A Hybrid Effectiveness-Implementation Trial of a School-Based Teen Marijuana Checkup
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 264
- 试验地点
- 2
- 主要终点
- Student Participants: Change in Number of Marijuana Use Days
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 21 and older
- •in an administrative role at one of the 10 participating high schools.
排除标准
- •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.
结局指标
主要结局
Student Participants: Change in Number of Marijuana Use Days
时间窗: 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
时间窗: within two weeks before training, 2 week, 6, 12, 18, and 24 month follow-up post training
Adherent MITI score.
次要结局
- School Based Interventionists - implementation acceptability(within two weeks before training, 2 week, 6, 12, 18, and 24 month follow-up post training)
- Student Participants - change in marijuana related problems(baseline, 3, and 6 month follow-up)
研究者
Denise Walker
Research Associate Professor
University of Washington