Project Chill: Tailored Youth Drug Intervention In Primary Care
Primary Purpose
Marijuana Use
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
BMI-T
BMI-C
Sponsored by
About this trial
This is an interventional health services research trial for Marijuana Use
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
BMI-T
BMI-C
DPB
Arm Description
Brief Motivational Intervention (BMI-T): social worker/therapist-delivered intervention (25-minute tailored structured module).
Computer-delivered intervention (BMI-C): computerized tailored 25-minute intervention.
Drug Prevention Booklet (DPB)- National Institute on Drug Abuse (NIDA)-developed drug prevention booklet to address preventing marijuana initiation, and marijuana use.
Outcomes
Primary Outcome Measures
marijuana use
initiation of marijuana use or escalation of use
Secondary Outcome Measures
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
risk involvement
delinquency, peer affiliation and social context influences
Full Information
NCT ID
NCT01329315
First Posted
March 29, 2011
Last Updated
April 3, 2014
Sponsor
University of Michigan
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT01329315
Brief Title
Project Chill: Tailored Youth Drug Intervention In Primary Care
Official Title
Tailored Youth Drug Intervention In Primary Care
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marijuana Use
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1141 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BMI-T
Arm Type
Active Comparator
Arm Description
Brief Motivational Intervention (BMI-T): social worker/therapist-delivered intervention (25-minute tailored structured module).
Arm Title
BMI-C
Arm Type
Active Comparator
Arm Description
Computer-delivered intervention (BMI-C): computerized tailored 25-minute intervention.
Arm Title
DPB
Arm Type
No Intervention
Arm Description
Drug Prevention Booklet (DPB)- National Institute on Drug Abuse (NIDA)-developed drug prevention booklet to address preventing marijuana initiation, and marijuana use.
Intervention Type
Behavioral
Intervention Name(s)
BMI-T
Intervention Description
Brief Motivational Intervention (BMI-T): social worker/therapist-delivered intervention (25-minute tailored structured module).
Intervention Type
Behavioral
Intervention Name(s)
BMI-C
Intervention Description
Computer-delivered intervention (BMI-C): computerized tailored 25-minute intervention.
Primary Outcome Measure Information:
Title
marijuana use
Description
initiation of marijuana use or escalation of use
Time Frame
12 months
Secondary Outcome Measure Information:
Title
alcohol, tobacco, and illicit drug use
Description
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
Time Frame
12 months
Title
risk involvement
Description
delinquency, peer affiliation and social context influences
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederic C Blow, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
23711998
Citation
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.
Results Reference
derived
Learn more about this trial
Project Chill: Tailored Youth Drug Intervention In Primary Care
We'll reach out to this number within 24 hrs