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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
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Marijuana Use

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    March 29, 2011
    Last Updated
    April 3, 2014
    Sponsor
    University of Michigan
    Collaborators
    National Institute on Drug Abuse (NIDA)
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    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

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    Project Chill: Tailored Youth Drug Intervention In Primary Care

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