired by adolescents, with a higher burden among racial/ethnic minorities. However, racial/ethnic minorities have been underrepresented in previous HPV vaccine trials. Ongoing and future HPV vaccine optimization trials would benefit from racially- and ethnically-diverse sample of adolescent trial participants. This study examined factors influencing parental willingness to consent to their adolescents' participation in HPV vaccine clinical trials and tested for possible racial differences. A convenience sample of parents of adolescents (N = 256) completed a cross-sectional survey. Chi square analyses were used to assess racial differences in parental HPV vaccine awareness and intentions and willingness to consent to their child participating in an HPV vaccine clinical trial. Ordinal logistic regression was used to identify factors associated with willingness. Approximately 47% of parents were willing to allow their adolescent to participate in HPV vaccine clinical trials (30.7% African American and 48.3% Caucasian, p = .081). African Americans had lower HPV vaccine awareness (p = .006) but not lower intentions to vaccinate (p = .086). Parental willingness was positively associated with the following variables: Child's age (p < .039), Perceived Advantages of HPV Vaccination for Adolescents (p = .002), Parental Trust in Medical Researchers (p < .001), and Level of Ease in Understanding Clinical Trial Information (p = .010). Educating parents about the advantages of HPV vaccines for younger adolescents using low-literacy educational materials and building trust between parents and researchers may increase parental willingness to consent to adolescent participation in HPV vaccine clinical trials.

  12. 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…

  13. Active Clinical Trials for Personalized Medicine

    PubMed Central

    Minsker, Stanislav; Zhao, Ying-Qi; Cheng, Guang

    2016-01-01

    Individualized treatment rules (ITRs) tailor treatments according to individual patient characteristics. They can significantly improve patient care and are thus becoming increasingly popular. The data collected during randomized clinical trials are often used to estimate the optimal ITRs. However, these trials are generally expensive to run, and, moreover, they are not designed to efficiently estimate ITRs. In this article, we propose a cost-effective estimation method from an active learning perspective. In particular, our method recruits only the “most informative” patients (in terms of learning the optimal ITRs) from an ongoing clinical trial. Simulation studies and real-data examples show that our active clinical trial method significantly improves on competing methods. We derive risk bounds and show that they support these observed empirical advantages. Supplementary materials for this article are available online. PMID:28018014

  14. 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

  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. 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…

  17. Adolescent consent for vaccination: a position paper of the Society for Adolescent Health and Medicine.

    PubMed

    English, Abigail; Ford, Carol A; Kahn, Jessica A; Kharbanda, Elyse Olshen; Middleman, Amy B

    2013-10-01

    Vaccines currently recommended for adolescents by the Advisory Committee on Immunization Practices have the potential to improve the health of youth by preventing conditions such as: tetanus, pertussis, meningococcal disease, influenza, and genital warts, as well as later adult outcomes such as cervical and other human papillomavirus-related cancers. Adolescent vaccine coverage lags behind that for younger age groups. A requirement to obtain parental consent for vaccination can present a significant barrier to improving adolescent vaccine uptake across all health care settings in which adolescents access care. The ability of minors to consent to vaccination can influence whether adolescents receive indicated vaccines during adolescent health care visits when parents are absent and when adolescents are seen for confidential services. State laws govern consent for the delivery of health care to minors. All states have some laws that allow minors to consent to health care based either on their status or on the services they are seeking. Some of these laws would allow them to consent to vaccination. It is the Position of the Society for Adolescent Health and Medicine that, within ethical and legal guidelines, it will be important to develop strategies that maximize opportunities for minors to receive vaccinations when parents are not physically present, including opportunities for them to give their own consent.

  18. Placebo effect in child and adolescent psychiatric trials.

    PubMed

    Parellada, Mara; Moreno, Carmen; Moreno, Miguel; Espliego, Ana; de Portugal, Enrique; Arango, Celso

    2012-11-01

    Much literature has been written in the field of child psychiatry regarding the placebo as a tool to test drug efficacy in clinical trials, but quite little regarding the placebo effect itself or its clinical use in child psychiatry. In this article, we aim to critically review the literature regarding the placebo effect in children and adolescents with mental disorders, focusing especially on factors influencing the placebo effect and how they may influence the interpretation of clinical trials. The placebo effect seems to be more marked in children than adults, and particularly in children and adolescents with depression, although it is pervasive across ages and is present in non-psychiatric conditions as well. The use of a placebo in clinical trials as a comparator with drugs that have moderate efficacy at most makes it difficult to obtain positive results, and much effort is needed to design very high quality clinical trials that may overcome the limitations of using a placebo. In addition, the placebo effect across ages and clinical conditions must be tested directly (compared with no treatment whenever possible), in order to characterise which placebos work for what and to determine their use in clinical settings.

  19. 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.

  20. Altruistic reasoning in adolescent-parent dyads considering participation in a hypothetical sexual health clinical trial for adolescents.

    PubMed

    Chávez, Noé Rubén; Williams, Camille Y; Ipp, Lisa S; Catallozzi, Marina; Rosenthal, Susan L; Breitkopf, Carmen Radecki

    2016-04-01

    Altruism is a well-established reason underlying research participation. Less is known about altruism in adolescent-parent decision-making about clinical trials enrolling healthy adolescents. This qualitative investigation focused on identifying spontaneous statements of altruism within adolescent-parent (dyadic) discussions of participation in a hypothetical phase I clinical trial related to adolescent sexual health. Content analysis revealed several response patterns to each other's altruistic reasoning. Across 70 adolescent-parent dyads in which adolescents were 14-17 years of age and 91% of their parents were mothers, a majority (61%) of dyadic discussions included a statement reflecting altruism. Parents responded to adolescents' statements of altruism more frequently than adolescents responded to parents' statements. Responses included: expresses concern, reiterates altruistic reasoning, agrees with altruistic reasoning, and adds to/expands altruistic reasoning. Since an altruistic perspective was often balanced with concerns about risk or study procedures, researchers cannot assume that altruism will directly lead to study participation. Optimizing the informed consent process for early phase clinical trials involving healthy adolescents may include supporting parents to have conversations with their adolescents which will enhance their capacity to consider all aspects of trial participation.

  1. Drug development: EU paediatric legislation, the European Medicines Agency and its Paediatric Committee--adolescents' melanoma as a paradigm.

    PubMed

    Rose, Klaus; Senn, Stephen

    2014-01-01

    The European Medicines Agency (EMA) website lists all diseases that officially exist in adults only. The class waiver for juvenile melanoma was revoked in 2008 referring to US SEER statistics. This statistical justification is misleading. Melanoma in adolescents is much rarer than claimed by EMA/Paediatric Committee; < 1 ∕ 4 of adolescents with melanoma need systemic treatment; separate efficacy studies are neither medically justified nor feasible. The scarce adolescent patients should be allowed to participate in adult trials. To force companies to investigate them separately turns them into paediatric hostages, to adapt the term therapeutic orphans coined in 1968 by Shirkey. There are now five melanoma Paediatric Investigation Plans (PIPs). Probably none of the PIP-triggered clinical studies will ever be completed; we propose to call them ghost studies. An oncology research network considering a reasonable trial in melanoma, including adolescents, will compete for recruitment with the PIP-triggered trials designed by regulatory tunnel vision and sponsored by companies under EMA-imposed pressure. EMA/Paediatric Committee's territorial enthusiasm ("our patients") damages oncology research.

  2. Altruistic reasoning in adolescent-parent dyads considering participation in a hypothetical sexual health clinical trial for adolescents

    PubMed Central

    Chávez, Noé Rubén; Williams, Camille Y; Ipp, Lisa S; Catallozzi, Marina; Rosenthal, Susan L; Breitkopf, Carmen Radecki

    2014-01-01

    Altruism is a well-established reason underlying research participation. Less is known about altruism in adolescent-parent decision-making about clinical trials enrolling healthy adolescents. This qualitative investigation focused on identifying spontaneous statements of altruism within adolescent-parent (dyadic) discussions of participation in a hypothetical phase I clinical trial related to adolescent sexual health. Content analysis revealed several response patterns to each other’s altruistic reasoning. Across 70 adolescent-parent dyads in which adolescents were 14–17 years of age and 91% of their parents were mothers, a majority (61%) of dyadic discussions included a statement reflecting altruism. Parents responded to adolescents’ statements of altruism more frequently than adolescents responded to parents’ statements. Responses included: expresses concern, reiterates altruistic reasoning, agrees with altruistic reasoning, and adds to/expands altruistic reasoning. Since an altruistic perspective was often balanced with concerns about risk or study procedures, researchers cannot assume that altruism will directly lead to study participation. Optimizing the informed consent process for early phase clinical trials involving healthy adolescents may include supporting parents to have conversations with their adolescents which will enhance their capacity to consider all aspects of trial participation. PMID:27019669

  3. 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…

  4. Off-label medicine use in children and adolescents: results of a population-based study in Germany

    PubMed Central

    2013-01-01

    Background Population-based self-reported data on off-label medicine use independent from health care provisions are lacking. The purpose of this study is to investigate off-label medicine use in children and adolescents in Germany in a non-clinical setting and to identify prevalence, determinants and spectrum of off-label medicine use. Methods Data were obtained from the German Health Interview and Examination Survey for Children and Adolescents (KiGGS) conducted by the Robert Koch Institute (2003–2006). 17,450 randomly selected children aged 0–17 years took part in the drug interviews. Of those, 8,899 took at least one medicine during the 7 days preceding the interview. Off-label medicine use was defined as the discrepancy between actual use and the intended use described in the summary of product characteristics. Off-label medicine use was stratified into off-label indication, off-label age, off-label over-dosing, and off-label under-dosing. Results The prevalence rate of off-label medicine use among those who used medicines amount of is 40.2%. The prevalence rate is significantly higher in boys (41.4%), in children aged 3 to 6 years (48.7%), without migration background (40.9%), with high social status (42.5%), living in small (42.0%) and medium sized cities (41.6%), and with a poor parents rated health status (41.7%). 12,667 preparations (attributable in respect to off-label use) were taken by 8,899 children. 30% of the medicines have been used off-label. Off-label medicine use was highest in preparations of the ATC-class “C00 Cardiovascular System”. In all origins of medicine, all age groups and all ATC-classes under-dosing was the most frequent reason for off-label medicine use. Conclusions There is a considerable level of self-reported off-label medicines use in the general paediatric population. Further investigations are needed to examine in how far off-label medicine use is based on lack of knowledge or on empiricism in paediatric

  5. 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.

  6. Society for Adolescent Medicine Position Paper on Reproductive Health Care for Adolescents.

    PubMed

    Emans, S J; Brown, R T; Davis, A; Felice, M; Hein, K

    1991-12-01

    This article is a revision of a 1983 position paper of the Society for Adolescent Medicine with inclusion of the newest medical advances in research on adolescent sexuality; i.e., contraceptive compliance, promotion of behavior change, relationships of ethnicity and pregnancy, and male reproductive health. The issues for the 1990's will be sexually transmitted diseases' morbidity and mortality. Topics identified are sexual activity and adolescent pregnancy, care of the pregnant teen, sexually transmitted diseases, HIV infection, the male adolescent, sexual abuse in adolescents, gay and lesbian youth, interventions, reproductive health care of adolescents with disabilities and chronic illnesses, and training of primary care physicians. The HIV/AIDS epidemic has focused attention on the reproductive behavior of males. Sexual activity varies by racial/ethnic group. Interventions to delay sexual initiation needs to be examined, although condom use has increased among 17-19 year olds from 21% to 58% in metropolitan areas. However condom use is lowest among the group of men at highest risk of STDs: those who had ever used drugs, those who had ever had sex with a prostitute, and those that had 5 or more partners/year. Male beliefs about contraception have been infrequently examined. There are misconceptions about heterosexual transmission of HIV. Better screening is needed for STD detection. Fathers are more involved in prenatal care and postnatal intervention programs. 7% of children have been subjected to nonvoluntary sexual intercourse between the ages of 18-21. ; i.e., 12.7% of white women, 9% of black women, 1.9% of white males, and 6.1% of black males. Risk factors for white women were living apart form parents at 16 years, poverty, physical and emotional limitations, parental alcohol and smoking and drug use. Sexual assault was associated with hitchhiking and alcohol and drug use in 1 study cited. Physicians need to be sensitive to this issue and probe for

  7. Personalized Medicine Enrichment Design for DHA Supplementation Clinical Trial.

    PubMed

    Lei, Yang; Mayo, Matthew S; Carlson, Susan E; Gajewski, Byron J

    2017-03-01

    Personalized medicine aims to match patient subpopulation to the most beneficial treatment. The purpose of this study is to design a prospective clinical trial in which we hope to achieve the highest level of confirmation in identifying and making treatment recommendations for subgroups, when the risk levels in the control arm can be ordered. This study was motivated by our goal to identify subgroups in a DHA (docosahexaenoic acid) supplementation trial to reduce preterm birth (gestational age<37 weeks) rate. We performed a meta-analysis to obtain informative prior distributions and simulated operating characteristics to ensure that overall Type I error rate was close to 0.05 in designs with three different models: independent, hierarchical, and dynamic linear models. We performed simulations and sensitivity analysis to examine the subgroup power of models and compared results to a chi-square test. We performed simulations under two hypotheses: a large overall treatment effect and a small overall treatment effect. Within each hypothesis, we designed three different subgroup effects scenarios where resulting subgroup rates are linear, flat, or nonlinear. When the resulting subgroup rates are linear or flat, dynamic linear model appeared to be the most powerful method to identify the subgroups with a treatment effect. It also outperformed other methods when resulting subgroup rates are nonlinear and the overall treatment effect is big. When the resulting subgroup rates are nonlinear and the overall treatment effect is small, hierarchical model and chi-square test did better. Compared to independent and hierarchical models, dynamic linear model tends to be relatively robust and powerful when the control arm has ordinal risk subgroups.

  8. 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…

  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.

  10. 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

  11. 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…

  12. 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…

  13. 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,…

  14. 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.…

  15. 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

  16. Evaluating traditional Chinese medicine using modern clinical trial design and statistical methodology: application to a randomized controlled acupuncture trial.

    PubMed

    Lao, Lixing; Huang, Yi; Feng, Chiguang; Berman, Brian M; Tan, Ming T

    2012-03-30

    Traditional Chinese medicine (TCM), used in China and other Asian counties for thousands of years, is increasingly utilized in Western countries. However, due to inherent differences in how Western medicine and this ancient modality are practiced, employing the so-called Western medicine-based gold standard research methods to evaluate TCM is challenging. This paper is a discussion of the obstacles inherent in the design and statistical analysis of clinical trials of TCM. It is based on our experience in designing and conducting a randomized controlled clinical trial of acupuncture for post-operative dental pain control in which acupuncture was shown to be statistically and significantly better than placebo in lengthening the median survival time to rescue drug. We demonstrate here that PH assumptions in the common Cox model did not hold in that trial and that TCM trials warrant more thoughtful modeling and more sophisticated models of statistical analysis. TCM study design entails all the challenges encountered in trials of drugs, devices, and surgical procedures in the Western medicine. We present possible solutions to some but leave many issues unresolved.

  17. [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.

  18. 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

  19. Psychosocial barriers and facilitators to clinical trial enrollment and adherence for adolescents with cancer.

    PubMed

    Buchanan, Natasha D; Block, Rebecca; Smith, Ashley Wilder; Tai, Eric

    2014-06-01

    Adolescents (aged 15-19 years) have not experienced the same survival gains as children and older adults diagnosed with cancer. Poor clinical trial enrollment and adherence rates among adolescents may account for some of this disparity. Although biological, regulatory, systemic, and practice-related challenges to clinical trial enrollment and adherence have been examined, studies of psychosocial factors, which can serve as barriers or facilitators to enrollment and adherence, are limited. To bring attention to these psychological factors, we reviewed existing literature on psychosocial barriers and facilitators that can affect an adolescent's decision to enroll and adhere to a clinical trial. We also provide potential strategies to address psychosocial factors affecting clinical trial accrual and adherence.

  20. Recruitment strategies in two Reproductive Medicine Network infertility trials

    PubMed Central

    Usadi, Rebecca S.; Diamond, Michael P.; Legro, Richard S.; Schlaff, William D.; Hansen, Karl R.; Casson, Peter; Christman, Gregory; Bates, G. Wright; Baker, Valerie; Seungdamrong, Aimee; Rosen, Mitchell P.; Lucidi, Scott; Thomas, Tracey; Huang, Hao; Santoro, Nanette; Eisenberg, Esther; Zhang, Heping; Alvero, Ruben

    2016-01-01

    Background Recruitment of individuals into clinical trials is a critical step in completing studies. Reports examining the effectiveness of different recruitment strategies, and specifically in infertile couples, are limited. Methods We investigated recruitment methods used in two NIH sponsored trials, Pregnancy in Polycystic Ovary Syndrome (PPCOS II) and Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS), and examined which strategies yielded the greatest number of participants completing the trials. Results 3683 couples were eligible for screening. 1650 participants were randomized and 1339 completed the trials. 750 women were randomized in PPCOS II; 212 of the participants who completed the trial were referred by physicians. Participants recruited from radio ads (84/750) and the internet (81/750) resulted in similar rates of trial completion in PPCOS II. 900 participants were randomized in AMIGOS. 440 participants who completed the trial were referred to the study by physicians. The next most successful method in AMIGOS was use of the internet, achieving 78 completed participants. Radio ads proved the most successful strategy in both trials for participants who earned <$50,000 annually. Radio ads were most successful in enrolling white patients in PPCOS II and black patients in AMIGOS. Seven ancillary Clinical Research Scientist Training (CREST) sites enrolled 324 of the participants who completed the trials. Conclusions Physician referral was the most successful recruitment strategy. Radio ads and the internet were the next most successful strategies, particularly for women of limited income. Ancillary clinical sites were important for overall recruitment. PMID:26386293

  1. 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.

  2. The need for precision medicine clinical trials in childhood asthma: rationale and design of the PUFFIN trial.

    PubMed

    Vijverberg, Susanne Jh; Pijnenburg, Mariëlle W; Hövels, Anke M; Koppelman, Gerard H; Maitland-van der Zee, Anke-Hilse

    2017-03-01

    A 'one-size fits all'-approach does not fit all pediatric asthma patients. Current evidence suggests that in children with persistent asthma, ADRB2 genotype-guided treatment can improve treatment outcomes, yet this evidence is mainly derived from observational and genotype-stratified studies. Implementation of precision medicine-guided asthma treatment in clinical practice will only occur if randomized clinical trials can show that this approach will improve patient outcomes and is cost effective. In this paper, we will discuss why precision medicine trials are currently needed to improve childhood asthma management and present the rationale and design of the PUFFIN trial, that has been set up to address this need.

  3. 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

  4. [Harmonization procedures directed toward clinical trials in laboratory medicine at the National Cancer Center Hospital].

    PubMed

    Ozeki, Mitsuru; Shioya, Kana; Furuta, Koh

    2009-09-01

    Recent advances in pharmacology and molecular sciences made it possible to develop drugs for patients with various maladies. Frustration has existed concerning the delayed provision of these drugs for routine practices in the clinical field. To correct this problem, the importance of clinical trials is increasing. Although there exists a strong demand for participation of clinical laboratories in clinical trials, an awkward attitude in clinical laboratories frustrates those performing clinical trials. We are attempting to correct this problem by introducing our experience with harmonization procedures directed toward clinical trials in laboratory medicine in general. First we described the current status of clinical trials in our hospital. Then we will show personnel in need for clinical trials. Finally we describe in detail our clinical trial procedures. We focus particularly on three aspects of participation in clinical trials: pre-analytical, analytical, and post analytical. Additionally we describe the problems and perspectives in clinical trials by giving special reference to the clinical laboratories in general through discussion with various personnel and specialists. Our goal in the field of laboratory medicine is to benefit patients through the establishment of a harmony between clinical trials and clinical laboratories.

  5. An open trial of Acceptance-based Separated Family Treatment (ASFT) for adolescents with anorexia nervosa.

    PubMed

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

    2015-06-01

    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.

  6. 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…

  7. 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

  8. Bibliometric and content analysis of the Cochrane Complementary Medicine Field specialized register of controlled trials

    PubMed Central

    2013-01-01

    Background The identification of eligible controlled trials for systematic reviews of complementary and alternative medicine (CAM) interventions can be difficult. To increase access to these difficult to locate trials, the Cochrane Collaboration Complementary Medicine Field (CAM Field) has established a specialized register of citations of CAM controlled trials. The objective of this study is to describe the sources and characteristics of citations included in the CAM Field specialized register. Methods Between 2006 and 2011, regular searches for citations of CAM trials in MEDLINE and the Cochrane Central Register of Controlled Trials (CENTRAL) were supplemented with contributions of controlled trial citations from international collaborators. The specialized register was ‘frozen’ for analysis in 2011, and frequencies were calculated for publication date, language, journal, presence in MEDLINE, type of intervention, and type of medical condition. Results The CAM Field specialized register increased in size from under 5,000 controlled trial citations in 2006 to 44,840 citations in 2011. Most citations (60%) were from 2000 or later, and the majority (71%) were reported in English; the next most common language was Chinese (23%). The journals with the greatest number of citations were CAM journals published in Chinese and non-CAM nutrition journals published in English. More than one-third of register citations (36%) were not indexed in MEDLINE. The most common CAM intervention type in the register was non-vitamin, non-mineral dietary supplements (e.g., glucosamine, fish oil) (34%), followed by Chinese herbal medicines (e.g., Astragalus membranaceus, Schisandra chinensis) (27%). Conclusions The availability of the CAM Field specialized register presents both opportunities and challenges for CAM systematic reviewers. While the register provides access to thousands of difficult to locate trial citations, many of these trials are of low quality and may overestimate

  9. Precision Medicine Clinical Trials: Defining New Treatment Strategies

    PubMed Central

    Heckman-Stoddard, Brandy M.; Smith, Judith J.

    2014-01-01

    Objectives To discuss the role of clinical trials in the changing landscape of cancer care resulting in individualized cancer treatment plans including a discussion of several innovative randomized studies designed to evaluate multiple targeted therapies in molecularly defined subsets of individuals. Data Sources Medical and nursing literature, research articles, and clinicaltrials.gov. Conclusion Recent advancements in cancer biomarkers and biomedical technology have begun to transform fundamentals of cancer therapeutics and clinical trials through innovative adaptive trial designs. The goal of these studies is to learn not only if a drug is safe and effective but also how it is best delivered and who will derive the most benefit. Implications for Nursing Practice Implementation of clinical trials in the cancer biomarker era requires knowledge, skills, and expertise related to the use of biomarkers and molecularly defined processes underlying a malignancy, as well as an understanding of associated ethical, legal, and social issues to provide competent, safe, and effective health care and patient communication. PMID:24794084

  10. Immigrant background and medicine use for aches: national representative study of adolescents

    PubMed Central

    2014-01-01

    Objectives The aims of the study were to examine the association between immigrant background and medicine use for headache and stomach-ache among adolescents, and whether symptoms of headache and stomach-ache could explain the differences in medicine use. Methods We used data from the Danish contribution to the WHO-affiliated international cross-sectional survey Health Behaviour in School-aged Children (HBSC) in 2006. Among boys, a total of 4170 ethnic Danes, 244 descendants of immigrants, and 224 immigrants participated. Among girls, 4310 ethnic Danes, 264 descendants of immigrants, and 232 immigrants were included. The associations between migrant background and medicine use for headache and stomach-ache by means of multilevel multivariate logistic regression analyses adjusted for age group, symptoms and the clustering effect of school and stratified by sex due to interactions. Results Among boys, the risk of medicine use for stomach-ache was higher for immigrants (odds ratio (OR), 1.54; 95% confidence intervals (CI), 0.99-2.44)) and descendants (OR, 1.97 (1.33-2.94)) compared to ethnic Danes. Similar associations were found for use of medicine for stomach-ache for immigrant girls (OR, 1.55 (1.12-2.15) and use of medicine for headache among boys (immigrants (OR, 1.36 (1.02-1.97 and descendants (1.48 (1.12-1.97)). Symptoms of aches were all independently associated with medicine use. After adjusting for these factors the association between immigrant background and medicine use attenuated slightly. Conclusion Among adolescents in Denmark, the risk of medicine use for headache and stomach-ache was higher for immigrants and descendants as compared to ethnic Danes, with the exception of medicine use for headache among girls. PMID:25848541

  11. 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

  12. THE CASE OF VERTEBROPLASTY TRIALS: PROMOTING A CULTURE OF EVIDENCE-BASED PROCEDURAL MEDICINE

    PubMed Central

    Miller, Franklin G.; Kallmes, David F.

    2010-01-01

    Two independent, randomized controlled trials of vertebroplasty for the relief of pain associated with vertebral fractures demonstrated that this procedure was no better than a sham intervention. Publication of the trial results prompted strong, critical commentaries by practitioners and professional societies. In this article we offer a psychological explanation of this dismissive response to rigorous scientific evidence, which appeals to the “placebo reactions” of physicians when dramatic improvement is noted in patients’ symptoms following administration of invasive procedures. We argue that the story of the response to the vertebroplasty trials underscores the need to develop a culture of evidence-based procedural medicine. PMID:20938382

  13. The Effect of an Egg Breakfast on Satiety in Children and Adolescents: A Randomized Crossover Trial

    PubMed Central

    Liu, Ann G.; Puyau, Renee S.; Han, Hongmei; Johnson, William D.; Greenway, Frank L.; Dhurandhar, Nikhil V.

    2016-01-01

    Objective To evaluate the effects of an egg breakfast on lunchtime energy intake in children (age 4–6 years) and adolescents (age 14–17 years). Methods In 2 randomized crossover trials, participants received either an egg breakfast or an isocaloric bagel breakfast. In both trials, subsequent lunchtime energy intake was the primary outcome. The trial with adolescents also measured each participant’s serum ghrelin, serum peptide YY (PYY), and self-assessment of appetite rated using a visual analog scale. Results Lunchtime food intakes after egg and bagel breakfasts were not significantly different for either age group. Visual analog scale ratings of hunger and satiety were also not different between the 2 treatments in adolescents. Consumption of the egg breakfast led to a significant increase in serum PYY levels (p = 0.0001) in adolescents. However, increased levels of PYY were not correlated with reduced food intake. Conclusion Short-term food intake in children and adolescents is not differentially altered by an egg breakfast compared to a bagel breakfast. PMID:25748830

  14. Integrative medicine for subacute stroke rehabilitation: a study protocol for a multicentre, randomised, controlled trial

    PubMed Central

    Fang, Jianqiao; Chen, Lifang; Chen, Luni; Wang, Chao; Keeler, Crystal Lynn; Ma, Ruijie; Xu, Shouyu; Shen, Laihua; Bao, Yehua; Ji, Conghua

    2014-01-01

    Introduction Many patients with stroke receive integrative medicine in China, which includes the basic treatment of Western medicine and routine rehabilitation, in conjunction with acupuncture and Chinese medicine. The question of whether integrative medicine is efficacious for stroke rehabilitation is still controversial and very little research currently exists on the integrated approach for this condition. Consequently, we will conduct a multicentre, randomised, controlled, assessor-blinded clinical trial to assess the effectiveness of integrative medicine on stroke rehabilitation. Methods and analysis 360 participants recruited from three large Chinese medical hospitals in Zhejiang Province will be randomly divided into the integrative medicine rehabilitation (IMR) group and the conventional rehabilitation (CR) group in a 1:1 ratio. Participants in the IMR group will receive acupuncture and Chinese herbs in addition to basic Western medicine and rehabilitation treatment. The CR group will not receive acupuncture and Chinese herbal medicine. The assessment data will be collected at baseline, 4 and 8 weeks postrandomisation, and then at 12 weeks’ follow-up. The primary outcome is measured by the Modified Barthel Index. The secondary outcomes are the National Institutes of Health Stroke Scale (NIHSS), Fugl-Meyer Assessment, the mini-mental state examination and Montreal Cognitive, Hamilton's Depression Scale and Self-Rating Depression Scale, and the incidence of adverse events. Ethics and dissemination Ethical approval was obtained from ethics committees of three hospitals. The results will be disseminated in a peer-reviewed journal and presented at international congresses. The results will also be disseminated to patients by telephone, during follow-up calls inquiring on patient's post-study health status. Trial registration number Chinese Clinical Trial Register: ChiCTR-TRC-12001972, http://www.chictr.org/en/proj/show.aspx?proj=2561 PMID:25475247

  15. 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

  16. 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.

  17. 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…

  18. 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…

  19. 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…

  20. School-Based Cardiovascular Health Promotion: The Child and Adolescent Trial for Cardiovascular Health (CATCH).

    ERIC Educational Resources Information Center

    Perry, Cheryl L.; And Others

    1990-01-01

    Describes objectives of the Child and Adolescent Trial for Cardiovascular Health multisite intervention study which develops behavioral school health education plans. It targets third through fifth graders, stressing cardiovascular health behaviors (e.g., eating habits, physical activity, and smoking). Curricula, school environmental change, and…

  1. 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…

  2. The proposed EU-regulation on clinical trials on medicinal products: an unethical proposal?

    PubMed

    Heringa, Jilles; Dute, Joseph

    2013-09-01

    The Commission has proposed a regulation 'on clinical trials on medicinal products for human use' to introduce one regulatory framework for clinical trials in the European Union. This regulation should replace the current clinical trials directive (2001/20/EC). In this article we describe and critically review the main provisions of the proposed regulation. We assess the consequences for a sound authorisation procedure of clinical trials and the level of protection for human subjects. We note that the proposed regulation is inconsistent with applicable international legal documents, such as the Biomedicine Convention and the Declaration of Helsinki. We conclude that the proposed regulation does not ensure a "high level of human health protection"--required by its legal basis in the TFEU--because it may force Member States concerned to accept a reporting Member States' approval of--in their estimation--an unethical clinical trial.

  3. Transition of adolescents with HIV to adult care: characteristics and current practices of the adolescent trials network for HIV/AIDS interventions.

    PubMed

    Gilliam, Patricia P; Ellen, Jonathan M; Leonard, Lori; Kinsman, Sara; Jevitt, Cecilia M; Straub, Diane M

    2011-01-01

    The transition process from pediatric to adult health care for adolescents with chronic diseases is always challenging and can be even more so for adolescents with HIV disease. The purpose of this study was to describe characteristics and current practices surrounding the transition of adolescents from the clinics of the Adolescent Trials Network for HIV/AIDS Interventions to adult medical care. This report focuses on the processes of transition, perceived barriers and facilitators, and anecdotal reports of successes and failures. Practice models used to assist adolescents during transition to adult medical care are described. Interviews were conducted with 19 key informants from 14 Adolescent Trials Network clinics. Findings revealed no consistent definition of "successful" transition, little consensus among the sites regarding specific elements of a transition program, and a lack of mechanisms to assess outcomes. Sites that viewed transition as a process rather than an event consistently described more structured program elements.

  4. Parent Programs for Reducing Adolescent's Antisocial Behavior and Substance Use: A Randomized Controlled Trial.

    PubMed

    Jalling, Camilla; Bodin, Maria; Romelsjö, Anders; Källmén, Håkan; Durbeej, Natalie; Tengström, Anders

    Two theoretically based parent training programs, delivered in real-world settings by the social services, were examined in this randomized controlled trial for effectiveness in reducing adolescents' antisocial behavior and substance use. Two hundred and thirty-seven (237) adolescents in ages between 12 and 18 and their parents were assigned to one of two programs or to a wait-list control condition. The programs were the nine weekly group sessions program Comet 12-18 (Swedish Parent Management Training Program) and the six weekly ParentSteps (Swedish shortened version by Strengthening Families Program 10-14). Outcome measures were antisocial behavior, substance use, and delinquency, and psychosocial dysfunction. Data based on adolescents' and parents' ratings of the adolescents' problem behavior at baseline and 6 months later were analyzed with repeated measures ANVOA, Logistic regression, and Kruskal-Wallis H test. The results showed that parents' ratings of adolescents' antisocial behaviors decreased significantly over time, but no time by group effect emerged. No program effects were found in the adolescents' self-reported antisocial behavior, delinquency, or psychosocial functioning. A threefold risk of illicit drug use was found in both intervention groups. The results suggest that neither Comet nor ParentSteps had beneficial effects on adolescent's antisocial or delinquent behavior, or on alcohol use. The only significant group difference found was a threefold risk of drug use in the intervention adolescents at follow-up, but for several reasons this finding should be interpreted with caution. Trial registration number: ISRCTN76141538.

  5. 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.

  6. 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

  7. Curcumin: From ancient medicine to current clinical trials

    PubMed Central

    Hatcher, H.; Planalp, R.; Cho, J.; Torti, S. V.

    2015-01-01

    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-κB, 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. PMID:18324353

  8. From cradle to adolescence: the development of Research in European Pediatric Emergency Medicine.

    PubMed

    Mintegi, Santiago; Lyttle, Mark D; Maconochie, Ian K; Benito, Javier; Gervaix, Alain; Moll, Henriette; Shavit, Itai; Da Dalt, Liviana; Waisman, Yehezkel

    2014-02-01

    Pediatric emergency medicine (PEM) has been developing rapidly but heterogeneously in many European countries in recent years, and many national PEM societies have been founded to improve the quality of care of ill and injured children and adolescents. Key facets of any such improvement are the development, delivery and translation of high-quality research. Research in European Pediatric Emergency Medicine (REPEM) has developed a robust international structure involving clinicians, academics and national PEM research networks. This structure facilitates research collaboration within Europe and with PEM research networks from other continents. Multicentre research carried out in this way will bring about improvements in the quality of emergency care for children in European emergency departments, and result in a better quality of life for children and adolescents. This paper outlines the background and achievements of REPEM to date and describes the current structure and next steps.

  9. 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…

  10. Cognitive behavioral therapy for depressed adolescents exposed to interpersonal trauma: an initial effectiveness trial.

    PubMed

    Shirk, Stephen R; Deprince, Anne P; Crisostomo, Patrice S; Labus, Jennifer

    2014-03-01

    Four clinical trials have shown that a history of interpersonal trauma is associated with diminished response to cognitive-behavioral therapy (CBT) for adolescent depression. An efficacious CBT protocol for adolescent depression was modified to address cognitive deficits and distortions associated with interpersonal trauma. Initial feasibility, acceptability, and treatment impact of the modified treatment (m-CBT) were evaluated in a randomized effectiveness trial conducted in community clinics. Clients were 43 referred adolescents with a depressive disorder and a history of interpersonal trauma. Adolescents either received m-CBT or usual care (UC) therapy. Results indicated that m-CBT was delivered with good fidelity by community clinicians, but that number of sessions completed was attenuated in both m-CBT and UC. Adolescents reported high levels of treatment satisfaction and acceptability for the new treatment. There were significant reductions in depressive symptoms over time, but no differences in outcomes between groups. Although the new treatment produced promising results, it did not outperform UC. Implications for treatment development are considered.

  11. Statistical issues and limitations in personalized medicine research with clinical trials.

    PubMed

    Rubin, Daniel B; van der Laan, Mark J

    2012-07-20

    We discuss using clinical trial data to construct and evaluate rules that use baseline covariates to assign different treatments to different patients. Given such a candidate personalization rule, we first note that its performance can often be evaluated without actually applying the rule to subjects, and a class of estimators is characterized from a statistical efficiency standpoint. We also point out a recently noted reduction of the rule construction problem to a classification task and extend results in this direction. Together these facts suggest a natural form of cross-validation in which a personalized medicine rule can be constructed from clinical trial data using standard classification tools and then evaluated in a replicated trial. Because replication is often required by the FDA to provide evidence of safety and efficacy before pharmaceutical drugs can be marketed, there are abundant data with which to explore the potential benefits of more tailored therapy. We constructed and evaluated personalized medicine rules using simulations based on two active-controlled randomized clinical trials of antibacterial drugs for the treatment of skin and skin structure infections. Unfortunately we present negative results that did not suggest benefit from personalization. We discuss the implications of this finding and why statistical approaches to personalized medicine problems will often face difficult challenges.

  12. Treatment Algorithms Based on Tumor Molecular Profiling: The Essence of Precision Medicine Trials

    PubMed Central

    Le Tourneau, Christophe; Kamal, Maud; Tsimberidou, Apostolia-Maria; Bedard, Philippe; Pierron, Gaëlle; Callens, Céline; Rouleau, Etienne; Vincent-Salomon, Anne; Servant, Nicolas; Alt, Marie; Rouzier, Roman; Paoletti, Xavier; Delattre, Olivier; Bièche, Ivan

    2016-01-01

    With the advent of high-throughput molecular technologies, several precision medicine (PM) studies are currently ongoing that include molecular screening programs and PM clinical trials. Molecular profiling programs establish the molecular profile of patients’ tumors with the aim to guide therapy based on identified molecular alterations. The aim of prospective PM clinical trials is to assess the clinical utility of tumor molecular profiling and to determine whether treatment selection based on molecular alterations produces superior outcomes compared with unselected treatment. These trials use treatment algorithms to assign patients to specific targeted therapies based on tumor molecular alterations. These algorithms should be governed by fixed rules to ensure standardization and reproducibility. Here, we summarize key molecular, biological, and technical criteria that, in our view, should be addressed when establishing treatment algorithms based on tumor molecular profiling for PM trials. PMID:26598514

  13. Why Prospectively Randomized Clinical Trials Have Been Rare in Reproductive Medicine and Will Remain So?

    PubMed

    Gleicher, Norbert; Kushnir, Vitaly A; Barad, David H

    2016-01-01

    There is almost unanimity that modern medicine should be "evidence based." In this context, lack of prospectively randomized clinical trials (RCTs) is widely lamented in reproductive medicine. Some leading voices, indeed, increasingly suggest that only RCT-based clinical conclusions should be integrated into clinical practice, since lower levels of evidence are inadequate. We have argued that reproductive medicine requires special considerations because, like clinical oncology, fertility treatments (especially in older women) are time dependent. Unlike clinical oncology, reproductive medicine, however, does not receive substantial financial research support from government or industry and, at least in the United States, has, therefore, to be primarily funded via patient revenues. Given a 50% chance of receiving placebo, infertility patients are, understandably, reluctant to fund their own RCTs. We here selectively review this subject, contrasting opposing opinions recently published in the literature by a prominent reproductive scientist and one of the world's leading experts on evidence-based medicine. Placing these recent publications into the evolving context of infertility practice, as also addressed in this journal in recent publications, we conclude that objective reasons explain why relatively few RCTs are performed in reproductive medicine and predict that this will not change in the foreseeable future. Reproductive medicine, therefore, has to find ways to develop satisfactory clinical evidence in other ways, satisfying patients' rights to easy access to potentially beneficial medical treatments with low costs and low risks. The RCTs should be reserved for relatively high risk and/or high cost treatments.

  14. Management of Pneumothorax in Emergency Medicine Departments: Multicenter Trial

    PubMed Central

    Ince, Abdulkadir; Ozucelik, Dogac Niyazi; Avci, Akkan; Nizam, Ozgur; Dogan, Halil; Topal, Mehmet Ali

    2013-01-01

    Background: Pneumothorax is common and life-threatening clinical condition which may require emergency treatment in Emergency Medicine Departments. Objectives: We aimed to reveal the epidemiological analysis of the patients admitted to the Emergency Department with pneumothorax. Material and Methods: This case-control and multi-center study was conducted in the patients treated with the diagnosis of pneumothorax between 01.01.2010-31.12.2010. Patient data were collected from hospital automation system. According to the etiology of the pneumothorax, study groups were arranged like spontaneous pneumothorax and traumatic pneumothorax. Results: 82.2% (n = 106) of patients were male and 17.8% (n = 23) of patients were female and mean age were 31.3 ± 20,2 (Minimum: 1, Maximum: 87). 68.2% (n = 88) of patients were spontaneous pneumothorax (61.36%, n=79 were primary spontaneous pneumothorax) and 31.8% (n = 41) of patients were traumatic pneumothorax (21.95% were iatrogenic pneumothorax). Main complaint is shortness of breath (52.3%, n=67) and 38% (n=49) of patients were smokers. Posteroanterior (PA) Chest X-Ray has been enough for 64.3% (n = 83) of the patients' diagnosis. Tube thoracostomy is applied to 84.5% (n = 109) of patients and surgery is applied to 9.3% (n = 12) of patients and 6.2% (n = 8) of patients were discharged with conservative treatment. Spontaneous pneumothorax showed statistically significant high recurrence compared with traumatic pneumothorax (P = 0.007). 4.65% of (n = 6) patients died. The average age of those who died (9.3 ± 19.9), statistically were significantly lower the mean age of living patients (32.4 ± 19.7) (t test, P = 0,006). 83.33% of the patients who died were neonatals and in the 0-1 years age group, and five of these patients were secondary spontaneous pneumothorax, and one of these patients were iatrogenic pneumothorax due to mechanical ventilation. Conclusions: Pneumothorax in adults can be treated by tube thoracostomy or

  15. 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

  16. 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.

  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. 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…

  19. 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

  20. Spinal manipulation and exercise for low back pain in adolescents: study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Low back pain is among the most common and costly chronic health care conditions. Recent research has highlighted the common occurrence of non-specific low back pain in adolescents, with prevalence estimates similar to adults. While multiple clinical trials have examined the effectiveness of commonly used therapies for the management of low back pain in adults, few trials have addressed the condition in adolescents. The purpose of this paper is to describe the methodology of a randomized clinical trial examining the effectiveness of exercise with and without spinal manipulative therapy for chronic or recurrent low back pain in adolescents. Methods/design This study is a randomized controlled trial comparing twelve weeks of exercise therapy combined with spinal manipulation to exercise therapy alone. Beginning in March 2010, a total of 184 participants, ages 12 to 18, with chronic or recurrent low back pain are enrolled across two sites. The primary outcome is self-reported low back pain intensity. Other outcomes include disability, quality of life, improvement, satisfaction, activity level, low back strength, endurance, and motion. Qualitative interviews are conducted to evaluate participants’ perceptions of treatment. Discussion This is the first randomized clinical trial assessing the effectiveness of combining spinal manipulative therapy with exercise for adolescents with low back pain. The results of this study will provide important evidence on the role of these conservative treatments for the management of low back pain in adolescents. Trial registration (ClinicalTrials.gov NCT01096628). PMID:24904748

  1. 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

  2. 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

  3. 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

  4. Topical herbal medicines for atopic eczema: a systematic review of randomized controlled trials.

    PubMed

    Thandar, Y; Gray, A; Botha, J; Mosam, A

    2017-02-01

    Despite the availability of medicines with proven efficacy, many patients use complementary or alternative medicines (CAMs) to manage atopic eczema (AE). Due to the lack of objective information on topical CAMs, this systematic review evaluates the current evidence for the efficacy and safety of topical herbal preparations in AE. Using Cochrane systematic review methodology, PubMed, the Cochrane Library, the Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL (via EBSCO), MEDLINE (via EBSCO), Proquest Health and Medical Complete, GREAT and CAM-QUEST were searched from inception until June 2014. Bibliographies of retrieved studies were hand searched for further relevant trials. All controlled clinical trials of topical herbal medicines for AE in humans of any age were included regardless of the control intervention or randomization. Only English-language publications were considered. Eight studies met the inclusion criteria. Seven investigated extracts of single plants and one an extract from multiple plants. Only two studies that showed a positive effect were considered to have a low risk of bias across all domains (those of liquorice gel and Hypericum perforatum). In these two, the test product was reported to be superior to placebo. Despite variations in diagnostic criteria and lack of validated tools for outcome assessments in one of these, the promising results may warrant continued research in better-designed studies. No meta-analysis was performed due to heterogeneity in all studies. There is currently insufficient evidence of efficacy for any topical herbal extract in AE. Many studies had methodological flaws and even those showing efficacy were single trials with small patient cohorts.

  5. 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…

  6. 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.

  7. Evidence-based medicine training during residency: a randomized controlled trial of efficacy

    PubMed Central

    2010-01-01

    Background Evidence-based medicine (EBM) has been widely integrated into residency curricula, although results of randomized controlled trials and long term outcomes of EBM educational interventions are lacking. We sought to determine if an EBM workshop improved internal medicine residents' EBM knowledge and skills and use of secondary evidence resources. Methods This randomized controlled trial included 48 internal medicine residents at an academic medical center. Twenty-three residents were randomized to attend a 4-hour interactive workshop in their PGY-2 year. All residents completed a 25-item EBM knowledge and skills test and a self-reported survey of literature searching and resource usage in their PGY-1, PGY-2, and PGY-3 years. Results There was no difference in mean EBM test scores between the workshop and control groups at PGY-2 or PGY-3. However, mean EBM test scores significantly increased over time for both groups in PGY-2 and PGY-3. Literature searches, and resource usage also increased significantly in both groups after the PGY-1 year. Conclusions We were unable to detect a difference in EBM knowledge between residents who did and did not participate in our workshop. Significant improvement over time in EBM scores, however, suggests EBM skills were learned during residency. Future rigorous studies should determine the best methods for improving residents' EBM skills as well as their ability to apply evidence during clinical practice. PMID:20807453

  8. CUPID: a protocol of a randomised controlled trial to identify characteristics of similar Chinese patent medicines

    PubMed Central

    Cao, Hongbo; Zhai, Jingbo; Li, Nan; Cao, Hongxia; Lei, Xiang; Mu, Wei; Liu, Zhi; Wang, Hui; Shang, Hongcai

    2014-01-01

    Introduction Traditional Chinese medicine (TCM) has accumulated some experience in curing stable angina pectoris (SAP) and efficacy has been demonstrated. Chinese patent medicines, known as modern dosage forms of TCM, can attain the desired effect in clinical application only with the guidance of TCM syndrome theory. However, due to their use by a large number of persons with little knowledge of TCM theories and practices, their efficacy and reputation have been seriously affected. Method and analysis Two common syndrome types of SAP in TCM, ‘qi deficiency and blood stasis’ and ‘qi stagnation and blood stasis’, will be studied in 144 subjects from four TCM hospitals in Tianjin in China using a partial crossover design. The two syndromes will be broken down into six symptom combinations; patients will select a combination of the most distressing to them, and then will be randomised into two groups. Each group, on the basis of routine medication, will be administered one kind of Chinese patent drug: Qishenyiqi Dripping Pills or Compound Danshen Dripping Pills. The treatment characteristics of the two medicines will be evaluated with the COME-PIO method developed by our research team. Ethics and dissemination This protocol has been approved by the medical ethics committee of Tianjin University of TCM (registration number TJUTCM-EC20130005). The study is safe and reliable. Trial registration number Chinese clinical trials register ChiCTR-TTRCC-14004406. PMID:25431225

  9. 02A. Design, Methods, and Outcomes for Recent Clinical Trials Utilizing Ayurvedic Medicine, Yoga, and Meditation

    PubMed Central

    Saper, Robert; Vinjamury, Sivarama; Elder, Charles

    2013-01-01

    Focus Area: Integrative Approaches to Care The panel discussants will present on the outcomes of four recent pragmatic trials covering the spectrum of Ayurvedic medicine, yoga, and meditation as therapeutic approaches for both acute and chronic conditions. The presenters will discuss: (1) a pilot study of a whole-systems Ayurveda and Yoga Therapy intervention for obesity; (2) a comparative effectiveness randomized controlled trial of hatha yoga, physical therapy, and education for non-specific chronic low back pain in low-income minority populations; (3) an investigation of the therapeutic usefulness of Shirodhara (Ayurvedic oil dripping therapy) as a treatment for insomnia; and (4) a discussion of the evidence base supporting implementation of meditation interventions in schools and workplace settings. Discussants will present information on study designs, research methodology, and outcome measure selection to highlight special considerations in conducting research on whole medical systems that use multi-target therapies and focus on patient-centered outcomes. Ayurvedic medicine and yoga are characterized by low-cost, noninvasive interventions that can be usefully offered as part of an integrative medicine therapeutic approach.

  10. 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

  11. A Web-Based Intervention to Reduce Indoor Tanning Motivations in Adolescents: a Randomized Controlled Trial.

    PubMed

    Hillhouse, Joel; Turrisi, Rob; Scaglione, Nichole M; Cleveland, Michael J; Baker, Katie; Florence, L Carter

    2017-02-01

    Youthful indoor tanning as few as ten sessions can increase the risk of melanoma by two to four times with each additional session adding another 2 % to the risk. Recent research estimates that indoor tanning can be linked to approximately 450,000 cases of skin cancer annually in the USA, Europe, and Australia. Despite these risks, indoor tanning remains popular with adolescents. This study tested the efficacy of a web-based skin cancer prevention intervention designed to reduce indoor tanning motivations in adolescent females. A nationally representative sample of 443 female teens was enrolled from an online panel into a two-arm, parallel group design, randomized controlled trial. Treatment participants received an appearance-focused intervention grounded in established health behavior change models. Controls viewed a teen alcohol prevention website. Outcome variables included willingness and intentions to indoor tan, willingness to sunless tan, and measures of indoor tanning attitudes and beliefs. The intervention decreased willingness and intentions to indoor tan and increased sunless tanning willingness relative to controls. We also examined indirect mechanisms of change through intervening variables (e.g., indoor tanning attitudes, norms, positive and negative expectancies) using the product of coefficient approach. The web-based intervention demonstrated efficacy in changing adolescent indoor tanning motivations and improving their orientation toward healthier alternatives. Results from the intervening variable analyses give guidance to future adolescent skin cancer prevention interventions.

  12. [Exploration into the preparation of placebos used in Chinese medicinal clinical trial].

    PubMed

    Tang, Xu-Dong; Bian, Li-Qun; Gao, Rui

    2009-07-01

    Placebo-controlled clinical trials have been more and more emphasized in traditional Chinese medicine (TCM) researches, while the preparation of TCM placebos is still to be improved. For this work, some elements should be taken into consideration comprehensively, including the design of clinical trial, the characteristics of researched disease, the nature of testing drugs, and the way of medication, etc. And the technological process for placebo manufacturing should be selected properly depending upon the basis of the above elements. Un-biased foodstuff is good as excipient for TCM placebos preparation. The placebo should be made in dosage-form similar to that of the testing drug as possible, if there are difficulties for simulating them in appearance and smell completely. However, its potential pharmacological activity meeting to the acceptance of researchers should be ensured.

  13. 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

  14. 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

  15. 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

  16. Randomized Controlled Trial: Multimodal Anxiety and Social Skill Intervention for Adolescents with Autism Spectrum Disorder

    PubMed Central

    White, Susan W.; Ollendick, Thomas; Albano, Anne Marie; Oswald, Donald; Johnson, Cynthia; Southam-Gerow, Michael A.; Kim, Inyoung; Scahill, Lawrence

    2012-01-01

    Anxiety is common among adolescents with autism spectrum disorders (ASD) and may amplify the core social disability, thus necessitating combined treatment approaches. This pilot, randomized controlled trial (RCT) evaluated the feasibility and preliminary outcomes of the Multimodal Anxiety and Social Skills Intervention (MASSI) program in a sample of 30 adolescents with ASD and anxiety symptoms of moderate or greater severity. The treatment was acceptable to families, subject adherence was high, and therapist fidelity was high. A 16% improvement in ASD social impairment (within-group effect size = 1.18) was observed on a parent-reported scale. Although anxiety symptoms declined by 26%, the change was not statistically significant. These findings suggest MASSI is a feasible treatment program and further evaluation is warranted. PMID:22735897

  17. Effects of naltrexone on adolescent alcohol cue reactivity and sensitivity: an initial randomized trial.

    PubMed

    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

    2014-09-01

    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 non-existent. We conducted a randomized, double-blinded, placebo-controlled cross-over study, comparing naltrexone (50 mg/daily) and placebo in 22 adolescent problem drinkers aged 15-19 years (M = 18.36, standard deviation = 0.95; 12 women). 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 ≤ 0.03), blunted craving in the laboratory and in the natural environment (P's ≤ 0.04), and altered subjective responses to alcohol consumption (P's ≤ 0.01). 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.

  18. Mindfulness-based Intervention for Female Adolescents with Chronic Pain: A Pilot Randomized Trial

    PubMed Central

    Chadi, Nicholas; McMahon, Audrey; Vadnais, Majorie; Malboeuf-Hurtubise, Catherine; Djemli, Anissa; Dobkin, Patricia L.; Lacroix, Jacques; Luu, Thuy Mai; Haley, Nancy

    2016-01-01

    Objective To test the feasibility of a randomized-controlled trial measuring the impact of an adapted mindfulness-based intervention (MBI) in female adolescents with chronic pain. Methods This was a single center, single-blind, prospective, experimental, longitudinal trial conducted in a pediatric tertiary care center. Participants had a history of chronic pain during at least three months. They were randomized into an intervention group or a wait-list control group. Both groups successively followed an adapted eight-week MBI designed specifically for adolescents with chronic pain. Pre-determined criteria were established to assess the feasibility, validity and acceptability of the study model. Data evaluating changes in quality of life, depression, anxiety, pain perception, psychological distress and salivary cortisol were collected throughout the 4-month study period. Results Nineteen female participants completed the study and had a mean age of 15.8 years (range 13.9 -17.8). Attrition rate was low (17%). Attendance to mindfulness sessions (84%) and compliance to study protocol (100%) were high. All participants reported a positive change in the way they coped with pain. No changes in quality of life, depression, anxiety, pain perception, and psychological distress were detected. Significant reductions in pre-and post-mindfulness session salivary cortisol levels were observed (p<0.001). Conclusions Mindfulness is a promising therapeutic approach for which limited data exist in adolescents with chronic pain. Our study indicates the feasibility of conducting such interventions in teenage girls. A large trial is needed to demonstrate the efficacy and bio-physiological impacts of MBIs in teenagers with chronic pain. PMID:27924146

  19. 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

  20. Ethical standards for clinical trials conducted in third countries: the new strategy of the European Medicines Agency.

    PubMed

    Altavilla, Annagrazia

    2011-01-01

    Clinical trials increasingly occur on a global scale as industry and government sponsors in wealthy countries move trials to low- and middle-income countries. The globalization of clinical research raises important questions about the economical and ethical aspects of clinical research and the translation of trial results to clinical practice: which ethical standards are applied? Are trials results accurate and valid, and can they be extrapolated to other settings? This article provides an overview of the strategy approved by the European Medicines Agency (EMA) to clarify ethical standards for clinical research conducted outside the European Economic Area (EEA) and included in Marketing Authorization Applications. Reference to the EMA Reflection paper is made.

  1. Transparently reporting adverse effects of traditional Chinese medicine interventions in randomized controlled trials.

    PubMed

    Cheng, Chung-Wah; Bian, Zhao-Xiang; Li, You-Ping; Moher, David; Wu, Tai-Xiang; Dagenais, Simon; Li, Jing; Li, Ting-Qian

    2008-09-01

    Although all Chinese materia medica (CMM) come from nature, CMM interventions have both therapeutic effects and adverse effects (AEs). Normally, AEs in randomized controlled trial (RCT) with traditional Chinese medicine (TCM) could be divided into five types as follows: 1) AEs under proper TCM principles and guidelines, such as the toxicity (acute and chronic) and allergy; 2) AEs due to improper usage without following TCM principles, involving without following the TCM therapeutic principles, over-dosage, improper processing and preparation methods, improper formula strategy, etc; 3) AEs due to contamination in CMM, such as heavy metal and pesticides contaminations in Chinese herbal medicine interventions, and intentional or unintentional contamination with drug(s); 4) AEs due to replacement of CMMs; 5) AEs due to drug-herb interaction. AEs of TCM should be treated properly. Overestimation or underestimation about AEs of TCM intervention will bring a wrong message to patients and health care providers. In order to give readers a more comprehensive understanding about the safety issue of study intervention, Consolidated Standards of Reporting Trials (CONSORT) for TCM should involve the background information on side effects of each CMM constituents and/or the study intervention, specific outcome assessment on AEs, the details of reported AEs and the interpretation of the AEs occurrence in a structural RCT report.

  2. Challenges in Conducting A Multi-Site Randomized Clinical Trial Comparing Treatments for Adolescent Anorexia Nervosa

    PubMed Central

    Brandt, Harry; Woodside, Blake; Agras, Stewart; Halmi, Katherine; Johnson, Craig; Kaye, Walter; Wilfley, Denise

    2011-01-01

    Objective To describe obstacles in the implementation of a controlled treatment trial of adolescent anorexia nervosa (AN). Method The original aim was to enter 240 participants with AN to one of 4 cells: Behavioral family therapy (BFT) plus fluoxetine; BFT plus placebo; systems family therapy (SFT) plus fluoxetine; SFT plus placebo. Results Recruitment was delayed pending a satisfactory resolution concerning participant safety. After 6 months of recruitment it became clear that the medication was associated with poor recruitment leading to a study redesign resulting in a comparison of two types of family therapy with a projected sample size of 160. One site was unable to recruit and was replaced. Discussion Problems with the delineation of safety procedures, recruitment, re-design of the study, and replacement of a site, were the main elements resulting in a 1-year delay. Suggestions are made for overcoming such problems in future AN trials. PMID:21495052

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

    PubMed

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

    2013-07-01

    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.

  4. 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

  5. Prevalence and correlates of e-cigarette perceptions and trial among Mexican adolescents

    PubMed Central

    Thrasher, James F.; Abad-Vivero, Erika N.; Barrientos-Gutíerrez, Inti; Pérez-Hernández, Rosaura; Reynales-Shigematsu, Luz Miriam; Mejía, Raúl; Arillo-Santillán, Edna; Hernández-Ávila, Mauricio; Sargent, James D.

    2016-01-01

    PURPOSE Assess the prevalence and correlates of e-cigarette perceptions and trial among adolescents in Mexico, where e-cigarettes are banned. METHODS Cross-sectional data were collected in 2015 from a representative sample of middle school students (n=10,146). Prevalence of e-cigarette awareness, relative harm, and trial were estimated, adjusting for sampling weights and school-level clustering. Multilevel logistic regression models adjusted for school-level clustering to assess correlates of e-cigarette awareness and trial. Finally, students who had tried only e-cigarettes were compared with students who had tried: 1) conventional cigarettes only; 2) both e-cigarettes and conventional cigarettes (dual triers); 3) neither cigarette type (never triers). RESULTS 51% of students had heard about e-cigarettes, 19% believed e-cigarettes were less harmful than conventional cigarettes, and 10% had tried them. Independent correlates of e-cigarette awareness and trial included established risk factors for smoking, as well as technophilia (i.e., use of more media technologies) and greater Internet tobacco advertising exposure. Exclusive e-cigarette triers (4%) had significantly higher technophilia, bedroom Internet access, and Internet tobacco advertising exposure compared to conventional cigarette triers (19%) and never triers (71%), but not compared to dual triers (6%), even though dual triers had significantly stronger conventional cigarette risk factors. CONCLUSIONS This study suggests that adolescent e-cigarette awareness and use is high in Mexico, in spite of its e-cigarette ban. A significant number of medium-risk youth have tried e-cigarettes only, suggesting that e-cigarettes could lead to more intensive substance use. Strategies to reduce e-cigarette use should consider reducing exposures to Internet marketing. PMID:26903433

  6. 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

  7. 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.

  8. An overview of the NCI precision medicine trials-NCI MATCH and MPACT.

    PubMed

    Do, Khanh; O'Sullivan Coyne, Geraldine; Chen, Alice P

    2015-09-01

    The concept of oncogene addiction was first proposed by Weinstein in 2002, postulating that tumors rely on a single dominant mutation, the oncogenic "driver", for growth and survival. We have since come to realize that the genomic landscape of tumors is heterogeneous and more complex than previously thought. Advances in biotechnology and bioinformatics over the past decade have shifted treatment paradigms with regard to the development of molecular targeted therapeutics to identify and target the presumptive dominant lesion. As such, the decision of choosing targeted treatment strategies has become increasingly more reliant on the reporting of genomic screens of patients' tumor tissue. Whether this change in treatment paradigm will translate into improved clinical benefit, remains to be seen. To this end, the United States National Cancer Institute (NCI) has launched precision-based medicine trials to address this question. NCI Molecular Analysis for Therapy Choice (MATCH), a genomic pre-screening study, was designed to explore the efficacy of using targeted agents to target specific molecular aberrations and whether these same therapies have comparable activity across different tumor subtypes. Molecular Profiling-based Assignment of Cancer Therapy (MPACT), is a smaller, provocative trial designed to address whether targeting an oncogenic "driver" would be more efficacious than one not. The Exceptional Responders' initiative further aims to evaluate patients who have derived an unexpected durable benefit to these therapies, with retrospective analysis of their tumors to delineate potential predictive biomarkers which could predict response. The results of these trials will serve to help guide the field of precision medicine and personalized care.

  9. 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

  10. 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

  11. 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

  12. 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

  13. Internet-Delivered Cognitive Behavior Therapy for Adolescents with Obsessive-Compulsive Disorder: An Open Trial

    PubMed Central

    Lenhard, Fabian; Vigerland, Sarah; Andersson, Erik; Rück, Christian; Mataix-Cols, David; Thulin, Ulrika; Ljótsson, Brjánn; Serlachius, Eva

    2014-01-01

    Background International guidelines recommend Cognitive Behavior Therapy (CBT) as the first line treatment for pediatric obsessive-compulsive disorder (OCD). However, a substantial proportion of patients do not have access to such treatment. We developed and tested the feasibility, efficacy and acceptability of a novel therapist-guided, Internet-delivered CBT (ICBT) platform for adolescents with OCD. Methods An interactive, age-appropriate ICBT platform (“BiP OCD”) was developed. Twenty-one adolescents (12–17 years) with a DSM-IV diagnosis of OCD and their parents were enrolled in the study. All participants received 12 weeks of ICBT with therapist support. The primary outcome measure was the Children’s Yale-Brown Obsessive-Compulsive Scale (CY-BOCS). Acceptability was assessed at post-treatment. Results Participants completed on average 8.29 (SD = 3.0) of the 12 treatment chapters. Treatment yielded significant improvements on all clinician-, parent- and most self-administered outcome measures, with a large effect size of d = 2.29 (95% CI 1.5–3.07) on the CY-BOCS. Patients continued to improve at follow-up. At 6-month follow-up, 71% were classified as responders (≥35% decrease on the CY-BOCS) and 76% as being in remission (CY-BOCS score ≤12). Average clinician support time was less than 20 minutes per patient per week. The majority of participants felt that BiP OCD was age-appropriate and rated the treatment as good or very good. Conclusions ICBT could be efficacious, acceptable, and cost-effective for adolescents with OCD. More rigorously controlled studies are needed to further evaluate the treatment. Trial Registration ClinicalTrials.gov; NCT01809990. PMID:24949622

  14. 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

  15. 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.

  16. 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.

  17. 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

  18. Use of complementary and alternative medicine in children and adolescents with autism spectrum disorder: A systematic review.

    PubMed

    Höfer, Juliana; Hoffmann, Falk; Bachmann, Christian

    2017-05-01

    Despite limited evidence, complementary and alternative medicine treatments are popular in autism spectrum disorder. The aim of this review was to summarize the available evidence on complementary and alternative medicine use frequency in autism spectrum disorder. A systematic search of three electronic databases was performed. All research studies in English or German reporting data on the frequency of complementary and alternative medicine use in individuals with autism spectrum disorder were included. Two independent reviewers searched the literature, extracted information on study design and results, and assessed study quality using an established quality assessment tool. Twenty studies with a total of 9540 participants were included. The prevalence of any complementary and alternative medicine use ranged from 28% to 95% (median: 54%). Special diets or dietary supplements (including vitamins) were the most frequent complementary and alternative medicine treatments, ranking first in 75% of studies. There was some evidence for a higher prevalence of complementary and alternative medicine use in autism spectrum disorder compared to other psychiatric disorders and the general population. Approximately half of children and adolescents with autism spectrum disorder use complementary and alternative medicine. Doctors should be aware of this and should discuss complementary and alternative medicine use with patients and their carers, especially as the evidence is mixed and some complementary and alternative medicine treatments are potentially harmful.

  19. Brief Cognitive-Behavioral Depression Prevention Program for High-Risk Adolescents Outperforms Two Alternative Interventions: A Randomized Efficacy Trial

    ERIC Educational Resources Information Center

    Stice, Eric; Rohde, Paul; Seeley, John R.; Gau, Jeff M.

    2008-01-01

    In this depression prevention trial, 341 high-risk adolescents (mean age = 15.6 years, SD = 1.2) with elevated depressive symptoms were randomized to a brief group cognitive-behavioral (CB) intervention, group supportive-expressive intervention, bibliotherapy, or assessment-only control condition. CB participants showed significantly greater…

  20. 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…

  1. 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-,…

  2. 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…

  3. 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…

  4. 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…

  5. 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…

  6. 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.

  7. New Strategies in Personalized Medicine for Solid Tumors: Molecular Markers and Clinical Trial Designs

    PubMed Central

    Jürgensmeier, Juliane M.; Eder, Joseph P.; Herbst, Roy S.

    2017-01-01

    The delineation of signaling pathways to understand tumor biology combined with the rapid development of technologies that allow broad molecular profiling and data analysis, has led to a new era of personalized medicine in oncology. Many academic institutions now routinely profile patients and discuss them in personalized medicine tumor boards before making treatment recommendations. Clinical trials initiated by pharmaceutical companies often require specific markers for enrollment or at least explore multiple options for future markers. In addition to the still small number of targeted agents that are approved for the therapy of patients with histological and molecularly defined tumors, there is a broad range of novel targeted agents in development that are undergoing clinical studies with companion profiling to determine the best responding patient population. While the present focus of profiling are genetic analyses, additional testing of RNA, protein and immune parameters are being developed and incorporated in clinical research and are likely to contribute significantly to future patient selection and treatment approaches. As the advances in tumor biology and human genetics have identified promising tumor targets, the ongoing clinical evaluation of novel agents will now need to show if the promise can be translated into benefit for patients. PMID:25183480

  8. Randomized controlled trials in pediatric complementary and alternative medicine: Where can they be found?

    PubMed Central

    Sampson, Margaret; Campbell, Kaitryn; Ajiferuke, Isola; Moher, David

    2003-01-01

    Background The safety and effectiveness of CAM interventions are of great relevance to pediatric health care providers. The objective of this study is to identify sources of reported randomized controlled trials (RCTs) in the field of pediatric complementary and alternative medicine (CAM). Methods Reports of RCTs were identified by searching Medline and 12 additional bibliographic databases and by reviewing the reference lists of previously identified pediatric CAM systematic reviews. Results We identified 908 reports of RCTs that included children under 18 and investigated a CAM therapy. Since 1965, there has been a steady growth in the number of these trials that are being published. The four journals that published the most reported RCTs are The American Journal of Clinical Nutrition, Pediatrics, Journal of Pediatrics, and Lancet. Medline, CAB Health, and Embase were the best database sources for identifying these studies; they indexed 93.2%, 58.4% and 42.2 % respectively of the journals publishing reports of pediatric CAM RCTs. Conclusions Those working or interested in the field of pediatric CAM should routinely search Medline, CAB Health and Embase for literature in the field. The four core journals identified above should be included in their collection. PMID:12589711

  9. 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

  10. Effect of Hibiscus sabdariffa Calices on Dyslipidemia in Obese Adolescents: A Triple-masked Randomized Controlled Trial

    PubMed Central

    Sabzghabaee, Ali Mohammad; Ataei, Ehsan; Kelishadi, Roya; Ghannadi, Alireza; Soltani, Rasool; Badri, Shirinsadat; Shirani, Shahin

    2013-01-01

    Conflict of interest: none declared. Objective We aimed to evaluate the effects of Hibiscus sabdariffa (HS) calices on controlling dyslipidemia in obese adolescents. Methodology In this triple blind randomized placebo-controlled clinical trial which was registered in the Iranian registry for clinical trials (IRCT201109122306N2), 90 obese adolescents aged 12-18 years with documented dyslipidemia were randomly assigned in two groups of cases who received 2 grams of fine powdered calices of Hibiscus sabdariffa per day for one month and controls who received placebo powder with the same dietary and physical activity recommendations and duration of exposure. Full lipid profile and fasting blood sugar measured before and after the trial. Data were analyzed using multivariate general linear model. Findings Overall, 72 participants (mean age of 14.21±1.6, 35 boys) completed the trial. The two arms of the study (cases and controls) were not statistically different in terms of age, gender, weight, body mass index (BMI) and lipid profile before the trial. Serum total cholesterol, low density lipoprotein cholesterol and serum triglyceride showed a significant decrease in cases group but high density lipoprotein cholesterol level was not changed significantly. Conclusion It is concluded that Hibiscus sabdariffa calyces powder may have significant positive effects on lipid profile of adolescents which maybe attributed to its polyphenolic and antioxidant content. Further studies are needed on dose-response and formulation optimization. PMID:24082826

  11. 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.

  12. Excess Weight Gain Prevention in Adolescents: Three-year Outcome following a Randomized-Controlled Trial

    PubMed Central

    Tanofsky-Kraff, Marian; Shomaker, Lauren B.; Wilfley, Denise E.; Young, Jami F.; Sbrocco, Tracy; Stephens, Mark; Brady, Sheila M.; Galescu, Ovidiu; Demidowich, Andrew; Olsen, Cara H.; Kozlosky, Merel; Reynolds, James C.; Yanovski, Jack A.

    2016-01-01

    Objective Interpersonal psychotherapy (IPT) prevents weight gain in adults with obesity and binge-eating-disorder, and is especially effective among those with increased psychosocial problems. However, IPT was not superior to health-education (HE) to prevent excess weight gain at 1-year follow-up in 113 adolescent girls at high-risk for excess weight gain because of loss-of-control (LOC)-eating and high BMI (kg/m2) (Tanofsky-Kraff et al., 2014). Method Participants from the original trial were re-contacted 3-years later for assessment. At baseline, adolescent- and parent-reported social-adjustment problems and trait-anxiety were evaluated. At baseline and follow-ups, BMIz and adiposity by dual-energy X-ray absorptiometry were obtained. Results Nearly 60% were re-assessed at 3-years, with no group differences in participation (ps≥.70). Consistent with 1-year, there was no main effect of group on change in BMIz/adiposity (ps≥.18). In exploratory analyses, baseline social-adjustment problems and trait-anxiety moderated outcome (ps<.01). Among girls with high self-reported baseline social-adjustment problems or anxiety, IPT, compared to HE, was associated with the steepest declines in BMIz (p<.001). For adiposity, girls with high- or low-anxiety in HE, and girls with low-anxiety in IPT experienced gains (ps≤.03), while girls in IPT with high-anxiety stabilized. Parent-reports yielded complementary findings. Conclusion In obesity-prone adolescent girls, IPT was not superior to HE in preventing excess weight gain at 3-years. Consistent with theory, exploratory analyses suggested that IPT was associated with improvements in BMIz over 3-years among youth with high social-adjustment problems or trait-anxiety. Future studies should test the efficacy of IPT for obesity prevention among at-risk girls with social-adjustment problems and/or anxiety. PMID:27808536

  13. Relation of depression to perceived social support: results from a randomized adolescent depression prevention trial.

    PubMed

    Stice, Eric; Rohde, Paul; Gau, Jeff; Ochner, Chris

    2011-05-01

    Theorists posit that certain behaviors exhibited by depressed individuals (e.g., negative self-statements, dependency, reassurance seeking, inappropriate or premature disclosures, passivity, social withdrawal) reduce social support, yet there have been few experimental tests of this hypothesis. Using data from a randomized depression prevention trial (N=253) involving adolescents (M age=15.5, SD=1.2), we tested whether a cognitive behavioral group intervention that significantly reduced depressive symptoms relative to bibliotherapy and educational brochure control conditions through 2-year follow-up produced improvements in perceived parental and friend social support and whether change in depressive symptoms mediated the effect on change in social support. Cognitive behavioral group participants showed significantly greater increases in perceived friend social support through 1-year follow-up relative to bibliotherapy and brochure controls, but there were no significant effects for perceived parental support. Further, change in depressive symptoms appeared to mediate the effects of the intervention on change in perceived friend support. Results provide experimental support for the theory that depressive symptoms are inversely related to perceived social support, but imply that this effect may be specific to friend vs. parental support for adolescents.

  14. Dialectical Behavior Therapy for Adolescents With Bipolar Disorder: A 1-Year Open Trial

    PubMed Central

    GOLDSTEIN, TINA R.; AXELSON, DAVID A.; BIRMAHER, BORIS; BRENT, DAVID A.

    2010-01-01

    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) includes 24 weekly sessions; sessions alternate between the two treatment modalities. Continuation treatment consists of 12 additional sessions tapering in frequency through 1 year. We conducted an open pilot trial of the treatment, designed as an adjunct to pharmacological management, to establish feasibility and acceptability of the treatment for this population. Participants included 10 patients (mean age 15.8 ± 1.5 years, range 14–18) receiving treatment in an outpatient pediatric bipolar specialty clinic. Symptom severity and functioning were assessed quarterly by an independent evaluator. Consumer satisfaction was also assessed posttreatment. Results Feasibility and acceptability of the intervention were high, with 9 of 10 patients completing treatment, 90% of scheduled sessions attended, and high treatment satisfaction ratings. Patients exhibited significant improvement from pre- to posttreatment in suicidality, nonsuicidal self-injurious behavior, emotional dysregulation, and depressive symptoms. Conclusions Dialectical behavior therapy may offer promise as an approach to the psychosocial treatment of adolescent bipolar disorder. PMID:17581446

  15. A randomised controlled trial of tiotropium in adolescents with severe symptomatic asthma

    PubMed Central

    Bernstein, Jonathan A.; Vandewalker, Mark; Moroni-Zentgraf, Petra; Verri, Daniela; Unseld, Anna; Engel, Michael; Boner, Attilio L.

    2017-01-01

    We present results from the first phase III trial of once-daily tiotropium add-on to inhaled corticosteroids (ICS) plus one or more controller therapies in adolescents with severe symptomatic asthma. In this double-blind, parallel-group trial (NCT01277523), 392 patients aged 12–17 years were randomised to receive once-daily tiotropium 5 µg or 2.5 µg, or placebo, as an add-on to ICS plus other controller therapies over 12 weeks. The primary and key secondary end-points were change from baseline (response) in peak forced expiratory volume in 1 s (FEV1) within 3 h post-dosing (FEV1(0–3h)) and trough FEV1, respectively, after 12 weeks of treatment. Tiotropium 5 µg provided numerical improvements in peak FEV1(0–3h) response, compared with placebo (90 mL; p=0.104), and significant improvements were observed with tiotropium 2.5 µg (111 mL; p=0.046). Numerical improvements in trough FEV1 response and asthma control were observed with both tiotropium doses, compared with placebo. The safety and tolerability of tiotropium were comparable with those of placebo. Once-daily tiotropium Respimat add-on to ICS plus one or more controller therapies in adolescents with severe symptomatic asthma was well tolerated. The primary end-point of efficacy was not met, although positive trends for improvements in lung function and asthma control were observed. PMID:27811070

  16. A randomised controlled trial of tiotropium in adolescents with severe symptomatic asthma.

    PubMed

    Hamelmann, Eckard; Bernstein, Jonathan A; Vandewalker, Mark; Moroni-Zentgraf, Petra; Verri, Daniela; Unseld, Anna; Engel, Michael; Boner, Attilio L

    2017-01-01

    We present results from the first phase III trial of once-daily tiotropium add-on to inhaled corticosteroids (ICS) plus one or more controller therapies in adolescents with severe symptomatic asthma.In this double-blind, parallel-group trial (NCT01277523), 392 patients aged 12-17 years were randomised to receive once-daily tiotropium 5 µg or 2.5 µg, or placebo, as an add-on to ICS plus other controller therapies over 12 weeks. The primary and key secondary end-points were change from baseline (response) in peak forced expiratory volume in 1 s (FEV1) within 3 h post-dosing (FEV1(0-3h)) and trough FEV1, respectively, after 12 weeks of treatment.Tiotropium 5 µg provided numerical improvements in peak FEV1(0-3h) response, compared with placebo (90 mL; p=0.104), and significant improvements were observed with tiotropium 2.5 µg (111 mL; p=0.046). Numerical improvements in trough FEV1 response and asthma control were observed with both tiotropium doses, compared with placebo. The safety and tolerability of tiotropium were comparable with those of placebo.Once-daily tiotropium Respimat add-on to ICS plus one or more controller therapies in adolescents with severe symptomatic asthma was well tolerated. The primary end-point of efficacy was not met, although positive trends for improvements in lung function and asthma control were observed.

  17. Randomized Control Trial to Improve Adiposity and Insulin Resistance in Overweight Latino Adolescents

    PubMed Central

    Davis, Jaimie N.; Kelly, Louise A.; Lane, Christianne J.; Ventura, Emily E.; Byrd-Williams, Courtney E.; Alexandar, Katharine A.; Azen, Stanley P.; Chou, Chih-Ping; Spruijt-Metz, Donna; Weigensberg, Marc J.; Berhane, Kiros; Goran, Michael I.

    2010-01-01

    Few randomized trials attempt to improve insulin sensitivity and associated metabolic risks in overweight Latino youth. The purpose of this study is to examine the effects of a modified carbohydrate nutrition program combined with strength training on insulin sensitivity, adiposity, and other type 2 diabetes risk factors in overweight Latino adolescents. In a 16-week randomized trial, 54 overweight Latino adolescents (15.5 ± 1.0 years) were randomly assigned to: (i) Control (C; n = 16), (ii) Nutrition (N; n = 21), or (iii) Nutrition + Strength training (N+ST; n = 17). The N group received modified carbohydrate nutrition classes (once per week), while the N+ST received the same nutrition classes plus strength training (twice per week). The following were measured at pre- and postintervention: strength by 1-repetition maximum, dietary intake by 3-day records, body composition by dual-energy X-ray absorptiometry, glucose/insulin indices by oral glucose tolerance test (OGTT) and intravenous glucose tolerance test with minimal modeling. Across intervention group effects were tested using analysis of covariance with post hoc pairwise comparisons. A significant overall intervention effect was found for improvement in bench press (P < 0.001) and reductions in energy (P = 0.05), carbohydrate (P = 0.04) and fat intake (P = 0.03). There were no significant intervention effects on insulin sensitivity, body composition, or most glucose/insulin indices with the exception of glucose incremental area under the curve (IAUC) (P = 0.05), which decreased in the N and N+ST group by 18 and 6.3% compared to a 32% increase in the C group. In conclusion, this intense, culturally tailored intervention resulted in no significant intervention effects on measured risk factors with the exception of a beneficial effect on glycemic response to oral glucose. PMID:19247280

  18. 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

  19. 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

  20. Exploring integrative medicine for back and neck pain - a pragmatic randomised clinical pilot trial

    PubMed Central

    Sundberg, Tobias; Petzold, Max; Wändell, Per; Rydén, Anna; Falkenberg, Torkel

    2009-01-01

    Background A model for integrative medicine (IM) adapted to Swedish primary care was previously developed. The aim of this study was to explore the feasibility of a pragmatic randomised clinical trial to investigate the effectiveness of the IM model versus conventional primary care in the management of patients with non-specific back/neck pain. Specific objectives included the exploration of recruitment and retention rates, patient and care characteristics, clinical differences and effect sizes between groups, selected outcome measures and power calculations to inform the basis of a full-scale trial. Methods Eighty patients with back/neck pain of at least two weeks duration were randomised to the two types of care. Outcome measures were standardised health related quality of life (the eight domains of SF-36) complemented by a set of exploratory "IM tailored" outcomes targeting self-rated disability, stress and well-being (0-10 scales); days in pain (0-14); and the use of analgesics and health care over the last two weeks (yes/no). Data on clinical management were derived from medical records. Outcome changes from baseline to follow-up after 16 weeks were used to explore the differences between the groups. Results Seventy-five percent (80/107) of screened patients in general practice were eligible and feasible to enrol into the trial. Eighty-two percent (36/44) of the integrative and 75% (27/36) of the conventional care group completed follow-up after 16 weeks. Most patients had back/neck pain of at least three months duration. Conventional care typically comprised advice and prescription of analgesics, occasionally complemented with sick leave or a written referral to physiotherapy. IM care generally integrated seven treatment sessions from two different types of complementary therapies with conventional care over ten weeks. The study was underpowered to detect any statistically significant differences between the groups. One SF-36 domain showed a clinically

  1. New medicinal products for chronic heart failure: advances in clinical trial design and efficacy assessment.

    PubMed

    Cowie, Martin R; Filippatos, Gerasimos S; Alonso Garcia, Maria de Los Angeles; Anker, Stefan D; Baczynska, Anna; Bloomfield, Daniel M; Borentain, Maria; Bruins Slot, Karsten; Cronin, Maureen; Doevendans, Pieter A; El-Gazayerly, Amany; Gimpelewicz, Claudio; Honarpour, Narimon; Janmohamed, Salim; Janssen, Heidi; Kim, Albert M; Lautsch, Dominik; Laws, Ian; Lefkowitz, Martin; Lopez-Sendon, Jose; Lyon, Alexander R; Malik, Fady I; McMurray, John J V; Metra, Marco; Figueroa Perez, Santiago; Pfeffer, Marc A; Pocock, Stuart J; Ponikowski, Piotr; Prasad, Krishna; Richard-Lordereau, Isabelle; Roessig, Lothar; Rosano, Giuseppe M C; Sherman, Warren; Stough, Wendy Gattis; Swedberg, Karl; Tyl, Benoit; Zannad, Faiez; Boulton, Caroline; De Graeff, Pieter

    2017-03-27

    Despite the availability of a number of different classes of therapeutic agents with proven efficacy in heart failure, the clinical course of heart failure patients is characterized by a reduction in life expectancy, a progressive decline in health-related quality of life and functional status, as well as a high risk of hospitalization. New approaches are needed to address the unmet medical needs of this patient population. The European Medicines Agency (EMA) is undertaking a revision of its Guideline on Clinical Investigation of Medicinal Products for the Treatment of Chronic Heart Failure. The draft version of the Guideline was released for public consultation in January 2016. The Cardiovascular Round Table of the European Society of Cardiology (ESC), in partnership with the Heart Failure Association of the ESC, convened a dedicated two-day workshop to discuss three main topic areas of major interest in the field and addressed in this draft EMA guideline: (i) assessment of efficacy (i.e. endpoint selection and statistical analysis); (ii) clinical trial design (i.e. issues pertaining to patient population, optimal medical therapy, run-in period); and (iii) research approaches for testing novel therapeutic principles (i.e. cell therapy). This paper summarizes the key outputs from the workshop, reviews areas of expert consensus, and identifies gaps that require further research or discussion. Collaboration between regulators, industry, clinical trialists, cardiologists, health technology assessment bodies, payers, and patient organizations is critical to address the ongoing challenge of heart failure and to ensure the development and market access of new therapeutics in a scientifically robust, practical and safe way.

  2. Cognitive-behavioral therapy for binge eating disorder in adolescents: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Binge eating disorder is a prevalent adolescent disorder, associated with increased eating disorder and general psychopathology as well as an increased risk for overweight and obesity. As opposed to binge eating disorder in adults, there is a lack of validated psychological treatments for this condition in adolescents. The goal of this research project is therefore to determine the efficacy of age-adapted cognitive-behavioral therapy in adolescents with binge eating disorder – the gold standard treatment for adults with binge eating disorder. Methods/design In a single-center efficacy trial, 60 12- to 20-year-old adolescents meeting diagnostic criteria of binge eating disorder (full-syndrome or subthreshold) according to the Diagnostic and Statistical Manual of Mental Disorders 4th or 5th Edition, will be centrally randomized to 4 months of cognitive-behavioral therapy (n = 30) or a waiting-list control condition (n = 30). Using an observer-blind design, patients are assessed at baseline, mid-treatment, post-treatment, and at 6- and 12-month follow-ups after the end of treatment. In 20 individual outpatient sessions, cognitive-behavioral therapy for adolescents focuses on eating behavior, body image, and stress; parents receive psychoeducation on these topics. Primary endpoint is the number of episodes with binge eating over the previous 28 days at post-treatment using a state-of-the art clinical interview. Secondary outcome measures address the specific eating disorder psychopathology, general psychopathology, mental comorbidity, self-esteem, quality of life, and body weight. Discussion This trial will allow us to determine the short- and long-term efficacy of cognitive-behavioral therapy in adolescent binge eating disorder, to determine cost-effectiveness, and to identify predictors of treatment outcome. Evidence will be gathered regarding whether this treatment will help to prevent excessive weight gain. If efficacy can be demonstrated, the results

  3. 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

  4. 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

  5. Use of a Modified Pediatric Early Warning Score in a Department of Pediatric and Adolescent Medicine

    PubMed Central

    Solevåg, Anne L.; Eggen, Elisabeth H.; Schröder, Judith; Nakstad, Britt

    2013-01-01

    Background Several versions of the Pediatric Early Warning Score (PEWS) exist, but there is limited information available on the use of such systems in different contexts. In the present study, we aimed to examine the relationship between a modified version of The Brighton Paediatric Early Warning Score (PEWS) and patient characteristics in a Norwegian department of pediatric and adolescent medicine. In addition, we sought to establish guidelines for escalation in patient care based on the PEWS in our patient population. Methods The medical records of patients referred for acute care from March to May 2011 were retrospectively reviewed. Children with a PEWS ≥3 were compared to children with a PEWS 0–2 with regard to age, diagnostic group and indicators of severe disease. Results A total of 761 patients (0−18 years of age) were included in the analysis. A younger age and diagnostic groups such as lower airway and cardiovascular disease were associated with PEWS ≥3. Upper airway disease and minor injury were more frequent in patients with PEWS 0−2. Children with PEWS ≥3 received fluid resuscitation, intravenous antibiotics, and oxygen supplementation, and were transferred to a higher level of care more often than children with PEWS 0−2. Conclusions A PEWS ≥3 was associated with severe illnesses and surrogate markers of cardio-respiratory compromise. Patients with PEWS ≥3 should be carefully monitored to prevent further deterioration. PMID:23991121

  6. 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

  7. 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...

  8. Coordination and Management of Multisite Complementary and Alternative Medicine (CAM) Therapies: Experience from a Multisite Reflexology Intervention Trial

    PubMed Central

    Rahbar, Mohammad H.; Wyatt, Gwen; Sikorskii, Alla; Victorson, David; Ardjomand-Hessabi, Manouchehr

    2011-01-01

    Background Multisite randomized clinical trials allow for increased research collaboration among investigators and expedite data collection efforts. As a result, government funding agencies typically look favorably upon this approach. As the field of complementary and alternative medicine (CAM) continues to evolve, so do increased calls for the use of more rigorous study design and trial methodologies, which can present challenges for investigators. Purpose To describe the processes involved in the coordination and management of a multisite randomized clinical trial of a CAM intervention. Methods Key aspects related to the coordination and management of a multisite CAM randomized clinical trial are presented, including organizational and site selection considerations, recruitment concerns and issues related to data collection and randomization to treatment groups. Management and monitoring of data, as well as quality assurance procedures are described. Finally, a real world perspective is shared from a recently conducted multisite randomized clinical trial of reflexology for women diagnosed with advanced breast cancer. Results The use of multiple sites in the conduct of CAM-based randomized clinical trials can provide an efficient, collaborative and robust approach to study coordination and data collection that maximizes efficiency and ensures the quality of results. Conclusions Multisite randomized clinical trial designs can offer the field of CAM research a more standardized and efficient approach to examine the effectiveness of novel therapies and treatments. Special attention must be given to intervention fidelity, consistent data collection and ensuring data quality. Assessment and reporting of quantitative indicators of data quality should be required. PMID:21664296

  9. 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

  10. 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

  11. [Basic requirements on post-marketing clinical re-evaluation of chinese medicine and phase IV clinical trials].

    PubMed

    Xie, Yanming; Wang, Yanping; Tian, Feng; Wang, Yongyan

    2011-10-01

    As information on safety and effectiveness is not comprehensive, gained from the researches for listing approval of Chinese medicine, it is very necessary to conduct post-marketing clinical re-evaluation of Chinese medicine. Effectiveness, safety and economic evaluation are three main aspects of post-marketing clinical re-evaluation. In this paper, the difference and relations between the post-marketing clinical re-evaluation and the phase IV clinical trials were discussed, and the basic requests and suggestions were proposed, according to the domestic and foreign relevant regulations and experts' suggestions, and discussed the requirements of the phase IV clinical trials on indications, design methods, inclusion and exclusion criteria, sample size, etc.

  12. 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

  13. 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.

  14. 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

  15. 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.

  16. Common issues encountered in adolescent sports medicine: guide to completing the preparticipation physical evaluation.

    PubMed

    Heinke, Blair; Mullner, Justin

    2014-09-01

    Participation in athletic activities among children and adolescents is on the rise in the United States. Approximately 35 million children ages 5 to 18 play organized sports each year. High school athletes suffer approximately 2 million injuries per year, resulting in 500,000 doctor visits and 30,000 hospitalizations. In addition, early specialization in sports has led to increased incidence of overuse injury in adolescents. Head injuries among adolescents are also on the rise. Primary care providers are called on to complete preparticipation evaluations and to see adolescents with acute injuries. The goal of this article is to discuss these issues common to adolescent athletes.

  17. Peer mentorship to promote effective pain management in adolescents: study protocol for a randomised controlled trial

    PubMed Central

    2011-01-01

    Background This protocol is for a study of a new program to improve outcomes in children suffering from chronic pain disorders, such as fibromyalgia, recurrent headache, or recurrent abdominal pain. Although teaching active pain self-management skills through cognitive-behavioral therapy (CBT) or a complementary program such as hypnotherapy or yoga has been shown to improve pain and functioning, children with low expectations of skill-building programs may lack motivation to comply with therapists' recommendations. This study will develop and test a new manualized peer-mentorship program which will provide modeling and reinforcement by peers to other adolescents with chronic pain (the mentored participants). The mentorship program will encourage mentored participants to engage in therapies that promote the learning of pain self-management skills and to support the mentored participants' practice of these skills. The study will examine the feasibility of this intervention for both mentors and mentored participants, and will assess the preliminary effectiveness of this program on mentored participants' pain and functional disability. Methods This protocol will recruit adolescents ages 12-17 with chronic pain and randomly assign them to either peer mentorship or a treatment-as-usual control group. Mentored participants will be matched with peer mentors of similar age (ages 14-18) who have actively participated in various treatment modalities through the UCLA Pediatric Pain Program and have learned to function successfully with a chronic pain disorder. The mentors will present information to mentored participants in a supervised and monitored telephone interaction for 2 months to encourage participation in skill-building programs. The control group will receive usual care but without the mentorship intervention. Mentored and control subjects' pain and functioning will be assessed at 2 months (end of intervention for mentored participants) and at 4 month follow-up to

  18. 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.

  19. 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

  20. 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

  1. 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

  2. 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…

  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. 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)…

  5. 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.…

  6. 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…

  7. 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

  8. 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

  9. Factors Affecting Recruitment and Attrition in Randomised Controlled Trials of Complementary and Alternative Medicine for Pregnancy-Related Issues

    PubMed Central

    2016-01-01

    Background. Randomised controlled trials (RCTs) investigating Complementary and Alternative Medicine (CAM) for pregnancy-related issues have encountered issues with recruitment and attrition. Little is known about the cause of these issues. Methods. Data was gathered from an antenatal CAM randomised controlled trial. During foetal anomaly appointments, women meeting inclusion criteria were invited to participate in the trial. Numbers of women invited and eligible were recorded. Reasons for noninterest were noted and analysed. Focus groups exploring trial experience of participants were also conducted. Findings. Of the 428 women invited to participate, 376 were eligible and just under a quarter participated. Reasons for nonparticipation included concerns about CAM and lack of interest in participation in research. Other factors negatively affecting recruitment included recruitment timing, competition for participants, limited support from staff, and inadequate trial promotion. Factors encouraging recruitment included being interested in research and seeking pain relief. Reasons for dropping out were time constraints, travel issues, work commitments, and pregnancy issues. Several women in the sham and usual care group dropped out due to dissatisfaction with treatment allocation. Conclusion. CAM researchers must explore problems encountered with recruitment and attrition so that evidence-based implementation strategies to address the issues can be developed. PMID:27956921

  10. 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.

  11. 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.

  12. Cost-Effectiveness of Group and Internet Cognitive Behavioral Therapy for Insomnia in Adolescents: Results from a Randomized Controlled Trial

    PubMed Central

    De Bruin, Eduard J.; van Steensel, Francisca J.A.; Meijer, Anne Marie

    2016-01-01

    Study Objectives: To investigate cost-effectiveness of adolescent cognitive behavioral therapy for insomnia (CBTI) in group- and Internet-delivered formats, from a societal perspective with a time horizon of 1 y Methods: Costs and effects data up to 1-y follow-up were obtained from a randomized controlled trial (RCT) comparing Internet CBTI to face-to-face group CBTI. The study was conducted at the laboratory of the Research Institute of Child Development and Education at the University of Amsterdam, and the academic youth mental health care center UvAMinds in Amsterdam. Sixty-two participants meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision criteria for insomnia were randomized to face-to-face group CBTI (GT; n = 31, age = 15.6 y ± 1.8, 71.0% girls) or individual Internet CBTI (IT; n = 31, age = 15.4 y ± 1.5, 83.9% girls). The intervention consisted of six weekly sessions and a 2-mo follow up booster-session of CBTI, consisting of psychoeducation, sleep hygiene, restriction of time in bed, stimulus control, cognitive therapy, and relaxation techniques. GT sessions were held in groups of six to eight adolescents guided by two trained sleep therapists. IT consisted of individual Internet therapy with preprogrammed content similar to GT, and guided by trained sleep therapists. Results: Outcome measures were subjective sleep efficiency (SE) ≥ 85%, and quality-adjusted life-years (QALY). Analyses were conducted from a societal perspective. Incremental cost-effectiveness ratios (ICERs) were calculated using bootstrap sampling, and presented in cost-effectiveness planes. Primary analysis showed costs over 1 y were higher for GT but effects were similar for IT and GT. Bootstrapped ICERs demonstrated there is a high probability of IT being cost-effective compared to GT. Secondary analyses confirmed robustness of results. Conclusions: Internet CBTI is a cost-effective treatment compared to group CBTI for adolescents, although

  13. 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 ...

  14. 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

  15. 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

  16. 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

  17. An initial waitlist-controlled trial of the unified protocol for the treatment of emotional disorders in adolescents.

    PubMed

    Ehrenreich-May, Jill; Rosenfield, David; Queen, Alexander H; Kennedy, Sarah M; Remmes, Cara S; Barlow, David H

    2017-03-01

    A substantial proportion of adolescents are non-responders to well-established treatments for anxiety and depression, and many existent approaches do not adequately address comorbidity. There is a need to develop and evaluate unified treatments for adolescents that flexibly address higher order factors shared among internalizing or emotional disorders. The Unified Protocol for the Treatment of Emotional Disorders in Adolescents (UP-A) is a transdiagnostic treatment that targets shared vulnerability and maintenance factors in a flexible format. This study examined initial outcomes of a randomized, waitlist-controlled trial of the UP-A. The UP-A outperformed waitlist at mid-treatment with respect to disorder severity and functional impairment, and there was a significant treatment effect in favor of the UP-A on all outcome measures at post-treatment. Within-subjects analyses collapsing across participants revealed significant improvements on outcome measures over time. Results support further study of the UP-A and its potential efficacy in treating adolescent anxiety and depression.

  18. Mediators Affecting Girls’ Levels of Physical Activity Outside of School: Findings from the Trial of Activity in Adolescent Girls

    PubMed Central

    Lytle, Leslie A.; Murray, David M.; Evenson, Kelly R.; Moody, Jamie; Pratt, Charlotte A.; Metcalfe, Lauve; Parra-Medina, Deborah

    2010-01-01

    Background Providing after school activities is a community level approach for reducing the decline in physical activity of girls as they reach early adolescence. Purpose The purpose of this study was to examine psychosocial, environmental, and behavioral factors as potential mediators of after school physical activity in adolescent girls. Methods We assessed objectively measured levels of physical activity occurring outside of school and potential predictors and mediators of activity in girls participating in the Trial of Activity in Adolescent Girls (TAAG). Results We found that the TAAG intervention had a statistically significant and positive effect on out of school activity in the 2006 cohort. Self-efficacy, friends’ social support, total social support, and difficulty getting to and from community activities mediated the level of moderate to vigorous physical activity in girls. Conclusions Parents, communities, and schools should provide and enhance opportunities outside of the school day for adolescents to be active. Reducing transportation barriers and enlisting social support appear to be key. PMID:20012810

  19. Challenges and recommendations for placebo controls in randomized trials in physical and rehabilitation medicine: a report of the international placebo symposium working group.

    PubMed

    Fregni, Felipe; Imamura, Marta; Chien, Hsin Fen; Lew, Henry L; Boggio, Paulo; Kaptchuk, Ted J; Riberto, Marcelo; Hsing, Wu Tu; Battistella, Linamara Rizzo; Furlan, Andrea

    2010-02-01

    Compared with other specialties, the field of physical and rehabilitation medicine has not received the deserved recognition from clinicians and researchers in the scientific community. One of the reasons is the lack of sound evidence to support the traditional physical and rehabilitation medicine treatments. The best way to change this disadvantage is through a well conducted clinical research, such as standard placebo- or sham-controlled randomized clinical trials. Therefore, having placebo groups in clinical trials is essential to improve the level of evidence-based practice in physical and rehabilitation medicine that ultimately translates to better clinical care. To address the challenges for the use of placebo in physical and rehabilitation medicine and randomized clinical trials and to create useful recommendations, we convened a working group during the inaugural International Symposium in Placebo (February 2009, in Sao Paulo, Brazil) in which the following topics were discussed: (1) current status of randomized clinical trials in physical and rehabilitation medicine, (2) challenges for the use of placebo in physical and rehabilitation medicine, (3) bioethics, (4) use of placebo in acupuncture trials and for the treatment of low-back pain, (5) mechanisms of placebo, and (6) insights from other specialties. The current article represents the consensus report from the working group.

  20. 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

  1. Calcium, dairy products, and energy balance in overweight adolescents: a controlled trial1234

    PubMed Central

    Campbell, Wayne W; Teegarden, Dorothy; Craig, Bruce A; Martin, Berdine R; Singh, Rajni; Braun, Michelle M; Apolzan, John W; Hannon, Tamara S; Schoeller, Dale A; DiMeglio, Linda A; Hickey, Yvonne; Peacock, Munro

    2011-01-01

    Background: Dairy product and calcium consumption have been associated with modifying body fat and body weight in children and adults. Objective: In overweight adolescent boys and girls, we aimed to determine the effect of the doubling of habitual calcium intake to the recommended intake from dairy or calcium carbonate on energy balance and purported mechanisms including fecal fat excretion, macronutrient use, and parathyroid hormone suppression. Design: Twenty-five girls with a mean (±SD) BMI (in kg/m2) of 33 ± 5 and 17 boys with a BMI of 28 ± 5, aged 12–15 y, participated in two 3-wk controlled feeding sessions that used a crossover design in random order as a summer research camp. In one session, 756 mg Ca/d was consumed; in the other session, an additional 650 mg Ca/d was provided as dairy or calcium carbonate supplements that were matched to the control in macronutrient content. Total energy and macronutrient intakes were controlled and were the same for the 2 sessions for each subject. Primary outcome measures were energy balance, fecal fat excretion, lipid oxidation, and postprandial energy expenditure. Results: There were no effects of quantity or source of calcium on energy or fat balance, despite calcium-induced increases (P <0.01) in postprandial serum parathyroid hormone suppression. Conclusion: These data lend little evidence to support the proposed mechanisms for the relation between an increase in calcium intake from calcium carbonate or dairy and weight loss or weight maintenance in children. This trial was registered at clinicaltrials.gov as NCT00592137. PMID:21918216

  2. 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.

  3. The effect of vitamin C on upper respiratory infections in adolescent swimmers: a randomized trial.

    PubMed

    Constantini, Naama W; Dubnov-Raz, Gal; Eyal, Ben-Bassat; Berry, Elliot M; Cohen, Avner H; Hemilä, Harri

    2011-01-01

    The risk of upper respiratory infections (URIs) is increased in people who are under heavy physical stress, including recreational and competitive swimmers. Additional treatment options are needed, especially in the younger age group. The aim of this study was to determine whether 1 g/day vitamin C supplementation affects the rate, length, or severity of URIs in adolescent swimmers. We carried out a randomized, double-blind, placebo-controlled trial during three winter months, among 39 competitive young swimmers (mean age 13.8 ± 1.6 years) in Jerusalem, Israel. Vitamin C had no effect on the incidence of URIs (rate ratio = 1.01; 95% confidence interval (CI) = 0.70-1.46). The duration of respiratory infections was 22% shorter in vitamin C group, but the difference was not statistically significant. However, we found a significant interaction between vitamin C effect and sex, so that vitamin C shortened the duration of infections in male swimmers by 47% (95% CI: -80% to -14%), but had no effect on female swimmers (difference in duration: +17%; 95% CI: -38% to +71%). The effect of vitamin C on the severity of URIs was also different between male and female swimmers, so that vitamin C was beneficial for males, but not for females. Our study indicates that vitamin C does not affect the rate of respiratory infections in competitive swimmers. Nevertheless, we found that vitamin C decreased the duration and severity of respiratory infections in male swimmers, but not in females. This finding warrants further research.

  4. The application of observational data in translational medicine: analyzing tobacco-use behaviors of adolescents

    PubMed Central

    2012-01-01

    Background Translational Medicine focuses on “bench to bedside”, converting experimental results into clinical use. The “bedside to bench” transition remains challenging, requiring clinicians to define true clinical need for laboratory study. In this study, we show how observational data (an eleven-year data survey program on adolescent smoking behaviours), can identify knowledge gaps and research questions leading directly to clinical implementation and improved health care. We studied gender-specific trends (2000–2010) in Italian students to evaluate the specific impact of various anti-smoking programs, including evaluation of perceptions of access to cigarettes and health risk. Methods The study used, ESPAD-Italia® (European School Survey Project on Alcohol and other Drugs), is a nationally representative sample of high-school students. The permutation test for joinpoint regression was used to calculate the annual percent change in smoking. Changes in smoking habits by age, perceived availability and risk over a 11-year period were tested using a gender-specific logistic model and a multinomial model. Results Gender-stratified analysis showed 1) decrease of lifetime prevalence, then stabilization (both genders); 2) decrease in last month and occasional use (both genders); 3) reduction of moderate use (females); 4) no significant change in moderate use (males) and in heavy use (both genders). Perceived availability positively associates with prevalence, while perceived risk negatively associates, but interact with different effects depending on smoking patterns. In addition, government implementation of public policies concerning access to tobacco products in this age group during this period presented a unique background to examine their specific impact on behaviours. Conclusion Large observational databases are a rich resource in support of translational research. From these observations, key clinically relevant issues can be identified and form the

  5. A description of the social–ecological framework used in the trial of activity for adolescent girls (TAAG)

    PubMed Central

    Elder, John P.; Lytle, Leslie; Sallis, James F.; Young, Deborah Rohm; Steckler, Allan; Simons-Morton, Denise; Stone, Elaine; Jobe, Jared B.; Stevens, June; Lohman, Tim; Webber, Larry; Pate, Russell; Saksvig, Brit I.; Ribisl, Kurt

    2009-01-01

    Social–ecological (SE) models are becoming more widely used in health behavior research. Applying SE models to the design of interventions is challenging because models must be tailor-made for each behavior and population, other theories need to be integrated into multilevel frameworks, and empirical research to guide model development is limited. The purpose of the present paper is to describe a SE framework that guided the intervention and measurement plans for a specific study. The trial of activity for adolescent girls (TAAG) is a multi-center study of interventions to reduce the decline of physical activity in adolescent girls. The TAAG framework incorporates operant learning theory, social cognitive theory, organizational change theory and the diffusion of innovation model in a multi-level model. The explicit and practical model developed for TAAG has already benefited the study and may have elements that can generalize to other health promotion studies. PMID:16855014

  6. Treatment of posttraumatic stress symptoms in adolescent survivors of childhood cancer and their families: a randomized clinical trial.

    PubMed

    Kazak, Anne E; Alderfer, Melissa A; Streisand, Randi; Simms, Steven; Rourke, Mary T; Barakat, Lamia P; Gallagher, Paul; Cnaan, Avital

    2004-09-01

    Posttraumatic stress symptoms (PTSS), particularly intrusive thoughts, avoidance, and arousal, are among the most common psychological aftereffects of childhood cancer for survivors and their mothers and fathers. We conducted a randomized wait-list control trial of a newly developed 4-session, 1-day intervention aimed at reducing PTSS that integrates cognitive-behavioral and family therapy approaches--the Surviving Cancer Competently Intervention Program (SCCIP). Participants were 150 adolescent survivors and their mothers, fathers, and adolescent siblings. Significant reductions in intrusive thoughts among fathers and in arousal among survivors were found in the treatment group. A multiple imputations approach was used to address nonrandom missing data and indicated that treatment effects would likely have been stronger had more distressed families been retained. The data are supportive of brief interventions to reduce PTSS in this population and provide additional support for the importance of intervention for multiple members of the family.

  7. A Controlled Trial Using Natural Language Processing to Examine the Language of Suicidal Adolescents in the Emergency Department.

    PubMed

    Pestian, John P; Grupp-Phelan, Jacqueline; Bretonnel Cohen, Kevin; Meyers, Gabriel; Richey, Linda A; Matykiewicz, Pawel; Sorter, Michael T

    2016-04-01

    What adolescents say when they think about or attempt suicide influences the medical care they receive. Mental health professionals use teenagers' words, actions, and gestures to gain insight into their emotional state and to prescribe what they believe to be optimal care. This prescription is often inconsistent among caregivers, however, and leads to varying outcomes. This variation could be reduced by applying machine learning as an aid in clinical decision support. We designed a prospective clinical trial to test the hypothesis that machine learning methods can discriminate between the conversation of suicidal and nonsuicidal individuals. Using semisupervised machine learning methods, the conversations of 30 suicidal adolescents and 30 matched controls were recorded and analyzed. The results show that the machines accurately distinguished between suicidal and nonsuicidal teenagers.

  8. 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.

  9. Randomized, controlled trial of Behavioral Family Systems Therapy for Diabetes: maintenance and generalization of effects on parent-adolescent communication.

    PubMed

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

    2008-03-01

    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 independent rating of videotaped family problem-solving discussions. BFST-D improved individual communication of adolescents and mothers, but not fathers. BFST-D significantly improved quality of family interaction compared to SC (10 of 12 comparisons) and ES (6 of 12 comparisons). Changes in family communication were differentially associated with changes in glycemic control, adherence, and family conflict. BFST-D improved family communication and problem solving relative to SC and modestly relative to ES.

  10. Chinese herbal medicine for Mild Cognitive Impairment and Age Associated Memory Impairment: a review of randomised controlled trials.

    PubMed

    May, Brian H; Yang, Angela W H; Zhang, Anthony L; Owens, Michael D; Bennett, Louise; Head, Richard; Cobiac, Lynne; Li, Chun Guang; Hugel, Helmut; Story, David F; Xue, Charlie C L

    2009-04-01

    This review assesses the effectiveness and safety of Chinese herbal medicines (CHM) for Mild Cognitive Impairment (MCI) and Age Associated Memory Impairment (AAMI). Electronic searches of English and Chinese databases and hand searches of Chinese journal holdings were conducted. Randomised controlled trials comparing orally administered CHM with placebo, no intervention or other therapy were considered. Ginkgo biloba was excluded. Ten trials met inclusion criteria. Eight different CHM were investigated. Methodological quality was assessed using the Jadad scale and five studies scored three or above. Two studies compared CHM with placebo and eight with another intervention. This review found an overall benefit on some outcome measures for the eight CHMs involved in the 10 RCTs but methodological and data reporting issues were evident. Meta-analysis of three studies found the effects of the CHMs were at least equivalent to piracetam on Mini-Mental State Examination (MMSE) scores. No severe adverse events were reported.

  11. [Decree on the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use].

    PubMed

    Schwerdtfeger, W K

    2005-02-01

    In Germany, Directive 2001/20/EC is implemented by articles 40 to 42a of the Federal Drug Act and by the Decree on Good Clinical Practice. Pivotal provisions have been included into the Federal Drug Act, such as those aiming at the clinical trial subject's protection and defining responsibilities for the evaluation of applications as well as for pharmacovigilance and surveillance. The Decree comprises: relevant definitions; requirements for manufacturing, importation and labelling of investigational medicinal products; the procedures to obtain the ethics committee's opinion and the authorization from the competent authority on the trial application and on amendments thereof; documentation and information tasks of the investigator, sponsor and competent authority; rules for inspection to verify compliance with good clinical and manufacturing practice. Finally, the decree lists infringements within the meaning of article 97, paragraph 2, no. 31 of the Federal Drug Act, and lays down the necessary provisions for a transitional period and the entering into force of the new provisions.

  12. Herbal medicines for the treatment of otitis media with effusion: a systematic review of randomised controlled trials

    PubMed Central

    Choi, Songie; Kim, Young-Eun; Kim, Yun Hee

    2016-01-01

    Objectives This systematic review aimed to assess the clinical evidence supporting the use of herbal medicines (HMs) for the treatment of otitis media with effusion (OME). Design Systematic review and meta-analysis. Data sources MEDLINE, EMBASE, Cochrane Library, AMED, CINAHL and three trial registries were searched up to January 2015. We also searched five Korean medical databases (KoreaMed, RISS, OASIS, DBPIA and KISS) and three Chinese databases (CNKI, Wanfang and VIP). Study eligibility criteria This study included randomised clinical trials that reported the effects of HM for OME. The primary outcome was the complete resolution of OME at 2 or 3 months post randomisation. Secondary outcomes included the partial or complete resolution at all possible time points and hearing test. Three authors independently screened the titles and abstracts, selected studies and extracted the data relating to trial quality, characteristics and results. Results A total of 2141 potentially relevant studies were identified, of which 17 randomised clinical trials met our inclusion criteria. Most were evaluated as having a high or unclear risk of bias. Tongqiao tablets, Tongqiao huoxue decoctions and Tsumura-Saireito were associated with a lower complete or partial resolution rate when compared with conventional medicines (CMs) (p=0.02, p=0.0001, and p=0.04, respectively), and similar outcomes were observed with Huanglong tonger pills, Erzhang decoctions and Shenling baizhu powder when combined with CM versus CM alone (p<0.00001, p=0.02, and p=0.05, respectively). Tongqiao huoxue decoction plus CM appeared to be more effective than CM in terms of improving the pure tone threshold levels (p=0.0007). Tsumura-Saireito was found to affect the proportion of patients with normalised tympanometry (p=0.03). Conclusions Despite some indications of potential symptom improvement, the evidence regarding the effectiveness and efficacy of HMs for OME is of poor quality and therefore inconclusive

  13. 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…

  14. 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.…

  15. Youth-Nominated Support Team for Suicidal Adolescents (Version 1): A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    King, Cheryl A.; Kramer, Anne; Preuss, Lesli; Kerr, David C. R.; Weisse, Lois; Venkataraman, Sanjeev

    2006-01-01

    In this study, the authors investigated the efficacy of the Youth-Nominated Support Team-Version 1 (YST-1), a psychoeducational social network intervention, with 289 suicidal, psychiatrically hospitalized adolescents (197 girls, 92 boys). Adolescents were randomly assigned to treatment-as-usual plus YST-1 or treatment-as-usual only. Assessments…

  16. 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…

  17. 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…

  18. 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…

  19. Developing Treatment for Adolescents Who Stutter: A Phase I Trial of the Camperdown Program

    ERIC Educational Resources Information Center

    Hearne, Anna; Packman, Ann; Onslow, Mark; O'Brian, Sue

    2008-01-01

    Purpose: To investigate in detail how adolescents who stutter perform during treatment, with the aim of informing treatment development for this age group. Method: The Camperdown Program was conducted with 3 adolescents who stutter. Their performance during treatment was recorded in detail, and outcome measures were collected before treatment and…

  20. Strength Training for Adolescents with cerebral palsy (STAR): study protocol of a randomised controlled trial to determine the feasibility, acceptability and efficacy of resistance training for adolescents with cerebral palsy

    PubMed Central

    Ryan, Jennifer M; Theis, Nicola; Kilbride, Cherry; Baltzopoulos, Vasilios; Waugh, Charlie; Shortland, Adam; Lavelle, Grace; Noorkoiv, Marika; Levin, Wendy; Korff, Thomas

    2016-01-01

    Introduction Gait is inefficient in children with cerebral palsy, particularly as they transition to adolescence. Gait inefficiency may be associated with declines in gross motor function and participation among adolescents with cerebral palsy. Resistance training may improve gait efficiency through a number of biomechanical and neural mechanisms. The aim of the Strength Training for Adolescents with cerebral palsy (STAR) trial is to evaluate the effect of resistance training on gait efficiency, activity and participation in adolescents with cerebral palsy. We also aim to determine the biomechanical and neural adaptations that occur following resistance training and evaluate the feasibility and acceptability of such an intervention for adolescents with cerebral palsy. Methods and analysis 60 adolescents (Gross Motor Function Classification System level I–III) will be randomised to a 10-week resistance training group or a usual care control group according to a computer-generated random schedule. The primary outcome is gait efficiency. Secondary outcomes are habitual physical activity, participation, muscle–tendon mechanics and gross motor function. General linear models will be used to evaluate differences in continuous data between the resistance training and usual care groups at 10 and 22 weeks, respectively. A process evaluation will be conducted alongside the intervention. Fidelity of the resistance training programme to trial protocol will be quantified by observations of exercise sessions. Semistructured interviews will be conducted with participants and physiotherapists following the resistance training programme to determine feasibility and acceptability of the programme. Ethics and dissemination This trial has ethical approval from Brunel University London's Department of Clinical Sciences' Research Ethics Committee and the National Research Ethics Service (NRES) Committee London—Surrey Borders. The results of the trial will be submitted for

  1. 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

  2. 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.

  3. Medicine and Human Rights: Reflections on the Fiftieth Anniversary of the Doctors' Trial.

    PubMed

    Annas; Grodin

    1996-01-01

    1996 marks the fiftieth anniversary of the commencement of the trial of Nazi physicians at Nuremberg, a trial that has been variously designated as the "Doctors' Trial" and the "Medical Case." In addition to documenting atrocities committed by physicians and scientists during WWII, the most significant contribution of the trial has come to be known as the "Nuremberg Code," a judicial codification of 10 prerequisites for the moral and legal use of human beings in experiments. Anniversaries provide us with an opportunity to reflect upon the past, but they also enable us to renew our efforts to plan for the future. This article describes briefly the historical evolution of the Nuremberg Code, discusses its current relevance and applicability by using a case study example, and proposes future steps to be taken by the international community.

  4. 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

  5. Developmentally informed research on the effectiveness of clinical trials: a primer for assessing how developmental issues may influence treatment responses among adolescents with alcohol use problems.

    PubMed

    Wagner, Eric F

    2008-04-01

    The goal of this article is to familiarize readers with the adolescent developmental issues and processes most likely to affect responses to treatment for alcohol use problems. Although the need for research that blends developmental science and treatment outcome research is widely acknowledged, scant information exists about developmentally informed approaches to treatment research with alcohol-abusing teens. Exactly how developmental issues may influence treatment responses among adolescents with alcohol use problems remains an open question. In the hope of moving developmentally informed research forward, this article reports findings from a literature review regarding the degree to which developmental issues and processes have been considered in adolescent alcohol treatment research. Moreover, promising concepts and methods from applied developmental science are discussed, as are various developmental processes and transitions that may influence adolescent risk behavior. Finally, guidance is provided regarding how applied developmental science conceptualizations and methods may be incorporated successfully into randomized, clinical trials with adolescents with alcohol use problems.

  6. Effect of Internet-based Intervention on Obesity among Adolescents in Kuala Lumpur: A School-based Cluster Randomised Trial

    PubMed Central

    Mohammed Nawi, AZMAWATI; Che Jamaludin, FARRAH ILYANI

    2015-01-01

    Background: Co-morbidities in adulthood is a significant problem and is associated with obesity during adolescent. Methods: This 3-months randomised controlled trial was aimed at determining the effectiveness of having internet-based intervention (obeseGO!) toward obesity among adolescents in Kuala Lumpur. Forty seven students were assigned randomly to the obeseGO! (intervention) group for internet-based intervention i.e., information on healthy lifestyle and diet were provided via the internet. Fifty students were assigned to the control group, where pamphlets containing health education were provided to these students. The measurement of body mass index (BMI), waist circumference, and the body fat percentage was taken at baseline and after 12 weeks of intervention. Results: The multivariate analysis of variance (MANOVA) analysis found that obeseGO! had a small effect in reducing BMI, waist circumference and body fat percentage. Conclusion: The internet-based obesity intervention program may be an effective medium for promoting healthy diet and physical activity among the obese adolescents. PMID:26715908

  7. JinQi-Jiangtang tablet, a Chinese patent medicine, for pre-diabetes: a randomized controlled trial

    PubMed Central

    2010-01-01

    Background Pre-diabetes is a growing health concern where a large percentage of these patients develop full type 2 diabetes. Effective interventions on pre-diabetes can prevent or delay the occurrence or development of diabetes. Pharmaco-dynamics and pre-clinical of JinQi-Jiangtang tablets (JQJT) suggest that it could be benefit for pre-diabetes. Methods/Design Randomized controlled trial (RCT) is implemented in this study. The study term is 24 months (12 months for intervention and 12 months for follow up). Participants are recruited from four cities of China: Beijing, Tianjin, Xi'an and Nanning. Four hundred participants are randomized to treatment group (JQJT tablets) and control group (Placebo); two hundred participants each. People being included in this study must have been diagnosed as pre-diabetes via western medicine criteria and traditional Chinese medicine (TCM) criteria. The end-point indexes include: incidence of diabetes mellitus and reversion rate. Primary outcome indexes include: oral glucose tolerance test; insulin releasing test; glycosylated hemoglobin (HA1c). Secondary outcome indexes include: score of the Short Form 36 Health Survey Questionnaire (SF-36); score of TCM symptoms; blood lipid test. Indexes of safety include: general medical examination; blood and urine regular test; electrocardiogram (ECG), liver function (ALT) and renal function (BUN, Creatinine) test; record of adverse event, such as headache, faint, etc. Qualitative control will be implemented and a number of standard operating processes (SOPs) will be formed throughout the study: laboratory quality control measures; compliance control for researchers and participants; researcher training before study; supervision; investigational drug management and others. Discussion The aim of this study is to evaluate the effectiveness and safety of JinQi JiangTang (JQJT) tablets for the treatment of patients with pre-diabetes. Trial registration Chinese clinical trials register Chi

  8. An explorative analysis of the recruitment of patients to a randomised controlled trial in adolescents with dental anxiety.

    PubMed

    Wide Boman, Ulla; Broberg, Anders G; Krekmanova, Larisa; Staberg, Marie; Svensson, Carina; Robertson, Agneta

    2014-01-01

    Randomised controlled trials (RCTs) are considered to provide the most reliable evidence on the efficacy of interventions. The aim of this study was to describe the recruitment process of an RCT study set up to evaluate a Cognitive Behavioural Therapy (CBT) intervention programme for adolescent patients with dental anxiety (DA). The participants were recruited from a consecutive sample of adolescent patients (12-19 yrs old) referred for DA to a specialised pediatric dentistry clinic. Age, gender, and reason for referral were recorded for the possible eligible patients as part of the drop-out analysis of the recruitment process. Participants were then randomized to the intervention (CBT integrated with dental treatment) or control (adapted dental treatment) condition. In the recruitment process, 138 possible eligible patients met inclusion criteria, of these 55 were enrolled, 44 declined participation and 39 patients were excluded.The patients enrolled in the RCT did not differ from the non-participants with regard to age, gender or cause of referral. As a result of difficulties in the recruitment process, the study period was extended. The considerable proportion of non-participants as evident from the recruitment process may pose a threat to the external validity of the clinical trial. From a clinical perspective, the reasons for the lack of motivation to participate in behavioural interventions and the failure to appear warrant further investigation.

  9. 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

  10. 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

  11. Brazil nuts intake improves lipid profile, oxidative stress and microvascular function in obese adolescents: a randomized controlled trial

    PubMed Central

    2011-01-01

    Background Obesity is a chronic disease associated to an inflammatory process resulting in oxidative stress that leads to morpho-functional microvascular damage that could be improved by some dietary interventions. In this study, the intake of Brazil nuts (Bertholletia excelsa), composed of bioactive substances like selenium, α- e γ- tocopherol, folate and polyunsaturated fatty acids, have been investigated on antioxidant capacity, lipid and metabolic profiles and nutritive skin microcirculation in obese adolescents. Methods Obese female adolescents (n = 17), 15.4 ± 2.0 years and BMI of 35.6 ± 3.3 kg/m2, were randomized 1:1 in two groups with the diet supplemented either with Brazil nuts [BNG, n = 08, 15-25 g/day (equivalent to 3 to 5 units/day)] or placebo [PG (lactose), n = 09, one capsule/day] and followed for 16 weeks. Anthropometry, metabolic-lipid profiles, oxidative stress and morphological (capillary diameters) and functional [functional capillary density, red blood cell velocity (RBCV) at baseline and peak (RBCVmax) and time (TRBCVmax) to reach it during post-occlusive reactive hyperemia, after 1 min arterial occlusion] microvascular variables were assessed by nailfold videocapillaroscopy at baseline (T0) and after intervention (T1). Results T0 characteristics were similar between groups. At T1, BNG (intra-group variation) had increased selenium levels (p = 0.02), RBCV (p = 0.03) and RBCVmax (p = 0.03) and reduced total (TC) (p = 0.02) and LDL-cholesterol (p = 0.02). Compared to PG, Brazil nuts intake reduced TC (p = 0.003), triglycerides (p = 0.05) and LDL-ox (p = 0.02) and increased RBCV (p = 0.03). Conclusion Brazil nuts intake improved the lipid profile and microvascular function in obese adolescents, possibly due to its high level of unsaturated fatty acids and bioactive substances. Trial Registration Clinical Trials.gov NCT00937599 PMID:21619692

  12. Randomized Trial of Family Therapy versus Non-Family Treatment for Adolescent Behavior Problems in Usual Care

    PubMed Central

    Hogue, Aaron; Dauber, Sarah; Henderson, Craig E.; Bobek, Molly; Johnson, Candace; Lichvar, Emily; Morgenstern, Jon

    2014-01-01

    Objective A major focus of implementation science is discovering whether evidence-based approaches can be delivered with fidelity and potency in routine practice. This randomized trial compared usual care family therapy (UC-FT), implemented without a treatment manual or extramural support as the standard-of-care approach in a community clinic, to non-family treatment (UC-Other) for adolescent conduct and substance use disorders. Method The study recruited 205 adolescents (mean age 15.7 years; 52% male; 59% Hispanic American, 21% African American) from a community referral network, enrolling 63% for primary mental health problems and 37% for primary substance use problems. Clients were randomly assigned to either the UC-FT site or one of five UC-Other sites. Implementation data confirmed that UC-FT showed adherence to the family therapy approach and differentiation from UC-Other. Follow-ups were completed at 3, 6, and 12 months post-baseline. Results There was no between-group difference in treatment attendance. Both conditions demonstrated improvements in externalizing, internalizing, and delinquency symptoms. However, UC-FT produced greater reductions in youth-reported externalizing and internalizing among the whole sample, in delinquency among substance-using youth, and in alcohol and drug use among substance-using youth. The degree to which UC-FT outperformed UC-Other was consistent with effect sizes from controlled trials of manualized family therapy models. Conclusions Non-manualized family therapy can be effective for adolescent behavior problems within diverse populations in usual care, and it may be superior to non-family alternatives. PMID:25496283

  13. 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

  14. 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.

  15. 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

  16. 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.

  17. 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.

  18. 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

  19. Effects of serotonin reuptake inhibitors on aggressive behavior in psychiatrically hospitalized adolescents: results of an open trial.

    PubMed

    Constantino, J N; Liberman, M; Kincaid, M

    1997-01-01

    Low concentrations of the neurotransmitter serotonin and its 5-hydroxyindoleacetic acid metabolite in the central nervous system have been associated with increased aggressive behavior in animals and humans. Controlled clinical trials of serotonin agonists in depressed adults have suggested that aggressive behavior is less likely during treatment with these medications than with placebo, but there have been no previous studies of selective serotonin reuptake inhibitors (SSRIs) and aggression in children. We prospectively followed the course of aggressive behavior in 19 psychiatrically hospitalized adolescents (not selected for aggressiveness) who received open clinical trials of fluoxetine, paroxetine, or sertraline. The patients received standard doses (equivalent to fluoxetine 10-40 mg daily) for a minimum of 5 weeks. The starting dose was 15 +/- 5 mg, and dosages were raised at a mean rate of 5 mg every 4 days up to a mean dose of 25 +/- 10 mg daily. Results from trials of the three SSRIs were clustered because the sample sizes were not sufficient for separate analyses. Overall, there were no statistically meaningful improvements in the level of aggressive behavior, as measured on a modified version of the Overt Aggression Scale, over the course of these patients' SSRI trials. Symptoms of physical aggression toward others or self were manifest in 12 of the 19 patients while on SSRIs. Of the 19 patients, 13 were assessed both on and off SSRIs: verbal aggression (p = 0.04), physical aggression toward objects (p = 0.05), and physical aggression toward self (p < 0.02) occurred significantly more frequently on SSRIs than off; no increase was observed in physical aggression toward others. Patients with the highest baseline aggressivity scores did not show greater improvement during SSRI treatment. Further research is warranted, particularly to explore whether SSRIs may have therapeutic effects on aggression at higher (or lower) doses than were administered in this

  20. Results of a feasibility randomised controlled trial (RCT) for WATCH IT: a programme for obese children and adolescents

    PubMed Central

    Farrin, Amanda; Christie, Deborah; Jebb, Susan A; Cooper, Ashley R; Rudolf, Mary

    2011-01-01

    Background In the evaluation of childhood obesity interventions, few researchers undertake a rigorous feasibility stage in which the design and procedures of the evaluation process are examined. Consequently, phase III studies often demonstrate methodological weaknesses. Purpose Our aim was to conduct a feasibility trial of the evaluation of WATCH IT, a community obesity intervention for children and adolescents. We sought to determine an achievable recruitment rate; acceptability of randomisation, assessment procedures, and dropout rate; optimal outcome measures for the definitive trial; and a robust sample size calculation. Method Our goal was to recruit 70 participants over 6 months, randomise them to intervention or control group, and retain participation for 12 months. Assessments were taken prior to randomisation and after 6 and 12 months. Procedures mirrored those intended for a full-scale trial, but multiple measures of similar outcomes were included as a means to determine those most appropriate for future research. Acceptability of the research and impact of the research on the programme were ascertained through interviewing participants and staff. Results We recruited 70 participants and found that randomisation and data collection procedures were acceptable. Self-referral (via media promotion) was more effective than professional referral. Blinding of assessors was sustained to a reasonable degree, and optimal outcome measures for a full-scale trial were identified. Estimated sample size was significantly greater than sample sized reported in published trials. There was some negative impact on the existing programme as a result of the research, a lesson for designers of future trials. Limitations We successfully recruited socially disadvantaged families, but the majority of families were of White British nationality. The composition of the participants was an added valuable lesson, suggesting that recruitment strategies to obtain a more heterogeneous

  1. 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

  2. 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…

  3. 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...

  4. 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…

  5. 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…

  6. The Effects of the Child and Adolescent Trial for Cardiovascular Health Intervention on Psychosocial Determinants of Cardiovascular Disease Risk Behavior among Third-Grade Students.

    ERIC Educational Resources Information Center

    Edmundson, Elizabeth; And Others

    1996-01-01

    Schools within the Child and Adolescent Trial for Cardiovascular Health intervention were randomized into control, school-based, and school-based plus family intervention conditions. Measures of third graders' psychosocial determinants of risk behavior indicated significant improvements in all psychosocial determinants following the interventions,…

  7. 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…

  8. Efficacy Trial of a Brief Cognitive-Behavioral Depression Prevention Program for High-Risk Adolescents: Effects at 1- and 2-Year Follow-Up

    ERIC Educational Resources Information Center

    Stice, Eric; Rohde, Paul; Gau, Jeff M.; Wade, Emily

    2010-01-01

    Objective: To evaluate the effects of a brief group cognitive-behavioral (CB) depression prevention program for high-risk adolescents with elevated depressive symptoms at 1- and 2-year follow-up. Method: In this indicated prevention trial, 341 at-risk youths were randomized to a group CB intervention, group supportive expressive intervention, CB…

  9. 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.

  10. Clinical trial opportunities in Transfusion Medicine: proceedings of a National Heart, Lung, and Blood Institute State-of-the-Science Symposium.

    PubMed

    Blajchman, Morris A; Glynn, Simone A; Josephson, Cassandra D; Kleinman, Steve H

    2010-10-01

    The use of blood products to support patients undergoing the large variety of medical and surgical interventions requiring such support has continued to escalate very significantly over time. Relevantly, significant practice variation in the use of blood products exists among practitioners and institutions, largely because of the lack of robust clinical trial data, in many instances, which are critical for providing practitioners with evidence-based guidelines for appropriate blood product utilization. Recognizing this gap, the National Heart, Lung, and Blood Institute recently established a State-of-the-Science Symposium to help define areas of clinical trial research that would enhance the opportunity for developing appropriate practice guidelines for both Transfusion Medicine and Hemostasis/Thrombosis. Such a Symposium was held in September 2009 to identify important clinical trial research issues in these 2 subject areas of endeavor. The aims of this Symposium were to specifically identify phase 2 and 3 clinical trials that, if conducted over the next 5 to 10 years, could impact the treatment of patients with hemostatic and other disorders as well as to optimize the use of blood products in patients who need such interventions. This article reports on the deliberations that were held relating to the various clinical trial concepts developed by 7 Transfusion Medicine subcommittees. This Symposium generated a rich assortment of clinical trial proposals that will undergo further refinement before final implementation into pilot or full randomized clinical trials. The various proposals identified many opportunities for clinical trial research and most importantly underscored the ongoing need for well-developed evidence-based clinical trial research in the field of Transfusion Medicine.

  11. 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

  12. 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

  13. 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

  14. Traditional Chinese medicine (Shun-Qi-Tong-Xie Granule) for irritable bowel syndrome: study protocol for a randomised controlled trial

    PubMed Central

    2014-01-01

    Background Irritable bowel syndrome (IBS) is a common gastrointestinal functional disorder with no effective therapy. Traditional Chinese medicine (TCM) is one of the most common complementary therapies in China. We designed this study to evaluate the efficacy and safety of Shun-Qi-Tong-Xie Granule (SQTX Granule), a TCM treatment, in patients with IBS with diarrhea (IBS-D). Methods/Design A randomised, double-blinded, placebo-controlled, multi-centre, superiority clinical trial to evaluate the efficacy and safety of SQTX Granule is proposed. Eligible patients (Rome III) with IBD-S will be randomly assigned into SQTX Granule group and the placebo group. Patients will receive a 28-day treatment and a 2-month follow-up. The primary outcome measures include the scores of IBS-quality of life (IBS-QOL) rating scale and IBS-symptom severity scale (IBS-SSS) rating scale. The secondary outcome measures include the improvement of symptom scores, and the duration of abdominal pain and diarrhea. Discussion According to TCM theory, SQTX Granule has a regulating effect on abdominal pain, diarrhea and the syndrome of liver-spleen disharmony, which is similar to the symptoms of IBS-D. This study will provide objective evidence to evaluate the efficiency and safety of SQTX Granule in IBS-D treatment. Trial registration ChiCTR-TRC-14004241. Date of registration: 9 February 2014. PMID:25002196

  15. 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.

  16. 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…

  17. Peer Network Counseling with Urban Adolescents: A Randomized Controlled Trial with Moderate Substance Users.

    PubMed

    Mason, Michael; Light, John; Campbell, Leah; Keyser-Marcus, Lori; Crewe, Stephanie; Way, Thomas; Saunders, Heather; King, Laura; Zaharakis, Nikola M; McHenry, Chantal

    2015-11-01

    Close peer networks can affect adolescents' health behaviors by altering their social environments, and thus their risk for and protection against substance use involvement. We tested a 20 minute intervention named Peer Network Counseling that integrates motivational interviewing and peer network strategies with 119 urban adolescents who reported occasional or problem substance use. Adolescents presenting at primary care clinic were randomized to intervention or control conditions and followed for 6 months. Mixed-effect latent growth models were used to evaluate intervention effects on trajectories of alcohol and marijuana use, offers to use substances, and moderation models to test for interactions between intervention condition and peer network characteristics. A significant intervention effect was found for boys for offers to use alcohol from friends (p<.05), along with a trend significant effect for alcohol use (p<.08). Intervention was more effective in reducing marijuana use, vs. control, for participants with more peer social support (p<.001) and with more peer encouragement for prosocial behavior (school, clubs, sports, religious activities); however, intervention did not affect these network characteristics. Results provide support to continue this line of research to test brief interventions that activate protective peer network characteristics among at-risk adolescents, while also raising some interesting gender-based intervention questions for future research.

  18. 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

  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. 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…

  1. 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…

  2. 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)…

  3. 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…

  4. 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…

  5. 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

  6. Leveraging microfinance to impact HIV and financial behaviors among adolescents and their mothers in West Bengal: a cluster randomized trial.

    PubMed

    Spielberg, Freya; Crookston, Benjamin T; Chanani, Sheila; Kim, Jaewhan; Kline, Sean; Gray, Bobbi L

    2013-01-01

    Microfinance can be used to reach women and adolescent girls with HIV prevention education. We report findings from a cluster-randomized control trial among 55 villages in West Bengal to determine the impact of non-formal education on knowledge, attitudes and behaviors for HIV prevention and savings. Multilevel regression models were used to evaluate differences between groups for key outcomes while adjusting for cluster correlation and differences in baseline characteristics. Women and girls who received HIV education showed significant gains in HIV knowledge, awareness that condoms can prevent HIV, self-efficacy for HIV prevention, and confirmed use of clean needles, as compared to the control group. Condom use was rare and did not improve for women. While HIV testing was uncommon, knowledge of HIV-testing resources significantly increased among girls, and trended in the positive direction among women in intervention groups. Conversely, the savings education showed no impact on financial knowledge or behavior change.

  7. Low Enrollment of Adolescents and Young Adults Onto Cancer Trials: Insights From the Community Clinical Oncology Program

    PubMed Central

    Roth, Michael E.; O’Mara, Ann M.; Seibel, Nita L.; Dickens, David S.; Langevin, Anne-Marie; Pollock, Brad H.

    2016-01-01

    Purpose: Stagnant outcomes for adolescents and young adults (AYAs; 15 to 39 years old) with cancer are partly attributed to poor enrollment onto clinical trials. The National Cancer Institute (NCI) Community Clinical Oncology Program (CCOP) was developed to improve clinical trial participation in the community setting, where AYAs are most often treated. Further, many CCOP sites had pediatric and medical oncologists with collaborative potential for AYA recruitment and care. For these reasons, we hypothesized that CCOP sites enrolled proportionately more AYAs than non-CCOP sites onto Children’s Oncology Group (COG) trials. Methods: For the 10-year period 2004 through 2013, the NCI Division of Cancer Prevention database was queried to evaluate enrollments into relevant COG studies. The proportional enrollment of AYAs at CCOP and non-CCOP sites was compared and the change in AYA enrollment patterns assessed. All sites were COG member institutions. Results: Although CCOP sites enrolled a higher proportion of patients in cancer control studies than non-CCOP sites (3.5% v 1.8%; P < .001), they enrolled a lower proportion of AYAs (24.1% v 28.2%, respectively; P < .001). Proportional AYA enrollment at CCOP sites decreased during the intervals 2004 through 2008 and 2009 through 2013 (26.7% v 21.7%; P < .001). Conclusion: Despite oncology practice settings that might be expected to achieve otherwise, CCOP sites did not enroll a larger proportion of AYAs in clinical trials than traditional COG institutions. Our findings suggest that the CCOP (now the NCI Community Oncology Research Program) can be leveraged for developing targeted interventions for overcoming AYA enrollment barriers. PMID:27026648

  8. Randomized Clinical Trial of Family-Based Treatment and Cognitive-Behavioral Therapy for Adolescent Bulimia Nervosa

    PubMed Central

    Le Grange, Daniel; Lock, James; Agras, W. Stewart; Bryson, Susan W.; Jo, Booil

    2015-01-01

    Objective There is a paucity of randomized clinical trials (RCTs) for adolescents with bulimia nervosa (BN). Prior studies suggest cognitive-behavioral therapy adapted for adolescents (CBT-A) and family-based treatment (FBT-BN) could be effective for this patient population. The objective of this study was to compare the relative efficacy of these two specific therapies, FBT-BN and CBT-A. In addition, a smaller group was randomized to a non-specific treatment (supportive psychotherapy [SPT]), whose data were to be used if there were no differences between FBT-BN and CBT-A at end of treatment (EOT). Method This two-site RCT (Chicago and Stanford) randomized 130 participants (aged 12–18 years) meeting DSM, 4th Edition criteria for BN or partial BN (binge eating and purging ≥once per week for six months). Outcomes were assessed at baseline, EOT, 6 and 12 months post treatment. Treatments involved 18 outpatient sessions over 6 months. Primary outcome was defined as abstinence from binge eating and purging for 4 weeks prior to assessment, using the Eating Disorder Examination. Results Participants in FBT-BN achieved higher abstinence rates than in CBT-A at EOT (39% vs. 20%; p=.040, number needed to treat [NNT]=5) and at 6-month follow-up (44% vs. 25%; p=.030, NNT=5). Abstinence rates between these two groups did not differ statistically at 12- month follow-up (49% vs. 32%; p=.130, NNT=6). Conclusion FBT-BN is more effective in promoting abstinence from binge eating and purging than CBT-A in adolescent BN at EOT and 6-month follow-up. By 12-month follow-up there were no statistically significant differences between the two treatments. PMID:26506579

  9. 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.

  10. 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

  11. 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.

  12. Risk reduction for substance use and trauma-related psychopathology in adolescent sexual assault victims: Findings from an open trial

    PubMed Central

    Danielson, Carla Kmett; McCart, Michael R.; de Arellano, Michael A.; Macdonald, Alexandra; Silcott, Lauren; Resnick, Heidi S.

    2011-01-01

    Limited attention has been paid to the development and evaluation of interventions that reduce risk for substance use, while also targeting trauma-related psychopathology among maltreated adolescents. Risk Reduction through Family Therapy (RRFT) is a multi-component treatment that integrates principles and interventions from existing empirically supported treatments. The purpose of the current study was to evaluate the feasibility of implementation and initial efficacy of RRFT through an open pilot trial involving a small sample (N=10) of female adolescents (aged 13–17 years) who had experienced at least one memorable sexual assault in their lifetime. Measures of substance use and substance use risk factors (e.g., family functioning), PTSD, and depression symptoms were assessed pre-and post-treatment as well as at 3 month and 6 month post-treatment follow-up assessments. Results demonstrated reductions in multiple areas, including substance use and related risk factors, PTSD, and depression symptoms, which were maintained through follow-up. Clinical implications and future directions with this line of research are discussed. PMID:20534594

  13. 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

  14. Reducing substance use risk and mental health problems among sexually assaulted adolescents: A pilot randomized controlled trial

    PubMed Central

    Danielson, Carla Kmett; McCart, Michael R.; Walsh, Kate; de Arellano, Michael A.; White, Deni; Resnick, Heidi S.

    2012-01-01

    The current study reports results from a pilot randomized controlled trial evaluating the feasibility and efficacy of Risk Reduction through Family Therapy (RRFT) for reducing substance use risk and trauma-related mental health problems among sexually assaulted adolescents. Thirty adolescents (aged 13–17 years; M=14.80; SD=1.51) who had experienced at least one sexual assault and their caregivers were randomized to RRFT or treatment as usual (TAU) conditions. Participants completed measures of substance use, substance use risk factors (e.g., family functioning), mental health problems (i.e., posttraumatic stress disorder, depression, and general internalizing/externalizing symptoms) and risky sexual behavior at four time points (baseline, post-treatment, and 3- and 6-month follow-up). Mixed-effects regression models yielded significantly greater reductions in substance use, specific substance use risk factors, and (parent-reported) PTSD, depression, and general internalizing symptoms among youth in the RRFT condition relative to youth in the TAU condition. However, significant baseline differences in functioning between the two conditions warrant caution in interpreting between-group findings. Instead, emphasis is placed on replication of feasibility findings and within-group improvements over time among the RRFT youth. PMID:22686269

  15. The Relationship between Psychosocial Correlates and Physical Activity in Underserved Adolescent Boys and Girls in the ACT Trial

    PubMed Central

    Lawman, Hannah G.; Wilson, Dawn K.; Van Horn, M. Lee; Resnicow, Ken; Kitzman-Ulrich, Heather

    2011-01-01

    Background Previous research suggests motivation, enjoyment, and self-efficacy may be important psychosocial factors for understanding physical activity (PA) in youth. While previous studies have shown mixed results, emerging evidence indicates relationships between psychosocial factors and PA may be stronger in boys than girls. This study expands on previous research by examining the effects of motivation, enjoyment and self-efficacy on PA in underserved adolescent (low income, ethnic minorities) boys and girls. Based on previous literature, it was hypothesized the effects of motivation, enjoyment and self-efficacy on moderate-to-vigorous PA (MVPA) would be stronger in boys than in girls. Methods Baseline cross-sectional data were obtained from a randomized, school-based trial (Active by Choice Today; ACT) in underserved 6th graders (N=771 girls, 651 boys). Intrapersonal variables for PA were assessed via self-report and confirmatory factor analyses were conducted for each predictor. MVPA was assessed with 7-day accelerometry estimates. Results Multivariate regression analyses stratified by sex demonstrated a significant positive main effect of self-efficacy and motivation on MVPA for girls. Boys also showed a positive trend for the effect of motivation on MVPA. Conclusions The results from this study suggest motivation and self-efficacy should be better integrated to facilitate the development of more effective interventions for increasing PA in underserved adolescents. PMID:21359129

  16. Alternative and Integrative Medicine

    MedlinePlus

    ... Alternative & Integrative Medicine Clinical Trials GBM AGILE TTFields – Optune™ Brain Tumor Treatment Locations Treatment Side Effects & their ... Alternative & Integrative Medicine Clinical Trials GBM AGILE TTFields – Optune™ Brain Tumor Treatment Locations Treatment Side Effects & their ...

  17. 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…

  18. Study protocol for a cluster-randomised controlled trial of an NCD access to medicines initiative: evaluation of Novartis Access in Kenya

    PubMed Central

    Rockers, Peter C; Wirtz, Veronika J; Vian, Taryn; Onyango, Monica A; Ashigbie, Paul G; Laing, Richard

    2016-01-01

    Introduction Novartis recently launched Novartis Access, an initiative to provide a basket of reduced price medicines for non-communicable diseases (NCDs) to be sold through the public and private non-profit sectors in programme countries. This study will evaluate the impact of Novartis Access on the availability and price of NCD medicines at health facilities and households in Kenya, the first country to receive the programme. Methods and analysis This study will be a cluster-randomised controlled trial. 8 counties in Kenya will be randomly assigned to the intervention or control group using a covariate constrained randomisation method to maximise balance on demographic and health characteristics. In intervention counties, public and private non-profit health facilities will be able to order Novartis Access NCD medicines from the Mission for Essential Drugs and Supplies (MEDS). Data will be collected from a random sample of 384 health facilities and 800 households at baseline, midline after 1-year of intervention, and end-line after 2 years. Quarterly surveillance data will also be collected from health facilities and a subsample of households through phone-based interviews. Households will be eligible if at least one resident has been previously diagnosed and prescribed a medicine for an NCD addressed by Novartis Access, including hypertension and diabetes. The primary outcomes will be availability and price of NCD medicines at health facilities, and availability, price, and expenditures on NCD medicines at households. Impacts will be estimated using intention-to-treat analysis. Ethics and dissemination This protocol was approved by the Institutional Review Boards at Strathmore University and at Boston University. Informed consent will be obtained from all participants at the start of the trial. The findings of the trial will be disseminated through peer-reviewed journals, international conferences, and meetings and events organised with local stakeholders

  19. 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.

  20. 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.

  1. Personalized medicine in metastatic non-small-cell lung cancer: promising targets and current clinical trials

    PubMed Central

    Black, A.; Morris, D.

    2012-01-01

    Non-small-cell lung cancer (nsclc) remains the leading cause of cancer-related death globally, with most patients presenting with non-curable disease. Platinum-based doublet chemotherapy has been the cornerstone of treatment for patients with advanced-stage disease and has resulted in a modest increase in overall survival (on the order of an incremental 2 months increased survival per decade) and quality of life. Improved knowledge of the molecular signalling pathways found in nsclc has led to the development of biomarkers with associated targeted therapeutics, thus changing the treatment paradigm for many nsclc patients. In this review, we present a summary of many of the currently investigated nsclc targets, discuss their current clinical trial status, and provide commentary as to the likelihood of their success making a positive impact for nsclc patients. PMID:22787415

  2. 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.

  3. 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.

  4. 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

  5. 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

  6. 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.

  7. The effects of two Chinese herbal medicinal formulae vs. placebo controls for treatment of allergic rhinitis: a randomised controlled trial

    PubMed Central

    2014-01-01

    Background Allergic rhinitis is a chronic illness, affecting 10 to 40% of the worldwide population. Chinese herbal medicines, the treatment of allergic rhinitis, adopted thousands of years in ancient China, has recently raised much attention among researchers globally. This study evaluates the effects of two Chinese herbal formulae [Cure-allergic-rhinitis Syrup (CS) and Yu-ping-feng San (YS)] in treating undergraduate nursing students with allergic rhinitis over a 3-month follow-up, when compared to a placebo control group. Methods A double-blind, randomised controlled trial with repeated-measures, three-parallel-groups design was conducted in a random sample of 249 participants recruited from one university in Hong Kong. After baseline measurements, participants were randomly assigned to CS, YS, or placebo groups (n = 83 per group). The main outcomes, including symptom severity, quality of life, and body constitution, were measured with self-administered questionnaires at baseline and immediately, 1 and 3 months after the 4-week interventions. Results 240 participants completed the trial, with 9 (3.6%) drop-outs. The results of Generalised Estimating Equations test followed by pairwise contrasts tests indicated that the participants who received CS showed significantly greater reduction of symptoms (mean difference of CS vs. placebo = 26.13–34.55, P <0.0005) and improvements in quality of life (mean difference of CS vs. placebo = 12.81–16.76, P <0.001), and body constitution in ‘Qi-deficiency’, ‘Yang-deficiency’, and ‘Inherited Special’ (mean difference of CS vs. placebo = 7.05–8.12, 7.56–8.92, and 4.48–8.10, P = 0.01– < 0.0005, 0.001–0.004, and 0.01– < 0.0005, accordingly, at three post-tests). The participants who received YS also indicated significant greater improvements in symptom severity, quality of life, and a few patterns of body constitution when compared to the placebo group. However, its effects

  8. 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…

  9. A Randomized Effectiveness Trial of Brief Cognitive-Behavioral Therapy for Depressed Adolescents Receiving Antidepressant Medication

    ERIC Educational Resources Information Center

    Clarke, Gregory; DeBar, Lynn; Lynch, Frances; Powell, James; Gale, John; O'Connor, Elizabeth; Ludman, Evette; Bush, Terry; Lin, Elizabeth H. B.; Von Korff, Michael; Hertert, Stephanie

    2005-01-01

    Objective: To test a collaborative-care, cognitive-behavioral therapy (CBT) program adjunctive to selective serotonin reuptake inhibitor (SSRI) treatment in HMO pediatric primary care. Method: A randomized effectiveness trial comparing a treatment-as-usual (TAU) control condition consisting primarily of SSRI medication delivered outside the…

  10. Effectiveness of a Parent Training Program in (Pre)Adolescence: Evidence from a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Leijten, Patty; Overbeek, Geertjan; Janssens, Jan M. A. M.

    2012-01-01

    The present randomized controlled trial examined the effectiveness of the parent training program Parents and Children Talking Together (PCTT) for parents with children in the preadolescent period who experience parenting difficulties. The program is focused on reducing child problem behavior by improving parents' communication and problem solving…

  11. Pediatric Hodgkin lymphoma– biomarkers, drugs, and clinical trials for translational science and medicine

    PubMed Central

    Nagpal, Poonam; Akl, Mohamed R.; Ayoub, Nehad M.; Tomiyama, Tatsunari; Cousins, Tasheka; Tai, Betty; Carroll, Nicole; Nyrenda, Themba; Bhattacharyya, Pritish; Harris, Michael B.; Goy, Andre; Pecora, Andrew; Suh, K. Stephen

    2016-01-01

    Hodgkin lymphoma (HL) is a lymphoid malignancy that is typically derived from germinal-center B cells. EBV infection, mutations in NF-κB pathway genes, and genetic susceptibility are known risk factors for developing HL. CD30 and NF-κB have been identified as potential biomarkers in pediatric HL patients, and these molecules may represent therapeutic targets. Although current risk adapted and response based treatment approaches yield overall survival rates of >95%, treatment of relapse or refractory patients remains challenging. Targeted HL therapy with the antibody-drug conjugate Brentuximab vedotin (Bv) has proven to be superior to conventional salvage chemotherapy and clinical trials are being conducted to incorporate Bv into frontline therapy that substitutes Bv for alkylating agents to minimize secondary malignancies. The appearance of secondary malignancies has been a concern in pediatric HL, as these patients are at highest risk among all childhood cancer survivors. The risk of developing secondary leukemia following childhood HL treatment is 10.4 to 174.8 times greater than the risk in the general pediatric population and the prognosis is significantly poorer than the other hematological malignancies with a mortality rate of nearly 100%. Therefore, identifying clinically valuable biomarkers is of utmost importance to stratify and select patients who may or may not need intensive regimens to maintain optimal balance between maximal survival rates and averting late effects. Here we discuss epidemiology, risk factors, staging, molecular and genetic prognostic biomarkers, treatment for low and high-risk patients, and the late occurrence of secondary malignancies in pediatric HL. PMID:27563824

  12. 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

  13. 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

  14. Computerised cognitive–behavioural therapy for depression in adolescents: feasibility results and 4-month outcomes of a UK randomised controlled trial

    PubMed Central

    Wright, Barry; Tindall, Lucy; Littlewood, Elizabeth; Allgar, Victoria; Abeles, Paul; Trépel, Dominic; Ali, Shehzad

    2017-01-01

    Objectives Computer-administered cognitive–behavioural therapy (CCBT) may be a promising treatment for adolescents with depression, particularly due to its increased availability and accessibility. The feasibility of delivering a randomised controlled trial (RCT) comparing a CCBT program (Stressbusters) with an attention control (self-help websites) for adolescent depression was evaluated. Design Single centre RCT feasibility study. Setting The trial was run within community and clinical settings in York, UK. Participants Adolescents (aged 12–18) with low mood/depression were assessed for eligibility, 91 of whom met the inclusion criteria and were consented and randomised to Stressbusters (n=45) or websites (n=46) using remote computerised single allocation. Those with comorbid physical illness were included but those with psychosis, active suicidality or postnatal depression were not. Interventions An eight-session CCBT program (Stressbusters) designed for use with adolescents with low mood/depression was compared with an attention control (accessing low mood self-help websites). Primary and secondary outcome measures Participants completed mood and quality of life measures and a service Use Questionnaire throughout completion of the trial and 4 months post intervention. Measures included the Beck Depression Inventory (BDI) (primary outcome measure), Mood and Feelings Questionnaire (MFQ), Spence Children's Anxiety Scale (SCAS), the EuroQol five dimensions questionnaire (youth) (EQ-5D-Y) and Health Utility Index Mark 2 (HUI-2). Changes in self-reported measures and completion rates were assessed by treatment group. Results From baseline to 4 months post intervention, BDI scores and MFQ scores decreased for the Stressbusters group but increased in the website group. Quality of life, as measured by the EQ-5D-Y, increased for both groups while costs at 4 months were similar to baseline. Good feasibility outcomes were found, suggesting the trial process to be

  15. Targeting Ruminative Thinking in Adolescents at Risk for Depressive Relapse: Rumination-Focused Cognitive Behavior Therapy in a Pilot Randomized Controlled Trial with Resting State fMRI

    PubMed Central

    Watkins, Edward R.; Peters, Amy T.; Feldhaus, Claudia G.; Barba, Alyssa; Carbray, Julie; Langenecker, Scott A.

    2016-01-01

    This pilot randomized control trial was designed to examine whether Rumination-Focused Cognitive Behavior Therapy (RFCBT) reduces rumination and residual depressive symptoms among adolescents with a history of Major Depressive Disorder (MDD) who are at risk for relapse. We also examined whether these changes in symptoms were associated with changes in functional connectivity of the posterior cingulate cortex (PCC), a key node in the default mode network (DMN). Thirty-three adolescents (ages 12–18) were randomized to eight weeks of RFCBT or an assessment only (AO) control. Twenty two adolescents successfully completed fMRI scans pre- and post-intervention. Adolescents were recruited from the clinic and community and met criteria for at least one previous episode of MDD and were currently in full or partial remission. An Independent Evaluator interviewed parent and child before and after the eight-week intervention. The left PCC (-5, -50, 36) seed was used to probe resting state functional connectivity of the DMN. Adolescents who received RFCBT demonstrated reduced rumination (F = -2.76, df = 112, p < .01, 95% CI [-4.72,-0.80]) and self-report depression across eight weeks (F = -2.58, df = 113, p < .01, 95% CI [-4.21, -0.94]). Youth who received RFCBT also demonstrated significant decreases in connectivity between the left PCC and the right inferior frontal gyrus (IFG) and bilateral inferior temporal gyri (ITG). Degree of change in connectivity was correlated with changes in self-report depression and rumination. These data suggest that rumination can be reduced over eight weeks and that this reduction is associated with parallel decreases in residual depressive symptoms and decreased functional connectivity of the left PCC with cognitive control nodes. These changes may enhance the ability of vulnerable youth to stay well during the transition to adulthood. Trial Registration: ClinicalTrials.gov NCT01905267 PMID:27880789

  16. Adolescent Outpatient Treatment and Continuing Care: Main Findings from a Randomized Clinical Trial*

    PubMed Central

    Godley, Susan H.; Garner, Bryan R.; Passetti, Lora L.; Funk, Rodney R.; Dennis, Michael L.; Godley, Mark D.

    2010-01-01

    This study evaluated the effectiveness and cost-effectiveness of two types of outpatient treatment with and without Assertive Continuing Care (ACC) for 320 adolescents with substance use disorders. Study participants were randomly assigned to one of four conditions: (a) Chestnut’s Bloomington Outpatient Treatment (CBOP) without ACC; (b) CBOP with ACC; (c) Motivational Enhancement Therapy/Cognitive Behavior Therapy-7 session model (MET/CBT7) without ACC; and (d) MET/CBT7 with ACC. All study conditions attained high rates of participant engagement and retention. Follow-up interviews were completed with over 90% of the adolescents at three, six, nine, and twelve months after treatment admission. There was a significant time by condition effect over 12 months, with CBOP having a slight advantage for average percentage of days abstinent. Unlike previous findings that ACC provided incremental effectiveness following residential treatment, there were no statistically significant findings with regard to the incremental effectiveness of ACC following outpatient treatment. Analysis of the costs of each intervention combined with its outcomes revealed that the most cost-effective condition was MET/CBT7 without ACC. PMID:20219293

  17. Effective Treatment of Depressive Disorders in Medical Clinics for Adolescents and Young Adults living with HIV: A controlled trial

    PubMed Central

    Brown, Larry K.; Kennard, Betsy D.; Emslie, Graham J.; Mayes, Taryn L.; Whiteley, Laura B.; Bethel, James; Xu, Jiahong; Thornton, Sarah; Tanney, Mary R.; Hawkins, Linda A.; Garvie, Patricia A.; Subramaniam, Geetha A.; Worrell, Carol J.; Stoff, Laura W.

    2015-01-01

    Objective Preliminary test of a manualized, measurement-guided treatment for depression for adolescents and young adults in care at four sites of the Adolescent Trials Network for HIV/AIDS Interventions (ATN). Design The U.S. sites were randomly assigned to either a 24-week, combination cognitive behavioral therapy and medication management algorithm (COMB) tailored for youth living with HIV (YLWH) or to treatment as usual (TAU). Methods Youth at TAU sites had access to therapists and medication management as needed. COMB site clinicians were trained in the manualized intervention and participated in supervision calls to monitor intervention fidelity. Results Over the course of the study with 44 participants, those in COMB, compared to those in TAU, reported fewer depressive symptoms, p<0.01 (as measured by the Quick Inventory for Depression Symptomatology) and were more likely to be in remission, p<0.001, (65% vs.10% at week 24 end of treatment, and 71% vs. 7% at week 48 final follow-up). A greater proportion of COMB participants received psychotherapy (95% vs. 45%, p<0.001) and attended more sessions (12.6 vs. 5, p<0.001) than those in TAU. Viral load decreased in both groups and was associated (p<0.05) with reduction in depressive symptoms. Conclusions A 24-week manualized, measurement-guided psychotherapy and medication management algorithm tailored for YLWH was more effective in achieving and sustaining remission from depression than treatment as usual at HIV care clinic sites. Given observed treatment efficacy, this structured combination treatment could be disseminated to medical clinics in order to successfully treat YLWH, who are at particular risk for depression. PMID:26761270

  18. School-Based Randomized Controlled Trial of an HIV/STD Risk-Reduction Intervention for South African Adolescents

    PubMed Central

    Jemmott, John B.; Jemmott, Loretta S.; O’Leary, Ann; Ngwane, Zolani; Icard, Larry D.; Bellamy, Scarlett L.; Jones, Shasta F.; Landis, J. Richard; Heeren, G. Anita; Tyler, Joanne C.; Makiwane, Monde B.

    2015-01-01

    Objectives We tested the efficacy of a school-based HIV/STD risk-reduction intervention for South African adolescents. Design A cluster-randomized controlled design, with assessments of self-reported sexual behavior collected pre-intervention and 3, 6, and 12 months post-intervention. Setting Primary schools in a large Black township and a neighboring rural settlement in Eastern Cape Province, South Africa. Participants 9 of 17 matched-pairs of schools were randomly selected. Grade 6 learners with parent/guardian consent were eligible. Interventions Two 6-session interventions based on behavior-change theories and qualitative research: HIV/STD risk-reduction intervention targeted sexual-risk behaviors; attention-matched health-promotion control intervention targeted health issues unrelated to sexual behavior. Main Outcome Measures The primary outcome was self-report of unprotected vaginal intercourse in the previous 3 months averaged over the 3 follow-ups. Secondary outcomes were other sexual behaviors. Results A total of 1,057 (94.5%) of 1,118 eligible learners (mean age = 12.4 years) participated, with 96.7% retained at the 12-month follow-up. Generalized estimating equations analyses, adjusting for clustering from 18 schools, revealed that averaged over the 3 follow-ups a significantly smaller percentage of HIV/STD risk-reduction intervention participants reported having unprotected vaginal intercourse (OR = 0.51; 95% CI, 0.30-0.85), vaginal intercourse (OR = 0.62; 95% CI, 0.42-0.94), and multiple sexual partners (OR = 0.50; 95% CI, 0.28-0.89), when adjusted for baseline prevalences, compared with health-promotion control participants. Conclusions This is the first large-scale community-level randomized intervention trial to obtain significant effects on HIV/STD sexual-risk behavior among South African adolescents in the earliest stages of entry into sexual activity. PMID:20921349

  19. Modafinil as a treatment for Attention-Deficit/Hyperactivity Disorder in children and adolescents: a double blind, randomized clinical trial.

    PubMed

    Amiri, Shahrokh; Mohammadi, Mohammad-Reza; Mohammadi, Mohammad; Nouroozinejad, Gholam-Hossein; Kahbazi, Manijeh; Akhondzadeh, Shahin

    2008-01-01

    Attention-Deficit/Hyperactivity Disorder (ADHD) is the most prevalent psychiatric disorder currently afflicting children and is among the most common chronic conditions affecting school-age children. Modafinil is structurally different from the psychostimulants that are typically used to treat ADHD and has been reported to be effective in improving the symptoms of ADHD. The aim of the present study was to further evaluate, under double blind and controlled conditions, the efficacy of modafinil for ADHD in children and adolescents as compared to methylphenidate. Patients included 60 outpatients, children (47 boys and 13 girls) between the ages of 6-15 who clearly met the DSM-IV-TR diagnostic criteria for ADHD. Subjects were recruited from an outpatient child and adolescent clinic for a 6 week double blind, randomized clinical trial. All study subjects were randomly assigned to receive either treatment with modafinil film coated tablet (in doses of 200-300 mg/day) depending on weight (200 mg/day for <30 kg and 300 mg/day for >30 kg) (group 1) or methylphenidate (in doses of 20-30 mg/day) depending on weight (20 mg/day for <30 kg and 30 mg/day for >30 kg) (group 2). The principal measure of outcome was the Teacher and Parent ADHD Rating Scale-IV. Patients were assessed at baseline and at 21 and 42 days after the medication started. No significant differences were observed between the two groups on the Parent and Teacher Rating Scale scores. Side effects of decreased appetite and difficulty falling asleep were observed more in the methylphenidate group. The results of this study indicate that modafinil significantly improved symptoms of ADHD and was well tolerated and it is beneficial in the treatment of children with ADHD.

  20. A cross-sectional survey of complementary and alternative medicine use by children and adolescents attending the University Hospital of Wales

    PubMed Central

    Crawford, Nigel W; Cincotta, Domenic R; Lim, Alissa; Powell, Colin VE

    2006-01-01

    Background A high prevalence of CAM use has been documented worldwide in children and adolescents with chronic illnesses. Only a small number of studies, however, have been conducted in the United Kingdom. The primary aim of this study was to examine the use of CAM by children and adolescents with a wide spectrum of acute and chronic medical problems in a tertiary children's hospital in Wales. Methods Structured personal interviews of 100 inpatients and 400 outpatients were conducted over a 2-month period in 2004. The yearly and monthly prevalence of CAM use were assessed and divided into medicinal and non-medicinal therapies. This use was correlated with socio-demographic factors. Results There were 580 patients approached to attain 500 completed questionnaires. The use of at least one type of CAM in the past year was 41% (95% CI 37–46%) and past month 26% (95% CI 23–30%). The yearly prevalence of medicinal CAM was 38% and non-medicinal 12%. The users were more likely to have parents that were tertiary educated (mother: OR = 2.3, 95%CI 1.6–3.3) and a higher family income (Pearson chi-square for trend = 14.3, p < 0.001). The most common medicinal types of CAM were non-prescribed vitamins and minerals (23%) and herbal therapies (10%). Aromatherapy (5%) and reflexology (3%) were the most prevalent non-medicinal CAMs. None of the inpatient medical records documented CAM use in the past month. Fifty-two percent of medicinal and 38% of non-medicinal CAM users felt their doctor did not need to know about CAM use. Sixty-six percent of CAM users did not disclose the fact to their doctor. Three percent of all participants were using herbs and prescription medicines concurrently. Conclusion There is a high prevalence of CAM use in our study population. Paediatricians need to ensure that they ask parents and older children about their CAM usage and advise caution with regard to potential interactions. CAM is a rapidly expanding industry that requires further evidence

  1. 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.

  2. Recruitment Strategies and the Retention of Obese Urban Racial/Ethnic Minority Adolescents in Clinical Trials: The FIT Families Project, Michigan, 2010–2014

    PubMed Central

    Jacques-Tiura, Angela J.; Naar-King, Sylvie; Ellis, Deborah A.; Jen, Kai-Lin Catherine; Marshall, Sharon

    2015-01-01

    Introduction The successful recruitment and retention of participants is integral to the translation of research findings. We examined the recruitment and retention rates of racial/ethnic minority adolescents at a center involved in the National Institutes of Health Obesity Research for Behavioral Intervention Trials (ORBIT) initiative by the 3 recruitment strategies used: clinic, informatics, and community. Methods During the 9-month study, 186 family dyads, each composed of an obese African American adolescent and a caregiver, enrolled in a 6-month weight-loss intervention, a sequential multiple assignment randomized trial. We compared recruitment and retention rates by recruitment strategy and examined whether recruitment strategy was related to dyad baseline characteristics. Results Of the 186 enrolled families, 110 (59.1%) were recruited through clinics, 53 (28.5%) through informatics, and 23 (12.4%) through community. Of those recruited through community, 40.4% enrolled in the study, compared with 32.7% through clinics and 8.2% through informatics. Active refusal rate was 3%. Of the 1,036 families identified for the study, 402 passively refused to participate: 290 (45.1%) identified through informatics, 17 (29.8%) through community, and 95 (28.3%) through clinics. Recruitment strategy was not related to the age of the adolescent, adolescent comorbidities, body mass index of the adolescent or caregiver, income or education of the caregiver, or retention rates at 3 months, 7 months, or 9 months. Study retention rate was 87.8%. Conclusion Using multiple recruitment strategies is beneficial when working with racial/ethnic minority adolescents, and each strategy can yield good retention. Research affiliated with health care systems would benefit from the continued specification, refinement, and dissemination of these strategies. PMID:25695260

  3. 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

  4. 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.

  5. Efficacy of an HIV/STI Sexual Risk-Reduction Intervention for African American Adolescent Girls in Juvenile Detention Centers: A Randomized Controlled Trial

    PubMed Central

    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

    Background Few HIV/STI interventions exist for African American adolescent girls in juvenile detention. Objective The objective was to evaluate the efficacy of an intervention to reduce incident STIs, improve HIV-preventive behaviors, and enhance psychosocial outcomes. Methods 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. Intervention 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. Results 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. Conclusions 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. 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

  7. 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…

  8. 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.

  9. Health markers in obese adolescents improved by a 12-week recreational soccer program: a randomised controlled trial.

    PubMed

    Vasconcellos, Fabrício; Seabra, Andre; Cunha, Felipe; Montenegro, Rafael; Penha, Jociene; Bouskela, Eliete; Nogueira Neto, José Firmino; Collett-Solberg, Paulo; Farinatti, Paulo

    2016-01-01

    The effects of a recreational soccer program (RSP) upon body composition, heart rate variability (HRV), biochemical markers, cardio-respiratory fitness, and endothelial function in obese adolescents were investigated. A randomised controlled clinical trial was conducted with 30 adolescents aged 12-17 years and body mass index (BMI) >2 standard deviations of WHO reference values, which were assigned to RSP (n = 10, 2 girls) and obese control (n = 10, 4 girls) groups. The 12-week RSP included 60-min sessions performed 3 times/week. BMI, waist circumference, blood pressure, blood glucose, lipid profile, insulin, C-reactive protein, HRV, and maximal oxygen consumption (VO2peak) were evaluated following standardised procedures. Body composition was determined by dual-energy X-ray absorptiometry and endothelial function by venous occlusion plethysmography. After intervention, RSP exhibited significant reductions in BMI (-0.7 ± 0.2 kg · m(-2)), waist circumference (-8.2 ± 1.4 cm), %body fat (-2.2 ± 0.4%), systolic blood pressure (-5.0 ± 2.3 mmHg), total cholesterol (-16.2 ± 5.8 mg · dL(-1)), triglycerides (-20.5 ± 12.9 mg · dL(-1)), C-reactive protein (-0.06 ± 0.01 mg · dL(-1)), insulin resistance (HOMA-IR, -1.4 ± 0.6), and sympathetic activity (LF, -13.9 ± 6.6 un) vs. controls (P < 0.05). Significant increase was observed in parasympathetic activity (HF, 13.9 ± 6.6 un), VO2peak (7.9 ± 2.8 ml · kg(-1) · min(-1)), and high-density lipoprotein cholesterol (11.0 ± 6.3 mg · dL(-1)) (P < 0.05). Vascular conductance (19.5 ± 8.1 ml · min(-1) · 100 ml, P = 0.005) increased and vascular resistance (-5.9 ± 2.4 ml · min(-1) · 100 ml, P = 0.041) decreased in RSP, but not in controls. A 12-week recreational soccer intervention was effective to improve biochemical, cardiovascular, and fitness health markers in obese adolescents.

  10. European society of intensive care medicine study of therapeutic hypothermia (32-35°C) for intracranial pressure reduction after traumatic brain injury (the Eurotherm3235Trial)

    PubMed Central

    2011-01-01

    Background Traumatic brain injury is a major cause of death and severe disability worldwide with 1,000,000 hospital admissions per annum throughout the European Union. Therapeutic hypothermia to reduce intracranial hypertension may improve patient outcome but key issues are length of hypothermia treatment and speed of re-warming. A recent meta-analysis showed improved outcome when hypothermia was continued for between 48 hours and 5 days and patients were re-warmed slowly (1°C/4 hours). Previous experience with cooling also appears to be important if complications, which may outweigh the benefits of hypothermia, are to be avoided. Methods/design This is a pragmatic, multi-centre randomised controlled trial examining the effects of hypothermia 32-35°C, titrated to reduce intracranial pressure <20 mmHg, on morbidity and mortality 6 months after traumatic brain injury. The study aims to recruit 1800 patients over 41 months. Enrolment started in April 2010. Participants are randomised to either standard care or standard care with titrated therapeutic hypothermia. Hypothermia is initiated with 20-30 ml/kg of intravenous, refrigerated 0.9% saline and maintained using each centre's usual cooling technique. There is a guideline for detection and treatment of shivering in the intervention group. Hypothermia is maintained for at least 48 hours in the treatment group and continued for as long as is necessary to maintain intracranial pressure <20 mmHg. Intracranial hypertension is defined as an intracranial pressure >20 mmHg in accordance with the Brain Trauma Foundation Guidelines, 2007. Discussion The Eurotherm3235Trial is the most important clinical trial in critical care ever conceived by European intensive care medicine, because it was launched and funded by the European Society of Intensive Care Medicine and will be the largest non-commercial randomised controlled trial due to the substantial number of centres required to deliver the target number of patients. It

  11. Complications and comorbidities of T2DM in adolescents: findings from the TODAY clinical trial.

    PubMed

    Tryggestad, Jeanie B; Willi, Steven M

    2015-03-01

    With the rise in childhood obesity, type 2 diabetes mellitus (T2DM) has been recognized to occur in adolescents with increasing frequency. Although much is known about T2DM in adults, few studies have examined the treatment and complications of T2DM in youth. The Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) study was designed to evaluate the efficacy of various treatments and provided a unique opportunity to study the disease progression and appearance of complications in a pediatric cohort with recent onset of the disease. In the TODAY study, hypertension was present in 11.6% of the population at baseline and increased to 33.8% by the end of the study. Prevalence of high-risk LDL-cholesterol rose from 4.5% at baseline to 10.7% at the end of the study. Microalbuminuria was found in 6.3% of the cohort at baseline and increased to 16.6%. Retinopathy was not assessed upon entry into TODAY, but was present in 13.9% of the TODAY cohort at the end of the study. Experience to date indicates that these complications and comorbidities are similar to those seen in adults, but occur on an accelerated timeline. The early manifestation of diabetes complications in youth-onset T2DM suggests that this group will be burdened with the tangible consequences of cardiovascular disease, nephropathy, and retinopathy in the third and fourth decades of life. It is hoped that through an early, aggressive approach to treatment and prevention, we may be able to curb the onset and progression of these potentially devastating outcomes.

  12. Randomized Controlled Trial of the Acceptability, Feasibility, and Preliminary Effects of a Cognitive Behavioral Skills Building Intervention in Adolescents with Chronic Daily Headaches: A Pilot Study

    PubMed Central

    Hickman, Carolyn; Jacobson, Diana; Melnyk, Bernadette

    2014-01-01

    Introduction The treatment challenge of adolescents with chronic daily headaches (CDHs) creates an urgent need for evidence-based interventions. Therefore, the purpose of this pilot study was to evaluate the acceptability, feasibility, and preliminary effects of a brief cognitive behavioral skills building intervention (CBSB) with thirty-six, 13-17 year-old, adolescents with CDHs and mild to moderate depressive symptoms. Methods Participants were randomly assigned either to the Creating Opportunities for Personal Empowerment Headache Education Program (COPE-HEP) or to a headache education comparison group. Results Adolescents and parents found the COPE-HEP to be highly acceptable. Medium to large positive effects were demonstrated on the adolescents’ depression in both groups and on anxiety and beliefs in the COPE-HEP group. COPE-HEP offered additional benefits of a larger decrease in adolescent anxiety over time and stronger beliefs in the teens’ ability to manage their headaches. Discussion Adolescents with CDHs and elevated depressive and anxiety symptoms should be offered headache hygiene education plus cognitive-behavioral skills building interventions. A full-scale trial to determine the more long-term benefits of COPE-HEP is now warranted. PMID:25017938

  13. Reporting quality of randomized controlled trial abstracts published in leading laser medicine journals: an assessment using the CONSORT for abstracts guidelines.

    PubMed

    Jin, Lu; Hua, Fang; Cao, Qiang

    2016-11-01

    The objectives of this study were to assess the reporting quality of randomized controlled trial (RCT) abstracts published in leading laser medicine journals and investigate the association between potential predictors and reporting quality. The official online archives of four leading laser medicine journals were hand-searched to identify RCTs published in 2014 and 2015. A reporting quality assessment was carried out using the original 16-item CONsolidated Standards Of Reporting Trials (CONSORT) for Abstracts checklist. For each abstract, an overall CONSORT score (OCS) was calculated (score range, 0 to 16). Univariable and multivariable linear regression analyses were performed to identify significant predictors of reporting quality. Chi-square (or Fisher's exact) tests were used to analyze the adequate reporting rate of each quality item by specialty area. A total of 129 RCT abstracts were included and assessed. The mean OCS was 4.5 (standard deviation, 1.3). Only three quality items (interventions, objective, conclusions) were reported adequately in most abstracts (>80 %). No abstract adequately reported results for the primary outcome, source of funding, and status of the trial. In addition, sufficient reporting of participants, outcome in the methods section, randomization, and trial registration was rare (<5 %). According to multivariable linear regression analysis, the specialty area of RCT abstracts was significantly associated with their reporting quality (P = 0.008). The reporting quality of RCT abstracts published in leading laser medicine journals is suboptimal. Joint efforts by authors, editors, and other stakeholders in the field to improve trial abstract reporting are needed.

  14. 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.

  15. Brief cognitive-behavioral depression prevention program for high-risk adolescents outperforms two alternative interventions: a randomized efficacy trial.

    PubMed

    Stice, Eric; Rohde, Paul; Seeley, John R; Gau, Jeff M

    2008-08-01

    In this depression prevention trial, 341 high-risk adolescents (mean age = 15.6 years, SD = 1.2) with elevated depressive symptoms were randomized to a brief group cognitive-behavioral (CB) intervention, group supportive-expressive intervention, bibliotherapy, or assessment-only control condition. CB participants showed significantly greater reductions in depressive symptoms than did supportive-expressive, bibliotherapy, and assessment-only participants at posttest, though only the difference compared with assessment controls was significant at 6-month follow-up. CB participants showed significantly greater improvements in social adjustment and reductions in substance use at posttest and 6-month follow-up than did participants in all 3 other conditions. Supportive-expressive and bibliotherapy participants showed greater reductions in depressive symptoms than did assessment-only controls at certain follow-up assessments but produced no effects for social adjustment and substance use. CB, supportive-expressive, and bibliotherapy participants showed a significantly lower risk for major depression onset over the 6-month follow-up than did assessment-only controls. The evidence that this brief CB intervention reduced risk for future depression onset and outperformed alternative interventions for certain ecologically important outcomes suggests that this intervention may have clinical utility.

  16. Effects of a classroom-based educational resource on adolescent mental health literacy: a cluster randomized controlled trial.

    PubMed

    Perry, Yael; Petrie, Katherine; Buckley, Hannah; Cavanagh, Lindy; Clarke, Deborah; Winslade, Matthew; Hadzi-Pavlovic, Dusan; Manicavasagar, Vijaya; Christensen, Helen

    2014-10-01

    Evidence suggests that poor mental health literacy is a key barrier to help-seeking for mental health difficulties in adolescence. Educational programs have shown positive effects on literacy, however, the evidence base remains limited and available studies have many methodological limitations. Using cluster Randomised Control Trial (RCT) methodology, the current study examines the impact of 'HeadStrong', a school-based educational intervention, on mental health literacy, stigma, help-seeking, psychological distress and suicidal ideation. A total of 380 students in 22 classes (clusters) from 10 non-government secondary schools was randomised to receive either HeadStrong or Personal Development, Health and Physical Education (PDHPE) classes. Participants were assessed pre- and post-intervention, and at 6-month follow-up. Literacy improved and stigma reduced in both groups at post-intervention and follow-up, relative to baseline. However, these effects were significantly greater in the HeadStrong condition. The study demonstrates the potential of HeadStrong to improve mental health literacy and reduce stigma.

  17. 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

  18. Predictors of overweight and overfatness in a multiethnic pediatric population. Child and Adolescent Trial for Cardiovascular Health Collaborative Research Group.

    PubMed

    Dwyer, J T; Stone, E J; Yang, M; Feldman, H; Webber, L S; Must, A; Perry, C L; Nader, P R; Parcel, G S

    1998-04-01

    The goal of the study was to determine whether overweight or overfatness were predicted from sex, race or ethnicity, school site, and intervention or control status for children who were 9 y old at the outset of the Child and Adolescent Trial for Cardiovascular Health (CATCH). In this ethnically and geographically diverse group of 5106 students, height, weight, and triceps skinfold thickness were measured at 9 (baseline) and 11 y (follow-up) of age. The strongest predictors of status at follow-up were baseline overweight (odds ratio: 69.0; 95% CI: 54.9, 96.3) and overfatness (odds ratio: 27.4; 95% CI: 22.4, 33.4); site, African American race or ethnicity, and male sex were also significant independent associations. Children in the overweight (> 85th percentile for body mass index) group had significantly higher adjusted means for total blood cholesterol, higher apolipoprotein B concentrations, lower mean HDL-cholesterol concentrations, and lower performance on the 9-min run than those in other groups (< 15th, 15-49th, or 50-85th body mass index percentiles). Similar results were found for these factors for those subjects with greater triceps skinfold-thickness measurements. Groups of children who were overweight and overfat at baseline were more likely to be overweight and overfat at follow-up and to have more cardiovascular risk factors than their peers.

  19. Systematic review of the methodological quality of controlled trials evaluating Chinese herbal medicine in patients with rheumatoid arthritis

    PubMed Central

    Pan, Xin; Lopez-Olivo, Maria A; Song, Juhee; Pratt, Gregory; Suarez-Almazor, Maria E

    2017-01-01

    Objectives We appraised the methodological and reporting quality of randomised controlled clinical trials (RCTs) evaluating the efficacy and safety of Chinese herbal medicine (CHM) in patients with rheumatoid arthritis (RA). Design For this systematic review, electronic databases were searched from inception until June 2015. The search was limited to humans and non-case report studies, but was not limited by language, year of publication or type of publication. Two independent reviewers selected RCTs, evaluating CHM in RA (herbals and decoctions). Descriptive statistics were used to report on risk of bias and their adherence to reporting standards. Multivariable logistic regression analysis was performed to determine study characteristics associated with high or unclear risk of bias. Results Out of 2342 unique citations, we selected 119 RCTs including 18 919 patients: 10 108 patients received CHM alone and 6550 received one of 11 treatment combinations. A high risk of bias was observed across all domains: 21% had a high risk for selection bias (11% from sequence generation and 30% from allocation concealment), 85% for performance bias, 89% for detection bias, 4% for attrition bias and 40% for reporting bias. In multivariable analysis, fewer authors were associated with selection bias (allocation concealment), performance bias and attrition bias, and earlier year of publication and funding source not reported or disclosed were associated with selection bias (sequence generation). Studies published in non-English language were associated with reporting bias. Poor adherence to recommended reporting standards (<60% of the studies not providing sufficient information) was observed in 11 of the 23 sections evaluated. Limitations Study quality and data extraction were performed by one reviewer and cross-checked by a second reviewer. Translation to English was performed by one reviewer in 85% of the included studies. Conclusions Studies evaluating CHM often fail to

  20. Guided internet-administered self-help to reduce symptoms of anxiety and depression among adolescents and young adults diagnosed with cancer during adolescence (U-CARE: YoungCan): a study protocol for a feasibility trial

    PubMed Central

    Ander, Malin; Wikman, Anna; Ljótsson, Brjánn; Grönqvist, Helena; Ljungman, Gustaf; Woodford, Joanne; Lindahl Norberg, Annika; von Essen, Louise

    2017-01-01

    Introduction A subgroup of adolescents and young adults diagnosed with cancer during adolescence reports elevated levels of anxiety and depressive symptoms and unmet needs for psychological support. Evidence-based psychological treatments tailored for this population are lacking. This protocol describes a feasibility study of a guided-internet-administered self-help programme (YoungCan) primarily targeting symptoms of anxiety and depression among young persons diagnosed with cancer during adolescence and of the planned study procedures for a future controlled trial. Methods/analysis The study is an uncontrolled feasibility trial with a pre-post and 3-month follow-up design. Potential participants aged 15–25 years, diagnosed with cancer during adolescence, will be identified via the Swedish Childhood Cancer Registry. 30 participants will be included. Participants will receive YoungCan, a 12-week therapist-guided, internet-administered self-help programme consisting primarily of cognitive–behavioural therapy organised into individually assigned modules targeting depressive symptoms, worry and anxiety, body dissatisfaction and post-traumatic stress. Interactive peer support and psychoeducative functions are also available. Feasibility outcomes include: recruitment and eligibility criteria; data collection; attrition; resources needed to complete the study and programme; safety procedures; participants' and therapists' adherence to the programme; and participants' acceptability of the programme and study methodology. Additionally, mechanisms of impact will be explored and data regarding symptoms of anxiety, depression, post-traumatic stress, body dissatisfaction, reactions to social interactions, quality of life, axis I diagnoses according to the Mini International Neuropsychiatric Interview and healthcare service use will be collected. Exploratory analyses of changes in targeted outcomes will be conducted. Ethics/dissemination This feasibility protocol was

  1. 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

  2. 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

  3. 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

  4. Interactive video behavioral intervention to reduce adolescent females' STD risk: a randomized controlled trial.

    PubMed

    Downs, Julie S; Murray, Pamela J; Bruine de Bruin, Wändi; Penrose, Joyce; Palmgren, Claire; Fischhoff, Baruch

    2004-10-01

    A longitudinal randomized design was used to evaluate the impact of a theoretically based, stand-alone interactive video intervention on 300 urban adolescent girls' (a) knowledge about sexually transmitted diseases (STDs), (b) self-reported sexual risk behavior, and (c) STD acquisition. It was compared to two controls, representing high-quality informational interventions. One used the same content in book form; the other used commercially available brochures. Following randomization, the interventions were administered at baseline, with booster sessions at 1, 3, and 6 months. Self-reports revealed that those assigned to the interactive video were significantly more likely to be abstinent in the first 3 months following initial exposure to the intervention, and experienced fewer condom failures in the following 3 months, compared to controls. Six months after enrollment, participants in the video condition were significantly less likely to report having been diagnosed with an STD. A non-significant trend in data from a clinical PCR assay of Chlamydia trachomatis was consistent with that finding.

  5. 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

  6. 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

  7. 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

  8. 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

  9. Characteristics of HIV-infected adolescents enrolled in a disclosure intervention trial in western Kenya

    PubMed Central

    Vreeman, Rachel C.; Scanlon, Michael L.; Marete, Irene; Mwangi, Ann; Inui, Thomas S.; McAteer, Carole I.; Nyandiko, Winstone M.

    2015-01-01

    Knowledge of one’s own HIV status is essential for long-term disease management, but there are few data on how disclosure of HIV status to infected children and adolescents in sub-Saharan Africa is associated with clinical and psychosocial health outcomes. We conducted a detailed baseline assessment of the disclosure status, medication adherence, HIV stigma, depression, emotional and behavioral difficulties, and quality of life among a cohort of Kenyan children enrolled in an intervention study to promote disclosure of HIV status. Among 285 caregiver–child dyads enrolled in the study, children’s mean age was 12.3 years. Caregivers were more likely to report that the child knew his/her diagnosis (41%) compared to self-reported disclosure by children (31%). Caregivers of disclosed children reported significantly more positive views about disclosure compared to caregivers of non-disclosed children, who expressed fears of disclosure related to the child being too young to understand (75%), potential psychological trauma for the child (64%), and stigma and discrimination if the child told others (56%). Overall, the vast majority of children scored within normal ranges on screenings for behavioral and emotional difficulties, depression, and quality of life, and did not differ by whether or not the child knew his/her HIV status. A number of factors were associated with a child’s knowledge of his/her HIV diagnosis in multivariate regression, including older age (OR 1.8, 95% CI 1.5–2.1), better WHO disease stage (OR 2.5, 95% CI 1.4–4.4), and fewer reported caregiver-level adherence barriers (OR 1.9, 95% CI 1.1–3.4). While a minority of children in this cohort knew their HIV status and caregivers reported significant barriers to disclosure including fears about negative emotional impacts, we found that disclosure was not associated with worse psychosocial outcomes. PMID:26616121

  10. 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

  11. Factors affecting linkage to care and engagement in care for newly diagnosed HIV-positive adolescents within fifteen adolescent medicine clinics in the United States.

    PubMed

    Philbin, Morgan M; Tanner, Amanda E; DuVal, Anna; Ellen, Jonathan M; Xu, Jiahong; Kapogiannis, Bill; Bethel, Jim; Fortenberry, J Dennis

    2014-08-01

    Early linkage to care and engagement in care are critical for initiation of medical interventions. However, over 50 % of newly diagnosed persons do not receive HIV-related care within 6 months of diagnosis. We evaluated a linkage to care and engagement in care initiative for HIV-positive adolescents in 15 U.S.-based clinics. Structural and client-level factors (e.g. demographic and behavioral characteristics, clinic staff and location) were evaluated as predictors of successful linkage and engagement. Within 32 months, 1,172/1,679 (69.8 %) of adolescents were linked to care of which 1,043/1,172 (89 %) were engaged in care. Only 62.1 % (1,043/1,679) of adolescents were linked and engaged in care. Linkage to care failure was attributed to adolescent, provider, and clinic-specific factors. Many adolescents provided incomplete data during the linkage process or failed to attend appointments, both associated with failure to linkage to care. Additional improvements in HIV care will require creative approaches to coordinated data sharing, as well as continued outreach services to support newly diagnosed adolescents.

  12. The effect of an energy restricted low glycemic index diet on blood lipids, apolipoproteins and lipoprotein (a) among adolescent girls with excess weight: a randomized clinical trial.

    PubMed

    Rouhani, Mohammad Hossein; Kelishadi, Roya; Hashemipour, Mahin; Esmaillzadeh, Ahmad; Azadbakht, Leila

    2013-12-01

    Some studies focused on the effect of the dietary glycemic index on lipoproteins and apolipoproteins in adults; however, little evidence exists among adolescents regarding the effect of a low glycemic index (LGI) diet on apolipoproteins and lipoprotein (a) (Lpa). This study was conducted to evaluate the effect of an LGI diet on the lipid profile, apolipoproteins and Lpa among overweight and obese adolescent girls. For this parallel designed randomized clinical trial, 50 healthy overweight/obese girls at pubertal ages were randomly allocated to an LGI or a healthy nutritional recommendations (HNR) based diet. Equal macronutrient distributed diets were prescribed to both groups. Biochemical measurements included lipid profile, apolipoprotein A, apolipoprotein B and Lpa were conducted before and after 10 weeks of intervention. Forty one adolescent girls completed the study. The dietary glycemic index in the LGI group was 42.67 ± 0.067. There were no differences in the mean of blood lipid indices baseline and after intervention between two groups. There were no significant differences between the two groups regarding lipid profiles, apolipoproteins and Lpa. There were no significant differences in lipid profiles, apolipoproteins and Lpa between the LGI diet and the HNR-based diet and the impact of these two diets on lipid profile was equal in this trial.

  13. Anxiety status affects nicotine- and baclofen-induced locomotor activity, anxiety, and single-trial conditioned place preference in male adolescent rats.

    PubMed

    Falco, Adriana M; McDonald, Craig G; Smith, Robert F

    2014-09-01

    Adolescents have an increased vulnerability to nicotine and anxiety may play a role in the development of nicotine abuse. One possible treatment for anxiety disorders and substance abuse is the GABAB agonist, baclofen. The aim of the present study was to determine the effect of anxiety-like behavior on single-trial nicotine conditioned place preference in adolescent rats, and to assess the action of baclofen. Baclofen was shown to have effects on locomotor and anxiety-like behavior in rats divided into high-anxiety and low-anxiety groups. Baclofen decreased locomotor behavior in high-anxiety rats. Baclofen alone failed to produce differences in anxiety-like behavior, but nicotine and baclofen + nicotine administration were anxiolytic. High- and low-anxiety groups also showed differences in single-trial nicotine-induced place preference. Only high-anxiety rats formed place preference to nicotine, while rats in the low-anxiety group formed no conditioned place preference. These results suggest that among adolescents, high-anxiety individuals are more likely to show preference for nicotine than low-anxiety individuals.

  14. Protocol for a randomised controlled trial of a school based cognitive behaviour therapy (CBT) intervention to prevent depression in high risk adolescents (PROMISE)

    PubMed Central

    2010-01-01

    Background Depression in adolescents is a significant problem that impairs everyday functioning and increases the risk of severe mental health disorders in adulthood. Relatively few adolescents with depression are identified and referred for treatment indicating the need to investigate alternative preventive approaches. Study Design A pragmatic cluster randomised controlled trial evaluating the effectiveness of a school based prevention programme on symptoms of depression in "high risk" adolescents (aged 12-16). The unit of allocation is year groups (n = 28) which are assigned to one of three conditions: an active intervention based upon cognitive behaviour therapy, attention control or treatment as usual. Assessments will be undertaken at screening, baseline, 6 months and 12 months. The primary outcome measure is change on the Short Mood and Feeling Questionnaire at 12 months. Secondary outcome measures will assess changes in negative thoughts, self esteem, anxiety, school connectedness, peer attachment, alcohol and substance misuse, bullying and self harm. Discussion As of August 2010, all 28 year groups (n = 5023) had been recruited and the assigned interventions delivered. Final 12 month assessments are scheduled to be completed by March 2011. Trial Registration ISRCTN19083628 PMID:21114808

  15. Chinese Herbal Medicine Qi Ju Di Huang Wan for the Treatment of Essential Hypertension: A Systematic Review of Randomized Controlled Trials

    PubMed Central

    Wang, Jie; Xiong, Xingjiang; Yang, Guoyan; Zhang, Yuqing; Liu, Yongmei; Zhang, Yun; Zhang, Zhenpeng; Li, Jun; Yang, Xiaochen

    2013-01-01

    Background. Chinese herbs are potentially effective for hypertension. Qi Ju Di Huang Wan (QJDHW) is a commonly used Chinese herbal medicine as a monotherapy or in combination with other antihypertensive agents for the treatment of essential hypertension (EH). However, there is no critically appraised evidence such as systematic reviews or meta-analyses on the effectiveness and safety of QJDHW for EH. Methods and Findings. CENTRAL, PubMed, CBM, CNKI, VIP, and online clinical trial registry websites were searched for published and unpublished randomized controlled trials (RCTs) of QJDHW for essential hypertension up to January 2013 with no language restrictions. A total of 10 randomized trials involving 1024 patients were included. Meta-analysis showed that QJDHW combined with antihypertensive drugs was more effective in lowering blood pressure and improving TCM syndrome for the treatment of essential hypertension than antihypertensive drugs used alone. No trials reported severe adverse events related to QJDHW. Conclusions. Our review suggests that QJDHW combined with antihypertensive drugs might be an effective treatment for lowering blood pressure and improving symptoms in patients with essential hypertension. However, the finding should be interpreted with caution because of the poor methodological quality of included trials. There is an urgent need for well-designed, long-term studies to assess the effectiveness of QJDHW in the treatment of essential hypertension. PMID:23878593

  16. Klapp method effect on idiopathic scoliosis in adolescents: blind randomized controlled clinical trial

    PubMed Central

    Dantas, Diego De Sousa; De Assis, Sanderson José Costa; Baroni, Marina Pegoraro; Lopes, Johnnatas Mikael; Cacho, Enio Walker Azevedo; Cacho, Roberta De Oliveira; Pereira, Silvana Alves

    2017-01-01

    [Purpose] To estimate the effect of Klapp method on idiopathic scoliosis in school students. [Subjects and Methods] A single-blind randomized clinical trial with 22 students randomly divided into intervention group (n=12) and inactive control group (n=10). Exercise protocol consisted of Klapp method, 20 sessions, three times a week for intervention group, and inactivity for control group. Dorsal muscle strength was measured by dynamometer; body asymmetries and gibbosity angles were measured by biophotogrammetry. Data were obtained by Generalized Estimated Equation, with 5% significance level. Clinical impact for dependent variables was estimated by “d” Cohen. [Results] There was no change in intragroup analysis and intergroup for all postural symmetry variables. However, it was detected intergroup difference in extensor muscle strength and intergroup difference with marginal significance of gibbosity angles. Regarding extensor muscle strength, intervention group produced average improvement of 7.0 kgf compared to control group. Gibbosity angles progressed less in intervention group, with 5.71° average delay compared to control group. [Conclusion] Klapp method was effective for gibbosity stabilization and it improves spine extensor muscle strength. PMID:28210027

  17. Klapp method effect on idiopathic scoliosis in adolescents: blind randomized controlled clinical trial.

    PubMed

    Dantas, Diego De Sousa; De Assis, Sanderson José Costa; Baroni, Marina Pegoraro; Lopes, Johnnatas Mikael; Cacho, Enio Walker Azevedo; Cacho, Roberta De Oliveira; Pereira, Silvana Alves

    2017-01-01

    [Purpose] To estimate the effect of Klapp method on idiopathic scoliosis in school students. [Subjects and Methods] A single-blind randomized clinical trial with 22 students randomly divided into intervention group (n=12) and inactive control group (n=10). Exercise protocol consisted of Klapp method, 20 sessions, three times a week for intervention group, and inactivity for control group. Dorsal muscle strength was measured by dynamometer; body asymmetries and gibbosity angles were measured by biophotogrammetry. Data were obtained by Generalized Estimated Equation, with 5% significance level. Clinical impact for dependent variables was estimated by "d" Cohen. [Results] There was no change in intragroup analysis and intergroup for all postural symmetry variables. However, it was detected intergroup difference in extensor muscle strength and intergroup difference with marginal significance of gibbosity angles. Regarding extensor muscle strength, intervention group produced average improvement of 7.0 kgf compared to control group. Gibbosity angles progressed less in intervention group, with 5.71° average delay compared to control group. [Conclusion] Klapp method was effective for gibbosity stabilization and it improves spine extensor muscle strength.

  18. Cognitive-behavioral treatment of insomnia and depression in adolescents: A pilot randomized trial.

    PubMed

    Clarke, Greg; McGlinchey, Eleanor L; Hein, Kerrie; Gullion, Christina M; Dickerson, John F; Leo, Michael C; Harvey, Allison G

    2015-06-01

    We tested whether augmenting conventional depression treatment in youth by treating sleep issues with cognitive behavioral therapy for insomnia (CBT-I) improved depression outcomes. We randomized youth 12-20 years of age to 10 weekly sessions of a sleep hygiene control condition (SH) combined with CBT for depression (CBT-D) (n = 20), or an experimental condition consisting of CBT-I combined with CBT-D (n = 21). We assessed outcomes through 26 weeks of follow-up and found medium-large effects favoring the experimental CBT-I arm on some sleep outcomes (actigraphy total sleep time and Insomnia Severity Index "caseness") and depression outcomes (higher percentage recovered, faster time to recovery), but little effect on other measures. Total sleep time improved by 99 min from baseline to week 12 in the CBT-I arm, but not in the SH arm. In addition, our pilot yielded important products to facilitate future studies: the youth-adapted CBT-I program; the study protocol; estimates of recruitment, retention, and attrition; and performance and parameters of candidate outcome measures. ClinicalTrials.gov Identifier NCT00949689.

  19. 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

  20. Evaluation of a school-based depression prevention program among adolescents from low-income areas: a randomized controlled effectiveness trial.

    PubMed

    Kindt, Karlijn C M; Kleinjan, Marloes; Janssens, Jan M A M; Scholte, Ron H J

    2014-05-15

    A randomized controlled trial was conducted among a potential high-risk group of 1,343 adolescents from low-income areas in The Netherlands to test the effectiveness of the depression prevention program Op Volle Kracht (OVK) as provided by teachers in a school setting. The results showed no main effect of the program on depressive symptoms at one-year follow-up. A moderation effect was found for parental psychopathology; adolescents who had parents with psychopathology and received the OVK program had less depressive symptoms compared to adolescents with parents with psychopathology in the control condition. No moderating effects on depressive symptoms were found for gender, ethnical background, and level of baseline depressive symptoms. An iatrogenic effect of the intervention was found on the secondary outcome of clinical depressive symptoms. Based on the low level of reported depressive symptoms at baseline, it seems that our sample might not meet the characteristics of a high-risk selective group for depressive symptoms. Therefore, no firm conclusions can be drawn about the selective potential of the OVK depression prevention program. In its current form, the OVK program should not be implemented on a large scale in the natural setting for non-high-risk adolescents. Future research should focus on high-risk participants, such as children of parents with psychopathology.

  1. 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

  2. Comparative Effectiveness of Web-Based vs. Educator-Delivered HIV Prevention for Adolescent Substance Users: A Randomized, Controlled Trial

    PubMed Central

    Marsch, Lisa A.; Guarino, Honoria; Grabinski, Michael J.; Syckes, Cassandra; Dillingham, Elaine T.; Xie, Haiyi; Crosier, Benjamin S.

    2015-01-01

    Background Young people who engage in substance use are at risk for becoming infected with HIV and diseases with similar transmission dynamics. Effective disease prevention programs delivered by prevention specialists exist but are rarely provided in systems of care due to staffing/resource constraints and operational barriers - and are thus of limited reach. Web-based prevention interventions could possibly offer an effective alternative to prevention specialist-delivered interventions and may enable widespread, cost-effective access to evidence-based prevention programming. Previous research has shown the HIV/disease prevention program within the web-based Therapeutic Education System (TES) to be an effective adjunct to a prevention specialist-delivered intervention. The present study was the first randomized, clinical trial to evaluate the comparative effectiveness of this web-based intervention as a standalone intervention relative to a traditional, prevention specialist-delivered intervention. Methods Adolescents entering outpatient treatment for substance use participated in this multi-site trial. Participants were randomly assigned to either a traditional intervention delivered by a prevention specialist (n = 72) or the web-delivered TES intervention (n = 69). Intervention effectiveness was assessed by evaluating changes in participants’ knowledge about HIV, hepatitis, and sexually transmitted infections, intentions to engage in safer sex, sex-related risk behavior, self-efficacy to use condoms, and condom use skills. Findings Participants in the TES intervention achieved significant and comparable increases in HIV/disease-related knowledge, condom use self-efficacy, and condom use skills and comparable decreases in HIV risk behavior relative to participants who received the intervention delivered by a prevention specialist. Participants rated TES as easier to understand. Conclusion This study indicates that TES is as effective as HIV/disease prevention

  3. 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

  4. Concordance between self-report and urine drug screen data in adolescent opioid dependent clinical trial participants.

    PubMed

    Wilcox, Claire E; Bogenschutz, Michael P; Nakazawa, Masato; Woody, George

    2013-10-01

    Objective measures of drug use are very important in treatment outcome studies of persons with substance use disorders, but obtaining and interpreting them can be challenging and not always practical. Thus, it is important to determine if, and when, drug-use self-reports are valid. To this end we explored the relationships between urine drug screen results and self-reported substance use among adolescents and young adults with opioid dependence participating in a clinical trial of buprenorphine-naloxone. In this study, 152 individuals seeking treatment for opioid dependence were randomized to a 2-week detoxification with buprenorphine-naloxone (DETOX) or 12weeks of buprenorphine-naloxone (BUP), each with weekly individual and group drug counseling. Urine drug screens and self-reported frequency of drug use were obtained weekly, and patients were paid $5 for completing weekly assessments. At weeks 4, 8, and 12, more extensive assessments were done, and participants were reimbursed $75. Self-report data were dichotomized (positive vs. negative), and for each major drug class we computed the kappa statistic and the sensitivity, specificity, positive predictive value, and negative predictive value of self-report using urine drug screens as the "gold standard". Generalized linear mixed models were used to explore the effect of treatment group assignment, compensation amounts, and participant characteristics on self-report. In general, findings supported the validity of self-reported drug use. However, those in the BUP group were more likely to under-report cocaine and opioid use. Therefore, if used alone, self-report would have magnified the treatment effect of the BUP condition.

  5. Twelve-Month Outcomes of a Randomized Trial of the Positive Thoughts and Action Program for Depression among Early Adolescents

    PubMed Central

    Duong, Mylien T.; Cruz, Rick A.; King, Kevin M.; Violette, Heather D.; McCarty, Carolyn A.

    2015-01-01

    Objective This study was conducted to examine the 12-month effects on depression and depressive symptoms of a group-based cognitive-behavioral preventive intervention for middle school students (Positive Thoughts and Actions, or PTA), relative to a brief, individually administered supportive intervention (Individual Support Program, or ISP). Method A randomized clinical trial was conducted with 120 early adolescents (73 girls and 47 boys; age 12–14 years) drawn from a school-based population who had elevated depressive symptoms. Youths completed measures of depressive symptoms at baseline, post-intervention, and 6 and 12 months into the follow-up phase. Measures of internalizing problems, externalizing problems, school adjustment, interpersonal relationships, and health behavior were obtained from parents and/or youth. Results Multilevel models indicated that the effect of PTA on youth-reported depressive symptoms persisted until 12-month follow-up; d = .36 at post-intervention, d =.24 at 6-month follow-up, and d = .21 at 12-month follow-up. PTA youths also reported lower internalizing symptoms at post-intervention, d = .44, and at 12-month follow-up, d = .39. Time-limited effects were found for parent-reported internalizing symptoms and health behavior. Onset of new depressive episodes did not differ based on intervention group (21% ISP; 17% PTA). Conclusions Results demonstrate support for the long-term efficacy of PTA, a cognitive-behavioral preventive intervention in which youths engage in personal goal-setting and practice social-emotional skills. PMID:26486632

  6. 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

  7. 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

  8. 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

  9. 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.

  10. 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

  11. 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.

  12. 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

  13. 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

  14. The Effect of Wilderness Therapy on Adolescents' Cognitive Autonomy and Self-Efficacy: Results of a Non-Randomized Trial

    ERIC Educational Resources Information Center

    Margalit, Daniella; Ben-Ari, Amichai

    2014-01-01

    Background: Adolescents participate in decision-making processes involving risky behaviors. Management of these important decisions may be promoted by enhancing adolescents' self-efficacy beliefs and cognitive autonomy. Objective: In order to elucidate the value of wilderness therapy to the successful management of decision making processes among…

  15. 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…

  16. 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…

  17. 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…

  18. 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…

  19. Evidence-based medicine: quality and comparability of clinical trials investigating the efficacy of prostaglandin F(2α) for the treatment of bovine endometritis.

    PubMed

    Haimerl, Peggy; Arlt, Sebastian; Heuwieser, Wolfgang

    2012-08-01

    The objective of this study was to evaluate the quality and comparability of published literature, and to summarize the effect of prostaglandin F(2α) (PGF(2α)) for the treatment of endometritis. It has been postulated that there is a dearth of high-level evidence-based research results in veterinary medicine. Also, there is a marked variation in the quality of studies in veterinary and animal science. Post-partum uterine infections occur commonly in dairy cattle and are reported to have a negative impact on reproductive performance. A comprehensive literature search was conducted utilizing online databases revealing a total of 2723 references. After applying specific exclusion criteria, a total of 68 trials were eligible for further analysis. These articles were evaluated utilizing specific parameters listed in an evaluation form such as randomization and the involvement of control groups. The analysis revealed that more than half of the trials (51·5%) were at least 20 years old. Furthermore, we found that about one third (36·8%) of all trials were controlled and randomized, while 3 of those (4·4%) were also blinded. Of those trials which calculated a calving-to-conception interval (n=30), 50% of the authors claimed an improvement, which was statistically significant in 23·3% of the cases. We conclude that there is a wide discrepancy between research results investigating the efficacy of PGF(2α).

  20. 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

  1. Combination of flying needle with Chinese Herbal Medicine in the treatment of Atopic dermatitis: A clinical trial.

    PubMed

    X Quan, Xiaohong; Cheng, Shenrong; Ma, Hong; Huang, Hengxuan; Wang, Bin; Chen, Xiuhua

    2014-09-01

    Atopic dermatitis (Atopic dermatitis, AD) is a kind of chronic recurrent dermatitis. So far, no curative treatment has been found yet. Acupuncture, as a kind of alternative medicine, Flying Needle is a kind of acupuncture, which has a unique curative effectiveness in improving the skin lesion and itch. A single-center, prospective, randomized clinical design was conducted. The curative effect of the combination of Chinese herbal medicine and acupuncture for the treatment of Atopic dermatitis was assessed. Thirty (30) patients were treated with Flying Needle and Chinese herbal medicine. Because of personal reasons, one (1) dropped out. The patients accepted Flying Needle treatment 3 times a week and the internal medicine 3 times daily for in all 12 weeks. Before treatment, and after treat 4,8 and 12 weeks, assessments were performed. After treat 12 weeks, all patients of SCORAD score were dropped, with the mean SCORAD score declining to 19.58 ± 12.21. The recovery and removal rate comparison (*δx² = 5.28, P= 0.03<0.05). There are no side effects. The results hint that combine Flying Needle with Chinese herbal medicine are benefit on patients with atopic dermatitis and the effectiveness may better than oral medicine alone.

  2. What Value Can Qualitative Research Add to Quantitative Research Design? An Example From an Adolescent Idiopathic Scoliosis Trial Feasibility Study.

    PubMed

    Toye, Francine; Williamson, Esther; Williams, Mark A; Fairbank, Jeremy; Lamb, Sarah E

    2016-08-09

    Using an example of qualitative research embedded in a non-surgical feasibility trial, we explore the benefits of including qualitative research in trial design and reflect on epistemological challenges. We interviewed 18 trial participants and used methods of Interpretive Phenomenological Analysis. Our findings demonstrate that qualitative research can make a valuable contribution by allowing trial stakeholders to see things from alternative perspectives. Specifically, it can help to make specific recommendations for improved trial design, generate questions which contextualize findings, and also explore disease experience beyond the trial. To make the most out of qualitative research embedded in quantitative design it would be useful to (a) agree specific qualitative study aims that underpin research design, (b) understand the impact of differences in epistemological truth claims, (c) provide clear thematic interpretations for trial researchers to utilize, and (d) include qualitative findings that explore experience beyond the trial setting within the impact plan.

  3. Effects of the traditional Chinese medicine Yi Shen Jian Gu granules on aromatase inhibitor-associated musculoskeletal symptoms: a study protocol for a multicenter, randomized, controlled clinical trial

    PubMed Central

    2014-01-01

    Background Aromatase inhibitors (AIs) are widely used as an adjuvant endocrine treatment in postmenopausal women with early-stage breast cancer. One of the main adverse effects of AIs is musculoskeletal symptoms, which leads to a lower quality of life and poor adherence to AI treatment. To date, no effective management of aromatase inhibitor-associated musculoskeletal symptoms (AIMSS) has been developed. Methods/design To determine whether the traditional Chinese medicine Yi Shen Jian Gu granules could effectively manage AIMSS we will conduct a multicenter, randomized, double-blind, placebo-controlled clinical trial. Patients experiencing musculoskeletal symptoms after taking AIs will be enrolled and treated with traditional Chinese medicine or placebo for 12 weeks. The primary outcome measures include Brief Pain Inventory-Short Form, Western Ontario and McMaster Universities Osteoarthritis Index, and Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands, which will be obtained at baseline and at 4, 8, 12 and 24 weeks. Discussion The results of this study will provide a new strategy to help relieve AIMSS. Trial registration ISCTN: ISRCTN06129599 (assigned 14 August 2013). PMID:24885324

  4. 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

  5. Ultrasonographic reference values for peripheral nerves and nerve roots in the normal population of children and adolescents: study protocol for an observational-prospective trial

    PubMed Central

    Décard, Bernhard F; Schädelin, Sabine; Grimm, Alexander; Fischer, Dirk; Hafner, Patricia

    2016-01-01

    Background High-resolution ultrasonography is a new and promising technique to evaluate peripheral and spinal nerves. Its validity as a diagnostic tool in neurological diseases has been demonstrated in adults. Up to now no reference values have been published in children and adolescents although this technique would be ideal in this population as it is fast and non-invasive. Methods/design Our aim is to generate ultrasonographic reference values for several peripheral nerves (median, ulnar, radial, tibial, sural, peroneal and tibial nerve) as well as for the spinal nerves C5 and C6 and the vagus nerve in children and adolescents. In an observational prospective study, we will recruit 205 children and adolescents aged between ≥2 and ≤18 years without neuromuscular symptoms/signs and without a history of neuromuscular disease. After the collection of demographic and anthropometric data (height, weight, body mass index, age, gender and handedness) and a neurologic examination, a high-resolution ultrasonography of peripheral and spinal nerves at several anatomic landmarks will be performed. These data will be used to estimate age-dependent percentile curves and to evaluate inter-rater, intrarater and interequipment reliability of the measurements. Ethics and dissemination This study was approved by the local ethics committee (EKNZ 2015-210). The findings from this study will be disseminated through peer-reviewed publications and conference presentations. Trial registration number NCT02570802, pre-results publication. PMID:27940636

  6. Effect of School-Based Home-Collaborative Lifestyle Education on Reducing Subjective Psychosomatic Symptoms in Adolescents: A Cluster Randomised Controlled Trial.

    PubMed

    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.

  7. 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

  8. Efficacy of a text messaging (SMS) based smoking cessation intervention for adolescents and young adults: Study protocol of a cluster randomised controlled trial

    PubMed Central

    2012-01-01

    Background Particularly in groups of adolescents with lower educational level the smoking prevalence is still high and constitutes a serious public health problem. There is limited evidence of effective smoking cessation interventions in this group. Individualised text messaging (SMS) based interventions are promising to support smoking cessation and could be provided to adolescents irrespective of their motivation to quit. The aim of the current paper is to outline the study protocol of a trial testing the efficacy of an SMS based intervention for smoking cessation in apprentices. Methods/Design A two-arm cluster-randomised controlled trial will be conducted to test the efficacy of an SMS intervention for smoking cessation in adolescents and young adults compared to an assessment only control group. A total of 910 daily or occasional (≥ 4 cigarettes in the preceding month and ≥ 1 cigarette in the preceding week) smoking apprentices will be proactively recruited in vocational school classes and, using school class as a randomisation unit, randomly assigned to an intervention group (n = 455) receiving the SMS based intervention or an assessment only control group (n = 455). Individualised text messages taking into account demographic data and the individuals' smoking behaviours will be sent to the participants of the intervention group over a period of 3 months. Participants will receive two text messages promoting smoking cessation per week. Program participants who intend to quit smoking have the opportunity to use a more intensive SMS program to prepare for their quit day and to prevent a subsequent relapse. The primary outcome measure will be the proportion of participants with 7-day point prevalence smoking abstinence assessed at 6-months follow-up. The research assistants conducting the baseline and the follow-up assessments will be blinded regarding group assignment. Discussion It is expected that the program offers an effective and inexpensive way to

  9. 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

  10. Research into the (Cost-) effectiveness of the ketogenic diet among children and adolescents with intractable epilepsy: design of a randomized controlled trial

    PubMed Central

    2011-01-01

    Background Epilepsy is a neurological disorder, characterized by recurrent unprovoked seizures which have a high impact on the individual as well as on society as a whole. In addition to the economic burden, epilepsy imposes a substantial burden on the patients and their surroundings. Patients with uncontrolled epilepsy depend heavily on informal care and on health care professionals. About 30% of patients suffer from drug-resistant epilepsy. The ketogenic diet can be a treatment of last resort, especially for children. The beneficial effect of the ketogenic diet has been proven, but information is lacking about its cost-effectiveness. In the current study we will evaluate the (cost-) effectiveness of the ketogenic diet in children and adolescents with intractable epilepsy. Methods/Design In a RCT we will compare the ketogenic diet with usual care. Embedded in this RCT will be a trial-based and model-based economic evaluation, looking from a societal perspective at the cost-effectiveness and cost-utility of the ketogenic diet versus usual care. Fifty children and adolescents (aged 1-18) with intractable epilepsy will be screened for eligibility before randomization into the intervention or the usual care group. The primary outcome measure is the proportion of children with a 50% or more reduction in seizure frequency. Secondary outcomes include seizure severity, side effects/complaints, neurocognitive, socio-emotional functioning, and quality of life. Costs and productivity losses will be assessed continuously by a prospective diary and a retrospective questionnaire. Measurements will take place during consults at baseline, at 6 weeks and at 4 months after the baseline period, and 3, 6, 9 and 12 months follow-up after the 4 months consult. Discussion The proposed research project will be the first study to provide data about the cost-effectiveness of the ketogenic diet for children and adolescents with intractable epilepsy, in comparison with usual care. It is

  11. The effect of Citrus Aurantifolia (Lemon) peels on cardiometabolic risk factors and markers of endothelial function in adolescents with excess weight: A triple-masked randomized controlled trial

    PubMed Central

    Hashemipour, Mahin; Kargar, Maryam; Ghannadi, Alireza; Kelishadi, Roya

    2016-01-01

    Background: Childhood obesity is becoming a global problem and its incidence is increasing. The role of dietary intervention with fruits containing vitamin C and flavonoid to control obesity consequences in childhood has not been yet defined. Lemon (Citrus aurantifolia) peels contain flavonoid, pectin and vitamin C. We aimed to compare the effects of lemon peels and placebo on cardiometabolic risk factors and markers of endothelial function among adolescents with overweight and obesity. Methods: In this triple-masked, randomized controlled trial, 60 overweight/obese adolescents were enrolled in a 4-week trial. Eligible participants were randomly assigned into two groups of equal number receiving daily oral capsules containing lemon powder or placebo. Fasting blood sugar, lipid profile, ICAM-1 and VCAM-1, as well as systolic and diastolic blood pressure were compared between the two groups before and after administration of medication and placebo. Results: Of the total 60 enrolled patients, 30 and 29 patients in the lemon and control groups completed the study, respectively. The results of within-group analysis demonstrated a slight reduction in body mass index, LDL-C and systolic blood pressure in the lemon group, but no between group differences existed in the studied variables. Conclusion: This study revealed that consumption of lemon peel extract has some beneficial effects for childhood obesity; however, no considerable effect was documented on anthropometric measures and biochemical factors. Future studies with longer follow up are highly recommended. PMID:28210594

  12. The effect of Citrus Aurantifolia (Lemon) peels on cardiometabolic risk factors and markers of endothelial function in adolescents with excess weight: A triple-masked randomized controlled trial.

    PubMed

    Hashemipour, Mahin; Kargar, Maryam; Ghannadi, Alireza; Kelishadi, Roya

    2016-01-01

    Background: Childhood obesity is becoming a global problem and its incidence is increasing. The role of dietary intervention with fruits containing vitamin C and flavonoid to control obesity consequences in childhood has not been yet defined. Lemon (Citrus aurantifolia) peels contain flavonoid, pectin and vitamin C. We aimed to compare the effects of lemon peels and placebo on cardiometabolic risk factors and markers of endothelial function among adolescents with overweight and obesity. Methods: In this triple-masked, randomized controlled trial, 60 overweight/obese adolescents were enrolled in a 4-week trial. Eligible participants were randomly assigned into two groups of equal number receiving daily oral capsules containing lemon powder or placebo. Fasting blood sugar, lipid profile, ICAM-1 and VCAM-1, as well as systolic and diastolic blood pressure were compared between the two groups before and after administration of medication and placebo. Results: Of the total 60 enrolled patients, 30 and 29 patients in the lemon and control groups completed the study, respectively. The results of within-group analysis demonstrated a slight reduction in body mass index, LDL-C and systolic blood pressure in the lemon group, but no between group differences existed in the studied variables. Conclusion: This study revealed that consumption of lemon peel extract has some beneficial effects for childhood obesity; however, no considerable effect was documented on anthropometric measures and biochemical factors. Future studies with longer follow up are highly recommended.

  13. 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

  14. Computeen: a randomized trial of a preventive computer and psychosocial skills curriculum for at-risk adolescents.

    PubMed

    Lang, Jason M; Waterman, Jill; Baker, Bruce L

    2009-09-01

    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 years old who were living in affordable housing communities participated in this randomized wait-list control study. Results showed considerable improvements in computer self-efficacy, decreases in internalizing behavior problems, and excellent attendance and consumer satisfaction. Self-esteem and school motivation results were mixed. Computer self-efficacy mediated the relationship between improved computer skills and self-esteem. Younger adolescents showed greater improvement than did older adolescents. EDITORS' STRATEGIC IMPLICATIONS: Although there are limitations to this study's sample size and scope, Computeen appears promising as a developmentally appropriate, strengths-based prevention program.

  15. 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.

  16. Does Effectiveness of Adolescent Smoking-Cessation Intervention Endure Into Young Adulthood? 7-Year Follow-Up Results from a Group-Randomized Trial

    PubMed Central

    Peterson, Arthur V.; Marek, Patrick M.; Kealey, Kathleen A.; Bricker, Jonathan B.; Ludman, Evette J.; Heffner, Jaimee L.

    2016-01-01

    Background The Hutchinson Study of High School Smoking was the first randomized trial to show effectiveness of a smoking cessation intervention on 6-months prolonged smoking abstinence at one year post-intervention in a large population-based sample of adolescent smokers. An important question remains: Do the positive effects from teen smoking cessation interventions seen at up to 12 months post-intervention endure into young adulthood? This study examines for the first time whether such positive early effects from teen smoking cessation intervention can endure into young adulthood in the absence of additional intervention. Methods High school smokers (n = 2,151) were proactively recruited into the trial from fifty randomly selected Washington State high schools randomized to the experimental (Motivational Interviewing + Cognitive Behavioral Skills Training telephone counseling intervention) or control (no intervention) condition. These smokers were followed to 7 years post high school to ascertain rates of six-year prolonged smoking abstinence in young adulthood. All statistical tests are two-sided. Results No evidence of intervention impact at seven years post high school was observed for the main endpoint of six-year prolonged abstinence, neither among all smokers (14.2% in the experimental condition vs. 13.1% in the control condition, difference = +1.1%, 95% confidence interval (CI) = -3.4 to 5.8, p = .61), nor among the subgroups of daily smokers and less-than-daily smokers, nor among other a priori subgroups. But, observed among males was some evidence of an intervention impact on two endpoints related to progress towards quitting: reduction in number of days smoked in the past month, and increase in the length of the longest quit attempt in the past year. Conclusions There was no evidence from this trial among adolescent smokers that positive effectiveness of the proactive telephone intervention for smoking abstinence, observed previously at one year post

  17. Feasibility study and pilot cluster-randomised controlled trial of the GoActive intervention aiming to promote physical activity among adolescents: outcomes and lessons learnt

    PubMed Central

    Corder, Kirsten; Brown, Helen E; Schiff, Annie; van Sluijs, Esther M F

    2016-01-01

    Objectives Assess the feasibility of implementing the GoActive intervention in secondary schools, to identify improvements, test study procedures, determine preliminary effectiveness to increase moderate-to-vigorous physical activity (MVPA), and inform power calculations to establish programme effectiveness. Setting Feasibility study (1 school) and pilot cluster-randomised controlled trial (CRCT; 2 intervention; 1 control school(s)). Participants 460 participants (46.6% female; 13.2 (0.4) years old). Interventions 8-week intervention (2013) involved: classes choosing weekly activities encouraged by mentors (older adolescents) and in-class peer leaders. Students gain points for trying activities which are entered into an intramural competition. Primary and secondary outcome measures Planned quantitative (questionnaire) and qualitative (focus groups) process evaluation addressed enjoyment, confidence, participation, suggested improvements. Outcomes were assessed at baseline and follow-up (week 8) in pilot CRCT and included accelerometer-assessed MVPA; adolescent-reported activity type, well-being, peer support, shyness, sociability. Analysis of covariance was used to assess preliminary effectiveness as change in MVPA adjusted for baseline. Results All year 9 students in intervention schools were exposed to the intervention; over all schools 77% of eligible students were measured. 71% boys and 74% girls found GoActive ‘fun’; 38% boys and 32% girls said it increased confidence, and 64% boys and 59% girls said they would continue with a GoActive activity. Suggested improvements included more mentorship; improved training; streamlined points recording. Pilot results indicated potential effectiveness ((adjusted mean difference (95% CI) p value; MVPA mins; 5.1 (1.1 to 9.2) p=0.014)) and suggest recruitment of 16 schools (2400 adolescents) for a full trial. Compared with control, intervention students reported greater peer support 0.5 (0.1 to 0.9) p=0.03, well-being 1

  18. 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

  19. 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

  20. Traditional Herbal Medicine: A Review of Potential of Inhibitory Hepatocellular Carcinoma in Basic Research and Clinical Trial

    PubMed Central

    Wang, Zhidong; Li, Jun; Ji, Yuanyuan; An, Peng; Zhang, Shu; Li, Zongfang

    2013-01-01

    Although significantly develops in hepatocellular carcinoma (HCC), features of HCC remain an aggressive cancer with a dismal outcome. Traditional Chinese medicine (TCM), specifically Chinese herbal medicine (CHM), is one of the most popular complementary and alternative medicine modalities worldwide. The use of heat-clearing and detoxicating (Chinese named qingre jiedu) CHM has attracted great attention as an alternative antitumor including HCC considering its low toxicity and high activity. Together these reports indicate that CHM is a promising anti-HCC herbal remedy in basic research. For patients with advanced HCC, CHM including formula and single combined with transcatheter arterial chemoembolization or chemotherapy is able to decrease tumor growth and the side effect of toxicity and improve overall survival, quality of life, and immune function. Due to its abundance, low cost, and safety in consumption, CHM remains a species with tremendous potential for further investigation in HCC. PMID:23956767

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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

  7. Effects of Intranasal Oxytocin on Emotion Regulation in Insecure Adolescents: Study Protocol for a Double-Blind, Randomized Controlled Trial

    PubMed Central

    Chateau Smith, Carmela; Monnin, Julie; Andrieu, Patrice; Girard, Frédérique; Galdon, Lucie; Schneider, Marie; Pazart, Lionel; Nezelof, Sylvie; Vulliez-Coady, Lauriane

    2016-01-01

    Background Emotional dysregulation and impaired attachment are potential contributors to the development of psychopathology in adolescence. This raises the question of whether oxytocin (OT), the paradigmatic “attachment hormone,” may be beneficial in such contexts. Recent evidence suggests that intranasal administration of OT increases affiliative behavior, including trust and empathy. OT may also facilitate social reciprocity by attenuating the stress response to interpersonal conflict. To date, few studies have investigated the effects of intranasal oxytocin (IN-OT) on neurophysiological emotion regulation strategies in healthy adolescents, particularly during parent-adolescent interaction. To understand these mechanisms, our study will examine the effects of IN-OT on emotion regulation in adolescents during parent-adolescent stressful interactions, and on each adolescent’s visual and neurophysiological strategies when visualizing attachment-related pictures. We hypothesize that IN-OT will influence psychophysiological outcomes under conditions of stress. We predict that IN-OT will momentarily increase feelings of safety and attenuate stress and hostile behavior during conflict situations. OT may also enhance attachment security by increasing comfort and proximity-seeking, and reducing neurophysiological hyperactivation. Objective The objective of this study is to evaluate the effects of IN-OT on insecure adolescents by studying their behavior and discourse during a disagreement with one of their parents. Their neurophysiological responses to pictures eliciting attachment-related emotions and their visual exploration strategies will also be investigated. Methods In this randomized, double-blind, placebo-controlled parallel-group design, 60 healthy male adolescents classified as insecurely attached will receive 24 international units (IU) of IN-OT versus placebo (PB), 45 minutes before the experimental tasks. Each adolescent will then be invited to engage in

  8. 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…

  9. 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.

  10. Child and Adolescent Mental Health

    MedlinePlus

    ... Chats with Experts Clinical Trials Share Child and Adolescent Mental Health Overview Teen Depression Study: Understanding Depression ... Continue reading Recruitment Begins for Landmark Study of Adolescent Brain Development September 13, 2016 • Press Release The ...

  11. 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

  12. 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

  13. 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

  14. 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…

  15. 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…

  16. 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

  17. Breast Cancer Screening in the Precision Medicine Era: Risk-Based Screening in a Population-Based Trial.

    PubMed

    Shieh, Yiwey; Eklund, Martin; Madlensky, Lisa; Sawyer, Sarah D; Thompson, Carlie K; Stover Fiscalini, Allison; Ziv, Elad; Van't Veer, Laura J; Esserman, Laura J; Tice, Jeffrey A

    2017-01-01

    Ongoing controversy over the optimal approach to breast cancer screening has led to discordant professional society recommendations, particularly in women age 40 to 49 years. One potential solution is risk-based screening, where decisions around the starting age, stopping age, frequency, and modality of screening are based on individual risk to maximize the early detection of aggressive cancers and minimize the harms of screening through optimal resource utilization. We present a novel approach to risk-based screening that integrates clinical risk factors, breast density, a polygenic risk score representing the cumulative effects of genetic variants, and sequencing for moderate- and high-penetrance germline mutations. We demonstrate how thresholds of absolute risk estimates generated by our prediction tools can be used to stratify women into different screening strategies (biennial mammography, annual mammography, annual mammography with adjunctive magnetic resonance imaging, defer screening at this time) while informing the starting age of screening for women age 40 to 49 years. Our risk thresholds and corresponding screening strategies are based on current evidence but need to be tested in clinical trials. The Women Informed to Screen Depending On Measures of risk (WISDOM) Study, a pragmatic, preference-tolerant randomized controlled trial of annual vs personalized screening, will study our proposed approach. WISDOM will evaluate the efficacy, safety, and acceptability of risk-based screening beginning in the fall of 2016. The adaptive design of this trial allows continued refinement of our risk thresholds as the trial progresses, and we discuss areas where we anticipate emerging evidence will impact our approach.

  18. 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

  19. Combined cognitive and parent training interventions for adolescents with ADHD and their mothers: A randomized controlled trial.

    PubMed

    Steeger, Christine M; Gondoli, Dawn M; Gibson, Bradley S; Morrissey, Rebecca A

    2016-01-01

    This study examined the individual and combined effects of two nonpharmacological treatments for attention deficit/hyperactivity disorder (ADHD): Cogmed working memory training (CWMT) for adolescents and behavioral parent training (BPT) for mothers. Ninety-one adolescents (ages 11-15) and their mothers were randomized to one of four CWMT and BPT treatment and active control (placebo) group combinations of 5-week interventions. At pre- and posttest, mothers and teachers completed rating forms, and adolescents completed neuropsychological measures of working memory (WM). Individual intervention effects showed that treatment CWMT significantly improved WM spans, whereas there were no significant differences for treatment or control BPT on reports of parent-related outcomes. Combined treatment effects indicated an overall pattern of greatest improvements for the control CWMT/treatment BPT group, as compared to the other three groups, on adolescent WM deficit, behavioral regulation problems, and global executive deficit. Most significant effects for outcomes were main effects of improvements over time. A combination of CWMT and BPT did not result in increased treatment gains. However, potential effects of combined treatment may have been masked by greater perceived benefits arising from lack of struggle in the nonadaptive, CWMT active control condition. Future combined intervention research should focus on specific, theoretically driven WM deficits among individuals with ADHD, should include possible adaptations to the standard CWMT program, should examine effectiveness of cognitive treatments combined with contextual interventions and should utilize appropriate control groups to fully understand the unique and combined effects of interventions.

  20. 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…

  1. 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…

  2. 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…

  3. 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…

  4. 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...

  5. 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…

  6. 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…

  7. 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…

  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.

  9. 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

  10. European youth care sites serve different populations of adolescents with cannabis use disorder. Baseline and referral data from the INCANT trial

    PubMed Central

    2011-01-01

    Background MDFT (Multidimensional Family Therapy) is a family based outpatient treatment programme for adolescent problem behaviour. MDFT has been found effective in the USA in adolescent samples differing in severity and treatment delivery settings. On request of five governments (Belgium, France, Germany, the Netherlands, and Switzerland), MDFT has now been tested in the joint INCANT trial (International Cannabis Need of Treatment) for applicability in Western Europe. In each of the five countries, study participants were recruited from the local population of youth seeking or guided to treatment for, among other things, cannabis use disorder. There is little information in the literature if these populations are comparable between sites/countries or not. Therefore, we examined if the study samples enrolled in the five countries differed in baseline characteristics regarding demographics, clinical profile, and treatment delivery setting. Methods INCANT was a multicentre phase III(b) randomized controlled trial with an open-label, parallel group design. It compared MDFT with treatment as usual (TAU) at and across sites in Berlin, Brussels, Geneva, The Hague and Paris. Participants of INCANT were adolescents of either sex, from 13 through 18 years of age, with a cannabis use disorder (dependence or abuse), and at least one parent willing to take part in the treatment. In total, 450 cases/families were randomized (concealed) into INCANT. Results We collected data about adolescent and family demographics (age, gender, family composition, school, work, friends, and leisure time). In addition, we gathered data about problem behaviour (substance use, alcohol and cannabis use disorders, delinquency, psychiatric co-morbidity). There were no major differences on any of these measures between the treatment conditions (MDFT and TAU) for any of the sites. However, there were cross-site differences on many variables. Most of these could be explained by variations in treatment

  11. Sources of Site Differences in the Efficacy of a Multi-site Clinical Trial: The Treatment of SSRI Resistant Depression in Adolescents

    PubMed Central

    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. In the primary analyses of a six-site MRCT, the Treatment of SSRI-resistant Depression in Adolescents (TORDIA), there was substantial variation by site in the performance of a medication-only condition and a combined medication plus Cognitive Behavioral Therapy (CBT) condition. Two potential primary causes of site differences in MRCT outcomes are examined in this paper: sampling factors, particularly clinical characteristics of participants, and treatment protocol factors, particularly fidelity. We found that differences in the clinical characteristics of participants at baseline across-site and within-site/across conditions were the most salient explanators for site differences and differences within sites across conditions in outcome. Study findings are discussed with respect to the overall study outcomes in TORDIA as well as MRCTs in general. PMID:19485586

  12. 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

  13. 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

  14. Linking vitamin D status, executive functioning and self-perceived mental health in adolescents through multivariate analysis: A randomized double-blind placebo control trial.

    PubMed

    Grung, Bjørn; Sandvik, Asle M; Hjelle, Kay; Dahl, Lisbeth; Frøyland, Livar; Nygård, Irene; Hansen, Anita L

    2017-04-01

    The aim of the present randomized double-blind placebo control trial was to investigate if vitamin D supplementation had an effect on vitamin D status, executive functioning and self-perceived mental health in a group of Norwegian adolescents during winter time. Fifty adolescents were randomly assigned into an intervention group (vitamin D pearls) or a control group (placebo pearls). Before (pre-test in December/January) and after (post-test in April/May) the intervention period the participants were exposed to a test procedure, consisting of blood draw, completion of cognitive tests (Tower of Hanoi and Tower of London), and the Youth Self-report version of the Child Behavior Checklist. Multivariate data analysis showed that participants with low vitamin D status scored worse on the Tower of London tests and the more difficult sub-tasks on the Tower of Hanoi tests. They also had a tendency to report higher frequency of externalizing behavior problems and attention deficit. At pre-test, the overall mean vitamin D status measured as 25-hydroxy vitamin D was 42 nmol/L, defining deficiency (Intervention group = 44 nmol/L, Control group = 39 nmol/L). However, vitamin D supplementation caused a significant increase in vitamin D status resulting in a sufficient level in the Intervention group at post-test (mean 62 nmol/L). The results also revealed that the intervention group improved their performance on the most demanding sub-tasks on the ToH. Overall, the study indicates that vitamin D status in adolescents may be important for both executive functioning and mental health.

  15. The Efficacy of Augment of D-Cycloserine and Cognitive-behavioral Therapy on Adolescent with one Type of Anxiety Disorders: A Double-blind Randomized Controlled Trial

    PubMed Central

    Arman, Soroor; Soheilimehr, Ali; Maracy, Mohammad Reza

    2017-01-01

    Background: This study was designed to investigating the effect of combining D-cycloserine (DCS) and cognitive-behavioral therapy (CBT) on adolescent with at least one type of anxiety disorders. Materials and Methods: The present study was conducted as a double-blind randomized controlled trial on 36 adolescent with anxiety disorders. Patients were assessed in two groups. In addition to 4 sessions of weekly CBT in both groups; case group, received a 50-mg DCS capsules, control group, received Placebo daily for a month. Patients received DCS capsules or placebo 1 h before sessions of CBT. Age, sex, kind of anxiety disorders “screen for child anxiety related disorders (SCARED)” and “cognitive abilities test (CATS)” scores were evaluated and compared between groups. Results: The mean age of the studied patients (29 females (80.6%) and 7 males (19.4%)) was 14.1 ± 1.8 years. The most frequent anxiety disorder among the study population was generalized social disorder (GAD) (77.7%). Age, sex and the frequency of anxiety disorders were not statistically significant between the study groups (P > 0.05). The mean score of “SCARED” and “CATS” at before starting the treatment, after treatment and three month after the treatment were not statistically significant between groups (P > 0.05). Also, decrease in values of “SCARED” and “CATS” during the evaluation time periods was not statistically significant between groups (P > 0.05). Conclusions: Findings of this study showed that there has been no difference in symptoms improvement in adolescent with anxiety disorder who received treatment protocol including 4 sessions of CBT, weekly, together with 50 mgs of DCS compared to the patients of the control group. PMID:28299303

  16. 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

  17. 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

  18. 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

  19. Effects of a Six-Week Hip Thrust vs. Front Squat Resistance Training Program on Performance in Adolescent Males: A Randomized Controlled Trial.

    PubMed

    Contreras, Bret; Vigotsky, Andrew D; Schoenfeld, Brad J; Beardsley, Chris; McMaster, Daniel T; Reyneke, Jan H T; Cronin, John B

    2017-04-01

    Contreras, B, Vigotsky, AD, Schoenfeld, BJ, Beardsley, C, McMaster, DT, Reyneke, JHT, and Cronin, JB. Effects of a six-week hip thrust vs. front squat resistance training program on performance in adolescent males: A randomized controlled trial. J Strength Cond Res 31(4): 999-1008, 2017-The barbell hip thrust may be an effective exercise for increasing horizontal force production and may thereby enhance performance in athletic movements requiring a horizontal force vector, such as horizontal jumping and sprint running. The ergogenic ability of the squat is well known. The purpose of this study was to compare the effects of 6-week front squat and hip thrust programs in adolescent male athletes. Vertical jump height, horizontal jump distance, 10- and 20-m sprint times, and isometric midthigh pull peak force were among the measured performance variables, in addition to front squat and hip thrust 3 repetition maximum (3RM) strength. Magnitude-based effect sizes revealed potentially beneficial effects for the front squat in both front squat 3RM strength and vertical jump height when compared with the hip thrust. No clear benefit for one intervention was observed for horizontal jump performance. Potentially beneficial effects were observed for the hip thrust compared with the front squat in 10- and 20-m sprint times. The hip thrust was likely superior for improving normalized isometric midthigh pull strength and very likely superior for improving hip thrust 3RM and isometric midthigh pull strength. These results support the force vector theory.

  20. 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.

  1. Cognitive-Behavioral Health-Promotion Intervention Increases Fruit and Vegetable Consumption and Physical Activity among South African Adolescents: A Cluster-Randomized Controlled Trial

    PubMed Central

    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; Makiwane, Monde B.

    2015-01-01

    Rates of chronic diseases are high among Black South Africans. Few studies have tested cognitive-behavioral health-promotion interventions to reduce chronic diseases in South Africa. We tested the efficacy of such an intervention among adolescents in a cluster-randomized controlled trial. We randomly selected 9 of 17 matched-pairs of schools and randomized one school in each pair to the cognitive-behavioral health-promotion intervention designed to encourage health-related behaviors and the other to a HIV/STD risk-reduction intervention that served as the control. Interventions were based on social cognitive theory, the theory of planned behavior, 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 1,057 grade 6 learners (mean age = 12.4 years), with 96.7% retained at 12-month follow-up. Generalized 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, contextually appropriate interventions may increase health behaviors among young adolescents in sub-Saharan Africa. PMID:21318928

  2. A community-based cluster randomized controlled trial of "directly observed home-based daily iron therapy" in lowering prevalence of anemia in rural women and adolescent girls.

    PubMed

    Bharti, Sahul; Bharti, Bhavneet; Naseem, Shano; Attri, Savita Verma

    2015-03-01

    In a community-based cluster randomized controlled trial, we randomly assigned clusters of anemic women and adolescent girls to either "directly observed home-based daily iron therapy" (DOHBIT; n = 524 in 16 villages) or unsupervised self-treatment at home (n = 535 in 16 villages) for a period of 90 days. Those in the DOHBIT group, when compared with those in the unsupervised self-treatment group, had significantly lower relative risk (RR) of anemia (16.8% vs 35.3%, RR = 0.47 [95% confidence interval (CI) = 0.33-0.65]; P < .0001), higher hemoglobin (Hb) rise of ≥2 g/dL (70.2% vs 42.2%, RR = 1.56 [95% CI = 1.31-1.87]; P <.0001), and nonsignificant trend for lower side effects (3.5% vs 6.7%, RR = 0.49 [95% CI = 0.22-1.08; P < .08) on intention-to-treat analyses. On linear mixed model analysis, the subjects in the intervention group demonstrated higher mean Hb levels (13.01 vs 12.32 g/dL; P < .0001) and higher adherence to iron therapy (93% vs 60%; P < .0001). DOHBIT is effective in lowering the prevalence of anemia in rural women and adolescent girls.

  3. A randomized controlled trial testing an adherence-optimized Vitamin D regimen to mitigate bone change in adolescents being treated for acute lymphoblastic leukemia.

    PubMed

    Orgel, Etan; Mueske, Nicole M; Sposto, Richard; Gilsanz, Vicente; Wren, Tishya A L; Freyer, David R; Butturini, Anna M; Mittelman, Steven D

    2017-02-20

    Adolescents with acute lymphoblastic leukemia (ALL) develop osteopenia early in therapy, potentially exacerbated by high rates of concurrent Vitamin D deficiency. We conducted a randomized clinical trial testing a Vitamin D-based intervention to improve Vitamin D status and reduce bone density decline. Poor adherence to home supplementation necessitated a change to directly observed therapy (DOT) with intermittent, high-dose Vitamin D3 randomized versus standard of care (SOC). Compared to SOC, DOT Vitamin D3 successfully increased trough Vitamin 25(OH)D levels (p = .026) with no residual Vitamin D deficiency, 100% adherence to DOT Vitamin D3, and without associated toxicity. However, neither Vitamin D status nor supplementation impacted bone density. Thus, this adherence-optimized intervention is feasible and effective to correct Vitamin D deficiency in adolescents during ALL therapy. Repletion of Vitamin D and calcium alone did not mitigate osteopenia, however, and new, comprehensive approaches are needed to address treatment-associated osteopenia during ALL therapy.

  4. Circulating tumor DNA as a non-invasive substitute to metastasis biopsy for tumor genotyping and personalized medicine in a prospective trial across all tumor types.

    PubMed

    Lebofsky, Ronald; Decraene, Charles; Bernard, Virginie; Kamal, Maud; Blin, Anthony; Leroy, Quentin; Rio Frio, Thomas; Pierron, Gaëlle; Callens, Céline; Bieche, Ivan; Saliou, Adrien; Madic, Jordan; Rouleau, Etienne; Bidard, François-Clément; Lantz, Olivier; Stern, Marc-Henri; Le Tourneau, Christophe; Pierga, Jean-Yves

    2015-04-01

    Cell-free tumor DNA (ctDNA) has the potential to enable non-invasive diagnostic tests for personalized medicine in providing similar molecular information as that derived from invasive tumor biopsies. The histology-independent phase II SHIVA trial matches patients with targeted therapeutics based on previous screening of multiple somatic mutations using metastatic biopsies. To evaluate the utility of ctDNA in this trial, as an ancillary study we performed de novo detection of somatic mutations using plasma DNA compared to metastasis biopsies in 34 patients covering 18 different tumor types, scanning 46 genes and more than 6800 COSMIC mutations with a multiplexed next-generation sequencing panel. In 27 patients, 28 of 29 mutations identified in metastasis biopsies (97%) were detected in matched ctDNA. Among these 27 patients, one additional mutation was found in ctDNA only. In the seven other patients, mutation detection from metastasis biopsy failed due to inadequate biopsy material, but was successful in all plasma DNA samples providing three more potential actionable mutations. These results suggest that ctDNA analysis is a potential alternative and/or replacement to analyses using costly, harmful and lengthy tissue biopsies of metastasis, irrespective of cancer type and metastatic site, for multiplexed mutation detection in selecting personalized therapies based on the patient's tumor genetic content.

  5. 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

  6. 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

  7. 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.

  8. 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

  9. 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...

  10. Multicentre, randomised, placebo-controlled trial of extract of Japanese herbal medicine Daikenchuto to prevent bowel dysfunction after adult liver transplantation (DKB 14 Study)

    PubMed Central

    Kaido, Toshimi; Shimamura, Tsuyoshi; Sugawara, Yasuhiko; Sadamori, Hiroshi; Shirabe, Ken; Yamamoto, Michio; Uemoto, Shinji

    2015-01-01

    Introduction This multicentre randomised controlled clinical trial will aim to determine the ability of an extract (TJ-100) of Daikenchuto (traditional Japanese herbal medicine; Kampo) to prevent bowel dysfunction in at least 110 patients after liver transplantation (LT). Methods and analysis The following co-primary end points will be evaluated on postoperative day 7: total oral and enteral caloric intake, abdominal distension and abdominal pain. The secondary end points will comprise sequential changes of total oral and enteral caloric intake after LT, sequential changes in numeric rating scales for abdominal distension and pain, elapsed time to the first postoperative passage of stool, quality of life assessment using the Gastrointestinal Symptom Rating Scale score (Japanese version), postoperative liver function, liver regeneration rate, incidence of bacteraemia and bacterial strain, trough level of immunosuppressants, occurrence of acute cellular rejection, discharge or not within 2 months after LT, sequential changes of portal venous flow to the graft and ascites discharge. The two arms of the study will comprise 55 patients per arm. Ethics and dissemination The study has been conducted according to the CONSORT statement. All participants signed a written consent form, and the study has been approved by the institutional review board of each participating institute and conducted in accordance with the Declaration of Helsinki of 1996. The findings will be disseminated through scientific and professional conferences, and in peer-reviewed journals. Trial registration number The DKB 14 Study was registered in the University Hospital Medical Information Network Clinical Trial Registration (UMIN-CTR), Japan (registration number: UMIN000014326) during 2014. PMID:26419681

  11. 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.

  12. 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

  13. Study protocol of a randomized controlled trial to improve cancer prevention behaviors in adolescents and adults using a web-based intervention supplemented with SMS

    PubMed Central

    2013-01-01

    Background The overall number of cancer cases is increasing and, therefore, strengthening cancer prevention has become a priority. The institutions responsible for its control establish guidelines for primary prevention. These include recommendations, such as: not smoking, following a healthy diet, doing daily physical exercise or avoiding overweight. Adolescence is a period of adoption and/or consolidation of health behaviors, and both school- and family-based interventions have proven effective to improve them. Furthermore, online and mobile phone educational interventions are encouraging. Consequently, the main aim of this study is to assess the efficacy of an intervention in which these requirements (school, family, the Internet and SMS) are combined to prevent behavioral cancer risk. Methods This protocol describes the design and implementation of a complex online program that includes a randomized controlled trial put into practice in two countries: Spain and Mexico. Adolescents and adults of their environment (relatives and teachers) who voluntarily participate will be randomly assigned to the experimental group or to the control group once they have completed the online pre-test. The experimental group members will have free access to a tailor-made and interactive website (http://www.alertagrumete.com). During the academic year, this website will be periodically updated with different school and leisure activities related to the avoidance of risk behaviors. To encourage participation, the program includes a competition that gives rewards to the winners. SMS are also sent to students to stimulate the adoption of healthy behaviors and as a reminder of participation. Finished the intervention, an online post-test is performed in both groups and the impact on the risk behaviors is therefore assessed. Discussion The program is pioneer, since it combines many components which have already proven effective in previous researches. Moreover, it aims to compare

  14. Online group-based cognitive-behavioural therapy for adolescents and young adults after cancer treatment: A multicenter randomised controlled trial of Recapture Life-AYA

    PubMed Central

    2012-01-01

    Background A cancer diagnosis is 2.9 times more likely to occur during the adolescent and young adult years than in younger children. This spike in incidence coincides with a life stage characterised by psychological vulnerability as young people strive to attain numerous, critical developmental milestones. The distress young people experience after cancer treatment seriously jeopardises their ability to move into well-functioning adulthood. Methods/Design This article presents the protocol of the Recapture Life study, a phase II three-arm randomised controlled trial designed to evaluate the feasibility and efficacy of a new intervention in reducing distress and improving quality of life for adolescent and young adult cancer survivors. The novel intervention, “ReCaPTure LiFe” will be compared to a both a wait-list, and a peer-support group control. Ninety young people aged 15–25 years who have completed cancer treatment in the past 1–6 months will be recruited from hospitals around Australia. Those randomised to receive Recapture Life will participate in six, weekly, 90-minute online group sessions led by a psychologist, involving peer-discussion around cognitive-behavioural coping skills (including: behavioural activation, thought challenging, communication and assertiveness skills training, problem-solving and goal-setting). Participants randomised to the peer-support group control will receive non-directive peer support delivered in an identical manner. Participants will complete psychosocial measures at baseline, post-intervention, and 12-months post-intervention. The primary outcome will be quality of life. Secondary outcomes will include depression, anxiety, stress, family functioning, coping, and cancer-related identity. Discussion This article reviews the empirical rationale for using group-based, online cognitive-behavioural therapy in young people after cancer treatment. The potential challenges of delivering skills-based programs in an online

  15. 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.

  16. Combined Cognitive and Parent Training Interventions for Adolescents with ADHD and Their Mothers: A Randomized Controlled Trial

    PubMed Central

    Steeger, Christine M.; Gondoli, Dawn M.; Gibson, Bradley S.; Morrissey, Rebecca A.

    2015-01-01

    Objective This study examined the individual and combined effects of two non-pharmacological treatments for Attention-Deficit/Hyperactivity Disorder (ADHD): Cogmed working memory training (CWMT) for adolescents, and behavioral parent training (BPT) for mothers. Method Ninety-one adolescents (ages 11–15) and their mothers were randomized to one of four CWMT and BPT treatment and active control (placebo) group combinations of 5-week interventions. At pre- and post-test, mothers and teachers completed rating forms, and adolescents completed neuropsychological measures of working memory (WM). Results Individual intervention effects showed that treatment CWMT significantly improved WM spans, whereas there were no significant differences for treatment or control BPT on reports of parenting-related outcomes. Combined treatment effects indicated an overall pattern of greatest improvements for the control CWMT/treatment BPT group, as compared to the other three groups, on adolescent WM deficit, behavioral regulation problems, and global executive deficit. Most significant effects for outcomes were main effects of improvements over time. Conclusions: Combination CWMT and BPT did not result in increased treatment gains. However, potential effects of combined treatment may have been masked by greater perceived benefits arising from lack of struggle in the non-adaptive, CWMT active control condition. Future combined intervention research should focus on specific, theoretically-driven WM deficits among individuals with ADHD, include possible adaptations to the standard CWMT program, examine effectiveness of cognitive treatments combined with contextual interventions, and utilize appropriate control groups to fully understand the unique and combined effects of interventions. PMID:25731907

  17. Online visual search attentional bias modification for adolescents with heightened anxiety and depressive symptoms: A randomized controlled trial.

    PubMed

    De Voogd, E L; Wiers, R W; Salemink, E

    2017-05-01

    Anxiety and depression, which are highly prevalent in adolescence, are both characterized by a negative attentional bias. As Attentional Bias Modification (ABM) can reduce such a bias, and might also affect emotional reactivity, it could be a promising early intervention. However, a growing number of studies also report comparable improvements in both active and placebo groups. The current study investigated the effects of eight online sessions of visual search (VS) ABM compared to both a VS placebo-training and a no-training control group in adolescents with heightened symptoms of anxiety and/or depression (n = 108). Attention bias, interpretation bias, and stress-reactivity were assessed pre- and post-training. Primary outcomes of anxiety and depressive symptoms, and secondary measures of emotional resilience were assessed pre- and post-training and at three and six months follow-up. Results revealed that VS training reduced attentional bias compared to both control groups, with stronger effects for participants who completed more training sessions. Irrespective of training condition, an overall reduction in symptoms of anxiety and depression and an increase in emotional resilience were observed up to six months later. The training was evaluated relatively negatively. Results suggest that online ABM as employed in the current study has no added value as an early intervention in adolescents with heightened symptoms.

  18. Control of oral human papillomavirus (HPV) by medicinal mushrooms, Trametes versicolor and Ganoderma lucidum: a preliminary clinical trial.

    PubMed

    Donatini, Bruno

    2014-01-01

    This preliminary randomized study investigated the efficacy of medicinal mushrooms, Trametes versicolor (TV), Ganoderma lucidum (GL), and Laetiporus sulphureus (LS), on the clearance of oral human papillomavirus (HPV, serotypes 16 and 18). Among 472 patients who underwent oral swabs for gingivitis, 61 patients were positive for HPV16 or HPV18. Twenty patients were included in group 1 (LS) and 41 patients were included in group 2 (TV+GL) for 2 months. Polymerase chain reaction (PCR) for HPV was performed at inclusion and after 2 months. In group 1, the clearance was equal to 5% after 2 months of treatment. In group 2, the clearance was equal to 88% (P<0.001). The detection of HPV16 or HPV18 could become relevant in routine since positivity is frequent and because a harmless and costless treatment may exist. The use of TV+GL for the clearance of oral HPV deserves further investigation.

  19. Clinical Trials

    MedlinePlus

    ... your information private 5. What happens when the study ends The Possible Risks and Benefits The trial may provide treatments or screenings, but there is no promise that your health will get better. The medicine, test, or treatment may not work for you. 6. The benefits of the treatments ...

  20. 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

  1. Assessment of the Reporting Quality of Randomized Controlled Trials on Treatment of Coronary Heart Disease with Traditional Chinese Medicine from the Chinese Journal of Integrated Traditional and Western Medicine: A Systematic Review

    PubMed Central

    Fan, Fang-fang; Xu, Qin; Sun, Qi; Zhao, Sheng-jun; Wang, Ping; Guo, Xue-rui

    2014-01-01

    Background Due to language limitations, little is known about the reporting quality of randomized clinical trials (RCTs) on the treatment of coronary heart disease (CHD) with traditional Chinese medicine (TCM) in Chinese Journal of Integrated Traditional and Western Medicine (CJITWM). Objective In this study, we utilized the CONSORT 2010 statement to understand the reporting quality of RCTs on CHD with TCM from the CJITWM. Methods The China National Knowledge Infrastructure (CNKI) electronic database was searched for CJITWM RCTs on the treatment of CHD with TCM, published between Janurary 1, 2006 and December 31, 2011. We excluded articles reported as “animal studies,” “topic review,” “diagnostic test,” “editorials,” or “others.” The CONSORT checklist was applied to evaluate the reporting quality of all eligible articles by two independent authors after extensive discussion. Each item was graded as either “yes” or “no” depending on whether the authors had reported it or not. Results We identified 21 articles meeting our inclusion criteria. The percentage of 11 of the 37 items was 4.8∼95.2%, 14 of the 37 items were reported in all included articles, while 12 items were not mentioned at all. The average reporting percentage for the “title and abstract” section was 52.4%, for the “introduction” section 100.0%, for the “methods” section 45.4%, for the “results” section 57.1%, for the “discussion” section 79.4%, and for the “other information” section 17.5%. Conclusion In general, the reviewed RCTs were not consistent with the CONSORT 2010 statement. Authors should adhere to the CONSORT statement in reporting RCTs; editorial departments may consider the CONSORT statement as a guideline and should instruct authors to write manuscripts, and reviewers to judge them according to CONSORT statutes. PMID:24489719

  2. 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

  3. 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

  4. Chinese Medicinal Formula (MHGWT) for Relieving Diabetic Neuropathic Pain: A Randomized, Double-Blind, Placebo-Controlled Trial.

    PubMed

    Tsai, Chia-I; Li, Tsai-Chung; Chang, Ming-Hong; Lin, Shih-Yi; Lee, I-Te; Lee, Cheng-Hung; Wang, Tzu-Yuan; Su, Yi-Chang

    2013-01-01

    Objective. To investigate the effects of modified Hungqi Guizhi Wuwu Tang (MHGWT), a formula that comprises Chinese medicinal herbs, in relieving neuropathic pain in diabetics. Method. Between March 2008 and April 2009, 112 participants were randomly assigned to either the MHGWT group, whose members received MHGWT (n = 56), or the control group, whose members received a placebo (n = 56). Diabetic neuropathic pain (DNP) was rated using the 15-item Short-Form Brief Pain Inventory (SF-BPI), the 17-item Short-Form McGill Pain Questionnaire (SF-MPQ), the 13-item Modified Michigan Neuropathy Screening Instrument (MMNSI), and the 36-item "SF-36." Nerve conduction studies (NCSs) were performed before and after treatment. Results. After 12 weeks of treatment, the SF-MPQ and SF-BPI scores of the MHGWT group were significantly (P < 0.05) reduced and a significant difference between the groups was observed (P < 0.05). The levels of NCS in the MHGWT group were nonsignificantly (P > 0.05) reduced, and no significant difference in NCS level was observed between the groups (P > 0.05). Conclusions. MHGWT shows promise in relieving DNP and deserves further investigation.

  5. An alternative medicine treatment for Parkinson's disease: results of a multicenter clinical trial. HP-200 in Parkinson's Disease Study Group.

    PubMed

    1995-01-01

    The natural occurrence of antiparkinsonian drugs in plants--anticholinergics in Datura stramonium, levodopa in Mucuna pruriens and Vicia faba, dopamine agonist activity in Claviceps purpura, and MAO inhibitor activity in Banisteria caapi-are known. Our study examined the efficacy and tolerability of HP-200, derived from Mucuna prurient, in patients with Parkinson's disease. Sixty patients with Parkinson's disease (46 male and 14 female) with a mean (+/- SD) age of 59 +/- 9 years were treated in an open study for 12 weeks. Of these, 26 patients were taking synthetic levodopa/carbidopa formulations before treatment with HP-200, and the remaining 34 were levodopa naive. HP-200, a powder (supplied as a 7.5 g sachet), was mixed with water and given orally. The Unified Parkinson's Disease Rating Scale (UPDRS) was used at baseline and periodically during the 12-week evaluation. Statistically significant reductions in Hoehn and Yahr stage and UPDRS scores were seen from baseline to the end of the 12-week treatment (p < 0.0001, t-test). The group mean (+/- SD) dose for optimal control of symptoms was 6 +/- 3 sachets. Adverse effects were mild and were mainly gastrointestinal in nature. No adverse effects were seen in clinical laboratory reports. HP-200, developed from an alternative medicine source, Ayurveda, was found to be an effective treatment for patients with Parkinson's disease.

  6. 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

  7. 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.

  8. IMPACT - Integrative Medicine PrimAry Care Trial: protocol for a comparative effectiveness study of the clinical and cost outcomes of an integrative primary care clinic model

    PubMed Central

    2014-01-01

    Background Integrative medicine (IM) is a patient-centered, healing-oriented clinical paradigm that explicitly includes all appropriate therapeutic approaches whether they originate in conventional or complementary medicine (CM). While there is some evidence for the clinical and cost-effectiveness of IM practice models, the existing evidence base for IM depends largely on studies of individual CM therapies. This may in part be due to the methodological challenges inherent in evaluating a complex intervention (i.e., many interacting components applied flexibly and with tailoring) such as IM. Methods/Design This study will use a combination of observational quantitative and qualitative methods to rigorously measure the health and healthcare utilization outcomes of the University of Arizona Integrative Health Center (UAIHC), an IM adult primary care clinic in Phoenix, Arizona. There are four groups of study participants. The primary group consists of clinic patients for whom clinical and cost outcomes will be tracked indicating the impact of the UAIHC clinic (n = 500). In addition to comparing outcomes pre/post clinic enrollment, where possible, these outcomes will be compared to those of two matched control groups, and for some self-report measures, to regional and national data. The second and third study groups consist of clinic patients (n = 180) and clinic personnel (n = 15-20) from whom fidelity data (i.e., data indicating the extent to which the IM practice model was implemented as planned) will be collected. These data will be analyzed to determine the exact nature of the intervention as implemented and to provide covariates to the outcomes analyses as the clinic evolves. The fourth group is made up of patients (n = 8) whose path through the clinic will be studied in detail using qualitative (periodic semi-structured interviews) methods. These data will be used to develop hypotheses regarding how the clinic works. Discussion The US health care

  9. 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…

  10. Effect of Chinese patent medicine Si-Mo-Tang oral liquid for functional dyspepsia: A systematic review and meta-analysis of randomized controlled trials

    PubMed Central

    Hu, Yunxia; Bai, Yu; Hua, Zhiyun; Yang, Jie; Yang, Huahui; Chen, Wenjun; Xu, Junwei; Zhao, Zhiqiang

    2017-01-01

    Background Si-Mo-Tang oral liquid (SMT) has been widely used to treat functional dyspepsia (FD), but the effectiveness is still controversial. A systematic review and meta-analysis of randomized controlled trials (RCTs) were performed to assess the efficacy and adverse effects of SMT for FD. Methods Investigators searched for articles with publication dates to June 21, 2016, from 9 English and Chinese electronic databases. Comparisons were SMT alone or SMT in combination with western medicine as experimental intervention, and western medicine or placebo as the control. We used the Cochrane collaboration tool for assessing risk of bias to evaluate methodologies. Data were synthesized with RevMan 5.3 software. (PROSPERO Registration #CRD42016042003) Results Twenty-seven RCTs were included in the review, involving 2,713 participants: 1,383 subjects were in the experimental group and 1,330 in the control group. SMT showed a significant improvement in clinical efficacy (RR 1.14; 95% CI 1.09, 1.20; P<0.00001), but the heterogeneity was also significant (P = 0.0002, I2 = 56%). Because of the different interventions in the 2 groups, we performed subgroup and sensitivity analyses to investigate potential sources of heterogeneity. The heterogeneity was smaller after subgroup analysis and the exclusion of a study by Zhu from 2009. The corresponding pooled RR has no obvious change (RR 1.17; 95% CI 1.13, 1.21; P<0.00001). Subgroup analysis by age and drugs administered in control interventions between SMT and western medicine also showed improvement in the efficacy rate. But a data synthesis that excluded high risk of bias in the blinding of participants and personnel showed no significant difference (RR 1.14; 95% CI 0.97, 1.35; P = 0.12). Three studies measured gastric emptying. Two of these studies reported no significant difference between the experimental and control groups, while 1 study showed that SMT reduced the time of gastric emptying. The relapse rate and adverse

  11. 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

  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. 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.

  15. 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

  16. 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

  17. 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

  18. Use of short message service reminders to improve attendance at an internal medicine outpatient clinic in Saudi Arabia: a randomized controlled trial.

    PubMed

    Youssef, A

    2014-06-09

    Non-attendance at outpatient appointments is a major problem. This study aimed to evaluate the efficacy of sending short message service (SMS) reminders to patients' mobile phones in reducing non-attendance at scheduled appointments. A randomized clinical trial was conducted in 2011 in an internal medicine outpatient clinic at a hospital in Eastern Province, Saudi Arabia. Eligible patients (n = 502) were randomly allocated to receive an SMS reminder of their appointment (intervention group) or no reminder (control group). The non-attendance rate was significantly lower in the reminder group (26.3%) than the non-reminder group (39.8%). In multivariate logistic regression, age, sex and nationality did not affect attendance rates but having their first contact with the hospital (OR = 7.40) and not receiving an SMS reminder (OR = 0.56) were significant factors in non-attendance. All patients surveyed about their perceptions of the SMS reminder (n = 76) reported they would like to continue to receive SMS reminders in the future.

  19. Gonadal function, fertility, and reproductive medicine in childhood and adolescent cancer patients: a national survey of Japanese pediatric endocrinologists

    PubMed Central

    Miyoshi, Yoko; Yorifuji, Tohru; Horikawa, Reiko; Takahashi, Ikuko; Nagasaki, Keisuke; Ishiguro, Hiroyuki; Fujiwara, Ikuma; Ito, Junko; Oba, Mari; Kawamoto, Hiroshi; Fujisaki, Hiroyuki; Kato, Masashi; Shimizu, Chikako; Kato, Tomoyasu; Matsumoto, Kimikazu; Sago, Haruhiko; Takimoto, Tetsuya; Okada, Hiroshi; Suzuki, Nao; Yokoya, Susumu; Ogata, Tsutomu; Ozono, Keiichi

    2016-01-01

    Abstract. An increasing number of pediatric cancer patients survive, and treatment-related infertility represents one of the most important issues for these patients. While official guidelines in Japan recommend long-term follow-up of childhood cancer survivors (CCSs), their gonadal function and fertility have not been clarified. To address this issue, we organized a working panel to compile evidence from long-term survivors who received treatments for cancer during childhood or adolescence. In collaboration with members of the CCS Committee of the Japanese Society for Pediatric Endocrinology (JSPE), we conducted a questionnaire survey regarding reproductive function in pediatric cancer patients. A cross-sectional survey was sent to 178 JSPE-certified councilors who were asked to self-evaluate the medical examinations they had performed. A total of 151 responses were obtained, revealing that 143 endocrinologists were involved in the care of CCSs. A quarter of the respondents reported having experienced issues during gonadal or reproductive examinations. Several survivors did not remember or fully understand the explanation regarding gonadal damage, and faced physical and psychological distress when discussing the risk of becoming infertile. Pediatric endocrinologists had anxieties regarding their patients’ infertility and the risk of miscarriage, premature birth, and delivery problems. Only a limited number of endocrinologists had experience with managing childbirth and fertility preservation. Many councilors mentioned the necessity for inter-disciplinary communication among healthcare providers. Both endocrinologists and oncologists should set and follow a uniform clinical guideline that includes management of fertility of CCSs. PMID:27212796

  20. 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

  1. 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

  2. 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.

  3. Controlled clinical trial addressing teeth whitening with hydrogen peroxide in adolescents: a 12-month follow-up

    PubMed Central

    Pinto, Marcelo Mendes; Gonçalves, Marcela Leticia Leal; da Mota, Ana Carolina Costa; Deana, Alessandro Melo; Olivan, Silvia Regina; Bortoletto, Carolina; de Godoy, Camila Haddad Leal; Vergilio, Katia Lumi Tanikawa; Altavista, Olga Maria; Motta, Lara J; Bussadori, Sandra Kalil

    2017-01-01

    OBJECTIVES: To evaluate the colorimetric change in incisors and canines of adolescents aged 12 to 20 years submitted to at-home whitening and to evaluate satisfaction, sensitivity and discomfort during the procedures through a questionnaire. METHOD: Thirty adolescents were randomly assigned to the following groups: 1) 6.0% hydrogen peroxide (White Class with calcium – FGM); 2) 7.5% hydrogen peroxide (White Class with calcium - FGM); 3) 10% hydrogen peroxide (Oral B 3D White – Oral-B); 4) Control group – placebo. Assessments were performed prior to treatment as well as at 7, 30, 180 and 360 days after treatment. Friedman’s ANOVA was used to analyze color. The Kruskal-Wallis test followed by Dunn’s post hoc test was used to compare the groups at the different evaluation times. Answers on the questionnaires were ranked, and non-parametrical tests were employed. The groups were compared in each period using the Kruskal-Wallis test followed by the Student-Newman-Keuls test. Categorical data were analyzed using Fisher's exact test, and the Wilcoxon test was used for the analysis of different periods. P-values were corrected using the Hyan-Holm step-down Bonferroni procedure. Clinicaltrials.gov: NCT01998386. RESULTS: Similar results were obtained one month after treatment with both tooth whitening gels and whitening strips. Patients were partially satisfied with the treatment after the first and second weeks and would recommend it. All products demonstrated color stability after 12 months of follow-up. CONCLUSIONS: The bleaching procedure was efficient, and the patients could perceive its result. Further investigations are needed to determine the effects of bleaching on young teeth. PMID:28355362

  4. A universal harm-minimisation approach to preventing psychostimulant and cannabis use in adolescents: a cluster randomised controlled trial

    PubMed Central

    2014-01-01

    Background Psychostimulants and cannabis are two of the three most commonly used illicit drugs by young Australians. As such, it is important to deliver prevention for these substances to prevent their misuse and to reduce associated harms. The present study aims to evaluate the feasibility and effectiveness of the universal computer-based Climate Schools: Psychostimulant and Cannabis Module. Methods A cluster randomised controlled trial was conducted with 1734 Year 10 students (mean age = 15.44 years; SD = 0.41) from 21 secondary schools in Australia. Schools were randomised to receive either the six lesson computer-based Climate Schools program or their usual health classes, including drug education, over the year. Results The Climate Schools program was shown to increase knowledge of cannabis and psychostimulants and decrease pro-drug attitudes. In the short-term the program was effective in subduing the uptake and plateauing the frequency of ecstasy use, however there were no changes in meth/amphetamine use. In addition, females who received the program used cannabis significantly less frequently than students who received drug education as usual. Finally, the Climate Schools program was related to decreasing students’ intentions to use meth/amphetamine and ecstasy in the future, however these effects did not last over time. Conclusions These findings provide support for the use of a harm-minimisation approach and computer technology as an innovative platform for the delivery of prevention education for illicit drugs in schools. The current study indicated that teachers and students enjoyed the program and that it is feasible to extend the successful Climate Schools model to the prevention of other drugs, namely cannabis and psychostimulants. Trial registration Australian and New Zealand Clinical Trials Registry ACTRN12613000492752. PMID:24943829

  5. Impact of an Intervention Designed to Reduce Sexual Health Risk Behaviors of African American Adolescents: Results of a Randomized Controlled Trial

    PubMed Central

    Jenner, Lynne W.; Walsh, Sarah; Demby, Hilary; Gregory, Alethia; Davis, Erin

    2016-01-01

    Objectives. To replicate an evidence-based HIV risk reduction program and assess its impact on 2 behavioral outcomes—inconsistency of condom use and frequency of sex—6 months after the program. Methods. The study was an individual-level randomized controlled trial in which we randomly assigned 850 youths (aged 14–18 years) to 1 of 2 conditions. The treatment (Becoming a Responsible Teen) is a group-level sociocognitive and skills training sexual education course; the control is a general health intervention that includes the same initial informational component as the treatment. Participants were recruited over 3 summers (2012–2014) from a summer employment program in New Orleans, Louisiana, that serves primarily African American adolescents. Results. Six months after program exposure, we found no statistically significant difference between treatment and control group members’ self-reported inconsistency of condom use or frequency of sex (P > .05). Conclusions. Although previous evidence has indicated that this particular program can be effective, this study’s findings indicate that it was not effective in this setting with this specific population. Results should provide an incentive to learn why the intervention works in some cases and what conditions are necessary for causal impacts. PMID:27689499

  6. Children and adolescents infected with Wuchereria bancrofti in Greater Recife, Brazil: a randomized, year-long clinical trial of single treatments with diethylcarbamazine or diethylcarbamazine-albendazole.

    PubMed

    Rizzo, J A; Belo, C; Lins, R; Dreyer, G

    2007-07-01

    In filariasis-endemic areas beyond sub-Saharan Africa, the World Health Organization's recommended strategy for interrupting transmission of the causative parasites is annual, single-dose, mass treatment with a combination of diethylcarbamazine (DEC; given at 6 mg/kg) and albendazole (ALB; given at 400 mg) for 4-6 years (the minimum estimated life-span of the adult parasites). In an open, hospital-based, randomized and controlled trial, with a blinded evaluation of outcome, 82 children and adolescents from Recife, all with Wuchereria bancrofti microfilaraemias, were given either DEC alone (6 mg/kg) or the same dose of DEC combined with ALB (at 400 mg/patient). Every 90 days for 1 year after the single treatment, each patient was checked for microfilaraemia by the filtration of up to 5 ml of venous blood collected at night. One year post-treatment, 16 (39%) of the 41 patients given DEC alone and 20 (49%) of the 41 given DEC-ALB were found microfilaraemic (relative risk=0.8, with a 95% confidence interval of 0.49-1.31) and the corresponding geometric mean levels of microfilaraemia were 2.0% and 1.8% of the levels recorded immediately pre-treatment, respectively (P>0.05). In terms of the prevalences and intensities of microfilaraemia, therefore, the addition of ALB to the DEC appeared to offer no significant benefit.

  7. Biochemical and Psychological Effects of Omega-3/6 Supplements in Male Adolescents with Attention-Deficit/Hyperactivity Disorder: A Randomized, Placebo-Controlled, Clinical Trial

    PubMed Central

    Gow, Rachel V.; Kelly, Joanna; Murphy, Caroline; Potts, Laura; Sumich, Alexander; Ghebremeskel, Kebreab; Crawford, Michael A.; Taylor, Eric

    2015-01-01

    Abstract Background: An abnormality in long chain-polyunsaturated fatty acid (LC-PUFA) levels has been implicated in attention-deficit/hyperactivity disorder (ADHD). Studies evaluating LC-PUFA supplementation for therapeutic eff