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Sample records for adolescents trial registration

  1. [A review of international clinical trial registration].

    PubMed

    Yu, He; Liu, Jian-ping

    2007-05-01

    Clinical trials play a critical role in medical research. However, only a few clinical trials conducted at present have been registered at various clinical trial registries. Clinical trial registration can prevent bias in these registered trials effectively and avoid unnecessary waste of resources due to meaningless repeats. Moreover, it will benefit the development of evidence-based medicine, and promote human welfare. Great attention has been paid to the importance and necessity of clinical trial registration. This review briefly introduced the definition, justification, contents, history, current status of clinical trial registration, and introduced the information regarding important international clinical trial registries in detail. Clinical trial registration should be developed toward a transparent, compulsory and comprehensive stage. PMID:17498477

  2. Legislation for trial registration and data transparency.

    PubMed

    Bian, Zhao-Xiang; Wu, Tai-Xiang

    2010-01-01

    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. PMID:20504337

  3. 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. PMID:24350423

  4. Is Mandatory Prospective Trial Registration Working to Prevent Publication of Unregistered Trials and Selective Outcome Reporting? An Observational Study of Five Psychiatry Journals That Mandate Prospective Clinical Trial Registration

    PubMed Central

    Scott, Amelia; Rucklidge, Julia J.; Mulder, Roger T.

    2015-01-01

    Objective To address the bias occurring in the medical literature associated with selective outcome reporting, in 2005, the International Committee of Medical Journal Editors (ICMJE) introduced mandatory trial registration guidelines and member journals required prospective registration of trials prior to patient enrolment as a condition of publication. No research has examined whether these guidelines are impacting psychiatry publications. Our objectives were to determine the extent to which articles published in psychiatry journals adhering to ICMJE guidelines were correctly prospectively registered, whether there was evidence of selective outcome reporting and changes to participant numbers, and whether there was a relationship between registration status and source of funding. Materials and Methods Any clinical trial (as defined by ICMJE) published between 1 January 2009 and 31 July 2013 in the top five psychiatry journals adhering to ICMJE guidelines (The American Journal of Psychiatry, Archives of General Psychiatry/JAMA Psychiatry, Biological Psychiatry, Journal of the American Academy of Child and Adolescent Psychiatry, and The Journal of Clinical Psychiatry) and conducted after July 2005 (or 2007 for two journals) was included. For each identified trial, where possible we extracted trial registration information, changes to POMs between publication and registry to assess selective outcome reporting, changes to participant numbers, and funding type. Results Out of 3305 articles, 181 studies were identified as clinical trials requiring registration: 21 (11.6%) were deemed unregistered, 61 (33.7%) were retrospectively registered, 37 (20.4%) had unclear POMs either in the article or the registry and 2 (1.1%) were registered in an inaccessible trial registry. Only 60 (33.1%) studies were prospectively registered with clearly defined POMs; 17 of these 60 (28.3%) showed evidence of selective outcome reporting and 16 (26.7%) demonstrated a change in participant

  5. Trials and Tribulations: An Industry Perspective on Conducting Registrational Trials in Alpha-1 Antitrypsin Deficiency.

    PubMed

    Forshag, Mark S

    2016-08-01

    Registrational trials in rare and orphan diseases present complexities related to the identification of subjects, recruitment, logistical hurdles incumbent with far-flung study sites, and end points that are often less well defined than are those used in more common illnesses. Alpha-1 antitrypsin deficiency is an orphan disease of genetic origin that carries the additional challenges of variable penetration and slow disease progression. Registrational trials of augmentation therapy using plasma-derived alpha-1 antitrypsin carry all of the above-noted burdens, as well as competition from commercially available augmentation therapy in many countries. PMID:27564675

  6. Association of trial registration with the results and conclusions of published trials of new oncology drugs

    PubMed Central

    2009-01-01

    Background Registration of clinical trials has been introduced largely to reduce bias toward statistically significant results in the trial literature. Doubts remain about whether advance registration alone is an adequate measure to reduce selective publication, selective outcome reporting, and biased design. One of the first areas of medicine in which registration was widely adopted was oncology, although the bulk of registered oncology trials remain unpublished. The net influence of registration on the literature remains untested. This study compares the prevalence of favorable results and conclusions among published reports of registered and unregistered randomized controlled trials of new oncology drugs. Methods We conducted a cross-sectional study of published original research articles reporting clinical trials evaluating the efficacy of drugs newly approved for antimalignancy indications by the United States Food and Drug Administration (FDA) from 2000 through 2005. Drugs receiving first-time approval for indications in oncology were identified using the FDA web site and Thomson Centerwatch. Relevant trial reports were identified using PubMed and the Cochrane Library. Evidence of advance trial registration was obtained by a search of clinicaltrials.gov, WHO, ISRCTN, NCI-PDQ trial databases and corporate trial registries, as well as articles themselves. Data on blinding, results for primary outcomes, and author conclusions were extracted independently by two coders. Univariate and multivariate logistic regression identified associations between favorable results and conclusions and independent variables including advance registration, study design characteristics, and industry sponsorship. Results Of 137 original research reports from 115 distinct randomized trials assessing 25 newly approved drugs for treating cancer, the 54 publications describing data from trials registered prior to publication were as likely to report statistically significant efficacy

  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. Surgical trials and trial registers: a cross-sectional study of randomized controlled trials published in journals requiring trial registration in the author instructions

    PubMed Central

    2013-01-01

    Background Trial registration and the reporting of trial results are essential to increase transparency in clinical research. Although both have been strongly promoted in recent years, it remains unclear whether they have been successfully implemented in surgery and surgery-related disciplines. In this cross-sectional study, we assessed whether randomized controlled trials (RCTs) published in surgery journals requiring trial registration in their author instructions were indeed registered, and whether the study results of registered RCTs had been submitted to the trial register and were thus publicly available. Methods The ten highest ranked surgery journals requiring trial registration by impact factor (Journal Citation Reports, JCR, 2011) were chosen. We then searched MEDLINE (in PubMed) for RCTs published in the selected journals between 1 June 2012 and 31 December 2012. Any trials recruiting participants before 2004 were excluded because the International Committee of Medical Journal Editors (ICMJE) first proposed trial registration in 2004. We then searched the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) to assess whether the identified RCTs were indeed registered and whether the results of the registered RCTs were available in the register. Results The search retrieved 588 citations. Four hundred and sixty references were excluded in the first screening. A further 25 were excluded after full-text screening. A total of 103 RCTs were finally included. Eighty-five of these RCTs (83%) could be found via the ICTRP. For 7 of 59 (12%) RCTs, which were registered on ClinicalTrials.gov, summary study data had been posted in the results database. Conclusions Although still not fully implemented, trial registration in surgery has gained momentum. In general, however, the submission of summary study data to ClinicalTrials.gov remains poor. PMID:24289719

  9. Comparison of published orthopaedic trauma trials following registration in Clinicaltrials.gov

    PubMed Central

    2011-01-01

    Background After the Food and Drug Administration Modernization Act of 1997, the registration of all clinical trials became mandatory prior to publication. Our primary objective was to determine publication rates for orthopaedic trauma trials registered with ClinicalTrials.gov. We further evaluated methodological consistency between registration and publication. Methods We searched Clinical Trials.gov for all trials related to orthopaedic trauma. We excluded active trials and trials not completed by July 2009, and performed a systematic search for publications resulting from registered closed trials. Information regarding primary and secondary outcomes, intervention, study sponsors, and sample size were extracted from registrations and publications. Results Of 130 closed trials, 37 eligible trials resulted in 16 publications (43.2%). We found no significant differences in publication rates between funding sources for industry sponsored studies and nongovernment/nonindustry sponsored studies (p > 0.05). About half the trials (45%) did not include the NCT ID in the publication. Two (10%) publications had major changes to the primary outcome measure and ten (52.6%) to sample size. Conclusions Registration of orthopaedic trauma trials does not consistently result in publication. When trials are registered, many do not cite NCT ID in the publication. Furthermore, changes that are not reflected in the registry of the trial are frequently made to the final publication. PMID:22151841

  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. Inclusion of South African adolescents in HIV vaccine trials

    PubMed Central

    Adler, David H.

    2013-01-01

    South Africa has more people living with HIV than any other nation. The HIV epidemic in South Africa is being driven by new infections among adolescents. Inclusion of adolescents in HIV vaccine trials is essential for successful vaccine development, however, recruitment and retention of at-risk South African adolescents into these trials poses a number of legal, ethical and operational challenges. This article discusses the South African ethico-legal context in which future adolescent HIV vaccine trials would be conducted followed by a review of available data regarding strategies for recruitment into these trials and retention of trial participants. PMID:24729929

  12. Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology

    PubMed Central

    Azar, Marleine; Riehm, Kira E.; McKay, Dean; Thombs, Brett D.

    2015-01-01

    Background Confidence that randomized controlled trial (RCT) results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP) is the primary trials journal amongst American Psychological Association (APA) journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1) adequacy of primary outcome analysis definitions; (2) registration status; and, (3) among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals. Methods Eligible RCTs were published in JCCP in 2013–2014. For each RCT, two investigators independently extracted data on (1) adequacy of outcome analysis definitions in the published report, (2) whether the RCT was registered prior to enrolling patients, and (3) adequacy of outcome registration. Results Of 70 RCTs reviewed, 12 (17.1%) adequately defined primary or secondary outcome analyses, whereas 58 (82.3%) had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7%) registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029). The proportion of registered trials in JCCP (55.7%) was comparable to behavioral medicine journals (52.6%; p = 0.709). Conclusions The quality of published outcome analysis

  13. [Clinical trial requests of indigenous diagnostic imaging ultrasound devices in first-time registration application].

    PubMed

    Guo, Zhaojun; Cao, Guofang; Tao, Kan

    2012-11-01

    This article introduces the clinical requests of indigenous diagnostic imaging ultrasound devices in first-time registration application and the clinical trial requests in Technical Review Guidance of Ultrasound Imaging Diagnostic Devices (category III) Registration and puts forward some questions of the guidance's implementation. It is hoped to help concerned people. PMID:23461122

  14. A randomised controlled trial of the efficacy of the ABCD Parenting Young Adolescents Program: rationale and methodology

    PubMed Central

    2010-01-01

    for the promotion of protective factors associated with adolescent wellbeing and will add to the literature regarding the relationships between parent, parenting and adolescent factors. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12609000194268. PMID:20723219

  15. Evaluating adherence to the International Committee of Medical Journal Editors’ policy of mandatory, timely clinical trial registration

    PubMed Central

    Huser, Vojtech; Cimino, James J

    2013-01-01

    Objective To determine whether two specific criteria in Uniform Requirements for Manuscripts (URM) created by the International Committee of Medical Journal Editors (ICMJE)—namely, including the trial ID registration within manuscripts and timely registration of trials, are being followed. Materials and methods Observational study using computerized analysis of publicly available Medline article data and clinical trial registry data. We analyzed a purposive set of five ICMJE founding journals looking at all trial articles published in those journals during 2010–2011, and data from the ClinicalTrials.gov (CTG) trial registry. We measured adherence to trial ID inclusion policy as the percentage of trial journal articles that contained a valid trial ID within the article (journal-based sample). Adherence to timely registration was measured as the percentage of trials that registered the trial before enrolling the first participant within a 60-day grace period. We also examined timely registration rates by year of all phase II and higher interventional trials in CTG (registry-based sample). Results To determine trial ID inclusion, we analyzed 698 clinical trial articles in five journals. A total of 95.8% (661/690) of trial journal articles included the trial ID. In 88.3% the trial-article link is stored within a structured Medline field. To evaluate timely registration, we analyzed trials referenced by 451 articles from the selected five journals. A total of 60% (272/451) of articles were registered in a timely manner with an improving trend for trials initiated in later years (eg, 89% of trials that began in 2008 were registered in a timely manner). In the registry-based sample, the timely registration rates ranged from 56% for trials registered in 2006 to 72% for trials registered in 2011. Discussion Adherence to URM requirements for registration and trial ID inclusion increases the utility of PubMed and links it in an important way to clinical trial repositories

  16. 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. PMID:26515793

  17. Study protocol: A cluster randomised controlled trial of implementation intentions to reduce smoking initiation in adolescents

    PubMed Central

    2013-01-01

    Background The current literature suggests that forming implementation intentions (simple ‘if-then’ plans) about how to refuse the offer of a cigarette may be an effective intervention to reduce smoking initiation in adolescents. This study is a pragmatic trial to test the effectiveness and cost-effectiveness of such an intervention in reducing smoking initiation in a sample of UK adolescents. Methods/Design A cluster randomised controlled trial with at least 36 schools randomised to receive an implementation intention intervention targeting reducing smoking initiation (intervention group) or increasing homework (control group). Interventions will be conducted at the classroom level and be repeated every six months for four years (eight interventions). Objectively assessed (carbon monoxide monitor) and self-reported smoking plus smoking related cognitions (e.g., smoking intentions, attitudes, norms and self-efficacy) will be assessed at baseline and 12, 24, 36 and 48 months post baseline. Objectively assessed smoking at 48 months post baseline will be the primary outcome variable. Health economic analyses will assess life years gained. Discussion The results of the trial will provide information on the impact of a repeated implementation intention for refusing offers of cigarettes on rates of smoking initiation in adolescents. Trial registration ISRCTN27596806 PMID:23332020

  18. ClinicalTrials.gov registration can supplement information in abstracts for systematic reviews: a comparison study

    PubMed Central

    2013-01-01

    Background The inclusion of randomized controlled trials (RCTs) reported in conference abstracts in systematic reviews is controversial, partly because study design information and risk of bias is often not fully reported in the abstract. The Association for Research in Vision and Ophthalmology (ARVO) requires trial registration of abstracts submitted for their annual conference as of 2007. Our goal was to assess the feasibility of obtaining study design information critical to systematic reviews, but not typically included in conference abstracts, from the trial registration record. Methods We reviewed all conference abstracts presented at the ARVO meetings from 2007 through 2009, and identified 496 RCTs; 154 had a single matching registration record in ClinicalTrials.gov. Two individuals independently extracted information from the abstract and the ClinicalTrials.gov record, including study design, sample size, inclusion criteria, masking, interventions, outcomes, funder, and investigator name and contact information. Discrepancies were resolved by consensus. We assessed the frequencies of reporting variables appearing in the abstract and the trial register and assessed agreement of information reported in both sources. Results We found a substantial amount of study design information in the ClinicalTrials.gov record that was unavailable in the corresponding conference abstract, including eligibility criteria associated with gender (83%; 128/154); masking or blinding of study participants (53%, 82/154), persons administering treatment (30%, 46/154), and persons measuring the outcomes (40%, 61/154)); and number of study centers (58%; 90/154). Only 34% (52/154) of abstracts explicitly described a primary outcome, but a primary outcome was included in the “Primary Outcome” field in the ClinicalTrials.gov record for 82% (126/154) of studies. One or more study interventions were reported in each abstract, but agreed exactly with those reported in ClinicalTrials

  19. Trends in global clinical trial registration: an analysis of numbers of registered clinical trials in different parts of the world from 2004 to 2013

    PubMed Central

    Viergever, Roderik F; Li, Keyang

    2015-01-01

    Objectives To analyse developments (and their causes) in the number and proportion of clinical trials that were registered in different parts of the world after the International Committee of Medical Journal Editors (ICMJE) announced in 2004 that it would require registration of clinical trials as a condition for publication. Setting The International Clinical Trials Registry Platform (ICTRP). Design The ICTRP database was searched for all clinical trials that were registered up to 31 December 2013. Results The ICTRP database contained data on 186 523 interventional clinical trials. The annual number of registered clinical trials increased from 3294 in 2004 to 23 384 in 2013. Relative to the number of clinical trial research publications, the global number of registered clinical trials increased fivefold between 2004 and 2013, rising particularly strongly between 2004 and 2005. In certain regions, especially Asia, the annual number of registered trials increased more gradually and continued to increase up to 2013. In India and Japan, two countries with marked but more gradual increases, these increases only happened after several local measures were implemented that encouraged and enforced registration. In most regions, there was a trend toward trials being registered at local registries. Conclusions Clinical trial registration has greatly improved transparency in clinical trial research. However, these improvements have not taken place equally in all parts of the world. Achieving compliance with registration requires a coalescence of global and local measures, and remains a key challenge in many countries. Poor quality of registered trial data and the inaccessibility of trial protocols, results and participant-level data further undermine the potential benefits of clinical trial registration. National and regional registries and the ICTRP have played a leading role in achieving the successes of trial registration to date and should be supported in addressing

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed Central

    2013-01-01

    implemented widely in contemporary clinical practice. Anticipated difficulties for the trial are the recruitment and retention of participants, particularly adolescents. To avert these concerns and maximize recruitment, several strategies will be adopted to optimize referral rates as well as reduce participant drop-outs. Trial registration This trial is registered with the Australian and New Zealand Clinical Trials Registry, registration number: ACTRN12611001280998 PMID:23672442

  4. 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

  5. The views of doctors on registration trials in a Japanese rural area: a survey of medical institutions registered to the Tokushima Network for Clinical Trials.

    PubMed

    Yanagawa, H; Irahara, M; Kawashima, S; Kagawa, S

    2008-01-01

    Tokushima University Hospital has established the Tokushima Network for Clinical Trials (TNCT) to promote clinical trials in the area in collaboration with the Tokushima Medical Association. The present study investigated the views of doctors towards registration trials in the TNCT. A questionnaire was provided to 49 clinics/hospitals registered to the TNCT in 2006 and 38 (78%) responded. It revealed that 48% of doctors were aware of registration trials and 87% were favourable towards participating as investigators in them. They considered close contact with developmental drugs, advancement of therapy and the opportunity to learn about state-of-the-art treatment as benefits of participation. The main areas of difficulty included management of adverse reactions and patients' refusal to take part. Many doctors wanted more opportunity to learn about trial-related issues such as regulations. The survey indicates that the TNCT needs to develop the infrastructure and enlighten participants to promote registration trials in this rural regional area. PMID:18831909

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

    PubMed Central

    2014-01-01

    anorexia nervosa. If found to be efficacious, parent-focused treatment will offer an alternative approach for clinicians who treat adolescents with anorexia nervosa. Trial registration Australian and New Zealand Clinical Trials Registry ACTRN12610000216011. PMID:24712855

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

    PubMed Central

    2014-01-01

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

  8. 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…

  9. 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

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

    PubMed Central

    2013-01-01

    development, non-compliance of adolescents with requirements of assessment, questionnaire completion and treatment attendance, breaking randomization, and measuring the complexity of change in the context of a family-based intervention. Trial registration Australia and New Zealand Clinical Trials Registry Title: engaging youth with high prevalence mental health problems using family based interventions; number 12612000398808. Prospectively registered on 10 April 2012. PMID:24220547

  11. Improving mental health of adolescents with Type 1 diabetes: protocol for a randomized controlled trial of the Nothing Ventured Nothing Gained online adolescent and parenting support intervention

    PubMed Central

    2013-01-01

    -efficacy, and parent experience of child illness); and family outcomes (parent and adolescent reported parent-adolescent communication, responsibility for diabetes care, diabetes related conflict). Process variables including recruitment, retention, intervention completion and intervention satisfaction will also be assessed. Discussion The results of this study will provide valuable information about the efficacy, acceptability and therefore the viability of delivering online interventions to families affected by chronic illnesses such as Type 1 diabetes. Trial registration Australian New Zealand clinical trials registry (ANZCTR); ACTRN12610000170022 PMID:24341465

  12. Ten Years after the International Committee of Medical Journal Editors’ Clinical Trial Registration Initiative, One Quarter of Phase 3 Pediatric Epilepsy Clinical Trials Still Remain Unpublished: A Cross Sectional Analysis

    PubMed Central

    Lampert, Anette; Hoffmann, Georg F.; Ries, Markus

    2016-01-01

    Introduction Although selective reporting of clinical trial results introduces bias into evidence based clinical decision making, publication bias in pediatric epilepsy is unknown today. Since there is a considerable ambiguity in the treatment of an important and common clinical problem, pediatric seizures, we assessed the public availability of results of phase 3 clinical trials that evaluated treatments of seizures in children and adolescents as a surrogate for the extent of publication bias in pediatric epilepsy. Methods We determined the proportion of published and unpublished study results of phase 3 clinical trials that were registered as completed on ClinicalTrials.gov. We searched ClinicalTrials.gov, PubMed, and Google Scholar for publications and contacted principal investigators or sponsors. The analysis was performed according to STROBE criteria. Results Considering studies that were completed before 2014 (N = 99), 75 (76%) pediatric phase 3 clinical trials were published but 24 (24%) remained unpublished. The unpublished studies concealed evidence from 4,437 patients. Mean time-to-publication was 25 SD ± 15.6 months, more than twice as long as mandated. Conclusion Ten years after the ICMJE’s clinical trials registration initiative there is still a considerable amount of selective reporting and delay of publication that potentially distorts the body of evidence in the treatment of pediatric seizures. PMID:26735955

  13. 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. PMID:24231337

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

    PubMed Central

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

    2007-01-01

    coefficient will be calculated and used to inform sample size calculations for subsequent large-scale trials. Qualitative data regarding process implementation will be collected quarterly from focus groups with participating clinicians over 18 months, plus phone interviews with participating adolescents and parent/guardians at 12 weeks and 24 weeks of treatment. The focus group qualitative data will be analysed using a Fourth Generation Evaluation methodology that includes a constant comparative cyclic analysis method. Discussion This study protocol will be informative for researchers and clinicians interested in considering, designing and/or conducting cluster randomised trials within community practice such as mental health services. Trial Registration Australian Clinical Trials Registry ACTRNO12607000324415 PMID:17915032

  15. Multidimensional family therapy decreases the rate of externalising behavioural disorder symptoms in cannabis abusing adolescents: outcomes of the INCANT trial

    PubMed Central

    2014-01-01

    Background US-based trials have shown that Multidimensional Family Therapy (MDFT) not only reduces substance abuse among adolescents, but also decreases mental and behavioural disorder symptoms, most notably externalising symptoms. In the INCANT trial, MDFT decreased the rate of cannabis dependence among Western European youth. We now focus on other INCANT outcomes, i.e., lessening of co-morbidity symptoms and improvement of family functioning. Methods INCANT was a randomised controlled trial comparing MDFT with individual therapy (IP) at and across sites in Berlin, Brussels, Geneva, The Hague, and Paris. We recruited 450 boys and girls aged 13 up to 18 years with a cannabis use disorder, and their parent(s), and followed them for 12 months. Mental and behavioural characteristics (classified as 'externalising’ or 'internalising’) and family conflict and cohesion were assessed. Results From intake through 12 months, MDFT and IP groups improved on all outcome measures. Models including treatment, site, and referral source showed that MDFT outperformed IP in reducing externalising symptoms. Adolescents were either self-referred to treatment (mostly on the initiative from people close to the teen) or referred under some measure of coercion by an external authority. These two groups reacted equally well to treatment. Conclusions Both MDFT and IP reduced the rate of externalising and internalising symptoms and improved family functioning among adolescents with a cannabis use disorder. MDFT outperformed IP in decreasing the rate of externalising symptoms. Contrary to common beliefs among therapists in parts of Western Europe, the 'coerced’ adolescents did at least as well in treatment as the self-referred adolescents. MDFT shows promise as a treatment for both substance use disorders and externalising symptoms. Trial registration ISRNCT: ISRCTN51014277 PMID:24485347

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

    PubMed

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

    2013-03-01

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

  17. 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

  18. 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

  19. Effectiveness of depression and anxiety prevention in adolescents with high familial risk: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    for preventing depression and/or anxiety in high-risk adolescents over a 12-month follow-up period. If the program showed to be effective in reducing symptoms of depression and anxiety and preventing adolescents from developing clinical levels of these disorders, our results would be relevant to practice. Thus, the intervention could be used on a large scale. Moreover, this study aims to contribute to the evidence-based prevention of depression and anxiety of adolescents. Trial registration Dutch Trial Register NTR3720 PMID:24268128

  20. Prevention of acute knee injuries in adolescent female football players: cluster randomised controlled trial

    PubMed Central

    Atroshi, Isam; Magnusson, Henrik; Wagner, Philippe; Hägglund, Martin

    2012-01-01

    Objective To evaluate the effectiveness of neuromuscular training in reducing the rate of acute knee injury in adolescent female football players. Design Stratified cluster randomised controlled trial with clubs as the unit of randomisation. Setting 230 Swedish football clubs (121 in the intervention group, 109 in the control group) were followed for one season (2009, seven months). Participants 4564 players aged 12-17 years (2479 in the intervention group, 2085 in the control group) completed the study. Intervention 15 minute neuromuscular warm-up programme (targeting core stability, balance, and proper knee alignment) to be carried out twice a week throughout the season. Main outcome measures The primary outcome was rate of anterior cruciate ligament injury; secondary outcomes were rates of severe knee injury (>4 weeks’ absence) and any acute knee injury. Results Seven players (0.28%) in the intervention group, and 14 (0.67%) in the control group had an anterior cruciate ligament injury. By Cox regression analysis according to intention to treat, a 64% reduction in the rate of anterior cruciate ligament injury was seen in the intervention group (rate ratio 0.36, 95% confidence interval 0.15 to 0.85). The absolute rate difference was −0.07 (95% confidence interval −0.13 to 0.001) per 1000 playing hours in favour of the intervention group. No significant rate reductions were seen for secondary outcomes. Conclusions A neuromuscular warm-up programme significantly reduced the rate of anterior cruciate ligament injury in adolescent female football players. However, the absolute rate difference did not reach statistical significance, possibly owing to the small number of events. Trial registration Clinical trials NCT00894595. PMID:22556050

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

    PubMed Central

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

    2014-01-01

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

  2. 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…

  3. 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

  4. Doses of apixaban and rivaroxaban prescribed in real-world United States cardiology practices compared to registration trials.

    PubMed

    Nguyen, Elaine; White, C Michael; Patel, Manesh R; Fields, Larry E; Peacock, W Frank; Crivera, Concetta; Coleman, Craig I

    2016-07-01

    Using an I.M.S. LifeLink dataset (19 September 2014-11 September 2015), we compared U.S. cardiologist prescribing of the reduced dose of apixaban (2.5 mg) or rivaroxaban (15 mg) to utilization in their corresponding nonvalvular atrial fibrillation registration randomized trials. Of all prescriptions written by cardiologists for these agents, 20.8% of apixaban and 21.7% of rivaroxaban prescriptions were for a reduced dose; corresponding to a 4.4-fold (16.1% absolute) increase in the use of reduced dose apixaban and a 3% relative (0.6% absolute) increase in reduced dose rivaroxaban use vs. their respective registration trials. Further research is needed to better understand appropriate dosing of patients with novel anticoagulants. PMID:27009372

  5. 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

  6. 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

  7. Process Evaluation in the Multicenter Child and Adolescent Trial for Cardiovascular Health (CATCH).

    ERIC Educational Resources Information Center

    McGraw, Sarah A.; And Others

    1994-01-01

    Includes "Design of Process Evaluation (PE) within the Child and Adolescent Trial for Cardiovascular Health,""Classroom PE in a Multicenter Trial,""Food Service Program PE,""Physical Activity PE,""Family PE,""PE of Environmental Factors and Programs,""Challenges of Conducting PE in a Multicenter Trial." (SK)

  8. 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

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

    PubMed Central

    2014-01-01

    compared to oral conjugated equine estrogen but did not result in an otherwise different biochemical profile in this limited number of heterogeneous patients. OBE and TBE provide safe and effective alternatives to OCEE to induce puberty in girls, but larger prospective randomized trials are required. Trial registration Clinical Trials Identifier: NCT01023178. PMID:24982681

  10. 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

  11. Psyllium Supplementation in Adolescents Improves Fat Distribution & Lipid Profile: A Randomized, Participant-Blinded, Placebo-Controlled, Crossover Trial

    PubMed Central

    de Bock, Martin; Derraik, José G. B.; Brennan, Christine M.; Biggs, Janene B.; Smith, Greg C.; Cameron-Smith, David; Wall, Clare R.; Cutfield, Wayne S.

    2012-01-01

    Aims We aimed to assess the effects of psyllium supplementation on insulin sensitivity and other parameters of the metabolic syndrome in an at risk adolescent population. Methods This study encompassed a participant-blinded, randomized, placebo-controlled, crossover trial. Subjects were 47 healthy adolescent males aged 15–16 years, recruited from secondary schools in lower socio-economic areas with high rates of obesity. Participants received 6 g/day of psyllium or placebo for 6 weeks, with a two-week washout before crossing over. Fasting lipid profiles, ambulatory blood pressure, auxological data, body composition, activity levels, and three-day food records were collected at baseline and after each 6-week intervention. Insulin sensitivity was measured by the Matsuda method using glucose and insulin values from an oral glucose tolerance test. Results 45 subjects completed the study, and compliance was very high: 87% of participants took >80% of prescribed capsules. At baseline, 44% of subjects were overweight or obese. 28% had decreased insulin sensitivity, but none had impaired glucose tolerance. Fibre supplementation led to a 4% reduction in android fat to gynoid fat ratio (p = 0.019), as well as a 0.12 mmol/l (6%) reduction in LDL cholesterol (p = 0.042). No associated adverse events were recorded. Conclusions Dietary supplementation with 6 g/day of psyllium over 6 weeks improves fat distribution and lipid profile (parameters of the metabolic syndrome) in an at risk population of adolescent males. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12609000888268 PMID:22848584

  12. Design of the Trial of Activity in Adolescent Girls (TAAG)

    PubMed Central

    Stevens, June; Murray, David M.; Catellier, Diane J.; Hannan, Peter J.; Lytle, Leslie A.; Elder, John P.; Young, Deborah R.; Simons-Morton, Denise G.; Webber, Larry S.

    2005-01-01

    The primary aim of the Trial of Activity in Adolescent Girls (TAAG) is to test an intervention to reduce by half the age-related decline in moderate to vigorous physical activity (MVPA) in middle school girls. The intervention will be evaluated using a group-randomized trial involving 36 middle schools. The primary endpoint is the mean difference in intensity-weighted minutes (i.e., MET-minutes) of MVPA between intervention and comparison schools assessed using accelerometry. The TAAG study design calls for two cross-sectional samples, one drawn from 6th graders at the beginning of the study and the second drawn from 8th graders at the end of the study following the 2-year implementation of the intervention. An important strength of this design over a cohort design is the consistency with the goals of TAAG, which focus on environmental-level rather than individual-level interventions to produce change. The study design specifies a recruitment rate of 80% and a smaller sample of girls at baseline (n=48 per school) than at follow-up (n=96 per school). A two-stage model will be used to test the primary hypothesis. In the first stage, MET-weighted minutes of MVPA will be regressed on school, time (baseline or follow-up), their interaction, ethnicity and week of data collection. The second stage analysis will be conducted on the 72 adjusted means from the first stage. In the main-effects model, we will regress the follow-up school mean MET-weighted minutes of MVPA on study condition, adjusting for the baseline school mean. The TAAG study addresses an important health behavior, and also advances the field of group-randomized trials through the use of a study design and analysis plan tailored to serve the main study hypothesis. PMID:15837442

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

    ERIC Educational Resources Information Center

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

    2010-01-01

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

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

    ERIC Educational Resources Information Center

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

    2014-01-01

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

  15. 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.…

  16. 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…

  17. 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…

  18. “Hardly worth the effort”? Medical journals’ policies and their editors’ and publishers’ views on trial registration and publication bias: quantitative and qualitative study

    PubMed Central

    Williams, Peter

    2013-01-01

    Objectives To determine the proportion of medical journals requiring trial registration and to understand their reasons for adopting (or not adopting) such policies and other measures designed to reduce publication bias. Design Quantitative study of journals’ instructions to authors (in June 2012) and qualitative study of editors’ and publishers’ views on trial registration and publication bias (carried out in Autumn 2012). Setting Random selection of 200 medical journals publishing clinical trials identified from the Cochrane CENTRAL database. Participants Editors (n=13) and publishers (n=3) of journals with different policies on trial registration (and with recently changed policies) identified from the survey of their instructions to authors. Results Only 55/200 journals (28%) required trial registration according to their instructions and a further three (2%) encouraged it. The editors and publishers interviewed explained their journals’ reluctance to require registration in terms of not wanting to lose out to rival journals, not wanting to reject otherwise sound articles or submissions from developing countries, and perceptions that such policies were not relevant to all journals. Some interviewees considered that registration was unnecessary for small or exploratory studies. Conclusions Although many major medical journals state that they will only publish clinical trials that have been prospectively registered, and such policies have been associated with a dramatic increase in the number of trials being registered, most smaller journals have not adopted such policies. Editors and publishers may be reluctant to require registration because they do not understand its benefits or because they fear that adopting such a policy would put their journal at a disadvantage to competitors. PMID:24014339

  19. 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

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed Central

    2012-01-01

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

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

    PubMed Central

    2014-01-01

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

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

    PubMed

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

    2013-05-01

    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 learned in recruiting adolescents, a description of our treatment approach, acceptability of the treatment for teens and parents, as well as results from the pilot trial. Participants in the CBT group had significantly fewer posttreatment eating binges than those in a treatment as usual/delayed treatment (TAU-DT) control group; 100% of CBT participants were abstinent at follow-up. Our results provide preliminary support for the efficacy of this adolescent adaptation of evidence-based CBT for recurrent binge eating. The large, robust effect size estimate observed for the main outcome (NNT=2) places this among the larger effects observed for any mental health intervention. PMID:23645978

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

    PubMed Central

    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 learned in recruiting adolescents, a description of our treatment approach, acceptability of the treatment for teens and parents, as well as results from the pilot trial. Participants in the CBT group had significantly fewer posttreatment eating binges than those in a treatment as usual/delayed treatment (TAU-DT) control group; 100% of CBT participants were abstinent at follow-up. Our results provide preliminary support for the efficacy of this adolescent adaptation of evidence-based CBT for recurrent binge eating. The large, robust effect size estimate observed for the main outcome (NNT=2) places this among the larger effects observed for any mental health intervention. PMID:23645978

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

    PubMed Central

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

    2012-01-01

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

  6. The Association Between Weight Loss in Caregivers and Adolescents in a Treatment Trial of Adolescents With Obesity

    PubMed Central

    Moore, Reneé H.; Wadden, Thomas A.; Bishop-Gilyard, Chanelle T.; Gehrman, Christine A.; Berkowitz, Robert I.

    2013-01-01

    Objective The relationship between weight change in caregivers and their adolescents was evaluated following a randomized trial of lifestyle modification for adolescents, which included either a conventional diet or meal replacements. Methods Adolescents (N = 113) had an M ± SD age of 15.0 ± 1.3 years (62% African American; 26% Caucasian, 12% other; 81% female) and body mass index of 37.1 ± 5.1 kg/m2. Results Mixed effects models yielded a significant association between percentage change in body mass index of caregivers and adolescents from baseline to months 4 and 12 (p = .01). When caregivers lost above the median (−1.67%) at month 4, their adolescents achieved a significantly greater loss at month 12 (−9.1 ± 1.3%) compared with adolescents whose caregivers lost less than the median (−4.3 ± 1.3%) (p = .003). Conclusion Engaging caregivers in their own weight loss efforts during adolescent weight loss treatment may improve adolescent weight loss. PMID:23629145

  7. Preventing Internalizing Symptoms Among Hispanic Adolescents: A Synthesis Across Familias Unidas Trials

    PubMed Central

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

    2014-01-01

    Studies document that there are efficacious interventions to prevent adolescent depression and internalizing symptoms, including several family-focused interventions. Questions remain about for whom interventions work (moderation) and by what mechanisms they work (mediation) to prevent internalizing symptoms. Unfortunately, single trials are often underpowered to address moderation and mediation, an issue addressed in this paper. This synthesis study combined individual-level, longitudinal data from 721 adolescents across 3 randomized clinical trials of Familias Unidas, a family-focused prevention intervention for Hispanic youth. Using integrative data analysis (IDA) methods applied to trials, the study examined intervention moderation and mediation effects on internalizing symptoms. Baseline internalizing symptoms were a significant moderator of the intervention's effects on internalizing symptoms, while baseline externalizing symptoms did not moderate intervention effects. Baseline parent–adolescent communication, a modifiable risk factor and hypothesized mechanism by which the intervention works, significantly moderated the intervention's effects. Specifically, the intervention was more efficacious in its impact on internalizing symptoms for youth with lower initial levels of parent–adolescent communication compared to those with higher communication levels. Moderated mediation analyses showed that parent–adolescent communication changes mediated the intervention's effects on internalizing symptoms, with stronger effects for those with poorer baseline communication. Results suggest a potential benefit of identifying youth risks prior to interventions, and targeting specific modifiable mediators that lead to reductions of internalizing problems of adolescents. Findings also highlight advantages of utilizing data from combined trials and IDA for examining intervention moderators and mediators. PMID:24390684

  8. 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

  9. CANABIC: CANnabis and Adolescents: effect of a Brief Intervention on their Consumption – study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Cannabis is the most consumed illegal substance in France. General practitioners (GPs) are the health professionals who are most consulted by adolescents. Brief intervention (BI) is a promising care initiative for the consumption of cannabis, and could be a tool for GPs in caring for adolescents who consume cannabis. The aim of the CANABIC study is to measure the impact of a BI carried out by a GP on the consumption of cannabis by adolescents of 15 to 25 years of age. Methods A randomized clustered controlled trial, stratified over three areas (Auvergne, Languedoc-Roussillon, and Rhône - Alpes), comparing an intervention group, which carries out the BI in consultation, and a control group, which ensures routine medical care. The main assessment criterion is the consumption of cannabis by amount of joints per month, at 12 months. The amount necessary to highlight a significant difference between the two groups of 30% of consumption at 12 months is 250 patients (50 GPs, 5 patients per GP; risk α = 5%; power = 90%; intra-cluster correlation coefficient ρ = 0.2; Hawthorne effect = 15%; lost to follow-up rates for GPs = 10% and for patients = 20%). This plan is replicated for the three areas, and therefore a total of 750 patients are expected. The secondary criteria for judgment are the associated consumption of tobacco and alcohol, the perception of the consequences of consumption, and the driving of a vehicle following consumption. Discussion Research about BI for young cannabis users is underway. The aim of the CANABIC study is to validate a BI suited to adolescents who consume cannabis, which may be performed in the general practice. This would provide a tool for their treatment by a GP, which could be widely distributed during initial or further medical training. Trial registration CANABIC is a randomized clustered trial (NCT01433692, registered 2011 Sept 12), PHRC funded: Clinical Research Hospital Program (Governmental

  10. Classroom based cognitive behavioural therapy in reducing symptoms of depression in high risk adolescents: pragmatic cluster randomised controlled trial

    PubMed Central

    Sayal, Kapil; Phillips, Rhiannon; Taylor, John A; Spears, Melissa; Anderson, Rob; Araya, Ricardo; Lewis, Glyn; Millings, Abigail; Montgomery, Alan A

    2012-01-01

    Objective To compare the effectiveness of classroom based cognitive behavioural therapy with attention control and usual school provision for adolescents at high risk of depression. Design Three arm parallel cluster randomised controlled trial. Setting Eight UK secondary schools. Participants Adolescents (n=5030) aged 12-16 years in school year groups 8-11. Year groups were randomly assigned on a 1:1:1 ratio to cognitive behavioural therapy, attention control, or usual school provision. Allocation was balanced by school, year, number of students and classes, frequency of lessons, and timetabling. Participants were not blinded to treatment allocation. Interventions Cognitive behavioural therapy, attention control, and usual school provision provided in classes to all eligible participants. Main outcome measures Outcomes were collected by self completed questionnaire administered by researchers. The primary outcome was symptoms of depression assessed at 12 months by the short mood and feelings questionnaire among those identified at baseline as being at high risk of depression. Secondary outcomes included negative thinking, self worth, and anxiety. Analyses were undertaken on an intention to treat basis and accounted for the clustered nature of the design. Results 1064 (21.2%) adolescents were identified at high risk of depression: 392 in the classroom based cognitive behavioural therapy arm, 374 in the attention control arm, and 298 in the usual school provision arm. At 12 months adjusted mean scores on the short mood and feelings questionnaire did not differ for cognitive behavioural therapy versus attention control (−0.63, 95% confidence interval −1.85 to 0.58, P=0.41) or for cognitive behavioural therapy versus usual school provision (0.97, −0.20 to 2.15, P=0.12). Conclusion In adolescents with depressive symptoms, outcomes were similar for attention control, usual school provision, and cognitive behavioural therapy. Classroom based cognitive behavioural

  11. 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

  12. Efficacy of a Web-Based Computer-Tailored Smoking Prevention Intervention for Dutch Adolescents: Randomized Controlled Trial

    PubMed Central

    Candel, Math; Segaar, Dewi; Cremers, Henricus-Paul; de Vries, Hein

    2014-01-01

    adolescents for at least 6 months, in particular among the age cohort of 14-16 years. Further research is needed to focus on long-term effects. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): 77864351; http://www.controlled-trials.com/ISRCTN77864351 (Archived by WebCite at http://www.webcitation.org/6BSLKSTm5). PMID:24657434

  13. The effect of ‘sleep high and train low’ on weight loss in overweight Chinese adolescents: study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Exercise and diet are the cornerstones for the treatment of obesity in obese children and adolescents. However, compensatory changes in appetite and energy expenditure elicited by exercise and dieting make it hard to maintain a reduced weight over the longterm. The anorexic effect of hypoxia can be potentially utilized to counteract this compensatory increase, thereby enhancing the success of weight loss. The purpose of the study is to assess the effectiveness of four week intermittent hypoxia exposure added to a traditional exercise and diet intervention on inducing short- and longterm weight loss in obese adolescents. Methods/Design In this randomized parallel group controlled clinical trial, 40 obese adolescents (20 boys and 20 girls, 11 to 15-years-old), will be recruited from a summer weight loss camp at the Shanghai University of Sport, China. Participants will be stratified by gender and randomly assigned to either the control group or the hypoxia group. During the four-week intervention period, both groups will exercise and eat a balanced diet. Additionally, the control group will sleep in normal conditions, while the hypoxia group will sleep in a normobaric hypoxia chamber (sleep high and train low). The primary outcome will be body composition and the main secondary outcomes will be the circulating levels of appetite regulatory gastrointestinal hormones. All the outcome measures will be assessed at baseline, after the four-week intervention, and at two months follow-up. Discussion Our study will be the first to evaluate the effectiveness of ‘sleep high and train low’ on short- and longterm weight loss among obese adolescents. A potential mechanism for the appetite regulatory effect of hypoxia will also be explored. The results of the study will provide an evidence-based recommendation for the use of hypoxia in a weight loss intervention among obese children and adolescents. Furthermore, the clarification of mechanisms leading to weight loss

  14. A randomised controlled trial of a community-based healthy lifestyle program for overweight and obese adolescents: the Loozit® study protocol

    PubMed Central

    Shrewsbury, Vanessa A; O'Connor, Janice; Steinbeck, Katharine S; Stevenson, Kate; Lee, Anthea; Hill, Andrew J; Kohn, Michael R; Shah, Smita; Torvaldsen, Siranda; Baur, Louise A

    2009-01-01

    Background There is a need to develop sustainable and clinically effective weight management interventions that are suitable for delivery in community settings where the vast majority of overweight and obese adolescents should be treated. This study aims to evaluate the effect of additional therapeutic contact as an adjunct to the Loozit® group program – a community-based, lifestyle intervention for overweight and lower grade obesity in adolescents. The additional therapeutic contact is provided via telephone coaching and either mobile phone Short Message Service or electronic mail, or both. Methods and design The study design is a two-arm randomised controlled trial that aims to recruit 168 overweight and obese 13–16 year olds (Body Mass Index z-score 1.0 to 2.5) in Sydney, Australia. Adolescents with secondary causes of obesity or significant medical illness are excluded. Participants are recruited via schools, media coverage, health professionals and several community organisations. Study arm one receives the Loozit® group weight management program (G). Study arm two receives the same Loozit® group weight management program plus additional therapeutic contact (G+ATC). The 'G' intervention consists of two phases. Phase 1 involves seven weekly group sessions held separately for adolescents and their parents. This is followed by phase 2 that involves a further seven group sessions held regularly, for adolescents only, until two years follow-up. Additional therapeutic contact is provided to adolescents in the 'G+ATC' study arm approximately once per fortnight during phase 2 only. Outcome measurements are assessed at 2, 12 and 24 months post-baseline and include: BMI z-score, waist z-score, metabolic profile indicators, physical activity, sedentary behaviour, eating patterns, and psychosocial well-being. Discussion The Loozit® study is the first randomised controlled trial of a community-based adolescent weight management intervention to incorporate

  15. Clinical trials for drug registrations in Asian-Pacific countries: proposal for a new paradigm from a statistical perspective.

    PubMed

    Shih, W J

    2001-08-01

    The world has become more interdependent in the movement of free trade and global markets. The regulations for approval of new drugs in the Asian markets have always been an important issue in the free trade negotiation between the U.S.- and E.U.-based international manufacturers and the Asian-Pacific countries, since pharmaceuticals are of large trade value for them. In 1998 the University of Hong Kong and the Singapore National Medical Research Council jointly hosted the first Asian Clinical Trials Conference. The Society for Clinical Trials was invited as a collaborator for the event, which signified a milestone for interaction between the East and West in the discussion of clinical trials. Many have participated in the discussion of drug approval and registration issues for the Asian region based on the drug development experience in the United States. However, there are many interesting differences between the two regions, which lead to different approval processes for new drugs developed by the U.S.- and E.U.-based international manufacturers. This article highlights some regulatory dilemmas and some key statistical concepts pertinent to these differences. The purpose of this paper is to resolve the regional regulatory and scientific dilemma. A new paradigm of sample size design and data analysis for drug approval for countries in the Asian-Pacific region is proposed. The central premise is that substantial information from multicenter studies has already shown efficacy in the United States or the European Union when a drug manufacturer seeks marketing approval in an Asian country. This leads to the idea of a "consistency trial" using the method of Bayesian most plausible prediction. The method is illustrated with an example. PMID:11514037

  16. The 24-h Energy Intake of Obese Adolescents Is Spontaneously Reduced after Intensive Exercise: A Randomized Controlled Trial in Calorimetric Chambers

    PubMed Central

    Thivel, David; Isacco, Laurie; Montaurier, Christophe; Boirie, Yves

    2012-01-01

    Background Physical exercise can modify subsequent energy intake and appetite and may thus be of particular interest in terms of obesity treatment. However, it is still unclear whether an intensive bout of exercise can affect the energy consumption of obese children and adolescents. Objective To compare the impact of high vs. moderate intensity exercises on subsequent 24-h energy intake, macronutrient preferences, appetite sensations, energy expenditure and balance in obese adolescent. Design This randomized cross-over trial involves 15 obese adolescent boys who were asked to randomly complete three 24-h sessions in a metabolic chamber, each separated by at least 7 days: (1) sedentary (SED); (2) Low-Intensity Exercise (LIE) (40% maximal oxygen uptake, VO2max); (3) High-Intensity Exercise (HIE) (75%VO2max). Results Despite unchanged appetite sensations, 24-h total energy intake following HIE was 6–11% lower compared to LIE and SED (p<0.05), whereas no differences appeared between SED and LIE. Energy intake at lunch was 9.4% and 8.4% lower after HIE compared to SED and LIE, respectively (p<0.05). At dinner time, it was 20.5% and 19.7% lower after HIE compared to SED and LIE, respectively (p<0.01). 24-h energy expenditure was not significantly altered. Thus, the 24-h energy balance was significantly reduced during HIE compared to SED and LIE (p<0.01), whereas those of SED and LIE did not differ. Conclusions In obese adolescent boys, HIE has a beneficial impact on 24-h energy balance, mainly due to the spontaneous decrease in energy intake during lunch and dinner following the exercise bout. Prescribing high-intensity exercises to promote weight loss may therefore provide effective results without affecting appetite sensations and, as a result, food frustrations. Trial Registration ClinicalTrial.gov NCT01036360 PMID:22272251

  17. [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. PMID:22241267

  18. 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

  19. 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. PMID:24682593

  20. 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

  1. 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

  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. 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

  4. 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

  5. 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…

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

    ERIC Educational Resources Information Center

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

    2013-01-01

    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 evaluated the feasibility and preliminary outcomes of the Multimodal Anxiety and Social Skills Intervention (MASSI) program in a sample of 30…

  7. 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.

  8. 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…

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

    ERIC Educational Resources Information Center

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

    2008-01-01

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

  10. A Parent-Adolescent Intervention to Increase Sexual Risk Communication: Results of a Randomized Controlled Trial

    ERIC Educational Resources Information Center

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

    2008-01-01

    This article reports results of a randomized controlled trial designed to test an intervention to increase parent-adolescent sexual risk communication among Mexican parents. Data were analyzed from parents (n = 791) randomly assigned to an HIV risk reduction or health promotion intervention. Measures were administered at pretest, posttest, and 6-…

  11. 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…

  12. 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…

  13. 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

  14. Handbook on Tentative Standards and Procedures for the Registration of Secondary Schools. 1979-80 Field Trial Edition.

    ERIC Educational Resources Information Center

    New York State Education Dept., Albany.

    This handbook contains the tentative secondary school registration standards and procedures approved by the New York State Board of Regents for the 1979-80 school year. It explains the program providing for the registration (or accreditation) of New York schools and outlines the steps that will make up the registration procedure. Most of the…

  15. 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…

  16. 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. PMID:24377410

  17. Preventing Obesity Among Adolescent Girls: One-Year Outcomes of the Nutrition and Enjoyable Activity for Teen Girls (NEAT Girls) Cluster Randomized Controlled Trial.

    PubMed

    Lubans, David R; Morgan, Philip J; Okely, Anthony D; Dewar, Deborah; Collins, Clare E; Batterham, Marijka; Callister, Robin; Plotnikoff, Ronald C

    2012-09-01

    OBJECTIVE To evaluate the impact of a 12-month multicomponent school-based obesity prevention program, Nutrition and Enjoyable Activity for Teen Girls among adolescent girls. DESIGN Group randomized controlled trial with 12-month follow-up. SETTING Twelve secondary schools in low-income communities in the Hunter and Central Coast regions of New South Wales, Australia. PARTICIPANTS Three hundred fifty-seven adolescent girls aged 12 to 14 years. INTERVENTION A multicomponent school-based intervention program tailored for adolescent girls. The intervention was based on social cognitive theory and included teacher professional development, enhanced school sport sessions, interactive seminars, nutrition workshops, lunch-time physical activity sessions, handbooks and pedometers for self-monitoring, parent newsletters, and text messaging for social support. MAIN OUTCOME MEASURES Body mass index (BMI, calculated as weight in kilograms divided by height in meters squared), BMI z score, body fat percentage, physical activity, screen time, dietary intake, and self-esteem. RESULTS After 12 months, changes in BMI (adjusted mean difference, -0.19; 95% CI, -0.70 to 0.33), BMI z score (mean, -0.08; 95% CI, -0.20 to 0.04), and body fat percentage (mean, -1.09; 95% CI, -2.88 to 0.70) were in favor of the intervention, but they were not statistically different from those in the control group. Changes in screen time were statistically significant (mean, -30.67 min/d; 95% CI, -62.43 to -1.06), but there were no group by time effects for physical activity, dietary behavior, or self-esteem. CONCLUSIONS A school-based intervention tailored for adolescent girls from schools located in low-income communities did not significantly reduce BMI gain. However, changes in body composition were of a magnitude similar to previous studies and may be associated with clinically important health outcomes. TRIAL REGISTRATION anzctr.org.au Identifier: 12610000330044. PMID:22566517

  18. 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

  19. 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

  20. Persistent Effect of Vitamin D Supplementation on Musculoskeletal Parameters in Adolescents One Year After Trial Completion.

    PubMed

    Ghazal, Nisrine; Al-Shaar, Laila; Maalouf, Joyce; Nabulsi, Mona; Arabi, Asma; Choucair, Mahmoud; Tamim, Hani; Mahfoud, Ziad; El-Hajj Fuleihan, Ghada

    2016-07-01

    We showed a beneficial effect of vitamin D supplementation on musculoskeletal parameters in adolescent girls in a 1-year, randomized, double-blinded placebo-controlled trial (RCT). Our objective for this study was to investigate the residual effect of vitamin D supplementation on bone mineral content (BMC), bone mineral density (BMD), at the lumbar spine and hip, lean mass, and height, 1 year after trial completion. We performed post hoc analyses in 167 adolescents, 86 girls and 81 boys, age 13.9 ± 2 years, who received vitamin D or placebo during the trial, and continued into the follow-up trial. Musculoskeletal parameters were measured at baseline, 12 months (intervention), and 24 months (follow-up). ANOVA and t tests were used to compare results between the placebo group and the merged vitamin D arms (200 or 2000 IU/day), by gender. Baseline characteristics were comparable between treatment groups at entry into the extension. Girls who had received vitamin D during the trial, had significantly larger hip BMC increments compared to those assigned to placebo, at 24 months compared to study entry, but not 24 compared to 12 months, which persisted in adjusted analyses. There were no significant differences in bone mass changes between treatment groups in boys, at 24 months compared to 12 months or to baseline. The beneficial effect of vitamin D supplementation on hip bone mass, achieved in girls during the trial, persisted 1 year after trial completion. These net cumulative increments, 1 year after discontinuation of supplementation, may have important implications on optimizing peak bone mass accretion in adolescent girls. © 2016 American Society for Bone and Mineral Research. PMID:26841085

  1. 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.

  2. 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

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

    ERIC Educational Resources Information Center

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

    2010-01-01

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

  4. 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…

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

    ERIC Educational Resources Information Center

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

    2004-01-01

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

  6. 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…

  7. 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

  8. 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

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

    PubMed

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

    2015-12-01

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

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

    PubMed

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

    2016-01-01

    The purpose of this study was to develop an adaptive behavioral treatment for African American adolescents with obesity. In a sequential multiple assignment randomized trial, 181 youth ages 12-16 years with primary obesity and their caregiver were first randomized to 3 months of home-based versus office-based delivery of motivational interviewing plus skills building. After 3 months, nonresponders to first phase treatment were rerandomized to continued home-based skills or contingency management. Primary outcome was percent overweight and hypothesized moderators were adolescent executive functioning and depression. There were no significant differences in primary outcome between home-based or office-based delivery or between continued home-based skills or contingency management for nonresponders to first-phase treatment. However, families receiving home-based treatment initially attended significantly more sessions in both phases of the trial, and families receiving contingency management attended more sessions in the second phase. Overall, participants demonstrated decreases in percent overweight over the course of the trial (3%), and adolescent executive functioning moderated this effect such that those with higher functioning lost more weight. More potent behavioral treatments to address the obesity epidemic are necessary, targeting new areas such as executive functioning. Delivering treatment in the home with contingency management may increase session attendance for this population. PMID:25668386

  11. 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…

  12. Exercise and BMI z-score in overweight and obese children and adolescents: protocol for a systematic review and network meta-analysis of randomised trials

    PubMed Central

    Kelley, George A; Kelley, Kristi S

    2016-01-01

    Introduction While overweight and obesity in children and adolescents is a major global health problem, the effects of exercise on overweight and obesity in children and adolescents are not well established despite numerous studies on this topic. The purpose of this study is to use the network meta-analytic approach to determine the effects of exercise (aerobic, strength training or both) on body mass index (BMI) z-score in overweight and obese children and adolescents. Methods and analysis Randomised exercise intervention trials >4 weeks, published in any language between 1 January 1990 and 31 September 2015, and which include direct and/or indirect evidence, will be included. Studies will be retrieved by searching 6 electronic databases, cross-referencing and expert review. Dual abstraction of data will occur. The primary outcome will be changes in BMI z-score while the secondary outcome will be changes in body weight in kilograms (kg). Risk of bias will be assessed using the Cochrane risk of bias assessment instrument while confidence in the cumulative evidence will be assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) instrument for network meta-analysis. Network meta-analysis will be performed using multivariate random-effects meta-regression models. The surface under the cumulative ranking curve will be used to provide a hierarchy of exercise treatments (aerobic, strength training or both). Dissemination The results of this study will be presented at a professional conference and published in a peer-reviewed journal. Trial registration number CRD42015026377. PMID:27084289

  13. A cluster randomised trial of a school-based intervention to prevent decline in adolescent physical activity levels: study protocol for the ‘Physical Activity 4 Everyone’ trial

    PubMed Central

    2013-01-01

    Background Adolescence is an established period of physical activity decline. Multi-component school-based interventions have the potential to slow the decline in adolescents’ physical activity; however, few interventions have been conducted in schools located in low-income or disadvantaged communities. This study aims to assess the effectiveness of a multi-component school-based intervention in reducing the decline in physical activity among students attending secondary schools located in disadvantaged communities. Methods/Design The cluster randomised trial will be conducted with 10 secondary schools located in selected regions of New South Wales, Australia. The schools will be selected from areas that have a level of socio-economic status that is below the state average. Five schools will be allocated to receive an intervention based on the Health Promoting Schools framework, and will be supported by a part-time physical activity consultant placed in intervention schools who will implement a range of intervention adoption strategies. Study measures will be taken at baseline when students are in Year 7 (12–13 years) and again after 12- and 24-months. The primary outcome, minutes of moderate- to-vigorous- intensity physical activity per day and percentage of time in moderate- to vigorous-intensity physical activity (MVPA), will be objectively assessed using accelerometers (Actigraph GT3x+). Group allocation and intervention delivery will commence after baseline data collection. The intervention will continue during school terms through to 24-month follow-up. Discussion The study will provide evidence regarding the effectiveness of a multi-component school-based intervention that includes an in-school physical activity consultant targeting the physical activity levels of adolescents in disadvantaged Australian secondary schools. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12612000382875. PMID:23336603

  14. 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

  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. 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

  18. A parent-adolescent intervention to increase sexual risk communication: results of a randomized controlled trial.

    PubMed

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

    2008-10-01

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

  19. 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

  20. 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

  1. 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

  2. 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

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

    PubMed Central

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

    2012-01-01

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

  4. 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

  5. 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

  6. 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

  7. 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

  8. A randomized controlled trial of attention bias modification training for socially anxious adolescents.

    PubMed

    Fitzgerald, Amanda; Rawdon, Caroline; Dooley, Barbara

    2016-09-01

    The current study aimed to examine the efficacy of attention bias modification (ABM) training to reduce social anxiety in a community-based sample of adolescents 15-18 years. The study used a single-blind, parallel group, randomized controlled trial design (Clinical Trials ID: NCT02270671). Participants were screened in second-level schools using a social anxiety questionnaire. 130 participants scoring ≥24 on the Social Phobia and Anxiety Inventory for Children (SPAI-C) were randomized to the ABM training (n = 66)/placebo (n = 64) group, 120 of which completed pre-, post-, and 12-week follow-up data collection including threat bias, anxiety, and depression measures. The ABM intervention included 4 weekly training sessions using a dot-probe task designed to reduce attention bias to threatening stimuli. ABM training did not alter the primary outcomes of attention bias to threat or social anxiety symptoms raising questions about the efficacy of ABM as an intervention for adolescents. PMID:27379745

  9. 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

  10. 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

  11. The Eat Smart Study: A randomised controlled trial of a reduced carbohydrate versus a low fat diet for weight loss in obese adolescents

    PubMed Central

    2010-01-01

    Background Despite the recognition of obesity in young people as a key health issue, there is limited evidence to inform health professionals regarding the most appropriate treatment options. The Eat Smart study aims to contribute to the knowledge base of effective dietary strategies for the clinical management of the obese adolescent and examine the cardiometablic effects of a reduced carbohydrate diet versus a low fat diet. Methods and design Eat Smart is a randomised controlled trial and aims to recruit 100 adolescents over a 2 1/2 year period. Families will be invited to participate following referral by their health professional who has recommended weight management. Participants will be overweight as defined by a body mass index (BMI) greater than the 90th percentile, using CDC 2000 growth charts. An accredited 6-week psychological life skills program 'FRIENDS for Life', which is designed to provide behaviour change and coping skills will be undertaken prior to volunteers being randomised to group. The intervention arms include a structured reduced carbohydrate or a structured low fat dietary program based on an individualised energy prescription. The intervention will involve a series of dietetic appointments over 24 weeks. The control group will commence the dietary program of their choice after a 12 week period. Outcome measures will be assessed at baseline, week 12 and week 24. The primary outcome measure will be change in BMI z-score. A range of secondary outcome measures including body composition, lipid fractions, inflammatory markers, social and psychological measures will be measured. Discussion The chronic and difficult nature of treating the obese adolescent is increasingly recognised by clinicians and has highlighted the need for research aimed at providing effective intervention strategies, particularly for use in the tertiary setting. A structured reduced carbohydrate approach may provide a dietary pattern that some families will find more

  12. The Outcomes of a 12-Week Internet Intervention Aimed at Improving Fitness and Health-Related Quality of Life in Overweight Adolescents: The Young & Active Controlled Trial

    PubMed Central

    Riiser, Kirsti; Løndal, Knut; Ommundsen, Yngvar; Småstuen, Milada Cvancarova; Misvær, Nina; Helseth, Sølvi

    2014-01-01

    intervention with tailored physical activity counseling can have beneficial short-term effect on cardiorespiratory fitness, HRQoL and BMI among adolescents with overweight and obesity. Trial Registration ClinicalTrials.gov NCT01700309 PMID:25478791

  13. Effectiveness of interventions to promote physical activity in children and adolescents: systematic review of controlled trials

    PubMed Central

    McMinn, Alison M; Griffin, Simon J

    2007-01-01

    Objective To review the published literature on the effectiveness of interventions to promote physical activity in children and adolescents. Design Systematic review. Data sources Literature search using PubMed, SCOPUS, Psychlit, Ovid Medline, Sportdiscus, and Embase up to December 2006. Review methods Two independent reviewers assessed studies against the following inclusion criteria: controlled trial, comparison of intervention to promote physical activity with no intervention control condition, participants younger than 18 years, and reported statistical analyses of a physical activity outcome measure. Levels of evidence, accounting for methodological quality, were assessed for three types of intervention, five settings, and three target populations. Results The literature search identified 57 studies: 33 aimed at children and 24 at adolescents. Twenty four studies were of high methodological quality, including 13 studies in children. Interventions that were found to be effective achieved increases ranging from an additional 2.6 minutes of physical education related physical activity to 283 minutes per week of overall physical activity. Among children, limited evidence for an effect was found for interventions targeting children from low socioeconomic populations, and environmental interventions. Strong evidence was found that school based interventions with involvement of the family or community and multicomponent interventions can increase physical activity in adolescents. Conclusion Some evidence was found for potentially effective strategies to increase children's levels of physical activity. For adolescents, multicomponent interventions and interventions that included both school and family or community involvement have the potential to make important differences to levels of physical activity and should be promoted. A lack of high quality evaluations hampers conclusions concerning effectiveness, especially among children. PMID:17884863

  14. 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

  15. Ontogeny of methamphetamine-induced and cocaine-induced one-trial behavioral sensitization in preweanling and adolescent rats.

    PubMed

    Kozanian, Olga O; Gutierrez, Arnold; Mohd-Yusof, Alena; McDougall, Sanders A

    2012-08-01

    The ontogenetic profile of psychostimulant-induced one-trial behavioral sensitization has not been determined. The purpose of this study was to systematically assess the ontogeny of methamphetamine-induced and cocaine-induced behavioral sensitization across the preweanling and adolescent periods. To this end, rats were injected with methamphetamine, cocaine, or saline in either an activity chamber or home cage during the preweanling [postnatal day (PD) 12, PD 16, or PD 20], preadolescent (PD 24), or adolescent (PD 34) periods. One day later, rats were challenged with the same psychostimulant and locomotion was measured in an activity chamber. The results showed that methamphetamine produced one-trial locomotor sensitization on PD 13 and PD 17; whereas, cocaine-induced behavioral sensitization was only evident on PD 21. The sensitized responding of preweanling rats was not influenced by environmental context. Interestingly, preadolescent and adolescent rats did not exhibit locomotor sensitization. The latter result is generally consistent with past studies showing that rats from the middle and late adolescent periods do not exhibit cocaine-induced one-trial behavioral sensitization. The present results show that methamphetamine, as well as cocaine, can produce one-trial context-independent behavioral sensitization during early ontogeny, but sensitized responding is only apparent within a narrow developmental window. PMID:22732208

  16. 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…

  17. 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…

  18. 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…

  19. 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…

  20. Process Evaluation Results from a School- and Community-Linked Intervention: The Trial of Activity for Adolescent Girls (TAAG)

    ERIC Educational Resources Information Center

    Young, D. R.; Steckler, A.; Cohen, S.; Pratt, C.; Felton, G.; Moe, S. G.; Pickrel, J.; Johnson, C. C.; Grieser, M.; Lytle, L. A.; Lee, J.-S.; Raburn, B.

    2008-01-01

    Process evaluation is a component of intervention research that evaluates whether interventions are delivered and received as intended. Here, we describe the process evaluation results for the Trial of Activity for Adolescent Girls (TAAG) intervention. The intervention consisted of four synergistic components designed to provide supportive school-…

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

    ERIC Educational Resources Information Center

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

    2009-01-01

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

  2. Randomized 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…

  3. 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…

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

    PubMed

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

    2016-01-01

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

  5. 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

  6. Single trial nicotine conditioned place preference in pre-adolescent male and female rats.

    PubMed

    Edwards, Alexander W; Konz, Nathan; Hirsch, Zahava; Weedon, Jeremy; Dow-Edwards, Diana L

    2014-10-01

    The mean age of first voluntary tobacco inhalation is 12.3 years (DiFranza et al., 2004). 60% of smokers start smoking before the age of 14 and 90% are dependent before reaching the age of 19. Females are typically more sensitive to nicotine than males yet few studies examine the effects of nicotine on the reward systems in pre-adolescent female subjects. This study utilized the single trial conditioned place preference (CPP) test in very young (postnatal day 25-27) rats of both sexes. Latent effects on anxiety and amphetamine response were determined 5 and 7 days following a second nicotine exposure. Results show that 0.05 mg/kg nicotine induced CPP in females following a single trial while both sexes showed CPP following the 0.5 mg/kg dose. Five days later, rats dosed with 0.05 mg/kg show increased time on the open arm of the elevated plus maze, an anxiolytic response. While baseline activity was increased in nicotine-exposed males 7 days following dosing, amphetamine response was not affected by the treatments in either sex. Therefore, our data suggest that young females are more sensitive to nicotine reward than males supporting a heightened sensitivity of the mesolimbic dopamine system in very young females. However, alterations in baseline activity were only seen in males suggesting that different components of the system are affected by nicotine in each sex. An anxiolytic response to nicotine 5 days after dosing may suggest that this very young age group is uniquely affected by this very low nicotine dose. Clearly, nicotine has substantial acute and lasting effects during pre-adolescence at doses substantially lower than seen at older ages as reported by others. These effects, which could potentially result from cigarette or e-cigarette smoking by 11-12 year old children , focus attention on the vulnerability of this age group to nicotine. PMID:25109273

  7. A physical education trial improves adolescents' cognitive performance and academic achievement: the EDUFIT study.

    PubMed

    Ardoy, D N; Fernández-Rodríguez, J M; Jiménez-Pavón, D; Castillo, R; Ruiz, J R; Ortega, F B

    2014-02-01

    To analyze the effects of an intervention focused on increasing the time and intensity of Physical Education (PE), on adolescents' cognitive performance and academic achievement. A 4-month group-randomized controlled trial was conducted in 67 adolescents from South-East Spain, 2007. Three classes were randomly allocated into control group (CG), experimental group 1 (EG1) and experimental group 2 (EG2). CG received usual PE (two sessions/week), EG1 received four PE sessions/week and EG2 received four PE sessions/week of high intensity. Cognitive performance (non-verbal and verbal ability, abstract reasoning, spatial ability, verbal reasoning and numerical ability) was assessed by the Spanish Overall and Factorial Intelligence Test, and academic achievement by school grades. All the cognitive performance variables, except verbal reasoning, increased more in EG2 than in CG (all P < 0.05). Average school grades (e.g., mathematics) increased more in EG2 than in CG. Overall, EG2 improved more than EG1, without differences between EG1 and CG. Increased PE can benefit cognitive performance and academic achievement. This study contributes to the current knowledge by suggesting that the intensity of PE sessions might play a role in the positive effect of physical activity on cognition and academic success. Future studies involving larger sample sizes should confirm or contrast these preliminary findings. PMID:23826633

  8. Effects of a lifestyle modification trial among phenotypically obese metabolically normal and phenotypically obese metabolically abnormal adolescents in comparison with phenotypically normal metabolically obese adolescents.

    PubMed

    Kelishadi, Roya; Hashemipour, Mahin; Sarrafzadegan, Nizal; Mohammadifard, Noushin; Alikhasy, Hasan; Beizaei, Maryam; Sajjadi, Firouzeh; Poursafa, Parinaz; Amin, Zahra; Ghatreh-Samani, Shohreh; Khavarian, Noushin; Siadat, Zahra Dana

    2010-07-01

    This study aimed to assess the effects of a 2-month lifestyle modification trial on cardio-metabolic abnormalities and C-reactive protein (CRP) among obese adolescents with metabolic syndrome [phenotypically obese metabolically abnormal (POMA)] and obese adolescents without a cardio-metabolic disorder [phenotypically obese metabolically normal (POMN)], as well as in normal-weight adolescents with at least one cardio-metabolic disorder [phenotypically normal metabolically obese (PNMO)]. The study comprised 360 adolescents assigned in three groups of equal number of POMN, POMA and PNMO. They were enrolled in a trial consisting of aerobic activity classes, diet and behaviour modification, and were recalled after 6 months. Overall, 94.7% of participants completed the 2-month trial, and 87.3% of them returned after 6 months. The mean CRP was not significantly different between the POMA and PNMO groups, but was higher than in the POMN group. After the trial, body mass index (BMI) and waist circumference (WC) decreased in obese participants, and the mean body fat mass decreased in all groups. At 2 months, the mean total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG) and CRP decreased in the POMA and PNMO groups. After 2 and 6 months, the decrease in mean TC, LDL-C, TG, CRP and systolic blood pressure was greater in the POMA than in the POMN group. The magnitude of decrease in CRP correlated with that of BMI, WC, fat mass, TG, TC and LDL-C. Lifestyle modification programmes for primordial/primary prevention of chronic diseases would be beneficial at the population level and should not be limited to obese children. PMID:20929499

  9. Scientific standards for human intervention trials evaluating health benefits of foods, and their application to infants, children and adolescents.

    PubMed

    Woodside, Jayne V; Koletzko, Berthold V; Patterson, Chris C; Welch, Robert W

    2013-01-01

    Associations between the consumption of particular foods and health outcomes may be indicated by observational studies. However, intervention trials that evaluate the health benefits of foods provide the strongest evidence to support dietary recommendations for health. Thus, it is important that these trials are carried out safely, and to high scientific standards. Accepted standards for the reporting of the health benefits of pharmaceutical and other medical interventions have been provided by the Consolidated Standards of Reporting Trials (CONSORT) statement. However, there are no generally accepted standards for trials to evaluate the health benefits of foods. Trials with foods differ from medical trials in issues related to safety, ethics, research governance and practical implementation. Furthermore, these important issues can deter the conduct of both medical and nutrition trials in infants, children and adolescents. This paper provides standards for the planning, design, conduct, statistical analysis and interpretation of human intervention trials to evaluate the health benefits of foods that are based on the CONSORT guidelines, and outlines the key issues that need to be addressed in trials in participants in the paediatric age range. PMID:24029783

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

    PubMed Central

    2011-01-01

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

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

    PubMed Central

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

    2015-01-01

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

  12. 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

  13. ETHICAL TRADEOFFS IN TRIAL DESIGN: CASE STUDY OF AN HPV VACCINE TRIAL IN HIV-INFECTED ADOLESCENT GIRLS IN LOWER INCOME SETTINGS

    PubMed Central

    LINDSEY, J. C.; SHAH, S. K.; SIBERRY, G. K.; JEAN-PHILIPPE, P.; LEVIN, M. J.

    2013-01-01

    The Declaration of Helsinki and the Council of the International Organization of Medical Sciences provide guidance on standards of care and prevention in clinical trials. In the current and increasingly challenging research environment, the ethical status of a trial design depends not only on protection of participants, but also on social value, feasibility, and scientific validity. Using the example of a study assessing efficacy of a vaccine to prevent human papilloma virus in HIV-1 infected adolescent girls in low resource countries without access to the vaccine, we compare several trial designs which rank lower on some criteria and higher on others, giving rise to difficult trade-offs. This case demonstrates the need for developing more nuanced guidance documents to help researchers balance these often conflicting criteria. PMID:23725055

  14. The child and adolescent psychiatry trials network (CAPTN): infrastructure development and lessons learned

    PubMed Central

    Shapiro, Mark; Silva, Susan G; Compton, Scott; Chrisman, Allan; DeVeaugh-Geiss, Joseph; Breland-Noble, Alfiee; Kondo, Douglas; Kirchner, Jerry; March, John S

    2009-01-01

    Background In 2003, the National Institute of Mental Health funded the Child and Adolescent Psychiatry Trials Network (CAPTN) under the Advanced Center for Services and Intervention Research (ACSIR) mechanism. At the time, CAPTN was believed to be both a highly innovative undertaking and a highly speculative one. One reviewer even suggested that CAPTN was "unlikely to succeed, but would be a valuable learning experience for the field." Objective To describe valuable lessons learned in building a clinical research network in pediatric psychiatry, including innovations intended to decrease barriers to research participation. Methods The CAPTN Team has completed construction of the CAPTN network infrastructure, conducted a large, multi-center psychometric study of a novel adverse event reporting tool, and initiated a large antidepressant safety registry and linked pharmacogenomic study focused on severe adverse events. Specific challenges overcome included establishing structures for network organization and governance; recruiting over 150 active CAPTN participants and 15 child psychiatry training programs; developing and implementing procedures for site contracts, regulatory compliance, indemnification and malpractice coverage, human subjects protection training and IRB approval; and constructing an innovative electronic casa report form (eCRF) running on a web-based electronic data capture system; and, finally, establishing procedures for audit trail oversight requirements put forward by, among others, the Food and Drug Administration (FDA). Conclusion Given stable funding for network construction and maintenance, our experience demonstrates that judicious use of web-based technologies for profiling investigators, investigator training, and capturing clinical trials data, when coupled to innovative approaches to network governance, data management and site management, can reduce the costs and burden and improve the feasibility of incorporating clinical research into

  15. 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...

  16. 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

  17. Effect of peer led programme for asthma education in adolescents: cluster randomised controlled trial

    PubMed Central

    Shah, Smita; Peat, Jennifer K; Mazurski, Evalynn J; Wang, Han; Sindhusake, Doungkamol; Bruce, Colleen; Henry, Richard L; Gibson, Peter G

    2001-01-01

    Objective To determine the effect of a peer led programme for asthma education on quality of life and related morbidity in adolescents with asthma. Design Cluster randomised controlled trial. Setting Six high schools in rural Australia. Participants 272 students with recent wheeze, recruited from a cohort of 1515 students from two school years (mean age 12.5 and 15.5 years); 251 (92.3%) completed the study. Intervention A structured education programme for peers comprising three steps (the “Triple A Program”). Main outcome measures Quality of life, school absenteeism, asthma attacks, and lung function. Results When adjusted for year and sex, mean total quality of life scores showed significant improvement in the intervention than control group. Clinically important improvement in quality of life (>0.5 units) occurred in 25% of students with asthma in the intervention group compared with 12% in the control group (P=0.01). The number needed to treat was 8 (95% confidence interval 4.5 to 35.7). The effect of the intervention was greatest in students in year 10 and in females. Significant improvements occurred in the activities domain (41% v 28%) and in the emotions domain (39% v 19%) in males in the intervention group. School absenteeism significantly decreased in the intervention group only. Asthma attacks at school increased in the control group only. Conclusion The triple A programme leads to a clinically relevant improvement in quality of life and related morbidity in students with asthma. Wider dissemination of this programme in schools could play an important part in reducing the burden of asthma in adolescents. PMID:11238152

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

    PubMed

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

    2016-01-01

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

  19. Group-Randomized Trial of a Proactive, Personalized Telephone Counseling Intervention for Adolescent Smoking Cessation

    PubMed Central

    Kealey, Kathleen A.; Mann, Sue L.; Marek, Patrick M.; Ludman, Evette J.; Liu, Jingmin; Bricker, Jonathan B.

    2009-01-01

    Background The Hutchinson Study of High School Smoking randomized trial was designed to rigorously evaluate a proactive, personalized telephone counseling intervention for adolescent smoking cessation. Methods Fifty randomly selected Washington State high schools were randomized to the experimental or control condition. High school junior smokers were proactively identified (N = 2151). Trained counselors delivered the motivational interviewing plus cognitive behavioral skills training telephone intervention to smokers in experimental schools during their senior year of high school. Participants were followed up, with 88.8% participation, to outcome ascertainment more than 1 year after random assignment. The main outcome was 6-months prolonged abstinence from smoking. All statistical tests were two-sided. Results The intervention increased the percentage who achieved 6-month prolonged smoking abstinence among all smokers (21.8% in the experimental condition vs 17.7% in the control condition, difference = 4.0%, 95% confidence interval [CI] = −0.2 to 8.1, P = .06) and in particular among daily smokers (10.1% vs 5.9%, difference = 4.1%, 95% CI = 0.8 to 7.1, P = .02). There was also generally strong evidence of intervention impact for 3-month, 1-month, and 7-day abstinence and duration since last cigarette (P = .09, .015, .01, and .03, respectively). The intervention effect was strongest among male daily smokers and among female less-than-daily smokers. Conclusions Proactive identification and recruitment of adolescents via public high schools can produce a high level of intervention reach; a personalized motivational interviewing plus cognitive behavioral skills training counseling intervention delivered by counselor-initiated telephone calls is effective in increasing teen smoking cessation; and both daily and less-than-daily teen smokers participate in and benefit from telephone-based smoking cessation intervention. PMID:19822836

  20. 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

  1. “läuft.” - a school-based multi-component program to establish a physically active lifestyle in adolescence: study protocol for a cluster-randomized controlled trial

    PubMed Central

    2013-01-01

    discussions and document analyses. Discussion “läuft.” aims at fostering a physically active lifestyle in adolescence while a considerable decline of physical activity is present. Physical activity programs based in the school setting and following a multicomponent approach have been proven to be most successful. Furthermore, the use of pedometers is promising to enhance physical activity during the entire day and targets a wide range of adolescents regarding fitness and weight. Trial registration Current Controlled Trials ISRCTN49482118. PMID:24304715

  2. 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

  3. 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…

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

    PubMed

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

    2015-05-01

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

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

    PubMed Central

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

    2009-01-01

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

  6. 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

  7. 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)…

  8. 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…

  9. 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.…

  10. 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)…

  11. 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

  12. 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

  13. 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. PMID:26638219

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

    PubMed

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

    2014-09-01

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

  15. 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

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

    PubMed Central

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

    2012-01-01

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

  17. A Randomized Trial of the Positive Thoughts and Action Program for Depression among Early Adolescents

    PubMed Central

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

    2013-01-01

    Objective This study was conducted to compare the outcomes of a group-based cognitive-behavioral preventive intervention (Positive Thoughts and Actions, or PTA) tailored to youth in middle school with a brief, individually administered supportive intervention (Individual Support Program, or ISP). Method A randomized, clinical trial was conducted with 120 early adolescents (72 girls and 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 pre-intervention (Time1) and post-intervention (Time 2, 5–7 months after pre-intervention). Results 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. Conclusions Cognitive-behavioral preventive interventions in which youth engage in personal goal-setting and practice social-emotional skills, such as PTA, may be beneficial for the reduction of depressive symptoms over and above general support and empathy. PMID:23560384

  18. 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

  19. 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

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

    PubMed

    Kristjánsdóttir, Ólöf; Kristjánsdóttir, Guðrún

    2011-03-01

    Distraction has shown to be a helpful pain intervention for children; however, few investigations have studied the effectiveness of this method with adolescents. The aim of this study was to evaluate the usefulness of an easy and practical musical distraction in reducing adolescents' immunization pain. Furthermore, to examine whether musical distraction techniques (with or without headphones) used influenced the pain outcome. Hundred and eighteen 14-year-old adolescents, scheduled for polio immunization, participated. Adolescents were randomly assigned to one of three research groups; musical distraction with headphones (n=38), musical distraction without headphones (n=41) and standard care control (n=39). Results showed adolescents receiving musical distraction were less likely to report pain compared to the control group, controlling for covariates. Comparing musical distraction techniques, eliminating headphone emerged as a significant predictor of no pain. Results suggest that an easy and practical musical distraction intervention, implemented without headphones, can give some pain relief to adolescents during routine vaccination. PMID:20409050

  1. 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. PMID:23927515

  2. Comparative efficacy, acceptability, and tolerability of lisdexamfetamine in child and adolescent ADHD: a meta-analysis of randomized, controlled trials

    PubMed Central

    Maneeton, Benchalak; Maneeton, Narong; Likhitsathian, Surinporn; Suttajit, Sirijit; Narkpongphun, Assawin; Srisurapanont, Manit; Woottiluk, Pakapan

    2015-01-01

    Background Several studies have shown that lisdexamfetamine (LDX) is efficacious in children and adolescents with attention-deficit/hyperactivity disorder (ADHD). Objectives Aims of this study were to systematically review the efficacy, acceptability, and tolerability of LDX in child and adolescent ADHD. Any randomized controlled trials (RCTs) of LDX versus placebo carried out in children and adolescents with ADHD were included. Data sources The searches of the SCOPUS, MEDLINE, CINAHL and Cochrane Controlled Trials Register were performed in September 2014. Additional searches in the ClinicalTrials. gov and EU Clinical Trials Register database were conducted. Study eligibility criteria, participants, and interventions This review included all RCTs of LDX versus placebo which were carried out in children and adolescents up to 18 years old. Additionally, the included studies must have reported the final outcomes of: i) severity of ADHD symptoms with standardized scales, ii) rates of improvement, iii) rates of discontinuation. To be more thorough, the languages of such RCTs were not limited. Study appraisal and synthesis methods The abstracts from databases were inspected and the full text versions of relevant trials were examined and extracted for important outcomes. The efficacious measurements included either the pooled mean end-point or changed scores of ADHD rating scales, and the rate of improvement. Acceptability and tolerability were measured by the pooled overall discontinuation rate and the pooled discontinuation rate due to adverse events, respectively. A random effect model technique was utilized to synthesize the mean differences (either standardized mean differences or weighted mean differences) and relative risks (RRs) with 95% confidence intervals (CIs). Results A total of 1,016 children and adolescents with ADHD were included. The dosage of LDX was 30 to 70 mg/day. The pooled mean change scores of LDX-treated group was significantly greater than that

  3. Population-based enrolment of adolescents in a long-term follow-up trial of human papillomavirus vaccine efficacy.

    PubMed

    Lehtinen, M; Idänpään-Heikkilä, I; Lunnas, T; Palmroth, J; Barr, E; Cacciatore, R; Isaksson, R; Kekki, M; Koskela, P; Kosunen, E; Kuortti, M; Lahti, L; Liljamo, T; Luostarinen, T; Apter, D; Pukkala, E; Paavonen, J

    2006-04-01

    We evaluated a study setting for assessment of the long-term vaccine efficacy (VE) of human papillomavirus (HPV) virus-like-particle (VLP) vaccine against cervical carcinoma. A total of 22,412 16- to 17-year old adolescent women from seven cities in Finland were invited by letter to participate in a phase III study of a quadrivalent HPV (types 6, 11, 16, 18) VLP vaccine, between September 2002 and March 2003. A total of 30,947 18-year old women were invited to participate as unvaccinated controls. These women were asked about their willingness to participate in an HPV vaccination trial and to fill a health questionnaire. These three population-based cohorts of adolescent women, including women vaccinated with HPV vaccine or placebo vaccine and unvaccinated control women, are systematically followed over time. The study cohort database will be linked with the Finnish Cancer Registry using cervical carcinoma in situ (CIS) and invasive cervical carcinoma (ICC) as endpoints. Assuming that the cumulative incidence of CIS and ICC over 15 years is 0.45%, and that there is no loss to follow-up, and power of 80%, the determination of 70% total VE will require 3357 HPV vaccine recipients, 3357 placebo vaccine recipients, and 6714 unvaccinated controls. At the baseline, 2632 (12%) of the invited adolescents volunteered to the phase III vaccination trial, and 6790 (22%) responded to the questionnaire study. During a recruitment period of 10 months, 874 HPV vaccine recipients, 875 placebo recipients and 1919 unvaccinated controls were enrolled. Population-based enrollment of large cohorts of vaccinated and unvaccinated adolescents for passive registry-based follow-up with cervical carcinoma as the end-point is feasible and currently going on in Finland. PMID:16595046

  4. 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

  5. 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

  6. Treating Adolescents with Social Anxiety Disorder in School: An Attention Control Trial

    ERIC Educational Resources Information Center

    Warner, Carrie Masia; Fisher, Paige H.; Shrout, Patrick E.; Rathor, Snigdha; Klein, Rachel G.

    2007-01-01

    Background: Anxiety disorders are often undetected and untreated in adolescents. This study evaluates the relative efficacy of a school-based, cognitive-behavioral intervention compared to an educational-supportive treatment for adolescents with social anxiety disorder. Methods: Thirty-six students (30 females), ages 14 to 16, were randomized to a…

  7. 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…

  8. 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…

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

    ERIC Educational Resources Information Center

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

    2012-01-01

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

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

    ERIC Educational Resources Information Center

    Lin, Hsiu-Ching; Wuang, Yee-Pay

    2012-01-01

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

  11. 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…

  12. Familias Unidas' Crossover Effects on Suicidal Behaviors among Hispanic Adolescents: Results from an Effectiveness Trial.

    PubMed

    Vidot, Denise C; Huang, Shi; Poma, Sofia; Estrada, Yannine; Lee, Tae Kyoung; Prado, Guillermo

    2016-04-01

    The long-term impact of Familias Unidas on suicidal behaviors among Hispanic 8th graders (N = 746) was examined along with parent-adolescent communication as a moderator of intervention effectiveness. At baseline, 9.2% (95% CI = 7.3%-11.6%) of adolescents reported suicide ideation and 5.7% (95% CI = 4.1%-7.7%) reported a past year suicide attempt. There were no significant intervention effects on suicidal behaviors; however, parent-adolescent communication was a moderator of suicide attempts in the past year, across the intervention (b = -.01, p = .01). Results suggest that Familias Unidas reduces suicidal behaviors among Hispanic adolescents with low levels of parent-adolescent communication despite no suicide-specific intervention content. Implications of these findings are discussed. PMID:27094111

  13. LOCAT (low-dose computed tomography for appendicitis trial) comparing clinical outcomes following low- vs standard-dose computed tomography as the first-line imaging test in adolescents and young adults with suspected acute appendicitis: study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Computed tomography is widely used to diagnose acute appendicitis. Many adolescents and young adults are exposed to the associated radiation. A recent single-institution trial has reported promising results for low-dose computed tomography; however, this technique has not yet been widely adopted. LOCAT (low-dose computed tomography for appendicitis trial), a multi-institution randomized controlled non-inferiority trial, aims to compare low-dose computed tomography and standard-dose computed tomography as the first-line imaging tests for adolescents and young adults, and therefore to test the generalizability of the previous single-institution trial results. Methods/Design Participants with suspected appendicitis are randomly assigned to either the low-dose group (with a typical effective dose of 2 mSv) or the standard-dose group (as used in normal practice at each participating site, typically 8 mSv). The primary end point is the negative appendectomy rate (the percentage of the number of uninflamed appendices that were removed among all non-incidental appendectomies), which is a consequence of false-positive diagnoses, with a non-inferiority margin of 4.5 percentage points. The key secondary end point is the appendiceal perforation rate, which is a consequence of delayed (or false-negative) diagnoses. Participant recruitment will be continued until the number of non-incidental appendectomies for each group exceeds 444. The total number of expected participants approximates 3,000, including those not undergoing appendectomy. Discussion In addition to the study protocol, we elaborate on several challenging or potentially debatable components of the study design, including the broad eligibility criteria, choice of the primary end point, potential effect of using advanced imaging techniques on study results, determining and adjusting the radiation doses, ambiguities in reference standards, rationale for the non-inferiority margin, use of the intention

  14. Integrative Internet-Based Depression Prevention for Adolescents: A Randomized Clinical Trial in Primary Care for Vulnerability and Protective Factors

    PubMed Central

    Van Voorhees, Benjamin W.; Vanderplough-Booth, Karen; Fogel, Joshua; Gladstone, Tracy; Bell, Carl; Stuart, Scott; Gollan, Jackie; Bradford, Nathan; Domanico, Rocco; Fagan, Blake; Ross, Ruth; Larson, Jon; Watson, Natalie; Paunesku, Dave; Melkonian, Stephanie; Kuwabara, Sachiko; Holper, Tim; Shank, Nicholas; Saner, Donald; Butler, Amy; Chandler, Amy; Louie, Tina; Weinstein, Cynthia; Collins, Shannon; Baldwin, Melinda; Wassel, Abigail; Reinecke, Mark A.

    2008-01-01

    Background Adolescent depression is both a major public health and clinical problem, yet primary care physicians have limited intervention options. We developed two versions of an Internet-based behavioral intervention to prevent the onset of major depression and compared them in a randomized clinical trial in 13 US primary care practices. Methods We enrolled 84 adolescents at risk for developing major depression and randomly assigned them to two groups: brief advice (BA; 1–2 minutes) + Internet program versus motivational interview (MI; 5–15 minutes) + Internet program. We compared pre/post changes and between group differences for protective and vulnerability factors (individual, family, school and peer). Results Compared with pre-study values, both groups demonstrated declines in depressed mood; [MI: 21.2 to 16.74 (p < 0.01), BA: 23.34 to 16.92 (p < 0.001)]. Similarly, both groups demonstrated increases in social support by peers [MI: 8.6 to 12.1 (p = 0.002), BA: 7.10 to 12.5 (p < 0.001)] and reductions in depression related impairment in school [MI: 2.26 to 1.76 (p = 0.06), BA: 2.16 to 1.93 (p = 0.07)]. Conclusions Two forms of a primary care/Internet-based behavioral intervention to prevent adolescent depression may lower depressed mood and strengthen some protective factors for depression. PMID:19018321

  15. Integrating Family-Based Treatment and Dialectical Behavior Therapy for Adolescent Bulimia Nervosa: Preliminary Outcomes of an Open Pilot Trial.

    PubMed

    Murray, Stuart B; Anderson, Leslie K; Cusack, Anne; Nakamura, Tiffany; Rockwell, Roxanne; Griffiths, Scott; Kaye, Walter H

    2015-01-01

    Adolescent bulimia nervosa (BN) remains relatively understudied, and the complex interaction between core eating psychopathology and emotional regulation difficulties provides ongoing challenges for full symptom remission. In an open pilot trial, we aimed to investigate the efficacy of a program integrating family-based treatment (FBT) and dialectical behavior therapy (DBT) in treating adolescent BN, without exclusion criteria. Participants were 35 adolescents who underwent partial hospital treatment for BN, and outcomes included measures of core BN pathology and emotional regulation difficulties, as well as parental measures of self-efficacy, completed at intake and discharge. Results indicate significant improvements in overall eating disorder pathology, t(68) = 4.52, p = .002, and in core BN symptoms, including objective binge episodes, t(68) = 2.01, p = .041, and self-induced vomiting, t(68) = 2.90, p = .005. Results also illustrated a significant increase in parental efficacy throughout the course of treatment, t(20) = .081, p = .001, although no global improvement in difficulties in emotion regulation was noted, t(68) = 1.12, p = .285. These preliminary findings support the utility of this integration of FBT and DBT, although raise interesting questions as to the mechanism of symptom remission. PMID:26009971

  16. Management of psychiatric disorders in children and adolescents with atypical antipsychotics: a systematic review of published clinical trials.

    PubMed

    Jensen, Peter S; Buitelaar, Jan; Pandina, Gahan J; Binder, Carin; Haas, Magali

    2007-03-01

    We aimed to provide a descriptive review of treatment studies of atypical antipsychotics in paediatric psychiatric disorders. A systematic review of the literature used Medline and EMBASE databases to identify clinical trials of atypical antipsychotics in children and adolescents between 1994 and 2006. Trials were limited to double-blind studies and open-label studies of > or = 8 weeks duration that included > or = 20 patients. Nineteen double-blind and 22 open-label studies were identified. Studies included use of clozapine, olanzapine, quetiapine, risperidone, and ziprasidone in the treatment of disruptive behavioural disorders (DBDs), pervasive developmental disorders (PDDs), tic disorder, psychotic disorders, and mania. These medications generally reduced the severity of a variety of psychiatric symptoms in children and adolescents. Less frequent adverse events included extrapyramidal symptoms, hyperglycaemia and diabetes, and endocrine effects. The review of published scientific data suggests that most of the atypical antipsychotics, excluding clozapine, have a favourable risk/benefit profile and effectively reduce disabling behaviours in paediatric psychiatric patients. While there is a body of evidence published of treatment of DBDs and PDDs, there is a lack of controlled data to guide clinical practice for the use of atypical antipsychotics for paediatric psychotic disorders and bipolar disorder. While there have been studies with duration up to 2 years, no definitive data are available that suggest long-term safety; additional studies are warranted. PMID:17075688

  17. 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. PMID:26995811

  18. 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

  19. 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

  20. Reducing Smoking in Adolescents: Cost-Effectiveness Results From the Cluster Randomized ASSIST (A Stop Smoking In Schools Trial)

    PubMed Central

    Cohen, David; Hawkins, James; Hughes, Rachael A.; Moore, Laurence A. R.; Holliday, Jo C.; Audrey, Suzanne; Starkey, Fenella; Campbell, Rona

    2012-01-01

    Introduction: School-based smoking prevention programmes can be effective, but evidence on cost-effectiveness is lacking. We conducted a cost-effectiveness analysis of a school-based “peer-led” intervention. Methods: We evaluated the ASSIST (A Stop Smoking In Schools Trial) programme in a cluster randomized controlled trial. The ASSIST programme trained students to act as peer supporters during informal interactions to encourage their peers not to smoke. Fifty-nine secondary schools in England and Wales were randomized to receive the ASSIST programme or usual smoking education. Ten thousand seven hundred and thirty students aged 12–13 years attended participating schools. Previous work has demonstrated that the ASSIST programme achieved a 2.1% (95% CI = 0%–4.2%) reduction in smoking prevalence. We evaluated the public sector cost, prevalence of weekly smoking, and cost per additional student not smoking at 24 months. Results: The ASSIST programme cost of £32 (95% CI = £29.70–£33.80) per student. The incremental cost per student not smoking at 2 years was £1,500 (95% CI = £669–£9,947). Students in intervention schools were less likely to believe that they would be a smoker at age 16 years (odds ratio [OR] = 0.80; 95% CI = 0.66–0.96). Conclusions: A peer-led intervention reduced smoking among adolescents at a modest cost. The intervention is cost-effective under realistic assumptions regarding the extent to which reductions in adolescent smoking lead to lower smoking prevalence and/or earlier smoking cessation in adulthood. The annual cost of extending the intervention to Year 8 students in all U.K. schools would be in the region of £38 million and could result in 20,400 fewer adolescent smokers. PMID:22180581

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

    PubMed Central

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

    2013-01-01

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

  2. 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. PMID:23748156

  3. 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

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

    PubMed

    Walther, Birte; Hanewinkel, Reiner; Morgenstern, Matthis

    2014-09-01

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

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

    PubMed Central

    2016-01-01

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

  6. 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…

  7. 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…

  8. 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…

  9. 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…

  10. 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…

  11. 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...

  12. Targeted prevention of excess weight gain and eating disorders in high-risk adolescent girls: a randomized controlled trial12345

    PubMed Central

    Shomaker, Lauren B; Wilfley, Denise E; Young, Jami F; Sbrocco, Tracy; Stephens, Mark; Ranzenhofer, Lisa M; Elliott, Camden; Brady, Sheila; Radin, Rachel M; Vannucci, Anna; Bryant, Edny J; Osborn, Robyn; Berger, Sarah S; Olsen, Cara; Kozlosky, Merel; Reynolds, James C; Yanovski, Jack A

    2014-01-01

    Background: The high prevalence and incidence of obesity and eating disorders in US adolescent girls are serious health problems. Because of the shared risk factors for obesity and eating disorders, a targeted prevention of both conditions is a priority. Objective: We determined whether an adapted interpersonal psychotherapy prevention program is more efficacious for reducing excess weight gain and worsening disordered eating than health education in adolescent girls at high risk of obesity and eating disorders. Design: A parallel-group, randomized controlled trial was conducted between September 2008 and January 2013 in a university-based laboratory and a federal research hospital. The study included 113 adolescent (12–17-y-old) girls deemed at high risk of adult obesity and eating disorders because of a body mass index (BMI) between the 75th and 97th percentiles and reports of episodes of a loss of control over their eating. Girls were randomly assigned to participate in an adapted interpersonal psychotherapy or a health-education group program for 12 weekly 90-min group sessions. Follow-up assessments occurred immediately after group programs and at 6 and 12 mo. Results: Participation in both conditions was associated with decreases in expected BMI gain, age-adjusted BMI metrics, the percentage of fat by using dual-energy X-ray absorptiometry, symptoms of depression and anxiety, and the frequency of loss-of-control eating over 12 mo of follow-up (Ps < 0.001) with no group difference. In follow-up analyses, interpersonal psychotherapy was more efficacious than health education at reducing objective binge eating at the 12-mo follow-up (P < 0.05). Conclusions: The intervention with adolescent girls with loss-of-control eating is associated with lower age-adjusted BMI and percentage of adiposity as well as improved mood symptoms over 1 y. Interpersonal psychotherapy further reduced objective binge eating. Additional research is needed to elucidate the mechanisms

  13. 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

  14. Using Genetically Informed, Randomized Prevention Trials to Test Etiological Hypotheses About Child and Adolescent Drug Use and Psychopathology

    PubMed Central

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

    2013-01-01

    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. PMID:23927515

  15. 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. PMID:23324373

  16. 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

  17. 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…

  18. 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…

  19. A Randomized Trial of Contingency Management for Adolescent Marijuana Abuse and Dependence

    PubMed Central

    Stanger, Catherine; Budney, Alan J.; Kamon, Jody L.; Thostensen, Jeff

    2009-01-01

    An initial efficacy test of an innovative behavioral outpatient treatment model for adolescents with problematic use of marijuana enrolled 69 adolescents, aged 14–18, and randomly assigned them to one of two treatment conditions. Both conditions received individualized Motivational Enhancement and Cognitive Behavioral Therapy (MET/CBT) and a twice-weekly drug-testing program. The experimental contingency management condition involved a clinic delivered, abstinence-based incentive program, and weekly behavioral parent training sessions that included a parent-delivered, abstinence-based, substance monitoring contract. The comparison condition included an attendance-based incentive program, and weekly psychoeducational parent sessions. Follow-up assessments were performed at 3, 6, 9 months post-treatment. The experimental condition showed greater marijuana abstinence during treatment, e.g., 7.6 vs. 5.1 continuous weeks and 50% vs. 18% achieved ≥ 10 weeks of abstinence. Improvements were found in parenting and youth psychopathology across treatment conditions, and improvements in negative parenting uniquely predicted post treatment abstinence. The outcomes observed in the experimental condition are consistent with adult substance dependence treatment literature, and suggest that integrating CM abstinence-based approaches with other empirically-based outpatient interventions provides an alternative and efficacious treatment model for adolescent substance abuse/dependence. Replication and continued development of more potent interventions remain needed to further advance the development of effective substance abuse treatments for adolescents. PMID:19717250

  20. 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)…

  1. 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. PMID:26234955

  2. 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…

  3. Group trauma-informed treatment for adolescent psychiatric inpatients: a preliminary uncontrolled trial.

    PubMed

    Gudiño, Omar G; Weis, J Rebecca; Havens, Jennifer F; Biggs, Emily A; Diamond, Ursula N; Marr, Mollie; Jackson, Christie; Cloitre, Marylene

    2014-08-01

    Despite high rates of trauma exposure (46%-96%) and significant posttraumatic stress disorder (PTSD; 21%-29%) symptoms in adolescent psychiatric inpatients, there is a dearth of research on effective interventions delivered in inpatient settings. The current report describes the development of Brief STAIR-A, a repeatable 3-module version of skills training in affective and interpersonal regulation (STAIR) developed for adolescents in inpatient care. An uncontrolled design was used to conduct a preliminary examination of the group intervention's effectiveness. Adolescent psychiatric inpatients (N = 38; ages 12 years-17 years) admitted to a public hospital participated in Brief STAIR-A and attended a median of 6 sessions (range 3-36). They completed measures of PTSD and depressive symptom severity, coping skill use, and coping efficacy upon admission and again prior to discharge. Participants reported significant reductions in symptom severity (d = 0.65-0.67), no change in the absolute level of coping skills used (d = 0.16), but greater coping efficacy when discharged from care (d = 0.75). Results from this pilot study suggest that this brief group treatment shows promise for treating adolescents' trauma-related difficulties in inpatient psychiatry settings, but additional research examining its effectiveness is essential. PMID:25070927

  4. 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…

  5. Plasticity of risky decision making among maltreated adolescents: Evidence from a randomized controlled trial.

    PubMed

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

    2015-05-01

    Childhood maltreatment has lasting negative effects throughout the life span. 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 nonmaltreated age and socioeconomic status 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 nonmaltreated 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. A Randomized Controlled Trial Testing the Efficacy of a Brief Cannabis Universal Prevention Program among Adolescents in Primary Care

    PubMed Central

    Walton, Maureen A.; Resko, Stella; Barry, Kristen L.; Chermack, Stephen T.; Zucker, Robert A.; Zimmerman, Marc A.; Booth, Brenda M.; Blow, Frederic C.

    2014-01-01

    Aims To examine the efficacy of a brief intervention delivered by a therapist (TBI) or a computer (CBI), in preventing cannabis use among adolescents in urban primary care clinics. Design A randomized controlled trial comparing: CBI and TBI versus control. Setting Urban primary care clinics in the United States. Participants Research staff recruited 714 adolescents (ages 12-18) who reported no lifetime cannabis use on a screening survey for this study, which included a baseline survey, randomization (stratified by gender and grade) to conditions (control; CBI; TBI), and 3, 6, and 12 month assessments. Measurements Using an intent to treat approach, primary outcomes were cannabis use (any, frequency); secondary outcomes included frequency of other drug use, severity of alcohol use, and frequency of delinquency (among 85% completing follow-ups). Findings Compared with controls, CBI participants had significantly lower rates of any cannabis use over 12 months (24.2%, 16.8%, respectively, p<.05), frequency of cannabis use at 3 and 6 months (p<.05) and other drug use at 3 months (p<.01). Compared with controls, TBI participants did not differ in cannabis use or frequency, but had significantly less other drug use at 3 months (p<.05), alcohol use at 6 months (p<.01), and delinquency at 3 months (p<.01). Conclusions Among adolescents in urban primary care in the United States, a computer brief intervention appeared to prevent and reduce cannabis use. Both computer and therapist delivered brief interventions appeared to have small effects in reducing other risk behaviors, but these dissipated over time. PMID:24372937

  7. Clinical Effects of Portulaca Oleracea Seeds on Dyslipidemia in Obese Adolescents: a Triple-blinded Randomized Controlled Trial

    PubMed Central

    Sabzghabaee, Ali Mohammad; Kelishadi, Roya; Jelokhanian, Hadi; Asgary, Sedigheh; Ghannadi, Alireza; Badri, Shirinsadat

    2014-01-01

    Objective: Childhood obesity is a major public health concern worldwide while the current epidemic may be secondary to over consumption of high-fat, energy-rich foods. Purslane (Portulaca oleracea L.) has been traditionally used in medicine for several antioxidant and anti-atherogenic activities. In this study the anti-dyslipidemic effects of P.oleracea was evaluated in obese adolescents. Methods: In this triple-blinded randomized placebo-controlled clinical trial which was done from July 2011 to June 2012, obese adolescent patients whom were referred to the Isfahan Cardiovascular Research Institute (Iran) were randomly allocated to the two arms of cases and controls. The cases group was asked to take one capsule containing powdered P. oleracea seeds (500 milligrams) two times a day for one month, and the controls group were asked to take identical but placebo (lactose) capsules in the same way. Biochemical parameters including 12-hours fasting serum levels of total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides (TG) were measured before the initiation and after the completion of the study protocol. Findings: Total cholesterol, LDL-C, and TG showed statistically significant changes over time (one month) in the P. oleracea group (p < 0.05). However, between-group analysis using general linear model (multivariate) test revealed that the differences in the mentioned parameters between two study groups were statistically significant just for LDL-C and TG, while others did not differ significantly. Conclusion: P. oleracea L. may have positive effects on serum lipids profile which may be attributed to its polyphenolic and antioxidant compounds. This herbal drug seems to be well-tolerated in adolescent population as well. Further studies are recommended. PMID:25568533

  8. 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. PMID:26335910

  9. Multisystemic therapy for adolescents with poorly controlled type I diabetes: Stability of treatment effects in a randomized controlled trial.

    PubMed

    Ellis, Deborah A; Templin, Thomas; Naar-King, Sylvie; Frey, Maureen A; Cunningham, Phillippe B; Podolski, Cheryl-Lynn; Cakan, Nedim

    2007-02-01

    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 treatment. A randomized controlled trial was conducted with 127 adolescents and their families. Mean participant age was 13.2 years. Sixty-three percent of participants were African American, and 51% were female. Data were collected at baseline, treatment termination, and 6-month follow-up. Changes in glycated hemoglobin (HbA1c), frequency of blood glucose testing (BGT), and rate of DKA admissions were assessed. In intent-to-treat analyses, a main effect of MST on DKA admissions was found at both treatment termination and follow-up. Improvements in BGT were moderated by family composition; only 2-parent MST families maintained improvements at follow-up. Improvements in HbA1c for the MST group at treatment termination were lost at follow-up. Results show that intensive, home-based psychotherapy created stable reductions in serious lapses in adherence, as indexed by episodes of DKA, among youth with poorly controlled diabetes. PMID:17295576

  10. 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

  11. Study on the safety and efficacy of miltefosine for the treatment of children and adolescents with post-kala-azar dermal leishmaniasis in Bangladesh, and an association of serum vitamin E and exposure to arsenic with post-kala-azar dermal leishmaniasis: an open clinical trial and case–control study protocol

    PubMed Central

    Mondal, D; Hasnain, M G; Hossain, M S; Ghosh, D; Ghosh, P; Hossain, H; Baker, J; Nath, R; Haque, R; Matlashewski, G; Hamano, S

    2016-01-01

    Introduction Post-kala-azar dermal leishmaniasis (PKDL) is a dermatological complication that occurs primarily among treated visceral leishmaniasis (VL) patients, and sporadically in a few without a history of VL. It mostly affects children and adolescents but is also common in adults. The conventional treatment with 120 intramuscular injections of sodium stibogluconate (SSG) is phasing out. Miltefosine (MF) is the only eventual alternative to SSG; however, its efficacy and safety profiles for treatment of children and adolescents with PKDL are lacking. In addition, risk factors for PKDL are poorly investigated. Host genetic, nutritional and environmental factors could be potential risk factors. As such, here we propose to evaluate the efficacy and safety of MF for 12 weeks at an allometric dose for children and adolescents with PKDL, and also to explore potential risk factors for PKDL. Methods and analysis A cross-sectional survey will look for suspected participants with PKDL among treated VL children and adolescents, a subsequent open clinical trial with MF at allometric dose, with a follow-up at 12 months. A case–control study will be carried out for PKDL risk factors. Assuming 95% cure rate, 95% CI and α=0.05, a sample size of 73 children with PKDL is needed. Considering an attrition rate of 10%, the final sample size is 80 children in each group. Descriptive and analytical analyses will be performed. Primary outcome is safety and cure rate of 12 weeks of treatment with MF. Ethics and dissemination International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B) Ethical Review Committee (ERC) approved the protocol (PR#013045). Written informed consent will be taken from all participants and their guardians (in case of minor). A Data and Safety Monitoring Board (DSMB) of ICDDR,B ERC will monitor all study activities to ensure the safety of the participants. Trial registration number NCT02193022; Pre-results. PMID:27188804

  12. Adolescent HIV Risk Reduction in the Bahamas: Results from Two Randomized Controlled Intervention Trials Spanning Elementary School Through High School.

    PubMed

    Stanton, Bonita; Dinaj-Koci, Veronica; Wang, Bo; Deveaux, Lynette; Lunn, Sonja; Li, Xiaoming; Rolle, Glenda; Brathwaite, Nanika; Marshall, Sharon; Gomez, Perez

    2016-06-01

    To address global questions regarding the timing of HIV-prevention efforts targeting youth and the possible additional benefits of parental participation, researchers from the USA and The Bahamas conducted two sequential longitudinal, randomized trials of an evidence-based intervention spanning the adolescent years. The first trial involved 1360 grade-6 students and their parents with three years of follow-up and the second 2564 grade-10 students and their parents with two years of follow-up. Through grade-12, involvement in the combined child and parent-child HIV-risk reduction interventions resulted in increased consistent condom-use, abstinence/protected sex, condom-use skills and parent-child communication about sex. Receipt of the grade-6 HIV-prevention intervention conferred lasting benefits regarding condom-use skills and self-efficacy. Youth who had not received the grade-six intervention experienced significantly greater improvement over baseline as a result of the grade-10 intervention. The HIV-risk reduction intervention delivered in either or both grade-6 and grade-10 conferred sustained benefits; receipt of both interventions appears to confer additional benefits. PMID:26499123

  13. Laser acupuncture for adolescent smokers--a randomized double-blind controlled trial.

    PubMed

    Yiming, C; Changxin, Z; Ung, W S; Lei, Z; Kean, L S

    2000-01-01

    A double blind, randomized, placebo-controlled clinical study was conducted to evaluate the efficacy of laser acupuncture treatment in adolescent smokers. Three hundred and thirty adolescent smokers at the Smoking Cessation Clinic of Child Guidance Clinic, Institute of Health, Singapore, were randomly assigned in equal numbers to laser acupuncture treatment and sham acupuncture (control) groups. The proportions of patients with complete smoking cessation after completing treatment for four weeks were 21.9% in the treatment group and 21.4% in the control group. At three months post-treatment, the rates for complete cessation were 24.8% and 26.2%, respectively. Thus, there was no significant difference in the rates of smoking cessation in the treatment and control groups. PMID:11154059

  14. Strength and agility training in adolescents with Down syndrome: a randomized controlled trial.

    PubMed

    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±3.2 and 11.2±3.5 respectively. The exercise training program consisted of a 5-min treadmill exercise and one 20-min virtual-reality based activity administered three times a week for 6 weeks. Pre- and post-test measures were taken for muscle strength and agility performance. The measured muscle included hip extensor, hip flexor, knee extensor, knee flexors, hip abductors, and ankle plantarflexor. A handheld dynamometer was used to measure the lower extremities muscle strength, and agility performance was assessed by the strength and agility subtests of the Bruininks-Oseretsky Test of Motor Proficiency-Second Edition. The exercise group had significant improvements in agility (p=0.02, d=0.80) and muscle strength of all muscle group (all p's<0.05, d=0.51-0.89) assessed in comparison to the control group after the 6-week intervention. Knee muscle groups including both flexors and extensors had the greatest gains among all the muscles measured. A short-term exercise training program used in this study is capable of improving muscle strength and agility performance of adolescents with DS. PMID:22820064

  15. Prolonged Exposure vs Dynamic Therapy for Adolescent PTSD: A Pilot Randomized Controlled Trial

    PubMed Central

    Gilboa-Schechtman, Eva; Foa, Edna; 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 (PE-A) compared to active control Time Limited Dynamic Therapy (TLDP-A) for reducing post-traumatic and depressive symptoms in adolescent victims of single event traumas. Method 38 adolescents (age 12–18) were randomly assigned to receive either PE-A or TLDP-A. Results Both treatments resulted in decreased post-traumatic stress disorder and depression, and increased functioning. PE-A exhibited greater reduction of PTSD and depression symptom severity, and greater increase in global functioning than did TDLP-A. At post-treatment, 68.4% of adolescents beginning treatment with PE-A and 36.8% of those beginning treatment with TLDP-A no longer met diagnostic criteria for PTSD. Treatment gains were maintained at 6 and 17 months follow-up. Conclusions Brief individual therapy is effective in reducing post-traumatic distress and behavioral trauma-focused components enhance efficacy. PMID:20855048

  16. 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

  17. 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

  18. 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…

  19. 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…

  20. 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…

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

    PubMed Central

    2014-01-01

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

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

    PubMed Central

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

    2008-01-01

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

  3. Atomoxetine Improved Attention in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder and Dyslexia in a 16 Week, Acute, Randomized, Double-Blind Trial

    PubMed Central

    Williams, David; Shaywitz, Sally; Shaywitz, Bennett; Hooper, Stephen R.; Wigal, Sharon B.; Dunn, David; McBurnett, Keith

    2013-01-01

    Abstract Objective The purpose of this study was to evaluate atomoxetine treatment effects in attention-deficit/hyperactivity disorder (ADHD-only), attention-deficit/hyperactivity disorder with comorbid dyslexia (ADHD+D), or dyslexia only on ADHD core symptoms and on sluggish cognitive tempo (SCT), working memory, life performance, and self-concept. Methods Children and adolescents (10–16 years of age) with ADHD+D (n=124), dyslexia-only (n=58), or ADHD-only (n=27) received atomoxetine (1.0–1.4 mg/kg/day) or placebo (ADHD-only subjects received atomoxetine) in a 16 week, acute, randomized, double-blind trial with a 16 week, open-label extension phase (atomoxetine treatment only). Changes from baseline were assessed to weeks 16 and 32 in ADHD Rating Scale-IV-Parent-Version:Investigator-Administered and Scored (ADHDRS-IV-Parent:Inv); ADHD Rating Scale-IV-Teacher-Version (ADHDRS-IV-Teacher-Version); Life Participation Scale—Child- or Parent-Rated Version (LPS); Kiddie-Sluggish Cognitive Tempo (K-SCT) Interview; Multidimensional Self Concept Scale (MSCS); and Working Memory Test Battery for Children (WMTB-C). Results At week 16, atomoxetine treatment resulted in significant (p<0.05) improvement from baseline in subjects with ADHD+D versus placebo on ADHDRS-IV-Parent:Inv Total (primary outcome) and subscales, ADHDRS-IV-Teacher-Version Inattentive subscale, K-SCT Interview Parent and Teacher subscales, and WMTB-C Central Executive component scores; in subjects with Dyslexia-only, atomoxetine versus placebo significantly improved K-SCT Youth subscale scores from baseline. At Week 32, atomoxetine-treated ADHD+D subjects significantly improved from baseline on all measures except MSCS Family subscale and WMTB-C Central Executive and Visuo-spatial Sketchpad component scores. The atomoxetine-treated dyslexia-only subjects significantly improved from baseline to week 32 on ADHDRS-IV-Parent:Inv Inattentive subscale, K-SCT Parent and Teacher subscales, and WMTB

  4. A feasible method to improve adherence of Hawley retainer in adolescent orthodontic patients: a randomized controlled trial

    PubMed Central

    Lin, Feiou; Sun, Hao; Ni, Zhenyu; Zheng, Minling; Yao, Linjie

    2015-01-01

    Background Retention is an important component of orthodontic treatment; however, poor compliance with retainer use is often encountered, especially in adolescents. The purpose of this study was to prove the hypothesis that verbal instructions combined with images showing the severe consequences of poor compliance can increase retainer use. Methods This study was a randomized controlled trial. The sample was recruited from Wenzhou, People’s Republic of China, between February 2013 and May 2014, and 326 participants were randomized into three groups. Patients and parents in Group A (n=106) were given routine retainer wear instructions only; in Group B (n=111), images illustrating the severe consequences of poor compliance with Hawley retainer use were shown to patients, combined with routine instructions; and in Group C (n=109), images illustrating the severe consequences of poor compliance with Hawley retainer use were shown to patients and parents, combined with routine instructions. Three months after debonding, questionnaires were used to investigate daily wear time and the reasons for poor compliance. Differences in means between the groups were tested by one-way analysis of variance. Results The mean daily wear time in Group C (15.09±4.13 hours) was significantly greater than in Group A (12.37±4.58 hours, P<0.01) or Group B (13.50±4.22 hours, P<0.05); the mean daily wear time in Group B was greater than in Group A, but was not significant (P=0.67). Reasons for nonusage were forgetting to wear the retainer (51%) and finding the retainer bothersome to frequently insert and remove (42%). Conclusion Verbal instructions combined with images showing the severe consequences of poor compliance can increase retainer use. Parents play an important role in compliance with retainer use in adolescent patients. PMID:26604705

  5. Seeds of prevention: the impact on health behaviors of young adolescent girls in Uttar Pradesh, India, a cluster randomized control trial.

    PubMed

    Kapadia-Kundu, Nandita; Storey, Douglas; Safi, Basil; Trivedi, Geetali; Tupe, Rama; Narayana, G

    2014-11-01

    Of the world's 1.2 billion adolescents (10-19 years), India is home to the largest number globally, about 243 million. However not much is known about the health of young adolescent girls (11-14 years) in India who enter puberty with substantial nutritional and health deficits. Identifying early adolescence as a "gateway" moment, the Saloni pilot study is arandomized control trial (RCT) to improve nutrition, hygiene and reproductive health behaviors in 30 schools in rural Uttar Pradesh (UP), India. A prevention model that includes Sadharanikaran, an ancient Indian theory of communication, guided the development of the intervention. The Saloni strategy includes a 10 session in-school intervention based on compassion, self efficacy, emotional well being, peer and parental support, packaged in the form of short, easy-to-use instructional modules. A diary designed to engage adolescent girls is provided to each girl. The cluster RCT was conducted from January 2010 to October 2011 with adolescent girls (11-14 years of age) in Hardoi district. The trial is a two-level, nested RCT with the unit of randomization being the block with 15 schools in the intervention arm and 15 schools in the control arm. A sample of 1200 girls was randomly selected. The intervention had a significant impact on more than 13 preventive health behaviors. About 65 percent girls in the intervention group had adopted 13 or more health behaviors at end line compared 4.5 percent in the control group at end line and 5 percent at baseline. Behavioral impact was demonstrated in all three areas of nutrition, hygiene and reproductive health. The study provides evidence that early adolescence is indeed a "gateway moment" to build nutritional and health reserves. PMID:25254614

  6. 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

  7. Omega-3/Omega-6 Fatty Acids for Attention Deficit Hyperactivity Disorder: A Randomized Placebo-Controlled Trial in Children and Adolescents

    ERIC Educational Resources Information Center

    Johnson, Mats; Ostlund, Sven; Fransson, Gunnar; Kadesjo, Bjorn; Gillberg, Christopher

    2009-01-01

    Objective: The aim of the study was to assess omega 3/6 fatty acids (eye q) in attention deficit hyperactivity disorder (ADHD). Method: The study included a randomized, 3-month, omega 3/6 placebo-controlled, one-way crossover trial with 75 children and adolescents (8-18 years), followed by 3 months with omega 3/6 for all. Investigator-rated ADHD…

  8. The efficacy of systemic therapy for internalizing and other disorders of childhood and adolescence: a systematic review of 38 randomized trials.

    PubMed

    Retzlaff, Ruediger; von Sydow, Kirsten; Beher, Stefan; Haun, Markus W; Schweitzer, Jochen

    2013-12-01

    Systemic therapy (ST) is one of the most widely applied psychotherapeutic approaches in the treatment of children and adolescents, yet few systematic reviews exist on the efficacy of ST with this age group. Parallel to a similar study on adults, a systematic review was performed to analyze the efficacy of ST in the treatment of children and adolescents. All randomized or matched controlled trials (RCT) evaluating ST in any setting with child and adolescent index patients were identified by database searches and cross-references, as well as in existing meta-analyses and reviews. Inclusion criteria were: index patient diagnosed with a DSM-IV or ICD-10 listed psychological disorder, or suffering from other clinically relevant conditions, and trial published by December 2011. Studies were analyzed according to their sample, research methodology, interventions applied, and results at end-of-treatment and at follow-up. This article presents findings for internalizing and mixed disorders. Thirty-eight trials were identified, with 33 showing ST to be efficacious for the treatment of internalizing disorders (including mood disorders, eating disorders, and psychological factors in somatic illness). There is some evidence for ST being also efficacious in mixed disorders, anxiety disorders, Asperger disorder, and in cases of child neglect. Results were stable across follow-up periods of up to 5 years. Trials on the efficacy of ST for externalizing disorders are presented in a second article. There is a sound evidence base for the efficacy of ST as a treatment for internalizing disorders of child and adolescent patients. PMID:24329407

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

    PubMed Central

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

    2016-01-01

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

  10. Efficacy of an HIV/STI sexual risk-reduction intervention for African American adolescent girls in juvenile detention centers: a randomized controlled trial.

    PubMed

    DiClemente, Ralph J; Davis, Teaniese L; Swartzendruber, Andrea; Fasula, Amy M; Boyce, Lorin; Gelaude, Deborah; Gray, Simone C; Hardin, James; Rose, Eve; Carry, Monique; Sales, Jessica M; Brown, Jennifer L; Staples-Horne, Michelle

    2014-01-01

    Few HIV/STI interventions exist for African American adolescent girls in juvenile detention. The objective was to evaluate the efficacy of an intervention to reduce incident STIs, improve HIV-preventive behaviors, and enhance psychosocial outcomes. We conducted a randomized controlled trial among African American adolescent girls (13-17 years, N = 188) in juvenile detention from March 2011 to May 2012. Assessments occurred at baseline and 3- and 6-months post-randomization and included: audio computer-assisted self-interview, condom skills assessment, and self-collected vaginal swab to detect Chlamydia and gonorrhea. The Imara intervention included three individual-level sessions and four phone sessions; expedited partner therapy was offered to STI-positive adolescents. The comparison group received the usual care provided by the detention center: STI testing, treatment, and counseling. At the 6-month assessment (3-months post-intervention), Imara participants reported higher condom use self-efficacy (p < 0.001), HIV/STI knowledge (p < 0.001), and condom use skills (p < 0.001) compared to control participants. No significant differences were observed between trial conditions in incident Chlamydia or gonorrhea infections, condom use, or number of vaginal sex partners. Imara for detained African American adolescent girls can improve condom use skills and psychosocial outcomes; however, a critical need for interventions to reduce sexual risk remains. PMID:25190056

  11. 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

  12. Escitalopram in the Treatment of Adolescent Depression: A Randomized, Double-Blind, Placebo-Controlled Extension Trial

    PubMed Central

    Robb, Adelaide; Bose, Anjana

    2013-01-01

    Abstract Objective The purpose of this study was to evaluate the extended efficacy, safety, and tolerability of escitalopram relative to placebo in adolescents with major depressive disorder (MDD). Methods Adolescents (12–17 years) who completed an 8-week randomized, double-blind, flexible-dose, placebo-controlled, lead-in study of escitalopram 10–20 mg versus placebo could enroll in a 16–24-week, multisite extension trial; patients maintained the same lead-in randomization (escitalopram or placebo) and dosage (escitalopram 10 or 20 mg/day, or placebo) during the extension. The primary efficacy was Children's Depression Rating Scale-Revised (CDRS-R) change from the lead-in study baseline to treatment week 24 (8-week lead-in study plus 16-week extension); the secondary efficacy was Clinical Global Impressions-Improvement (CGI-I) score at week 24. All efficacy analyses used the last observation carried forward (LOCF) approach; sensitivity analyses used observed cases (OC) and mixed-effects model for repeated measures (MMRM). Safety was evaluated via adverse event (AE) reports and the clinician-rated Columbia-Suicide Severity Rating Scale (C-SSRS). Results Following lead-in, 165 patients enrolled in the double-blind extension (82 placebo; 83 escitalopram); 40 (48.8%) placebo and 37 (44.6%) escitalopram patients completed treatment. CDRS-R total score improvement was significantly greater for escitalopram than for placebo (p=0.005, LOCF; p=0.014; MMRM). Response rates (CDRS-R ≥40% reduction from baseline [adjusted and unadjusted] and CGI-I ≤2) were significantly higher for escitalopram than for placebo (LOCF); remission rates (CDRS-R ≤28) were 50.6% for escitalopram and 35.7% for placebo (p=0.002). OC analyses were not significantly different between groups. The most frequent escitalopram AEs (≥5% and more frequent than placebo) were headache, nausea, insomnia, vomiting, influenza-like symptoms, diarrhea, and urinary tract infection. Most AEs were

  13. 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. PMID:26208409

  14. Practice brief: adolescents and HIV clinical trials: ethics, culture, and context.

    PubMed

    MacQueen, Kathleen M; Karim, Quarraisha Abdool

    2007-01-01

    One quarter of HIV infections globally occur among young people 15 to 24 years of age, and more than half of all new infections are in people younger than 25 years. Clearly, there is a need to identify and implement effective HIV prevention strategies among at-risk teens. Some of the most effective options for slowing the epidemic are biomedical, and several promising methods are in development, including microbicides, vaccines, and preexposure prophylaxis (PREP, or the daily use of antiretrovirals to prevent the acquisition of HIV). There is widespread reluctance to enroll minors in such biomedical prevention trials because of concerns about vulnerability related to physical maturity, experiential maturity, and diminished autonomy as well as legal and social challenges that vary across and within nations. However, excluding minors from trials misses an important opportunity to evaluate the effectiveness, acceptability, and safety of innovative interventions under the best conditions for identifying and resolving potential problems. The challenges of including minors in HIV prevention trials are highlighted through the example of one rural South African community that has been particularly devastated by the HIV epidemic. PMID:17403499

  15. 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

  16. Nocebo Effect in Randomized Clinical Trials of Antidepressants in Children and Adolescents: Systematic Review and Meta-Analysis

    PubMed Central

    Rojas-Mirquez, Johanna Carolina; Rodriguez-Zuñiga, Milton Jose Max; Bonilla-Escobar, Francisco Javier; Garcia-Perdomo, Herney Andres; Petkov, Mike; Becerra, Lino; Borsook, David; Linnman, Clas

    2014-01-01

    Objective: To compare the incidence of adverse events between active and placebo arms of randomized clinical trials in depressive children and adolescents (C&A) with antidepressant treatments, in order to look for similarities in both groups that allow to establish a possible nocebo effect. Methods: Systematic search strategy (January 1974–March 2013) in electronic databases, conference abstracts, and reference list of systematic reviews and included studies to identify parallel randomized placebo-controlled trials of antidepressants in C&A (<19 years) with major depressive disorder, and one or more interventions of any orally administered antidepressant. The pooled adverse events were calculated based on a fixed-effect model and statistical analysis involved the risk ratio (RR) of adverse events, with 95% confidence intervals (95% CI). Results: Sixteen studies were included in the review, of which seven studies with a sample of 1911 patients had data to include in the meta-analysis. There was similar risk for the incidence of adverse events between non-active and active group (global RR 1.04, 95% CI: 0.97–1.11). Conclusion: Depressive C&A allocated to placebo or active group had similar risk to develop adverse events. These similarities in both groups are attributed to the nocebo effect. It is of note that defining “nocebo” effects is challenging in clinical populations because adverse effects may be attributed to the intervention or may be manifestation of the disease itself. The inclusion of a no-treatment arm may be warranted. Nocebo effects are likely when adverse events of placebo mimic the adverse events of active treatment, as was the case here. PMID:25404901

  17. Amplitude variability over trials in hemodynamic responses in adolescents with ADHD: The role of the anterior default mode network and the non-specific role of the striatum.

    PubMed

    Sørensen, L; Eichele, T; van Wageningen, H; Plessen, K J; Stevens, M C

    2016-01-01

    It has been suggested that intra-individual variability (IIV) in performance on attention and other cognitive tasks might be a cognitive endophenotype in individuals with ADHD. Despite robust IIV findings in behavioral data, only sparse data exist on how what type of brain dysfunction underlies variable response times. In this study, we asked whether ADHD IIV in reaction time on a commonly-used test of attention might be related to variation in hemodynamic responses (HRs) observed trial-to-trial. Based on previous studies linking IIV to regions within the "default mode" network (DMN), we predicted that adolescents with ADHD would have higher HR variability in the DMN compared with controls, and this in turn would be related to behavioral IIV. We also explored the influence of social anxiety on HR variability in ADHD as means to test whether higher arousal associated with high trait anxiety would affect the neural abnormalities. We assessed single-trial variability of HRs, estimated from fMRI event-related responses elicited during an auditory oddball paradigm in adolescents with ADHD and healthy controls (11-18 years old; N = 46). Adolescents with ADHD had higher HR variability compared with controls in anterior regions of the DMN. This effect was specific to ADHD and not associated with traits of age, IQ and anxiety. However, an ADHD effect of higher HR variability also appeared in a basal ganglia network, but for these brain regions the relationships of HR variability and social anxiety levels were more complex. Performance IIV correlated significantly with variability of HRs in both networks. These results suggest that assessment of trial-to-trial HR variability in ADHD provides information beyond that detectable through analysis of behavioral data and average brain activation levels, revealing specific neural correlates of a possible ADHD IIV endophenotype. PMID:27622136

  18. 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

  19. Interdisciplinary therapy changes superoxide dismutase activity and adiponectin in obese adolescents: a randomised controlled trial.

    PubMed

    Nunes, João Elias Dias; Cunha, Heitor Santos; Freitas, Zulmária Rezende; Nogueira, Ana Maria Caixeta; Dâmaso, Ana Raimunda; Espindola, Foued Salmen; Cheik, Nadia Carla

    2016-05-01

    The objective of this study is to evaluate the effect of interdisciplinary therapy in the parameters of the oxidative stress and the anti-inflammatory responses of obese adolescents. We selected 57 participants, who were randomly divided into 2 groups: interdisciplinary therapy group and a control group. After 6 months of intervention, 17 participants of the interdisciplinary therapy group and 8 of the control group returned for re-evaluation. The interdisciplinary therapy group participated in a treatment with 4 weekly sessions of exercise, a weekly group therapy session and a weekly nutritional education session. Blood parameters of oxidative stress and anti-inflammatory response were evaluated. The results demonstrated that there were significant increases in the interdisciplinary therapy group for superoxide dismutase activity (6.56 ± 3.22 to 11.40 ± 7.49) and ferric-reducing antioxidant potential concentration (532.91 ± 106.48 to 573.25 ± 112.57), although adiponectin levels did not reduce (40.9 ± 29.34 to 49.05 ± 41.22). A significant decrease in nitrite levels was also found (14.23 ± 8.48 to 11.45 ± 6.05). In the control group, significant reduction was found in adiponectin (31.56 ± 18.88 to 18.01 ± 11.66). This study suggests that interdisciplinary therapy for 6 months was effective in improving the anti-inflammatory responses and the antioxidant defences in obese adolescents. PMID:26367325

  20. A randomized trial of Assertive Continuing Care and Contingency Management for adolescents with substance use disorders

    PubMed Central

    Godley, Mark D.; Godley, Susan H.; Dennis, Michael L.; Funk, Rodney R.; Passetti, Lora L.; Petry, Nancy M.

    2014-01-01

    Objective Most adolescents relapse within 90 days of discharge from residential substance use treatment. We hypothesized that Contingency Management (CM), Assertive Continuing Care (ACC), and their combination (CM+ACC) would each be more effective than Usual Continuing Care (UCC). Method 337 adolescents were randomized to 4 continuing care conditions following residential treatment: UCC alone, CM, ACC, or CM+ACC. UCC was available across all conditions. Outcome measures over 12 months included percentage of days abstinent from alcohol, heavy alcohol, marijuana, and any alcohol or other drugs (AOD) using self-reports and toxicology testing and remission status at 12 months. Results CM had significantly higher rates of abstinence than UCC for heavy alcohol use (t(297)= 2.50, p<.01, d = 0.34), any alcohol use (t(297)= 2.58, p<.01, d = 0.36), any AOD use (t(297)= 2.12, p=.01, d = 0.41), and had a higher rate in remission (Odds Ratio [OR]=2.45 [90% CI: 1.18 to 5.08], p=.02). ACC had significantly higher rates of abstinence than UCC from heavy alcohol use (t(297)= 2.66, p<.01, d = 0.31), any alcohol use (t(297)= 2.63, p<.01, d = 0.30), any marijuana use (t(297)= 1.95, p=.02, d = 0.28), any AOD use (t(297)= 1.88, p=.02, d = 0.30), and had higher rates in remission (OR=2.31 [90% CI: 1.10 to 4.85], p=.03). The ACC+CM condition was not significantly different from UCC on any outcomes. Conclusions CM and ACC are promising continuing care approaches after residential treatment. Future research should seek to further improve their effectiveness. PMID:24294838

  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. PMID:25468310

  2. Supporting Adolescent Orphan Girls to Stay in School as HIV Risk Prevention: Evidence From a Randomized Controlled Trial in Zimbabwe

    PubMed Central

    Cho, Hyunsan; Rusakaniko, Simbarashe; Iritani, Bonita; Mapfumo, John; Halpern, Carolyn

    2011-01-01

    Objectives. Using a randomized controlled trial in rural eastern Zimbabwe, we tested whether comprehensive support to keep orphan adolescent girls in school could reduce HIV risk. Methods. All orphan girls in grade 6 in 25 primary schools were invited to participate in the study in fall 2007 (n = 329). Primary schools were randomized to condition. All primary schools received a universal daily feeding program; intervention participants received fees, uniforms, and a school-based helper to monitor attendance and resolve problems. We conducted annual surveys and collected additional information on school dropout, marriage, and pregnancy rates. We analyzed data using generalized estimating equations over 3 time points, controlling for school and age at baseline. Results. The intervention reduced school dropout by 82% and marriage by 63% after 2 years. Compared with control participants, the intervention group reported greater school bonding, better future expectations, more equitable gender attitudes, and more concerns about the consequences of sex. Conclusions. We found promising evidence that comprehensive school support may reduce HIV risk for orphan girls. Further study, including assessment of dose response, cost benefit, and HIV and herpes simplex virus 2 biomarker measurement, is warranted. PMID:21493943

  3. 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

  4. Cinnarizine versus Topiramate in Prophylaxis of Migraines among Children and Adolescents: A Randomized, Double-Blind Clinical Trial

    PubMed Central

    ASHRAFI, Mahmoud Reza; NAJAFI, Zeinab; SHAFIEI, Masih; HEIDARI, Kazem; TOGHA, Mansoureh

    2014-01-01

    Objective Migraines, a common health problem in children and adolescents, still do not have an FDA approved preventive treatment for patients under the age of 18 years. This study compares and contrasts the efficacy and safety of cinnarizine and topiramate in preventing pediatric migraines. Materials & Methods In this randomized, double-blind clinical trial 44 migrainous (from 4–15 years of age) were equally allocated to receive cinnarizine or topiramate. The primary efficacy measure was monthly migraine frequency. Secondary efficacy measures were monthly migraine intensity and ≥ 50% responder rate. Efficacy measures were recorded at the baseline and at 4, 8, and 12 weeks of treatment. Results During the double-blind phase of the study, monthly migraine frequency and intensity were significantly decreased in both the cinnarizine and topiramate groups when compared to the baseline. However, at the end of the study, the cinnarizine group exhibits a significant decrease from the baseline in the mean monthly migraine intensity when compared to the topiramate group (4.7 vs. 3, respectively; 95% CI = -0.8 to -3.2). Conclusion No significant difference between cinnarizine and topiramate was found for the prevention of pediatric migraines. Both treatments were well tolerated. PMID:25657766

  5. Calcium supplementation trials and bone mass development in children, adolescents, and young adults.

    PubMed

    Vatanparast, Hassanali; Whiting, Susan J

    2006-04-01

    The development of bone mass during childhood through young adulthood is an important determinant of bone health later in life, and calcium is the major building block. Most randomized, double-blind, placebo-controlled trials of calcium supplementation have been done in girls; however, calcium supplementation in boys has been investigated in recent studies. Positive short-term effects on bone measures during growth has been shown in boys and girls, particularly in weight-bearing appendicular bone, although the lifelong effect is not certain. PMID:16673756

  6. Building Resilience After School for Early Adolescents in Urban Poverty: Open Trial of Leaders @ Play.

    PubMed

    Frazier, Stacy L; Dinizulu, Sonya Mathies; Rusch, Dana; Boustani, Maya M; Mehta, Tara G; Reitz, Kristin

    2015-11-01

    Leaders @ Play is a park after-school program for urban middle school youth designed to leverage recreational activities for social emotional learning. Mental health and park staff co-facilitated sports and games to teach and practice problem solving, emotion regulation, and effective communication. Additional practice occurred during multi-family groups and summer internships as junior camp counselors. We examined feasibility and promise via an open trial (n = 3 parks, 46 youth, 100 % African American, 100 % low-income, 59 % female, M = 13.09 years old). Improvements in social skills and reductions in problem behaviors lend support to after school programs as a space for mental health promotion. PMID:25425012

  7. Effectiveness of a drinking-motive-tailored emergency-room intervention among adolescents admitted to hospital due to acute alcohol intoxication - A randomized controlled trial.

    PubMed

    Wurdak, Mara; Wolstein, Jörg; Kuntsche, Emmanuel

    2016-06-01

    The aim of this study is to develop and test the effectiveness of a drinking-motive-tailored intervention for adolescents hospitalized due to alcohol intoxication in eight cities in Germany between December 2011 and May 2012 against a similar, non-motive-tailored intervention. In a randomized controlled trial, 254 adolescents received a psychosocial intervention plus motive-tailored (intervention group; IG) or general exercises (control group; CG). Adolescents in the IG received exercises in accordance with their drinking motives as indicated at baseline (e.g. alternative ways of spending leisure time or dealing with stress). Exercises for the CG contained alcohol-related information in general (e.g. legal issues). The data of 81 adolescents (age: M = 15.6, SD = 1.0; 42.0% female) who participated in both the baseline and the follow-up were compared using ANOVA with repeated measurements and effect sizes (available case analyses). Adolescents reported lower alcohol use at the four-week follow-up independently of the kind of intervention. Significant interaction effects between time and IG were found for girls in terms of drinking frequency (F = 7.770, p < 0.01) and binge drinking (F = 7.0005, p < 0.05) but not for boys. For the former, the proportional reductions and corresponding effect sizes of drinking frequency (d = - 1.18), binge drinking (d = - 1.61) and drunkenness (d = - 2.87) were much higher than the .8 threshold for large effects. Conducting psychosocial interventions in a motive-tailored way appears more effective for girls admitted to hospital due to alcohol intoxication than without motive-tailoring. Further research is required to address the specific needs of boys in such interventions. (German Clinical Trials Register, DRKS ID: DRKS00005588). PMID:26844193

  8. 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. PMID:22584456

  9. 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

  10. A retrospective open trial of adjunctive donepezil in children and adolescents with autistic disorder.

    PubMed

    Hardan, Antonio Y; Handen, Benjamin L

    2002-01-01

    In light of the recently reported neuropathologic and neurochemical abnormalities of the cholinergic pathways in autism, donepezil, a cholinesterase inhibitor, is a potentially useful agent in the treatment of cognitive and behavioral symptoms observed in this disorder. A retrospective pilot study was conducted to determine whether donepezil is effective in the treatment of children and adolescents with autism. Eight patients (mean age = 11.0 +/- 4.1 years; range 7-19 years) who met Diagnostic and Statistical Manual of Mental Disorders (4th edition) criteria for autistic disorder were openly treated with donepezil. All patients were on concomitant psychoactive medications. Four of these patients (50%) demonstrated significant improvement as assessed by the Aberrant Behavior Checklist and the Clinical Global Impression Scale. Decreases in the Irritability and Hyperactivity subscales were observed, but no changes in the Inappropriate Speech, Lethargy, and Stereotypies subscales were noted. Limited and transient side effects were reported, with one patient experiencing gastrointestinal disturbances and another reporting mild irritability. Double-blind, placebo-controlled investigations are needed to provide further evidence of the potential benefits of donepezil to patients with autistic disorder. PMID:12427297

  11. 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

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

    PubMed

    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. OBESITY AND DYSLIPIDEMIA IN BEHAVIORALLY HIV-INFECTED YOUNG WOMEN: ADOLESCENT TRIALS NETWORK (ATN) STUDY 021

    PubMed Central

    Mulligan, Kathleen; Harris, D. Robert; Monte, Dina; Stoszek, Sonia; Emmanuel, Patricia; Hardin, Dana S.; Kapogiannis, Bill G.; Worrell, Carol; Meyer, William A.; Sleasman, John; Wilson, Craig M.

    2009-01-01

    Background The goal of this study was to determine the nature and prevalence of abnormalities in lipids, glucose metabolism, and body composition in behaviorally HIV-infected young women and their relationship to different classes of antiretroviral therapy (ART) regimens. Methods We conducted a cross-sectional multicenter study in behaviorally infected women ages 12-24 years (HIVpos; N=173) and seronegative controls (HIVneg; N=61). HIVpos women were categorized as ART-naïve (N=85), on a non-nucleoside reverse transcriptase inhibitor-containing regimen (NNRTI; N=33), on a protease inhibitor-containing regimen (PI; N=36), or on a non-NNRTI/non-PI containing regimen (N=19). Measurements included fasting lipids; glucose and insulin before and 2 hours after an oral glucose challenge; high-sensitivity C-reactive protein (hsCRP); anthropometry; fat distribution (dual energy X-ray absorptiometry); and ART and medical histories. Race-adjusted results were compared across groups and within HIVpos groups. Results The median age was 20 (range 14-24) years. 77% of HIVpos were African American, 35% smoked cigarettes, and 32% reported exercising regularly. More than 40% had a BMI ≥25 kg/m2. Triglycerides; total, HDL, and non-HDL cholesterol; and hsCRP differed significantly among groups, with higher levels most common among those on ART. Indices of glucose metabolism did not differ among groups. In general, cholesterol, hsCRP, and indices of glucose metabolism worsened as BMI increased. Conclusions Obesity, dyslipidemia, and inflammation were prominent in HIV-infected adolescent women and, coupled with other risk factors, may accelerate the lifetime risk of cardiovascular disease and other adverse events. These results underscore the need for a multifaceted approach to addressing risk reduction in this population. PMID:19947855

  14. 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

  15. Enhancing adolescent self-efficacy and collective efficacy through public engagement around HIV/AIDS competence: a multilevel, cluster randomized-controlled trial.

    PubMed

    Carlson, Mary; Brennan, Robert T; Earls, Felton

    2012-09-01

    The potential capacity of children to confront the HIV/AIDS pandemic is rarely considered. Interventions to address the impact of the pandemic on children and adolescents commonly target only their vulnerabilities. We evaluated the Young Citizens Program, an adolescent-centered health promotion curriculum designed to increase self- and collective efficacy through public education and community mobilization across a municipality in the Kilimanjaro Region of Tanzania. The theoretical framework for the program integrates aspects of human capability, communicative action, social ecology and social cognition. The design consists of a cluster randomized-controlled trial (CRCT). Fifteen pairs of matched geopolitically defined neighborhoods of roughly 2000-4000 residents were randomly allocated to treatment and control arms. Within each neighborhood cluster, 24 randomly selected adolescents, ages 9-14, deliberated on topics of social ecology, citizenship, community health and HIV/AIDS competence. Building on their acquired understanding and confidence, they dramatized the scientific basis and social context of HIV infection, testing and treatment in their communities over a 28-week period. The curriculum comprised 5 modules: Group Formation, Understanding our Community, Health and our Community, Making Assessments and Taking Action in our Community and Inter-Acting in our Community. Adolescent participants and adult residents representative of their neighborhoods were surveyed before and after the intervention; data were analyzed using multilevel modeling. In treatment neighborhoods, adolescents increased their deliberative and communicative efficacy and adults showed higher collective efficacy for children. Following the CRCT assessments, the control group received the same curriculum. In the Kilimanjaro Region, the Young Citizens Program is becoming recognized as a structural, health promotion approach through which adolescent self-efficacy and child collective efficacy

  16. A Qualitative Study of Phase III Cancer Clinical Trial Enrollment Decision-Making: Perspectives from Adolescents, Young Adults, Caregivers, and Providers

    PubMed Central

    Schwartz, Lisa A.; Reilly, Anne; Deatrick, Janet A.; Balis, Frank

    2014-01-01

    Purpose: The mortality reduction rate for adolescents and young adults (AYAs) with cancer has not demonstrated the same rate of improvement as for children, due partly to insufficient phase III cancer clinical trial enrollment. This study describes three key components of phase III cancer clinical trial enrollment—family decision-making patterns, factors that influence AYAs' involvement, and attitudes (perceived barriers and benefits) toward trial participation—and evaluated a measure of attitudes. Methods: Participants were AYAs (15–23 years old at study) diagnosed with cancer and offered a phase III cancer clinical trial within the past 3–21 months, their primary caregivers, and their healthcare providers. Interviews assessed: (a) phase III clinical trial decision-making experiences and (b) relevance of the Pediatric Research Participation Questionnaire (PRPQ) in the assessment of AYAs' attitudes toward enrollment on phase III cancer clinical trials. Results: Thirteen AYAs, 16 caregivers, and 11 providers were interviewed. Four decision-making patterns were identified, with AYA abdicates to caregiver and caregiver-based and AYA-endorsed the most commonly described, but with variation across respondents. Distress and reduced health-related quality of life limited AYAs' involvement in the enrollment decision, while developmental and emotional maturity facilitated involvement. Perceived barriers and benefits to enrollment were reported, and the PRPQ was deemed relevant with minor modifications. Conclusions: Findings suggest that AYAs may not be fully involved in phase III cancer clinical trial enrollment decision-making, and caregivers and providers are challenged to overcome factors that limit their involvement. The PRPQ shows promise as a tool for systematically evaluating clinical trial attitudes. PMID:24669354

  17. A Qualitative Study of Phase III Cancer Clinical Trial Enrollment Decision-Making: Perspectives from Adolescents, Young Adults, Caregivers, and Providers.

    PubMed

    Barakat, Lamia P; Schwartz, Lisa A; Reilly, Anne; Deatrick, Janet A; Balis, Frank

    2014-03-01

    Purpose: The mortality reduction rate for adolescents and young adults (AYAs) with cancer has not demonstrated the same rate of improvement as for children, due partly to insufficient phase III cancer clinical trial enrollment. This study describes three key components of phase III cancer clinical trial enrollment-family decision-making patterns, factors that influence AYAs' involvement, and attitudes (perceived barriers and benefits) toward trial participation-and evaluated a measure of attitudes. Methods: Participants were AYAs (15-23 years old at study) diagnosed with cancer and offered a phase III cancer clinical trial within the past 3-21 months, their primary caregivers, and their healthcare providers. Interviews assessed: (a) phase III clinical trial decision-making experiences and (b) relevance of the Pediatric Research Participation Questionnaire (PRPQ) in the assessment of AYAs' attitudes toward enrollment on phase III cancer clinical trials. Results: Thirteen AYAs, 16 caregivers, and 11 providers were interviewed. Four decision-making patterns were identified, with AYA abdicates to caregiver and caregiver-based and AYA-endorsed the most commonly described, but with variation across respondents. Distress and reduced health-related quality of life limited AYAs' involvement in the enrollment decision, while developmental and emotional maturity facilitated involvement. Perceived barriers and benefits to enrollment were reported, and the PRPQ was deemed relevant with minor modifications. Conclusions: Findings suggest that AYAs may not be fully involved in phase III cancer clinical trial enrollment decision-making, and caregivers and providers are challenged to overcome factors that limit their involvement. The PRPQ shows promise as a tool for systematically evaluating clinical trial attitudes. PMID:24669354

  18. Prospective open-label pilot trial of mirtazapine in children and adolescents with social phobia.

    PubMed

    Mrakotsky, Christine; Masek, Bruce; Biederman, Joseph; Raches, Darcy; Hsin, Olivia; Forbes, Peter; de Moor, Carl; DeMaso, David Ray; Gonzalez-Heydrich, Joseph

    2008-01-01

    Mirtazapine is indicated for major depression and used for anxiety in adults; however, little is known about its application in pediatric populations. This is an 8-week open-label pilot study of mirtazapine in children with social phobia age 8-17 years. Primary outcomes were symptom improvement based on clinician rating and self-report, as well as tolerability based on rates of discontinuation due to adverse effects. Fifty-six percent (10/18) responded to treatment, 17% (3/18) achieved full remission. Social phobia symptoms improved significantly during the first 2 weeks of treatment, as did comorbid symptoms of depression and anxiety. Eleven patients (61%) did not complete all 8 weeks of treatment; four patients (22%) discontinued due to adverse effects including fatigue and irritability. The others discontinued due to study burden (28%), insufficient response (6%), or to pursue herbal treatment (6%). Significant weight gain was observed. Larger controlled trials are needed to further evaluate efficacy and safety. PMID:17419001

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

    PubMed Central

    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

    2015-01-01

    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 containing Grades 6 through 9. Australian children using Consider This reported reduced 30-day smoking prevalence. This reduction was mediated by decreased subjective norms. The amount of program exposure was low in many classes, but program use displayed a dose-response relationship with reduced smoking prevalence. American children only reported lower expectations for smoking in the future. Intervening to prevent smoking is a challenge, and this data suggest small benefits from an Internet-based program that are unlikely to be of practical significance unless increased by improved implementation. Implementation remains the major challenge to delivering interventions via the Internet, both for health educators and researchers. PMID:17114331

  20. Concordance Between Self-Report and Urine Drug Screen Data in Adolescent Opioid Dependent Clinical Trial Participants

    PubMed Central

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

    2013-01-01

    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 12 weeks 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. PMID:23811060

  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. PMID:23811060

  2. 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

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

    PubMed

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

    2015-01-01

    Autism spectrum disorders are difficult for older adolescents and young adults as impaired social communication affects the transition to adult life. d-Cycloserine, a partial glycine agonist at the N-methyl-d-aspartic acid receptor, was tested in a double-blind randomized trial in 20 older adolescents and young adults with autism spectrum disorders using two dosing strategies (50 mg daily versus 50 mg weekly) for 8 weeks with a 2-week follow-up after discontinuation. d-Cycloserine caused statistically and clinically significant improvement with no differentiation between dosing strategies on the Social Responsiveness Scale and the Aberrant Behavior Checklist before and after d-cycloserine administration. PMID:25923852

  4. Interprofessional attitudes and perceptions: Results from a longitudinal controlled trial of pre-registration health and social care students in Scotland.

    PubMed

    McFadyen, A K; Webster, V S; Maclaren, W M; O'neill, M A

    2010-09-01

    This study made use of a controlled longitudinal design to assess the impact on pre-registration health and social care students of an interprofessional intervention on the attitudes to and perceptions of interprofessional ideals. Evaluation, over four years, of Nursing, Occupational Therapy, Podiatry, Prosthetics and Orthotics, Physiotherapy and Radiography students was performed using the adapted versions of the Readiness for Interprofessional Learning Scale (RIPLS) and the Interdisciplinary Education Perception Scale (IEPS). Baseline samples of the control and experimental groups were 260 and 313 respectively. Support for Interprofessional Education (IPE) appears high but possibly idealistically so initially. Restricted Maximum Likelihood (REML) models were used to assess intervention effects as well as any possible profession or time effects. The intervention was found to have had a significant effect on five of the measured sub-scales and the professions were found to react in a significantly different way on four of the sub-scales. The inclusion of a control group has confirmed previous findings from other studies but also highlights the possible effects of the general learning and teaching methodologies employed within various professions as well as the need for research into the influence of the timing, duration, style and content of clinical placement periods. PMID:20218778

  5. 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

  6. Pain and pressure pain thresholds in adolescents with chronic fatigue syndrome and healthy controls: a cross-sectional study

    PubMed Central

    Winger, Anette; Kvarstein, Gunnvald; Wyller, Vegard Bruun; Sulheim, Dag; Fagermoen, Even; Småstuen, Milada Cvancarova; Helseth, Sølvi

    2014-01-01

    Objectives Although pain is a significant symptom in chronic fatigue syndrome (CFS), pain is poorly understood in adolescents with CFS. The aim of this study was to explore pain distribution and prevalence, pain intensity and its functional interference in everyday life, as well as pressure pain thresholds (PPT) in adolescents with CFS and compare this with a control group of healthy adolescents (HC). Methods This is a case–control, cross-sectional study on pain including 120 adolescents with CFS and 39 HCs, aged 12–18 years. We measured pain frequency, pain severity and pain interference using self-reporting questionnaires. PPT was measured using pressure algometry. Data were collected from March 2010 until October 2012 as part of the Norwegian Study of Chronic Fatigue Syndrome in Adolescents: Pathophysiology and Intervention Trial. Results Adolescents with CFS had significantly lower PPTs compared with HCs (p<0.001). The Pain Severity Score and the Pain Interference Score were significantly higher in adolescents with CFS compared with HCs (p<0.001). Almost all adolescents with CFS experienced headache, abdominal pain and/or pain in muscles and joints. Moreover, in all sites, the pain intensity levels were significantly higher than in HCs (p<0.001). Conclusions We found a higher prevalence of severe pain among adolescents with CFS and lowered pain thresholds compared with HCs. The mechanisms, however, are still obscure. Large longitudinal population surveys are warranted measuring pain thresholds prior to the onset of CFS. Trial registration number Clinical Trials, NCT01040429; The Norwegian Study of Chronic Fatigue Syndrome in Adolescents: Pathophysiology and Intervention Trial (NorCAPITAL) http://www.clinicaltrials.gov. PMID:25287104

  7. 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…

  8. 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…

  9. 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…

  10. 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…

  11. The Reinforcing Therapist Performance (RTP) experiment: Study protocol for a cluster randomized trial

    PubMed Central

    2010-01-01

    Background Rewarding provider performance has been recommended by the Institute of Medicine as an approach to improve the quality of treatment, yet little empirical research currently exists that has examined the effectiveness and cost-effectiveness of such approaches. The aim of this study is to test the effectiveness and cost-effectiveness of providing monetary incentives directly to therapists as a method to improve substance abuse treatment service delivery and subsequent client treatment outcomes. Design Using a cluster randomized design, substance abuse treatment therapists from across 29 sites were assigned by site to either an implementation as usual (IAU) or pay-for-performance (P4P) condition. Participants Substance abuse treatment therapists participating in a large dissemination and implementation initiative funded by the Center for Substance Abuse Treatment. Intervention Therapists in both conditions received comprehensive training and ongoing monitoring, coaching, and feedback. However, those in the P4P condition also were given the opportunity to earn monetary incentives for achieving two sets of measurable behaviors related to quality implementation of the treatment. Outcomes Effectiveness outcomes will focus on the impact of the monetary incentives to increase the proportion of adolescents who receive a targeted threshold level of treatment, months that therapists demonstrate monthly competency, and adolescents who are in recovery following treatment. Similarly, cost-effectiveness outcomes will focus on cost per adolescent receiving targeted threshold level of treatment, cost per month of demonstrated competence, and cost per adolescent in recovery. Trial Registration Trial Registration Number: NCT01016704 PMID:20205824

  12. Development of an exercise intervention to improve cognition in people with mild to moderate dementia: Dementia And Physical Activity (DAPA) Trial, registration ISRCTN32612072.

    PubMed

    Brown, Deborah; Spanjers, Katie; Atherton, Nicky; Lowe, Janet; Stonehewer, Louisa; Bridle, Chris; Sheehan, Bart; Lamb, Sarah E

    2015-06-01

    More than 800000 people in the UK have dementia, and it is a government priority to improve dementia care. Drug treatment options are relatively limited. The Dementia And Physical Activity (DAPA) study is a randomised trial which targets cognition in people with dementia, using an exercise programme. There is evidence to suggest that both aerobic and resistance exercise may be useful in improving cognition. Hence the intervention comprises a supervised part of twice-weekly exercise classes of one hour duration for 4 months, including aerobic exercise at moderate intensity on static bicycles, and resistance (weight training) exercise using weight vests, weight belts and dumbbells. Thereafter participants progress to unsupervised, independent exercise. Aids to behaviour modification have been incorporated into the intervention. The DAPA intervention has been designed to maximise likelihood of effectiveness and cost-effectiveness, and for delivery in the UK National Health Service. PMID:25724322

  13. Clinical Trial Participation and Time to Treatment Among Adolescents and Young Adults With Cancer: Does Age at Diagnosis or Insurance Make a Difference?

    PubMed Central

    Parsons, Helen M.; Harlan, Linda C.; Seibel, Nita L.; Stevens, Jennifer L.; Keegan, Theresa H.M.

    2011-01-01

    Purpose Because adolescent and young adult (AYA) patients with cancer have experienced variable improvement in survival over the past two decades, enhancing the quality and timeliness of cancer care in this population has emerged as a priority area. To identify current trends in AYA care, we examined patterns of clinical trial participation, time to treatment, and provider characteristics in a population-based sample of AYA patients with cancer. Methods Using the National Cancer Institute Patterns of Care Study, we used multivariate logistic regression to evaluate demographic and provider characteristics associated with clinical trial enrollment and time to treatment among 1,358 AYA patients with cancer (age 15 to 39 years) identified through the Surveillance, Epidemiology, and End Results Program. Results In our study, 14% of patients age 15 to 39 years had enrolled onto a clinical trial; participation varied by type of cancer, with the highest participation in those diagnosed with acute lymphoblastic leukemia (37%) and sarcoma (32%). Multivariate analyses demonstrated that uninsured, older patients and those treated by nonpediatric oncologists were less likely to enroll onto clinical trials. Median time from pathologic confirmation to first treatment was 3 days, but this varied by race/ethnicity and cancer site. In multivariate analyses, advanced cancer stage and outpatient treatment alone were associated with longer time from pathologic confirmation to treatment. Conclusion Our study identified factors associated with low clinical trial participation in AYA patients with cancer. These findings support the continued need to improve access to clinical trials and innovative treatments for this population, which may ultimately translate into improved survival. PMID:21931022

  14. A Randomized Controlled Trial of Personalized Text Message Reminders to Promote Medication Adherence Among HIV-Positive Adolescents and Young Adults.

    PubMed

    Garofalo, Robert; Kuhns, Lisa M; Hotton, Anna; Johnson, Amy; Muldoon, Abigail; Rice, Dion

    2016-05-01

    HIV-positive adolescents and young adults often experience suboptimal medication adherence, yet few interventions to improve adherence in this group have shown evidence of efficacy. We conducted a randomized trial of a two-way, personalized daily text messaging intervention to improve adherence to antiretroviral therapy (ART) among N = 105 poorly adherent HIV-positive adolescents and young adults, ages 16-29. Adherence to ART was assessed via self-reported visual analogue scale (VAS; 0-100 %) at 3 and 6-months for mean adherence level and proportion ≥90 % adherent. The average effect estimate over the 6-month intervention period was significant for ≥90 % adherence (OR = 2.12, 95 % CI 1.01-4.45, p < .05) and maintained at 12-months (6 months post-intervention). Satisfaction scores for the intervention were very high. These results suggest both feasibility and initial efficacy of this approach. Given study limitations, additional testing of this intervention as part of a larger clinical trial with objective and/or clinical outcome measures of adherence is warranted. PMID:26362167

  15. 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

  16. Comparative efficacy, acceptability, and tolerability of dexmethylphenidate versus placebo in child and adolescent ADHD: a meta-analysis of randomized controlled trials

    PubMed Central

    Maneeton, Narong; Maneeton, Benchalak; Woottiluk, Pakapan; Suttajit, Sirijit; Likhitsathian, Surinporn; Charnsil, Chawanun; Srisurapanont, Manit

    2015-01-01

    Background The efficacy of dexmethylphenidate (d-MPH) has been proven in the treatment of children and adolescents with attention-deficit hyperactivity disorder (ADHD). Objective The aim of this systematic review is to determine the efficacy, acceptability, and tolerability of d-MPH in child and adolescent ADHD. Methods The searches of SCOPUS, MEDLINE, CINAHL, and Cochrane Controlled Trials Register were performed in February 2015. All randomized controlled trials of d-MPH versus placebo that were performed in children and adolescents with ADHD up to 18 years of age were included in the study. The efficacy was measured by using the pooled mean-endpoint or mean-changed scores of ADHD rating scales and the response rate. Acceptability and tolerability were measured by using the pooled rates of overall discontinuation and discontinuation due to adverse events, respectively. Results A total of 1,124 children and adolescents diagnosed as having ADHD were included in this review. In a laboratory school setting, the pooled mean-change and mean-endpoint scores in the d-MPH-treated group were significantly greater than those of the placebo-treated group with standardized mean difference (95% confidence interval [CI]) of −1.20 (−1.73, −0.67), I2=95%. Additionally, the pooled mean-changed scores of the ADHD rating scales for teachers and parents in the d-MPH-treated group were significantly greater than that of the placebo-treated group with weighted mean difference (95% CI) of −13.01 (−15.97, −10.05), I2=0% and (95% CI) of −12.99 (−15.57, −10.42), I2=0%, respectively. The pooled response rate in the d-MPH-treated groups had a significance higher than that of the placebo-treated group. The rates of pooled overall discontinuation and discontinuation due to adverse events between the two groups were not significantly different. Conclusion Based on the findings in this review, it can be concluded that d-MPH medication is efficacious and tolerable in child and

  17. 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.

  18. A Family Focused Randomized Controlled Trial to Prevent Adolescent Alcohol and Tobacco Use: The Moderating Roles of Positive Parenting and Adolescent Gender

    ERIC Educational Resources Information Center

    Jones, Deborah J.; Olson, Ardis L.; Forehand, Rex; Gaffney, Cecelia A.; Zens, Michael S.; Bau, J. J.

    2005-01-01

    Four years of longitudinal data from 2,153 families with a 5th- or 6th-grade preadolescent participating in a family-focused pediatric primary-care-based prevention program were used to examine whether prevention effects were moderated by positive parenting and/or adolescent gender. Alcohol and tobacco use, internalizing problems, and…

  19. 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

  20. The Impact of a Low Glycemic Index Diet on Inflammatory Markers and Serum Adiponectin Concentration in Adolescent Overweight and Obese Girls: A Randomized Clinical Trial.

    PubMed

    Rouhani, M H; Kelishadi, R; Hashemipour, M; Esmaillzadeh, A; Surkan, P J; Keshavarz, A; Azadbakht, L

    2016-04-01

    Although the effects of dietary glycemic index (GI) on insulin resistance are well documented in adults, the complex interaction among glucose intolerance, inflammatory markers, and adipokine concentration has not been well studied, especially among adolescents. We investigated the effect of a low glycemic index (LGI) diet on insulin concentration, fasting blood sugar (FBS), inflammatory markers, and serum adiponectin concentration among healthy obese/overweight adolescent females. In this parallel randomized clinical trial, 2 different diets, an LGI diet and a healthy nutritional recommendation diet (HNRD) with similar macronutrient composition were prescribed to 50 obese and overweight adolescent girls with the same pubertal status. Biochemical markers FBS, serum insulin concentration, high sensitivity C-reactive protein (hs-CRP), interleukin 6 (IL-6), and adiponectin were measured before and after a 10 week intervention. Using an intention-to-treat analysis, data from 50 subjects were analyzed. According to a dietary assessment, GI in the LGI group was 43.22±0.54. While the mean for FBS, serum insulin concentration, the homeostasis model assessment (HOMA), the quantitative insulin sensitivity check index (QUICKI), and adiponectin concentration did not differ significantly within each group, the average hs-CRP and IL-6 decreased significantly in the LGI diet group after the 10 week intervention (p=0.009 and p=0.001; respectively). Comparing percent changes, we found a marginally significant decrease in hs-CRP in the LGI group compared with the HNRD group after adjusting for confounders. Compliance with an LGI diet may have favorable effect on inflammation among overweight and obese adolescent girls. PMID:27065462

  1. An Independent Randomized Clinical Trial of Multisystemic Therapy with Non-Court-Referred Adolescents with Serious Conduct Problems

    PubMed Central

    Weiss, Bahr; Han, Susan; Harris, Vicki; Catron, Tom; Ngo, Victoria K.; Caron, Annalise; Gallop, Robert; Guth, Carol

    2013-01-01

    Objective Adolescent conduct problems exact serious social as well as personal costs, and effective treatments are essential. One of the most widely disseminated and effective programs for the treatment of serious conduct problems in adolescents is Multisystemic Therapy (MST). However, most evaluations of MST have involved the developers of MST. The purpose of the present study was to conduct an independent evaluation of MST, with non-court-referred adolescents with conduct problems. Method Participants were 164 adolescents aged 11 to 18 years who were recruited from self-contained behavior intervention classrooms in public schools. Adolescents and their families were randomly assigned to receive MST or services as usual. Outcome measures assessed conduct problems, school functioning, and court records of criminal behavior. Participants were followed for 18 months after baseline using parent, adolescent, and teacher reports; arrest data were collected for 2.5 years post-baseline. Results Two of four primary outcome measures focused on externalizing problems showed significant treatment effects favoring MST. Several secondary and intervention targets pertaining to family functioning and parent psychopathology showed positive effects of MST, and no negative effects were identified. Conclusions Results provide some further support for the effectiveness of MST, although smaller effect sizes than previous studies also suggest the complexity of successful dissemination, particularly to non-court-referred populations. PMID:23937347

  2. Evaluation of Mail Registration.

    ERIC Educational Resources Information Center

    San Diego Community Coll. District, CA. Research and Planning.

    The San Diego Community College District (SDCCD) implemented mail registration for all continuing students in spring 1986. In fall 1986, a comprehensive evaluation of the registration system was conducted to assess the impact of mail registration on student enrollment, to determine the impact of mailing class schedules to students' homes, to…

  3. 37 CFR 2.133 - Amendment of application or registration during proceedings.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... the Trademark Trial and Appeal Board only in the context of a concurrent use registration proceeding... registration during proceedings. 2.133 Section 2.133 Patents, Trademarks, and Copyrights UNITED STATES PATENT... Partes Proceedings § 2.133 Amendment of application or registration during proceedings. (a)...

  4. 37 CFR 2.133 - Amendment of application or registration during proceedings.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... the Trademark Trial and Appeal Board only in the context of a concurrent use registration proceeding... registration during proceedings. 2.133 Section 2.133 Patents, Trademarks, and Copyrights UNITED STATES PATENT... Partes Proceedings § 2.133 Amendment of application or registration during proceedings. (a)...

  5. 37 CFR 2.133 - Amendment of application or registration during proceedings.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... the Trademark Trial and Appeal Board only in the context of a concurrent use registration proceeding... registration during proceedings. 2.133 Section 2.133 Patents, Trademarks, and Copyrights UNITED STATES PATENT... Partes Proceedings § 2.133 Amendment of application or registration during proceedings. (a)...

  6. 37 CFR 2.133 - Amendment of application or registration during proceedings.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... the Trademark Trial and Appeal Board only in the context of a concurrent use registration proceeding... registration during proceedings. 2.133 Section 2.133 Patents, Trademarks, and Copyrights UNITED STATES PATENT... Partes Proceedings § 2.133 Amendment of application or registration during proceedings. (a)...

  7. 37 CFR 2.133 - Amendment of application or registration during proceedings.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... the Trademark Trial and Appeal Board only in the context of a concurrent use registration proceeding... registration during proceedings. 2.133 Section 2.133 Patents, Trademarks, and Copyrights UNITED STATES PATENT... Partes Proceedings § 2.133 Amendment of application or registration during proceedings. (a)...

  8. RELIABILITY AND VALIDITY OF THE CHILD AND ADOLESCENT TRIAL FOR CARDIOVASCULAR HEALTH (CATCH) FOOD CHECKLIST: A SELF-REPORT INSTRUMENT TO MEASURE FAT AND SODIUM INTAKE BY MIDDLE SCHOOL STUDENTS

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Valid, reliable instruments that are sensitive enough to detect changes produced by interventions yet inexpensive and easy to administer are needed. The goal of this study was to develop a scoring algorithm and evaluate the reliability and validity of scores from the Child and Adolescent Trial for ...

  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. The successful pharmacological treatment of adolescents and young adults with borderline personality disorder: a preliminary open trial of flupenthixol.

    PubMed

    Kutcher, S; Papatheodorou, G; Reiter, S; Gardner, D

    1995-03-01

    Borderline personality disorder is a significantly disabling disturbance often arising in adolescents or young adults. In the absence of demonstrated effective treatments in this population, this open prospective study evaluated the effect of low dose (3 mg per day) flupenthixol in 13 rigorously diagnosed adolescents with borderline personality disorder. Therapeutic outcome over eight weeks of treatment assessed across measures of impulsivity, depression/dysphoria, general psychopathology and global functioning showed significant improvement in all spheres. These findings suggest that low dose flupenthixol may have a role to play in the short-term treatment of this population. PMID:7703220

  12. MEMO—A Mobile Phone Depression Prevention Intervention for Adolescents: Development Process and Postprogram Findings on Acceptability From a Randomized Controlled Trial

    PubMed Central

    Merry, Sally; Stasiak, Karolina; McDowell, Heather; Doherty, Iain; Shepherd, Matthew; Dorey, Enid; Parag, Varsha; Ameratunga, Shanthi; Rodgers, Anthony

    2012-01-01

    Background Prevention of the onset of depression in adolescence may prevent social dysfunction, teenage pregnancy, substance abuse, suicide, and mental health conditions in adulthood. New technologies allow delivery of prevention programs scalable to large and disparate populations. Objective To develop and test the novel mobile phone delivery of a depression prevention intervention for adolescents. We describe the development of the intervention and the results of participants’ self-reported satisfaction with the intervention. Methods The intervention was developed from 15 key messages derived from cognitive behavioral therapy (CBT). The program was fully automated and delivered in 2 mobile phone messages/day for 9 weeks, with a mixture of text, video, and cartoon messages and a mobile website. Delivery modalities were guided by social cognitive theory and marketing principles. The intervention was compared with an attention control program of the same number and types of messages on different topics. A double-blind randomized controlled trial was undertaken in high schools in Auckland, New Zealand, from June 2009 to April 2011. Results A total of 1348 students (13–17 years of age) volunteered to participate at group sessions in schools, and 855 were eventually randomly assigned to groups. Of these, 835 (97.7%) self-completed follow-up questionnaires at postprogram interviews on satisfaction, perceived usefulness, and adherence to the intervention. Over three-quarters of participants viewed at least half of the messages and 90.7% (379/418) in the intervention group reported they would refer the program to a friend. Intervention group participants said the intervention helped them to be more positive (279/418, 66.7%) and to get rid of negative thoughts (210/418, 50.2%)—significantly higher than proportions in the control group. Conclusions Key messages from CBT can be delivered by mobile phone, and young people report that these are helpful. Change in

  13. 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…

  14. 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…

  15. Cognitive behavioral therapy for early adolescents with autism spectrum disorders and clinical anxiety: a randomized, controlled trial.

    PubMed

    Wood, Jeffrey J; Ehrenreich-May, Jill; Alessandri, Michael; Fujii, Cori; Renno, Patricia; Laugeson, Elizabeth; Piacentini, John C; De Nadai, Alessandro S; Arnold, Elysse; Lewin, Adam B; Murphy, Tanya K; Storch, Eric A

    2015-01-01

    Clinically elevated anxiety is a common, impairing feature of autism spectrum disorders (ASD). A modular CBT program designed for preteens with ASD, Behavioral Interventions for Anxiety in Children with Autism (BIACA; Wood et al., 2009) was enhanced and modified to address the developmental needs of early adolescents with ASD and clinical anxiety. Thirty-three adolescents (11-15 years old) were randomly assigned to 16 sessions of CBT or an equivalent waitlist period. The CBT model emphasized exposure, challenging irrational beliefs, and behavioral supports provided by caregivers, as well as numerous ASD-specific treatment elements. Independent evaluators, parents, and adolescents rated symptom severity at baseline and posttreatment/postwaitlist. In intent-to-treat analyses, the CBT group outperformed the waitlist group on independent evaluators' ratings of anxiety severity on the Pediatric Anxiety Rating Scale (PARS) and 79% of the CBT group met Clinical Global Impressions-Improvement scale criteria for positive treatment response at posttreatment, as compared to only 28.6% of the waitlist group. Group differences were not found for diagnostic remission or questionnaire measures of anxiety. However, parent-report data indicated that there was a positive treatment effect of CBT on autism symptom severity. The CBT manual under investigation, enhanced for early adolescents with ASD, yielded meaningful treatment effects on the primary outcome measure (PARS), although additional developmental modifications to the manual are likely warranted. Future studies examining this protocol relative to an active control are needed. PMID:25526831

  16. 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…

  17. Effects of thirty-four adolescent tobacco use cessation and prevention trials on regular users of tobacco products.

    PubMed

    Sussman, S; Lichtman, K; Ritt, A; Pallonen, U E

    1999-09-01

    Since 1991, adolescent tobacco use rates have increased while adult use has steadily decreased. The failure of adolescent tobacco use cessation and prevention programs to reduce this overall smoking rate indicates that research must be advanced in this area. As a start, the current status of cessation and prevention research that targets adolescent regular tobacco users should be stated. This paper contributes to that goal by reviewing the last two and a half decades of research in this area. A total of 34 programs, equally divided between cessation and prevention (targeting regular tobacco users), are presented and relevant data are provided for each. Among the cessation studies, an emphasis of programming on immediate consequences of use, and instruction in coping strategies, may have led to relatively successful programs. Prevention studies arguably may have achieved lower success rates but were applied to a larger sample with a longer follow-up period. Despite showing some success, it is apparent that the scientific status of cessation research is less refined than prevention research. More research is needed to define the most successful approaches for cessation of adolescent tobacco use. PMID:10468104

  18. The Prevention of Depression and Anxiety in a Sample of High-Risk Adolescents: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Dobson, Keith S.; Hopkins, Jamie Ahnberg; Fata, Ladan; Scherrer, Martin; Allan, Lauren C.

    2010-01-01

    This study investigated the efficacy of cognitive behavioural therapy (CBT) techniques in preventing depression and anxiety in a group of adolescent high school students with elevated risk for developing emotional disorders. Students were screened using a measure of depression severity and clinical interview. Following screening procedures,…

  19. 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...

  20. 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

  1. Open Trial of Family-Based Treatment for Full and Partial Anorexia Nervosa in Adolescence: Evidence of Successful Dissemination

    ERIC Educational Resources Information Center

    Loeb, Katharine L.; Walsh, B. Timothy; Lock, James; Le Grange, Daniel; Jones, Jennifer; Marcus, Sue; Weaver, James; Dobrow, Ilyse

    2007-01-01

    Objective: There is a paucity of evidence-based interventions for anorexia nervosa (AN). An innovative family-based treatment (FBT), developed at the Maudsley Hospital and recently put in manual form, has shown great promise for adolescents with AN. Unlike traditional treatment approaches, which promote sustained autonomy around food, FBT…

  2. 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…

  3. 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. PMID:25731907

  4. 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…

  5. 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…

  6. An exploratory randomized controlled trial of a novel high-school-based smoking cessation intervention for adolescent smokers using abstinence-contingent incentives and cognitive behavioral therapy

    PubMed Central

    Krishnan-Sarin, Suchitra; Cavallo, Dana A.; Cooney, Judith L.; Schepis, Ty S.; Kong, Grace; Liss, Thomas B.; Liss, Amanda K.; McMahon, Thomas J.; Nich, Charla; Babuscio, Theresa; Rounsaville, Bruce J.; Carroll, Kathleen M.

    2013-01-01

    Background There are few effective smoking cessation interventions for adolescent smokers. We developed a novel intervention to motivate tobacco use behavior change by 1) enhancing desire to quit through the use of abstinence-contingent incentives (CM), 2) increasing cessation skills through the use of cognitive behavioral therapy (CBT), and 3) removing cessation barriers through delivery within high schools. Methods An exploratory four-week, randomized controlled trial was conducted in Connecticut high schools to dismantle the independent and combined effects of CM and CBT; smokers received CM alone, CBT alone, or CM+CBT. Participants included 82 adolescent smokers seeking smoking cessation treatment. The primary outcome was seven-day end-of-treatment (EOT) point prevalence (PP) abstinence, determined using self-reports confirmed using urine cotinine levels. Secondary outcomes included one-day EOT PP abstinence and cigarette use during treatment and follow up. Results Among participants who initiated treatment (n=72), group differences in seven-day EOT-PP abstinence were observed (χ2=10.48, p<0.01) with higher abstinence in the CM+CBT (36.7%) and CM (36.3%) conditions when compared with CBT (0%). One-day EOT-PP abstinence evidenced similar effects (χ2= 10·39, p<0·01; CM+CBT: 43%, CM: 43%, CBT: 4·3%). Survival analyses indicated differences in time to first cigarette during treatment (χ2=8·73, p =·003; CBT: Day 3, CM: Day 9, CM+CBT: Day 20). At one-and three-month follow ups, while no differences were observed, the CM alone group had the slowest increase in cigarette use. Conclusions High-school, incentive-based smoking cessation interventions produce high rates of short-term abstinence among adolescent smokers; adding cognitive behavioral therapy does not appear to further enhance outcomes. PMID:23523130

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

    PubMed

    Levitt Katz, Lorraine; Gidding, Samuel S; Bacha, Fida; Hirst, Kathryn; McKay, Siripoom; Pyle, Laura; Lima, Joao A C

    2015-02-01

    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 4½ yr from diagnosis of T2D, average age 18 yr), including MMode and 2D measurements of left ventricular (LV) and left atrial (LA) dimensions, LV tissue Doppler imaging (TDI), and tricuspid annular plane systolic excursion (TAPSE). Relationships between cardiac structure and function with demographic characteristics and baseline and change-from-baseline in CVD risk factors were examined in 455 participants. Mean LV mass (LVM) was high/normal and 16.2% had adverse LV geometry (8.1% concentric geometry, 4.5% LV hypertrophy, and 3.6% both). Determinants of higher LVM were male gender, black race, baseline and increasing body mass index (BMI), baseline and increasing systolic blood pressure (SBP), use of blood pressure (BP) medications, maintenance of glycemic control, and smoking; heart rate (HR) was inversely related. LV shortening fraction was high/normal and related to increasing BMI and higher baseline SBP. LV relative wall thickness was related to race-ethnicity, change in BMI, baseline glycated hemoglobin (HbA1c), and baseline and change in SBP. Mean LA internal dimension was high/normal and gender, baseline and increasing BMI, increasing SBP, and HR (inverse) were related. LV TDI was positively related to obesity (higher with adverse geometry). TAPSE was normal and related to higher baseline BMI and lower HR. There was no effect of T2D treatment on cardiac target organ injury. Adolescents with T2D have adverse measures of cardiac structure and function positively related to BMI and BP. PMID:24450390

  8. 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

  9. Alpha-Lipoic Acid and Antioxidant Diet Help to Improve Endothelial Dysfunction in Adolescents with Type 1 Diabetes: A Pilot Trial

    PubMed Central

    Scaramuzza, Andrea; Giani, Elisa; Redaelli, Francesca; Ungheri, Saverio; Macedoni, Maddalena; Giudici, Valentina; Bosetti, Alessandra; Ferrari, Matteo; Zuccotti, Gian Vincenzo

    2015-01-01

    After evaluating the prevalence of early endothelial dysfunction, as measured by means of reactive hyperemia in adolescents with type 1 diabetes, we started a 6-month, double-blind, randomized trial to test the efficacy of an antioxidant diet (± alpha-lipoic acid supplementation) to improve endothelial dysfunction. Seventy-one children and adolescents, ages 17 ± 3.9 yrs, with type 1 diabetes since 9.5 ± 5.3 yrs, using intensified insulin therapy, were randomized into 3 arms: (a) antioxidant diet 10.000 ORAC + alpha-lipoic acid; (b) antioxidant diet 10.000 ORAC + placebo; (c) controls. BMI, blood pressure, fasting lipid profile, HbA1c, insulin requirement, dietary habits, and body composition were determined in each patient. An antioxidant diet significantly improved endothelial dysfunction when supplemented with alpha-lipoic acid, unlike diet with placebo or controls. A significant reduction in bolus insulin was also observed. We speculate that alpha-lipoic acid might have an antioxidant effect in pediatric diabetes patients by reducing insulin. PMID:26171398

  10. 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. PMID:24239513

  11. 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. PMID:23666832

  12. 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

  13. 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.

  14. 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

  15. 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.

  16. Web-based weight management programs for children and adolescents: a systematic review of randomized controlled trial studies.

    PubMed

    An, Ji-Young; Hayman, Laura L; Park, Young-Shin; Dusaj, Tresa K; Ayres, Cynthia G

    2009-01-01

    More than 17% of children aged 6 to 19 years living in the United States are classified as overweight. Medical costs related to overweight and obesity were recently estimated to approximate $100 billion annually. The purpose of this systematic review was to provide the scientific evidence regarding Web-based weight management programs for overweight children and adolescents. Results suggest the potential for Web-based behavioral change programs for weight management in overweight children and adolescents. Future research should emphasize rigorous methodological adequacies, develop theory-based standardized frameworks, investigate types of interventions appropriate for boys and girls in this age group, evaluate long-term effect of interventions, and examine cost as well as clinical effectiveness. PMID:19707091

  17. Evaluation of a group cognitive-behavioral depression prevention program for young adolescents: A randomized effectiveness trial

    PubMed Central

    Gillham, Jane E.; Reivich, Karen J.; Brunwasser, Steven M.; Freres, Derek R.; Chajon, Norma D.; Megan Kash-MacDonald, V.; Chaplin, Tara M.; Abenavoli, Rachel M.; Matlin, Samantha L.; Gallop, Robert J.; Seligman, Martin E.P.

    2015-01-01

    Objective Depression is a common psychological problem in adolescence. Recent research suggests that group cognitive-behavioral interventions can reduce and prevent symptoms of depression in youth. Few studies have tested the effectiveness of such interventions when delivered by school teachers and counselors (as opposed to research team staff). Method We evaluated the effectiveness of the Penn Resiliency Program for adolescents (PRP-A), a school-based group intervention that targets cognitive behavioral risk factors for depression. We randomly assigned 408 middle school students (ages 10-15) to one of three conditions: PRP-A, PRP-AP (in which adolescents participated in PRP-A and parents were invited to attend a parent intervention component), or a school-as-usual control. Adolescents completed measures of depression and anxiety symptoms, cognitive style, and coping at baseline, immediately after the intervention, and at 6-month follow-up. Results PRP-A reduced depression symptoms relative to the school as usual control. Baseline levels of hopelessness moderated intervention effects. Among participants with average and high levels of hopelessness, PRP (A and AP) significantly improved depression symptoms, anxiety symptoms, hopelessness, and active coping relative to control. Among participants with low baseline hopelessness, we found no intervention effects. PRP-AP was not more effective than PRP-A alone. We found no intervention effects on clinical levels of depression or anxiety. Conclusion These findings suggest that cognitive-behavioral interventions can be beneficial when delivered by school teachers and counselors. These interventions may be most helpful to students with elevated hopelessness. PMID:22889296

  18. Efficacy of writing for recovery on traumatic grief symptoms of Afghani refugee bereaved adolescents: a randomized control trial.

    PubMed

    Kalantari, Mehrdad; Yule, William; Dyregrov, Atle; Neshatdoost, Hamidtaher; Ahmadi, S J

    2012-01-01

    Effective evidence-based intervention for traumatic bereavement is one of the current major research issues in the field of Post Traumatic Stress Disorder (PTSD) in children and adolescents. The "Writing for Recovery" group intervention is a new treatment approach developed by the Children and War Foundation for traumatized and bereaved children and adolescents after disasters. The purpose of this project was an empirical examination of this intervention with 12- to 18-year-old war bereaved Afghani refugees. Eighty-eight war bereaved Afghani refugees were screened using the Traumatic Grief Inventory for Children (TGIC). From those with the highest total score, 61 were randomly assigned to either an experimental (n = 29) or control group (n = 32). The experimental group received six sessions of group training on 3 consecutive days in their school. The difference of TGIC scores between the experimental group in pretest and posttest was significant (p = 0.001). Results of analysis of covariance also showed a significant effect of Writing for Recovery on the experimental group (p < 0.001). It is concluded that "Writing for Recovery" is an effective group intervention for bereaved children and adolescents after disasters. PMID:22953510

  19. Randomized trial of group interventions to reduce HIV/STD risk and change theoretical mediators among detained adolescents.

    PubMed

    Schmiege, Sarah J; Broaddus, Michelle R; Levin, Michael; Bryan, Angela D

    2009-02-01

    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 therapy component (GPI + GMET), or (3) an information-only control (INFO). All interventions were presented in same-sex groups in single sessions lasting from 2 to 4 hr. Changes to putative theoretical mediators (attitudes, perceived norms, self-efficacy, and intentions) were measured immediately following intervention administration. The primary outcomes were risky sexual behavior and sexual behavior while drinking measured 3 months later (65.1% retention). The GPI + GMET intervention demonstrated superiority over both other conditions in influencing theoretical mediators and over the INFO control in reducing risky sexual behavior. Self-efficacy and intentions were significant mediators between condition and later risky sexual behavior. This study contributes to an understanding of harm reduction among high-risk adolescents and has implications for understanding circumstances in which the inclusion of GMET components may be effective. PMID:19170452

  20. An open trial of 'grief-help': a cognitive-behavioural treatment for prolonged grief in children and adolescents.

    PubMed

    Spuij, Mariken; Dekovic, Maja; Boelen, Paul A

    2015-01-01

    In the past years, there is growing recognition of a syndrome of disturbed grief referred to as prolonged grief disorder (PGD). Although mostly studied in adults, clinically significant PGD symptoms have also been observed in children and adolescents. To date, no effective treatment for childhood PGD yet exists. We recently developed a nine-session cognitive-behavioural treatment for childhood PGD combined with five sessions of parental counselling. In the current article, we present outcomes of treatment of 10 consecutive children and adolescents turning to our university clinic with elevated PGD symptoms as their primary problem and main reason to seek therapy. Patients were significantly improved at post-treatment, with large improvements in self-rated PGD and post-traumatic stress (effect sizes > 0.8) and small to moderate improvement in depression and parent-rated internalizing and externalizing problems (0.2 < effect sizes < 0.8). Additional predictor analysis of outcomes suggested that, among other things, this treatment approach is less efficacious for children and adolescents further removed from loss and those confronted with suicidal loss. That said, the treatment appears promising, and controlled evaluation is clearly indicated. PMID:24227661

  1. 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

  2. A school-based rope skipping intervention for adolescents in Hong Kong: protocol of a matched-pair cluster randomized controlled trial

    PubMed Central

    2014-01-01

    Background Schools present venues for physical activity promotion among youth, with physical education (PE) considered the primary vehicle responsible for increasing activity levels. Yet students are not very physically active during typical school PE classes. With the aim to engage Hong Kong students in more moderate-to-vigorous physical activity (MVPA) during PE, a fitness infusion intervention using rope skipping was designed, and its effectiveness will be examined. Rope skipping was chosen because a) it provides moderate-to-high intensity physical activity; b) is inexpensive; c) students find it enjoyable; and d) is feasible in typical environments in Hong Kong, where PE classes are large in size (up to 40 students) and space available for physical activity is usually limited. Methods/Design A matched-pair cluster randomized controlled trial was designed. Secondary school students from 24 classes (from 12 schools) will be recruited to participate in the trial. Students’ baseline MVPA will be measured during school PE. Classes will be matched according to baseline variables and one class from each pair will be randomized into the experimental group. Teachers in the experimental group will be invited to attend a teacher workshop, and will insert a 15-minute rope skipping activity in four consecutive PE lessons. Motivational factors based on self-determination theory will also be measured as secondary outcomes. The effectiveness of the intervention will be evaluated by comparing changes in the proportion of lesson time spent in MVPA from baseline to follow-up across the experimental and control groups. Discussion Physical activity levels in PE are often very low and there is a need to identify feasible low-cost interventions that can be easily disseminated. If the results of the study suggest the intervention to be effective, it could be implemented to schools throughout Hong Kong and other cities where space is limited. Trail registration ANZCTR: ACTRN

  3. Voter Registration and Canvassing.

    ERIC Educational Resources Information Center

    Institute for Political/Legal Education, Sewell, NJ.

    Detailed procedures for community voter registration surveys to be conducted by high school students are presented. Methods for organizational structure, selection of canvassing districts, conducting the survey, processing the data, and initiating a registration drive are outlined. Student personnel include a general coordinator, a field staff to…

  4. Drug evaluation and registration in Hungary.

    PubMed

    Paál, T L; Káldor, A; Fäller, K

    1988-02-01

    In Hungary, the actual drug evaluation and registration system reflects international standards and national traditions. The compulsory drug registration system that was established in 1933 was among the first in Europe. Laboratory control (since 1927), clinical trials (since 1951) and human clinical pharmaceutical experiments (since 1967) are prerequisites for new-drug approval. Applications should be sent to the National Institute of Pharmacy, which has the overall responsibility for the registration of pharmaceutical products. Applications are assessed on the basis of the drug's quality, safety, and efficacy. The procedure follows several steps: evaluation of chemical and pharmaceutical data by the staff of the National Institute of Pharmacy; evaluation of toxicologic and pharmacologic documentation with the help of the Committee on Drug Administration; after consultation with the Committee on Medical Research Ethics (mandatory in cases of original new drugs), authorized clinical pharmacologic investigations are conducted in the units of the Clinical Pharmacological Network, which are supervised by the National Center for Clinical Pharmacology; clinical trials; application for registration (scientific evaluation); and finally, application to the Ministry of Health for a marketing authorization. The process may be facilitated appreciably for preparations already registered in another country. Moreover, Hungary is an active member in the World Health Organization (WHO), Pharmaceutical Inspection Convention of the European Free Trade Association (EFTA PIC), the Council of Mutual Economic Assistance (COMECON), and other international pharmaceutical and clinical pharmaceutical collaborations. PMID:3360964

  5. 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…

  6. 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. PMID:26881317

  7. Depressed Adolescents Treated with Exercise (DATE): A pilot randomized controlled trial to test feasibility and establish preliminary effect sizes

    PubMed Central

    Hughes, Carroll W.; Barnes, Shauna; Barnes, Conrad; DeFina, Laura F.; Nakonezny, Paul; Emslie, Graham J.

    2013-01-01

    The Depressed Adolescents Treated with Exercise (DATE) study evaluated a standardized aerobic exercise protocol to treat nonmedicated adolescents that met DSM-IV-TR criteria for major depressive disorder. From an initial screen of 90 individuals, 30 adolescents aged 12-18 years were randomized to either vigorous exercise (EXER) (>12 kg/kcal/week [KKW]) or a control stretching (STRETCH) activity (< 4 KKW) for 12 weeks. The primary outcome measure was the blinded clinician rating of the Children's Depression Rating Scale – Revised (CDRS-R) to assess depression severity and Actical (KKW) accelerometry 24hr/7days a week to assess energy expenditure and adherence. Follow-up evaluations occurred at weeks 26 and 52. The EXER group averaged 77% adherence and the STRETCH group 81% for meeting weekly target goals for the 12 week intervention based on weekly sessions completed and meeting KKW requirements. There was a significant increase in overall weekly KKW expenditures (p < .001) for both groups with the EXER group doubling the STRETCH group in weekly energy expenditure. Depressive symptoms were significantly reduced from baseline for both groups with the EXER group improving more rapidly than STRETCH after six weeks (p < .016) and nine weeks (p < .001). Both groups continued to improve such that there were no group differences after 12 weeks (p = .07). By week 12, the exercise group had a 100% response rate (86% remission), whereas the stretch group response rate was 67% (50% remission) (p = .02). Both groups had improvements in multiple areas of psychosocial functioning related to school and relationships with parents and peers. Anthropometry reflected decreased waist, hip and thigh measurements (p = .02), more so for females than males (p = .05), but there were no weight changes for either gender. The EXER group sustained 100% remission at week 26 and 52. The STRETCH group had 80% response and 70% remission rates at week 26 and by week 52 only one had not fully

  8. 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.

  9. The Impact of Peer Support and mp3 Messaging on Adherence to Inhaled Corticosteroids in Minority Adolescents with Asthma: A Randomized Controlled Trial

    PubMed Central

    Mosnaim, Giselle; Li, Hong; Martin, Molly; Richardson, DeJuran; Belice, Paula Jo; Avery, Elizabeth; Ryan, Norman; Bender, Bruce; Powell, Lynda

    2013-01-01

    Background Poor adherence to inhaled corticosteroids (ICS) is a critical risk factor contributing to asthma morbidity among low-income minority adolescents. Objective This trial tested whether peer support group meetings and peer asthma messages delivered via mp3 players improved adherence to ICS. Methods Low-income African American and/or Hispanic adolescents, ages 11–16, with persistent asthma, and poor (≤ 48%) adherence to prescription ICS during the 3-week run-in were randomized to intervention or attention control groups (ATG) for the 10-week treatment. During treatment, the intervention arm participated in weekly coping peer group support sessions and received mp3 peer-recorded asthma messages promoting adherence. The ATG participated in weekly meetings with a research assistant and received an equivalent number of mp3 doctor-recorded asthma messages. Adherence was measured using self-report and the DoserCT, (Meditrac, Inc.), an electronic dose counter. The primary outcome was the difference in adherence at 10 weeks between the two arms. Results Thirty-four subjects were randomized to each arm. At 10 weeks, no statistical difference in objectively measured adherence could be detected between the two arms adjusting for baseline adherence (P = 0.929). Adherence declined in both groups over the course of the active treatment period. Participants’ in both study arms self-reported adherence was significantly higher than their objectively measured adherence at week 10 (P < 0.0001). Conclusion Improving medication adherence in longitudinal studies is challenging. Peer support and mp3-delivered peer asthma messages may not be of sufficient dose to improve outcomes. PMID:24565620

  10. Efficacy of lisdexamfetamine dimesylate throughout the day in children and adolescents with attention-deficit/hyperactivity disorder: results from a randomized, controlled trial.

    PubMed

    Coghill, David R; Banaschewski, Tobias; Lecendreux, Michel; Zuddas, Alessandro; Dittmann, Ralf W; Otero, Isabel Hernández; Civil, Richard; Bloomfield, Ralph; Squires, Liza A

    2014-02-01

    Lisdexamfetamine dimesylate (LDX) is a long-acting, prodrug stimulant therapy for patients with attention-deficit/hyperactivity disorder (ADHD). This randomized placebo-controlled trial of an optimized daily dose of LDX (30, 50 or 70 mg) was conducted in children and adolescents (aged 6-17 years) with ADHD. To evaluate the efficacy of LDX throughout the day, symptoms and behaviors of ADHD were evaluated using an abbreviated version of the Conners' Parent Rating Scale-Revised (CPRS-R) at 1000, 1400 and 1800 hours following early morning dosing (0700 hours). Osmotic-release oral system methylphenidate (OROS-MPH) was included as a reference treatment, but the study was not designed to support a statistical comparison between LDX and OROS-MPH. The full analysis set comprised 317 patients (LDX, n = 104; placebo, n = 106; OROS-MPH, n = 107). At baseline, CPRS-R total scores were similar across treatment groups. At endpoint, differences (active treatment - placebo) in least squares (LS) mean change from baseline CPRS-R total scores were statistically significant (P < 0.001) throughout the day for LDX (effect sizes: 1000 hours, 1.42; 1400 hours, 1.41; 1800 hours, 1.30) and OROS-MPH (effect sizes: 1000 hours, 1.04; 1400 hours, 0.98; 1800 hours, 0.92). Differences in LS mean change from baseline to endpoint were statistically significant (P < 0.001) for both active treatments in all four subscales of the CPRS-R (ADHD index, oppositional, hyperactivity and cognitive). In conclusion, improvements relative to placebo in ADHD-related symptoms and behaviors in children and adolescents receiving a single morning dose of LDX or OROS-MPH were maintained throughout the day and were ongoing at the last measurement in the evening (1800 hours). PMID:23708466

  11. Trajectories of Change During a Randomized Controlled Trial of Internet-delivered Psychological Treatment for Adolescent Chronic Pain: How does Change in Pain and Function Relate?

    PubMed Central

    Palermo, Tonya M.; Law, Emily F.; Zhou, Chuan; Holley, Amy Lewandowski; Logan, Deirdre; Tai, Gabrielle

    2014-01-01

    Although pain and function improve at immediate post-treatment 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 in order to understand the temporal association of these changes during internet-delivered cognitive-behavioral treatment. Weekly repeated assessments of pain and function were conducted during eight weeks of treatment among 135 adolescents, ages 11 to 17 years, with chronic pain who were randomized to the cognitive-behavioral intervention (CBT) 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 as well as quadratic effects. Trajectories of change showed that some patients’ pain and functional disability was 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 following treatment. PMID:25775441

  12. 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

  13. Outcomes of a 1-year randomized controlled trial to evaluate a behavioral ‘stepped-down’ weight loss intervention for adolescent patients with obesity

    PubMed Central

    Norman, G.; Huang, J.; Davila, E. P.; Kolodziejczyk, J. K.; Carlson, J.; Covin, J. R.; Gootschalk, M.; Patrick, K.

    2015-01-01

    Summary Background Stepped-care approaches to weight loss have shown some success among adults. A ‘stepped-down’ version of the stepped-care approach to adolescent weight loss has never been evaluated. Objectives We conducted a one-year randomized controlled trial to compare a stepped-down weight loss intervention versus enhanced usual care (EUC). Methods Study participants were obese adolescents age 11–13 (N = 106, 51% girls, and 82% Hispanic) recruited from primary care clinics in San Diego, California. The stepped-down intervention was delivered through clinician and health educator counseling (in-person and by phone) and mailed content. The intervention consisted of four-month ‘steps’ beginning with the most intensive contact followed by reduced contact if treatment goals were met. The EUC group received an initial physician visit, one session with a health counselor, and monthly mailed materials. Body mass index (BMI kg/m2) was measured at baseline, 4, 8, and 12 months. Mixed-model regression analyses were stratified by sex. Results Results indicated a clinically significant treatment effect for boys on BMI (p < 0.001) but not girls. No between group differences were found for adiposity and biometric outcomes. Only 13% of intervention participants succeeded in stepping down from step 1 to step 2 or step 3. Conclusions A stepped-down approach to weight loss showed some evidence of efficacy for weight loss in boys but not girls. The findings suggest the program as designed was not intensive enough to result in weight loss in this population segment. PMID:25702630

  14. 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

  15. Smartphone app speeds registration.

    PubMed

    2011-03-01

    Two Denver area EDs have entered the digital world with the use of a mobile application that allows patients to pre-register before coming to the ED. Patients can use their smart phones to determine if they need to go to the ED and which one is closest. The ED registration desk receives the pre-registration form, which provides basic information, via fax. Once the information is received, registration notifies the charge nurse so the ED can prepare to receive the patient. PMID:21449510

  16. The SAFETY Program: A Treatment-Development Trial of a Cognitive-Behavioral Family Treatment for Adolescent Suicide Attempters

    PubMed Central

    Asarnow, Joan Rosenbaum; Berk, Michele; Hughes, Jennifer L.; Anderson, Nicholas L.

    2014-01-01

    Objective 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. Method Suicide-attempting youths, ages 11–18, 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- and 6-month follow-ups. Results At the 3-month post-treatment assessment, there were statistically significant improvements on measures of suicidal behavior, hopelessness, youth and parent depression, and youth social adjustment. There was one reported suicide attempt 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. Conclusions 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. PMID:25255931

  17. 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. PMID:25255931

  18. 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

  19. Effects of sixty six adolescent tobacco use cessation trials and seventeen prospective studies of self-initiated quitting

    PubMed Central

    Sussman, S

    2003-01-01

    This paper provides a review of the last two and a half decades of research in adolescent and young-adult tobacco use cessation. A total of 66 tobacco cessation intervention studies – targeted or population – are reviewed. In addition, an exhaustive review is completed of adolescent self-initiated tobacco use cessation, involving 17 prospective survey studies. Average reach and retention across the intervention studies was 61% and 78%, respectively, and was higher when whole natural units were treated (e.g., classrooms), than when units created specifically for the program were treated (e.g., school-based clinics). The mean quit-rate at a three to 12-month average follow-up among the program conditions was 12%, compared to approximately 7% across control groups. A comparison of intervention theories revealed that motivation enhancement (19%) and contingency-based reinforcement (16%) programs showed higher quit-rates than the overall intervention cessation mean. Regarding modalities (channels) of change, classroom-based programs showed the highest quit rates (17%). Computer-based (expert system) programs also showed promise (13% quit-rate), as did school-based clinics (12%). There was a fair amount of missing data and wide variation on how data points were measured in the programs' evaluations. Also, there were relatively few direct comparisons of program and control groups. Thus, it would be difficult to conduct a formal meta-analysis on the cessation programs. Still, these data suggest that use of adolescent tobacco use cessation interventions double quit rates on the average. In the 17 self-initiated quitting survey studies, key predictors of quitting were living in a social milieu that is composed of fewer smokers, less pharmacological or psychological dependence on smoking, anti-tobacco beliefs (e.g., that society should step in to place controls on smoking) and feeling relatively hopeful about life. Key variables relevant to the quitting process may

  20. 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...

  1. 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...

  2. 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...

  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, 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...

  5. Gender Differences in a Randomized Controlled Trial Treating Tobacco Use Among Adolescents and Young Adults With Mental Health Concerns

    PubMed Central

    Fromont, Sebastien C.; Ramo, Danielle E.; Young-Wolff, Kelly C.; Delucchi, Kevin; Brown, Richard A.; Hall, Sharon M.

    2015-01-01

    Introduction: Treatment of tobacco use in mental health settings is rare despite high rates of comorbidity. With a focus on early intervention, we evaluated a tobacco treatment intervention among adolescents and young adults recruited from outpatient, school-based, and residential mental health settings and tested for gender differences. Methods: Intervention participants received computerized motivational feedback at baseline, 3 months, and 6 months and were offered 12 weeks of cessation counseling and nicotine patches. Usual care participants received a self-help guide and brief cessation advice. We examined 7-day point prevalence abstinence with biochemical confirmation at 3, 6, and 12 months; smoking reduction; and 24-hr quit attempts. Results: At baseline, the sample (N = 60, 52% female, mean age = 19.5±2.9 years, 40% non-Hispanic Caucasian) averaged 7±6 cigarettes/day, 62% smoked daily, 38% smoked ≤ 30min of waking, 12% intended to quit in the next month, 47% had a parent who smoked, and 3 of 5 of participants’ closest friends smoked on average. During the 12-month study, 47% of the sample reduced their smoking, 80% quit for 24 hr, and 11%, 13%, and 17% confirmed 7-day point prevalence abstinence at 3-, 6-, and 12-month follow-up, respectively, with no differences by treatment condition (ps > .400). Over time, abstinence was greater among girls (adjusted odds ratio [AOR] = 8.9) than among boys, and abstinence was greater for lighter smokers than heavier smokers (AOR = 4.5) (p < .05). No mental health or other measured variables predicted abstinence. Conclusions: Adolescent and young adult smokers with mental health concerns are a challenging group to engage and to effectively treat for tobacco addiction, particularly heavier smokers and boys. Innovative approaches are needed. PMID:25762759

  6. SULFUR PESTICIDE REGISTRATION STANDARD

    EPA Science Inventory

    The document contains information regarding reregistration of pesticide products containing the subject active ingredient. The document includes how to register under a registration standard, regulatory position and rationale, and summaries of data requirements and data gaps. Als...

  7. Development of an Innovative Process Evaluation Approach for the Families Improving Together (FIT) for Weight Loss Trial in African American Adolescents

    PubMed Central

    Alia, Kassandra; Wilson, Dawn K.; McDaniel, Tyler; St. George, Sara M.; Kitzman-Ulrich, Heather; Smith, Kelsey; Heatley, VaShawn; Wise, Courtney

    2015-01-01

    This study demonstrates how a multi-theoretical, multilevel process evaluation was used to assess implementation of Families Improving Together (FIT) for weight loss intervention. FIT is a randomized controlled trial evaluating a culturally tailored, motivational plus family-based program on weight loss in African American adolescents and their parents. Social Cognitive, Self Determination, Family Systems theories and cultural tailoring principles guided the conceptualization of essential elements across individual/family, facilitator, and group levels. Data collection included an observational rating tool, attendance records, and a validated psychosocial measure. Results. Attendance records (0=absent, 1=present, criteria=≥70%) indicated that 71.5% of families attended each session. The survey (1=false, 6=true, criteria=≥4.5) indicated that participants perceived a positive group climate (M=5.16, SD=.69). A trained evaluator reported that facilitator dose delivered (0=no, 1=yes, criteria=≥75%) was high (99.6%), and fidelity (1=none to 4=all, criteria=≥3) was adequate at facilitator (M=3.63, SD=.41) and group levels (M=3.35, SD=.49). Five cultural topics were raised by participants related to eating (n=3) and physical activity (n=2) behaviors and were integrated as part of the final curriculum. Discussion. Results identify areas for program improvement related to delivery of multi-theoretical and cultural tailoring elements. Findings may inform future strategies for implementing effective weight loss programs for ethnic minority families. PMID:25614139

  8. "Unplugged," a European school-based program for substance use prevention among adolescents: overview of results from the EU-Dap trial.

    PubMed

    Vigna-Taglianti, Federica D; Galanti, Maria Rosaria; Burkhart, Gregor; Caria, Maria Paola; Vadrucci, Serena; Faggiano, Fabrizio

    2014-01-01

    The EU-Dap study aimed to develop and evaluate a school-based curriculum for the prevention of substance use among young people. The school curriculum, "Unplugged," is based on social influence approach and addresses social and personal skills, knowledge, and normative beliefs. It consists of 12 one-hour interactive sessions delivered by teachers. Its effectiveness was evaluated through a randomized trial involving 7,079 pupils of seven European countries. Unplugged was effective in reducing cigarette smoking, episodes of drunkenness, and the use of cannabis at short term. This association, however, was confined to boys, with age and self-esteem as possible explanations of this difference. Beneficial effects associated with the program persisted at fifteen-month follow-up for drunkenness, alcohol-related problems, and cannabis use, and were stronger among adolescents in schools of average low socioeconomic level. These results are of scientific importance and may inform the adoption of effective public health interventions at population level. PMID:24753279

  9. 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

  10. Effectiveness of a Web-Based Solution-Focused Brief Chat Treatment for Depressed Adolescents and Young Adults: Randomized Controlled Trial

    PubMed Central

    Conijn, Barbara; Oijevaar, Pien; Riper, Heleen

    2014-01-01

    those younger than 18 year old. Trial Registration Netherlands Trial Register: NTR 1696; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1696 (Archived by WebCite at http://www.webcitation.org/6DspeYWrJ). PMID:24874006

  11. Automatic parameter selection for multimodal image registration.

    PubMed

    Hahn, Dieter A; Daum, Volker; Hornegger, Joachim

    2010-05-01

    Over the past ten years similarity measures based on intensity distributions have become state-of-the-art in automatic multimodal image registration. An implementation for clinical usage has to support a plurality of images. However, a generally applicable parameter configuration for the number and sizes of histogram bins, optimal Parzen-window kernel widths or background thresholds cannot be found. This explains why various research groups present partly contradictory empirical proposals for these parameters. This paper proposes a set of data-driven estimation schemes for a parameter-free implementation that eliminates major caveats of heuristic trial and error. We present the following novel approaches: a new coincidence weighting scheme to reduce the influence of background noise on the similarity measure in combination with Max-Lloyd requantization, and a tradeoff for the automatic estimation of the number of histogram bins. These methods have been integrated into a state-of-the-art rigid registration that is based on normalized mutual information and applied to CT-MR, PET-MR, and MR-MR image pairs of the RIRE 2.0 database. We compare combinations of the proposed techniques to a standard implementation using default parameters, which can be found in the literature, and to a manual registration by a medical expert. Additionally, we analyze the effects of various histogram sizes, sampling rates, and error thresholds for the number of histogram bins. The comparison of the parameter selection techniques yields 25 approaches in total, with 114 registrations each. The number of bins has no significant influence on the proposed implementation that performs better than both the manual and the standard method in terms of acceptance rates and target registration error (TRE). The overall mean TRE is 2.34 mm compared to 2.54 mm for the manual registration and 6.48 mm for a standard implementation. Our results show a significant TRE reduction for distortion

  12. Design and rationale for the PREVAIL study: effect of e-Health individually tailored encouragements to physical exercise on aerobic fitness among adolescents with congenital heart disease--a randomized clinical trial.

    PubMed

    Klausen, Susanne Hwiid; Mikkelsen, Ulla Ramer; Hirth, Asle; Wetterslev, Jørn; Kjærgaard, Hanne; Søndergaard, Lars; Andersen, Lars Louis

    2012-04-01

    Intensive exercise may be an important part of rehabilitation in patients with congenital heart disease (CHD). However, performing regular physical exercise is challenging for many adolescent patients. Consequently, effective exercise encouragements may be needed. Little is known on the effect of e-Health encouragements on physical fitness, physical activity, and health-related quality of life in adolescents. This trial is a nationwide interactive e-Health rehabilitation study lasting 1 year, centered on interactive use of mobile phone and Internet technology. We hypothesize that e-Health encouragements and interactive monitoring of intensive exercise for 1 year can improve physical fitness, physical activity, and health-related quality of life. Two hundred sixteen adolescents (age, 13-16 years) with surgically corrected complex CHD but without significant hemodynamic residual defects and no restrictions to participate in physical activity are in the process of being enrolled by invitation after informed consent. Physical fitness is measured as the maximal oxygen uptake (Vo(2)) at baseline and after 12 months by an assessor blinded to the randomization group. After baseline testing, the patients are 1:1 randomized to an intervention group or a control group. Individually fully automated tailored e-Health encouragements--SMS, Internet, and mobile applications--aimed at increasing physical activity are delivered to the participants in the intervention group once a week. The Bandura's Social Cognitive Theory inspires the behavioral theoretical background. The e-Health intervention and the Godfrey cycle ergometer protocol have been feasibility tested and seem applicable to adolescents with CHD. The trial is expected to contribute with new knowledge regarding how physical activity in adolescents with CHD can be increased and, possibly, comorbidity be reduced. PMID:22520519

  13. Safety and Efficacy from an 8 Week Double-Blind Trial and a 26 Week Open-Label Extension of Asenapine in Adolescents with Schizophrenia

    PubMed Central

    Landbloom, Ronald P.; Mackle, Mary; Pallozzi, Wendi; Braat, Sabine; Hundt, Carla; Wamboldt, Marianne Z.; Mathews, Maju

    2015-01-01

    Abstract Objective: The purpose of this study was to evaluate the safety and efficacy of asenapine in adolescents with schizophrenia. Methods: In an 8 week, randomized, double-blind placebo-controlled trial, subjects (12–17 years of age) meeting Diagnostic and Statistical Manual of Mental Disorders, 4th ed., Text Revision (DSM-IV-TR) criteria for schizophrenia were randomized 1:1:1 to placebo, asenapine 2.5 mg b.i.d., or asenapine 5 mg b.i.d. Subjects who completed the 8 week acute study could participate in a 26 week flexible-dose asenapine-only open-label extension (OLE). Results: A similar percentage of subjects completed treatment on day 56 (2.5 mg b.i.d. (n=98): 83%; 5 mg b.i.d. [n=106]: 79%; placebo [n=102]: 79%). In the mixed model for repeated measures analysis of the primary end-point (with Hochberg correction for multiplicity), least squares (LS) mean differences between asenapine and placebo on the Positive and Negative Syndrome Scale (PANSS) total score at day 56 were not significant (−4.8 for 2.5 mg b.i.d., p=0.070; −5.6 for 5 mg b.i.d., p=0.064). Significant improvement in the Clinical Global Impressions-Severity score was observed in the 5 mg b.i.d. group versus placebo on day 56 (LS mean −0.3, p=0.024). In the acute phase, ≥7% weight gain and the composite event of somnolence, sedation, and hypersomnia were more common in both asenapine groups than in the placebo group. Akathisia, fasting glucose elevation, and extrapyramidal syndrome were more common in the 5 mg b.i.d. group than in the placebo group. There were no unexpected adverse events in the OLE, and PANSS total scores decreased by −16.1 points in the group previously treated with placebo (n=62) and by −11.2 points in the continuous asenapine group (n=131) from OLE baseline to week 26. Conclusions: Although improvements in PANSS total score at day 56 of the acute phase were numerically greater for both asenapine 2.5 and 5 mg b.i.d. than for placebo and were

  14. 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,...

  15. 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,...

  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. Predictors of participation in parenting workshops for improving adolescent behavioral and mental health: results from the common sense parenting trial.

    PubMed

    Fleming, Charles B; Mason, W Alex; Haggerty, Kevin P; Thompson, Ronald W; Fernandez, Kate; Casey-Goldstein, Mary; Oats, Robert G

    2015-04-01

    Engaging and retaining participants are crucial to achieving adequate implementation of parenting interventions designed to prevent problem behaviors among children and adolescents. This study examined predictors of engagement and retention in a group-based family intervention across two versions of the program: a standard version requiring only parent attendance for six sessions and an adapted version with two additional sessions that required attendance by the son or daughter. Families included a parent and an eighth grader who attended one of five high-poverty schools in an urban Pacific Northwest school district. The adapted version of the intervention had a higher rate of engagement than the standard version, a difference that was statistically significant after adjusting for other variables assessed at enrollment in the study. Higher household income and parent education, younger student age, and poorer affective quality in the parent-child relationship predicted greater likelihood of initial attendance. In the adapted version of the intervention, parents of boys were more likely to engage with the program than those of girls. The variables considered did not strongly predict retention, although retention was higher among parents of boys. Retention did not significantly differ between conditions. Asking for child attendance at workshops may have increased engagement in the intervention, while findings for other predictors of attendance point to the need for added efforts to recruit families who have less socioeconomic resources, as well as families who perceive they have less need for services. PMID:25656381

  18. Predictors of Participation in Parenting Workshops for Improving Adolescent Behavioral and Mental Health: Results from the Common Sense Parenting Trial

    PubMed Central

    Fleming, Charles B.; Mason, W. Alex; Haggerty, Kevin P.; Thompson, Ronald W.; Fernandez, Kate; Casey-Goldstein, Mary; Oats, Robert G.

    2015-01-01

    Engaging and retaining participants are crucial to achieving adequate implementation of parenting interventions designed to prevent problem behaviors among children and adolescents. This study examined predictors of engagement and retention in a group-based family intervention across two versions of the program: a standard version requiring only parent attendance for six sessions and an adapted version with two additional sessions that required attendance by the son or daughter. Families included a parent and an eighth grader who attended one of five high-poverty schools in an urban Pacific Northwest school district. The adapted version of the intervention had a higher rate of engagement than the standard version, a difference that was statistically significant after adjusting for other variables assessed at enrollment in the study. Higher household income and parent education, younger student age, and poorer affective quality in the parent-child relationship predicted greater likelihood of initial attendance. In the adapted version of the intervention, parents of boys were more likely to engage with the program than those of girls. The variables considered did not strongly predict retention, although retention was higher among parents of boys. Retention did not significantly differ between conditions. Asking for child attendance at workshops may have increased engagement in the intervention, while findings for other predictors of attendance point to the need for added efforts to recruit families who have less socioeconomic resources, as well as families who perceive they have less need for services. PMID:25656381

  19. 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.

  20. Two-year outcomes of a randomized, family-based substance use prevention trial for Asian American adolescent girls.

    PubMed

    Fang, Lin; Schinke, Steven P

    2013-09-01

    Asian Americans have been largely ignored in the prevention outcome literature. In this study, we tested a parent-child program with a sample of Asian American adolescent girls and their mothers, and evaluated the program's efficacy on decreasing girls' substance use and modifying risk and protective factors at individual, family, and peer levels. A total of 108 Asian American mother-daughter dyads recruited through online advertisements and from community service agencies were randomly assigned to an intervention arm (n = 56) or to a test-only control arm (n = 52). The intervention consisted of a nine-session substance abuse prevention program, delivered entirely online. Guided by family interaction theory, the prevention program aimed to strengthen the quality of girls' relationships with their mothers while increasing girls' resilience to resist substance use. Intent-to-treat analyses showed that at 2-year follow-up, intervention-arm dyads had significantly higher levels of mother-daughter closeness, mother-daughter communication, maternal monitoring, and family rules against substance use compared with the control-arm dyads. Intervention-arm girls also showed sustained improvement in self-efficacy and refusal skills and had lower intentions to use substances in the future. Most important, intervention-arm girls reported fewer instances of alcohol and marijuana use and prescription drug misuse relative to the control-arm girls. The study suggests that a culturally generic, family-based prevention program was efficacious in enhancing parent-child relationships, improving girls' resiliency, and preventing substance use behaviors among Asian American girls. PMID:23276322

  1. Two-Year Outcomes of a Randomized, Family-Based Substance Use Prevention Trial for Asian American Adolescent Girls

    PubMed Central

    Fang, Lin; Schinke, Steven P.

    2014-01-01

    Asian Americans have been largely ignored in the prevention outcome literature. In this study, we tested a parent-child program with a sample of Asian American adolescent girls and their mothers, and evaluated the program’s efficacy on decreasing girls’ substance use, and modifying risk and protective factors at individual, family, and peer levels. One hundred and eight Asian American mother-daughter dyads recruited through online advertisements and from community service agencies were randomly assigned to an intervention arm (n = 56) or to a test-only control arm (n = 52). The intervention consisted of a nine-session substance abuse prevention program, delivered entirely online. Guided by family interaction theory, the prevention program aimed to strengthen the quality of girls’ relationships with their mothers while increasing girls’ resilience to resist substance use. Intent-to-treat analyses showed that at 2-year follow-up, intervention-arm dyads had significantly higher levels of mother-daughter closeness, mother-daughter communication, maternal monitoring, and family rules against substance use compared to the control-arm dyads. Intervention-arm girls also showed sustained improvement in self-efficacy and refusal skills, and had lower intentions to use substances in the future. Most important, intervention-arm girls reported fewer instances of alcohol and marijuana use, and prescription drug misuse relative to the control-arm girls. The study suggests that a culturally generic, family-based prevention program was efficacious in enhancing parent-child relationships, improving girls’ resiliency, and preventing substance use behaviors among Asian American girls. PMID:23276322

  2. [Childhood and adolescent depression].

    PubMed

    Mikami, Katsunaka; Matsumoto, Hideo

    2007-09-01

    Depression is a common, chronic and recurrent disorder in children and adolescents. This article reviewed the epidemiology, clinical characteristics, natural course and treatment (pharmacological and psychotherapeutic treatment) of major depressive disorder (MDD) in children and adolescents. Several randomized controlled trials have shown that the selective serotonin reuptake inhibitors (SSRIs), in particular fluoxetine, and psychotherapeutic treatments such as cognitive behavioral therapy and interpersonal therapy are efficacious in children and adolescents with MDD. However, in Japan only three SSRIs (fluvoxamine, paroxetine and sertraline) are currently available, and few clinicians are trained to deliver psychotherapeutic treatment. Further clinical researches on the treatment to children and adolescents with MDD are needed in Japan. PMID:17876994

  3. 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.

  4. 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.

  5. The Effect of Fixed Orthodontic Appliances and Fluoride Mouthwash on the Oral Microbiome of Adolescents - A Randomized Controlled Clinical Trial.

    PubMed

    Koopman, Jessica E; van der Kaaij, Nicoline C W; Buijs, Mark J; Elyassi, Yassaman; van der Veen, Monique H; Crielaard, Wim; Ten Cate, Jacob M; Zaura, Egija

    2015-01-01

    While the aesthetic effect of orthodontic treatment is clear, the knowledge on how it influences the oral microbiota and the consequential effects on oral health are limited. In this randomized controlled clinical trial we investigated the changes introduced in the oral ecosystem, during and after orthodontic treatment with fixed appliances in combination with or without a fluoride mouthwash, of 10-16.8 year old individuals (N = 91). We followed several clinical parameters in time, in combination with microbiome changes using next-generation sequencing of the bacterial 16S rRNA gene. During the course of our study, the oral microbial community displayed remarkable resilience towards the disturbances it was presented with. The effects of the fluoride mouthwash on the microbial composition were trivial. More pronounced microbial changes were related to gingival health status, orthodontic treatment and time. Periodontal pathogens (e.g. Selenomonas and Porphyromonas) were highest in abundance during the orthodontic treatment, while the health associated Streptococcus, Rothia and Haemophilus gained abundance towards the end and after the orthodontic treatment. Only minor compositional changes remained in the oral microbiome after the end of treatment. We conclude that, provided proper oral hygiene is maintained, changes in the oral microbiome composition resulting from orthodontic treatment are minimal and do not negatively affect oral health. PMID:26332408

  6. 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

  7. Impact of Diabetes and Its Treatment on Cognitive Function Among Adolescents Who Participated in the Diabetes Control and Complications Trial

    PubMed Central

    Musen, Gail; Jacobson, Alan M.; Ryan, Christopher M.; Cleary, Patricia A.; Waberski, Barbara H.; Weinger, Katie; Dahms, William; Bayless, Meg; Silvers, Nancy; Harth, Judith; White, Neil

    2008-01-01

    OBJECTIVE—The purpose of this study was to evaluate whether severe hypoglycemia or intensive therapy affects cognitive performance over time in a subgroup of patients who were aged 13–19 years at entry in the Diabetes Control and Complications Trial (DCCT). RESEARCH DESIGN AND METHODS—This was a longitudinal study involving 249 patients with type 1 diabetes who were between 13 and 19 years old when they were randomly assigned in the DCCT. Scores on a comprehensive battery of cognitive tests obtained during the Epidemiology of Diabetes Interventions and Complications follow-up study, ∼18 years later, were compared with baseline performance. We assessed the effects of the original DCCT treatment group assignment, mean A1C values, and frequency of severe hypoglycemic events on eight domains of cognition. RESULTS—There were a total of 294 reported episodes of coma or seizure. Neither frequency of hypoglycemia nor previous treatment group was associated with decline on any cognitive domain. As in a previous analysis of the entire study cohort, higher A1C values were associated with declines in the psychomotor and mental efficiency domain (P < 0.01); however, the previous finding of improved motor speed with lower A1C values was not replicated in this subgroup analysis. CONCLUSIONS—Despite relatively high rates of severe hypoglycemia, cognitive function did not decline over an extended period of time in the youngest cohort of patients with type 1 diabetes. PMID:18606979

  8. 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

  9. 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

  10. 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. PMID:26573368

  11. The effect of low glycemic index diet on body weight status and blood pressure in overweight adolescent girls: a randomized clinical trial

    PubMed Central

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

    2013-01-01

    Although several studies have assessed the influence of the glycemic index on body weight and blood pressure among adults, limited evidence exists for the pediatric age population. In the current study, we compared the effects of low glycemic index (LGI) diet to the healthy nutritional recommendation (HNR)-based diet on obesity and blood pressure among adolescent girls in pubertal ages. This 10-week parallel randomized clinical trial comprised of 50 overweight or obese and sexually mature girls less than 18 years of age years, who were randomly assigned to LGI or HNR-based diet. Macronutrient distribution was equivalently prescribed in both groups. Blood pressure, weight and waist circumference were measured at baseline and after intervention. Of the 50 participants, 41 subjects (include 82%) completed the study. The GI of the diet in the LGI group was 42.67 ± 0.067. A within-group analysis illustrated that in comparison to the baseline values, the body weight and body mass index (not waist circumference and blood pressure) decreased significantly after the intervention in both groups (P = 0.0001). The percent changes of the body weight status, waist circumference and blood pressure were compared between the two groups and the findings did not show any difference between the LGI diet consumers and those in the HNR group. In comparison to the HNR, LGI diet could not change the weight and blood pressure following a 10-week intervention. Further longitudinal studies with a long-term follow up should be conducted in this regard. PMID:24133618

  12. Tobacco use prevalence and correlates among adolescents in a clinician initiated tobacco prevention trial in California, USA.

    PubMed Central

    Hovell, M F; Slymen, D J; Keating, K J; Jones, J A; Burkham-Kreitner, S; Hofstetter, C R; Noel, D; Rubin, B

    1996-01-01

    OBJECTIVES: Baseline data for the clinician initiated, tobacco prevention trial, the first non-school based clinician mediated tobacco prevention study, were used to explore the degree to which young people receiving orthodontic treatment use tobacco and the differences in use rates between national, California, and patient samples. Correlates of tobacco use were identified and these correlates were contrasted with findings from the published reports. DESIGN AND SETTING: A 26 item telephone survey assessed demographic information, tobacco use, selected health related behaviours, and variables based on social learning theory. The study was conducted among 11 to 18 year old orthodontic patients from San Diego, Orange, Riverside, San Bernardino, and Los Angeles Counties, California, USA. PARTICIPANTS: Of the 17925 patients who were eligible, 16915 (> 94%) completed the survey. MEASUREMENTS AND MAIN RESULTS: Multivariate analyses were conducted using a logistic mixed effects model. Although the 30 day prevalence rate of tobacco use (6%, n = 1010) proved lower than California and national samples, the rates for the age, gender, and race ethnicity subgroups showed trends similar to those seen in California and national samples. Ten variables were significantly associated with tobacco use (p < 0.05), including 30 day alcohol use (OR = 7.88), age (OR = 1.32), and living with a tobacco user (OR = 1.72). CONCLUSIONS: Because 6% of orthodontic patients use tobacco, interventions are warranted to reach the health "Objectives for the Nation". Patterns of correlates of tobacco use were essentially the same for orthodontic patients, California, and national samples, suggesting that these associations are generalisable. PMID:8935468

  13. 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. PMID

  14. Adverse maternal and perinatal outcomes in adolescent pregnancies: The Global Network’s Maternal Newborn Health Registry study

    PubMed Central

    2015-01-01

    with worse maternal outcomes, but is associated with worse perinatal outcomes, particularly in younger adolescents. However, this may not be the case in regions like South Asia where there are decreasing rates of adolescent pregnancies, concentrated among older adolescents. The increased risks observed among adolescents seems more likely to be associated with biological immaturity, than with socio-economic factors, inadequate antenatal or delivery care. Trial registration number NCT01073475 PMID:26063350

  15. 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)

  16. 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 registration…

  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. 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.

  19. Design of the Xylitol for Adult Caries Trial (X-ACT)

    PubMed Central

    2010-01-01

    Background Dental caries incidence in adults is similar to that in children and adolescents, but few caries preventive agents have been evaluated for effectiveness in adults populations. In addition, dentists direct fewer preventive services to their adult patients. Xylitol, an over-the-counter sweetener, has shown some potential as a caries preventive agent, but the evidence for its effectiveness is not yet conclusive and is based largely on studies in child populations. Methods/Design X-ACT is a three-year, multi-center, placebo controlled, double-blind, randomized clinical trial that tests the effects of daily use of xylitol lozenges versus placebo lozenges on the prevention of adult caries. The trial has randomized 691 participants (ages 21-80) to the two arms. The primary outcome is the increment of cavitated lesions. Discussion This trial should help resolve the overall issue of the effectiveness of xylitol in preventing caries by contributing evidence with a low risk of bias. Just as importantly, the trial will provide much-needed information about the effectiveness of a promising caries prevention agent in adults. An effective xylitol-based caries prevention intervention would represent an easily disseminated method to extend caries prevention to individuals not receiving caries preventive treatment in the dental office. Trial Registration ClinicalTrials.Gov NCT00393055 PMID:20920261

  20. 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. PMID:21923052

  1. Outline of Programe Registration System

    NASA Astrophysics Data System (ADS)

    Kono, Masamichi

    After the outline of the copyright registration system was described in this paper, the program registration system, which has started from April l, 1987, was introduced in focussing on the subjects as the special case and a methodology of registration procedures and how to submit the application.

  2. 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...

  3. 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...

  4. 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...

  5. 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…

  6. 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…

  7. 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...

  8. Image registration with uncertainty analysis

    DOEpatents

    Simonson, Katherine M.

    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.

  9. 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.

  10. Feature-Based Registration Techniques

    NASA Astrophysics Data System (ADS)

    Lorenz, Cristian; Klinder, Tobias; von Berg, Jens

    In contrast to intensity-based image registration, where a similarity measure is typically evaluated at each voxel location, feature-based registration works on a sparse set of image locations. Therefore, it needs an explicit step of interpolation to supply a dense deformation field. In this chapter, the application of feature-based registration to pulmonary image registration as well as hybrid methods, combining feature-based with intensity-based registration, is discussed. In contrast to pure feature based registration methods, hybrid methods are increasingly proposed in the pulmonary context and have the potential to out-perform purely intensity based registration methods. Available approaches will be classified along the categories feature type, correspondence definition, and interpolation type to finally achieve a dense deformation field.

  11. Automatic digital image registration

    NASA Technical Reports Server (NTRS)

    Goshtasby, A.; Jain, A. K.; Enslin, W. R.

    1982-01-01

    This paper introduces a general procedure for automatic registration of two images which may have translational, rotational, and scaling differences. This procedure involves (1) segmentation of the images, (2) isolation of dominant objects from the images, (3) determination of corresponding objects in the two images, and (4) estimation of transformation parameters using the center of gravities of objects as control points. An example is given which uses this technique to register two images which have translational, rotational, and scaling differences.

  12. 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).

  13. 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

  14. 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

  15. Longitudinal effect of curcumin-photodynamic antimicrobial chemotherapy in adolescents during fixed orthodontic treatment: a single-blind randomized clinical trial study.

    PubMed

    Paschoal, Marco Aurélio; Moura, Cíntia Maria Zanin; Jeremias, Fabiano; Souza, Juliana Feltrin; Bagnato, Vanderlei S; Giusti, Juçaíra S M; Santos-Pinto, Lourdes

    2015-11-01

    White spot lesions are one of the concerns during the fixed orthodontic treatment. Thus, the aim of the present study was to evaluate the antimicrobial/anti-inflammatory effect of curcumin-photodynamic antimicrobial chemotherapy (c-PACT) and chlorhexidine varnish on the plaque accumulation and gingival bleeding in adolescents under fixed orthodontic treatment. A randomized clinical trial was performed with an initial number of 45 patients being distributed into three groups: group I-chlorhexidine varnish 2%, group II-placebo varnish, and group III-c-PACT (curcumin at 1.5 mg.mL(-1)) exposed to blue Light-emitting diode (LED) light at 450 nm (power density = 165 mW.cm(-2), fluency = 96 J.cm(-2), total dose = 150.7 J). The treatments were performed for four consecutive times with an interval of 1 week each. After the interventions, two calibrated examiners (Kappa value = 0.75) analyzed the dental plaque accumulation by plaque index (PI) and gingivitis condition by gingival bleeding index (GBI) with 1 and 3 months of follow-up after the treatments comprised a final sample of 35 patients. No significant difference was found to PI between the groups during baseline and 1-month period. Group III (1.52 ± 0.51) presented significance difference from group I (0.91 ± 0.75) and group II (1.03 ± 0.51) at 3 months of follow-up. In this same period, there was more plaque accumulation with significant statistical difference (P ≤ 0.05) in comparison to the other periods to all studied groups. There was a GBI reduction statistically significant to groups I and III at 1-month follow-up in comparison to other periods. No effect was verified to dental plaque accumulation after the photodynamic application mediated with curcumin activated with a blue LED light. PMID:25543296

  16. 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 ...

  17. Adolescent development

    MedlinePlus

    Development - adolescent; Growth and development - adolescent ... rights and privileges. Establish and maintain satisfying relationships. Adolescents will learn to share intimacy without feeling worried ...

  18. 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...

  19. 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...

  20. 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...

  1. 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

  2. A comparison of seven methods of within-subjects rigid-body pedobarographic image registration.

    PubMed

    Pataky, Todd C; Goulermas, John Y; Crompton, Robin H

    2008-10-20

    Image registration, the process of transforming images such that homologous structures optimally overlap, provides the pre-processing foundation for pixel-level functional image analysis. The purpose of this study was to compare the performances of seven methods of within-subjects pedobarographic image registration: (1) manual, (2) principal axes, (3) centre of pressure trajectory, (4) mean squared error, (5) probability-weighted variance, (6) mutual information, and (7) exclusive OR. We assumed that foot-contact geometry changes were negligibly small trial-to-trial and thus that a rigid-body transformation could yield optimum registration performance. Thirty image pairs were randomly selected from our laboratory database and were registered using each method. To compensate for inter-rater variability, the mean registration parameters across 10 raters were taken as representative of manual registration. Registration performance was assessed using four dissimilarity metrics (#4-7 above). One-way MANOVA found significant differences between the methods (p<0.001). Bonferroni post-hoc tests revealed that the centre of pressure method performed the poorest (p<0.001) and that the principal axes method tended to perform more poorly than remaining methods (p<0.070). Average manual registration was not different from the remaining methods (p=1.000). The results suggest that a variety of linear registration methods are appropriate for within-subjects pedobarographic images, and that manual image registration is a viable alternative to algorithmic registration when parameters are averaged across raters. The latter finding, in particular, may be useful for cases of image peculiarities resulting from outlier trials or from experimental manipulations that induce substantial changes in contact area or pressure profile geometry. PMID:18790481

  3. A cluster randomised trial of a school-based resilience intervention to decrease tobacco, alcohol and illicit drug use in secondary school students: study protocol

    PubMed Central

    2012-01-01

    Background Whilst schools provide a potentially appropriate setting for preventing substance use among young people, systematic review evidence suggests that past interventions in this setting have demonstrated limited effectiveness in preventing tobacco, alcohol and other drug use. Interventions that adopt a mental wellbeing approach to prevent substance use offer considerable promise and resilience theory provides one method to impact on adolescent mental well-being. The aim of the proposed study is to examine the efficacy of a resilience intervention in decreasing the tobacco, alcohol and illicit drug use of adolescents. Methods A cluster randomised controlled trial with schools as the unit of randomisation will be undertaken. Thirty two schools in disadvantaged areas will be allocated to either an intervention or a control group. A comprehensive resilience intervention will be implemented, inclusive of explicit program adoption strategies. Baseline surveys will be conducted with students in Grade 7 in both groups and again three years later when the student cohort is in Grade 10. The primary outcome measures will include self-reported tobacco, alcohol, marijuana and other illicit drug use. Comparisons will be made post-test between Grade 10 students in intervention and control schools to determine intervention effectiveness across all measures. Discussion To the authors’ knowledge this is the first randomised controlled trial to evaluate the effectiveness of a comprehensive school-based resilience intervention, inclusive of explicit adoption strategies, in decreasing tobacco, alcohol and illicit drug use of adolescents attending disadvantaged secondary schools. Trial registration ACTRN12611000606987 PMID:23171383

  4. 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

  5. Effects of a Family Intervention in Reducing HIV Risk Behaviors Among High-Risk Hispanic Adolescents

    PubMed Central

    Prado, Guillermo; Pantin, Hilda; Huang, Shi; Cordova, David; Tapia, Maria I.; Velazquez, Maria-Rosa; Calfee, Meghan; Malcolm, Shandey; Arzon, Margaret; Villamar, Juan; Jimenez, Giselle Leon; Cano, Nicole; Brown, C. Hendricks; Estrada, Yannine

    2013-01-01

    Objective To determine the efficacy of a family intervention in reducing human immunodeficiency virus (HIV) risk behaviors among Hispanic delinquent adolescents. Design Randomized controlled trial. Setting Miami–Dade County Public School System and Miami–Dade County’s Department of Juvenile Services, Florida. Participants A total of 242 Hispanic delinquent youth aged 12 to 17 years and their primary caregivers completed outcome assessments at baseline and 3 months after intervention. Intervention Participants were randomized to either Familias Unidas (120 participants), a Hispanic-specific, family intervention designed to reduce HIV risk behaviors among Hispanic youth, or a community practice control condition (122 participants). Main Outcome Measures Self-reported measures included unprotected sexual behavior, engaging in sex while under the influence of alcohol and/or drugs, number of sexual partners, and incidence of sexually transmitted diseases. Family functioning (eg, parent-adolescent communication, positive parenting, and parental monitoring) was also assessed via self-report measures. Results Compared with community practice, Familias Unidas was efficacious in increasing condom use during vaginal and anal sex during the past 90 days, reducing the number of days adolescents were under the influence of drugs or alcohol and had sex without a condom, reducing sexual partners, and preventing unprotected anal sex at the last sexual intercourse. Familias Unidas was also efficacious, relative to community practice, in increasing family functioning and most notably in increasing parent-adolescent communication and positive parenting. Conclusion These results suggest that culturally tailored, family-centered prevention interventions may be appropriate and efficacious in reducing HIV risk behaviors among Hispanic delinquent adolescents. Trial Registration clinicaltrials.gov Identifier: NCT01257022 PMID:21969363

  6. A first step toward uncovering the truth about weight tuning in deformable image registration

    NASA Astrophysics Data System (ADS)

    Pirpinia, Kleopatra; Bosman, Peter A. N.; Sonke, Jan-Jakob; van Herk, Marcel; Alderliesten, Tanja

    2016-03-01

    Deformable image registration is currently predominantly solved by optimizing a weighted linear combination of objectives. Successfully tuning the weights associated with these objectives is not trivial, leading to trial-and-error approaches. Such an approach assumes an intuitive interplay between weights, optimization objectives, and target registration errors. However, it is not known whether this always holds for existing registration methods. To investigate the interplay between weights, optimization objectives, and registration errors, we employ multi-objective optimization. Here, objectives of interest are optimized simultaneously, causing a set of multiple optimal solutions to exist, called the optimal Pareto front. Our medical application is in breast cancer and includes the challenging prone-supine registration problem. In total, we studied the interplay in three different ways. First, we ran many random linear combinations of objectives using the well-known registration software elastix. Second, since the optimization algorithms used in registration are typically of a local-search nature, final solutions may not always form a Pareto front. We therefore employed a multi-objective evolutionary algorithm that finds weights that correspond to registration outcomes that do form a Pareto front. Third, we examined how the interplay differs if a true multi-objective (i.e., weight-free) image registration method is used. Results indicate that a trial-and-error weight-adaptation approach can be successful for the easy prone to prone breast image registration case, due to the absence of many local optima. With increasing problem difficulty the use of more advanced approaches can be of value in finding and selecting the optimal registration outcomes.

  7. Computer Assisted Operations: Registration Records, Schedules

    ERIC Educational Resources Information Center

    College and University, 1977

    1977-01-01

    Proceedings of AACRAO's 63rd annual meeting cover: computer networking in small colleges; continuous registration; computer logic; computerized academic record overview; on-line registration systems; and analysis of registration and records systems. (LBH)

  8. Promoting Competence Through Voter Registration.

    ERIC Educational Resources Information Center

    Hanrahan, Mary; And Others

    1986-01-01

    Describes a voter registration drive undertaken by a department of social work within a major medical teaching hospital. Provides highlights of the registration effort and several clinical vignettes that illustrate the meaning of the drive to psychiatric patients. Implications for social work and for the education of social work trainees are…

  9. 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

  10. 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

  11. 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.

  12. Examination of Perceived Neighborhood Characteristics and Transportation on Changes in Physical Activity and Sedentary Behavior: The Trial of Activity in Adolescent Girls

    PubMed Central

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

    2010-01-01

    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. PMID:20615746

  13. 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. PMID:20615746

  14. Suicidality and Migration among Adolescents in Hong Kong

    ERIC Educational Resources Information Center

    Kwan, Y. K.; Ip, W. C.

    2007-01-01

    Suicide as a cause of death among adolescents and migration as a component of population have been growing in importance. Very little research has been conducted on the connections between migration and suicidality among adolescents in Hong Kong, and so is the aim of this article. It uses census and registration data to study suicide mortality,…

  15. Physical fitness and mental health impact of a sport-for-development intervention in a post-conflict setting: randomised controlled trial nested within an observational study of adolescents in Gulu, Uganda

    PubMed Central

    2014-01-01

    Background Physical inactivity contributes to poor fitness and mental health disorders. This is of concern in post-conflict low-income settings where non-communicable diseases are emerging and there is limited evidence for physical activity interventions. We examined the effects of a sport-for-development programme on adolescent physical fitness and mental health in Gulu, Uganda. Methods We conducted a single-blinded RCT nested within an observational study with three unbalanced parallel groups. Participants were able-bodied adolescents aged 11–14 years. The intervention comprised an 11-week voluntary competitive sport-for-development football league. Participants who did not subscribe for the intervention formed a non-registered comparison group. Boys who registered for the sport-for-development programme were randomly allocated to the intervention or wait-listed. The girls programme subscription was insufficient to form a wait-list and all registrants received the intervention. Physical fitness was assessed by cardiorespiratory fitness (multi-stage fitness test), muscular power (standing broad jump) and body composition (BMI-for-age). Mental health was measured using the Acholi Psychosocial Assessment Instrument for local depression-like (DLS) and anxiety-like (ALS) syndromes. All randomisation was computer generated and assessors were masked to group allocation. An intention-to-treat analysis of adjusted effect size (ES) was applied. Results There were 1,462 adolescents in the study (intervention: boys = 74, girls = 81; wait-list: boys = 72; comparison: boys = 472, girls = 763). At four months follow-up there was no significant effect on the boys fitness when comparing intervention vs wait-listed and intervention vs non-registered groups. However, there was a negative effect on DLS when comparing boys intervention vs wait-listed (ES = 0.67 [0.33 to 1.00]) and intervention vs non-registered (ES = 0.25 [0.00 to 0.49]). Similar results were observed for ALS for

  16. A pedometer based physical activity self-management program for children and adolescents with physical disability – design and methods of the StepUp study

    PubMed Central

    2014-01-01

    Background Physical activity affords a wide range of physiological and psychological benefits for children and adolescents, yet many children with physical disabilities are insufficiently active to achieve these benefits. The StepUp program is a newly developed 6-week pedometer-based self-management program for children and adolescents with physical disability. Participants use a pedometer to undertake a 6-week physical activity challenge, with personalised daily step count goals set in consultation with a physiotherapist. The study aims to evaluate the effectiveness of the StepUp program, using a randomised control trial design. Methods/design A target sample of 70 young people with physical disabilities (aged 8–17 years, ambulant with or without aid, residing in Adelaide) will be recruited. Participants will be randomly allocated to either intervention or control following completion of baseline assessments. Assessments are repeated at 8 weeks (immediately post intervention) and 20 weeks (12 weeks post intervention). The primary outcome is objective physical activity determined from 7 day accelerometry, and the secondary outcomes are exercise intention, physical self-worth, quality of life and fatigue. Analyses will be undertaken on an intention-to-treat basis using random effects mixed modelling. Discussion This study will provide information about the potential of a low-touch and low-cost physical activity intervention for children and adolescents with cerebral palsy. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12613000023752. PMID:24490871

  17. Registration of 3-D images using weighted geometrical features

    SciTech Connect

    Maurer, C.R. Jr.; Aboutanos, G.B.; Dawant, B.M.; Maciunas, R.J.; Fitzpatrick, J.M.

    1996-12-01

    In this paper, the authors present a weighted geometrical features (WGF) registration algorithm. Its efficacy is demonstrated by combining points and a surface. The technique is an extension of Besl and McKay`s iterative closest point (ICP) algorithm. The authors use the WGF algorithm to register X-ray computed tomography (CT) and T2-weighted magnetic resonance (MR) volume head images acquired from eleven patients that underwent craniotomies in a neurosurgical clinical trial. Each patient had five external markers attached to transcutaneous posts screwed into the outer table of the skull. The authors define registration error as the distance between positions of corresponding markers that are not used for registration. The CT and MR images are registered using fiducial points (marker positions) only, a surface only, and various weighted combinations of points and a surface. The CT surface is derived from contours corresponding to the inner surface of the skull. The MR surface is derived from contours corresponding to the cerebrospinal fluid (CSF)-dura interface. Registration using points and a surface is found to be significantly more accurate than registration using only points or a surface.

  18. The Role of Religiousness/Spirituality in Health-Related Quality of Life Among Adolescents with HIV: A Latent Profile Analysis.

    PubMed

    Lyon, Maureen E; Kimmel, Allison L; Cheng, Yao Iris; Wang, Jichuan

    2016-10-01

    The purpose of this study was to determine whether distinct latent profiles of religiousness/spirituality exist for ALWH, and if so, are latent profile memberships associated with health-related quality of life (HRQoL). Latent profile analysis of religiosity identified four profiles/groups. Compared to the other three groups, higher levels of emotional well-being were found among young perinatally infected adolescents who attended religious services, but who did not pray privately, feel God's presence or identify as religious or spiritual. Social HRQoL was significantly higher among the highest overall religious/spiritual group. Understanding adolescent profiles of religiousness/spirituality on HRQoL could inform faith-based interventions. Trial registration NCT01289444. PMID:27071797

  19. 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…

  20. 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. PMID:26886261

  1. 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

  2. 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

  3. Adolescent Dose and Ratings of an Internet-Based Depression Prevention Program: A Randomized Trial of Primary Care Physician Brief Advice versus a Motivational Interview

    PubMed Central

    Van Voorhees, Benjamin W.; Fogel, Joshua; Pomper, Benjamin E.; Marko, Monika; Reid, Nicholas; Watson, Natalie; Larson, John; Bradford, Nathan; Fagan, Blake; Zuckerman, Steve; Wiedmann, Peggy; Domanico, Rocco

    2009-01-01

    Background Internet-based interventions for education and behavior change have proliferated, but most adolescents may not be sufficiently motivated to engage in Internet-based behavior change interventions. We sought to determine how two different forms of primary care physician engagement, brief advice (BA) versus motivational interview (MI), could enhance participation outcomes in an Internet-based depression prevention intervention. Methods Eighty-three adolescents at risk for developing major depression were recruited by screening in primary care and randomized to two groups: BA (1–2 minutes) + Internet program versus MI (10–15 minutes) + Internet program. We compared measures of participation and satisfaction for the two groups for a minimum of 12 months after enrollment. Results Both groups engaged the site actively (MI: 90% versus BA: 78%, p=0.12). MI had significantly higher levels of engagement than BA for measures including total time on site (143.7 minutes versus 100.2 minutes, p=0.03), number of sessions (8.16 versus 6.00, p=0.04), longer duration of session activity on Internet site (46.2 days versus 29.34 days, p=0.04), and with more characters typed into exercises (3532 versus 2004, p=0.01). Adolescents in the MI group reported higher trust in their physician (4.18 versus 3.74, p=0.05) and greater satisfaction with the Internet-based component (7.92 versus 6.66, p=0.01). Conclusions Primary care engagement, particularly using motivational interviewing, may increase Internet use dose, and some elements enhance and intensify adolescent use of an Internet-based intervention over a one to two month period. Primary care engagement may be a useful method to facilitate adolescent involvement in preventive mental health interventions. PMID:20694059

  4. METFORMIN: an efficacy, safety and pharmacokinetic study on the short-term and long-term use in obese children and adolescents – study protocol of a randomized controlled study

    PubMed Central

    2014-01-01

    Background The prevalence of childhood obesity and insulin resistance is rising, increasing the risk of diabetes mellitus type 2. To prevent these complications, lifestyle intervention is the corner stone in treatment. However, long-term efficacy of lifestyle intervention is questionable. In addition to lifestyle intervention, pharmacological treatments have been explored. Metformin has been shown to be moderately effective to reduce BMI in obese adolescents with hyperinsulinemia. However, data on pharmacokinetics and long-term efficacy and safety are lacking as well as an evidence-based dosing regimen for this age group. The primary objective of the METFORMIN study is to determine the effect of adding metformin treatment to lifestyle intervention in reducing BMI in obese adolescents with insulin resistance. In addition, the pharmacokinetics of metformin in obese adolescents will be studied. Methods/design The METFORMIN study is a multi-centre prospective study that consists of two 18-month phases: a double-blind randomized placebo-controlled trial (part 1) and an open-label follow-up study (part 2). During part 1, the participants will be given metformin 1,000 mg or placebo twice daily and will be offered a lifestyle intervention programme; 144 participants will be included, 72 in each arm. Primary endpoints are reduction in body mass index, insulin resistance, and percentage body fat. Discussion This study will provide data on short- and long-term efficacy and safety of metformin and on the pharmacokinetics of metformin in obese adolescents. Trial registration ClinicalTrials.gov number NCT01487993; EudraCT nr. 2010-023980-17. Registration date: 06-01-2011 PMID:24899137

  5. 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

  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. 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

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 9 CFR 381.179 - Registration.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 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. 40 CFR 79.13 - Registration.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... OF FUELS AND FUEL ADDITIVES Fuel Registration Procedures § 79.13 Registration. (a) If the Administrator determines that a manufacturer has submitted an application for registration of a designated fuel... the fuel and notify the fuel manufacturer of such registration. (b) The Administrator shall maintain...

  20. 40 CFR 79.13 - Registration.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... OF FUELS AND FUEL ADDITIVES Fuel Registration Procedures § 79.13 Registration. (a) If the Administrator determines that a manufacturer has submitted an application for registration of a designated fuel... the fuel and notify the fuel manufacturer of such registration. (b) The Administrator shall maintain...

  1. A randomized controlled trial comparing two cognitive-behavioral programs for adolescent girls with subclinical depression: A school-based program (Op Volle Kracht) and a computerized program (SPARX).

    PubMed

    Poppelaars, Marlou; Tak, Yuli R; Lichtwarck-Aschoff, Anna; Engels, Rutger C M E; Lobel, Adam; Merry, Sally N; Lucassen, Mathijs F G; Granic, Isabela

    2016-05-01

    Limited research has indicated the effectiveness of the school-based Cognitive Behavioral Therapy (CBT) prevention program 'Op Volle Kracht (OVK)' and the computerized CBT program 'SPARX' in decreasing depressive symptoms. Therefore, a randomized controlled trial of the effectiveness of OVK and SPARX was conducted among Dutch female adolescents (n = 208, mean age = 13.35) with elevated depressive symptoms. Participants were randomly assigned to one of four conditions: OVK only (n = 50), SPARX only (n = 51), OVK and SPARX combined (n = 56) and a monitoring control condition (n = 51). Participants in the first three conditions received OVK lessons and/or the SPARX game. Depressive symptoms were assessed before interventions started, weekly during the interventions, and immediately after the interventions ended, with follow-up assessments at 3, 6 and 12 months. Intention to treat results showed that depressive symptoms decreased in all conditions (F(12, 1853.03) = 14.62, p < .001), with no difference in depressive symptoms between conditions. Thus, all conditions, including the monitoring control condition, were equally effective in reducing depressive symptoms. Possible explanations for the decrease of depressive symptoms in all conditions are discussed and suggestions for future research are provided. Dutch Trial Register: NTR3737. PMID:27019280

  2. 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.

  3. A randomised controlled trial of a theory-based intervention to improve sun protective behaviour in adolescents ('you can still be HOT in the shade'): study protocol

    PubMed Central

    2012-01-01

    Background Most skin cancers are preventable by encouraging consistent use of sun protective behaviour. In Australia, adolescents have high levels of knowledge and awareness of the risks of skin cancer but exhibit significantly lower sun protection behaviours than adults. There is limited research aimed at understanding why people do or do not engage in sun protective behaviour, and an associated absence of theory-based interventions to improve sun safe behaviour. This paper presents the study protocol for a school-based intervention which aims to improve the sun safe behaviour of adolescents. Methods/design Approximately 400 adolescents (aged 12-17 years) will be recruited through Queensland, Australia public and private schools and randomized to the intervention (n = 200) or 'wait-list' control group (n = 200). The intervention focuses on encouraging supportive sun protective attitudes and beliefs, fostering perceptions of normative support for sun protection behaviour, and increasing perceptions of control/self-efficacy over using sun protection. It will be delivered during three × one hour sessions over a three week period from a trained facilitator during class time. Data will be collected one week pre-intervention (Time 1), and at one week (Time 2) and four weeks (Time 3) post-intervention. Primary outcomes are intentions to sun protect and sun protection behaviour. Secondary outcomes include attitudes toward performing sun protective behaviours (i.e., attitudes), perceptions of normative support to sun protect (i.e., subjective norms, group norms, and image norms), and perceived control over performing sun protective behaviours (i.e., perceived behavioural control). Discussion The study will provide valuable information about the effectiveness of the intervention in improving the sun protective behaviour of adolescents. PMID:22212211

  4. Collaborative Care for Adolescents With Depression in Primary Care

    PubMed Central

    Richardson, Laura P.; Ludman, Evette; McCauley, Elizabeth; Lindenbaum, Jeff; Larison, Cindy; Zhou, Chuan; Clarke, Greg; Brent, David; Katon, Wayne

    2015-01-01

    differences between groups. At 12 months, intervention youth were more likely than control youth to achieve depression response (67.6%vs 38.6%, OR = 3.3, 95%CI, 1.4–8.2; P = .009) and remission (50.4%vs 20.7%, OR = 3.9, 95%CI, 1.5–10.6; P = .007). CONCLUSIONS AND RELEVANCE Among adolescents with depression seen in primary care, a collaborative care intervention resulted in greater improvement in depressive symptoms at 12 months than usual care. These findings suggest that mental health services for adolescents with depression can be integrated into primary care. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01140464. PMID:25157724

  5. 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

  6. Flexible Lifestyles for Youth (FL3X) behavioural intervention for at-risk adolescents with Type 1 diabetes: a randomized pilot and feasibility trial

    PubMed Central

    Mayer-Davis, E. J.; Seid, M.; Crandell, J.; Dolan, L.; Lagarde, W. H.; Letourneau, L.; Maahs, D. M.; Marcovina, S.; Nachreiner, J.; Standiford, D.; Thomas, J.; Wysocki, T.

    2014-01-01

    Aim To determine the potential effect sizes for the Flexible Lifestyle for Youth (FL3X) behavioural intervention to improve glycaemic control (HbA1c) and quality of life for at-risk adolescents with Type 1 diabetes. Methods Participants [n=61; age 12–16 years, HbA1c 64–119 mmol/mol (8–13%)] were randomized to FL3X (minimum three sessions) or usual care. Effect sizes (Cohen’s d), comparing the mean difference between the groups, were calculated. Results Study retention (95%), attendance at intervention sessions (87% attended all three sessions) and acceptability were high (100% of the adolescents and 91% of parents would recommend the programme to others). Overall, 41% of participants in the intervention group and 24% of participants in the control group were ‘responders’ [HbA1c decreased by > 6 mmol/mol (0.5%); d=0.37]. HbA1c levels decreased (d= −0.18), diabetes-specific quality of life increased (d=0.29), but generic quality of life decreased (d= −0.23) in the intervention compared with the control group. Conclusions The FL3X programme merits further study for improving HbA1c and diabetes-specific quality of life in adolescents with Type 1 diabetes. PMID:25424501

  7. Community embedded reproductive health interventions for adolescents in Latin America: development and evaluation of a complex multi-centre intervention

    PubMed Central

    2013-01-01

    Background Adolescents in Latin America are at high risk for unwanted and unplanned pregnancies, which often result in unsafe abortions or poor maternal health outcomes. Both young men and women in the region face an increased risk of sexually transmitted infections due to inadequate sexual and reproductive health information, services and counselling. To date, many adolescent health programmes have targeted a single determinant of sexual and reproductive health. However, recent evidence suggests that the complexity of sexual and reproductive health issues demands an equally multi-layered and comprehensive approach. Methods This article describes the development, implementation and evaluation design of the community-embedded reproductive health care for adolescents (CERCA) study in three Latin American cities: Cochabamba (Bolivia), Cuenca (Ecuador) and Managua (Nicaragua). Project CERCA’s research methodology builds on existing methodological frameworks, namely: action research, community based participatory research and intervention-mapping. The interventions in each country address distinct target groups (adolescents, parents, local authorities and health providers) and seek improvement of the following sexual health behaviours: communication about sexuality, sexual and reproductive health information-seeking, access to sexual and reproductive health care and safe sexual relationships. In Managua, we implemented a randomised controlled study, and in Cochabamba and Cuenca we adopted a non-randomised controlled study to evaluate the effectiveness of Project CERCA interventions, in addition to a process evaluation. Discussion This research will result in a methodological framework that will contribute to the improved design and implementation of future adolescent sexual and reproductive health interventions. Trial registration ClinicalTrials.gov (NCT01722084) PMID:23311647

  8. 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...

  9. 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

  10. [Registration of ethnicity allowed with conditions].

    PubMed

    Ploem, M C Corrette

    2009-01-01

    Registration of an individual's ethnicity is, in the light of the potential risks of stigmatization and discrimination, rightfully considered a sensitive issue. Traditionally, privacy legislation offers special legal protection in the collection, registration etc. of data relating to race and ethnic background. However, if it can be established that registration of ethnicity is necessary for providing good care, registration is lawful. However, registration for health research purposes requires the explicit consent of the persons involved. PMID:19785803

  11. Smoking cessation treatment for adolescents.

    PubMed

    Karpinski, Julie P; Timpe, Erin M; Lubsch, Lisa

    2010-10-01

    Cigarette smoking in the adolescent population remains a public health concern. A significant portion of the adolescent population currently uses tobacco. Nicotine is particularly addicting in adolescents, and quitting is difficult. The goals for adolescent cigarette smoking efforts must include both primary prevention and smoking cessation. Bupropion and nicotine replacement therapies-including nicotine patches, gum, and nasal spray-have been studied to a limited extent in the adolescent population. Varenicline has not been evaluated as a treatment modality in adolescents. Long-term quit rates in the pharmacotherapy trials have not been optimal; however, decreases in cigarettes smoked per day have been observed. Several evidencebased guidelines include recommendations for smoking cessation in adolescents that include counseling and pharmacotherapy. Pharmacotherapy may be instituted for some adolescents in addition to counseling and behavioral interventions. Therapy should be individualized, based on smoking patterns, patient preferences, and concomitant disease states. Smoking cessation support for parents should be instituted as well. The pharmacist can play a large role in helping the adolescent quit smoking. Further studies evaluating pharmacotherapy options for smoking cessation in adolescents are necessary. If pharmacotherapy is used, it should be individualized and combined with psychosocial and behavioral interventions. PMID:22477813

  12. Prevention of Depression in At-Risk Adolescents

    PubMed Central

    Garber, Judy; Clarke, Gregory N; Robin Weersing, V; Beardslee, William R.; Brent, David A.; Gladstone, Tracy R. G.; DeBar, Lynn L.; Lynch, Frances L.; D’Angelo, Eugene; Hollon, Steven D.; Shamseddeen, Wael; Iyengar, Satish

    2009-01-01

    baseline, the CB prevention program was more effective in preventing onset of depression than usual care (11.7% vs 40.5%; HR, 0.24; 95% CI, 0.11–0.50), whereas for adolescents with a currently depressed parent, the CB prevention program was not more effective than usual care in preventing incident depression (31.2% vs 24.3%; HR, 1.43; 95% CI, 0.76–2.67). Conclusion The CB prevention program had a significant prevention effect through the 9-month follow-up period based on both clinical diagnoses and self-reported depressive symptoms, but this effect was not evident for adolescents with a currently depressed parent. Trial Registration clinicaltrials.gov Identifier: NCT00073671 PMID:19491183

  13. Baseline Factors Predicting Placebo Response to Treatment in Children and Adolescents With Autism Spectrum Disorders

    PubMed Central

    King, Bryan H.; Dukes, Kimberly; Donnelly, Craig L.; Sikich, Linmarie; McCracken, James T.; Scahill, Lawrence; Hollander, Eric; Bregman, Joel D.; Anagnostou, Evdokia; Robinson, Fay; Sullivan, Lisa; Hirtz, Deborah

    2016-01-01

    -Compulsive Scale). Family measures included the Caregiver Strain Questionnaire. RESULTS Several baseline predictors of response were identified, and a principal component analysis yielded 3 composite measures (disruptive behavior, autism/mood, and caregiver strain) that significantly predicted response at week 12. Specifically, participants in the placebo group were significantly less likely than participants in the citalopram group to respond at week 12 if they entered the study more symptomatic on each of the 3 composite measures, and they were at least 2 times less likely to be responders. CONCLUSIONS AND RELEVANCE This analysis suggests strategies that may be useful in anticipating and potentially mitigating the nonspecific response in randomized clinical trials of children and adolescents with autism spectrum disorders. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00086645 PMID:24061784

  14. Local image registration a comparison for bilateral registration mammography

    NASA Astrophysics Data System (ADS)

    Celaya-Padilaa, José M.; Rodriguez-Rojas, Juan; Trevino, Victor; Tamez-Pena, José G.

    2013-11-01

    Early tumor detection is key in reducing the number of breast cancer death and screening mammography is one of the most widely available and reliable method for early detection. However, it is difficult for the radiologist to process with the same attention each case, due the large amount of images to be read. Computer aided detection (CADe) systems improve tumor detection rate; but the current efficiency of these systems is not yet adequate and the correct interpretation of CADe outputs requires expert human intervention. Computer aided diagnosis systems (CADx) are being designed to improve cancer diagnosis accuracy, but they have not been efficiently applied in breast cancer. CADx efficiency can be enhanced by considering the natural mirror symmetry between the right and left breast. The objective of this work is to evaluate co-registration algorithms for the accurate alignment of the left to right breast for CADx enhancement. A set of mammograms were artificially altered to create a ground truth set to evaluate the registration efficiency of DEMONs , and SPLINE deformable registration algorithms. The registration accuracy was evaluated using mean square errors, mutual information and correlation. The results on the 132 images proved that the SPLINE deformable registration over-perform the DEMONS on mammography images.

  15. Medical and psychosocial implications of adolescent extreme obesity – acceptance and effects of structured care, short: Youth with Extreme Obesity Study (YES)

    PubMed Central

    2013-01-01

    elucidate medical and psychosocial outcomes. Our aim is to evaluate realistic treatment options. Therefore inclusion and exclusion criteria are minimized. We will recruit adolescents (age range 14–21 years) with extreme obesity (BMI ≥ 35 kg/m2) (extreme group) within 24 months (120 per centre, 5 centres) as well as obese adolescents being at risk for developing extreme obesity (BMI ≥ 30 – 34.9 kg/m2) (at risk group). Follow-up evalutations will be performed biannually after inclusion for several years depending on additional funding. In sum, we aim at establishing evaluated health care structures for extremely obese adolescents. Discussion The results of YES will be of importance for a frequently neglected group of individuals, for whom current medicine has little to offer in terms of structured access to empirically evaluated therapeutic programs. Thus, the results will be both a help for the adolescents within the study and for others in the future given that the trial will lead to a positive finding. Moreover, it will help practitioners and therapists to deal with this neglected group of individuals. Trial registration Project registration numbers for each subproject: 1.) ClinicalTrials.gov: NCT01625325, NCT01703273, NCT01662271, NCT01632098; 2.) Germanctr.de: DRKS00004172, DRKS00004195, DRKS00004198, DRKS00004197. PMID:23987123

  16. Mapping Evidence-Based Treatments for Children and Adolescents: Application of the Distillation and Matching Model to 615 Treatments from 322 Randomized Trials

    ERIC Educational Resources Information Center

    Chorpita, Bruce F.; Daleiden, Eric L.

    2009-01-01

    This study applied the distillation and matching model to 322 randomized clinical trials for child mental health treatments. The model involved initial data reduction of 615 treatment protocol descriptions by means of a set of codes describing discrete clinical strategies, referred to as practice elements. Practice elements were then summarized in…

  17. A Brief, Low-Cost, Theory-Based Intervention to Promote Dual Method Use by Black and Latina Female Adolescents: A Randomized Clinical Trial

    ERIC Educational Resources Information Center

    Roye, Carol; Perlmutter Silverman, Paula; Krauss, Beatrice

    2007-01-01

    HIV/AIDS disproportionately affects young women of color. Young women who use hormonal contraception are less likely to use condoms. Brief, inexpensive HIV-prevention interventions are needed for high-volume clinics. This study was a randomized clinical trial of two interventions: (a) a video made for this study and (b) an adaptation of Project…

  18. [Physiological adolescence, pathological adolescence].

    PubMed

    Olié, Jean-Pierre; Gourion, David; Canceil, Olivier; Lôo, Henri

    2006-11-01

    The uncertainties of looming adulthood, nostalgia for childhood, and a general malaise explain the crisis of adolescence. Rebellion, conflict, occasional failure at school or in society, and at-risk behaviors are not always signs of future psychiatric illness. In contrast, the physician must be in a position to identify tell-tale signs such as dysmorphophobia, existential anxiety, a feeling of emptiness, and school or social breakdown. Most psychiatric disorders that begin in adolescence are only diagnosed several years after onset. Yet early diagnosis is of utmost importance, as treatment becomes less effective and the long-term prognosis worsens with time. Suicide is the second cause of death during adolescence. All signs of suicidal behavior require hospitalization and evaluation in a psychiatric unit. Antidepressants may be necessary in adolescence. The recent controversy concerning a possible increase in the suicidal risk during antidepressant treatment should not mask the fact that the real public health issue is depression, and not antidepressants. Eating disorders are especially frequent among adolescent girls; it is important to identify psychiatric comorbidities such as schizophrenia, depression and obsessive-compulsive disorders, and to assess the vital risk. Illicit drug and alcohol consumption are frequent during adolescence; for example, close to half of all French adolescents have tried cannabis at least once. Once again, it is important to detect psychiatric comorbidities in substance-abusing adolescents. Phobia is an underdiagnosed anxiety disorder among adolescents; it may become chronic if proper treatment is not implemented, leading to suffering and disability. Finally, two major psychiatric disorders--schizophrenia and bipolar disorder--generally begin in adolescence. Treatment efficacy and the long-term prognosis both depend on early diagnosis. Treatment must be tailored to the individual patient. "Borderline" states are over

  19. Effects of an Adolescent Sexual and Reproductive Health Intervention on Health Service Usage by Young People in Northern Ghana: A Community-Randomised Trial

    PubMed Central

    Aninanya, Gifty Apiung; Debpuur, Cornelius Y.; Awine, Timothy; Williams, John E.; Hodgson, Abraham; Howard, Natasha

    2015-01-01

    Background While many Ghanaian adolescents encounter sexual and reproductive health problems, their usage of services remains low. A social learning intervention, incorporating environment, motivation, education, and self-efficacy to change behaviour, was implemented in a low-income district of northern Ghana to increase adolescent services usage. This study aimed to assess the impact of this intervention on usage of sexual and reproductive health services by young people. Methods Twenty-six communities were randomly allocated to (i) an intervention consisting of school-based curriculum, out-of-school outreach, community mobilisation, and health-worker training in youth-friendly health services, or (ii) comparison consisting of community mobilisation and youth-friendly health services training only. Outcome measures were usage of sexually-transmitted infections (STIs) management, HIV counselling and testing, antenatal care or perinatal services in the past year and reported service satisfaction. Data was collected, at baseline and three years after, from a cohort of 2,664 adolescents aged 15–17 at baseline. Results Exposure was associated with over twice the odds of using STI services (AOR 2.47; 95%CI 1.78–3.42), 89% greater odds of using perinatal services (AOR 1.89; 95%CI 1.37–2.60) and 56% greater odds of using antenatal services (AOR 1.56; 95%CI 1.10–2.20) among participants in intervention versus comparison communities, after adjustment for baseline differences. Conclusions The addition of targeted school-based and outreach activities increased service usage by young people more than community mobilisation and training providers in youth-friendly services provision alone. PMID:25928562

  20. Body composition and energy intake - skeletal muscle mass is the strongest predictor of food intake in obese adolescents: The HEARTY trial.

    PubMed

    Cameron, Jameason D; Sigal, Ronald J; Kenny, Glen P; Alberga, Angela S; Prud'homme, Denis; Phillips, Penny; Doucette, Steve; Goldfield, Gary

    2016-06-01

    There has been renewed interest in examining the relationship between specific components of energy expenditure and the overall influence on energy intake (EI). The purpose of this cross-sectional analysis was to determine the strongest metabolic and anthropometric predictors of EI. It was hypothesized that resting metabolic rate (RMR) and skeletal muscle mass would be the strongest predictors of EI in a sample of overweight and obese adolescents. 304 post-pubertal adolescents (91 boys, 213 girls) aged 16.1 (±1.4) years with body mass index at or above the 95th percentile for age and sex OR at or above the 85th percentile plus an additional diabetes risk factor were measured for body weight, RMR (kcal/day) by indirect calorimetry, body composition by magnetic resonance imaging (fat free mass (FFM), skeletal muscle mass, fat mass (FM), and percentage body fat), and EI (kcal/day) using 3 day food records. Body weight, RMR, FFM, skeletal muscle mass, and FM were all significantly correlated with EI (p < 0.005). After adjusting the model for age, sex, height, and physical activity, only FFM (β = 21.9, p = 0.007) and skeletal muscle mass (β = 25.8, p = 0.02) remained as significant predictors of EI. FFM and skeletal muscle mass also predicted dietary protein and fat intake (p < 0.05), but not carbohydrate intake. In conclusion, with skeletal muscle mass being the best predictor of EI, our results support the hypothesis that the magnitude of the body's lean tissue is related to absolute levels of EI in a sample of inactive adolescents with obesity. PMID:27111402

  1. Participant-Perceived Quality of Life in a Long-Term, Open-Label Trial of Lisdexamfetamine Dimesylate in Adolescents with Attention-Deficit/Hyperactivity Disorder

    PubMed Central

    Cutler, Andrew J.; Saylor, Keith; Gasior, Maria; Hamdani, Mohamed; Ferreira-Cornwell, M. Celeste; Findling, Robert L.

    2014-01-01

    Abstract Objectives: The purpose of this study was to assess long-term improvement in quality of life (QOL) in adolescents with attention-deficit/hyperactivity disorder (ADHD) treated with lisdexamfetamine dimesylate (LDX). Methods: Adolescents with ADHD treated for ≥3 weeks in a 4 week, placebo-controlled study entered a 1 year, open-label study. After the 4 week dose optimization (30, 50, and 70 mg/day LDX) period, treatment was maintained for 48 additional weeks. Change from baseline (of prior study) to week 52/early termination (ET) (of open-label study) in ADHD Rating Scale IV (ADHD-RS-IV) assessed effectiveness, and the Youth QOL-Research Version (YQOL-R) assessed participant-perceived QOL. Post-hoc analyses described effectiveness and QOL for participants with self-perceived poor QOL at baseline (≥1 SD below the mean) versus all others, and for study completers versus study noncompleters. Results: These post-hoc analyses included 265 participants. Participants with baseline self-perceived poor QOL (n=32) versus all others (n=232) exhibited robust YQOL-R perceptual score changes (improvement) with LDX, emerging by week 28 and maintained to week 52/ET. Week 52/ET mean change score ranged from +9.8 to +17.6 for participants with baseline self-perceived poor QOL and +0.4 to +5.1 for all others; week 52/ET improvements in ADHD-RS-IV total scores were similar, regardless of baseline YQOL-R total score. At week 52/ET, study completers had greater YQOL-R improvements than did noncompleters; ADHD-RS-IV total score changes were also numerically larger at week 52/ET for completers than for noncompleters. Conclusion: Participant-perceived QOL and ADHD symptoms improved from baseline with LDX in adolescents with ADHD; greatest improvements occurred among participants with baseline self-perceived poor QOL. PMID:24815910

  2. Randomized controlled trials of psychological therapies for management of chronic pain in children and adolescents: an updated meta-analytic review

    PubMed Central

    Palermo, Tonya M.; Eccleston, Christopher; Lewandowski, Amy S.; Williams, Amanda C de C; Morley, Stephen

    2009-01-01

    The purpose of this meta-analytic review was to quantify the effects of psychological therapies for the management of chronic pain in youth. Specifically, in this review we updated previous systematic reviews of randomized controlled trials by including new trials, and by adding disability and emotional functioning to pain as treatment outcomes. Electronic searches of the Cochrane Register of Randomised Controlled Trials, MEDLINE, PsycLIT, EMBASE, and the Social Sciences Citation Index were conducted from inception through August 2008. Methodological quality of the studies was assessed, and data extracted on the three primary outcomes of interest. Twenty-five trials including 1247 young people met inclusion criteria and were included in the meta-analysis. Meta-analytic findings demonstrated a large positive effect of psychological intervention on pain reduction at immediate post-treatment and follow-up in youth with headache, abdominal pain, and fibromyalgia. Small and non-significant effects were found for improvements in disability and emotional functioning, although there were limited data on these outcomes available in the included studies. Omnibus cognitive-behavioral therapy, relaxation therapy, and biofeedback all produced significant and positive effects on pain reduction. Studies directly comparing the effects of self-administered versus therapist-administered interventions found similar effects on pain reduction. Psychological therapies result in improvement in pain relief across several different pain conditions in children. Future trials are needed that incorporate non-pain outcome domains, that focus significant therapeutic content on reductions in disability, and that include extended follow up to better understand maintenance of treatment effects. PMID:19910118

  3. 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.

  4. Is Visual Registration Equivalent to Semiautomated Registration in Prostate Biopsy?

    PubMed Central

    Kwak, Jin Tae; Hong, Cheng William; Pinto, Peter A.; Williams, Molly; Xu, Sheng; Kruecker, Jochen; Yan, Pingkun; Turkbey, Baris; Choyke, Peter L.; Wood, Bradford J.

    2015-01-01

    In magnetic resonance iimaging- (MRI-) ultrasound (US) guided biopsy, suspicious lesions are identified on MRI, registered on US, and targeted during biopsy. The registration can be performed either by a human operator (visual registration) or by fusion software. Previous studies showed that software registration is fairly accurate in locating suspicious lesions and helps to improve the cancer detection rate. Here, the performance of visual registration was examined for ability to locate suspicious lesions defined on MRI. This study consists of 45 patients. Two operators with differing levels of experience (<1 and 18 years) performed visual registration. The overall spatial difference by the two operators in 72 measurements was 10.6 ± 6.0 mm. Each operator showed a spatial difference of 9.4 ± 5.1 mm (experienced; 39 lesions) and 12.1 ± 6.6 mm (inexperienced; 33 lesions), respectively. In a head-to-head comparison of the same 16 lesions from 12 patients, the spatial differences were 9.7 mm ± 4.9 mm (experienced) and 13.4 mm ± 7.4 mm (inexperienced). There were significant differences between the two operators (unpaired, P value = 0.042; paired, P value = 0.044). The substantial differences by the two operators suggest that visual registration could improperly and inaccurately target many tumors, thereby potentially leading to missed diagnosis or false characterization on pathology. PMID:25821799

  5. Intestinal permeability in children/adolescents with functional dyspepsia

    PubMed Central

    2014-01-01

    Background An altered intestinal mucosal barrier has been demonstrated in subsets of patients with IBS and FAP and may be an additional biological factor contributing to symptom generation in children with FD. The objective of this study was to determine if intestinal permeability is increased in children/adolescents with functional dyspepsia (FD) and whether intestinal permeability is correlated with mucosal inflammation and/or symptoms of anxiety or depression in this population. Methods A sugar absorption test was performed in 19 patients with FD and 19 controls. Anxiety and depression were assessed in both groups utilizing a standard questionnaire. In FD patients, duodenal mean and peak mast cell and eosinophil densities were determined. Results Intestinal permeability as measured by the sugar absorption test did not differ between children with FD and controls. In children with FD, there was no correlation between permeability and mast cell density, eosinophil density, anxiety scores, or depression scores, respectively. Conclusions Pediatric FD does not appear to be associated with increased small bowel intestinal permeability, however, there are some limitations to the current study. Trial registration ClinicalTrials.gov; NCT00363597. PMID:24886078

  6. Scan registration using planar features

    NASA Astrophysics Data System (ADS)

    Previtali, M.; Barazzetti, L.; Brumana, R.; Scaioni, M.

    2014-06-01

    Point cloud acquisition by using laser scanners provides an efficient way for 3D as-built modelling of indoor/outdoor urban environments. In the case of large structures, multiple scans may be required to cover the entire scene and registration is needed to merge them together. In general, the identification of corresponding geometric features among a series of scans can be used to compute the 3D rigid-body transformation useful for the registration of each scan into the reference system of the final point cloud. Different automatic or semi-automatic methods have been developed to this purpose. Several solutions based on artificial targets are available, which however may not be suitable in any situations. Methods based on surface matching (like ICP and LS3D) can be applied if the scans to align have a proper geometry and surface texture. In the case of urban and architectural scenes that present the prevalence of a few basic geometric shapes ("Legoland" scenes) the availability of many planar features is exploited here for registration. The presented technique does not require artificial targets to be added to the scanned scene. In addition, unlike other surface-based techniques (like ICP) the planar feature-based registration technique is not limited to work in a pairwise manner but it can handle the simultaneous alignment of multiple scans. Finally, some applications are presented and discussed to show how this technique can achieve accuracy comparable to a consolidated registration method.

  7. Functional outcomes from a head-to-head, randomized, double-blind trial of lisdexamfetamine dimesylate and atomoxetine in children and adolescents with attention-deficit/hyperactivity disorder and an inadequate response to methylphenidate.

    PubMed

    Nagy, Peter; Häge, Alexander; Coghill, David R; Caballero, Beatriz; Adeyi, Ben; Anderson, Colleen S; Sikirica, Vanja; Cardo, Esther

    2016-02-01

    Attention-deficit/hyperactivity disorder (ADHD) is associated with functional impairments in multiple domains of patients' lives. A secondary objective of this randomized, active-controlled, head-to-head, double-blind, dose-optimized clinical trial was to compare the effects of lisdexamfetamine dimesylate (LDX) and atomoxetine (ATX) on functional impairment in children and adolescents with ADHD. Patients aged 6-17 years with an ADHD Rating Scale IV total score ≥ 28 and an inadequate response to methylphenidate treatment (judged by investigators) were randomized (1:1) to once-daily LDX or ATX for 9 weeks. Parents/guardians completed the Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P) at baseline and at week 9 or early termination. p values were nominal and not corrected for multiple comparisons. Of 267 randomized patients, 200 completed the study (LDX 99, ATX 101). At baseline, mean WFIRS-P total score in the LDX group was 0.95 [standard deviation (SD) 0.474; 95% confidence interval (CI) 0.87, 1.03] and in the ATX group was 0.91 (0.513; 0.82, 1.00). Scores in all WFIRS-P domains improved from baseline to endpoint in both groups, with least-squares mean changes in total score of -0.35 (95% CI -0.42, -0.29) for LDX and -0.27 (-0.33, -0.20) for ATX. The difference between LDX and ATX was statistically significant (p < 0.05) for the Learning and School (effect size of LDX vs ATX, 0.43) and Social Activities (0.34) domains and for total score (0.27). Both treatments reduced functional impairment in children and adolescents with ADHD; LDX was statistically significantly more effective than ATX in two of six domains and in total score. PMID:25999292

  8. Results of the randomized international FAB/LMB96 trial for intermediate risk B-cell non-Hodgkin lymphoma in children and adolescents: it is possible to reduce treatment for the early responding patients

    PubMed Central

    Auperin, Anne; Gerrard, Mary; Michon, Jean; Pinkerton, Ross; Sposto, Richard; Weston, Claire; Raphael, Martine; Perkins, Sherrie L.; McCarthy, Keith; Cairo, Mitchell S.

    2007-01-01

    A previous study (LMB89) of the French Society of Pediatric Oncology for childhood mature B-cell lymphoma (B-NHL) demonstrated a 92% 3-year event-free survival (EFS) for intermediate-risk group B defined as “non-resected” stage I/II and CNS-negative advanced-stage III/IV (70% of cases). We performed the FAB/LMB96 trial to assess the possibility of reducing treatment in children/adolescents with intermediate-risk B-NHL without jeopardizing survival. “Early responding” patients (tumor response > 20% at day 7) were randomized in a factorial design between 4 arms, 2 receiving half-dose of cyclophosphamide in the second induction course with cyclophosphamide, Oncovin (vincristine), prednisone, Adriamycin (doxorubicin), methotrexate (COPADM) and 2 not receiving the maintenance course M1. A total of 657 patients were randomized (May 1996 to June 2001) and 637 were analyzed. The analysis showed no significant effect of any of the treatment reductions on EFS and survival. The 4-year EFS was 93.4% and 90.9% in the groups with full-dose and half-dose of cyclophosphamide (RR = 1.3, P = .40) and 91.9% and 92.5% in the groups with and without M1 (RR = 1.01, P = .98). There was no interaction between the 2 treatment reductions or between each treatment reduction and LDH level or histologic subtypes (Burkitt/Burkitt-like or large B-cell). Children/adolescents with intermediate-risk B-NHL who have an early response and achieve a complete remission after the first consolidation course can be cured with a 4-course treatment with a total dose of only 3.3 g/m2 cyclophosphamide and 120 mg/m2 doxorubicin. PMID:17132719

  9. ‘Physical Activity 4 Everyone’ school-based intervention to prevent decline in adolescent physical activity levels: 12 month (mid-intervention) report on a cluster randomised trial

    PubMed Central

    Sutherland, Rachel; Campbell, Elizabeth; Lubans, David R; Morgan, Philip J; Okely, Anthony D; Nathan, Nicole; Wolfenden, Luke; Wiese, Jarrod; Gillham, Karen; Hollis, Jenna; Wiggers, John

    2016-01-01

    Background Adolescence is a recognised period of physical activity decline, particularly among low-income communities. We report the 12-month (midpoint) effects of a 2-year multicomponent physical activity intervention implemented in disadvantaged secondary schools. Methods A cluster randomised trial was undertaken in 10 secondary schools located in disadvantaged areas in New South Wales, Australia. Students in Grade 7 were recruited, with follow-up in Grade 8. The intervention was guided by socioecological theory and included seven physical activity strategies, and six implementation adoption strategies. The primary outcome was mean minutes of moderate-to-vigorous physical activity (MVPA) per day assessed using Actigraph GT3X accelerometers. Outcome data were analysed using repeated measures linear mixed models. Results At baseline, 1150 (93%) students participated in the data collection (mean age 12 years, 48% boys) and 1050 (79%) students participated at 12-month follow-up. By the 12-month follow-up, the six implementation adoption strategies had been used to support schools to deliver four of the seven physical activity elements. There was a significant group-by-time interaction for mean minutes of MVPA per day in favour of the intervention group (adjusted difference between groups at follow-up=3.85 min, 95% CI (0.79 to 6.91), p≤0.01), including significantly more vigorous physical activity (2.45 min, p≤0.01), equating to 27 min more MVPA per week. Summary At 12-month follow-up, the intervention had reduced the decline in physical activity among adolescents from disadvantaged schools. The intervention may assist students to meet physical activity guidelines. PMID:26359346

  10. Review of the Registration in the Clinical Research Information Service

    PubMed Central

    2016-01-01

    Clinical research registration is required in many countries to improve transparency of clinical research and to ensure subject safety. Developed in February 2010, the Clinical Research Information Service (CRIS) is an online registration system for clinical studies in Korea and one of the primary registries of the World Health Organization (WHO) International Clinical Trials Registry Platform. The present analysis investigated the characteristics of studies registered in the CRIS between February 2010 and December 2014. Data for the analysis were extracted from the CRIS database. As of December 31, 2014, 1,323 clinical studies were registered. Of these, 938 (70.9%) were interventional studies and 385 (29.1%) were observational studies. A total of 248 (18.7%) studies were funded by government sources, 1,051 (79.4%) by non-government sources, and 24 (1.8%) by both. The most frequently studied disease category based on the ICD-10 classification was the digestive system (13.1%), followed by the nervous system (9.4%) and musculoskeletal system (9.1%). Only 17.8% of the studies were registered prior to enrollment of the first subject. Comparing the number of registered or approved clinical studies between the CRIS, the Ministry of Food and Drug Safety, and ClinicalTrials.gov suggests that a considerable number of clinical studies are not registered with the CRIS; therefore, we would suggest that such registration should be the mandatory legal requirement. PMID:26770030

  11. Evaluation of a new syringe presentation of reduced-antigen content diphtheria, tetanus, and acellular pertussis vaccine in healthy adolescents - A single blind randomized trial

    PubMed Central

    Pavia-Ruz, Noris; Abarca, Katia; Lepetic, Alejandro; Cervantes-Apolinar, Maria Yolanda; Hardt, Karin; Jayadeva, Girish; Kuriyakose, Sherine; Han, Htay Htay; de la O, Manuel

    2015-01-01

    Reduced-antigen-content diphtheria-tetanus-acellular pertussis (dTpa) vaccine, Boostrix™, is indicated for booster vaccination of children, adolescents and adults. The original prefilled disposable dTpa syringe presentation was recently replaced by another prefilled-syringe presentation with latex-free tip-caps and plunger-stoppers. 671 healthy adolescents aged 10–15 years who had previously received 5 or 6 previous DT(P)/dT(pa) vaccine doses, were randomized (1:1) to receive dTpa booster, injected using the new (dTpa-new) or previous syringe (dTpa-previous) presentations. Immunogenicity was assessed before and 1-month post-booster vaccination; safety/reactogenicity were assessed during 31-days post-vaccination. Non-inferiority of dTpa-new versus dTpa-previous was demonstrated for all antigens (ULs 95% CIs for GMC ratios ranged between 1.03-1.13). 1-month post-booster, immune responses were in similar ranges for all antigens with both syringe presentations. dTpa delivered using either syringe presentation was well-tolerated. These clinical results complement the technical data and support the use of the new syringe presentation to deliver the dTpa vaccine. PMID:26075317

  12. Evaluation of a new syringe presentation of reduced-antigen content diphtheria, tetanus, and acellular pertussis vaccine in healthy adolescents--A single blind randomized trial.

    PubMed

    Pavia-Ruz, Noris; Abarca, Katia; Lepetic, Alejandro; Cervantes-Apolinar, Maria Yolanda; Hardt, Karin; Jayadeva, Girish; Kuriyakose, Sherine; Han, Htay Htay; de la O, Manuel

    2015-01-01

    Reduced-antigen-content diphtheria-tetanus-acellular pertussis (dTpa) vaccine, Boostrix™, is indicated for booster vaccination of children, adolescents and adults. The original prefilled disposable dTpa syringe presentation was recently replaced by another prefilled-syringe presentation with latex-free tip-caps and plunger-stoppers. 671 healthy adolescents aged 10-15 years who had previously received 5 or 6 previous DT(P)/dT(pa) vaccine doses, were randomized (1:1) to receive dTpa booster, injected using the new (dTpa-new) or previous syringe (dTpa-previous) presentations. Immunogenicity was assessed before and 1-month post-booster vaccination; safety/reactogenicity were assessed during 31-days post-vaccination. Non-inferiority of dTpa-new versus dTpa-previous was demonstrated for all antigens (ULs 95% CIs for GMC ratios ranged between 1.03-1.13). 1-month post-booster, immune responses were in similar ranges for all antigens with both syringe presentations. dTpa delivered using either syringe presentation was well-tolerated. These clinical results complement the technical data and support the use of the new syringe presentation to deliver the dTpa vaccine. PMID:26075317

  13. Effects of 12-Week Endurance Training at Natural Low Altitude on the Blood Redox Homeostasis of Professional Adolescent Athletes: A Quasi-Experimental Field Trial.

    PubMed

    Tong, Tomas K; Kong, Zhaowei; Lin, Hua; He, Yeheng; Lippi, Giuseppe; Shi, Qingde; Zhang, Haifeng; Nie, Jinlei

    2016-01-01

    This field study investigated the influences of exposure to natural low altitude on endurance training-induced alterations of redox homeostasis in professional adolescent runners undergoing 12-week off-season conditioning program at an altitude of 1700 m (Alt), by comparison with that of their counterparts completing the program at sea-level (SL). For age-, gender-, and Tanner-stage-matched comparison, 26 runners (n = 13 in each group) were selected and studied. Following the conditioning program, unaltered serum levels of thiobarbituric acid reactive substances (TBARS), total antioxidant capacity (T-AOC), and superoxide dismutase accompanied with an increase in oxidized glutathione (GSSG) and decreases of xanthine oxidase, reduced glutathione (GSH), and GSH/GSSG ratio were observed in both Alt and SL groups. Serum glutathione peroxidase and catalase did not change in SL, whereas these enzymes, respectively, decreased and increased in Alt. Uric acid (UA) decreased in SL and increased in Alt. Moreover, the decreases in GSH and GSH/GSSG ratio in Alt were relatively lower compared to those in SL. Further, significant interindividual correlations were found between changes in catalase and TBARS, as well as between UA and T-AOC. These findings suggest that long-term training at natural low altitude is unlikely to cause retained oxidative stress in professional adolescent runners. PMID:26783415

  14. Effects of 12-Week Endurance Training at Natural Low Altitude on the Blood Redox Homeostasis of Professional Adolescent Athletes: A Quasi-Experimental Field Trial

    PubMed Central

    Tong, Tomas K.; Kong, Zhaowei; Lin, Hua; He, Yeheng; Lippi, Giuseppe; Shi, Qingde; Zhang, Haifeng

    2016-01-01

    This field study investigated the influences of exposure to natural low altitude on endurance training-induced alterations of redox homeostasis in professional adolescent runners undergoing 12-week off-season conditioning program at an altitude of 1700 m (Alt), by comparison with that of their counterparts completing the program at sea-level (SL). For age-, gender-, and Tanner-stage-matched comparison, 26 runners (n = 13 in each group) were selected and studied. Following the conditioning program, unaltered serum levels of thiobarbituric acid reactive substances (TBARS), total antioxidant capacity (T-AOC), and superoxide dismutase accompanied with an increase in oxidized glutathione (GSSG) and decreases of xanthine oxidase, reduced glutathione (GSH), and GSH/GSSG ratio were observed in both Alt and SL groups. Serum glutathione peroxidase and catalase did not change in SL, whereas these enzymes, respectively, decreased and increased in Alt. Uric acid (UA) decreased in SL and increased in Alt. Moreover, the decreases in GSH and GSH/GSSG ratio in Alt were relatively lower compared to those in SL. Further, significant interindividual correlations were found between changes in catalase and TBARS, as well as between UA and T-AOC. These findings suggest that long-term training at natural low altitude is unlikely to cause retained oxidative stress in professional adolescent runners. PMID:26783415

  15. Improving glycaemic control and life skills in adolescents with type 1 diabetes: A randomised, controlled intervention study using the Guided Self-Determination-Young method in triads of adolescents, parents and health care providers integrated into routine paediatric outpatient clinics

    PubMed Central

    2011-01-01

    Background Adolescents with type 1 diabetes face demanding challenges due to conflicting priorities between psychosocial needs and diabetes management. This conflict often results in poor glycaemic control and discord between adolescents and parents. Adolescent-parent conflicts are thus a barrier for health care providers (HCPs) to overcome in their attempts to involve both adolescents and parents in improvement of glycaemic control. Evidence-based interventions that involve all three parties (i.e., adolescents, parents and HCPs) and are integrated into routine outpatient clinic visits are lacking. The Guided Self-Determination method is proven effective in adult care and has been adapted to adolescents and parents (Guided Self-Determination-Young (GSD-Y)) for use in paediatric diabetes outpatient clinics. Our objective is to test whether GSD-Y used in routine paediatric outpatient clinic visits will reduce haemoglobin A1c (HbA1c) concentrations and improve adolescents' life skills compared with a control group. Methods/Design Using a mixed methods design comprising a randomised controlled trial and a nested qualitative evaluation, we will recruit 68 adolescents age 13 - 18 years with type 1 diabetes (HbA1c > 8.0%) and their parents from 2 Danish hospitals and randomise into GSD-Y or control groups. During an 8-12 month period, the GSD-Y group will complete 8 outpatient GSD-Y visits, and the control group will completes an equal number of standard visits. The primary outcome is HbA1c. Secondary outcomes include the following: number of self-monitored blood glucose values and levels of autonomous motivation, involvement and autonomy support from parents, autonomy support from HCPs, perceived competence in managing diabetes, well-being, and diabetes-related problems. Primary and secondary outcomes will be evaluated within and between groups by comparing data from baseline, after completion of the visits, and again after a 6-month follow-up. To illustrate how GSD

  16. 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.

  17. Improving physical fitness and emotional well-being in adolescents of low socioeconomic status in Chile: results of a school-based controlled trial.

    PubMed

    Bonhauser, Marco; Fernandez, Gonzalo; Püschel, Klaus; Yañez, Fernando; Montero, Joaquín; Thompson, Beti; Coronado, Gloria

    2005-06-01

    Regular physical activity is associated with a reduced risk of all-cause mortality, and mortality due to cardiovascular disease and cancer. Among adolescents, physical activity is associated with benefits in the prevention and control of emotional distress, and improvement of self-esteem. Countries in transitional epidemiological scenarios, such as Chile, need to develop effective strategies to improve physical activity as a way to face the epidemic of chronic diseases. The objective of this study was to evaluate the effects of a school-based physical activity program on physical fitness and mental health status of adolescents living in a low socioeconomic status area in Santiago, Chile. A quasi-experimental design was used to evaluate the effects of the program over one academic year. The study included 198 students aged 15 years old. Two ninth grade classes were randomly selected as the intervention group, with two classes of the same grade as controls. A social planning approach was used to develop the intervention. The program was designed and implemented based on student preferences, teachers' expertise and local resources. Changes in physiological and mental health status were assessed. After the intervention, maximum oxygen capacity achieved a significant increase of 8.5% in the intervention versus 1.8% in the control group (p < 0.0001). Speed and jump performance scores improved significantly more in the intervention versus the control group (p > 0.01). Anxiety score decreased 13.7% in the intervention group versus 2.8% in the control group (p < 0.01), and self-esteem score increased 2.3% in the intervention group and decreased 0.1% in the control group after the end of the program (p < 0.0001). No significant change was observed in the depressive score. Student participation and compliance with the program was > 80%. To conclude, a school-based program to improve physical activity in adolescents of low socioeconomic status, obtained a high level of

  18. Evaluation of Immunogenicity and Safety of the New Tetanus-Reduced Diphtheria (Td) Vaccines (GC1107) in Healthy Korean Adolescents: A Phase II, Double-Blind, Randomized, Multicenter Clinical Trial

    PubMed Central

    Rhim, Jung-Woo; Lee, Kyung-Yil; Kim, Sang-Yong; Kim, Jong-Hyun; Kim, Hyun-Hee; Kim, Hwang Min; Choi, Young-Youn; Ma, Sang-Hyuk; Kim, Dong-Ho; Ahn, Dong Ho

    2013-01-01

    This phase II clinical trial was conducted to compare the immunogenicity and safety of a newly developed tetanus-reduced diphtheria (Td) vaccine (GC1107-T5.0 and GC1107-T7.5) and control vaccine. This study was also performed to select the proper dose of tetanus toxoid in the new Td vaccines. Healthy adolescents aged between 11 and 12 yr participated in this study. A total of 130 subjects (44 GC1107-T5.0, 42 GC1107-T7.5 and 44 control vaccine) completed a single dose of vaccination. Blood samples were collected from the subjects before and 4 weeks after the vaccination. In this study, all subjects (100%) in both GC1107-T5.0 and GC1107-T7.5 groups showed seroprotective antibody levels (≥ 0.1 U/mL) against diphtheria or tetanus toxoids. After the vaccination, th