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Sample records for adolescents trial registration

  1. Clinical trial registration in oral health journals.

    PubMed

    Smaïl-Faugeron, V; Fron-Chabouis, H; Durieux, P

    2015-03-01

    Prospective registration of randomized controlled trials (RCTs) represents the best solution to reporting bias. The extent to which oral health journals have endorsed and complied with RCT registration is unknown. We identified journals publishing RCTs in dentistry, oral surgery, and medicine in the Journal Citation Reports. We classified journals into 3 groups: journals requiring or recommending trial registration, journals referring indirectly to registration, and journals providing no reference to registration. For the 5 journals with the highest 2012 impact factors in each group, we assessed whether RCTs with results published in 2013 had been registered. Of 78 journals examined, 32 (41%) required or recommended trial registration, 19 (24%) referred indirectly to registration, and 27 (35%) provided no reference to registration. We identified 317 RCTs with results published in the 15 selected journals in 2013. Overall, 73 (23%) were registered in a trial registry. Among those, 91% were registered retrospectively and 32% did not report trial registration in the published article. The proportion of trials registered was not significantly associated with editorial policies: 29% with results in journals that required or recommended registration, 15% in those that referred indirectly to registration, and 21% in those providing no reference to registration (P = 0.05). Less than one-quarter of RCTs with results published in a sample of oral health journals were registered with a public registry. Improvements are needed with respect to how journals inform and require their authors to register their trials.

  2. Legislation for trial registration and data transparency.

    PubMed

    Bian, Zhao-Xiang; Wu, Tai-Xiang

    2010-05-26

    Public confidence in clinical trials has been eroded by data suppression, misrepresentation and manipulation. Although various attempts have been made to achieve universal trial registration- e.g., Declaration of Helsinki, WHO clinical Trial Registry Platform (WHO ICTRP), the International Committee of Medical Journal Editors requirement- they have not succeeded, probably because they lack the enough power of enforcement.Legislation appears to be the most efficient and effective means to ensure that all researchers register their trials and disseminate their data accurately and in a timely manner. We propose that a global network be established. This could be accomplished in two steps. The first step is to legislate about trial registration and data transparency, such as USA's FDAAA Act 2007; and the second step to establish a global network to ensure uniform, international consistency in policy and enforcement of trial registration and data transparency.

  3. The Quality of Registration of Clinical Trials

    PubMed Central

    Viergever, Roderik F.; Ghersi, Davina

    2011-01-01

    Background Lack of transparency in clinical trial conduct, publication bias and selective reporting bias are still important problems in medical research. Through clinical trials registration, it should be possible to take steps towards resolving some of these problems. However, previous evaluations of registered records of clinical trials have shown that registered information is often incomplete and non-meaningful. If these studies are accurate, this negates the possible benefits of registration of clinical trials. Methods and Findings A 5% sample of records of clinical trials that were registered between 17 June 2008 and 17 June 2009 was taken from the International Clinical Trials Registry Platform (ICTRP) database and assessed for the presence of contact information, the presence of intervention specifics in drug trials and the quality of primary and secondary outcome reporting. 731 records were included. More than half of the records were registered after recruitment of the first participant. The name of a contact person was available in 94.4% of records from non-industry funded trials and 53.7% of records from industry funded trials. Either an email address or a phone number was present in 76.5% of non-industry funded trial records and in 56.5% of industry funded trial records. Although a drug name or company serial number was almost always provided, other drug intervention specifics were often omitted from registration. Of 3643 reported outcomes, 34.9% were specific measures with a meaningful time frame. Conclusions Clinical trials registration has the potential to contribute substantially to improving clinical trial transparency and reducing publication bias and selective reporting. These potential benefits are currently undermined by deficiencies in the provision of information in key areas of registered records. PMID:21383991

  4. Trials registration: a new era in Thailand.

    PubMed

    Kulvichit, Kittisak; Tulvatana, Wasee; Thinkhamrop, Bandit; Tatsanavivat, Pyatat

    2013-10-01

    Registration of clinical trials or research can result in many benefits. Patients have access to pertinent information. We have a better and more indicative picture of research status in areas where registration is mandatory. Researchers can use the information to form a common interest group and collaborate their research as well as to avoid unnecessary duplication. Registered information can also enable detection of defective design and can lead to improvements of trial protocol or its implementation. Most importantly, it can help to reduce problems of publication bias and selective reporting. Journals do not like to publish negative or inconclusive results. Pharmaceutical companies are reluctant to report results that may jeopardize their revenue. We need absolute transparency to utilize evidence with trust.

  5. Comparison of arthroplasty trial publications after registration in ClinicalTrials.gov.

    PubMed

    Smith, Holly N; Bhandari, Mohit; Mahomed, Nizar N; Jan, Meryam; Gandhi, Rajiv

    2012-08-01

    In 2005, the International Committee of Medical Journal Editors established a mandatory trial registration before study enrollment for publication in member journals. Our primary objective was to evaluate the publication rates of arthroplasty trials registered with ClinicalTrials.gov (CTG). We further aimed to examine the consistency of registration summaries with that of final publications. We searched CTG for all trials related to joint arthroplasty and conducted a thorough search for publications resulting from registered closed trials. Of 101 closed and completed trials, we found 23 publications, for an overall publication rate of 22.8%. Registration of arthroplasty trials in CTG does not consistently result in publication or disclosure of results. In addition, changes are frequently made to the final presentation of the data that are not reflected in the trial registry.

  6. Clinical Trials Registration and Results Information Submission. Final rule.

    PubMed

    2016-09-21

    This final rule details the requirements for submitting registration and summary results information, including adverse event information, for specified clinical trials of drug products (including biological products) and device products and for pediatric postmarket surveillances of a device product to ClinicalTrials.gov, the clinical trial registry and results data bank operated by the National Library of Medicine (NLM) of the National Institutes of Health (NIH). This rule provides for the expanded registry and results data bank specified in Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) to help patients find trials for which they might be eligible, enhance the design of clinical trials and prevent duplication of unsuccessful or unsafe trials, improve the evidence base that informs clinical care, increase the efficiency of drug and device development processes, improve clinical research practice, and build public trust in clinical research. The requirements apply to the responsible party (meaning the sponsor or designated principal investigator) for certain clinical trials of drug products (including biological products) and device products that are regulated by the Food and Drug Administration (FDA) and for pediatric postmarket surveillances of a device product that are ordered by FDA.

  7. 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…

  8. Trial Registration for Public Trust: Making the Case for Medical Devices

    PubMed Central

    2007-01-01

    Recently, several pharmaceutical companies have been shown to have withheld negative clinical trial results from the public. These incidents have resulted in a concerted global effort to register all trials at inception, so that all subsequent results can be tracked regardless of whether they are positive or negative. These trial registration policies have been driven in large part by concern about the pharmaceutical sector. The medical device industry is much smaller, and different from the pharmaceutical industry in some fundamental ways. This paper examines the issues surrounding registration of device trials and argues that these differences with pharmaceutical should not exempt device trials from registration. PMID:18095047

  9. Trial registration for public trust: making the case for medical devices.

    PubMed

    Sim, Ida

    2008-01-01

    Recently, several pharmaceutical companies have been shown to have withheld negative clinical trial results from the public. These incidents have resulted in a concerted global effort to register all trials at inception, so that all subsequent results can be tracked regardless of whether they are positive or negative. These trial registration policies have been driven in large part by concern about the pharmaceutical sector. The medical device industry is much smaller, and different from the pharmaceutical industry in some fundamental ways. This paper examines the issues surrounding registration of device trials and argues that these differences with pharmaceutical should not exempt device trials from registration.

  10. Discrepancies between registration and publication of randomised controlled trials: an observational study

    PubMed Central

    Stevenson, Graham; Thornton, James G

    2014-01-01

    Summary Objectives To determine the consistency between information contained in the registration and publication of randomised controlled trials (RCTs). Design An observational study of RCTs published between May 2011 and May 2012 in the British Medical Journal (BMJ) and the Journal of the American Medical Association (JAMA) comparing registry data with publication data. Participants and Settings Data extracted from published RCTs in BMJ and JAMA. Main outcome measures Timing of trial registration in relation to completion of trial data collection and publication. Registered versus published primary and secondary outcomes, sample size. Results We identified 40 RCTs in BMJ and 36 in JAMA. All 36 JAMA trials and 39 (98%) BMJ trials were registered. All registered trials were registered prior to publication. Thirty-two (82%) BMJ trials recorded the date of data completion; of these, in two trials the date of trial registration postdated the registered date of data completion. There were discrepancies between primary outcomes declared in the trial registry information and in the published paper in 18 (47%) BMJ papers and seven (19%) JAMA papers. The original sample size stated in the trial registration was achieved in 24 (60%) BMJ papers and 21 (58%) JAMA papers. Conclusions Compulsory registration of RCTs is meaningless if the content of registry information is not complete or if discrepancies between registration and publication are not reported. This study demonstrates that discrepancies in primary and secondary outcomes and sample size between trial registration and publication remain commonplace, giving further strength to the World Health Organisation’s argument for mandatory completion of a minimum number of compulsory fields. PMID:25057391

  11. Problems with registration-directed clinical trials for lung cancer in Japan.

    PubMed

    Sekine, Ikuo; Nokihara, Hiroshi; Yamamoto, Noboru; Kunitoh, Hideo; Ohe, Yuichiro; Saijo, Nagahiro; Tamura, Tomohide

    2007-09-01

    New anticancer agents against lung cancer are needed because efficacy of chemotherapy is limited. The long time required, low quality, and considerable costs of registration-directed clinical trials in Japan ("Chiken") have been pointed out. The quality of 24 phase I and 41 phase II trials of an anticancer drug for lung cancer were analyzed according to the approval year of the drug. The human resources and infrastructure to support oncology clinical practice and clinical trials were compared between Japan and the USA. A maximum tolerated dose was not defined in any of seven phase I trials before 1989, and was determined in two of six trials between 1989 and 1996 and in seven of 10 trials thereafter. Before 1989, 29 (20%) of 142 patients registered in two trials were ineligible, and the number of ineligible patients was not reported in the five trials. Sample size calculations were not performed in any of seven phase II trials before 1989 and were performed in only four of 10 trials between 1989 and 1996 and in all 23 trials conducted thereafter. The shortage of human resources, including medical oncologists, oncology nurse practitioners and clinical research coordinators, is serious and acute. The infrastructure to support clinical trials also remains insufficient in Japan. In conclusion, registration-directed clinical trials of anticancer agents have advanced significantly during last three decades but remain unsatisfactory. The development of infrastructure and human resources is an urgent task to ensure high-quality clinical trials without unnecessary delays.

  12. Prospective registration and results disclosure of clinical trials in the Americas: a roadmap toward transparency.

    PubMed

    Krleža-Jeriç, Karmela; Lemmens, Trudo; Reveiz, Ludovic; Cuervo, Luis Gabriel; Bero, Lisa Anne

    2011-07-01

    The objective of this article is to propose a roadmap toward transparency of clinical trials in the Americas by their prospective registration and results disclosure. This will broaden access to more complete and accurate data and facilitate evidence-informed decision-making and participation in research. Consequently, it should have a positive impact on people's health and should promote trust in health research. Existing initiatives were identified, registration of trials was analyzed following the World Health Organization (WHO) standards on trial registration, and a roadmap is proposed to address the gaps in advancing transparency. The analysis shows that, in spite of numerous regional and country initiatives, clinical trials taking place in nonEnglish-speaking parts of the Americas are underregistered. A roadmap is proposed to enhance research governance and good research practice by improving the transparency of clinical trials. The proposed roadmap includes strategies for implementing WHO international standards for trial registration, for developing international standards of public disclosure of trial results, and for a potential role of the Pan American Health Organization.

  13. Knowledge of juvenile sex offender registration laws predicts adolescent sexual behavior.

    PubMed

    Stevenson, Margaret C; Najdowski, Cynthia J; Wiley, Tisha R A

    2013-01-01

    Because juveniles can now be registered as sex offenders, we conducted a pilot study to investigate awareness of these policies and sexual behavior histories in a convenience sample of 53 young adults (ages 18 to 23, 79% women). These preliminary data revealed that 42% percent of participants were unaware that youth under the age of 18 can be registered as sex offenders, and when informed that they can be, participants were unaware of the breadth of adolescent sexual behavior that warrants registration. Furthermore, those unaware of juvenile registration policies, compared to those who were aware, were marginally more likely to have had sex prior to age 18. Thus, youth most at risk of registration were least aware of this possibility, suggesting that juvenile registration likely does little to deter many behaviors that are considered to be juvenile sex offenses.

  14. Impact of registration on clinical trials on infection risk in pediatric acute myeloid leukemia.

    PubMed

    Dix, David; Aplenc, Richard; Bowes, Lynette; Cellot, Sonia; Ethier, Marie-Chantal; Feusner, Jim; Gillmeister, Biljana; Johnston, Donna L; Lewis, Victor; Michon, Bruno; Mitchell, David; Portwine, Carol; Price, Victoria; Silva, Mariana; Stobart, Kent; Yanofsky, Rochelle; Zelcer, Shayna; Beyene, Joseph; Sung, Lillian

    2016-04-01

    Little is known about the impact of enrollment on therapeutic clinical trials on adverse event rates. Primary objective was to describe the impact of clinical trial registration on sterile site microbiologically documented infection for children with newly diagnosed acute myeloid leukemia (AML). We conducted a multicenter cohort study that included children aged ≤18 years with de novo AML. Primary outcome was microbiologically documented sterile site infection. Infection rates were compared between those registered and not registered on clinical trials. Five hundred seventy-four children with AML were included of which 198 (34.5%) were registered on a therapeutic clinical trial. Overall, 400 (69.7%) had at least one sterile site microbiologically documented infection. In multiple regression, registration on clinical trials was independently associated with a higher risk of microbiologically documented sterile site infection [adjusted odds ratio (OR) 1.24, 95% confidence interval (CI) 1.01-1.53; p = 0.040] and viridans group streptococcal infection (OR 1.46, 95% CI 1.08-1.98; p = 0.015). Registration on trials was not associated with Gram-negative or invasive fungal infections. Children with newly diagnosed AML enrolled on clinical trials have a higher risk of microbiologically documented sterile site infection. This information may impact on supportive care practices in pediatric AML.

  15. An outline for public registration of clinical trials evaluating medical devices.

    PubMed

    Popp, Richard L; Lorell, Beverly H; Stone, Gregg W; Laskey, Warren; Smith, John J; Kaplan, Aaron V

    2006-04-18

    Public registration of clinical trials is fundamentally important to the integrity of the medical device development process. In addition to fulfilling obligations to those study volunteers, a complete record of trial results provides the general public, clinical community, and medical device manufacturers with a more accurate understanding as to how a specific therapeutic should be used. Although the issues associated with public disclosure of clinical trials are similar to the pharmaceutical industries, the iterative nature of device development introduces differences in what type of information needs to be disclosed during development and commercialization. The Second Dartmouth Device Development Symposium (3D2) held in October 2004 brought together thought leaders representing many of the stakeholders associated with medical device development. This consensus document arising from the proceedings of the 3D2 is offered to provide background to these issues and recommend pathways to implementation of device trial registration.

  16. 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

  17. Limited Generalizability of Registration Trials in Hepatitis C: A Nationwide Cohort Study

    PubMed Central

    de Knegt, Robert J.; Blokzijl, Hans; Kuiken, Sjoerd D.; van Erpecum, Karel J. L.; Willemse, Sophie B.; den Hollander, Jan; van Vonderen, Marit G. A.; Friederich, Pieter; van Hoek, Bart; van Nieuwkerk, Carin M. J.; Drenth, Joost P. H.; Kievit, Wietske

    2016-01-01

    Background Approval of drugs in chronic hepatitis C is supported by registration trials. These trials might have limited generalizability through use of strict eligibility criteria. We compared effectiveness and safety of real world hepatitis C patients eligible and ineligible for registration trials. Methods We performed a nationwide, multicenter, retrospective cohort study of chronic hepatitis C patients treated in the real world. We applied a combined set of inclusion and exclusion criteria of registration trials to our cohort to determine eligibility. We compared effectiveness and safety in eligible vs. ineligible patients, and performed sensitivity analyses with strict criteria. Further, we used log binomial regression to assess relative risks of criteria on outcomes. Results In this cohort (n = 467) 47% of patients would have been ineligible for registration trials. Main exclusion criteria were related to hepatic decompensation and co-morbidity (cardiac disease, anemia, malignancy and neutropenia), and were associated with an increased risk for serious adverse events (RR 1.45–2.31). Ineligible patients developed significantly more serious adverse events than eligible patients (27% vs. 11%, p< 0.001). Effectiveness was decreased if strict criteria were used. Conclusions Nearly half of real world hepatitis C patients would have been excluded from registration trials, and these patients are at increased risk to develop serious adverse events. Hepatic decompensation and co-morbidity were important exclusion criteria, and were related to toxicity. Therefore, new drugs should also be studied in these patients, to genuinely assess benefits and risk of therapy in the real world population. PMID:27598789

  18. 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.

  19. 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.

  20. The effects of industry sponsorship on comparator selection in trial registrations for neuropsychiatric conditions in children.

    PubMed

    Dunn, Adam G; Mandl, Kenneth D; Coiera, Enrico; Bourgeois, Florence T

    2013-01-01

    Pediatric populations continue to be understudied in clinical drug trials despite the increasing use of pharmacotherapy in children, particularly with psychotropic drugs. Most pertinent to the clinical selection of drug interventions are trials directly comparing drugs against other drugs. The aim was to measure the prevalence of active drug comparators in neuropsychiatric drug trials in children and identify the effects of funding source on comparator selection. We analyzed the selection of drugs and drug comparisons in clinical trials registered between January 2006 and May 2012. Completed and ongoing interventional trials examining treatments for six neuropsychiatric conditions in children were included. Networks of drug comparisons for each condition were constructed using information about the trial study arms. Of 421 eligible trial registrations, 228 (63,699 participants) were drug trials addressing ADHD (106 trials), autism spectrum disorders (47), unipolar depression (16), seizure disorders (38), migraines and other headaches (15), or schizophrenia (11). Active drug comparators were used in only 11.0% of drug trials while 44.7% used a placebo control and 44.3% no drug or placebo comparator. Even among conditions with well-established pharmacotherapeutic options, almost all drug interventions were compared to a placebo. Active comparisons were more common among trials without industry funding (17% vs. 8%, p=0.04). Trials with industry funding differed from non-industry trials in terms of the drugs studied and the comparators selected. For 73% (61/84) of drugs and 90% (19/21) of unique comparisons, trials were funded exclusively by either industry or non-industry. We found that industry and non-industry differed when choosing comparators and active drug comparators were rare for both groups. This gap in pediatric research activity limits the evidence available to clinicians treating children and suggests a need to reassess the design and funding of pediatric

  1. Review of the registration of clinical trials in UMIN-CTR from 2 June 2005 to 1 June 2010 - focus on Japan domestic, academic clinical trials

    PubMed Central

    2013-01-01

    Background Established on 1 June 2005, the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) is the largest clinical trial registry in Japan, and joined the World Health Organization (WHO) registry network in October 2008. Our aim was to understand the registration trend and overall characteristics of Japan domestic, academic (non-industry-funded) clinical trials, which constitute the main body of registrations in UMIN-CTR. In addition, we aimed to investigate the accessibility of clinical trials in UMIN-CTR to people worldwide, as well as the accessibility of clinical trials conducted in Japan but registered abroad to Japanese people in the Japanese language. Methods We obtained the data for registrations in UMIN-CTR from the UMIN Center, and extracted Japan domestic, academic clinical trials to analyze their registration trend and overall characteristics. We also investigated how many of the trials registered in UMIN-CTR could be accessed from the International Clinical Trials Registry Platform (ICTRP). Finally, we searched ClinicalTrials.gov for all clinical trials conducted in Japan and investigated how many of them were also registered in Japanese registries. All of the above analyses included clinical trials registered from 2 June 2005 to 1 June 2010. Results During the period examined, the registration trend showed an obvious peak around September 2005 and rapid growth from April 2009. Of the registered trials, 46.4% adopted a single-arm design, 34.5% used an active control, only 10.9% were disclosed before trial commencement, and 90.0% did not publish any results. Overall, 3,063 of 3,064 clinical trials registered in UMIN-CTR could be accessed from ICTRP. Only 8.7% of all clinical trials conducted in Japan and registered in ClinicalTrials.gov were also registered in Japanese registries. Conclusions The International Committee of Medical Journal Editors (ICMJE) announcements about clinical trial registration and the Ethical

  2. Multi-System Verification of Registrations for Image-Guided Radiotherapy in Clinical Trials

    SciTech Connect

    Cui Yunfeng; Galvin, James M.; Straube, William L.; Bosch, Walter R.; Purdy, James A.; Li, X. Allen; Xiao Ying

    2011-09-01

    Purpose: To provide quantitative information on the image registration differences from multiple systems for image-guided radiotherapy (IGRT) credentialing and margin reduction in clinical trials. Methods and Materials: Images and IGRT shift results from three different treatment systems (Tomotherapy Hi-Art, Elekta Synergy, Varian Trilogy) have been sent from various institutions to the Image-Guided Therapy QA Center (ITC) for evaluation for the Radiation Therapy Oncology Group (RTOG) trials. Nine patient datasets (five head-and-neck and four prostate) were included in the comparison, with each patient having 1-4 daily individual IGRT studies. In all cases, daily shifts were re-calculated by re-registration of the planning CT with the daily IGRT data using three independent software systems (MIMvista, FocalSim, VelocityAI). Automatic fusion was used in all calculations. The results were compared with those submitted from institutions. Similar regions of interest (ROIs) and same initial positions were used in registrations for inter-system comparison. Different slice spacings for CBCT sampling and different ROIs for registration were used in some cases to observe the variation of registration due to these factors. Results: For the 54 comparisons with head-and-neck datasets, the absolute values of differences of the registration results between different systems were 2.6 {+-} 2.1 mm (mean {+-} SD; range 0.1-8.6 mm, left-right [LR]), 1.7 {+-} 1.3 mm (0.0-4.9 mm, superior-inferior [SI]), and 1.8 {+-} 1.1 mm (0.1-4.0 mm, anterior-posterior [AP]). For the 66 comparisons in prostate cases, the differences were 1.1 {+-} 1.0 mm (0.0-4.6 mm, LR), 2.1 {+-} 1.7 mm (0.0-6.6 mm, SI), and 2.0 {+-} 1.8 mm (0.1-6.9 mm, AP). The differences caused by the slice spacing variation were relatively small, and the different ROI selections in FocalSim and MIMvista also had limited impact. Conclusion: The extent of differences was reported when different systems were used for image

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

    PubMed Central

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

    2014-01-01

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

  4. 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…

  5. 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

    -based suicide prevention e-learning modules can be an effective educational method to enhance knowledge and self-confidence of gatekeepers with regard to adolescent suicide prevention. Gatekeepers with limited time and resources can benefit from the accessibility, simplicity, and flexibility of Web-based training. Trial Registration Netherlands Trial Register NTR3625; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3625 (Archived by WebCite at http://www.webcitation.org/6eHvyRh6M) PMID:26825006

  6. Complying with the European Clinical Trials directive while surviving the administrative pressure - an alternative approach to toxicity registration in a cancer trial.

    PubMed

    Frandsen, Thomas Leth; Heyman, Mats; Abrahamsson, Jonas; Vettenranta, Kim; Åsberg, Ann; Vaitkeviciene, Goda; Pruunsild, Kaie; Toft, Nina; Birgens, Henrik; Hallböök, Helena; Quist-Paulsen, Petter; Griškevičius, Laimonas; Helt, Louise; Hansen, Birgitte Vilsbøll; Schmiegelow, Kjeld

    2014-01-01

    The European Clinical Trials Directive of 2004 has increased the amount of paper work and reduced the number of initiated clinical trials. Particularly multinational trials have been delayed. To meet this challenge we developed a novel, simplified, fast and easy strategy for on-line toxicity registration for patients treated according to the Nordic/Baltic acute lymphoblastic leukaemia protocol, NOPHO ALL 2008, for children and young adults, including three randomisations. We used a risk-assessment based approach, avoiding reporting of expected adverse events and instead concentrating on 20 well-known serious, but rarer events with focus on changes in therapy introduced in the treatment protocol. This toxicity registration strategy was approved by the relevant regulatory authorities in all seven countries involved, as compliant within the EU directive of 2004. The centre compliance to registration was excellent with 98.9% of all patients being registered within 5weeks from the requested quarterly registration. Currently, four toxicities (thrombosis, fungal infections, pancreatitis and allergic reactions) have been chosen for further detailed exploration due to the cumulative fraction of patients with positive registrations exceeding 5%. This toxicity registration offers real-time toxicity profiles of the total study cohort and provides early warnings of specific toxicities that require further investigation.

  7. 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

  8. 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

  9. 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.

  10. 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.

  11. 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

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

    PubMed Central

    2013-01-01

    from this trial will enhance availability of evidence-based treatment of adolescent binge eating disorder. Trial registration German Clinical Trials Register: DRKS00000542 PMID:24066704

  13. How Commonly Used Inclusion and Exclusion Criteria in Antidepressant Registration Trials Affect Study Enrollment.

    PubMed

    Preskorn, Sheldon H; Macaluso, Matthew; Trivedi, Madhukar

    2015-07-01

    In clinical trials, each specific inclusion and exclusion criterion eliminates a percentage of the potentially eligible population from trial participation and thus increases the time and effort needed for enrollment in a study. Drug developers often do not have data on how these criteria affect the pool of potentially eligible subjects for their trials and, hence, they cannot factor in the impact of these criteria when designing a study and planning the time needed to complete it. Consequently, drug developers often have ambitious timelines that are unrealistic and can lead to actions that may interfere with the ability to separate the efficacy of drug versus placebo. To investigate the effects of inclusion and exclusion criteria on study enrollment, the authors quantified the effects of the inclusion and exclusion criteria commonly used in antidepressant registration trials (ARTs) by applying these criteria to the population treated in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study. In essence, the STAR*D study population was used as a surrogate for the general population of individuals with major depressive disorder. The effect of each criterion commonly used in ARTs was assessed in terms of the percentage of the STAR*D population that would have been excluded individually and collectively (i.e., when all criteria were applied at once). For continuous criteria such as age and severity of depression, the resulting effects have been presented graphically. Collectively, the typical inclusion and exclusion criteria used in ARTs would have eliminated at least 82% of the STAR*D population. This result means that more than 5 times the number of subjects would have to be screened to find a population that would meet the typical inclusion and exclusion criteria for an ART, directly determining the screening effort required in terms of both resources and time. Thus, developers of antidepressant drugs can use the data from this study to plan the

  14. 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

  15. 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…

  16. 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

    publication in academic journals, presented at conferences and distributed to adolescents, families and healthcare professionals through the media with the assistance of the STAR advisory group. Trial registration number ISRCTN90378161; Pre-results. PMID:27707836

  17. Participant Recruitment and Engagement in Automated eHealth Trial Registration: Challenges and Opportunities for Recruiting Women Who Experience Violence

    PubMed Central

    McLean, Christine; Rohan, Maheswaran; Sisk, Rose; Dobbs, Terry; Nada-Raja, Shyamala; Wilson, Denise; Vandal, Alain C

    2016-01-01

    Background Automated eHealth Web-based research trials offer people an accessible, confidential opportunity to engage in research that matters to them. eHealth trials may be particularly useful for sensitive issues when seeking health care may be accompanied by shame and mistrust. Yet little is known about people’s early engagement with eHealth trials, from recruitment to preintervention autoregistration processes. A recent randomized controlled trial that tested the effectiveness of an eHealth safety decision aid for New Zealand women in the general population who experienced intimate partner violence (isafe) provided the opportunity to examine recruitment and preintervention participant engagement with a fully automated Web-based registration process. The trial aimed to recruit 340 women within 24 months. Objective The objective of our study was to examine participant preintervention engagement and recruitment efficiency for the isafe trial, and to analyze dropout through the registration pathway, from recruitment to eligibility screening and consent, to completion of baseline measures. Methods In this case study, data collection sources included the trial recruitment log, Google Analytics reports, registration and program metadata, and costs. Analysis included a qualitative narrative of the recruitment experience and descriptive statistics of preintervention participant engagement and dropout rates. A Koyck model investigated the relationship between Web-based online marketing website advertisements (ads) and participant accrual. Results The isafe trial was launched on September 17, 2012. Placement of ads in an online classified advertising platform increased the average number of recruited participants per month from 2 to 25. Over the 23-month recruitment period, the registration website recorded 4176 unique visitors. Among 1003 women meeting eligibility criteria, 51.55% (517) consented to participate; among the 501 women who enrolled (consented, validated

  18. 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

  19. 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

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

    PubMed Central

    2014-01-01

    Germany. Second, prior research has not targeted adolescents in the presumed teachable moment following acute alcohol intoxication. Third, we included a comprehensive process evaluation to raise external validity. Fourth, the study involved important stakeholders from the start to set up organizational structures for implementation and maintaining project impact. Trial registration Current Controlled Trials ISRCTN31234060 (April 30th 2012). PMID:24975110

  1. 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

    improvement after treatment and at follow-up compared to WL. Conclusions: This study is the first randomized controlled trial that provides evidence that cognitive behavioral therapy for insomnia is effective for the treatment of adolescents with insomnia, with medium to large effect sizes. There were small differences between internet and group therapy, but both treatments reached comparable endpoints. Clinical Trial Registration: This study was part of the clinical trial: Effectiveness of cognitive behavioral therapy for sleeplessness in adolescents; URL: http://www.isrctn.com/ISRCTN33922163; registration: ISRCTN33922163. Citation: de Bruin EJ, Bögels SM, Oort FJ, Meijer AM. Efficacy of cognitive behavioral therapy for insomnia in adolescents: a randomized controlled trial with internet therapy, group therapy and a waiting list condition. SLEEP 2015;38(12):1913–1926. PMID:26158889

  2. 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

  3. 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

    effects were largely similar for both formats. Further studies in a clinical setting are warranted. Clinical Trial Registration: ID: ISRCTN33922163; trial name: Effectiveness of cognitive behavioral therapy for sleeplessness in adolescents; URL: http://www.isrctn.com/ISRCTN33922163 Citation: De Bruin EJ, van Steensel FJ, Meijer AM. Cost-effectiveness of group and internet cognitive behavioral therapy for insomnia in adolescents: results from a randomized controlled trial. SLEEP 2016;39(8):1571–1581. PMID:27306272

  4. 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…

  5. 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…

  6. 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,…

  7. 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.…

  8. 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

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

    PubMed Central

    2011-01-01

    see if improvements persist. Measures of treatment adherence, pain, disability, and anxiety and depression will be assessed throughout study participation. Qualitative interviews for mentors, mentored participants, and control subjects will also be administered. Trial registration ClinicalTrials.gov NCT01118988. PMID:21600053

  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. Equivalence and noninferiority trials – are they viable alternatives for registration of new drugs? (III)

    PubMed Central

    Pater, Cornel

    2004-01-01

    The scientific community's reliance on active-controlled trials is steadily increasing, as widespread agreement emerges concerning the role of these trials as viable alternatives to placebo trials. These trials present substantial challenges with regard to design and interpretation as their complexity increases, and the potential need for larger sample sizes impacts the cost and time variables of the drug development process. The potential efficacy and safety benefits derived from these trials may never be demonstrated by other methods. Active-controlled trials can develop valuable data to inform both prescribers and patients about the dose- and time-dependent actions of any new drug and can contribute to the management and communication of risks associated with the relevant therapeutic products. PMID:15312236

  13. 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.

  14. 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

  15. 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.

  16. 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

  17. 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

    adolescents. Trial registration Dutch Trial register NTR3228. PMID:24661535

  18. Registration of aggressive incidents in an adolescent forensic psychiatric unit and implications for further practice.

    PubMed

    Tremmery, S; Danckaerts, M; Bruckers, L; Molenberghs, G; De Hert, M; Wampers, M; De Varé, J; de Decker, A

    2014-09-01

    Although aggression is part of daily life in psychiatric units for adolescents, empirical data on its prevalence are sparse. Only few studies have described prevalence of aggressive incidents in adolescent psychiatric wards, and data in forensic psychiatric care are even more limited. Available studies reported high prevalence rates of aggression, ranging from 0.4 to 2.4 incidents of aggression per day across (forensic) child and adolescent psychiatric units. Between 27 and 78 % of all admitted youth committed an aggressive act. In this study, we collected systematically registered data of all aggressive incidents from the first 2 years (2010-2012) on a newly established forensic adolescent psychiatric unit, which used a formal aggression management program embedded in the social competence model, which is based on early intervention in the 'chain of behavior' to prevent any further escalation. The inclusion of also minor aggressive incidents is unique in the literature and the clinical relevance is highlighted. A mean of one incident a day took place, with each adolescent involved in at least one incident. Notably, 1.7 aggressive incidents per month made seclusion of restraint use necessary. Based on the social competence theory, the aggression management model suggests intervening early in the cascade of aggression, in order to prevent further escalation and reduce the need for intrusive interventions. Evidence supported that aggression is a contextual event, as external factors clearly influence the incidence of aggression. Aggression management should be built on both relational and structural security.

  19. [Progress and challenges of clinical trials registration in Latin America and the Caribbean's].

    PubMed

    Reveiz, Ludovic; Saenz, Carla; Murasaki, Renato T; Cuervo, Luis G; Ramalho, Luciano

    2011-12-01

    Clinical trial registries are one of the main sources of information concerning health research interventions that have been or are being carried out throughout the world. The World Health Organization (WHO) established a minimum data set to be recorded (20 items), which was agreed upon internationally with the stakeholders, and established a network of primary and associated records. In addition to the register ClinicalTrial.Gov (of the United States of America), there are currently two primary registries in the Americas (from Brazil and Cuba) that meet WHO requirements and provide data to WHO's International Clinical Trials Registry Platform (ICTRP). Furthermore, there are important advances in the region related to the regulations, development and implementation of national registries and to the support of the ethics committees and editors to this initiative.

  20. Exclusion of patients with concomitant chronic conditions in ongoing randomised controlled trials targeting 10 common chronic conditions and registered at ClinicalTrials.gov: a systematic review of registration details

    PubMed Central

    Buffel du Vaure, Céline; Dechartres, Agnès; Battin, Constance; Ravaud, Philippe; Boutron, Isabelle

    2016-01-01

    Objectives To systematically assess registration details of ongoing randomised controlled trials (RCTs) targeting 10 common chronic conditions and registered at ClinicalTrials.gov and to determine the prevalence of (1) trial records excluding patients with concomitant chronic condition(s) and (2) those specifically targeting patients with concomitant chronic conditions. Design Systematic review of trial registration records. Data sources ClinicalTrials.gov register. Study selection All ongoing RCTs registered from 1 January 2014 to 31 January 2015 that assessed an intervention targeting adults with coronary heart disease (CHD), hypertension, heart failure, stroke/transient ischaemic attack, atrial fibrillation, type 2 diabetes, chronic obstructive pulmonary disease, painful condition, depression and dementia with a target sample size ≥100. Data extraction From the trial registration records, 2 researchers independently recorded the trial characteristics and the number of exclusion criteria and determined whether patients with concomitant chronic conditions were excluded or specifically targeted. Results Among 319 ongoing RCTs, despite the high prevalence of the concomitant chronic conditions, patients with these conditions were excluded in 251 trials (79%). For example, although 91% of patients with CHD had a concomitant chronic condition, 69% of trials targeting such patients excluded patients with concomitant chronic condition(s). When considering the co-occurrence of 2 chronic conditions, 31% of patients with chronic pain also had depression, but 58% of the trials targeting patients with chronic pain excluded patients with depression. Only 37 trials (12%) assessed interventions specifically targeting patients with concomitant chronic conditions; 31 (84%) excluded patients with concomitant chronic condition(s). Conclusions Despite widespread multimorbidity, more than three-quarters of ongoing trials assessing interventions for patients with chronic conditions

  1. 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

  2. Trial Registration: Understanding and Preventing Reporting Bias in Social Work Research

    ERIC Educational Resources Information Center

    Harrison, Bronwyn A.; Mayo-Wilson, Evan

    2014-01-01

    Randomized controlled trials are considered the gold standard for evaluating social work interventions. However, published reports can systematically overestimate intervention effects when researchers selectively report large and significant findings. Publication bias and other types of reporting biases can be minimized through prospective trial…

  3. 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

    feasible and acceptable for adolescents with depression. Conclusions With modifications, a fully powered RCT is achievable to investigate a promising treatment for adolescent depression in a climate where child mental health service resources are limited. Trial registration number ISRCTN31219579. PMID:28132000

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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 Trialsregistration number (NCT01846000). PMID:23876095

  9. 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

  10. 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

  11. 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.

  12. 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…

  13. 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…

  14. 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…

  15. 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…

  16. 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…

  17. Comparison of global versus Asian clinical trial strategies supportive of registration of drugs in Japan.

    PubMed

    Shirotani, Mari; Kurokawa, Tatsuo; Chiba, Koji

    2014-07-01

    The number of worldwide and Asian multiregional clinical trials (MRCTs) submitted for Japanese New Drug Applications increased markedly between 2009 and 2013, with an increasing number performed for simultaneously submission in the USA, EU, and Japan. Asian studies accounted for 32% of MRCTs (14/44 studies) and had comparatively small sample sizes (<500 subjects). Moreover, the number of Japanese subjects in Asian studies was 2.1- to 13.4-fold larger than the sample size estimated using the method described in Japanese MRCT guidelines, whereas the ratio for worldwide studies was 0.05- to 4.9-fold. Before the introduction of this guidelines, bridging or domestic clinical development strategies were used as the regional development strategy in accordance with ICH E5 guidelines. The results presented herein suggest that Asian studies were conducted when the drug had already been approved in the US/EU, when phase 3 clinical trials were not be planned in the USA/EU, when there was insufficient knowledge of ethnic differences in drug efficacy and safety, or when Caucasian data could not be extrapolated to the Japanese population. New strategies with Asian studies including the Japanese population could be conducted instead of Japanese domestic development strategy.

  18. 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.

  19. 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…

  20. 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.

  1. 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.

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

    PubMed Central

    2014-01-01

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

  3. Clinical trial registration, reporting, publication and FDAAA compliance: a cross-sectional analysis and ranking of new drugs approved by the FDA in 2012

    PubMed Central

    Miller, Jennifer E; Korn, David; Ross, Joseph S

    2015-01-01

    Objective To evaluate clinical trial registration, reporting and publication rates for new drugs by: (1) legal requirements and (2) the ethical standard that all human subjects research should be publicly accessible to contribute to generalisable knowledge. Design Cross-sectional analysis of all clinical trials submitted to the Food and Drug Administration (FDA) for drugs approved in 2012, sponsored by large biopharmaceutical companies. Data sources Information from Drugs@FDA, ClinicalTrials.gov, MEDLINE-indexed journals and drug company communications. Main outcome measures Clinical trial registration and results reporting in ClinicalTrials.gov, publication in the medical literature, and compliance with the 2007 FDA Amendments Acts (FDAAA), analysed on the drug level. Results The FDA approved 15 drugs sponsored by 10 large companies in 2012. We identified 318 relevant trials involving 99 599 research participants. Per drug, a median of 57% (IQR 32–83%) of trials were registered, 20% (IQR 12–28%) reported results in ClinicalTrials.gov, 56% (IQR 41–83%) were published, and 65% (IQR 41–83%) were either published or reported results. Almost half of all reviewed drugs had at least one undisclosed phase II or III trial. Per drug, a median of 17% (IQR 8–20%) of trials supporting FDA approvals were subject to FDAAA mandated public disclosure; of these, a median of 67% (IQR 0–100%) were FDAAA-compliant. 68% of research participants (67 629 of 99 599) participated in FDAAA-subject trials, with 51% (33 405 of 67 629) enrolled in non-compliant trials. Transparency varied widely among companies. Conclusions Trial disclosures for new drugs remain below legal and ethics standards, with wide variation in practices among drugs and their sponsors. Best practices are emerging. 2 of our 10 reviewed companies disclosed all trials and complied with legal disclosure requirements for their 2012 approved drugs. Ranking new drugs on transparency criteria may improve

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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…

  9. 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…

  10. 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

  11. Developing Outcomes Assessments as Endpoints for Registrational Clinical Trials of Antibacterial Drugs: 2015 Update From the Biomarkers Consortium of the Foundation for the National Institutes of Health

    PubMed Central

    Talbot, George H.; Powers, John H.; Hoffmann, Steven C.

    2016-01-01

    One important component in determining the benefits and harms of medical interventions is the use of well-defined and reliable outcome assessments as endpoints in clinical trials. Improving endpoints can better define patient benefits, allowing more accurate assessment of drug efficacy and more informed benefit-vs-risk decisions; another potential plus is facilitating efficient trial design. Since our first report in 2012, 2 Foundation for the National Institutes of Health Biomarkers Consortium Project Teams have continued to develop outcome assessments for potential uses as endpoints in registrational clinical trials of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. In addition, the teams have initiated similar work in the indications of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. This report provides an update on progress to date in these 4 diseases. PMID:26668337

  12. 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…

  13. 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

  14. 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

  15. 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

    in the baseline assessment. At follow-up, 824 (31.11%) adolescents returned. The intervention was effective in reducing binge drinking among adolescents aged 15 years (P=.03) and those aged 16 years when they participated in at least 2 intervention sessions (P=.04). Interaction effects between excessive drinking and educational level (P=.08) and between weekly consumption and age (P=.09) were found; however, in-depth analyses revealed no significant subgroup effects for both interaction effects. Additional analyses revealed that prolonged use of the intervention was associated with stronger effects for binge drinking. Yet, overall adherence to the intervention was low. Analyses revealed that being Protestant, female, younger, a nonbinge drinker, and having a higher educational background were associated with adherence. Conclusions The intervention was effective for adolescents aged 15 and 16 years concerning binge drinking. Prevention messages may be more effective for those at the start of their drinking career, whereas other methods may be needed for those with a longer history of alcohol consumption. Despite using game elements, intervention completion was low. Trial Registration Dutch Trial Register: NTR4048; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4048 (Archived by WebCite® at http://www.webcitation.org/6eSJD3FiY) PMID:26842694

  16. 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

  17. 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

    promote smoking cessation among adolescents and young adults including those with lower educational level and independent of their motivation to quit. Trial registration number ISRCTN: ISRCTN19739792 PMID:22260736

  18. 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

    anticipated that positive results in (cost-) effectiveness of the proposed intervention will contribute to the improvement of treatment for epilepsy in children and adolescents and will lead to a smaller burden to society. Trial registration The study has been registered with the Netherlands Trial Registry (NTR2498). PMID:21262002

  19. 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.

  20. 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

  1. 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

  2. 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

  3. 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.

  4. 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

  5. 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

  6. 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

    sequence. Data are being collected at baseline, treatment completion, and at a 3-month follow-up. Results Currently, adolescents are being enrolled in the study. Enrolment is taking place between March 2014 and February 2016; data collection will conclude May 2016. We expect that analysis and results will be available by August 2016. Conclusions In many communities, the resources available for front-line anxiety treatment are outweighed by the need for care. This pilot RCT is an essential step to designing a robust RCT to evaluate the effectiveness of an Internet-based CBT program for adolescents with moderate to mild anxiety problems. Trial Registration Clinicaltrials.gov NCT02059226; http://clinicaltrials.gov/ct2/show/NCT02059226 (Archived by WebCite at http://www.webcitation.org/6epF8v7k4) PMID:26825111

  7. 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

  8. 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

  9. 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

  10. 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

  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. The Effect of Family-Centered Psycho-Education on Mental Health and Quality of Life of Families of Adolescents with Bipolar Mood Disorder: A Randomized Controlled Clinical Trial

    PubMed Central

    Sharif, Farkhondeh; Mahmoudi, Asyeh; Shooshtari, Ali Alavi; Vossoughi, Mehrdad

    2016-01-01

    Background: Bipolar Mood Disorder (BMD) is a type of mood disorder which is associated with various disabilities. The family members of the patients with BMD experience many difficulties and pressures during the periods of treatment, rehabilitation and recovery and their quality of life (QOL) is threatened. In the present study, we aimed to evaluate the effect of family-centered education on mental health and QOL of families with adolescents suffering from BMD. Methods: In this randomized controlled clinical trial performed on 40 families which were mostly mothers of the adolescents with BMD referred to the psychiatric clinics affiliated to Shiraz University of Medical Sciences during 2012-13. They were randomly assigned to intervention and control groups. Results: The results of single factor multivariate ANOVA/single-factor multivariate analysis of variance and Bonferroni post hoc tests showed that the interaction between the variables of group and time was significant (P<0.001). The mean of QOL and mental health scores increased in the intervention group, but it decreased in the control group at three measurement time points. Conclusion: The study findings confirmed the effectiveness of family-centered psychoeducation program on Mental Health and Quality of life of the families of adolescents with Bipolar Mood Disorder. Trial Registration Number: IRCT201304202812N15 PMID:27382589

  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

    intervention group in both the non-imputed (P=.010) and the EM-imputed sample (P=.022). Secondary analyses revealed a significant effect on drinking frequency (P=.037) and frequency of binge drinking (P=.044) in the non-imputation-based analyses and drinking quantity (P=.021) when missing data were imputed. Analyses for illegal drug use and polydrug use revealed no significant differences between the study groups (Ps>.05). Conclusions Although the study is limited by a large drop-out, significant between-group effects for alcohol use indicate that targeted brief motivational intervention in a fully automated Web-based format can be effective to reduce drinking and lessen existing substance use service barriers for at-risk drinking European adolescents. Trial Registration International Standard Randomized Controlled Trial Registry: ISRCTN95538913; http://www.isrctn.com/ISRCTN95538913 (Archived by WebCite at http://www.webcitation.org/6XkuUEwBx) PMID:27220276

  14. 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

  15. 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

  16. 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

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

    PubMed Central

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

    2015-01-01

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

  18. Adult and adolescent livestock productive asset transfer programmes to improve mental health, economic stability and family and community relationships in rural South Kivu Province, Democratic Republic of Congo: a protocol of a randomised controlled trial

    PubMed Central

    Kohli, Anjalee; Perrin, Nancy A; Remy, Mitima Mpanano; Alfred, Mirindi Bacikenge; Arsene, Kajabika Binkurhorhwa; Nadine, Mwinja Bufole; Heri, Banyewesize Jean; Clovis, Mitima Murhula; Glass, Nancy

    2017-01-01

    Introduction People living in poverty have limited access to traditional financial institutions. Microfinance programmes are designed to meet this gap and show promise in improving income, economic productivity and health. Our Congolese–US community academic research partnership developed two livestock productive asset transfer programmes, Pigs for Peace (PFP) and Rabbits for Resilience (RFR), to address the interlinked health, social and economic well-being of individuals, their families and communities. The community-based randomised controlled trials examine the effectiveness of PFP and RFR to improve health, economic stability, and family and community relationships among male and female adults and adolescents living in 10 rural, postconflict villages of eastern Democratic Republic of Congo. Methods and analysis PFP participants include adult permanent residents of rural villages; adolescent participants in RFR include male and female adolescents 10–15 years old living in the selected rural villages. Participants were randomised to intervention or delayed control group. Participants in PFP completed baseline interview prior to intervention and follow-up interview at 6, 12 and 18 months postintervention. In RFR, participants completed baseline interview prior to intervention and follow-up interview at 6, 12 and 18 months postbaseline. The primary outcome of both trials, the change in baseline mental health distress at 18 months in the intervention group (adults, adolescents) compared to control group, is used to calculate sample size. Ethics and dissemination The Johns Hopkins Medical Institute Internal Review Board approved this protocol. A committee of respected Congolese educators and community members (due to lack of local ethics review board) approved the study. The findings will provide important information on the potential for community-led sustainable development initiatives to build on traditional livelihood (livestock raising, agriculture

  19. 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.

  20. 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.

  1. 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

    effects of specialist psychotherapy that reduce relapse in unipolar major depression in adolescents and thereby costs of treatment to society. We also anticipate being able to utilise psychotherapy experience, neuroimaging, genetic and hormone measures to reveal what techniques and their protocols may work best for which patients. Trial Registration Current Controlled Trials ISRCTN83033550 PMID:21752257

  2. 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…

  3. 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…

  4. 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-,…

  5. 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…

  6. 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…

  7. 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…

  8. 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…

  9. 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

  10. 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.

  11. 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

    efficacy in two countries with different socio-economic levels to find out if these approaches are equally effective in countries with a lower income level. However, the vertiginous evolution of the Internet and mobile phones may make this tool less attractive for adolescents, who may prefer social networks and other mobile phone applications which are nowadays massively used by their peers. Trial registration ISRCTN27988779 PMID:23594381

  12. 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

    modality are highlighted, and the role of both peer and caregiver support in enhancing the effectiveness of this skills-based intervention is also discussed. The innovative videoconferencing delivery method Recapture Life uses has the potential to address the geographic and psychological isolation of adolescents and young adults as they move toward cancer survivorship. It is expected that teaching AYAs coping skills as they resume their normal lives after cancer may have long-term implications for their quality of life. Trial Registration ACTRN12610000717055 PMID:22862906

  13. 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

  14. 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.

  15. 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

  16. 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

  17. 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.

  18. 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

  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. 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

  1. Effectiveness of disease-specific cognitive–behavioural therapy on depression, anxiety, quality of life and the clinical course of disease in adolescents with inflammatory bowel disease: study protocol of a multicentre randomised controlled trial (HAPPY-IBD)

    PubMed Central

    van den Brink, Gertrude; Stapersma, Luuk; El Marroun, Hanan; Henrichs, Jens; Szigethy, Eva M; Utens, Elisabeth MWJ; Escher, Johanna C

    2016-01-01

    Introduction Adolescents with inflammatory bowel disease (IBD) show a higher prevalence of depression and anxiety, compared to youth with other chronic diseases. The inflammation-depression hypothesis might explain this association, and implies that treating depression can decrease intestinal inflammation and improve disease course. The present multicentre randomised controlled trial aims to test the effectiveness of an IBD-specific cognitive–behavioural therapy (CBT) protocol in reducing symptoms of subclinical depression and anxiety, while improving quality of life and disease course in adolescents with IBD. Methods and analysis Adolescents with IBD (10–20 years) from 7 hospitals undergo screening (online questionnaires) for symptoms of depression and anxiety. Those with elevated scores of depression (Child Depression Inventory (CDI) ≥13 or Beck Depression Inventory (BDI) II ≥14) and/or anxiety (Screen for Child Anxiety Related Disorders: boys ≥26, girls ≥30) receive a psychiatric interview. Patients meeting criteria for depressive/anxiety disorders are referred for psychotherapy outside the trial. Patients with elevated (subclinical) symptoms are randomly assigned to medical care-as-usual (CAU; n=50) or CAU plus IBD-specific CBT (n=50). Main outcomes: (1) reduction in depressive and/or anxiety symptoms after 3 months and (2) sustained remission for 12 months. Secondary outcomes: quality of life, psychosocial functioning, treatment adherence. In addition, we will assess inflammatory cytokines in peripheral blood mononuclear cells and whole blood RNA expression profiles. For analysis, multilevel linear models and generalised estimating equations will be used. Ethics and dissemination The Medical Ethics Committee of the Erasmus MC approved this study. If we prove that this CBT improves emotional well-being as well as disease course, implementation is recommended. Trial registration number NCT02265588. PMID:26966551

  2. The Impact of Curtin University's Activity, Food and Attitudes Program on Physical Activity, Sedentary Time and Fruit, Vegetable and Junk Food Consumption among Overweight and Obese Adolescents: A Waitlist Controlled Trial

    PubMed Central

    Straker, Leon M.; Howie, Erin K.; Smith, Kyla L.; Fenner, Ashley A.; Kerr, Deborah A.; Olds, Tim S.; Abbott, Rebecca A.; Smith, Anne J.

    2014-01-01

    Background To determine the effects of participation in Curtin University's Activity, Food and Attitudes Program (CAFAP), a community-based, family-centered behavioural intervention, on the physical activity, sedentary time, and healthy eating behaviours of overweight and obese adolescents. Methods In this waitlist controlled clinical trial in Western Australia, adolescents (n = 69, 71% female, mean age 14.1 (SD 1.6) years) and parents completed an 8-week intervention followed by 12 months of telephone and text message support. Assessments were completed at baseline, before beginning the intervention, immediately following the intervention, and at 3-, 6-, and 12- months follow-up. The primary outcomes were physical activity and sedentary time assessed by accelerometers and servings of fruit, vegetables and junk food assessed by 3-day food records. Results During the intensive 8-week intervention sedentary time decreased by −5.1 min/day/month (95% CI: −11.0, 0.8) which was significantly greater than the rate of change during the waitlist period (p = .014). Moderate physical activity increased by 1.8 min/day/month (95% CI: −0.04, 3.6) during the intervention period, which was significantly greater than the rate of change during the waitlist period (p = .041). Fruit consumption increased during the intervention period (monthly incidence rate ratio (IRR) 1.3, 95% CI: 1.10, 1.56) and junk food consumption decreased (monthly IRR 0.8, 95% CI: 0.74, 0.94) and these changes were different to those seen during the waitlist period (p = .004 and p = .020 respectively). Conclusions Participating in CAFAP appeared to have a positive influence on the physical activity, sedentary and healthy eating behaviours of overweight and obese adolescents and many of these changes were maintained for one year following the intensive intervention. Trial Registration Australia and New Zealand Clinical Trials Registry ACTRN12611001187932 PMID:25375109

  3. 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...

  4. 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

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

    PubMed

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

    2016-01-01

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

  6. 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

  7. Getting our house in order: an audit of the registration and publication of clinical trials supported by the National Institute for Health Research Oxford Biomedical Research Centre and the Musculoskeletal Biomedical Research Unit

    PubMed Central

    Tompson, A C; Petit-Zeman, S; Goldacre, B; Heneghan, C J

    2016-01-01

    Objectives To audit the proportion of clinical trials that had been publically registered and, of the completed trials, the proportion published. Setting 2 major research institutions supported by the National Institute of Health Research (NIHR). Primary and secondary outcome measures The proportion of trials reporting results within 12 months, 24 months and ‘ever’. Factors associated with non-publication were analysed using logistic regression. Inclusion criteria Phases 2–4 clinical trials identified from internal documents and publication lists. Results In total, 286 trials were identified. We could not find registration for 4 (1.4%) of these, all of which were completed and published. Of the trials with a registered completion date pre-January 2015, just over half (56%) were published, and half of these were published within 12 months (36/147, 25%). For some trials, information on the public registers was found to be out-of-date and/or inaccurate. No clinical trial characteristics were found to be significantly associated with non-publication. We have produced resources to facilitate similar audits elsewhere. Conclusions It was feasible to conduct an internal audit of registration and publication in 2 major research institutions. Performance was similar to, or better than, comparable cohorts of trials sampled from registries. The major resource input required was manually seeking information: if all registry entries were maintained, then almost the entire process of audit could be automated—and routinely updated—for all research centres and funders. PMID:26936902

  8. 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

  9. 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

  10. 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…

  11. 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)…

  12. 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)…

  13. 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.…

  14. 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…

  15. 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

  16. 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.

  17. 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

  18. 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.

  19. 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

  20. Cross-sectional and longitudinal analysis of cancer vaccination trials registered on the US Clinical Trials Database demonstrates paucity of immunological trial endpoints and decline in registration since 2008

    PubMed Central

    Lu, Liangjian; Yan, Haixi; Shyam-Sundar, Vijay; Janowitz, Tobias

    2014-01-01

    Introduction Cancer vaccination has been researched as a means of treating and preventing cancer, but successful translational efforts yielding clinical therapeutics have been limited. Numerous reasons have been offered in explanation, pertaining both to the vaccine formulation, and the clinical trial methodology used. This study aims to characterize the tumor vaccine clinical trial landscape quantitatively, and explore the possible validity of the offered explanations including the translational obstacles posed by the current common endpoints. Methods We performed a detailed cross-sectional and longitudinal analysis of tumor vaccine trials (n=955) registered in the US Clinical Trials database. Results The number of tumor vaccine trials initiated per annum has declined 30% since a peak in 2008. In terms of vaccine formulation, 25% of trials use tumor cell/lysate preparations; whereas, 73% of trials vaccinate subjects against defined protein/peptide antigens. Also, 68% of trials do not use vectors for antigen delivery. Both these characteristics of tumor vaccines have remained unchanged since 1996. The top five types of cancer studied are: melanoma (22.6%); cervical cancer (13.0%); breast cancer (11.3%); lung cancer (9.5%); and prostate cancer (9.4%). In addition, 86% of the trials are performed where there is established disease rather than prophylactically, of which 67% are performed exclusively in the adjuvant setting. Also, 42% of Phase II trials do not measure any survival-related endpoint, and only 23% of Phase III trials assess the immune response to vaccination. Conclusion The clinical trial effort in tumor vaccination is declining, necessitating a greater urgency in identifying and removing the obstacles to clinical translation. These obstacles may include: 1) vaccination against a small range of antigens; 2) naked delivery of antigen; 3) investigation of less immunogenic cancer types; and 4) investigation in the setting of established disease. In addition

  1. The impact of an organ donation registration information program for high school students in the Netherlands.

    PubMed

    Reubsaet, A; Brug, J; Nijkamp, M D; Candel, M J J M; van Hooff, J P; van den Borne, H W

    2005-04-01

    In 1998, a new organ donor registration system was implemented in the Netherlands to increase the number of potential donors. A high school education program was developed to prepare adolescents to make an informed decision about organ donation. A post-test only randomised controlled trial was conducted in 39 high schools including 2868 students. Students within schools were randomly allocated to either attend the organ donation education program or not. The impact of the program on students' intention to register their organ donation preference (and determinants thereof) were analysed using multivariate multileveling modelling (MlwiN). The results show that students who were exposed to the education program had more favourable registration intentions (B = .40), were more often willing to be donors (OR = 1.45), and had greater knowledge about (B = 3.84) and more positive social outcome expectations (B = .09) and self-efficacy regarding organ donation registration (B=.22). Lastly, they experienced significantly less negative outcome expectations related to organ donation registration (B = -.15). Students' evaluation of the school-based education program was favourable. The present organ donation registration program proved to be effective in changing determinants of organ donation registration, and a large-scale implementation in the Dutch high school curriculum is planned.

  2. 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

  3. 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

  4. 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.

  5. 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.

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. Breathe Easier Online: Evaluation of a Randomized Controlled Pilot Trial of an Internet-Based Intervention to Improve Well-being in Children and Adolescents With a Chronic Respiratory Condition

    PubMed Central

    Dunn, Tamara L; Casey, Leanne M; Sheffield, Jeanie K; Petsky, Helen; Anderson-James, Sophie; Chang, Anne B

    2012-01-01

    for the feasibility (acceptability and user satisfaction) and initial efficacy of an Internet-based intervention for improving well-being in children and adolescents with a chronic respiratory condition. Trial registration Australian New Zealand Clinical Trials Registry number: ACTRN12610000214033; http://www.anzctr.org.au/trial_view.aspx?ID=308074 (Archived by WebCite at http://www.webcitation.org/63BL55mXH) PMID:22356732

  12. [Effect of short term graded physical exercise on the level of glycemia in children and adolescents with type 1 diabetes mellitus: data of long term ECG monitoring and registration of motor activity].

    PubMed

    Laptev, D N; Kruzhkova, M N; Riabykina, G V; Poliakov, S D; Korneeva, I T

    2012-01-01

    Study aim was to elucidate effect of graded physical exercise on glycemia level and interval QT duration in children and adolescents with type 1 diabetes mellitus. We carried out 25-hours parallel monitoring of glycemia, ECG and physical activity in 15 children and adolescents aged 9-17 years. During monitoring these patients performed an exercise test (PWC170). We found that there were two periods of significant and prolonged lowering of glycemia: in 120-420 min and 19-21 hours after exercise. Lowering of glycemia after physical exercise was associated with prolongation of QT interval. Registration of motor activity allowed to exclude changes of glycemia due to physical activity unrelated to graded exercise.

  13. 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

  14. 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…

  15. 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.…

  16. 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…

  17. 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…

  18. 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…

  19. 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…

  20. 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…

  1. 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.

  2. 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.

  3. A protocol for a randomised controlled trial investigating the effect of increasing Omega-3 index with krill oil supplementation on learning, cognition, behaviour and visual processing in typically developing adolescents

    PubMed Central

    van der Wurff, I S M; von Schacky, C; Berge, K; Kirschner, P A; de Groot, R H M

    2016-01-01

    peer-reviewed journals. The study is approved by the Medical Ethical Committee of Atrium-Orbis-Zuyd Hospital and is registered at the Netherlands Trial Register (NTR4082). Trial registration numbers NTR4082 and NCT02240264; Pre-results. PMID:27401364

  4. Effectiveness of a structured educational intervention using psychological delivery methods in children and adolescents with poorly controlled type 1 diabetes: a cluster-randomized controlled trial of the CASCADE intervention

    PubMed Central

    Christie, Deborah; Thompson, Rebecca; Sawtell, Mary; Allen, Elizabeth; Cairns, John; Smith, Felicity; Jamieson, Elizabeth; Hargreaves, Katrina; Ingold, Anne; Brooks, Lucy; Wiggins, Meg; Oliver, Sandy; Jones, Rebecca; Elbourne, Diana; Santos, Andreia; Wong, Ian C K; O'Neil, Simon; Strange, Vicki; Hindmarsh, Peter; Annan, Francesca; Viner, Russell M

    2016-01-01

    Introduction Type 1 diabetes (T1D) in children and adolescents is increasing worldwide with a particular increase in children <5 years. Fewer than 1 in 6 children and adolescents achieve recommended glycated hemoglobin (HbA1c) values. Methods A pragmatic, cluster-randomized controlled trial assessed the efficacy of a clinic-based structured educational group incorporating psychological approaches to improve long-term glycemic control, quality of life and psychosocial functioning in children and adolescents with T1D. 28 pediatric diabetes services were randomized to deliver the intervention or standard care. 362 children (8–16 years) with HbA1c≥8.5% were recruited. Outcomes were HbA1c at 12 and 24 months, hypoglycemia, admissions, self-management skills, intervention compliance, emotional and behavioral adjustment, and quality of life. A process evaluation collected data from key stakeholder groups in order to evaluate the feasibility of delivering the intervention. Results 298/362 patients (82.3%) provided HbA1c at 12 months and 284/362 (78.5%) at 24 months. The intervention did not improve HbA1c at 12 months (intervention effect 0.11, 95% CI −0.28 to 0.50, p=0.584), or 24 months (intervention effect 0.03, 95% CI −0.36 to 0.41, p=0.891). There were no significant changes in remaining outcomes. 96/180 (53%) families in the intervention arm attended at least 1 module. The number of modules attended did not affect outcome. Reasons for low uptake included difficulties organizing groups and work and school commitments. Those with highest HbA1cs were less likely to attend. Mean cost of the intervention was £683 per child. Conclusions Significant challenges in the delivery of a structured education intervention using psychological techniques to enhance engagement and behavior change delivered by diabetes nurses and dietitians in routine clinical practice were found. The intervention did not improve HbA1c in children and adolescents with poor control

  5. 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

  6. 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.

  7. 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

  8. 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

  9. 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

  10. 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.

  11. 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.

  12. 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

  13. 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

  14. 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

  15. 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…

  16. 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...

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

    ERIC Educational Resources Information Center

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

    2014-01-01

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

  18. 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…

  19. 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,…

  20. 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…

  1. 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…

  2. 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

  3. 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…

  4. 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.

  5. 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

  6. 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…

  7. 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…

  8. 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…

  9. 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)…

  10. 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…

  11. 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…

  12. 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.

  13. 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

  14. 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

  15. 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.

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  1. Improving transparency of clinical trials.

    PubMed

    Dal-Ré, Rafael

    2015-06-01

    Recent data reveal that subtle selective publication affects critical aspects of trial reporting, in some cases altering the interpretation of results. Timely prospective registration could help deter selective reporting and clinical trial stakeholders from government authorities to journal editors should work together to foster prospective registration of trials.

  2. 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.

  3. 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.

  4. 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.

  5. A school-based intervention incorporating smartphone technology to improve health-related fitness among adolescents: rationale and study protocol for the NEAT and ATLAS 2.0 cluster randomised controlled trial and dissemination study

    PubMed Central

    Lubans, David R; Smith, Jordan J; Peralta, Louisa R; Plotnikoff, Ronald C; Okely, Anthony D; Salmon, Jo; Eather, Narelle; Dewar, Deborah L; Kennedy, Sarah; Lonsdale, Chris; Hilland, Toni A; Estabrooks, Paul; Finn, Tara L; Pollock, Emma; Morgan, Philip J

    2016-01-01

    Introduction Physical inactivity has been described as a global pandemic. Interventions aimed at developing skills in lifelong physical activities may provide the foundation for an active lifestyle into adulthood. In general, school-based physical activity interventions targeting adolescents have produced modest results and few have been designed to be ‘scaled-up’ and disseminated. This study aims to: (1) assess the effectiveness of two physical activity promotion programmes (ie, NEAT and ATLAS) that have been modified for scalability; and (2) evaluate the dissemination of these programmes throughout government funded secondary schools. Methods and analysis The study will be conducted in two phases. In the first phase (cluster randomised controlled trial), 16 schools will be randomly allocated to the intervention or a usual care control condition. In the second phase, the Reach, Effectiveness, Adoption, Implementation and Maintenance (Re-AIM) framework will be used to guide the design and evaluation of programme dissemination throughout New South Wales (NSW), Australia. In both phases, teachers will be trained to deliver the NEAT and ATLAS programmes, which will include: (1) interactive student seminars; (2) structured physical activity programmes; (3) lunch-time fitness sessions; and (4) web-based smartphone apps. In the cluster RCT, study outcomes will be assessed at baseline, 6 months (primary end point) and 12-months. Muscular fitness will be the primary outcome and secondary outcomes will include: objectively measured body composition, cardiorespiratory fitness, flexibility, resistance training skill competency, physical activity, self-reported recreational screen-time, sleep, sugar-sweetened beverage and junk food snack consumption, self-esteem and well-being. Ethics and dissemination This study has received approval from the University of Newcastle (H-2014-0312) and the NSW Department of Education (SERAP: 2012121) human research ethics committees. This

  6. FAST CP: protocol of a randomised controlled trial of the efficacy of a 12-week combined Functional Anaerobic and Strength Training programme on muscle properties and mechanical gait deficiencies in adolescents and young adults with spastic-type cerebral palsy

    PubMed Central

    Gillett, Jarred G; Lichtwark, Glen A; Boyd, Roslyn N; Barber, Lee A

    2015-01-01

    Introduction Individuals with cerebral palsy (CP) have muscles that are smaller, weaker and more resistant to stretch compared to typically developing people. Progressive resistance training leads to increases in muscle size and strength. In CP, the benefits of resistance training alone may not transfer to improve other activities such as walking; however, the transfer of strength improvements to improved mobility may be enhanced by performing training that involves specific functional tasks or motor skills. This study aims to determine the efficacy of combined functional anaerobic and strength training in (1) influencing muscle strength, structure and function and (2) to determine if any changes in muscle strength and structure following training impact on walking ability and gross motor functional capacity and performance in the short (following 3 months of training) and medium terms (a further 3 months post-training). Methods and analysis 40 adolescents and young adults with CP will be recruited to undertake a 12-week training programme. The training programme will consist of 3×75 min sessions per week, made up of 5 lower limb resistance exercises and 2–3 functional anaerobic exercises per session. The calf muscles will be specifically targeted, as they are the most commonly impacted muscles in CP and are a key muscle group involved in walking. If, as we believe, muscle properties change following combined strength and functional training, there may be long-term benefits of this type of training in slowing the deterioration of muscle function in people with spastic-type CP. Ethics and dissemination Ethical approval has been obtained from the ethics committees at The University of Queensland (2014000066) and Children's Health Queensland (HREC/15/QRCH/30). The findings will be disseminated by publications in peer-reviewed journals, conferences and local research organisations’ media. Trial registration number Australian and New Zealand Clinical Trials

  7. 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…

  8. 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…

  9. 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…

  10. 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

  11. 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

  12. 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

  13. 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.

  14. 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.

  15. 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

  16. 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.

  17. 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

  18. 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…

  19. 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.

  20. Effect of Novel, School-Based High-Intensity Interval Training (HIT) on Cardiometabolic Health in Adolescents: Project FFAB (Fun Fast Activity Blasts) - An Exploratory Controlled Before-And-After Trial

    PubMed Central

    2016-01-01

    development underlines the importance of our findings. We also demonstrated that school-based low-volume high-intensity interval training can be delivered as intended, thus representing a novel and scalable means of improving aspects of adolescents’ cardiometabolic health. Trial Registration ClinicalTrials.gov NCT02626767 PMID:27486660

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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.

  8. 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

  9. 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.

  10. 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

  11. 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

  12. 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

  13. 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.

  14. 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.

  15. 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

  16. 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.

  17. 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.

  18. 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

  19. 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.

  20. 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

  1. 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.

  2. 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

  3. 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

  4. Pesticide Registration Information System

    EPA Pesticide Factsheets

    PRISM provides an integrated, web portal for all pesticide related data, communications, registrations and transactions for OPP and its stakeholders, partners and customers. PRISM supports Strategic Goal 4 by automating pesticide registration processes.

  5. From the Experience of Interactivity and Entertainment to Lower Intention to Smoke: A Randomized Controlled Trial and Path Analysis of a Web-Based Smoking Prevention Program for Adolescents

    PubMed Central

    Wang, Hua; Calabro, Karen Sue; Mitra, Natasha; Shegog, Ross

    2017-01-01

    Adolescents’ experience of interactivity and entertainment contributed to the expected outcome of lower intention to smoke. Also, emphasis needs to be placed on the emotional experience during Web-based interventions in order to maximize reductions in smoking intentions. Going beyond mere evaluation of the effectiveness of a Web-based smoking prevention program, this study contributes to the understanding of adolescents’ psychological experience and its effect on their intention to smoke. With the results of this study, researchers can work to (1) enhance the experience of interactivity and entertainment and (2) amplify concepts of media effects (eg, presence and emotional involvement) in order to better reach health behavior outcomes. Trial Registration Clinicaltrials.gov NCT02469779; https://clinicaltrials.gov/ct2/show/NCT02469779 (Archived by WebCite at http://www.webcitation.org/6nxyZVOf0) PMID:28209560

  6. 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

  7. 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.

  8. 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…

  9. 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…

  10. 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…

  11. 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…

  12. 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…

  13. 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.

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

    PubMed Central

    Watanabe, Junko; Watanabe, Mariko; Yamaoka, Kazue; Adachi, Misa; Nemoto, Asuka; Tango, Toshiro

    2016-01-01

    In this study, we aimed to assess the effectiveness of a school-based home-collaborative lifestyle education program for adolescents (PADOK) in reducing poor subjective psychosomatic symptoms (SPS). The study was designed as a two-armed parallel cluster randomised controlled trial and the study population comprised adolescent students (aged 12–14 years, n = 1,565) who were recruited from 19 middle schools in Japan. The PADOK intervention or usual school programme was provided in schools to all eligible participants. The primary outcome was the SPS score at 6 months, while secondary outcomes included lifestyle factors, BMI, and dietary intakes. Analyses were undertaken on an intention to treat (ITT) basis accounting for the clustered design. Nineteen schools were randomised to the PADOK group (10 schools) and control group (9 schools). The numbers of students used for analysis were 1,509 for ITT and 1,420 (94.1%) for PPS. At 6 months, the crude mean change from baseline of the SPS scores by ITT analysis showed a significantly greater reduction in the PADOK group compared to that in the control group (−0.95, 95% CI −1.70 to −0.20, P = 0.016), while those for baseline-adjusted and multivariate-adjusted values showed similar directionality but were not significant (P = 0.063 and P = 0.130). The results indicated that the PADOK program may improve poor SPS scores among adolescents. PMID:27780251

  15. 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.

  16. 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

  17. A randomised placebo-exercise controlled trial of Kung Fu training for improvements in body composition in overweight/obese adolescents: the "Martial Fitness" study.

    PubMed

    Tsang, Tracey W; Kohn, Michael; Chow, Chin Moi; Singh, M Fiatarone

    2009-01-01

    The purpose of the study was to investigate if Chinese martial arts (Kung Fu, KF) might be effective for improving body composition, as well as being an appealing form of physical activity for inexperienced, sedentary, overweight/obese adolescents. Twenty subjects (age: 13.3 ± 1.8 y; BMI percentile: 98.6(86.5 - 99.8); 60% girls) were randomly-assigned to the supervised KF or placebo (Tai Chi, TC) control group 3 d.wk(-1) for 6 months. We assessed body composition, including total and regional fat and lean mass, total and regional bone mineral density (BMD), percent lean and fat mass, body mass index and waist circumference, at baseline and after 6 months of training using anthropometry and dual-energy X-ray absorptiometry (DXA). Habitual physical activity and dietary intake were recorded as covariates via self-report at each time-point. As expected due to natural growth, significant increases in height, weight, total and lumbar BMD, and lean mass were seen in the cohort over time, with a trend for increased whole body fat mass, with no difference between groups. By contrast, percent fat and android fat mass via DXA did not increase in either group over time. The absence of a similar expected increase in central adiposity over 6 months could indicate a positive effect of participation in both programs on the metabolically critical abdominal adiposity in this cohort. Further research in this area is warranted to determine ways to increase uptake and compliance, and to see if longer-term martial arts training not only maintains, but improves abdominal fat mass and related metabolic health indices in overweight/ obese adolescents. Key pointsParticipation in our martial arts trial attenuated the increases in body fat mass expected due to growth in our overweight/obese adolescent group.All subjects allocated to the Kung Fu intervention were satisfied with their Kung Fu training, in contrast to our placebo-exercise (Tai Chi) subjects, suggesting that this form of

  18. 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

  19. 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.

  20. 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.

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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

  6. 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

  7. Image Registration Workshop Proceedings

    NASA Technical Reports Server (NTRS)

    LeMoigne, Jacqueline (Editor)

    1997-01-01

    Automatic image registration has often been considered as a preliminary step for higher-level processing, such as object recognition or data fusion. But with the unprecedented amounts of data which are being and will continue to be generated by newly developed sensors, the very topic of automatic image registration has become and important research topic. This workshop presents a collection of very high quality work which has been grouped in four main areas: (1) theoretical aspects of image registration; (2) applications to satellite imagery; (3) applications to medical imagery; and (4) image registration for computer vision research.

  8. 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 ...

  9. 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…

  10. 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…

  11. Schroth Physiotherapeutic Scoliosis-Specific Exercises Added to the Standard of Care Lead to Better Cobb Angle Outcomes in Adolescents with Idiopathic Scoliosis – an Assessor and Statistician Blinded Randomized Controlled Trial

    PubMed Central

    Parent, Eric C.; Khodayari Moez, Elham; Hedden, Douglas M.; Hill, Douglas L.; Moreau, Marc; Lou, Edmond; Watkins, Elise M.; Southon, Sarah C.

    2016-01-01

    curve severity in patients with AIS. Trial Registration NCT01610908 PMID:28033399

  12. 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.

  13. 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…

  14. 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…

  15. 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…

  16. 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…

  17. 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...

  18. 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…

  19. 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…

  20. 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…

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  7. 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

  8. 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

  9. 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

  10. 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

  11. Sexuality Talk During Adolescent Health Maintenance Visits

    PubMed Central

    Alexander, Stewart C.; Fortenberry, J. Dennis; Pollak, Kathryn I.; Bravender, Terrill; Davis, J. Kelly; Østbye, Truls; Tulsky, James A.; Dolor, Rowena J.; Shields, Cleveland G.

    2015-01-01

    associations between adolescent, physician, and visit characteristics were significantly associated with greater adolescent participation. Conclusions and Relevance Our study may be the first to directly observe sexuality talk between physicians and adolescents. We found that one-third of all adolescents had annual visits without any mention of sexuality issues; when sexuality talk occurred, it was brief. Research is needed to identify successful strategies physicians can use to engage adolescents in discussions about sexuality to help promote healthy sexual development and decision making. Trial Registration clinicaltrials.gov Identifier: NCT01040975 PMID:24378686

  12. 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.

  13. 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.

  14. 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

  15. 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.

  16. 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.

  17. 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.

  18. 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

  19. 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.

  20. CSPP CDX Registration Guide

    EPA Pesticide Factsheets

    CDX allows users submitting data to the EPA to register for the specific program of interest. This Guide describes the registration process and information requirements associated with Submissions for the Chemical Safety and Pesticide Programs (CSPP).

  1. Lesson 6: Registration

    EPA Pesticide Factsheets

    Lesson 6 provides checklist items 1 through 4 are grouped under the Registration Process, where users establish their accounts in the system. This process typically requires users to provide information about them.

  2. Registration of Enlist Duo

    EPA Pesticide Factsheets

    EPA is proposing to amend the registration of Enlist Duo to allow use on GE cotton in the original 15 states and extend the use of Enlist Duo on GE corn, soybean and cotton to an additional 19 states.

  3. 21 CFR 710.8 - Misbranding by reference to registration or to registration number.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.8 Misbranding by reference to registration or to registration number. Registration of a cosmetic...

  4. 21 CFR 710.8 - Misbranding by reference to registration or to registration number.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.8 Misbranding by reference to registration or to registration number. Registration of a cosmetic...

  5. 21 CFR 710.8 - Misbranding by reference to registration or to registration number.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.8 Misbranding by reference to registration or to registration number. Registration of a cosmetic...

  6. 21 CFR 710.8 - Misbranding by reference to registration or to registration number.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.8 Misbranding by reference to registration or to registration number. Registration of a cosmetic...

  7. 21 CFR 710.8 - Misbranding by reference to registration or to registration number.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... HUMAN SERVICES (CONTINUED) COSMETICS VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS § 710.8 Misbranding by reference to registration or to registration number. Registration of a cosmetic...

  8. 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

  9. 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

  10. 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.

  11. 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…

  12. 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

  13. 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.

  14. 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

  15. 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.

  16. 14 CFR 47.15 - Registration number.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 1 2013-01-01 2013-01-01 false Registration number. 47.15 Section 47.15... REGISTRATION General § 47.15 Registration number. (a) Number required. An applicant for aircraft registration must place a U.S. registration number (registration mark) on the Aircraft Registration Application,...

  17. 14 CFR 47.15 - Registration number.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 1 2012-01-01 2012-01-01 false Registration number. 47.15 Section 47.15... REGISTRATION General § 47.15 Registration number. (a) Number required. An applicant for aircraft registration must place a U.S. registration number (registration mark) on the Aircraft Registration Application,...

  18. 14 CFR 47.15 - Registration number.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 1 2011-01-01 2011-01-01 false Registration number. 47.15 Section 47.15... REGISTRATION General § 47.15 Registration number. (a) Number required. An applicant for aircraft registration must place a U.S. registration number (registration mark) on the Aircraft Registration Application,...

  19. 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

  20. User Registration in EOSDIS

    NASA Astrophysics Data System (ADS)

    Murphy, K. J.; Mitchell, A. E.

    2009-12-01

    Throughout the lifetime of EOSDIS the topic of user registration has received varied attention. Initially, for example, users ordering data from the Earth Science Data Gateway were required to register for delivery of media orders, to check order status and save profile information for future interactions. As EOSDIS embraced evolution of its data systems, the mostly centralized search and order system was replaced with a more diverse set of interfaces allowing (mostly) anonymous online access to data, tools and services. The changes to EOSDIS were embraced by users but the anonymous nature of the interaction made it more difficult to characterize users, capture metrics and provide customized services that benefit users. Additionally, new tools and interfaces have been developed without a centralized registration system. Currently a patchwork of independent registration systems exists throughout EOSDIS for ordering data and interacting with online tools and services. Each requires a separate username and password that must be managed by users. A consolidation of registration systems presents an opportunity to improve not only the user experience through tool customization and simplification of password management, but the understanding of users. This work discusses the options for implementing a common user registration for the EOSDIS, anticipated benefits and pitfalls.

  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. 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

  3. 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.

  4. 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

  5. Image registration by parts

    NASA Technical Reports Server (NTRS)

    Chalermwat, Prachya; El-Ghazawi, Tarek; LeMoigne, Jacqueline

    1997-01-01

    In spite of the large number of different image registration techniques, most of these techniques use the correlation operation to match spatial image characteristics. Correlation is known to be one of the most computationally intensive operations and its computational needs grow rapidly with the increase in the image sizes. In this article, we show that, in many cases, it might be sufficient to determine image transformations by considering only one or several parts of the image rather than the entire image, which could result in substantial computational savings. This paper introduces the concept of registration by parts and investigates its viability. It describes alternative techniques for such image registration by parts and presents early empirical results that address the underlying trade-offs.

  6. Analysis of subpixel registration

    NASA Technical Reports Server (NTRS)

    Berenstein, C. A.; Kanal, L. N.; Lavine, D.; Olson, E. C.; Slud, E.

    1984-01-01

    The area of subpixel accuracy in image registration and edge detection was studied. Two main directions of research were pursued, edge detection and matching based on the digital geometry of edges, and random field models for probablistic analysis of registration error. In the edge detection approach, error bounds and error probabilities were computed using theoretical models. Algorithms were developed and tests on simulated imagery. The methods appear promising for high accuracy edge position estimation and registration, though further refinement of the procedures is required. Using random field models, a statistical measure of the quality of the cross correlation peak as an estimate of the offset between a sensed and a reference image was developed. Simulations were performed to determine the validity of this estimte with real imagery and to study the results of interpolating digital correlation functions to estimate the translation offset to subpixel accuracy.

  7. Towards operational multisensor registration

    NASA Technical Reports Server (NTRS)

    Rignot, Eric J. M.; Kwok, Ronald; Curlander, John C.

    1991-01-01

    To use data from a number of different remote sensors in a synergistic manner, a multidimensional analysis of the data is necessary. However, prior to this analysis, processing to correct for the systematic geometric distortion characteristic of each sensor is required. Furthermore, the registration process must be fully automated to handle a large volume of data and high data rates. A conceptual approach towards an operational multisensor registration algorithm is presented. The performance requirements of the algorithm are first formulated given the spatially, temporally, and spectrally varying factors that influence the image characteristics and the science requirements of various applications. Several registration techniques that fit within the structure of this algorithm are also presented. Their performance was evaluated using a multisensor test data set assembled from LANDSAT TM, SEASAT, SIR-B, Thermal Infrared Multispectral Scanner (TIMS), and SPOT sensors.

  8. 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

  9. 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.

  10. 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 efficacy in ADHD have shown mixed and, therefore, inconclusive results. Methods: Seventy-six male adolescents (age 12–16 years, mean = 13.7) with ADHD were assessed for the effects of 12 weeks omega-3 and omega-6 supplements on biochemical and psychological outcomes in a randomized, placebo-controlled, clinical trial. The primary outcome measure was change in the Conners' Teacher Rating Scales (CTRS) following 12 weeks of supplementation of LC-PUFA or placebo. At baseline, the placebo and treatment groups had comparable levels of LC-PUFA as measured by red blood cell phosphatidylcholine. In the treatment group, supplementation enhanced eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and total omega-3 fatty acid levels. Results: No superiority of LC-PUFAs to placebo was observed on the primary outcome. Further, there were no reliable treatment effects on aggression, impulsivity, depression, and anxiety. Conclusions: Future studies should use larger sample sizes and longer supplementation period to detect small-modest effects for clinical recommendations in ADHD. PMID:26682998

  11. A Randomized Controlled Trial Investigating the Effects of a Special Extract of Bacopa monnieri (CDRI 08) on Hyperactivity and Inattention in Male Children and Adolescents: BACHI Study Protocol (ANZCTRN12612000827831)

    PubMed Central

    Kean, James D.; Kaufman, Jordy; Lomas, Justine; Goh, Antionette; White, David; Simpson, David; Scholey, Andrew; Singh, Hemant; Sarris, Jerome; Zangara, Andrea; Stough, Con

    2015-01-01

    Clinical diagnoses of Attention Deficit Hyperactivity Disorder (ADHD) and the use of prescription medications for its treatment have increased in recent years. Current treatments may involve the administration of amphetamine-type substances, a treatment path many parents are apprehensive to take. Therefore, alternative pharmacological treatments are required. Few nutritional or pharmacological alternatives that reduce ADHD associated symptoms (hyperactivity and inattention) have been subjected to rigorous clinical trials. Bacopa monnieri is a perennial creeping herb. CDRI 08 is a special extract of Bacopa monnieri which has been subjected to hundreds of scientific studies and has been shown in human randomized controlled trials (RCTs) to improve memory, attention, and mood. It is hypothesised that chronic administration of CDRI 08 will improve attention, concentration and behaviour in children with high levels of hyperactivity and/or inattention. This paper reports the protocol for the first 16-week, randomized, placebo-controlled, double-blind, parallel groups trial examining the efficacy and safety of CDRI 08 in male children aged 6–14 years with high levels of inattention and hyperactivity. The primary outcome variable will be the level of hyperactivity and inattention measured by the Conners’ Parent Rating Scale (CPRS). Secondary outcome variables include cognition, mood, sleep, and EEG. Trial registration: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12612000827831. PMID:26633481

  12. Suspension of Registrations under FIFRA

    EPA Pesticide Factsheets

    Under FIFRA Section 3(c)(2)(B), this generally halts further distribution and sale of the suspended pesticide product by the registrant. Find suspension listings by product name, active ingredient, registrant name, date, and contact information.

  13. Registration Documents for Enlist Duo Herbicide (2014)

    EPA Pesticide Factsheets

    See details of the registration of Enlist Duo in 2014, including the notification to the registrant, the details of the assessment and registration decision, and the response to public comment on the proposed registration.

  14. Distributed Continuous Registration.

    ERIC Educational Resources Information Center

    Myers, Donald L.

    1981-01-01

    The development, implementation, and features of Northern Colorado's continuous registration system are described. The system is an online distributed processing system, written in COBOL for an IBM Series I under the CPS operating system. Course selection, permit to enroll, and drop/add forms are provided. (Author/MLW)

  15. Registration Priorities: A Report.

    ERIC Educational Resources Information Center

    Walters, Judy E.

    In May 1993, the California Community Colleges' Board of Governors adopted systemwide guidelines recommending student registration priorities to help address current discrepancies between available resources and courses and the colleges' open-door mission. This report describes the guidelines and results of a study conducted to determine their…

  16. Earth Science Imagery Registration

    NASA Technical Reports Server (NTRS)

    LeMoigne, Jacqueline; Morisette, Jeffrey; Cole-Rhodes, Arlene; Johnson, Kisha; Netanyahu, Nathan S.; Eastman, Roger; Stone, Harold; Zavorin, Ilya

    2003-01-01

    The study of global environmental changes involves the comparison, fusion, and integration of multiple types of remotely-sensed data at various temporal, radiometric, and spatial resolutions. Results of this integration may be utilized for global change analysis, as well as for the validation of new instruments or for new data analysis. Furthermore, future multiple satellite missions will include many different sensors carried on separate platforms, and the amount of remote sensing data to be combined is increasing tremendously. For all of these applications, the first required step is fast and automatic image registration, and as this need for automating registration techniques is being recognized, it becomes necessary to survey all the registration methods which may be applicable to Earth and space science problems and to evaluate their performances on a large variety of existing remote sensing data as well as on simulated data of soon-to-be-flown instruments. In this paper we present one of the first steps toward such an exhaustive quantitative evaluation. First, the different components of image registration algorithms are reviewed, and different choices for each of these components are described. Then, the results of the evaluation of the corresponding algorithms combining these components are presented o n several datasets. The algorithms are based on gray levels or wavelet features and compute rigid transformations (including scale, rotation, and shifts). Test datasets include synthetic data as well as data acquired over several EOS Land Validation Core Sites with the IKONOS and the Landsat-7 sensors.

  17. Registration Study. Research Note.

    ERIC Educational Resources Information Center

    Baratta, Mary Kathryne

    During spring 1977 registration, 3,255 or 45% of Moraine Valley Community College (MVCC) registering students responded to a scheduling preferences and problems questionnaire covering enrollment status, curriculum load, program preference, ability to obtain courses, schedule conflicts, preferred times for class offerings, actual scheduling of…

  18. CUNY's Voter Registration System.

    ERIC Educational Resources Information Center

    Hershenson, Jay; And Others

    This collection of items including public testimony by the Vice Chancellor, Jay Hershenson, a formal resolution, a press release, and brochures, documents the City University of New York's (CUNY) unique voter registration system, "CUNY Project Vote". As the press release describes it, Project Vote is the nation's largest student voter…

  19. Disclosure of investigators' recruitment performance in multicenter clinical trials: a further step for research transparency.

    PubMed

    Dal-Ré, Rafael; Moher, David; Gluud, Christian; Treweek, Shaun; Demotes-Mainard, Jacques; Carné, Xavier

    2011-12-01

    Rafael Dal-Ré and colleagues argue that the recruitment targets and performance of all site investigators in multi-centre clinical trials should be disclosed in trial registration sites before a trial starts, and when it ends.

  20. A randomized controlled trial of Kung Fu training for metabolic health in overweight/obese adolescents: the "martial fitness" study.

    PubMed

    Tsang, Tracey W; Kohn, Michael; Chow, Chin Moi; Singh, Maria Fiatarone

    2009-07-01

    Twenty overweight/obese adolescents underwent six months of Kung Fu or placebo (Tai Chi) training, 3x.wk(-1). Outcomes included fasting insulin and insulin resistance, lipids, glucose and HbA(1c), and C-reactive protein (CRP). CRP decreased significantly (p = 0.03) in both groups over time at six months. Although insulin sensitivity did not change, HbA(1c) tended to decrease over time (p = 0.09), again with no group difference (p = 0.60). Reduced CRP was related to increased upper body strength (p = 0.01). Increased lean body mass was related to reductions in HbA(1c), insulin resistance, triglycerides, and total cholesterol. Improvements in lean body mass appear to have a potential role in favorable metabolic outcomes, independent of changes in fat mass. Further research in this area is warranted before definite conclusions can be drawn about the efficacy of martial arts training for metabolic outcomes in this cohort.

  1. The hidden KPI registration accuracy.

    PubMed

    Shorrosh, Paul

    2011-09-01

    Determining the registration accuracy rate is fundamental to improving revenue cycle key performance indicators. A registration quality assurance (QA) process allows errors to be corrected before bills are sent and helps registrars learn from their mistakes. Tools are available to help patient access staff who perform registration QA manually.

  2. 77 FR 75670 - Importer of Controlled Substances; Notice of Registration; Fisher Clinical Services,Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-21

    ... Enforcement Administration Importer of Controlled Substances; Notice of Registration; Fisher Clinical Services... FR 60143, Fisher Clinical Services, Inc., 7554 Schantz Road, Allentown, Pennsylvania 18106, made... listed substances for analytical research and clinical trials. No comments or objections have...

  3. Implications of the ethical-legal framework for adolescent HIV vaccine trials--report of a consultative forum.

    PubMed

    Slack, Catherine; Strode, Ann; Grant, Catherine; Milford, Cecilia

    2005-09-01

    The ethical-legal framework in South Africa is in a period of transition, with a number of new developments changing the substantive principles and procedures for health research in the country. Some of the changing dynamics include both law reform and the review of ethical guidelines. This changing environment poses many complexities for researchers, research ethics committees and participating communities involved in planning, implementing and reviewing research with child participants, including HIV vaccine trials. This paper presents the major themes and outcomes of a consultative meeting convened by the HIV AIDS Vaccines Ethics Group in July 2004 for key stakeholder groups. At this forum participants discussed the complexities posed by a transitional and sometimes contradictory ethical-legal framework and how the framework could be improved to simultaneously promote critical research and the welfare of child participants.

  4. 14 CFR 47.43 - Invalid registration.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 1 2014-01-01 2014-01-01 false Invalid registration. 47.43 Section 47.43... REGISTRATION Certificates of Aircraft Registration § 47.43 Invalid registration. (a) The registration of an...) compliance with 49 U.S.C. 44101-44104. (b) If the registration of an aircraft is invalid under paragraph...

  5. 32 CFR 1615.1 - Registration.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 32 National Defense 6 2011-07-01 2011-07-01 false Registration. 1615.1 Section 1615.1 National... REGISTRATION § 1615.1 Registration. (a) Registration under selective service law consists of: (1) Completing a registration card or other method of registration prescribed by the Director of Selective Service by a...

  6. 32 CFR 1615.1 - Registration.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 32 National Defense 6 2013-07-01 2013-07-01 false Registration. 1615.1 Section 1615.1 National... REGISTRATION § 1615.1 Registration. (a) Registration under selective service law consists of: (1) Completing a registration card or other method of registration prescribed by the Director of Selective Service by a...

  7. 32 CFR 1615.1 - Registration.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 32 National Defense 6 2010-07-01 2010-07-01 false Registration. 1615.1 Section 1615.1 National... REGISTRATION § 1615.1 Registration. (a) Registration under selective service law consists of: (1) Completing a registration card or other method of registration prescribed by the Director of Selective Service by a...

  8. 14 CFR 47.43 - Invalid registration.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 1 2013-01-01 2013-01-01 false Invalid registration. 47.43 Section 47.43... REGISTRATION Certificates of Aircraft Registration § 47.43 Invalid registration. (a) The registration of an...) compliance with 49 U.S.C. 44101-44104. (b) If the registration of an aircraft is invalid under paragraph...

  9. 14 CFR 47.43 - Invalid registration.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Invalid registration. 47.43 Section 47.43... REGISTRATION Certificates of Aircraft Registration § 47.43 Invalid registration. (a) The registration of an...) compliance with 49 U.S.C. 44101-44104. (b) If the registration of an aircraft is invalid under paragraph...

  10. 32 CFR 1615.1 - Registration.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 32 National Defense 6 2014-07-01 2014-07-01 false Registration. 1615.1 Section 1615.1 National... REGISTRATION § 1615.1 Registration. (a) Registration under selective service law consists of: (1) Completing a registration card or other method of registration prescribed by the Director of Selective Service by a...

  11. 32 CFR 1615.1 - Registration.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 32 National Defense 6 2012-07-01 2012-07-01 false Registration. 1615.1 Section 1615.1 National... REGISTRATION § 1615.1 Registration. (a) Registration under selective service law consists of: (1) Completing a registration card or other method of registration prescribed by the Director of Selective Service by a...

  12. Sex differences in adolescents' glycaemic and insulinaemic responses to high and low glycaemic index breakfasts: a randomised control trial.

    PubMed

    Cooper, Simon B; Dring, Karah J; Morris, John G; Cousins, Ben E W; Nute, Maria L; Nevill, Mary E

    2017-03-13

    During puberty young people undergo significant hormonal changes which affect metabolism and, subsequently, health. Evidence suggests there is a period of transient pubertal insulin resistance, with this effect greater in girls than boys. However, the response to everyday high and low glycaemic index (GI) meals remains unknown. Following ethical approval, forty adolescents consumed a high GI or low GI breakfast, in a randomised cross-over design. Capillary blood samples were taken during a 2-h postprandial period, examining the glycaemic and insulinaemic responses. Maturity offset and homoeostatic model assessment (HOMA) were also calculated. The glycaemic response to the breakfasts was similar between boys and girls, as shown by similar peak blood glucose concentrations and incremental AUC (IAUC) following both high and low GI breakfasts (all P>0·05). Girls exhibited a higher peak plasma insulin concentration 30 min post-breakfast following both high GI (P=0·043, g=0·69) and low GI (P=0·010, g=0·84) breakfasts, as well as a greater IAUC following high GI (P=0·041, g=0·66) and low GI (P=0·041, g=0·66) breakfasts. HOMA was positively correlated with the insulinaemic responses (all P<0·0005) and maturity offset (P=0·037). The findings of the present study suggest that pubertal insulin resistance affects the postprandial insulinaemic responses to both high and low GI meals. Specifically, girls exhibit a greater insulinaemic response than boys to both meals, despite similar glycaemic responses. This study is the first to report the glycaemic and insulinaemic responses to everyday meals in boys and girls, supporting the recommendation for young people to base their diet on low GI carbohydrates.

  13. 75 FR 10312 - Importer of Controlled Substances; Notice of Registration

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-05

    ... importer of Fentanyl (9801), a basic class of controlled substance listed in schedule II. The company plans... for distribution to clinical trial sites. No comments or objections have been received. DEA has... company's registration is consistent with the public interest. The investigation has included...

  14. PROFESSIONAL REGISTRATION OF GOVERNMENT ENGINEERS.

    USGS Publications Warehouse

    Buchanan, Thomas J.

    1985-01-01

    The American Society of Civil Engineers views professional registration as an appropriate requirement for engineers, including those in government. The National Society of Professional Engineers makes registration a requirement for the grade of member and full privileges in the society. Some Federal agencies require engineering registration for certain positions in their agencies. Engineers in government service should consider the value of engineering registration to themselves and to their agencies and take pride in their professions and in their own capabilities by becoming registered engineers. They should also take steps to encourage their agencies to give more attention to engineering registration.

  15. Image registration with uncertainty analysis

    DOEpatents

    Simonson, Katherine M [Cedar Crest, NM

    2011-03-22

    In an image registration method, edges are detected in a first image and a second image. A percentage of edge pixels in a subset of the second image that are also edges in the first image shifted by a translation is calculated. A best registration point is calculated based on a maximum percentage of edges matched. In a predefined search region, all registration points other than the best registration point are identified that are not significantly worse than the best registration point according to a predetermined statistical criterion.

  16. Solithromycin Pharmacokinetics in Plasma and Dried Blood Spots and Safety in Adolescents

    PubMed Central

    Gonzalez, Daniel; Palazzi, Debra L.; Bhattacharya-Mithal, Leena; Al-Uzri, Amira; James, Laura P.; Bradley, John; Neu, Natalie; Jasion, Theresa; Hornik, Christoph P.; Smith, P. Brian; Benjamin, Daniel K.; Keedy, Kara; Fernandes, Prabhavathi

    2016-01-01

    We assessed the pharmacokinetics and safety of solithromycin, a fluoroketolide antibiotic, in a phase 1, open-label, multicenter study of 13 adolescents with suspected or confirmed bacterial infections. On days 3 to 5, the mean (standard deviation) maximum plasma concentration and area under the concentration versus time curve from 0 to 24 h were 0.74 μg/ml (0.61 μg/ml) and 9.28 μg · h/ml (6.30 μg · h/ml), respectively. The exposure and safety in this small cohort of adolescents were comparable to those for adults. (This study has been registered at ClinicalTrials.gov under registration no. NCT01966055.) PMID:26883693

  17. Memantine versus Methylphenidate in Children and Adolescents with Attention Deficit Hyperactivity Disorder: A Double-Blind, Randomized Clinical Trial

    PubMed Central

    Mohammadi, Mohammad Reza; Mohammadzadeh, Soleiman; Akhondzadeh, Shahin

    2015-01-01

    Objectives: The aim of this randomized clinical trial was to assess the efficacy of memantine versus methylphenidate in the treatment of children with attention deficit hyperactivity disorder. Method: Forty participants (34 boys and 6 girls) aged 6-11 who were diagnosed with attention deficit hyperactivity disorder based on (DSM-IV-TR) criteria were selected for this study. The participants were randomly assigned to two groups: group one (n = 22) received memantine and the other group (n = 18) received methylphenidate for six weeks. Treatment outcomes were assessed using the Attention Deficit Hyperactivity Rating Scale and Clinical Global Impression- Severity Scale administered at baseline and at weeks 3 and 6 following the treatment. Also, a two-way repeated measures analysis of variance (time- treatment interaction) was used. Results: At 6 weeks, methylphenidate produced a significantly better outcome on the Parent Rating Scale scores and Clinical Global Impression- Severity than memantine. Side effects were observed more often in the memantine group. However, with respect to the frequency of side effects, the difference between the memantine and methylphenidate groups was not significant. The most common side effects associated with memantine are appetite suppression, headache, vomiting, nausea and fatigue. Conclusion: The results of this study revealed that although memantine was less effective than methylphenidate in the treatment of attention deficit hyperactivity disorder, it may be considered as an alternative treatment. PMID:26884787

  18. Cluster Randomized Controlled Trial of Group Prenatal Care: Perinatal Outcomes Among Adolescents in New York City Health Centers

    PubMed Central

    Earnshaw, Valerie; Lewis, Jessica B.; Kershaw, Trace S.; Magriples, Urania; Stasko, Emily; Rising, Sharon Schindler; Cassells, Andrea; Cunningham, Shayna; Bernstein, Peter; Tobin, Jonathan N.

    2016-01-01

    Objectives. We compared an evidence-based model of group prenatal care to traditional individual prenatal care on birth, neonatal, and reproductive health outcomes. Methods. We performed a multisite cluster randomized controlled trial in 14 health centers in New York City (2008–2012). We analyzed 1148 pregnant women aged 14 to 21 years, at less than 24 weeks of gestation, and not at high obstetrical risk. We assessed outcomes via medical records and surveys. Results. In intention-to-treat analyses, women at intervention sites were significantly less likely to have infants small for gestational age (< 10th percentile; 11.0% vs 15.8%; odds ratio = 0.66; 95% confidence interval = 0.44, 0.99). In as-treated analyses, women with more group visits had better outcomes, including small for gestational age, gestational age, birth weight, days in neonatal intensive care unit, rapid repeat pregnancy, condom use, and unprotected sex (P = .030 to < .001). There were no associated risks. Conclusions. CenteringPregnancy Plus group prenatal care resulted in more favorable birth, neonatal, and reproductive outcomes. Successful translation of clinical innovations to enhance care, improve outcomes, and reduce cost requires strategies that facilitate patient adherence and support organizational change. PMID:26691105

  19. Impact of Two Adolescent Pregnancy Prevention Interventions on Risky Sexual Behavior: A Three-Arm Cluster Randomized Control Trial

    PubMed Central

    Cunningham, Michael R.; van Zyl, Michiel A.; Antle, Becky F.; Langley, Cheri N.

    2016-01-01

    Objectives. To test the efficacy of Reducing the Risk (RTR) and Love Notes (LN) on reducing risky sexual behavior among youths yet to experience or cause a pregnancy. Methods. The four dependent variables were ever had sex, condom use, birth control use, and number of sexual partners at 3- and 6-month follow-up in a 3-arm cluster randomized controlled trial of 1448 impoverished youths, aged 14 to 19 years, in 23 community-based organizations in Louisville, Kentucky, from September 2011 through March 2014. Results. At 3 and 6 months, compared with the control condition, youths in RTR reported fewer sexual partners and greater use of birth control. At 6 months, LN participants reported greater use of birth control and condoms, fewer sexual partners, and were less likely to have ever had sex compared with the control condition. Conclusions. We provided additional evidence for the continued efficacy of RTR and the first rigorous study of LN, which embeds sex education into a larger curriculum on healthy relationships and violence prevention. PMID:27689500

  20. Effects of a sleep education program with self-help treatment on sleeping patterns and daytime sleepiness in Japanese adolescents: A cluster randomized trial.

    PubMed

    Tamura, Norihisa; Tanaka, Hideki

    2016-01-01

    Subjective insufficient sleep and delayed sleep-wake patterns have been reported as the primary causes for daytime sleepiness, a reasonably significant and prevalent problem for adolescents worldwide. Systematic reviews have indicated that the success of sleep education programs has thus far been inconsistent, due to the lack of a tailored approach that allows for evaluation of individual differences in behavior patterns. One way to resolve this problem is to assess the individual sleep behaviors of adolescents by using a checklist containing the recommended behaviors for promoting sleep health. Such self-help education programs have already been implemented for elementary school children, school nurses and the elderly. The present study aimed to verify the effects of a sleep education program with supplementary self-help treatment, based on a checklist of sleep-promoting behaviors, in addition to evaluation of changes in sleeping patterns, sleep-promoting behaviors and daytime sleepiness in adolescents. A cluster randomized controlled trial involving 5 Japanese junior high schools was conducted, and 243 students (sleep education: n = 122; waiting list: n = 121; 50.6% female; 7th grade) were included in the final analysis. The sleep education group was provided with information on proper sleep health and sleep-promoting behaviors. The students in this group were asked to practice one sleep-promoting behavior as a goal for 2 weeks and to monitor their practice using sleep diaries. Both pre- and post-treatment questionnaires were administered to students in order to assess knowledge of sleep-promoting behaviors, sleeping patterns and daytime functioning. Students in the sleep education group showed significant improvement in their knowledge of sleep health (F1,121 = 648.05, p < 0.001) and in their sleep-promoting behaviors (F1,121 = 55.66, p < 0.001). Bedtime on both school nights (F1,121 = 50.86, p < 0.001) and weekends (F1,121 = 15.03, p < 0.001), sleep

  1. Spacecraft camera image registration

    NASA Technical Reports Server (NTRS)

    Kamel, Ahmed A. (Inventor); Graul, Donald W. (Inventor); Chan, Fred N. T. (Inventor); Gamble, Donald W. (Inventor)

    1987-01-01

    A system for achieving spacecraft camera (1, 2) image registration comprises a portion external to the spacecraft and an image motion compensation system (IMCS) portion onboard the spacecraft. Within the IMCS, a computer (38) calculates an image registration compensation signal (60) which is sent to the scan control loops (84, 88, 94, 98) of the onboard cameras (1, 2). At the location external to the spacecraft, the long-term orbital and attitude perturbations on the spacecraft are modeled. Coefficients (K, A) from this model are periodically sent to the onboard computer (38) by means of a command unit (39). The coefficients (K, A) take into account observations of stars and landmarks made by the spacecraft cameras (1, 2) themselves. The computer (38) takes as inputs the updated coefficients (K, A) plus synchronization information indicating the mirror position (AZ, EL) of each of the spacecraft cameras (1, 2), operating mode, and starting and stopping status of the scan lines generated by these cameras (1, 2), and generates in response thereto the image registration compensation signal (60). The sources of periodic thermal errors on the spacecraft are discussed. The system is checked by calculating measurement residuals, the difference between the landmark and star locations predicted at the external location and the landmark and star locations as measured by the spacecraft cameras (1, 2).

  2. A randomised double-blind placebo-controlled trial investigating the behavioural effects of vitamin, mineral and n-3 fatty acid supplementation in typically developing adolescent schoolchildren.

    PubMed

    Tammam, Jonathan D; Steinsaltz, David; Bester, D W; Semb-Andenaes, Turid; Stein, John F

    2016-01-28

    Nutrient deficiencies have been implicated in anti-social behaviour in schoolchildren; hence, correcting them may improve sociability. We therefore tested the effects of vitamin, mineral and n-3 supplementation on behaviour in a 12-week double-blind randomised placebo-controlled trial in typically developing UK adolescents aged 13-16 years (n 196). Changes in erythrocyte n-3 and 6 fatty acids and some mineral and vitamin levels were measured and compared with behavioural changes, using Conners' teacher ratings and school disciplinary records. At baseline, the children's PUFA (n-3 and n-6), vitamin and mineral levels were low, but they improved significantly in the group treated with n-3, vitamins and minerals (P=0·0005). On the Conners disruptive behaviour scale, the group given the active supplements improved, whereas the placebo group worsened (F=5·555, d=0·35; P=0·02). The general level of disciplinary infringements was low, thus making it difficult to obtain improvements. However, throughout the school term school disciplinary infringements increased significantly (by 25 %; Bayes factor=115) in both the treated and untreated groups. However, when the subjects were split into high and low baseline infringements, the low subset increased their offences, whereas the high-misbehaviour subset appeared to improve after treatment. But it was not possible to determine whether this was merely a statistical artifact. Thus, when assessed using the validated and standardised Conners teacher tests (but less clearly when using school discipline records in a school where misbehaviour was infrequent), supplementary nutrition might have a protective effect against worsening behaviour.

  3. A randomized, double-blind and placebo-controlled trial of modafinil in children and adolescents with attention deficit and hyperactivity disorder.

    PubMed

    Kahbazi, Manijeh; Ghoreishi, Aboulfazl; Rahiminejad, Fatemeh; Mohammadi, Mohammad-Reza; Kamalipour, Abbas; Akhondzadeh, Shahin

    2009-08-15

    Attention-deficit/hyperactivity disorder (ADHD) is the most common behavioral disorder in childhood, with an estimated prevalence worldwide of 7%-17% among school-aged children. Modafinil is a centrally acting agent that is structurally and pharmacologically different from stimulants such as amphetamine and methylphenidate. It has been reported that modafinil is effective in diminishing the symptoms of ADHD. The aim of the present study was to further evaluate, under double-blind and placebo-controlled conditions, the efficacy of modafinil for ADHD in children and adolescents. Patients were 46 outpatients, children (35 boys and 11 girls) between the ages of 6 and 15 who clearly met the DSM-IV-TR diagnostic criteria for ADHD. All study subjects were randomly assigned to receive treatment with modafinil in a film-coated tablet, 200-300 mg/day, depending on weight (200 mg/day for <30 kg and 300 mg/day for >30 kg) (group 1) or placebo (group 2) for a 6-week double-blind, randomized clinical trial. The principal outcome measure was the Teacher and Parent ADHD Rating Scale-IV. Patients were assessed by a psychiatrist at baseline, 14, 28 and 42 days after the medication started. At 6 weeks, modafinil produced a significantly better outcome on the Parent and Teacher Rating Scale scores than placebo. Decreased appetite was observed more often in the modafinil group. The results of this study indicate that modafinil significantly improved symptoms of ADHD, was well tolerated, and may open a new window in the treatment of children with ADHD.

  4. Effectiveness of Facebook-Delivered Lifestyle Counselling and Physical Activity Self-Monitoring on Physical Activity and Body Mass Index in Overweight and Obese Adolescents: A Randomized Controlled Trial

    PubMed Central

    Ruotsalainen, Heidi; Kyngäs, Helvi; Tammelin, Tuija; Heikkinen, Hanna; Kääriäinen, Maria

    2015-01-01

    Background. The aim was to evaluate the effects of a 12-week, Facebook-delivered lifestyle counselling intervention, with or without physical activity self-monitoring, on physical activity and body mass index (BMI) in overweight and obese 13–16-year-old adolescents. Methods. Three-arm randomized controlled trial. Participants (n = 46) were randomly assigned to intervention and control groups: one group received Facebook-delivered lifestyle counselling and monitoring of their physical activity (Fb + Act, n = 15), whereas a second experimental group received the same Facebook-delivered lifestyle counselling without self-monitoring (Fb, n = 16) and a third group served as the control group (n = 15). Objective and self-reported physical activity assessment were used. Nonparametric statistical tests were used. Results. There were no significant intervention effects in terms of changes in physical activity levels or BMI from baseline to the 12-week postintervention measurements between the intervention and control groups. The Fb + Act group had lower sedentary time on weekdays compared to the control group during postintervention measurements (p = 0.021), but there was no interaction between time and group. Conclusions. Interventions were not effective at increasing physical activity in overweight and obese adolescents. Before implementing such interventions, more evaluations on their effectiveness are needed. This trial is registered with ClinicalTrials.gov identifier NCT02295761 (2014-11-17). PMID:26697218

  5. Improving adolescent social competence and behavior: a randomized trial of an 11-week equine facilitated learning prevention program.

    PubMed

    Pendry, Patricia; Carr, Alexa M; Smith, Annelise N; Roeter, Stephanie M

    2014-08-01

    There is growing evidence that promoting social competence in youth is an effective strategy to prevent mental, emotional, and behavioral disorders in adulthood. Research suggests that programs delivered in collaboration with schools are particularly effective when they target social and emotional skill building, utilize an interactive instructional style, provide opportunities for youth participation and self-direction, and include explicit attempts to enhance youth social competence. A relatively new but popular approach that incorporates these characteristics is human animal interaction, which can be implemented in educational settings. We report the results from a randomized clinical trial examining the effects of an 11-week equine facilitated learning (EFL) program on the social competence and behavior of 5th-8th grade children. Children (N = 131) were recruited through referral by school counselors and school-based recruitment and then screened for low social competence. Researchers randomly assigned children to an experimental (n = 53) or waitlisted control group (n = 60). Children in the experimental group participated in an 11-week EFL program consisting of once-weekly, 90-min sessions of individual and team-focused activities, whereas children in the control group served as a wait-listed control and participated 16 weeks later. Parents of children in both groups rated child social competence at pretest and posttest. Three independent raters observed and reported children's positive and negative behavior using a validated checklist during each weekly session. Results indicated that program participation had a moderate treatment effect (d = .55) on social competence (p = .02) that was independent of pretest levels, age, gender, and referral status. Results showed that higher levels of program attendance predicted children's trajectories of observed positive (β = .500; p = .003) and negative behavior (β = -.062; p < .001) over the 11-week program.

  6. Adolescent Abstinence and Unprotected Sex in CyberSenga, an Internet-Based HIV Prevention Program: Randomized Clinical Trial of Efficacy

    PubMed Central

    Ybarra, Michele L.; Bull, Sheana S.; Prescott, Tonya L.; Korchmaros, Josephine D.; Bangsberg, David R.; Kiwanuka, Julius P.

    2013-01-01

    youth in the short term and, with the booster, may also promote HIV preventive behavior among sexually active youth in the longer term. Trial Registration NCT00906178. PMID:23967069

  7. A Randomized Controlled Trial of a Parent-Centered Intervention in Preventing Substance Use and HIV Risk Behaviors in Hispanic Adolescents

    ERIC Educational Resources Information Center

    Prado, Guillermo; Pantin, Hilda; Briones, Ervin; Schwartz, Seth J.; Feaster, Daniel; Huang, Shi; Sullivan, Summer; Tapia, Maria I.; Sabillon, Eduardo; Lopez, Barbara; Szapocznik, Jose

    2007-01-01

    The present study evaluated the efficacy of Familias Unidas + Parent-Preadolescent Training for HIV Prevention (PATH), a Hispanic-specific, parent-centered intervention, in preventing adolescent substance use and unsafe sexual behavior. Two hundred sixty-six 8th-grade Hispanic adolescents and their primary caregivers were randomly assigned to 1 of…

  8. Effect of metformin added to insulin on glycemic control among overweight/obese adolescents with type 1 diabetes: A randomized clinical trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Previous studies assessing the effect of metformin on glycemic control in adolescents with type 1 diabetes have produced inconclusive results. To assess the efficacy and safety of metformin as an adjunct to insulin in treating overweight adolescents with type 1 diabetes. Multicenter (26 pediatric en...

  9. 17 CFR 250.1 - Registration.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 17 Commodity and Securities Exchanges 3 2010-04-01 2010-04-01 false Registration. 250.1 Section... AND REGULATIONS, PUBLIC UTILITY HOLDING COMPANY ACT OF 1935 Registration and General Exemptions § 250.1 Registration. (a) Notification of registration. Notifications of registration pursuant to...

  10. 14 CFR 47.43 - Invalid registration.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 1 2012-01-01 2012-01-01 false Invalid registration. 47.43 Section 47.43... REGISTRATION Certificates of Aircraft Registration § 47.43 Invalid registration. Link to an amendment published... registration of an aircraft is invalid if, at the time it is made— (1) The aircraft is registered in a...

  11. 14 CFR 47.43 - Invalid registration.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 1 2011-01-01 2011-01-01 false Invalid registration. 47.43 Section 47.43... REGISTRATION Certificates of Aircraft Registration § 47.43 Invalid registration. Link to an amendment published... registration of an aircraft is invalid if, at the time it is made— (1) The aircraft is registered in a...

  12. 17 CFR 250.1 - Registration.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 17 Commodity and Securities Exchanges 3 2011-04-01 2011-04-01 false Registration. 250.1 Section... AND REGULATIONS, PUBLIC UTILITY HOLDING COMPANY ACT OF 1935 Registration and General Exemptions § 250.1 Registration. (a) Notification of registration. Notifications of registration pursuant to...

  13. Updates from guardian™: a comprehensive registration programme.

    PubMed

    Ozelo, Margareth C

    2015-12-01

    Turoctocog alfa is an approved B-domain truncated recombinant factor VIII concentrate for adults and children with haemophilia A. Clinical data for turoctocog alfa have been reported from the guardian(™) 1, guardian(™) 2 and guardian(™) 3 phase III trials. guardian(™) 1 and guardian(™) 3 phase III trials enrolled 150 adolescents/adults (≥ 12 yr), and 63 children (<12 yr), respectively, with previously treated severe haemophilia A and no history of inhibitors; 188 of these patients continued into the ongoing guardian(™) 2 extension trial. In the three trials, patients have received prophylaxis with turoctocog alfa three times weekly or every second day, with breakthrough bleeds resolved to an expected postinjection level of ≥ 0.50 IU/mL. No safety concerns have arisen, and no patients have developed confirmed inhibitors (primary endpoint). Indeed, no confirmed inhibitors have been detected in >200 patients treated for a cumulative total of >54,000 exposure days in the phase III trials. Pooled efficacy data show a favourable long-term effect of turoctocog alfa on annualised bleeding rate and a success rate for haemostatic response of 86%; 90% of bleeds were resolved with 1-2 doses. This article reviews the clinical development of turoctocog alfa with reference to the guardian(™) clinical programme, describing results obtained to date and ongoing trials.

  14. Acute versus chronic supplementation of sodium citrate on 200 m performance in adolescent swimmers

    PubMed Central

    2014-01-01

    Background A double-blinded, placebo-controlled, cross-over design was used to investigate whether two different sodium citrate dihydrate (Na-CIT) supplementation protocols improve 200 m swimming performance in adolescent swimmers. Methods Ten, male swimmers (14.9 ± 0.4 years of age; 63.5 ± 4 kg) performed four 200 m time trials with the following treatments: acute (ACU) supplementation (0.5 g kg-1 administered 120 min pre-trial), acute placebo (PLC-A), chronic (CHR) supplementation (0.1 g∙kg-1 for three days and 0.3 g kg-1 on the forth day 120 min pre-trial), and chronic placebo (PLC-C). The order of the trials was randomized, with at least a six-day wash-out period between trials. Blood samples were collected by finger prick pre-ingestion, 100 min post-ingestion, and 3 min post-trial. Performance time, rate of perceived exertion, pH, base excess, bicarbonate and lactate concentration were measured. Results Post-ingestion bicarbonate and base excess were higher (P < 0.05) in both the ACU and CHR trials compared to placebo showing adequate pre-exercise alkalosis. However, performance time, rate of perceived exertion as well as post-trial pH and lactate concentration were not significantly different between trials. Further analysis revealed that five swimmers, identified as responders, improved their performance time by 1.03% (P < 0.05) and attained higher post-trial lactate concentrations in the ACU versus PLC-A trial (P < 0.05). They also had significantly higher post-trial lactate concentrations compared to the non-responders in the ACU and CHR trials. Conclusions Acute supplementation of Na-CIT prior to 200 m swimming performance led to a modest time improvement and higher blood lactate concentrations in only half of the swimmers while the chronic Na-CIT supplementation did not provide any ergogenic effect in this group of adolescent swimmers. Trial registration Clinicaltrials.gov NCT01835912. PMID:24944546

  15. A Novel Behavioral Intervention in Adolescents with Type 1 Diabetes Mellitus Improves Glycemic Control: Preliminary Results from a Pilot Randomized Control Trial

    PubMed Central

    Maranda, Louise; Lau, May; Stewart, Sunita M; Gupta, Olga T

    2015-01-01

    Purpose The purpose of this study is to develop and pilot an innovative behavioral intervention in adolescents with type 1 diabetes mellitus (T1DM) incorporating structured care of a pet to improve glycemic control. Methods Twenty-eight adolescents with A1C > 8.5% (69 mmol/mol) were randomly assigned to either the intervention group (care of a Betta splendens pet fish) or the control group (usual care). Adolescents in the intervention group were given instructions to associate daily and weekly fish care duties with diabetes self-management tasks including blood glucose testing and parent-adolescent communication. Results After 3 months the participants in the intervention group exhibited a statistically significant decrease in A1C levels (−0.5%) compared to their peers in the control group who had an increase in A1C levels (0.8%)(p = 0.04). The younger adolescents (ages 10–13) demonstrated a greater response to the intervention which was statistically significant (−1.5% vs. 0.6%, p = 0.04) compared with the older adolescents (ages 14–17). Conclusions Structured care of a pet fish can improve glycemic control in adolescents with T1DM, likely by providing cues to perform diabetes self-management behaviors. PMID:25614529

  16. A randomized double blind placebo controlled clinical trial of N-Acetylcysteine added to risperidone for treating autistic disorders

    PubMed Central

    2013-01-01

    Background This study examined the efficacy and safety of N-acetylcysteine (NAC) augmentation for treating irritability in children and adolescents with autism spectrum disorders (ASD). Method Forty children and adolescents met diagnostic criteria for ASD according to DSM-IV. They were randomly allocated into one of the two groups of NAC (1200 mg/day)+risperidone or placebo+risperidone. NAC and placebo were administered in the form of effervescent and in two divided doses for 8 weeks. Irritability subscale score of Aberrant Behavior Checklist (ABC) was considered as the main outcome measure. Adverse effects were also checked. Results The mean score of irritability in the NAC+risperidone and placebo+risperidone groups at baseline was 13.2(5.3) and 16.7(7.8), respectively. The scores after 8 weeks were 9.7(4.1) and 15.1(7.8), respectively. Repeated measures of ANOVA showed that there was a significant difference between the two groups after 8 weeks. The most common adverse effects in the NAC+risperidone group were constipation (16.1%), increased appetite (16.1%), fatigue (12.9%), nervousness (12.9%), and daytime drowsiness (12.9%). There was no fatal adverse effect. Conclusions Risperidone plus NAC more than risperidone plus placebo decreased irritability in children and adolescents with ASD. Meanwhile, it did not change the core symptoms of autism. Adverse effects were not common and NAC was generally tolerated well. Trial registration This trial was registered at http://www.irct.ir. The registration number of this trial was IRCT201106103930N6 PMID:23886027

  17. Pre-Operative Autologous Blood Donation Does Not Affect Pre-Incision Hematocrit in Adolescent Idiopathic Scoliosis Patients. A Retrospective Cohort of a Prospective Randomized Trial

    PubMed Central

    Verma, Kushagra; Peters, Austin; Lonner, Baron S.; Errico, Thomas

    2016-01-01

    Background Pre-donation of autologous blood prior to spine fusion for adolescent idiopathic scoliosis (AIS) has been used in deformity surgery. The effect of pre-donation on pre-operative hematocrit (Hct) remains debated. Multiple factors may influence pre-operative Hct including intravascular volume status, patient factors, and timing of pre-operative blood donation. The purpose of this study was to determine if pre-donation significantly lowers pre-incision Hct in AIS patients. Methods A retrospective cohort study of a Level-1 prospective randomized trial was conducted. 125 patients from the homogeneous population were included. AIS patients undergoing a posterior only spinal fusion for AIS were separated into two groups based on their pre-operative blood donation history. Demographic variables, pre-incision Hct, and transfusion rates were compared between the two groups using the Student's T-test. Results Pre-donation and non pre-donation groups had 28 and 97 patients, respectively. Pre-donation group was 75% female (21F, 7M) and non pre-donation group was 78% female (76F, 21M). There was no difference between pre-donation and non pre-donation groups in mean age (15.6 ± 2.2 vs 14.8 ± 2.2, p = 0.081), BMI (23.1 ± 4.2 vs 21.7 ± 5.3, p = 0.219), and pre-incision Hct (32.8 ± 3.4 vs 33.8 ± 3.1, p = 0.628). The overall transfusion rates were equivalent (32.1± 48.0% vs 25.8 ± 44.0%, p = 0.509), however, the rate of allogenic transfusion for the pre-donation group was significantly lower (3.6 ± 18.9% vs 25.8 ± 44.0%, p = 0.011). Conclusions This study supports the use of pre-donation for AIS, without a significant drop in pre-incision Hct. Patients that donate are also much less likely to be exposed to allogenic blood. There may be a surgeon bias to recommend pre-donation in patients with a larger BMI and older age. Future studies are needed from a larger population of patients including those with non-AIS pathology. Level of evidence: Level III. PMID:27652198

  18. Effectiveness of a 12-week school-based educational preventive program on weight and fasting blood glucose in "at-risk" adolescents of type 2 diabetes mellitus: Randomised controlled trial.

    PubMed

    Bani Salameh, Ayman; Al-Sheyab, Nihaya; El-Hneiti, Mamdouh; Shaheen, Abeer; Williams, Leonie M; Gallagher, Robyn

    2017-02-28

    To assess the effectiveness of a 12-week school-based educational preventive program for type 2 diabetes by change in weight and fasting blood glucose level in Jordanian adolescents. Sixteen percent of Jordanian adults have obesity-related type 2 diabetes and 5.6% of obese adolescents examined, however one-third unexamined. Rates in Arabic countries will double in 20 years, but this can be prevented and reversed by controlling obesity. A single-blinded randomised controlled trial was conducted in 2 unisex high schools in Irbid, Jordan, in 2012. Intervention and control participants, aged 12 to 18 years, were visibly overweight/obese. They were randomly allocated to the intervention (n = 205) or control (n = 196) groups. At-risk students were assessed before and after the 12-week intervention, for change in weight and fasting blood glucose level following preventive instruction and parent-supported changes. Mean age of participants was 15.3 years with equal percentages of both males (49.4%) and females. Post intervention, the intervention group, demonstrated statistically significant reductions: mean difference of 3.3 kg in weight (P < .000) and 1.36 mg/dL (0.075 mmol/L) in fasting blood glucose (P < .000). School-based early prevention intervention effectively reduced weight and fasting blood glucose in Jordanian at-risk adolescents.

  19. 75 FR 23759 - Pesticide Products; Registration Applications

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-04

    ... AGENCY Pesticide Products; Registration Applications AGENCY: Environmental Protection Agency (EPA... Hill, Registration Division (7504P), Office of Pesticide Programs, Environmental Protection Agency... deadline identified. II. Registration Applications EPA has received applications to register...

  20. Adolescent development

    MedlinePlus

    Development - adolescent; Growth and development - adolescent ... During adolescence, children develop the ability to: Understand abstract ideas. These include grasping higher math concepts, and developing moral ...

  1. Automatic registration of satellite imagery

    NASA Technical Reports Server (NTRS)

    Fonseca, Leila M. G.; Costa, Max H. M.; Manjunath, B. S.; Kenney, C.

    1997-01-01

    Image registration is one of the basic image processing operations in remote sensing. With the increase in the number of images collected every day from different sensors, automated registration of multi-sensor/multi-spectral images has become an important issue. A wide range of registration techniques has been developed for many different types of applications and data. The objective of this paper is to present an automatic registration algorithm which uses a multiresolution analysis procedure based upon the wavelet transform. The procedure is completely automatic and relies on the grey level information content of the images and their local wavelet transform modulus maxima. The registration algorithm is very simple and easy to apply because it needs basically one parameter. We have obtained very encouraging results on test data sets from the TM and SPOT sensor images of forest, urban and agricultural areas.

  2. Promoting Healthy Lifestyles in High School Adolescents

    PubMed Central

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

    2014-01-01

    overweight was significantly different from pre-intervention to 6-month follow-up (Chi square=4.69, p=0.03), with COPE decreasing the proportion of overweight teens, versus an increase in overweight in control adolescents. There were no differences in alcohol use at 6 months (p=0.06). Conclusions COPE can improve short- and more long-term outcomes in high school teens. Trial registration This study is registered at www.clinicaltrials.gov NCT01704768. PMID:24050416

  3. Adolescents Just Do Not Know What They Want: A Qualitative Study to Describe Obese Adolescents’ Experiences of Text Messaging to Support Behavior Change Maintenance Post Intervention

    PubMed Central

    Kerr, Deborah A; Fenner, Ashley A; Straker, Leon M

    2014-01-01

    actual experiences. Parent reports provided a useful secondary view of adolescent experience. Conclusions The conflicting views described in this study suggest that overweight and obese adolescents may not know or have the ability to articulate how they would best be supported with text messages during a healthy lifestyle maintenance phase. Further, supporting both engagement and behavior change simultaneously with text messaging may not be possible. Intervention texts should be personalized as much as possible and minimize feelings of guilt and shame in overweight and obese adolescents. Future research with text messaging for overweight and obese adolescents should incorporate clear intervention aims and evaluation methods specifically related to adolescent engagement or behavior change. Trial Registration Australian New Zealand Clinical Trials Registry: ACTRN12611001187932; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12611001187932 (Archived by WebCite at http://www.webcitation.org/6LGSbk8d9). PMID:24713407

  4. Shoulder Arthroplasty Trials Are Infrequently Registered: A Systematic Review of Trials

    PubMed Central

    Sanchez, Zachary Carter; Herrington, James Murphy; Hensel, James Barrett; Henning, Nolan Michael; Scheckel, Caleb Josiah; Vassar, Matt

    2016-01-01

    Introduction With the intent of improving transparency in clinical research, the International Committee of Medical Journal Editors (ICMJE) established guidelines in 2005 regarding prospective clinical trial registration. This action worked to address bias related to selective outcome reporting in the medical literature. The objective of this study was to assess and characterize the quality of registration of clinical trials appearing in shoulder arthroplasty-related medical journals. Methods All randomized trials involving human subjects, pertaining to shoulder arthroplasty, published between July 1, 2005 and December 31, 2015, and indexed in either PubMed or SportDISCUS were analyzed. We assessed the prevalence of registration, the timing of registration relative to patient enrollment periods, and the variable rates of orthopedic journal compliance with ICMJE and Food and Drug Administration clinical registration standards for our study. Results Of the 382 articles identified, 345 (90.3%) were excluded due to failure to meet inclusion criteria. From the remaining 37, only 12 (32.4%) studies were found to be registered in a trial registry. Ten (10/12, 83.3%) of these provided their registration information within the body of the article. None of the included studies from ICMJE-recognized journals were registered. From 34 included studies from non-ICMJE recognized journals, 12 (35.3%) were registered. Conclusion The level of compliance with clinical trial registration guidelines in the decade since their release among shoulder arthroplasty trials in orthopedic journals is poor. Given the importance of the issue, the prevalence of the problem, and the fact that many other medical specialties have already made efforts to improve ICMJE compliance, further work on the part of orthopedic surgery journal authors and editors is needed to ensure the publication of unbiased results. Trial Registration UMIN000022487 PMID:27764210

  5. Adolescent Images of Adolescence.

    ERIC Educational Resources Information Center

    Falchikov, Nancy

    1989-01-01

    Examined extent to which Scottish adolescents (N=40) were influenced by negative images of adolescence present in the culture, investigating self-images by means of Q sort. Eleven factors emerged from analysis, six of which met criterion that distinguishes common factors. Little evidence was found to suggest that adolescents were influenced by…

  6. Image Registration: A Necessary Evil

    NASA Technical Reports Server (NTRS)

    Bell, James; McLachlan, Blair; Hermstad, Dexter; Trosin, Jeff; George, Michael W. (Technical Monitor)

    1995-01-01

    Registration of test and reference images is a key component of nearly all PSP data reduction techniques. This is done to ensure that a test image pixel viewing a particular point on the model is ratioed by the reference image pixel which views the same point. Typically registration is needed to account for model motion due to differing airloads when the wind-off and wind-on images are taken. Registration is also necessary when two cameras are used for simultaneous acquisition of data from a dual-frequency paint. This presentation will discuss the advantages and disadvantages of several different image registration techniques. In order to do so, it is necessary to propose both an accuracy requirement for image registration and a means for measuring the accuracy of a particular technique. High contrast regions in the unregistered images are most sensitive to registration errors, and it is proposed that these regions be used to establish the error limits for registration. Once this is done, the actual registration error can be determined by locating corresponding points on the test and reference images, and determining how well a particular registration technique matches them. An example of this procedure is shown for three transforms used to register images of a semispan model. Thirty control points were located on the model. A subset of the points were used to determine the coefficients of each registration transform, and the error with which each transform aligned the remaining points was determined. The results indicate the general superiority of a third-order polynomial over other candidate transforms, as well as showing how registration accuracy varies with number of control points. Finally, it is proposed that image registration may eventually be done away with completely. As more accurate image resection techniques and more detailed model surface grids become available, it will be possible to map raw image data onto the model surface accurately. Intensity

  7. School-based intervention to improve the mental health of low-income, secondary school students in Santiago, Chile (YPSA): study protocol for a randomized controlled trial

    PubMed Central

    2011-01-01

    Background Depression is common and can have devastating effects on the life of adolescents. Psychological interventions are the first-line for treating or preventing depression among adolescents. This proposal aims to evaluate a school-based, universal psychological intervention to reduce depressive symptoms among student's aged 13-14 attending municipal state secondary schools in Santiago, Chile. Study design This is a cluster randomised controlled trial with schools as the main clusters. We compared this intervention with a control group in a study involving 22 schools, 66 classes and approximately 2,600 students. Students in the active schools attended 11 weekly and 3 booster sessions of an intervention based on cognitive-behavioural models. The control schools received their usual but enhanced counselling sessions currently included in their curriculum. Mean depression scores and indicators of levels of functioning were assessed at 3 and 12 months after the completion of the intervention in order to assess the effectiveness of the intervention. Direct and indirect costs were measured in both groups to assess the cost-effectiveness of this intervention. Discussion As far as we are aware this is the first cluster randomised controlled trial of a school intervention for depression among adolescents outside the Western world. Trial Registration ISRCTN19466209 PMID:21333015

  8. Attachment-based family therapy for suicidal lesbian, gay, and bisexual adolescents: a treatment development study and open trial with preliminary findings.

    PubMed

    Diamond, Gary M; Diamond, Guy S; Levy, Suzanne; Closs, Cynthia; Ladipo, Tonya; Siqueland, Lynne

    2012-03-01

    The objective of this paper is to adapt attachment-based family therapy (ABFT) for use with suicidal lesbian, gay, and bisexual (LGB) adolescents and to obtain preliminary data on the feasibility and efficacy of the treatment with this population. In Phase I, a treatment development team modified ABFT to meet the unique needs of LGB suicidal youth. In Phase II, 10 suicidal LGB youth were offered 12 weeks of LGB sensitive ABFT. Adolescents' report of suicidal ideation, depressive symptoms, and maternal attachment-related anxiety and avoidance were gathered at pretreatment, 6 weeks, and 12 weeks (posttreatment). In Phase I, the treatment was adapted to: (a) include more individual time working with parents in order to process their disappointments, pain, anger, and fears related to their adolescent's minority sexual orientation; (b) address the meaning, implications, and process of acceptance; and (c) heighten parents' awareness of subtle yet potent invalidating responses to their adolescents' sexual orientation. Results of Phase II suggest this population can be recruited and successfully treated with a family based therapy, evidenced by high levels of treatment retention and significant decreases in suicidal ideation, depressive symptoms, and maternal attachment-related anxiety and avoidance. This is the first family-based treatment adapted and tested specifically for suicidal LGB adolescents. Though promising, the results are preliminary and more research on larger samples is warranted.

  9. Rectification and Registration of Remotely Sensed Data.

    DTIC Science & Technology

    2014-09-26

    intelligence Image registration Resampling Mapping Change detection Geometrical distortions Multisensor Signal processing Synthetic aperture radar...rectification and registration of images generated by onboard sensors. Accurate registration is a key requirement for detecting changes (in position...or "unwarping" of the image data before registration and information extraction, in the form of geometric and radiometric corrections and data

  10. 44 CFR 206.112 - Registration period.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 44 Emergency Management and Assistance 1 2011-10-01 2011-10-01 false Registration period. 206.112... Households § 206.112 Registration period. (a) Initial period. The standard FEMA registration period is 60...) Extension of the registration period. The regional administrator or his/her designee may extend...

  11. 22 CFR 122.3 - Registration fees.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 22 Foreign Relations 1 2014-04-01 2014-04-01 false Registration fees. 122.3 Section 122.3 Foreign Relations DEPARTMENT OF STATE INTERNATIONAL TRAFFIC IN ARMS REGULATIONS REGISTRATION OF MANUFACTURERS AND EXPORTERS § 122.3 Registration fees. (a) Frequency of registration and fee. A person who is required...

  12. 27 CFR 17.21 - Registration.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2014-04-01 2014-04-01 false Registration. 17.21... PRODUCTS Registration § 17.21 Registration. Every person claiming drawback under this part must register annually as a nonbeverage domestic drawback claimant. Registration will be accomplished when the...

  13. 49 CFR 390.201 - USDOT Registration.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 5 2014-10-01 2014-10-01 false USDOT Registration. 390.201 Section 390.201... SAFETY REGULATIONS; GENERAL Unified Registration System § 390.201 USDOT Registration. (a) Purpose. This section establishes who must register with FMCSA under the Unified Registration System, the...

  14. 9 CFR 381.179 - Registration.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Registration. 381.179 Section 381.179... CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Records, Registration, and Reports § 381.179 Registration... effective date. All information submitted shall be current and correct. The registration form shall...

  15. 40 CFR 79.23 - Registration.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 16 2011-07-01 2011-07-01 false Registration. 79.23 Section 79.23 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) REGISTRATION OF FUELS AND FUEL ADDITIVES Additive Registration Procedures § 79.23 Registration. (a) If...

  16. 17 CFR 48.3 - Registration required.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 17 Commodity and Securities Exchanges 2 2014-04-01 2014-04-01 false Registration required. 48.3...) REGISTRATION OF FOREIGN BOARDS OF TRADE § 48.3 Registration required. (a) Except as specified in this part, it... Registration to the foreign board of trade pursuant to the provisions of this part. (b) It shall be...

  17. 17 CFR 48.5 - Registration procedures.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 17 Commodity and Securities Exchanges 2 2014-04-01 2014-04-01 false Registration procedures. 48.5...) REGISTRATION OF FOREIGN BOARDS OF TRADE § 48.5 Registration procedures. (a) A foreign board of trade seeking registration with the Commission pursuant to this part must electronically file an application for...

  18. 40 CFR 79.13 - Registration.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 17 2014-07-01 2014-07-01 false Registration. 79.13 Section 79.13 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) REGISTRATION OF FUELS AND FUEL ADDITIVES Fuel Registration Procedures § 79.13 Registration. (a) If...

  19. 44 CFR 206.112 - Registration period.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 44 Emergency Management and Assistance 1 2014-10-01 2014-10-01 false Registration period. 206.112... Households § 206.112 Registration period. (a) Initial period. The standard FEMA registration period is 60...) Extension of the registration period. The regional administrator or his/her designee may extend...

  20. 32 CFR 634.19 - Registration policy.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 32 National Defense 4 2011-07-01 2011-07-01 false Registration policy. 634.19 Section 634.19... CRIMINAL INVESTIGATIONS MOTOR VEHICLE TRAFFIC SUPERVISION Motor Vehicle Registration § 634.19 Registration... registration of off-road vehicles and bicycles under a separate local system. (c) Commanders can grant...

  1. 44 CFR 206.112 - Registration period.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 44 Emergency Management and Assistance 1 2013-10-01 2013-10-01 false Registration period. 206.112... Households § 206.112 Registration period. (a) Initial period. The standard FEMA registration period is 60...) Extension of the registration period. The regional administrator or his/her designee may extend...

  2. 28 CFR 811.7 - Initial registration.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Initial registration. 811.7 Section 811.7... OFFENDER REGISTRATION § 811.7 Initial registration. (a) Duties of sex offender. (1) A sex offender must... purpose of registration, and must cooperate in such a meeting, including: (i) Providing any...

  3. 40 CFR 79.23 - Registration.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 17 2012-07-01 2012-07-01 false Registration. 79.23 Section 79.23 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) REGISTRATION OF FUELS AND FUEL ADDITIVES Additive Registration Procedures § 79.23 Registration. (a) If...

  4. 27 CFR 25.112 - Dealer registration.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2012-04-01 2012-04-01 false Dealer registration. 25..., DEPARTMENT OF THE TREASURY LIQUORS BEER Dealer Registration and Recordkeeping § 25.112 Dealer registration... appropriate TTB officer, will constitute the brewer's registration as a dealer at the brewery. Every...

  5. 27 CFR 17.21 - Registration.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Registration. 17.21... PRODUCTS Registration § 17.21 Registration. Every person claiming drawback under this part must register annually as a nonbeverage domestic drawback claimant. Registration will be accomplished when the...

  6. 28 CFR 811.7 - Initial registration.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Initial registration. 811.7 Section 811.7... OFFENDER REGISTRATION § 811.7 Initial registration. (a) Duties of sex offender. (1) A sex offender must... purpose of registration, and must cooperate in such a meeting, including: (i) Providing any...

  7. 28 CFR 5.200 - Registration.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 28 Judicial Administration 1 2013-07-01 2013-07-01 false Registration. 5.200 Section 5.200 Judicial Administration DEPARTMENT OF JUSTICE ADMINISTRATION AND ENFORCEMENT OF FOREIGN AGENTS REGISTRATION ACT OF 1938, AS AMENDED § 5.200 Registration. (a) Registration under the Act is accomplished by...

  8. 40 CFR 79.13 - Registration.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 16 2011-07-01 2011-07-01 false Registration. 79.13 Section 79.13 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) REGISTRATION OF FUELS AND FUEL ADDITIVES Fuel Registration Procedures § 79.13 Registration. (a) If...

  9. 40 CFR 79.13 - Registration.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 16 2010-07-01 2010-07-01 false Registration. 79.13 Section 79.13 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) REGISTRATION OF FUELS AND FUEL ADDITIVES Fuel Registration Procedures § 79.13 Registration. (a) If...

  10. 40 CFR 79.23 - Registration.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 17 2014-07-01 2014-07-01 false Registration. 79.23 Section 79.23 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) REGISTRATION OF FUELS AND FUEL ADDITIVES Additive Registration Procedures § 79.23 Registration. (a) If...

  11. 27 CFR 25.112 - Dealer registration.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Dealer registration. 25..., DEPARTMENT OF THE TREASURY LIQUORS BEER Dealer Registration and Recordkeeping § 25.112 Dealer registration... appropriate TTB officer, will constitute the brewer's registration as a dealer at the brewery. Every...

  12. 44 CFR 206.112 - Registration period.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 44 Emergency Management and Assistance 1 2012-10-01 2011-10-01 true Registration period. 206.112... Households § 206.112 Registration period. (a) Initial period. The standard FEMA registration period is 60...) Extension of the registration period. The regional administrator or his/her designee may extend...

  13. 28 CFR 5.200 - Registration.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Registration. 5.200 Section 5.200 Judicial Administration DEPARTMENT OF JUSTICE ADMINISTRATION AND ENFORCEMENT OF FOREIGN AGENTS REGISTRATION ACT OF 1938, AS AMENDED § 5.200 Registration. (a) Registration under the Act is accomplished by...

  14. 40 CFR 79.13 - Registration.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 17 2012-07-01 2012-07-01 false Registration. 79.13 Section 79.13 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) REGISTRATION OF FUELS AND FUEL ADDITIVES Fuel Registration Procedures § 79.13 Registration. (a) If...

  15. 27 CFR 25.112 - Dealer registration.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2013-04-01 2013-04-01 false Dealer registration. 25..., DEPARTMENT OF THE TREASURY ALCOHOL BEER Dealer Registration and Recordkeeping § 25.112 Dealer registration... appropriate TTB officer, will constitute the brewer's registration as a dealer at the brewery. Every...

  16. 44 CFR 206.112 - Registration period.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 44 Emergency Management and Assistance 1 2010-10-01 2010-10-01 false Registration period. 206.112... Households § 206.112 Registration period. (a) Initial period. The standard FEMA registration period is 60...) Extension of the registration period. The regional administrator or his/her designee may extend...

  17. 32 CFR 634.19 - Registration policy.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 32 National Defense 4 2012-07-01 2011-07-01 true Registration policy. 634.19 Section 634.19... CRIMINAL INVESTIGATIONS MOTOR VEHICLE TRAFFIC SUPERVISION Motor Vehicle Registration § 634.19 Registration... registration of off-road vehicles and bicycles under a separate local system. (c) Commanders can grant...

  18. 7 CFR 800.34 - Registration fee.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 7 2011-01-01 2011-01-01 false Registration fee. 800.34 Section 800.34 Agriculture... ADMINISTRATION (FEDERAL GRAIN INSPECTION SERVICE), DEPARTMENT OF AGRICULTURE GENERAL REGULATIONS Registration § 800.34 Registration fee. An applicant shall submit the registration fee prescribed in § 800.71...

  19. 7 CFR 800.34 - Registration fee.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 7 2010-01-01 2010-01-01 false Registration fee. 800.34 Section 800.34 Agriculture... ADMINISTRATION (FEDERAL GRAIN INSPECTION SERVICE), DEPARTMENT OF AGRICULTURE GENERAL REGULATIONS Registration § 800.34 Registration fee. An applicant shall submit the registration fee prescribed in § 800.71...

  20. 28 CFR 5.200 - Registration.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 28 Judicial Administration 1 2012-07-01 2012-07-01 false Registration. 5.200 Section 5.200 Judicial Administration DEPARTMENT OF JUSTICE ADMINISTRATION AND ENFORCEMENT OF FOREIGN AGENTS REGISTRATION ACT OF 1938, AS AMENDED § 5.200 Registration. (a) Registration under the Act is accomplished by...

  1. 9 CFR 381.179 - Registration.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Registration. 381.179 Section 381.179... CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Records, Registration, and Reports § 381.179 Registration... effective date. All information submitted shall be current and correct. The registration form shall...

  2. 27 CFR 25.112 - Dealer registration.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2011-04-01 2011-04-01 false Dealer registration. 25..., DEPARTMENT OF THE TREASURY LIQUORS BEER Dealer Registration and Recordkeeping § 25.112 Dealer registration... appropriate TTB officer, will constitute the brewer's registration as a dealer at the brewery. Every...

  3. 28 CFR 811.7 - Initial registration.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Initial registration. 811.7 Section 811.7... OFFENDER REGISTRATION § 811.7 Initial registration. (a) Duties of sex offender. (1) A sex offender must... purpose of registration, and must cooperate in such a meeting, including: (i) Providing any...

  4. 7 CFR 800.34 - Registration fee.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 7 2013-01-01 2013-01-01 false Registration fee. 800.34 Section 800.34 Agriculture... ADMINISTRATION (FEDERAL GRAIN INSPECTION SERVICE), DEPARTMENT OF AGRICULTURE GENERAL REGULATIONS Registration § 800.34 Registration fee. An applicant shall submit the registration fee prescribed in § 800.71...

  5. 28 CFR 5.200 - Registration.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 28 Judicial Administration 1 2011-07-01 2011-07-01 false Registration. 5.200 Section 5.200 Judicial Administration DEPARTMENT OF JUSTICE ADMINISTRATION AND ENFORCEMENT OF FOREIGN AGENTS REGISTRATION ACT OF 1938, AS AMENDED § 5.200 Registration. (a) Registration under the Act is accomplished by...

  6. 40 CFR 79.23 - Registration.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 17 2013-07-01 2013-07-01 false Registration. 79.23 Section 79.23 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) REGISTRATION OF FUELS AND FUEL ADDITIVES Additive Registration Procedures § 79.23 Registration. (a) If...

  7. 40 CFR 79.13 - Registration.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 17 2013-07-01 2013-07-01 false Registration. 79.13 Section 79.13 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) REGISTRATION OF FUELS AND FUEL ADDITIVES Fuel Registration Procedures § 79.13 Registration. (a) If...

  8. 32 CFR 634.19 - Registration policy.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 32 National Defense 4 2010-07-01 2010-07-01 true Registration policy. 634.19 Section 634.19... CRIMINAL INVESTIGATIONS MOTOR VEHICLE TRAFFIC SUPERVISION Motor Vehicle Registration § 634.19 Registration... registration of off-road vehicles and bicycles under a separate local system. (c) Commanders can grant...

  9. 9 CFR 381.179 - Registration.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Registration. 381.179 Section 381.179... CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Records, Registration, and Reports § 381.179 Registration... effective date. All information submitted shall be current and correct. The registration form shall...

  10. 40 CFR 79.23 - Registration.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 16 2010-07-01 2010-07-01 false Registration. 79.23 Section 79.23 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) REGISTRATION OF FUELS AND FUEL ADDITIVES Additive Registration Procedures § 79.23 Registration. (a) If...

  11. 7 CFR 800.34 - Registration fee.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 7 2014-01-01 2014-01-01 false Registration fee. 800.34 Section 800.34 Agriculture... ADMINISTRATION (FEDERAL GRAIN INSPECTION SERVICE), DEPARTMENT OF AGRICULTURE GENERAL REGULATIONS Registration § 800.34 Registration fee. An applicant shall submit the registration fee prescribed in § 800.71...

  12. 32 CFR 634.19 - Registration policy.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 32 National Defense 4 2013-07-01 2013-07-01 false Registration policy. 634.19 Section 634.19... CRIMINAL INVESTIGATIONS MOTOR VEHICLE TRAFFIC SUPERVISION Motor Vehicle Registration § 634.19 Registration... registration of off-road vehicles and bicycles under a separate local system. (c) Commanders can grant...

  13. 32 CFR 634.19 - Registration policy.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 32 National Defense 4 2014-07-01 2013-07-01 true Registration policy. 634.19 Section 634.19... CRIMINAL INVESTIGATIONS MOTOR VEHICLE TRAFFIC SUPERVISION Motor Vehicle Registration § 634.19 Registration... registration of off-road vehicles and bicycles under a separate local system. (c) Commanders can grant...

  14. 28 CFR 5.200 - Registration.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 28 Judicial Administration 1 2014-07-01 2014-07-01 false Registration. 5.200 Section 5.200 Judicial Administration DEPARTMENT OF JUSTICE ADMINISTRATION AND ENFORCEMENT OF FOREIGN AGENTS REGISTRATION ACT OF 1938, AS AMENDED § 5.200 Registration. (a) Registration under the Act is accomplished by...

  15. 27 CFR 17.21 - Registration.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2012-04-01 2012-04-01 false Registration. 17.21... PRODUCTS Registration § 17.21 Registration. Every person claiming drawback under this part must register annually as a nonbeverage domestic drawback claimant. Registration will be accomplished when the...

  16. 27 CFR 25.112 - Dealer registration.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2014-04-01 2014-04-01 false Dealer registration. 25..., DEPARTMENT OF THE TREASURY ALCOHOL BEER Dealer Registration and Recordkeeping § 25.112 Dealer registration... appropriate TTB officer, will constitute the brewer's registration as a dealer at the brewery. Every...

  17. 27 CFR 17.21 - Registration.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2011-04-01 2011-04-01 false Registration. 17.21... PRODUCTS Registration § 17.21 Registration. Every person claiming drawback under this part must register annually as a nonbeverage domestic drawback claimant. Registration will be accomplished when the...

  18. 9 CFR 381.179 - Registration.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Registration. 381.179 Section 381.179... CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Records, Registration, and Reports § 381.179 Registration... effective date. All information submitted shall be current and correct. The registration form shall...

  19. 27 CFR 17.21 - Registration.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2013-04-01 2013-04-01 false Registration. 17.21... PRODUCTS Registration § 17.21 Registration. Every person claiming drawback under this part must register annually as a nonbeverage domestic drawback claimant. Registration will be accomplished when the...

  20. 7 CFR 800.34 - Registration fee.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 7 2012-01-01 2012-01-01 false Registration fee. 800.34 Section 800.34 Agriculture... ADMINISTRATION (FEDERAL GRAIN INSPECTION SERVICE), DEPARTMENT OF AGRICULTURE GENERAL REGULATIONS Registration § 800.34 Registration fee. An applicant shall submit the registration fee prescribed in § 800.71...

  1. 28 CFR 811.7 - Initial registration.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Initial registration. 811.7 Section 811.7... OFFENDER REGISTRATION § 811.7 Initial registration. (a) Duties of sex offender. (1) A sex offender must... purpose of registration, and must cooperate in such a meeting, including: (i) Providing any...

  2. Validation of histology image registration

    NASA Astrophysics Data System (ADS)

    Shojaii, Rushin; Karavardanyan, Tigran; Yaffe, Martin; Martel, Anne L.

    2011-03-01

    The aim of this paper is to validate an image registration pipeline used for histology image alignment. In this work a set of histology images are registered to their correspondent optical blockface images to make a histology volume. Then multi-modality fiducial markers are used to validate the alignment of histology images. The fiducial markers are catheters perfused with a mixture of cuttlefish ink and flour. Based on our previous investigations this fiducial marker is visible in medical images, optical blockface images and it can also be localized in histology images. The properties of this fiducial marker make it suitable for validation of the registration techniques used for histology image alignment. This paper reports on the accuracy of a histology image registration approach by calculation of target registration error using these fiducial markers.

  3. Data Requirements for Pesticide Registration

    EPA Pesticide Factsheets

    In evaluating a pesticide registration application, we assess a wide variety of potential human health and environmental effects associated with use of the product. Learn about these data requirements.

  4. Explanation of Registration Review Schedule

    EPA Pesticide Factsheets

    Updated information on EPA's schedule for opening dockets to begin pesticide registration reviews during the next several years. The schedule is subdivided into conventional pesticides, antimicrobials, biochemicals, and microbials. \

  5. Child/Adolescent Anxiety Multimodal Study (CAMS): rationale, design, and methods

    PubMed Central

    2010-01-01

    Objective To present the design, methods, and rationale of the Child/Adolescent Anxiety Multimodal Study (CAMS), a recently completed federally-funded, multi-site, randomized placebo-controlled trial that examined the relative efficacy of cognitive-behavior therapy (CBT), sertraline (SRT), and their combination (COMB) against pill placebo (PBO) for the treatment of separation anxiety disorder (SAD), generalized anxiety disorder (GAD) and social phobia (SoP) in children and adolescents. Methods Following a brief review of the acute outcomes of the CAMS trial, as well as the psychosocial and pharmacologic treatment literature for pediatric anxiety disorders, the design and methods of the CAMS trial are described. Results CAMS was a six-year, six-site, randomized controlled trial. Four hundred eighty-eight (N = 488) children and adolescents (ages 7-17 years) with DSM-IV-TR diagnoses of SAD, GAD, or SoP were randomly assigned to one of four treatment conditions: CBT, SRT, COMB, or PBO. Assessments of anxiety symptoms, safety, and functional outcomes, as well as putative mediators and moderators of treatment response were completed in a multi-measure, multi-informant fashion. Manual-based therapies, trained clinicians and independent evaluators were used to ensure treatment and assessment fidelity. A multi-layered administrative structure with representation from all sites facilitated cross-site coordination of the entire trial, study protocols and quality assurance. Conclusions CAMS offers a model for clinical trials methods applicable to psychosocial and psychopharmacological comparative treatment trials by using state-of-the-art methods and rigorous cross-site quality controls. CAMS also provided a large-scale examination of the relative and combined efficacy and safety of the best evidenced-based psychosocial (CBT) and pharmacologic (SSRI) treatments to date for the most commonly occurring pediatric anxiety disorders. Primary and secondary results of CAMS will hold

  6. Examination of perceived neighborhood characteristics and transportation on changes in physical activity and sedentary behavior: The Trial of Activity in Adolescent Girls.

    PubMed

    Evenson, Kelly R; Murray, David M; Birnbaum, Amanda S; Cohen, Deborah A

    2010-09-01

    We examined the association between perceived neighborhood characteristics and transport and 2-year changes in accelerometer-determined nonschool MET-weighted moderate-to-vigorous physical activity (MW-MVPA) and sedentary behavior of adolescent girls. Reporting that children do not play outdoors in their neighborhood, that their neighborhood was well lit, and that there were trails in their neighborhood were each associated with significant decreases in nonschool MW-MVPA. None of the neighborhood or transportation measures was associated with changes in nonschool sedentary behavior. Further work is needed to understand the determinants of the decline in physical activity and the increase in sedentary behavior among adolescent girls.

  7. 75 FR 52859 - Re-Registration and Renewal of Aircraft Registration; OMB Approval of Information Collection

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-30

    ... Federal Aviation Administration 14 CFR Parts 13, 47, and 91 RIN 2120-AI89 Re-Registration and Renewal of... final rule, ``Re-Registration and Renewal of Aircraft Registration,'' which was published on July 20..., the FAA published the final rule, ``Re-Registration and Renewal of Aircraft Registration'' (75...

  8. Evaluation of multisystemic therapy pilot services in the Systemic Therapy for At Risk Teens (START) trial: study protocol for a randomised controlled trial

    PubMed Central

    2013-01-01

    Background There is an urgent need for clinically effective and cost-effective methods to manage antisocial and criminal behaviour in adolescents. Youth conduct disorder is increasingly prevalent in the UK and is associated with a range of negative outcomes. Quantitative systematic reviews carried out for the National Institute for Health and Clinical Excellence have identified multisystemic therapy, an intensive, multimodal, home-based, family intervention for youth with serious antisocial behaviour, as one of the most promising interventions for reducing antisocial or offending behaviour and improving individual and family functioning. Previous international trials of multisystemic therapy have yielded mixed outcomes, and it is questionable to what extent positive US findings can be generalised to a wider UK mental health and juvenile justice context. This paper describes the protocol for the Systemic Therapy for At Risk Teens (START) trial, a multicentre UK-wide randomised controlled trial of multisystemic therapy in antisocial adolescents at high risk of out-of-home placement. Methods/Design The trial is being conducted at 10 sites across the UK. Seven hundred participants and their families will be recruited and randomised on a 1:1 basis to multisystemic therapy or management as usual. Treatments are offered over a period of 3 to 5 months, with follow-up to 18 months post-randomisation. The primary outcome is out-of-home placement at 18 months. Secondary outcomes include offending rates, total service and criminal justice sector costs, and participant well-being and educational outcomes. Data will be gathered from police computer records, the National Pupil Database, and interview and self-report measures administered to adolescents, parents and teachers. Outcomes will be analysed on an intention-to-treat basis, using a logistic regression with random effects for the primary outcome and Cox regressions and linear mixed-effects models for secondary outcomes

  9. Improvement of registration accuracy in accelerated partial breast irradiation using the point-based rigid-body registration algorithm for patients with implanted fiducial markers

    SciTech Connect

    Inoue, Minoru; Yoshimura, Michio Sato, Sayaka; Nakamura, Mitsuhiro; Yamada, Masahiro; Hirata, Kimiko; Ogura, Masakazu; Hiraoka, Masahiro; Sasaki, Makoto; Fujimoto, Takahiro

    2015-04-15

    Purpose: To investigate image-registration errors when using fiducial markers with a manual method and the point-based rigid-body registration (PRBR) algorithm in accelerated partial breast irradiation (APBI) patients, with accompanying fiducial deviations. Methods: Twenty-two consecutive patients were enrolled in a prospective trial examining 10-fraction APBI. Titanium clips were implanted intraoperatively around the seroma in all patients. For image-registration, the positions of the clips in daily kV x-ray images were matched to those in the planning digitally reconstructed radiographs. Fiducial and gravity registration errors (FREs and GREs, respectively), representing resulting misalignments of the edge and center of the target, respectively, were compared between the manual and algorithm-based methods. Results: In total, 218 fractions were evaluated. Although the mean FRE/GRE values for the manual and algorithm-based methods were within 3 mm (2.3/1.7 and 1.3/0.4 mm, respectively), the percentages of fractions where FRE/GRE exceeded 3 mm using the manual and algorithm-based methods were 18.8%/7.3% and 0%/0%, respectively. Manual registration resulted in 18.6% of patients with fractions of FRE/GRE exceeding 5 mm. The patients with larger clip deviation had significantly more fractions showing large FRE/GRE using manual registration. Conclusions: For image-registration using fiducial markers in APBI, the manual registration results in more fractions with considerable registration error due to loss of fiducial objectivity resulting from their deviation. The authors recommend the PRBR algorithm as a safe and effective strategy for accurate, image-guided registration and PTV margin reduction.

  10. Mindfulness-based intervention for teenagers with cancer: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    . In spite of possible limitations, this project will be one among very few aimed at improving quality of life, sleep, and mood in adolescents living with cancer, will evaluate the potential benefits of such a practice on both psychological and physical health of youth with cancer, and help in creating mindfulness-based intervention programs, in order to provide the necessary psychological help to adolescents living with cancer. Trial registration Trial registration number: NCT01783418 PMID:23663534

  11. Development of a universal approach to increase physical activity among adolescents: the GoActive intervention

    PubMed Central

    Corder, Kirsten; Schiff, Annie; Kesten, Joanna M; van Sluijs, Esther M F

    2015-01-01

    . Future work will examine the feasibility and effectiveness of GoActive to increase PA among adolescents while monitoring potential negative effects. The approach developed is applicable to other population groups and health behaviours. Trial registration number ISRCTN31583496. PMID:26307618

  12. Psychological and behavioral interventions to reduce HIV risk: evidence from a randomized control trial among orphaned and vulnerable adolescents in South Africa.

    PubMed

    Thurman, T R; Kidman, R; Carton, T W; Chiroro, P

    2016-01-01

    Evidence-based approaches are needed to address the high levels of sexual risk behavior and associated HIV infection among orphaned and vulnerable adolescents. This study recruited adolescents from a support program for HIV-affected families and randomly assigned them by cluster to receive one of the following: (1) a structured group-based behavioral health intervention; (2) interpersonal psychotherapy group sessions; (3) both interventions; or (4) no new interventions. With 95% retention, 1014 adolescents were interviewed three times over a 22-month period. Intent-to-treat analyses, applying multivariate difference-in-difference probit regressions, were performed separately for boys and girls to assess intervention impacts on sexual risk behaviors. Exposure to a single intervention did not impact behaviors. Exposure to both interventions was associated with risk-reduction behaviors, but the outcomes varied by gender: boys reported fewer risky sexual partnerships (β = -.48, p = .05) and girls reported more consistent condom (β = 1.37, p = .02). There was no difference in the likelihood of sexual debut for either gender. Providing both psychological and behavioral interventions resulted in long-term changes in sexual behavior that were not present when either intervention was provided in isolation. Multifaceted approaches for reducing sexual risk behaviors among vulnerable adolescents hold significant promise for mitigating the HIV epidemic among this priority population.

  13. Psychological and behavioral interventions to reduce HIV risk: evidence from a randomized control trial among orphaned and vulnerable adolescents in South Africa

    PubMed Central

    Thurman, T. R.; Kidman, R.; Carton, T. W.; Chiroro, P.

    2016-01-01

    ABSTRACT Evidence-based approaches are needed to address the high levels of sexual risk behavior and associated HIV infection among orphaned and vulnerable adolescents. This study recruited adolescents from a support program for HIV-affected families and randomly assigned them by cluster to receive one of the following: (1) a structured group-based behavioral health intervention; (2) interpersonal psychotherapy group sessions; (3) both interventions; or (4) no new interventions. With 95% retention, 1014 adolescents were interviewed three times over a 22-month period. Intent-to-treat analyses, applying multivariate difference-in-difference probit regressions, were performed separately for boys and girls to assess intervention impacts on sexual risk behaviors. Exposure to a single intervention did not impact behaviors. Exposure to both interventions was associated with risk-reduction behaviors, but the outcomes varied by gender: boys reported fewer risky sexual partnerships (β = −.48, p = .05) and girls reported more consistent condom (β = 1.37, p = .02). There was no difference in the likelihood of sexual debut for either gender. Providing both psychological and behavioral interventions resulted in long-term changes in sexual behavior that were not present when either intervention was provided in isolation. Multifaceted approaches for reducing sexual risk behaviors among vulnerable adolescents hold significant promise for mitigating the HIV epidemic among this priority population. PMID:26886261

  14. Paroxetine Treatment in Children and Adolescents with Obsessive-Compulsive Disorder: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial

    ERIC Educational Resources Information Center

    Geller, Daniel A.; Wagner, Karen Dineen; Emslie, Graham; Murphy, Tanya; Carpenter, David J.; Wetherhold, Erica; Perera, Phil; Machin, Andrea; Gardiner, Christel

    2004-01-01

    Objective: To assess the efficacy and safety of paroxetine for the treatment of pediatric obsessive-compulsive disorder.Method: Children (7-11 years of age) and adolescents (12-17 years of age) meeting DSM-IV criteria for obsessive-compulsive disorder were randomized to paroxetine (10-50 mg/day) or placebo for 10 weeks. The primary efficacy…

  15. Randomized Controlled Trial of Osmotic-Release Methylphenidate with Cognitive-Behavioral Therapy in Adolescents with Attention-Deficit/Hyperactivity Disorder and Substance Use Disorders

    ERIC Educational Resources Information Center

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

    2011-01-01

    Objective: To evaluate the efficacy and safety of osmotic-release methylphenidate (OROS-MPH) compared with placebo for attention-deficit/hyperactivity disorder (ADHD), and the impact on substance treatment outcomes in adolescents concurrently receiving cognitive-behavioral therapy (CBT) for substance use disorders (SUD). Method: This was a…

  16. Neural Mechanisms of Cognitive-Behavioral Therapy for Aggression in Children and Adolescents: Design of a Randomized Controlled Trial Within the National Institute for Mental Health Research Domain Criteria Construct of Frustrative Non-Reward

    PubMed Central

    Wyk, Brent C. Vander; Eilbott, Jeffrey A.; McCauley, Spencer A.; Ibrahim, Karim; Crowley, Michael J.; Pelphrey, Kevin A.

    2016-01-01

    Abstract Objective: We present the rationale and design of a randomized controlled trial of cognitive-behavioral therapy (CBT) for aggression in children and adolescents, which is conducted in response to the National Institute of Mental Health (NIMH) Research Domain Criteria (RDoC) approach initiative. Specifically, the study is focused on the brain-behavior associations within the RDoC construct of frustrative non-reward. On the behavioral level, this construct is defined by reactions elicited in response to withdrawal or prevention of reward, most notably reactive aggression. This study is designed to test the functional magnetic resonance (fMRI) and electrophysiological (EEG) correlates of aggression and its reduction after CBT. Methods: Eighty children and adolescents with high levels of aggression across multiple traditional diagnostic categories, ages 8–16, will be randomly assigned to receive 12 sessions of CBT or 12 sessions of supportive psychotherapy. Clinical outcomes will be measured by the ratings of aggressive behavior collected at baseline, midpoint, and endpoint evaluations, and by the Improvement Score of the Clinical Global Impressions Scale assigned by an independent evaluator (blinded rater). Subjects will also perform a frustration-induction Go-NoGo task and a task of emotional face perception during fMRI scanning and EEG recording at baseline and endpoint. Results: Consistent with the NIMH strategic research priorities, if functional neuroimaging and EEG variables can identify subjects who respond to CBT for aggression, this can provide a neuroscience-based classification scheme that will improve treatment outcomes for children and adolescents with aggressive behavior. Conclusions: Demonstrating that a change in the key nodes of the emotion regulation circuitry is associated with a reduction of reactive aggression will provide evidence to support the validity of the frustrative non-reward construct. PMID:26784537

  17. Treatment of adolescents with depression: the effect of transference interventions in a randomized controlled study of dynamic psychotherapy

    PubMed Central

    2012-01-01

    disorder (PD) and quality of object relations (QOR) will be the preselected putative moderators. Discussion The object of this clinical trial is to explore the effect of transference interventions in psychodynamic psychotherapy in adolescents with a major depressive disorder. Using a randomized and dismantling design, we hope that the study will add more specific knowledge to the evidence base. Trial registration ClinicalTrials.gov Identifier: NCT01531101 First Experimental Study of Transference work Work–In Teenagers (FEST-IT) PMID:22950546

  18. Petition for Rulemaking to Evaluate Synergestic Effects of Pesticides during Registration and Registration Review

    EPA Pesticide Factsheets

    This petition from the Center for Biological Diversity asks that the Agency require all applicants and registrants to provide data on the potential synergistic effects of pesticides during the registration and registration review processes.

  19. 21 CFR 1309.42 - Certificate of registration; denial of registration.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...; denial of registration. (a) The Administrator shall issue a Certificate of Registration (DEA Form 511) to..., shall hold a hearing on the application pursuant to § 1309.51. (b) The Certificate of Registration...

  20. 21 CFR 1301.35 - Certificate of registration; denial of registration.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... registration. (a) The Administrator shall issue a Certificate of Registration (DEA Form 223) to an applicant if... Federal Register. (c) The Certificate of Registration (DEA Form 223) shall contain the name, address,...

  1. PRALIMAP: study protocol for a high school-based, factorial cluster randomised interventional trial of three overweight and obesity prevention strategies

    PubMed Central

    2010-01-01

    paid to clustering, multiple factorials and long-term duration to address common pitfalls in health promotion trials. The results should inform how best to implement, in a school environment, effective nutrition prevention programs targeting adolescents who are at a point their lives when they develop responsibilities and empowerment for health attitude behaviours. Trial registration This trial is registered at ClinicalTrials.gov under NCT00814554. PMID:21134278

  2. Treatment-resistant depression in adolescents: is the addition of cognitive behavioral therapy of benefit?

    PubMed Central

    Hetrick, Sarah E; Cox, Georgina R; Merry, Sally N

    2011-01-01

    Background Many young people with major depression fail first-line treatments. Treatment-resistant depression has various definitions in the literature but typically assumes nonresponse to medication. In young people, cognitive behavioral therapy (CBT) is the recommended first-line intervention, thus the definition of treatment resistance should be expanded. Therefore, our aim was to synthesize the existing evidence of any interventions for treatment-resistant depression, broadly defined, in children and adolescents and to investigate the effectiveness of CBT in this context. Methods We used Cochrane Collaboration methodology, with electronic searches of Medline, PsycINFO, Embase, and the Cochrane Depression Anxiety and Neurosis Group trials registers. Only randomized controlled trials were included, and were assessed for risk of bias. Meta- analysis was undertaken where possible and appropriate. Results Of 953 articles retrieved, four trials were eligible for inclusion. For one study, only the trial registration document was available, because the study was never completed. All other studies were well conducted with a low risk of bias, although one study had a high dropout rate. Two studies assessed the effect of adding CBT to medication. While an assertive trial of antidepressants does appear to lead to benefit, when compared with placebo, there was no significant advantage, in either study, or in a meta-analysis of data from these trials, that clearly demonstrated an additional benefit of CBT. The third trial showed little advantage of a tricyclic antidepressant over placebo in the context of an inpatient admission. Conclusion Few randomized controlled trials have investigated interventions for treatment-resistant depression in young people, and results from these show modest benefit from antidepressants with no additional benefit over medication from CBT. Overall, there is a lack of evidence about effective interventions to treat young people who have failed to

  3. Improving social functioning and challenging behaviors in adolescents with ASD and significant ID: A randomized pilot feasibility trial of reciprocal imitation training in a residential setting.

    PubMed

    Ingersoll, Brooke; Berger, Natalie; Carlsen, Danielle; Hamlin, Theresa

    2016-08-11

    There is a lack of effective social interventions for youths with ASD and co-morbid intellectual disability (ID). A previous single-case design study indicated that reciprocal imitation training (RIT) may improve social interaction and challenging behavior in this population. The current pilot study examined the feasibility of conducting an RCT to investigate the effectiveness of RIT for improving social functioning and challenging behaviors in 20 adolescents with ASD and severe ID in a residential program. The assessment protocol was feasible. RIT was well-tolerated by the adolescents and implemented with fidelity by teaching staff. Preliminary findings indicate that treatment had moderate to large effects on social functioning and challenging behavior, with mixed findings for imitation skills. A larger RCT of RIT for this population is feasible and warranted.

  4. Pesticide Registration Manual: Chapter 10 - Data Compensation Requirements

    EPA Pesticide Factsheets

    This chapter provides information about data compensation requirements, procedures, and obligations when submitting an application for registration, amended registration, reregistration or registration review.

  5. Contacts in the Office of Pesticide Programs, Registration Division

    EPA Pesticide Factsheets

    The Registration Division (RD) is responsible product registrations, amendments, registrations, tolerances, experimental use permits, and emergency exemptions for conventional chemical pesticides. Find contacts in this division.

  6. Design and evaluation protocol of "FATaintPHAT", a computer-tailored intervention to prevent excessive weight gain in adolescents

    PubMed Central

    Ezendam, Nicole PM; Oenema, Anke; van de Looij-Jansen, Petra M; Brug, Johannes

    2007-01-01

    Background Computer tailoring may be a promising technique for prevention of overweight in adolescents. However, very few well-developed, evidence-based computer-tailored interventions are available for this target group. We developed and evaluated a computer-tailored intervention for adolescents targeting energy balance-related behaviours: i.e. consumption of snacks, sugar-sweetened beverages, fruit, vegetables, and fibre, physical activity, and sedentary behaviours. This paper describes the planned development of a school-based computer-tailored intervention aimed at improving energy balance-related behaviours in order to prevent excessive weight gain in adolescents, and the protocol for evaluating this intervention. Methods/design Intervention development: Informed by the Precaution Adoption Process Model and the Theory of Planned Behaviour, the computer-tailored intervention provided feedback on personal behaviour and suggestions on how to modify it. The intervention (VETisnietVET translated as 'FATaintPHAT') has been developed for use in the first year of secondary school during eight lessons. Evaluation design: The intervention will be evaluated in a cluster-randomised trial including 20 schools with a 4-months and a 2-years follow-up. Outcome measures are BMI, waist circumference, energy balance-related behaviours, and potential determinants of these behaviours. Process measures are appreciation of and satisfaction with the program, exposure to the program's content, and implementation facilitators and barriers measured among students and teachers. Discussion This project resulted in a theory and evidence-based intervention that can be implemented in a school setting. A large-scale randomised controlled trial with a short and long-term follow-up will provide sound statements about the effectiveness of this computer-tailored intervention in adolescents. Trial Registration ISRCTN15743786 PMID:17997834

  7. Psychotherapy for depression in children and adolescents: study protocol for a systematic review and network meta-analysis

    PubMed Central

    Qin, Bin; Zhou, Xinyu; Michael, Kurt D; Liu, Yiyun; Whittington, Craig; Cohen, David; Zhang, Yuqing; Xie, Peng

    2015-01-01

    Introduction Depression is common among children and adolescents and is associated with significantly negative effects. A number of structured psychosocial treatments are administered for depression in children and adolescents; however, evidence of their effectiveness is not clear. We describe the protocol of a systematic review and network meta-analysis to evaluate the efficacy, quality of life, tolerability and acceptability of the use of psychological intervention for this young population. Methods and analysis We will search PubMed, EMBASE, CENTRAL (the Cochrane Central Register of Controlled Trials), Web of Science, PsycINFO, CINAHL, LiLACS, Dissertation Abstracts, European Association for Grey Literature Exploitation (EAGLE) and the National Technical Information Service (NTIS) from inception to July 2014. There will be no restrictions on language, publication year or publication type. Only randomised clinical trials (RCTs) with psychosocial treatments for depression in children and adolescents will be considered. The primary outcome of efficacy will be the mean overall change of the total score in continuous depression severity scales from baseline to end point. Data will be independently extracted by two reviewers. Traditional pairwise meta–analyses will be performed for studies that directly compared different treatment arms. Then we will perform a Bayesian network meta–analyses to compare the relative efficacy, quality of life, tolerability and acceptability of different psychological intervention. Subgroup analyses will be performed by the age of participants and the duration of psychotherapy, and sensitivity analyses will be conducted to assess the robustness of the findings. Ethics and dissemination No ethical issues are foreseen. The results will be published in a peer–reviewed journal and disseminated electronically and in print. The meta–analysis may be updated to inform and guide management of depression in children and adolescents. Trials

  8. Intraoperative ultrasound to stereocamera registration using interventional photoacoustic imaging

    NASA Astrophysics Data System (ADS)

    Vyas, Saurabh; Su, Steven; Kim, Robert; Kuo, Nathanael; Taylor, Russell H.; Kang, Jin U.; Boctor, Emad M.

    2012-02-01

    There are approximately 6000 hospitals in the United States, of which approximately 5400 employ minimally invasive surgical robots for a variety of procedures. Furthermore, 95% of these robots require extensive registration before they can be fitted into the operating room. These "registrations" are performed by surgical navigation systems, which allow the surgical tools, the robot and the surgeon to be synchronized together-hence operating in concert. The most common surgical navigation modalities include: electromagnetic (EM) tracking and optical tracking. Currently, these navigation systems are large, intrusive, come with a steep learning curve, require sacrifices on the part of the attending medical staff, and are quite expensive (since they require several components). Recently, photoacoustic (PA) imaging has become a practical and promising new medical imaging technology. PA imaging only requires the minimal equipment standard with most modern ultrasound (US) imaging systems as well as a common laser source. In this paper, we demonstrate that given a PA imaging system, as well as a stereocamera (SC), the registration between the US image of a particular anatomy and the SC image of the same anatomy can be obtained with reliable accuracy. In our experiments, we collected data for N = 80 trials of sample 3D US and SC coordinates. We then computed the registration between the SC and the US coordinates. Upon validation, the mean error and standard deviation between the predicted sample coordinates and the corresponding ground truth coordinates were found to be 3.33 mm and 2.20 mm respectively.

  9. A Randomized Controlled Trial of a Parent-Centered Intervention in Preventing Substance Use and HIV Risk Behaviors in Hispanic Adolescents

    PubMed Central

    Prado, Guillermo; Pantin, Hilda; Briones, Ervin; Schwartz, Seth J.; Feaster, Daniel; Huang, Shi; Sullivan, Summer; Tapia, Maria I.; Sabillon, Eduardo; Lopez, Barbara; Szapocznik, José

    2013-01-01

    The present study evaluated the efficacy of Familias Unidas + Parent–Preadolescent Training for HIV Prevention (PATH), a Hispanic-specific, parent-centered intervention, in preventing adolescent substance use and unsafe sexual behavior. Two hundred sixty-six 8th-grade Hispanic adolescents and their primary caregivers were randomly assigned to 1 of 3 conditions: Familias Unidas + PATH, English for Speakers of Other Languages (ESOL) + PATH, and ESOL + HeartPower! for Hispanics (HEART). Participants were assessed at baseline and at 6, 12, 24, and 36 months postbaseline. Results showed that (a) Familias Unidas + PATH was efficacious in preventing and reducing cigarette use relative to both control conditions; (b) Familias Unidas + PATH was efficacious, relative to ESOL + HEART, in reducing illicit drug use; and (c) Familias Unidas + PATH was efficacious, relative to ESOL + PATH, in reducing unsafe sexual behavior. The effects of Familias Unidas + PATH on these distal outcomes were partially mediated by improvements in family functioning. These findings suggest that strengthening the family system, rather than targeting specific health behaviors, may be most efficacious in preventing and/or reducing cigarette smoking, illicit drug use, and unsafe sex in Hispanic adolescents. PMID:18085908

  10. Registration of interferometric SAR images

    NASA Technical Reports Server (NTRS)

    Lin, Qian; Vesecky, John F.; Zebker, Howard A.

    1992-01-01

    Interferometric synthetic aperture radar (INSAR) is a new way of performing topography mapping. Among the factors critical to mapping accuracy is the registration of the complex SAR images from repeated orbits. A new algorithm for registering interferometric SAR images is presented. A new figure of merit, the average fluctuation function of the phase difference image, is proposed to evaluate the fringe pattern quality. The process of adjusting the registration parameters according to the fringe pattern quality is optimized through a downhill simplex minimization algorithm. The results of applying the proposed algorithm to register two pairs of Seasat SAR images with a short baseline (75 m) and a long baseline (500 m) are shown. It is found that the average fluctuation function is a very stable measure of fringe pattern quality allowing very accurate registration.

  11. Move it to improve it (Mitii): study protocol of a randomised controlled trial of a novel web-based multimodal training program for children and adolescents with cerebral palsy

    PubMed Central

    Boyd, Roslyn N; Mitchell, Louise E; James, Sarah T; Ziviani, Jenny; Sakzewski, Leanne; Smith, Anthony; Rose, Stephen; Cunnington, Ross; Whittingham, Koa; Ware, Robert S; Comans, Tracey A; Scuffham, Paul A

    2013-01-01

    disseminated widely through conference presentations, seminars and peer-reviewed scientific journals. Trial registration ACTRN12611001174976 PMID:23578686

  12. Evaluation of Yoga for Preventing Adolescent Substance Use Risk Factors in a Middle School Setting: A Preliminary Group-Randomized Controlled Trial.

    PubMed

    Butzer, Bethany; LoRusso, Amanda; Shin, Sunny H; Khalsa, Sat Bir S

    2017-03-01

    Adolescence is a key developmental period for preventing substance use initiation, however prevention programs solely providing educational information about the dangers of substance use rarely change adolescent substance use behaviors. Recent research suggests that mind-body practices such as yoga may have beneficial effects on several substance use risk factors, and that these practices may serve as promising interventions for preventing adolescent substance use. The primary aim of the present study was to test the efficacy of yoga for reducing substance use risk factors during early adolescence. Seventh-grade students in a public school were randomly assigned by classroom to receive either a 32-session yoga intervention (n = 117) in place of their regular physical education classes or to continue with physical-education-as-usual (n = 94). Participants (63.2 % female; 53.6 % White) completed pre- and post-intervention questionnaires assessing emotional self-regulation, perceived stress, mood impairment, impulsivity, substance use willingness, and actual substance use. Participants also completed questionnaires at 6-months and 1-year post-intervention. Results revealed that participants in the control condition were significantly more willing to try smoking cigarettes immediately post-intervention than participants in the yoga condition. Immediate pre- to post-intervention differences did not emerge for the remaining outcomes. However, long-term follow-up analyses revealed a pattern of delayed effects in which females in the yoga condition, and males in the control condition, demonstrated improvements in emotional self-control. The findings suggest that school-based yoga may have beneficial effects with regard to preventing males' and females' willingness to smoke cigarettes, as well as improving emotional self-control in females. However additional research is required, particularly with regard to the potential long-term effects of mind-body interventions

  13. Ethnic differences in BMI among Dutch adolescents: what is the role of screen-viewing, active commuting to school, and consumption of soft drinks and high-caloric snacks?

    PubMed Central

    Singh, Amika S; Chinapaw, Mai JM; Brug, Johannes; Kremers, Stef PJ; Visscher, Tommy LS; van Mechelen, Willem

    2009-01-01

    Background The threats posed by the rising prevalence of overweight and obesity on public health have been widely acknowledged. Several population groups, which deserve special attention because of their higher prevalence rates, have been identified. These include adolescents and ethnic sub-groups. The aim of the present study was twofold: (1) to assess ethnic differences in body mass index (BMI) and in behaviours that are related to both energy intake and energy expenditure, and (2) to examine whether these behaviours explain the relationship between ethnicity and BMI. Methods We conducted a cross-sectional data analysis among 957 Dutch adolescents (mean age = 12.7 years). Body height and weight were measured using a standardized protocol. Adolescents completed a questionnaire on screen-viewing behaviour, physical activity, consumption of sugar-containing beverages, and consumption of high-caloric snacks. Results In our study sample 121 adolescents (= 13%) were of Non-Western origin. BMI was significantly higher in Non-Western adolescents (boys: 19.9 kg/m2, SD = 3.0, girls: 20.9 kg/m2, SD = 3.8) compared to Dutch adolescents (boys: 18.4 kg/m2, SD = 2.8, girls: 19.0 kg/m2, SD = 3.0). Our results show that time spent on television viewing, active commuting to school, and consumption of fruit juices partially mediated the association between BMI and ethnicity. Conclusion Behaviours related to both energy expenditure and energy intake may contribute to the ethnic differences in BMI in adolescents and should be considered when tailoring overweight prevention programs to ethnic subpopulations. Trial registration International Standard Randomised Controlled Trial Number ISRCTN87127361 PMID:19383136

  14. Asperger syndrome and anxiety disorders (PAsSA) treatment trial: a study protocol of a pilot, multicentre, single-blind, randomised crossover trial of group cognitive behavioural therapy

    PubMed Central

    Langdon, Peter E; Murphy, Glynis H; Wilson, Edward; Shepstone, Lee; Fowler, David; Heavens, David; Malovic, Aida; Russell, Alexandra

    2013-01-01

    Introduction A number of studies have established that children, adolescents and adults with Asperger syndrome (AS) and high functioning autism (HFA) have significant problems with anxiety. Cognitive behavioural therapy (CBT) is an effective treatment for anxiety in a variety of clinical populations. There is a growing interest in exploring the effectiveness of CBT for people with AS who have mental health problems, but currently there are no known clinical trials involving adults with AS or HFA. Studies with children who have AS have reported some success. The current study aims to examine whether modified group CBT for clinically significant anxiety in an AS population is likely to be efficacious. Methods and analysis This study is a randomised, single-blind crossover trial. At least 36 individuals will be recruited and randomised into a treatment arm or a waiting-list control arm. During treatment, individuals will receive 3 sessions of individual CBT, followed by 21 sessions of group CBT. Primary outcome measures focus on anxiety. Secondary outcome measures focus on everyday social and psychiatric functioning, additional measures of anxiety and fear, depression, health-related quality of life and treatment cost. Assessments will be administered at pregroup and postgroup and at follow-up by researchers who are blinded to group allocation. The trial aims to find out whether or not psychological treatments for anxiety can be adapted and used to successfully treat the anxiety experienced by people with AS. Furthermore, we aim to determine whether this intervention represents good value for money. Ethics and dissemination The trial received a favourable ethical opinion from a National Health Service (NHS) Research Ethics Committee. All participants provided written informed consent. Findings will be shared with all trial participants, and the general public, as well as the scientific community. Trial Registration ISRCTN 30265294 (DOI: 10.1186/ISRCTN30265294), UKCRN

  15. 78 FR 58318 - Clinical Trial Design for Intravenous Fat Emulsion Products; Public Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-23

    ... HUMAN SERVICES Food and Drug Administration Clinical Trial Design for Intravenous Fat Emulsion Products... ``Clinical Trial Design for Intravenous Fat Emulsion Products.'' This workshop will provide a forum to discuss trial design of clinical trials intended to support registration of intravenous fat...

  16. Focus Meetings for Pesticide Registration Review

    EPA Pesticide Factsheets

    Focus meetings with affected registrants and possibly other stakeholders are based around the information needs identified by the EPA chemical review team and management for consideration during our registration reevaluation of a pesticide.

  17. Registration of video sequences from multiple sensors

    NASA Technical Reports Server (NTRS)

    Sharma, Ravi K.; Pavel, Misha

    1997-01-01

    In this paper, we describe an approach for registration of video sequences from a suite of multiple sensors including television, infrared and radar. Video sequences generated by these sensors may contain abrupt changes in local contrast and inconsistent image features, which pose additional difficulties for registration. Our approach to registration addresses the difficulties caused by using multiple sensors. We use a representation for registration that is invariant to local contrast changes, followed by smoothing of the resulting error measure used for registration, for robust estimation of registration parameters. We use an iterative procedure to reduce the effect of inconsistent features. Finally, we describe a method that uses same-sensor registration to aide in performing registration of sequences of video frames across multiple sensors.

  18. 75 FR 19388 - Pesticide Product; Registration Application

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-14

    ... From the Federal Register Online via the Government Publishing Office ENVIRONMENTAL PROTECTION AGENCY Pesticide Product; Registration Application AGENCY: Environmental Protection Agency (EPA). ACTION... deadline identified. II. Registration Applications EPA has received an application to register a...

  19. Fuels Registration, Reporting, and Compliance Help

    EPA Pesticide Factsheets

    Information about the requirements for registration and health effects testing of new fuels or fuel additives and mandatory registration for fuels reporting and about mandatory reporting forms for parties regulated under EPA fuel programs.

  20. Long-Term Behavioral Outcomes after a Randomized, Clinical Trial of Counselor-Assisted Problem Solving for Adolescents with Complicated Mild-to-Severe Traumatic Brain Injury.

    PubMed

    Wade, Shari L; Taylor, H Gerry; Cassedy, Amy; Zhang, Nanhua; Kirkwood, Michael W; Brown, Tanya M; Stancin, Terry

    2015-07-01

    Family problem-solving therapy (FPST) has been shown to reduce behavior problems after pediatric traumatic brain injury (TBI). It is unclear whether treatment gains are maintained. We sought to evaluate the maintenance of improvements in behavior problems after a Web-based counselor-assisted FPST (CAPS) intervention compared to an Internet resource comparison (IRC) intervention provided to adolescents within the initial year post-TBI. We hypothesized that family socioeconomic status, child educational status, and baseline levels of symptoms would moderate the efficacy of the treatment over time. Participants included 132 adolescents ages 12-17 years who sustained a complicated mild-to-severe TBI 1-6 months before study enrollment. Primary outcomes were the Child Behavior Checklist Internalizing and Externalizing Totals. Mixed-models analyses, using random intercepts and slopes, were conducted to examine group differences over time. There was a significant group×time×grade interaction (F(1,304)=4.42; p=0.03) for internalizing problems, with high school-age participants in CAPS reporting significantly lower symptoms at 18 months postbaseline than those in the IRC. Post-hoc analyses to elucidate the nature of effects on internalizing problems revealed significant group×time×grade interactions for the anxious/depressed (p=0.03) and somatic complaints subscales (p=0.04). Results also indicated significant improvement over time for CAPS participants who reported elevated externalizing behavior problems at baseline (F(1, 310)=7.17; p=0.008). Findings suggest that CAPS may lead to long-term improvements in behavior problems among older adolescents and those with pretreatment symptoms.