Project Chill: Tailored Youth Drug Intervention In Primary Care

Marijuana Use Clinical Trial

Official title:

Tailored Youth Drug Intervention In Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01329315
• Other study ID #: DA020075
• Secondary ID: R01DA020075-01
• Status: Completed
• Phase: N/A
• First received: March 29, 2011
• Last updated: April 3, 2014
• Start date: September 2005
• Est. completion date: November 2012

Study information

• Verified date: April 2014
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1141
• Est. completion date: November 2012
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Marijuana Use

Intervention

Behavioral:
• BMI-T
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute on Drug Abuse (NIDA)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	marijuana use	initiation of marijuana use or escalation of use	12 months	Yes
Secondary	alcohol, tobacco, and illicit drug use	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	12 months	Yes
Secondary	risk involvement	delinquency, peer affiliation and social context influences	12 months	Yes