Project Chill: Tailored Youth Drug Intervention In Primary Care

• Sponsor: University of Michigan (Other)
• Overall Status: Completed
• CT.gov ID: NCT01329315
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 1,141
• Arms: 3
• Duration (Months): 86

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Marijuana Use	Behavioral: BMI-T; Behavioral: BMI-C	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1141 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Tailored Youth Drug Intervention In Primary Care
• Study Start Date: Sep 1, 2005
• Actual Primary Completion Date: Nov 1, 2010
• Actual Study Completion Date: Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: BMI-T Brief Motivational Intervention (BMI-T): social worker/therapist-delivered intervention (25-minute tailored structured module).	Behavioral: BMI-T; Brief Motivational Intervention (BMI-T): social worker/therapist-delivered intervention (25-minute tailored structured module).
Active Comparator: BMI-C Computer-delivered intervention (BMI-C): computerized tailored 25-minute intervention.	Behavioral: BMI-C; Computer-delivered intervention (BMI-C): computerized tailored 25-minute intervention.
No Intervention: DPB Drug Prevention Booklet (DPB)- National Institute on Drug Abuse (NIDA)-developed drug prevention booklet to address preventing marijuana initiation, and marijuana use.

Outcome Measures

Primary Outcome Measures

1. marijuana use [12 months]

   initiation of marijuana use or escalation of use

Secondary Outcome Measures

1. 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

2. risk involvement [12 months]

   delinquency, peer affiliation and social context influences

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Michigan
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Frederic C Blow, PhD, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Frederic C. Blow, Professor, University of Michigan
• ClinicalTrials.gov Identifier: NCT01329315
• Other Study ID Numbers: DA020075; R01DA020075-01
• First Posted: Apr 5, 2011
• Last Update Posted: Apr 7, 2014
• Last Verified: Apr 1, 2014

• Additional relevant MeSH terms: Marijuana Use

Study Results

No Results Posted as of Apr 7, 2014