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Completed

NCT Number: NCT03111667

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

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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Key information

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington Innovative Programs Research Group

Seattle, Washington, 98105, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Teen Marijuana Check Up

Behavioral

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.

Treatment as Usual

Other

Referral to community resources

Gold Standard Coaching

Behavioral

Weekly coaching and feedback about adherence to Motivational Interviewing Skills and intervention delivery in a group setting.

As Needed Coaching

Behavioral

As needed coaching and feedback about adherence to Motivational Interviewing Skills and intervention delivery in an individual setting.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

  2. Student Participants - change in marijuana related problems

    Time frame: baseline, 3, and 6 month follow-up

    self-reported retrospective marijuana problems

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Acronym: TMCU5

Important dates

Study start
2016
Primary completion
2020
Study completion
2023
First posted
Apr 13, 2017
Registry last updated
May 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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