Cannabis UseTMCU5NCT03111667
A Hybrid Effectiveness-Implementation Trial of a School-Based Teen Marijuana Checkup
A study testing Teen Marijuana Check Up, Treatment as Usual and Gold Standard Coaching in people with Cannabis Use, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cannabis Use
- What is being tested?
- Teen Marijuana Check Up, Treatment as Usual and Gold Standard Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2016to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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,
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- 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.
- 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.
Who cannot join
- none
- Group 2: School Staff- Climate Survey Respondents.
- none
- Group 3: School Based Staff - Interventionists.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Innovative Programs Research Group
Seattle, Washington, 98105
About this study
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.
Read the 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
- Being tested
- Teen Marijuana Check Up, Treatment as Usual, Gold Standard Coaching, As Needed Coaching
- Keywords
- Marijuana, Motivational Enhancement Therapy, Adolescents
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teen Marijuana Check UpBehavioural
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 UsualOther
Referral to community resources
Gold Standard CoachingBehavioural
Weekly coaching and feedback about adherence to Motivational Interviewing Skills and intervention delivery in a group setting.
As Needed CoachingBehavioural
As needed coaching and feedback about adherence to Motivational Interviewing Skills and intervention delivery in an individual setting.
| Study group | Role | What they receive |
|---|---|---|
| Student Participants: Teen Marijuana Check Up | Experimental | 2 Session Motivational Enhancement Therapy intervention for adolescents who use marijuana. Receives: Behavioral: Teen Marijuana Check Up |
| Student Participants: Treatment As Usual | Other | 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. Receives: Other: Treatment as Usual |
| Interventionist Participants: Gold Standard Coaching | Experimental | Interventionists will receive weekly coaching and feedback about sessions and skills from the project PI. Receives: Behavioral: Gold Standard Coaching |
| Interventionist Participants: As Needed Coaching | Active comparator | Interventionists will receive coaching and feedback about sessions and skills from the project PI only when sessions fall below adherent skill levels. Receives: Behavioral: As Needed Coaching |
| Administrator Participants: Environment | No intervention | School Administrators will provide data about the school environment. |
| School Staff Participants: Environment | No intervention | Staff will provide data about the school environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Student Participants: Change in Number of Marijuana Use Days
self-reported, retrospective number of marijuana use days in the past 60.
Measured: baseline, 3, and 6 month follow-up
School Based Interventionists - change in behavioral fidelity
Adherent MITI score.
Measured: within two weeks before training, 2 week, 6, 12, 18, and 24 month follow-up post training
Secondary outcomes (2)
School Based Interventionists - implementation acceptability
School Based Interventionists - self-reported satisfaction with their experience in TMCU
Measured: within two weeks before training, 2 week, 6, 12, 18, and 24 month follow-up post training
Student Participants - change in marijuana related problems
self-reported retrospective marijuana problems
Measured: baseline, 3, and 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start15 May 2016
- Primary completionJul 2020
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cannabis UseStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Denise Walker, University of Washington
- Investigators
- Bryan Hartzler, PhD, Principal investigator, University of WashingtonDenise Walker, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03111667
- Sponsor's protocol ID
- STUDY00000988
- Acronym
- TMCU5
- Status last verified
- May 2023
- First submitted
- 20 Mar 2017
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28797270
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Hybrid Effectiveness-Implementation Trial of a School-Based Teen Marijuana Checkup
- ClinicalTrials.gov ID
- NCT03111667
- Acronym / sponsor ID
- TMCU5 / STUDY00000988
- Conditions
- Cannabis Use
- Keywords
- Marijuana, Motivational Enhancement Therapy, Adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 15 May 2016 (actual)
- Primary completion
- Jul 2020 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 13 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- 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
| Arm | Type | Receives |
|---|---|---|
| Student Participants: Teen Marijuana Check Up | Experimental | Behavioral: Teen Marijuana Check Up2 Session Motivational Enhancement Therapy intervention for adolescents who use marijuana. |
| Student Participants: Treatment As Usual | Other | Other: Treatment as UsualStudents 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. |
| Interventionist Participants: Gold Standard Coaching | Experimental | Behavioral: Gold Standard CoachingInterventionists will receive weekly coaching and feedback about sessions and skills from the project PI. |
| Interventionist Participants: As Needed Coaching | Active comparator | Behavioral: As Needed CoachingInterventionists will receive coaching and feedback about sessions and skills from the project PI only when sessions fall below adherent skill levels. |
| Administrator Participants: Environment | No intervention | –School Administrators will provide data about the school environment. |
| School Staff Participants: Environment | No intervention | –Staff will provide data about the school environment |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (21 listed)
- 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),
Key exclusion criteria (4 listed)
- none
- Group 2: School Staff- Climate Survey Respondents.
- none
- Group 3: School Based Staff - Interventionists.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teen Marijuana Check UpTwo 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. | Behavioural | Student Participants: Teen Marijuana Check Up |
| Treatment as UsualReferral to community resources | Other | Student Participants: Treatment As Usual |
| Gold Standard CoachingWeekly coaching and feedback about adherence to Motivational Interviewing Skills and intervention delivery in a group setting. | Behavioural | Interventionist Participants: Gold Standard Coaching |
| As Needed CoachingAs needed coaching and feedback about adherence to Motivational Interviewing Skills and intervention delivery in an individual setting. | Behavioural | Interventionist Participants: As Needed Coaching |
Primary outcome
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.
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.
2 secondary outcomes
School Based Interventionists - implementation acceptability
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- Derived from this study: PubMed 28797270Hartzler 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bryan Hartzler, PhD principal investigator
University of Washington
Denise Walker, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teen Marijuana Check Up, Treatment as Usual and Gold Standard Coaching in people with Cannabis Use, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Student Participants: Change in Number of Marijuana Use Days (time frame: baseline, 3, and 6 month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03111667, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2023.