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OpenTrials
Completed

NCT Number: NCT02463188

Promoting Sleep to Prevent Substance Use in Adolescence

The goal is to adapt and refine an innovative, developmentally-appropriate universal health promotion intervention to reduce insufficient sleep among adolescents aged 14 to 16, while engaging teens in the adaptation process to maximize the relevance, appeal, and effectiveness of the program for diverse school settings.

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Key information

Conditions

Sleep Chemically-Induced Disorders Mental Disorders Substance Use Substance-Related Disorders

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California at Berkeley

Berkeley, California, 94720-1650, United States

About this study

The goal is to adapt and refine an innovative, developmentally-appropriate universal health promotion intervention to reduce insufficient sleep among adolescents aged 14 to 16, while engaging teens in the adaptation process to maximize the relevance, appeal, and effectiveness of the program for diverse school settings.

The investigators aim to conduct a pilot feasibility randomized controlled trial (RCT) among adolescents (n = 300) who will be randomized to Sleep Fitness (SF) or Sleep Education (SE) to obtain effect size estimates in preparation for a larger scale intervention study. This pilot trial is designed to obtain preliminary data for the following hypotheses:

SF, compared to SE, will produce greater pre-post improvement in sleep after treatment and at 6 month follow-up (with the possibility of a 12 month follow-up for a subset of participants, depending on resources).

SF, compared to SE, will produce greater pre-post reductions in substance use after treatment and at 6 month follow-up (with the possibility of a 12 month follow-up for a subset of participants, depending on resources).

SF, compared to SE, will produce greater pre-post improvement on selected mental health outcomes (anxiety, depression) after treatment and at 6 month follow-up (with the possibility of a 12 month follow-up for a subset of participants, depending on resources).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion and exclusion criteria are considered at the level of schools, classes, and students.

Inclusion criteria

  • Schools: Only general education high schools, not "newcomer" schools that target immigrants with limited English ability. Our rationale is that we need students to read and understand English well enough to complete our study measures and understand the intervention.
  • Classes: After the selection of schools, we will select classes that are representative of the school, insofar as they do not reflect Advanced Placement or remedial classes and utilize similar criteria for admission to the classes (e.g. health, advisory) so that we minimize differences between the classes in the study.
  • Students: All participants must receive parental consent, provide their own consent, and must have sufficient English language ability

Exclusion criteria

  • We propose no exclusion criteria for students who receive parental consent, provide their own assent, and have sufficient English language ability.

Treatment and study plan

Sleep Fitness Intervention

Behavioral

The intervention consists of 5-7 sessions. Each session includes interactive and small group discussions. The intervention also includes lessons on sleep science, behavior change strategies, and one-on-one motivational interviews on behavior change motivation.

Primary outcomes

  1. Primary Sleep

    Time frame: Change from baseline to post-intervention, which will be conducted between 5 and 8 weeks after the baseline assessment, and at 6 month follow-up (with the possibility of a 12 month follow-up for a subset of participants, depending on resources)

    Sleep Diary 1 Week: Total sleep time (Average of weeknights)

  2. Primary Substance Use

    Time frame: Change from baseline to post-intervention, which will be conducted between 5 and 8 weeks after the baseline assessment, and at 6 month follow-up (with the possibility of a 12 month follow-up for a subset of participants, depending on resources)

    Measures from Monitoring the Future: 30-day use

Secondary outcomes

  1. Depressive Symptoms

    Time frame: Change from baseline to post-intervention, which will be conducted between 5 and 8 weeks after the baseline assessment, and at 6 month follow-up (with the possibility of a 12 month follow-up for a subset of participants, depending on resources)

    Center for Epidemiologic Studies- Depression

  2. Anxiety Symptoms

    Time frame: Change from baseline to post-intervention, which will be conducted between 5 and 8 weeks after the baseline assessment, and at 6 month follow-up (with the possibility of a 12 month follow-up for a subset of participants, depending on resources)

    Revised Children's Manifest Anxiety Scale

Other outcomes

  1. Sleep

    Time frame: Change from baseline to post-intervention, which will be conducted between 5 and 8 weeks after the baseline assessment, and at 6 month follow-up (with the possibility of a 12 month follow-up for a subset of participants, depending on resources)

    Sleep Diary 1 Week: Total sleep time (average of weekend nights); Difference between average TST on weeknights and average TST on weekend nights; Average weeknight bedtime; Average weekend bedtime, Difference between average weeknight bedtime and average weekend bedtime; Average weekend rise time; Difference between average weekday rise time and average weekend rise time; Sleep Onset Latency (calculated separately for weeknights and weekend nights) and Wake After Sleep Onset (calculated separately for weeknights and weekend nights) to create Total Wake Time for weeknights, weekends and to also compute the discrepancy between weeknights and weekend nights; Sleep efficiency.

    Pittsburgh Sleep Quality Index: Total Score and subscale scores.

  2. Substance Use

    Time frame: Change from baseline to post-intervention, which will be conducted between 5 and 8 weeks after the baseline assessment, and at 6 month follow-up (with the possibility of a 12 month follow-up for a subset of participants, depending on resources)

    Measures from Monitoring the Future: Substance use at all other applicable time points (in last day, in last week, in last 12 months, in lifetime).

  3. Sleep Motivation (moderator)

    Time frame: Change from baseline to post-intervention, which will be conducted between 5 and 8 weeks after the baseline assessment, and at 6 month follow-up (with the possibility of a 12 month follow-up for a subset of participants, depending on resources)

    Measure developed for this study to assess motivation to change sleep behaviors.

  4. Sleep Self-Efficacy (moderator)

    Time frame: Change from baseline to post-intervention, which will be conducted between 5 and 8 weeks after the baseline assessment, and at 6 month follow-up (with the possibility of a 12 month follow-up for a subset of participants, depending on resources)

    Measure developed for this study to assess self-efficacy to change sleep behaviors.

  5. Perceived Stress (moderator)

    Time frame: Change from baseline to post-intervention, which will be conducted between 5 and 8 weeks after the baseline assessment, and at 6 month follow-up (with the possibility of a 12 month follow-up for a subset of participants, depending on resources)

    Daily Hassles Scale: Total score

  6. Peer Norms of Substance Use (moderator)

    Time frame: Change from baseline to post-intervention, which will be conducted between 5 and 8 weeks after the baseline assessment, and at 6 month follow-up (with the possibility of a 12 month follow-up for a subset of participants, depending on resources)

    Monitoring the Future: Norms and Availability of Substance Use

Sponsors and collaborators

Lead sponsor

University of California, Berkeley

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jun 4, 2015
Registry last updated
Jul 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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