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Completed

NCT Number: NCT01329315

Project Chill: Tailored Youth Drug Intervention In Primary Care

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.

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Key information

Conditions

Marijuana Use Behavior Mental Disorders Substance-Related Disorders

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMI-T

Behavioral

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

BMI-C

Behavioral

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

Primary outcomes

  1. marijuana use

    Time frame: 12 months

    initiation of marijuana use or escalation of use

Secondary outcomes

  1. alcohol, tobacco, and illicit drug use

    Time frame: 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

    Time frame: 12 months

    delinquency, peer affiliation and social context influences

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Tailored Youth Drug Intervention In Primary Care

Important dates

Study start
2005
Primary completion
2010
Study completion
2012
First posted
Apr 5, 2011
Registry last updated
Apr 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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