- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01109563
Teen Marijuana Check-Up
Reaching and Motivating Change in Teen Marijuana Smokers
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Computer Check-In Control
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, 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.
|
|
Experimental: Marijuana Check-Ins
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
frequency (number of days) of marijuana use
Time Frame: 60 days
|
Global Appraisal of Individual Needs - I (self-report measure)
|
60 days
|
|
treatment utilization
Time Frame: 90 days
|
Global Appraisal of Individual Needs - I
|
90 days
|
|
marijuana abuse/dependence symptoms
Time Frame: 60 days
|
Global Appraisal of Individual Needs - I
|
60 days
|
|
engagement in cognitive behavioral skills training sessions
Time Frame: 90 days
|
Frequency of attendance at optional in-school counseling sessions
|
90 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
self-efficacy
Time Frame: 90 days
|
Self-efficacy scale that assesses self-efficacy for avoiding marijuana use
|
90 days
|
|
normative perceptions of peer marijuana use
Time Frame: 90 days
|
Descriptive perceived norms concerning the frequency of marijuana use by other adolescents of the participant's age
|
90 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Denise D Walker, PhD, University of Washington School of Social Work
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 37852-G
- 2R01DA014296-09A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cannabis Use Disorder
-
Indiana UniversityNational Institute on Drug Abuse (NIDA)RecruitingMarijuana Abuse | Marijuana Use | Addiction | Substance Use | Cannabis Dependence | Substance Use Disorders | Cannabis Use | Substance Abuse | Addiction, Substance | Marijuana Dependence | Substance Dependence | Marijuana Smoking | Cannabis Abuse | Cannabis Use Disorder | Marijuana | Cannabis Intoxication | Substance Related... and other conditionsUnited States
-
Medical University of South CarolinaNational Institute on Drug Abuse (NIDA); National Institutes of Health (NIH)Recruiting
-
Anders Fink-Jensen, MD, DMSciNeurobiology Research Unit, RigshospitaletRecruitingCannabis Dependence | Cannabis Abuse | Cannabis Use Disorder | Cannabis Use Disorders | Cannabis AddictionDenmark
-
Brigham and Women's HospitalNot yet recruitingCannabis Use Disorder
-
Medical University of South CarolinaNational Institute on Drug Abuse (NIDA)RecruitingBipolar Disorder | Cannabis Use | Bipolar I Disorder | Cannabis Use Disorder, Mild | Cannabis Use Disorder, Moderate | Cannabis Use Disorder, Severe | Bipolar II Disorder | Schizoaffective Disorder, Bipolar TypeUnited States
-
Medical University of South CarolinaNational Cancer Institute (NCI)RecruitingTobacco Use Disorder | Marijuana Use | Tobacco Use Cessation | Cannabis Use | Cannabis Use DisorderUnited States
-
Monash UniversityTurning PointCompletedCannabis Use Disorder, Moderate | Cannabis Use Disorder, SevereAustralia
-
Oregon Research InstituteCompletedCannabis Use Disorder, Mild | Cannabis Use Disorder, ModerateUnited States
-
McMaster UniversityCenter for Medicinal Cannabis Research; Peter Boris Centre for Addictions Research...RecruitingCannabis Use Disorder, Moderate | Cannabis Use Disorder, SevereCanada
-
Boston Children's HospitalNational Institute on Drug Abuse (NIDA)RecruitingCannabis Use | Cannabis Use Disorder | Cannabis IntoxicationUnited States
Clinical Trials on Marijuana Check-Ins
-
University of PittsburghCenters for Disease Control and Prevention; Population CouncilActive, not recruitingCoping Skills | Violence in Adolescence | Adolescent Behavior | Violence, Sexual | Violence, Physical | Violence, Gender-Based | Communication, Social | Racism | Violence, Non-accidental | Communication, PersonalUnited States
-
Vanderbilt University Medical CenterUniversity of ConnecticutCompletedType 1 Diabetes MellitusUnited States
-
University of Maryland, BaltimoreCompleted
-
Massachusetts General HospitalActive, not recruitingTobacco Use Disorder | Bipolar DisorderUnited States
-
University of AlbertaCanadian Institutes of Health Research (CIHR)CompletedHeart Failure | Cancer | Chronic Kidney Diseases | Cirrhosis, Liver | Primary Biliary Cholangitis | Digestive Diseases | Women Who Have Experienced a Cardiac Event | Post-Transplant | Other Chronic Physical ConditionCanada
-
Consumer Wellness SolutionsUniversity of Washington; SRI InternationalCompletedSmoking Cessation | Marijuana UseUnited States
-
Kingston Health Sciences CentreMuhimbili University of Health and Allied Sciences; Kilimanjaro Clinical Research...Not yet recruiting
-
Oregon Health and Science UniversityRecruiting
-
University of PennsylvaniaPatient-Centered Outcomes Research InstituteRecruitingOpioid Use Disorder | Opioid Dependence With Current Use (Disorder)United States
-
Seattle Children's HospitalUniversity of Washington; National Center for Complementary and Integrative...UnknownSleep Initiation and Maintenance DisordersUnited States