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Promoting Sleep to Prevent Substance Use in Adolescence

Primary Purpose

Sleep, Substance Use

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep Fitness Intervention
Sponsored by
University of California, Berkeley
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sleep focused on measuring Sleep, Substance Use, Adolescents

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of California at Berkeley

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Sleep Fitness Intervention

Psychoeducation (PE)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Primary Sleep
Sleep Diary 1 Week: Total sleep time (Average of weeknights)
Primary Substance Use
Measures from Monitoring the Future: 30-day use

Secondary Outcome Measures

Depressive Symptoms
Center for Epidemiologic Studies- Depression
Anxiety Symptoms
Revised Children's Manifest Anxiety Scale

Full Information

First Posted
May 26, 2015
Last Updated
July 19, 2017
Sponsor
University of California, Berkeley
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1. Study Identification

Unique Protocol Identification Number
NCT02463188
Brief Title
Promoting Sleep to Prevent Substance Use in Adolescence
Official Title
Promoting Sleep to Prevent Substance Use in Adolescence
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Berkeley

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep, Substance Use
Keywords
Sleep, Substance Use, Adolescents

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sleep Fitness Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Psychoeducation (PE)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sleep Fitness Intervention
Intervention Description
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 Outcome Measure Information:
Title
Primary Sleep
Description
Sleep Diary 1 Week: Total sleep time (Average of weeknights)
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)
Title
Primary Substance Use
Description
Measures from Monitoring the Future: 30-day 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)
Secondary Outcome Measure Information:
Title
Depressive Symptoms
Description
Center for Epidemiologic Studies- Depression
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)
Title
Anxiety Symptoms
Description
Revised Children's Manifest Anxiety Scale
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)
Other Pre-specified Outcome Measures:
Title
Sleep
Description
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.
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)
Title
Substance Use
Description
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).
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)
Title
Sleep Motivation (moderator)
Description
Measure developed for this study to assess motivation to change sleep behaviors.
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)
Title
Sleep Self-Efficacy (moderator)
Description
Measure developed for this study to assess self-efficacy to change sleep behaviors.
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)
Title
Perceived Stress (moderator)
Description
Daily Hassles Scale: Total score
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)
Title
Peer Norms of Substance Use (moderator)
Description
Monitoring the Future: Norms and Availability of 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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allison Harvey, PhD
Organizational Affiliation
University of California, Berkeley
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emily Ozer, PhD
Organizational Affiliation
University of California, Berkeley
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California at Berkeley
City
Berkeley
State/Province
California
ZIP/Postal Code
94720-1650
Country
United States

12. IPD Sharing Statement

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Promoting Sleep to Prevent Substance Use in Adolescence

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