Project Chill: Tailored Youth Drug Intervention In Primary Care

NCT ID: NCT01329315

Last Updated: 2014-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1141 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2012-11-30

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.

Conditions

Marijuana Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

BMI-T

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

Group Type: ACTIVE_COMPARATOR

BMI-T

Intervention Type: BEHAVIORAL

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

BMI-C

Computer-delivered intervention (BMI-C): computerized tailored 25-minute intervention.

Group Type: ACTIVE_COMPARATOR

BMI-C

Intervention Type: BEHAVIORAL

Computer-delivered intervention (BMI-C): computerized tailored 25-minute intervention.

DPB

Drug Prevention Booklet (DPB)- National Institute on Drug Abuse (NIDA)-developed drug prevention booklet to address preventing marijuana initiation, and marijuana use.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

BMI-T

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

Intervention Type: BEHAVIORAL

BMI-C

Computer-delivered intervention (BMI-C): computerized tailored 25-minute intervention.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Frederic C. Blow

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frederic C Blow, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

References

Walton MA, Bohnert K, Resko S, Barry KL, Chermack ST, Zucker RA, Zimmerman MA, Booth BM, Blow FC. Computer and therapist based brief interventions among cannabis-using adolescents presenting to primary care: one year outcomes. Drug Alcohol Depend. 2013 Oct 1;132(3):646-53. doi: 10.1016/j.drugalcdep.2013.04.020. Epub 2013 May 25.

Reference Type: DERIVED

PMID: 23711998 (View on PubMed)

Other Identifiers

R01DA020075-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DA020075

Identifier Type: -

Identifier Source: org_study_id