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Teen Marijuana Check-Up

Primary Purpose

Cannabis Use Disorder

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Marijuana Check-Ins
Sponsored by
Denise Walker
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis Use Disorder focused on measuring cannabis use disorder, marijuana, motivational enhancement treatment, cognitive behavioral treatment, continuing care

Eligibility Criteria

14 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. age (14-19 years old),
  2. grade level (9th through 11th) and
  3. marijuana use.

Exclusion Criteria:

Individuals will be excluded if:

  1. they are not fluent in English,
  2. they have a thought disorder that precludes full participation,
  3. they refuse to accept randomization to condition,
  4. they are high school seniors.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Computer Check-In Control

    Marijuana Check-Ins

    Arm Description

    The Computer Check-In gives the participant contact with the research therapist, an assessment of marijuana use and the current impact of use, and a reminder about optional support sessions.

    The MCI, a MET intervention, will include the provision of personalized feedback with a motivational interviewing style. The focus of these sessions will be individualized to participants based on recent marijuana use and related experiences. Feedback given to participants during the MCI session will review progress toward goals as self-reported in percent days abstinent, normative data regarding marijuana use, review of reported consequences of marijuana use, review of abuse and dependence criteria reported, comparison of consequences and abuse and dependence symptoms reported over time, review of the positive outcomes from reductions in use, and review of immediate and long-term life goals and how their marijuana goal will affect these. HEs will offer particular encouragement to take advantage of CBT sessions to participants who feel they currently need treatment.

    Outcomes

    Primary Outcome Measures

    frequency (number of days) of marijuana use
    Global Appraisal of Individual Needs - I (self-report measure)
    treatment utilization
    Global Appraisal of Individual Needs - I
    marijuana abuse/dependence symptoms
    Global Appraisal of Individual Needs - I
    engagement in cognitive behavioral skills training sessions
    Frequency of attendance at optional in-school counseling sessions

    Secondary Outcome Measures

    self-efficacy
    Self-efficacy scale that assesses self-efficacy for avoiding marijuana use
    normative perceptions of peer marijuana use
    Descriptive perceived norms concerning the frequency of marijuana use by other adolescents of the participant's age

    Full Information

    First Posted
    April 21, 2010
    Last Updated
    October 25, 2016
    Sponsor
    Denise Walker
    Collaborators
    Virginia Polytechnic Institute and State University, National Institute on Drug Abuse (NIDA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01109563
    Brief Title
    Teen Marijuana Check-Up
    Official Title
    Reaching and Motivating Change in Teen Marijuana Smokers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2011 (undefined)
    Primary Completion Date
    September 2014 (Actual)
    Study Completion Date
    September 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Denise Walker
    Collaborators
    Virginia Polytechnic Institute and State University, National Institute on Drug Abuse (NIDA)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study will test a behavioral intervention tailored for adolescents who smoke marijuana and have concerns about their use. The study's purpose is to determine whether this intervention (two-sessions of motivational enhancement intervention followed by 12 months of optional skills training) will be more effective in reducing the use of this drug if augmented by three periodic motivational enhancement treatment check-in sessions as compared to three periodic computer-based check-in sessions. HYPOTHESES: (1) Participants in the motivational enhancement treatment check-ins (MCI) condition will reduce their use of marijuana more than participants in the computer based (Comp) condition and report fewer negative consequences. These differences are expected to be greater at later follow-ups (i.e, 9, 12, and 15 months) after repeated check-ins exert a cumulative effect. (2)Engagement in CBT sessions will be greater for those in the MCI condition and will partially mediate the effect on marijuana related outcome indices. (3) The MCI intervention will lead to increased self-efficacy, and decreased normative perceptions of marijuana use by other teens that will also partially mediate the effect of the intervention.
    Detailed Description
    The goal of this trial is to evaluate the efficacy of an enhanced Teen Marijuana Check-Up protocol to reach and intervene with non-treatment seeking adolescents who use marijuana heavily. Two hundred fifty adolescents who use marijuana heavily will receive a 2-session individual motivational enhancement therapy. All participants will also be offered the opportunity, over a 12-month period, to repeatedly re-initiate marijuana counseling. Participants will be randomly assigned to receive one of two types of periodic follow-up contacts: Motivational interviewing-based Marijuana Check-Ins (MCI) or Computer Based Control (Comp) sessions. All participants will be reassessed at the 6, 9, 12, and 15-month anniversaries of enrollment. Following their initial motivational enhancement therapy, the 125 experimental condition participants will additionally have a motivational enhancement treatment "check-in" session with their counselor at the 4, 7, and 10-month anniversaries of enrollment intended to reinforce the maintenance of treatment gains and motivate continued success, increase motivation to change for participants who did not meet their marijuana use goals, and/or prompt utilization of cognitive-behavioral treatment (CBT) sessions as needed. The 125 comparison participants will complete a computer based questionnaire at the same time intervals to serve as an attentional control.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cannabis Use Disorder
    Keywords
    cannabis use disorder, marijuana, motivational enhancement treatment, cognitive behavioral treatment, continuing care

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    252 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Computer Check-In Control
    Arm Type
    Active Comparator
    Arm Description
    The Computer Check-In gives the participant contact with the research therapist, an assessment of marijuana use and the current impact of use, and a reminder about optional support sessions.
    Arm Title
    Marijuana Check-Ins
    Arm Type
    Experimental
    Arm Description
    The MCI, a MET intervention, will include the provision of personalized feedback with a motivational interviewing style. The focus of these sessions will be individualized to participants based on recent marijuana use and related experiences. Feedback given to participants during the MCI session will review progress toward goals as self-reported in percent days abstinent, normative data regarding marijuana use, review of reported consequences of marijuana use, review of abuse and dependence criteria reported, comparison of consequences and abuse and dependence symptoms reported over time, review of the positive outcomes from reductions in use, and review of immediate and long-term life goals and how their marijuana goal will affect these. HEs will offer particular encouragement to take advantage of CBT sessions to participants who feel they currently need treatment.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Marijuana Check-Ins
    Intervention Description
    The MCI, an MET intervention, will include the provision of personalized feedback with a motivational interviewing style. The focus of these sessions will be individualized to participants based on recent marijuana use and related experiences. Feedback given to participants during the MCI session will review progress toward goals as self-reported in percent days abstinent, normative data regarding marijuana use, review of reported consequences of marijuana use, review of abuse and dependence criteria reported, comparison of consequences and abuse and dependence symptoms reported over time, review of the positive outcomes from reductions in use, and review of immediate and long-term life goals and how their marijuana goal will affect these. HEs will offer particular encouragement to take advantage of CBT sessions to participants who feel they currently need treatment.
    Primary Outcome Measure Information:
    Title
    frequency (number of days) of marijuana use
    Description
    Global Appraisal of Individual Needs - I (self-report measure)
    Time Frame
    60 days
    Title
    treatment utilization
    Description
    Global Appraisal of Individual Needs - I
    Time Frame
    90 days
    Title
    marijuana abuse/dependence symptoms
    Description
    Global Appraisal of Individual Needs - I
    Time Frame
    60 days
    Title
    engagement in cognitive behavioral skills training sessions
    Description
    Frequency of attendance at optional in-school counseling sessions
    Time Frame
    90 days
    Secondary Outcome Measure Information:
    Title
    self-efficacy
    Description
    Self-efficacy scale that assesses self-efficacy for avoiding marijuana use
    Time Frame
    90 days
    Title
    normative perceptions of peer marijuana use
    Description
    Descriptive perceived norms concerning the frequency of marijuana use by other adolescents of the participant's age
    Time Frame
    90 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Years
    Maximum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age (14-19 years old), grade level (9th through 11th) and marijuana use. Exclusion Criteria: Individuals will be excluded if: they are not fluent in English, they have a thought disorder that precludes full participation, they refuse to accept randomization to condition, they are high school seniors.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Denise D Walker, PhD
    Organizational Affiliation
    University of Washington School of Social Work
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Teen Marijuana Check-Up

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