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

NCT ID: NCT03111667

Last Updated: 2023-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 264 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-15
• Study Completion Date: 2023-02-28

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

Conditions

Cannabis Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Student Participants: Teen Marijuana Check Up

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

Group Type: EXPERIMENTAL

Teen Marijuana Check Up

Intervention Type: 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.

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.

Group Type: OTHER

Treatment as Usual

Intervention Type: OTHER

Referral to community resources

Interventionist Participants: Gold Standard Coaching

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

Group Type: EXPERIMENTAL

Gold Standard Coaching

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

As Needed Coaching

Intervention Type: BEHAVIORAL

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

Administrator Participants: Environment

School Administrators will provide data about the school environment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

School Staff Participants: Environment

Staff will provide data about the school environment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Treatment as Usual

Referral to community resources

Intervention Type: OTHER

Gold Standard Coaching

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

Intervention Type: BEHAVIORAL

As Needed Coaching

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

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

• 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.

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

Exclusion Criteria

• none

Group 2: School Staff- Climate Survey Respondents.

• none

Group 3: School Based Staff - Interventionists.

• 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.

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

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Denise Walker

Research Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bryan Hartzler, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Denise Walker, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington Innovative Programs Research Group

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 28797270 (View on PubMed)

Other Identifiers

STUDY00000988

Identifier Type: -

Identifier Source: org_study_id