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.

Study Overview

• Status: Completed
• Conditions: Sleep; Substance Use
• Intervention / Treatment: Behavioral: Sleep Fitness Intervention

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 Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Berkeley, California, United States, 94720-1650
      • University of California at Berkeley

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Sleep Fitness Intervention; 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.
No Intervention: Psychoeducation (PE); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)
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)

Other Outcome Measures

Outcome Measure	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.	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)

Collaborators and Investigators

• Sponsor: University of California, Berkeley
• Investigators: Principal Investigator: Emily Ozer, PhD, University of California, Berkeley

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: May 26, 2015
• First Submitted That Met QC Criteria: June 1, 2015
• First Posted (Estimate): June 4, 2015

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 19, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Adolescents; Sleep; Substance Use
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 5R34DA035349-02 (U.S. NIH Grant/Contract)