A Hybrid Effectiveness-Implementation Trial of a School-Based Teen Marijuana Checkup (TMCU5)

May 11, 2023 updated by: Denise Walker, University of Washington
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

264

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98105
        • University of Washington Innovative Programs Research Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, 3, and 6 month follow-up
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.
within two weeks before training, 2 week, 6, 12, 18, and 24 month follow-up post training

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within two weeks before training, 2 week, 6, 12, 18, and 24 month follow-up post training
Student Participants - change in marijuana related problems
Time Frame: baseline, 3, and 6 month follow-up
self-reported retrospective marijuana problems
baseline, 3, and 6 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Investigators

  • Principal Investigator: Bryan Hartzler, PhD, University of Washington
  • Principal Investigator: Denise Walker, PhD, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2016

Primary Completion (Actual)

July 1, 2020

Study Completion (Actual)

February 28, 2023

Study Registration Dates

First Submitted

March 20, 2017

First Submitted That Met QC Criteria

April 7, 2017

First Posted (Actual)

April 13, 2017

Study Record Updates

Last Update Posted (Actual)

May 15, 2023

Last Update Submitted That Met QC Criteria

May 11, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00000988

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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