University of Washington Innovative Programs Research Group
Seattle, Washington, 98105, United States
NCT Number: NCT03111667
A hybrid effectiveness-implementation trial that is designed to assess the effectiveness of an intervention (The Teen Marijuana Check-Up) when delivered in real world settings. In addition, the study will assess the frequency of coaching support needed by providers to maintain adherent skill levels.
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Notify Me14 year and older
All sexes
Interventional
Not applicable
Seattle, Washington, 98105, United States
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Group 1: Administrators from local High Schools.
Inclusion criteria
Exclusion criteria
Group 2: School Staff- Climate Survey Respondents.
Inclusion criteria
Exclusion criteria
Group 3: School Based Staff - Interventionists.
Inclusion criteria
Exclusion criteria
Otherwise eligible SBS will be excluded if
Group 4: Marijuana Using Students.
Inclusion criteria
Exclusion criteria
Individuals otherwise eligible will be excluded if:
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.
Referral to community resources
Weekly coaching and feedback about adherence to Motivational Interviewing Skills and intervention delivery in a group setting.
As needed coaching and feedback about adherence to Motivational Interviewing Skills and intervention delivery in an individual setting.
Time frame: baseline, 3, and 6 month follow-up
self-reported, retrospective number of marijuana use days in the past 60.
Time frame: within two weeks before training, 2 week, 6, 12, 18, and 24 month follow-up post training
Adherent MITI score.
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
Time frame: baseline, 3, and 6 month follow-up
self-reported retrospective marijuana problems
University of Washington
Other
Acronym: TMCU5
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