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Sleep Promotion Program for Improving Sleep Behaviors in Adolescents: A Randomized Controlled Pilot Study.

ABSTRACT: Aims. The purpose of this pilot trial was to determine the efficacy of sleep promotion program to adapt it for the use of adolescents studying in various schools of Mangalore, India, and evaluate the feasibility issues before conducting a randomized controlled trial in a larger sample of adolescents. Methods. A randomized controlled trial design with stratified random sampling method was used. Fifty-eight adolescents were selected (mean age: 14.02 ± 2.15 years; intervention group, n = 34; control group, n = 24). Self-report questionnaires, including sociodemographic questionnaire with some additional questions on sleep and activities, Sleep Hygiene Index, Pittsburgh Sleep Quality Index, The Cleveland Adolescent Sleepiness Questionnaire, and PedsQL™ Present Functioning Visual Analogue Scale, were used. Results. Insufficient weekday-weekend sleep duration with increasing age of adolescents was observed. The program revealed a significant effect in the experimental group over the control group in overall sleep quality, sleep onset latency, sleep duration, daytime sleepiness, and emotional and overall distress. No significant effect was observed in sleep hygiene and other sleep parameters. All target variables showed significant correlations with each other. Conclusion. The intervention holds a promise for improving the sleep behaviors in healthy adolescents. However, the effect of the sleep promotion program treatment has yet to be proven through a future research. This trial is registered with ISRCTN13083118.

SUBMITTER: John B

PROVIDER: S-EPMC4818821 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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Sleep Promotion Program for Improving Sleep Behaviors in Adolescents: A Randomized Controlled Pilot Study.

John Bindu B Bellipady Sumanth Shetty SS Bhat Shrinivasa Undaru SU

Scientifica 20160320

Aims. The purpose of this pilot trial was to determine the efficacy of sleep promotion program to adapt it for the use of adolescents studying in various schools of Mangalore, India, and evaluate the feasibility issues before conducting a randomized controlled trial in a larger sample of adolescents. Methods. A randomized controlled trial design with stratified random sampling method was used. Fifty-eight adolescents were selected (mean age: 14.02 ± 2.15 years; intervention group, n = 34; contro ...[more]

PMID: 27088040

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Project description:BackgroundAdolescents with Juvenile Idiopathic Arthritis (JIA) are at risk for physical, emotional, social and role challenges that negatively impact quality of life. Peer mentoring has been shown to improve positive health behaviours in adolescents with chronic disease while simultaneously providing social support. The objectives of this paper are to examine the feasibility and acceptability of an online peer mentoring program (iPeer2Peer Program) for adolescents with JIA.MethodsThe iPeer2Peer program was examined using a waitlist pilot randomized control trial (RCT). Participants were randomly allocated to the intervention or wait-list control group via a secure, web-based randomization service. Health care providers and investigators were blinded to participant group allocation. Trained peer mentors (16-25 years; successfully managing their JIA) were matched to participants (12-18 years; diagnosed with JIA) randomized to the intervention group to provide peer support and education for effective self-management of JIA. Participant-mentor pairings connected ten times over 8 weeks using Skype video calls. Primary outcomes focused on implementation (i.e. measures of feasibility and acceptability). Secondary outcomes focused on effectiveness (i.e. measures of self-management, self-efficacy, pain, social support and quality of life).ResultsThirty adolescents (mean age 14.3 ± 1.7 years, 97 % female) completed the RCT (intervention n = 16, control n = 14).Primary outcomesOne third (32 %) of adolescents approached agreed to participate, completed baseline measures and were randomized. Half of pairings completed ten calls within 8 weeks. Average call length was twice the required amount with call lengths of 44.72 ± 15.76 min. Participants reported satisfaction with the program and all reported that they would recommend it to their peers. Participants' mean engagement level with the program was 8.53/10 (range = 7-10).Secondary outcomesParticipants who completed the iPeer2Peer Program demonstrated improvements in their perceived ability to manage JIA (p < 0.04), compared to controls. No adverse events were reported.ConclusionThe iPeer2Peer Program is a promising intervention that improves acceptability of self-management and peer support treatments for adolescents with JIA. By using the Internet to connect mentors to adolescents with JIA it may also improve accessibility to these resources. Findings will be used to adapt the program and refine the methodology for a full-scale RCT.Trial registrationClinicalTrials.gov Identifier: NCT01986400 . Registered November 11, 2013.

Project description:BackgroundInternet-based cognitive behavioral therapy (ICBT) is a treatment approach recently developed and studied to provide frontline treatment to adolescents with anxiety disorders.ObjectiveThis study aimed to pilot procedures and obtain data on methodological processes and intervention satisfaction to determine the feasibility of a definitive randomized controlled trial (RCT) to test the effectiveness of a self-managed ICBT program, Breathe (Being Real, Easing Anxiety: Tools Helping Electronically), for adolescents with anxiety concerns.MethodsThis study employed a two-arm, multisite, pilot RCT. Adolescents aged 13 to 17 years with a self-identified anxiety concern were recruited online from health care settings and school-based mental health care services across Canada between April 2014 and May 2016. We compared 8 weeks of ICBT with ad hoc telephone and email support (Breathe experimental group) to access to a static webpage listing anxiety resources (control group). The primary outcome was the change in self-reported anxiety from baseline to 8 weeks (posttreatment), which was used to determine the sample size for a definitive RCT. Secondary outcomes were recruitment and retention rates, a minimal clinically important difference (MCID) for the primary outcome, intervention acceptability and satisfaction, use of cointerventions, and health care resource use, including a cost-consequence analysis.ResultsOf the 588 adolescents screened, 94 were eligible and enrolled in the study (49 adolescents were allocated to Breathe and 45 were allocated to the control group). Analysis was based on 74% (70/94) of adolescents who completed baseline measures and progressed through the study. Enrolled adolescents were, on average, 15.3 years old (SD 1.2) and female (63/70, 90%). Retention rates at 8 weeks were 28% (13/46; Breathe group) and 58% (24/43; control group). Overall, 39% (14/36) of adolescents provided feedback on completion of the Breathe program. Adolescents' scores on a satisfaction survey indicated a moderate level of satisfaction. All but one adolescent indicated that Breathe was easy to use and they understood all the material presented. The most frequent barrier identified for program completion was difficulty in completing exposure activities. The power analysis indicated that 177 adolescents per group would be needed to detect a medium effect size (d=0.3) between groups in a definitive trial. Data for calculating an MCID or conducting a cost-consequence analysis were insufficient due to a low response rate at 8 weeks.ConclusionsAdolescents were moderately satisfied with Breathe. However, program adjustments will be needed to address attrition and reduce perceived barriers to completing key aspects of the program. A definitive RCT to evaluate the effectiveness of the program is feasible if protocol adjustments are made to improve recruitment and retention to ensure timely study completion and increase the completeness of the data at each outcome measurement time point.Trial registrationClinicalTrials.gov NCT02059226; http://clinicaltrials.gov/ct2/show/NCT02059226.

Project description:Background:Rates of participation in Diabetes Prevention Programs (DPPs) are low. This may be due, in part, to low levels of autonomous motivation (i.e., motivation that arises from internal sources and sustains healthy behaviors over time) to prevent type 2 diabetes (T2DM) among many individuals with prediabetes. Mobile health (mHealth) technologies that incorporate principles from the Self-Determination Theory offer an effective and scalable approach to increase autonomous motivation levels. One promising mobile phone-based application is JOOL Health, which aims to help users connect certain health behaviors (e.g., sleep and diet) with personal values in specific life domains (e.g., family and work). The first aim of this study is to estimate whether JOOL Health can increase autonomous motivation to prevent T2DM among individuals with prediabetes who declined DPP participation. The second aim of this pilot study is to examine the intervention's feasibility and acceptability. Methods:This is a 12-week, three-arm pilot randomized controlled trial. We will recruit 105 individuals with prediabetes who did not engage in a DPP despite invitation from their health plan to participate in face-to-face or web-based programs at no out-of-pocket-cost. Participants will be randomized to one of three study arms: (1) a group that receives information on prediabetes, evidence-based strategies to decrease progression to T2DM, and a list of resources for mHealth tools for monitoring diet, physical activity, and weight (comparison group); (2) a group that receives the JOOL Health application; and (3) a group that receives the JOOL Health application as well as a Fitbit activity tracker and wireless-enabled scale. Our primary outcome is change in autonomous motivation to prevent T2DM (measured using the Treatment Self-Regulation Questionnaire). We will also collect data related to the intervention's feasibility (recruitment and retention rates) and acceptability (adherence and qualitative experience) as well as changes in psychosocial outcomes, hemoglobin A1c, and weight. Discussion:To our knowledge, this is the first study that aims to promote positive health behaviors among individuals with prediabetes who previously declined to participate in a DPP. Our results will inform a larger trial to test the effect of JOOL Health on clinically relevant outcomes, including weight loss, physical activity, and DPP engagement. Trial registration:NCT03025607. Registered February 2017.

Project description:BackgroundSubstance use, sexual assault, and sexual risk behaviors are common among adolescents and are interrelated. Nearly 1 in 5 adolescents use substances before sexual encounters, placing these young people at risk for both sexual assault and sexual risk behaviors. Primary care visits present a unique opportunity to address multiple health risk behaviors.ObjectiveTeen Well Check is a web-based integrated prevention program for substance use, sexual assault, and sexual risk behaviors with demonstrated usability and acceptability among patients and providers. The aim of this study was to conduct a pilot randomized controlled trial to assess feasibility.MethodsAdolescents (n=123) aged 14 to 18 years from diverse backgrounds were recruited from primarily Medicaid-serving pediatric primary care clinics. Participants completed a baseline survey; were randomized to receive Teen Well Check or an assessment-only control; and completed 1-, 3-, and 6-month follow-up surveys. Feasibility was assessed in terms of recruitment and retention rates. Preliminary changes from baseline to follow-up periods were examined separately in the Teen Well Check and control conditions.ResultsWe recruited 123 participants (Teen Well Check: n=61, 49.6%; control: n=62, 50.4%). Of the 61 participants assigned to the Teen Well Check condition, 55 (90%) completed the full program and viewed all intervention content. Of the 123 participants, 105 (85.4%) were retained across at least 1 follow-up period, and there was no difference in follow-up rates between the conditions (χ21=0.6; P=.43). The completion of Teen Well Check took an average of 6.2 (SD 5.8) minutes. Preliminary analyses revealed that there were significant reductions in perceived peer norms (descriptive norms) for substance use before sex across follow-ups among participants in the Teen Well Check condition (P=.001 from baseline to 6 months), whereas there were significant increases among participants in the control condition (P=.003 from baseline to 6 months). In addition, there were nonsignificant reductions in substance misuse risk from baseline to the 6-month follow-up among participants in the Teen Well Check condition (P=.16).ConclusionsThese findings support the feasibility of Teen Well Check delivery within pediatric primary care clinics. A randomized clinical trial is needed to assess efficacy.Trial registrationClinicalTrials.gov NCT3489434; https://www.clinicaltrials.gov/study/NCT03489434.

Project description:BackgroundPredictive theoretical models suggest that health knowledge works in conjunction with motivation and behavioral skills to influence adolescents' obesogenic behavior. However, most of the existing adolescent interventions target these variables in isolation. Furthermore, health literacy (HL), a precursor to health knowledge, is necessary for translating health knowledge into behavior and is negatively related to adolescents' obesity status. However, HL has not been included in obesity interventions targeting adolescents.ObjectiveThis study aims to pilot the feasibility of a 2-armed web-based obesity prevention intervention in school settings and assess the preliminary effectiveness of adding an HL module to an obesity prevention intervention for adolescents.MethodsThis web-based pilot feasibility study will take place in the Northeastern United States. Participants will be adolescents (aged 13-16 years) attending school, and recruitment will be conducted through flyers to parents and adolescents in participating classes or advisory groups at the school. The intervention includes 2 arms: an experimental arm that will receive an HL module and 3 obesity prevention modules and a comparison arm that will receive a vaping module and 3 obesity prevention modules. A blinded randomized procedure will be used to allocate classrooms and advisory groups to the experimental and comparison arms. The intervention will be fully web-based. Participants will complete measures of their HL and obesogenic behavior-related health knowledge, motivation, and behaviors at 3 time points (baseline, 1 month after the intervention, and 3 months after the intervention) via web-based surveys. The primary outcomes will be the measures of study feasibility (recruitment, retention, completion, and treatment fidelity rates). Secondary outcomes will be preliminary efficacy, as measured by logistic and linear regressions and calculation of effect sizes. Descriptive statistics will be calculated for all measures at each time point.ResultsThis study was approved by the City University of New York Institutional Review Board in August 2020. As of June 2022, the web-based intervention design is complete and ready for use. Recruitment, data collection, and intervention implementation are scheduled to begin in September 2022. These results are expected to be published in 2023.ConclusionsThis study's feasibility findings will inform changes to the intervention content and randomized controlled trial design. The study's efficacy findings will inform the sample size for the full-scale randomized controlled trial and the preliminary utility of the intervention.Trial registrationClinicalTrials.gov NCT04252677; https://clinicaltrials.gov/ct2/show/NCT04252677.International registered report identifier (irrid)PRR1-10.2196/40191.

Dataset Information

Sleep Promotion Program for Improving Sleep Behaviors in Adolescents: A Randomized Controlled Pilot Study.

Publications

Sleep Promotion Program for Improving Sleep Behaviors in Adolescents: A Randomized Controlled Pilot Study.

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