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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 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep Fitness Intervention | Experimental | The intervention consists of 5-7 sessions on sleep science, the connection between sleep and substance use, behavior change strategies, and motivation to change behavior. |
|
| Psychoeducation (PE) | No Intervention | The control classes will receive an 1-session psycho-educational (PE) intervention that provides information on sleep but does not provide guidance for implementing behavior change and does not explicitly teach about sleep's relationship to substance use. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Sleep | Sleep Diary 1 Week: Total sleep time (Average of weeknights) | 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) |
| Primary Substance Use | Measures from Monitoring the Future: 30-day use | 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 | Description | Time Frame |
|---|---|---|
| Depressive Symptoms | Center for Epidemiologic Studies- Depression | 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 | Description | Time Frame |
|---|---|---|
| Sleep | 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. |
Inclusion and exclusion criteria are considered at the level of schools, classes, and students.
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Allison Harvey, PhD | University of California, Berkeley | Principal Investigator |
| Emily Ozer, PhD | University of California, Berkeley | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California at Berkeley | Berkeley | California | 94720-1650 | United States |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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|
| Anxiety Symptoms |
Revised Children's Manifest Anxiety Scale |
| 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) |
| 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) |
| Substance Use | 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). | 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 Motivation (moderator) | Measure developed for this study to assess motivation to change sleep behaviors. | 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 Self-Efficacy (moderator) | Measure developed for this study to assess self-efficacy to change sleep behaviors. | 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) |
| Perceived Stress (moderator) | Daily Hassles Scale: Total score | 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) |
| Peer Norms of Substance Use (moderator) | Monitoring the Future: Norms and Availability of Substance Use | 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) |