Clinical trial NCT02463188: Promoting Sleep to Prevent Substance Use in Adolescence
Official title: Promoting Sleep to Prevent Substance Use in Adolescence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Substance Use
Keywords: Sleep
Substance Use
Adolescents
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
First posted: 2015-06-04
Enrollment: 300
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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.

Primary outcomes:
measure: Primary Sleep
timeFrame: 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: Primary Substance Use
timeFrame: 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 outcomes:
measure: Depressive Symptoms
timeFrame: 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: Anxiety Symptoms
timeFrame: 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 outcomes:
measure: Sleep
timeFrame: 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: Substance Use
timeFrame: 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: Sleep Motivation (moderator)
timeFrame: 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: Sleep Self-Efficacy (moderator)
timeFrame: 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: Perceived Stress (moderator)
timeFrame: 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: Peer Norms of Substance Use (moderator)
timeFrame: 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)
Locations:
city: Berkeley
country: United States
facility: University of California at Berkeley
state: California
Study officials:
affiliation: University of California, Berkeley
name: Allison Harvey, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Berkeley
name: Emily Ozer, PhD
role: PRINCIPAL_INVESTIGATOR
References: