Project Chill: Tailored Youth Drug Intervention In Primary Care

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Frederic C. Blow, University of Michigan
ClinicalTrials.gov Identifier:
NCT01329315
First received: March 29, 2011
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

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 Intervention
Marijuana Use
Behavioral: BMI-T
Behavioral: BMI-C

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Tailored Youth Drug Intervention In Primary Care

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • marijuana use [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    initiation of marijuana use or escalation of use


Secondary Outcome Measures:
  • alcohol, tobacco, and illicit drug use [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    delinquency, peer affiliation and social context influences


Enrollment: 1141
Study Start Date: September 2005
Study Completion Date: November 2012
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01329315

Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Frederic C Blow, PhD University of Michigan
  More Information

No publications provided by University of Michigan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Frederic C. Blow, Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01329315     History of Changes
Other Study ID Numbers: DA020075, R01DA020075-01
Study First Received: March 29, 2011
Last Updated: April 3, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Marijuana Abuse
Marijuana Smoking
Substance-Related Disorders
Mental Disorders
Smoking
Habits

ClinicalTrials.gov processed this record on July 24, 2014