A Hybrid Effectiveness-Implementation Trial of a School-Based Teen Marijuana Checkup (TMCU5)
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|ClinicalTrials.gov Identifier: NCT03111667|
Recruitment Status : Recruiting
First Posted : April 13, 2017
Last Update Posted : January 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cannabis Use||Behavioral: Teen Marijuana Check Up Other: Treatment as Usual Behavioral: Gold Standard Coaching Behavioral: As Needed Coaching||Not Applicable|
The objectives of the proposed study are to advance Type 2 translational science through an effectiveness-implementation "type 2" hybrid design to evaluate the clinical and cost-effectiveness of an efficacious intervention (Teen Marijuana Check-Up, TMCU) and compare the feasibility, acceptability, impact and cost-effectiveness of two integrity monitoring support systems. Marijuana continues to be the most frequently used drug in the U.S. and adolescent use is associated with negative effects such as academic failure, dropout, and emotional problems. Although marijuana is the most common presenting substance for 12-17 year olds seeking substance abuse treatment, few voluntarily seek indicated services. The TMCU is a brief, school-based motivational enhancement therapy approach that has been systematically evaluated in three randomized controlled trials with reliable beneficial effects in prompting voluntary participation in the intervention and decreasing adolescent marijuana use. With TMCU now well-positioned for broad dissemination, its public health impact may be enhanced by further research addressing: 1) to what extent its documented efficacy under controlled conditions translates to real-world effectiveness, and 2) what support systems are most useful in promoting sustained integrity in its delivery by the available school-based personnel. The proposed type 2 effectiveness/implementation hybrid trial will include randomization at multiple levels. Students will be randomly-assigned in a 1:2 ratio to 'services-as-usual' and TMCU intervention conditions, and school-based personnel identified to deliver TMCU will be randomly-assigned to do so under governance of a 'gold-standard' training/oversight support system (i.e., rapid, continual performance-based feedback and weekly coaching about integrity of TMCU delivery) or a less resource-intensive support system similarly including performance-based feedback but with process benchmarking (defined by prior performance of research interventionists in TMCU efficacy trials) prompting points at which these school-based personnel receive purveyor coaching. Expected trial participation of ten schools will enable recruitment of 30 TMCU interventionists, and access to a pool of 250 marijuana-using students during a two-year implementation period. This nested design (e.g., students in schools/intervention conditions; interventionists in schools/training/oversight support systems) will utilize multilevel models in study analyses to account for possible school-level clustering. A cost analysis will also be conducted. Longitudinal outcome and process data will be collected from school based staff (6, 12, 18, & 24 month follow-ups) and students (3 and 6 month followups).
The trial will occur in Washington state at an opportune time when legislative, fiscal, and socio-cultural factors converge to heighten potential adolescent exposure to marijuana-related harms—represents an effort by this investigative team to respond to such local challenges in a manner that will advance understanding of best practices for dissemination and implementation of this and other efficacious, school-based interventions
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||327 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Student Participants will be assigned in a 2:1 ratio to the Experimental "Teen Marijuana Check Up" or a Control "Treatment as Usual" condition.
Interventionist Participants will be assigned in a 1:1 ratio to "Gold Standard" or "As Needed" Coaching
|Masking:||None (Open Label)|
|Official Title:||A Hybrid Effectiveness-Implementation Trial of a School-Based Teen Marijuana Checkup|
|Actual Study Start Date :||May 15, 2016|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||May 2020|
Experimental: Student Participants: Teen Marijuana Check Up
2 Session Motivational Enhancement Therapy intervention for adolescents who use marijuana.
Behavioral: Teen Marijuana Check Up
Two session Motivational Enhancement Therapy intervention. The first MET session relies on the use of motivational interviewing skills to hear the student's history and current concerns with marijuana. The second session involves the provision of a personalized feedback report based on the student's baseline assessment that reviews normative feedback on marijuana use, consequences experienced, money spent on marijuana, other drug and alcohol use, social supports for quitting and life goals.
Student Participants: Treatment As Usual
Students will receive referrals to local agencies and other resources as typically done by school based staff. At the end of research follow-up period, students in this condition will be eligible to receive the active intervention.
Other: Treatment as Usual
Referral to community resources
Experimental: Interventionist Participants: Gold Standard Coaching
Interventionists will receive weekly coaching and feedback about sessions and skills from the project PI.
Behavioral: Gold Standard Coaching
Weekly coaching and feedback about adherence to Motivational Interviewing Skills and intervention delivery in a group setting.
Active Comparator: Interventionist Participants: As Needed Coaching
Interventionists will receive coaching and feedback about sessions and skills from the project PI only when sessions fall below adherent skill levels.
Behavioral: As Needed Coaching
As needed coaching and feedback about adherence to Motivational Interviewing Skills and intervention delivery in an individual setting.
No Intervention: Administrator Participants: Environment
School Administrators will provide data about the school environment.
No Intervention: School Staff Participants: Environment
Staff will provide data about the school environment
- Student Participants: Change in Number of Marijuana Use Days [ Time Frame: baseline, 3, and 6 month follow-up ]self-reported, retrospective number of marijuana use days in the past 60.
- School Based Interventionists - change in behavioral fidelity [ Time Frame: within two weeks before training, 2 week, 6, 12, 18, and 24 month follow-up post training ]Adherent MITI score.
- School Based Interventionists - implementation acceptability [ Time Frame: within two weeks before training, 2 week, 6, 12, 18, and 24 month follow-up post training ]School Based Interventionists - self-reported satisfaction with their experience in TMCU
- Student Participants - change in marijuana related problems [ Time Frame: baseline, 3, and 6 month follow-up ]self-reported retrospective marijuana problems
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03111667
|Contact: Lauren Matthews, MSWemail@example.com|
|Contact: Denise Walker, PhDfirstname.lastname@example.org|
|United States, Washington|
|University of Washington Innovative Programs Research Group||Recruiting|
|Seattle, Washington, United States, 98105|
|Contact: Denise D Walker, PhD 206-543-7511 email@example.com|
|Contact: Lauren Matthews, MSW 206-616-3235 firstname.lastname@example.org|
|Principal Investigator: Denise D Walker, PhD|
|Principal Investigator: Bryan Hartzler, PhD|
|Principal Investigator:||Bryan Hartzler, PhD||University of Washington|
|Principal Investigator:||Denise Walker, PhD||University of Washington|