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Trial record 9 of 95 for:    Recruiting, Not yet recruiting, Active, not recruiting Studies | marijuana | United States

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

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ClinicalTrials.gov Identifier: NCT03111667
Recruitment Status : Recruiting
First Posted : April 13, 2017
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
Denise Walker, University of Washington

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.

Condition or disease Intervention/treatment Phase
Cannabis Use Behavioral: Teen Marijuana Check Up Other: Treatment as Usual Behavioral: Gold Standard Coaching Behavioral: As Needed Coaching Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 327 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Hybrid Effectiveness-Implementation Trial of a School-Based Teen Marijuana Checkup
Actual Study Start Date : May 15, 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

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.

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



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

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:

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03111667


Contacts
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Contact: Lauren Matthews, MSW 206-616-3235 lmatt@uw.edu
Contact: Denise Walker, PhD 206-543-7511 ddwalker@uw.edu

Locations
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United States, Washington
University of Washington Innovative Programs Research Group Recruiting
Seattle, Washington, United States, 98105
Contact: Denise D Walker, PhD    206-543-7511    ddwalker@uw.edu   
Contact: Lauren Matthews, MSW    206-616-3235    lmatt@uw.edu   
Principal Investigator: Denise D Walker, PhD         
Principal Investigator: Bryan Hartzler, PhD         
Sponsors and Collaborators
University of Washington
Investigators
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Principal Investigator: Bryan Hartzler, PhD University of Washington
Principal Investigator: Denise Walker, PhD University of Washington

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Denise Walker, Research Associate Professor, University of Washington
ClinicalTrials.gov Identifier: NCT03111667     History of Changes
Other Study ID Numbers: STUDY00000988
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Denise Walker, University of Washington:
Marijuana
Motivational Enhancement Therapy
Adolescents

Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders