Project Chill: Tailored Youth Drug Intervention In Primary Care

Not Applicable

Completed

• Conditions: Marijuana Use
• Interventions: Behavioral: BMI-T; Behavioral: BMI-C

• Registration Number: NCT01329315
• Lead Sponsor: University of Michigan

Brief Summary

This study examines the impact of tailored computer-delivered and therapist-delivered brief motivations prevention/interventions both for adolescents who have not initiated marijuana use (prevention), and those who use marijuana (intervention). Key moderators of prevention/intervention effectiveness will be examined, including behavioral intentions, self-efficacy, stage of change, school involvement, susceptibility to peer pressure, and potential health consequences such as STD/HIV risk behaviors. This project will provide the critical first step toward the development and implementation of marijuana use prevention/intervention programs that have the potential to be delivered to a large segment of youth who seek care in our nation's primary care settings.

Detailed Description

The primary care setting represents an underutilized venue for prevention interventions addressing drug use/abuse among youth. The purpose of the study is to: (1) develop and refine promising, empirically-derived, BMI prevention/intervention modules delivered by a clinician or a computer to target marijuana use, and (2) test the effectiveness of BMI in preventing initiation/escalation of marijuana use among youth in community health clinics. This randomized controlled trial screened adolescents in primary care clinics in Flint, MI. A random sample of those who screened negative for past year marijuana use were selected to participate in the study and all subjects who screened positive for past year use were enrolled in the study. These subjects were stratified by gender, age, and past year marijuana use and randomized to one of three conditions: 1) computer-delivered brief motivational approach (BMI-C); 2) therapist-delivered brief motivational approach (BMI-T); or 3) a NIDA drug education booklet. Primary outcomes are evaluated at 3-, 6- and 12-months and include marijuana, alcohol, tobacco and other drug use. Key moderators of effectiveness will be examined, including behavioral intentions, self-efficacy, stage of change, school involvement, susceptibility to peer pressure, and potential health consequences (e.g., STD/HIV risk behaviors). This project will provide the critical first step toward the implementation of tailored marijuana prevention and intervention in primary care clinics.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2005-09
• Primary Completion: 2010-11
• Study First Submitted: 2011-03-29
• Study First Submitted QC: 2011-04-01
• Study First Posted: 2011-04-05
• Study Completion: 2012-11
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-03
• Last Update Posted: 2014-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1141

Inclusion Criteria

• adolescents (ages 12-18) presenting to the approved health clinics (except exclusions as noted below)
• ability to provide informed assent
• access to a parent or guardian for parental consent

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Exclusion Criteria

• adolescents who do not understand English
• adolescents deemed unable to provide informed consent by research staff (e.g., cognitive issues)
• adolescents who come to the clinic because of sexual assault or suicide attempt, or are presenting with high psychological distress requiring intensive attention
• prisoners
• adolescents who are deaf
• adolescents with a sibling or other household member in the study will be excluded from Phase II

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
BMI-T	BMI-T	Brief Motivational Intervention (BMI-T): social worker/therapist-delivered intervention (25-minute tailored structured module).
BMI-C	BMI-C	Computer-delivered intervention (BMI-C): computerized tailored 25-minute intervention.

Primary Outcome Measures

Name	Time	Method
marijuana use	12 months	initiation of marijuana use or escalation of use

Secondary Outcome Measures

Name	Time	Method
alcohol, tobacco, and illicit drug use	12 months	initiation of drug use (defined as tobacco, alcohol, marijuana, or other drugs), escalation of substance use within substances (e.g., increased frequency of use), escalation of drug use to other substances (movement from tobacco to alcohol, or alcohol to marijuana, or marijuana to other "harder" drugs
risk involvement	12 months	delinquency, peer affiliation and social context influences