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

Primary Purpose

Cannabis Use

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Teen Marijuana Check Up
Treatment as Usual
Gold Standard Coaching
As Needed Coaching
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis Use focused on measuring Marijuana, Motivational Enhancement Therapy, Adolescents

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Washington Innovative Programs Research Group

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Other

Experimental

Active Comparator

No Intervention

No Intervention

Arm Label

Student Participants: Teen Marijuana Check Up

Student Participants: Treatment As Usual

Interventionist Participants: Gold Standard Coaching

Interventionist Participants: As Needed Coaching

Administrator Participants: Environment

School Staff Participants: Environment

Arm Description

2 Session Motivational Enhancement Therapy intervention for adolescents who use marijuana.

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.

Interventionists will receive weekly coaching and feedback about sessions and skills from the project PI.

Interventionists will receive coaching and feedback about sessions and skills from the project PI only when sessions fall below adherent skill levels.

School Administrators will provide data about the school environment.

Staff will provide data about the school environment

Outcomes

Primary Outcome Measures

Student Participants: Change in Number of Marijuana Use Days
self-reported, retrospective number of marijuana use days in the past 60.
School Based Interventionists - change in behavioral fidelity
Adherent MITI score.

Secondary Outcome Measures

School Based Interventionists - implementation acceptability
School Based Interventionists - self-reported satisfaction with their experience in TMCU
Student Participants - change in marijuana related problems
self-reported retrospective marijuana problems

Full Information

First Posted
March 20, 2017
Last Updated
May 11, 2023
Sponsor
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT03111667
Brief Title
A Hybrid Effectiveness-Implementation Trial of a School-Based Teen Marijuana Checkup
Acronym
TMCU5
Official Title
A Hybrid Effectiveness-Implementation Trial of a School-Based Teen Marijuana Checkup
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 15, 2016 (Actual)
Primary Completion Date
July 2020 (Actual)
Study Completion Date
February 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use
Keywords
Marijuana, Motivational Enhancement Therapy, Adolescents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
264 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Student Participants: Teen Marijuana Check Up
Arm Type
Experimental
Arm Description
2 Session Motivational Enhancement Therapy intervention for adolescents who use marijuana.
Arm Title
Student Participants: Treatment As Usual
Arm Type
Other
Arm Description
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.
Arm Title
Interventionist Participants: Gold Standard Coaching
Arm Type
Experimental
Arm Description
Interventionists will receive weekly coaching and feedback about sessions and skills from the project PI.
Arm Title
Interventionist Participants: As Needed Coaching
Arm Type
Active Comparator
Arm Description
Interventionists will receive coaching and feedback about sessions and skills from the project PI only when sessions fall below adherent skill levels.
Arm Title
Administrator Participants: Environment
Arm Type
No Intervention
Arm Description
School Administrators will provide data about the school environment.
Arm Title
School Staff Participants: Environment
Arm Type
No Intervention
Arm Description
Staff will provide data about the school environment
Intervention Type
Behavioral
Intervention Name(s)
Teen Marijuana Check Up
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment as Usual
Intervention Description
Referral to community resources
Intervention Type
Behavioral
Intervention Name(s)
Gold Standard Coaching
Intervention Description
Weekly coaching and feedback about adherence to Motivational Interviewing Skills and intervention delivery in a group setting.
Intervention Type
Behavioral
Intervention Name(s)
As Needed Coaching
Intervention Description
As needed coaching and feedback about adherence to Motivational Interviewing Skills and intervention delivery in an individual setting.
Primary Outcome Measure Information:
Title
Student Participants: Change in Number of Marijuana Use Days
Description
self-reported, retrospective number of marijuana use days in the past 60.
Time Frame
baseline, 3, and 6 month follow-up
Title
School Based Interventionists - change in behavioral fidelity
Description
Adherent MITI score.
Time Frame
within two weeks before training, 2 week, 6, 12, 18, and 24 month follow-up post training
Secondary Outcome Measure Information:
Title
School Based Interventionists - implementation acceptability
Description
School Based Interventionists - self-reported satisfaction with their experience in TMCU
Time Frame
within two weeks before training, 2 week, 6, 12, 18, and 24 month follow-up post training
Title
Student Participants - change in marijuana related problems
Description
self-reported retrospective marijuana problems
Time Frame
baseline, 3, and 6 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryan Hartzler, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Denise Walker, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington Innovative Programs Research Group
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28797270
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.
Results Reference
derived

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

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