Clinical trial NCT03111667: A Hybrid Effectiveness-Implementation Trial of a School-Based Teen Marijuana Checkup
Official title: A Hybrid Effectiveness-Implementation Trial of a School-Based Teen Marijuana Checkup
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cannabis Use
Keywords: Marijuana
Motivational Enhancement Therapy
Adolescents
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 264
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Group 1: Administrators from local High Schools.

Inclusion Criteria:

* age 21 and older
* in an administrative role at one of the 10 participating high schools.

Exclusion Criteria:

* none

Group 2: School Staff- Climate Survey Respondents.

Inclusion Criteria:

* age 21 and older
* in a staff position at one of the 10 participating high schools.

Exclusion Criteria:

* none

Group 3: School Based Staff - Interventionists.

Inclusion Criteria:

* willing to participate in TMCU implementation procedures (i.e., randomization to coaching group, training, supervision and feedback, monitored performance via audio-recorded sessions),
* willing to share some personal demographic data,
* permission from supervisor,
* a two -year commitment and availability to participate in the project, and
* willingness to have sessions audio-recorded for feedback.

Exclusion Criteria: Otherwise eligible SBS will be excluded if

* plan to leave the school within the next year or,
* have an extended absence (e.g., 3 month parental leave, semester sabbatical) planned.

Group 4: Marijuana Using Students.

Inclusion Criteria:

* age (14-21 years old),
* grade (9-12)
* marijuana use
* willing to have sessions audio-recorded.

Exclusion Criteria: Individuals otherwise eligible will be excluded if:

* not fluent in English,
* have a thought disorder that precludes full participation, or
* refuse to accept randomization to condition.

Primary outcomes:
measure: Student Participants: Change in Number of Marijuana Use Days
timeFrame: baseline, 3, and 6 month follow-up
measure: School Based Interventionists - change in behavioral fidelity
timeFrame: within two weeks before training, 2 week, 6, 12, 18, and 24 month follow-up post training
Secondary outcomes:
measure: School Based Interventionists - implementation acceptability
timeFrame: within two weeks before training, 2 week, 6, 12, 18, and 24 month follow-up post training
measure: Student Participants - change in marijuana related problems
timeFrame: baseline, 3, and 6 month follow-up
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Innovative Programs Research Group
state: Washington
Study officials:
affiliation: University of Washington
name: Bryan Hartzler, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Denise Walker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hartzler B, Lyon AR, Walker DD, Matthews L, King KM, McCollister KE. Implementing the teen marijuana check-up in schools-a study protocol. Implement Sci. 2017 Aug 10;12(1):103. doi: 10.1186/s13012-017-0633-5.