Promoting Sleep to Prevent Substance Use in Adolescence

Not Applicable

Completed

• Conditions: Sleep; Substance Use
• Interventions: Behavioral: Sleep Fitness Intervention

• Registration Number: NCT02463188
• Lead Sponsor: University of California, Berkeley

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2015-05-26
• Study First Submitted QC: 2015-06-01
• Study First Posted: 2015-06-04
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-19
• Last Update Posted: 2017-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleep Fitness Intervention	Sleep Fitness Intervention	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.

Primary Outcome Measures

Name	Time	Method
Primary 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)	Measures from Monitoring the Future: 30-day use
Primary Sleep	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)

Secondary Outcome Measures

Name	Time	Method
Anxiety Symptoms	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
Depressive Symptoms	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

Trial Locations

Locations (1)

University of California at Berkeley; 🇺🇸 Berkeley, California, United States