Clinical Trials Directory

Trials / Completed

CompletedNCT02463188

Promoting Sleep to Prevent Substance Use in Adolescence

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
300 (actual)
Sponsor
University of California, Berkeley · Academic / Other
Sex
All
Age
13 Years – 18 Years
Healthy volunteers
Accepted

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).

Conditions

Interventions

TypeNameDescription
BEHAVIORALSleep Fitness InterventionThe 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.

Timeline

Start date
2014-02-01
Primary completion
2017-04-01
Completion
2017-04-01
First posted
2015-06-04
Last updated
2017-07-21

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02463188. Inclusion in this directory is not an endorsement.