Preventing Substance Use Among Youth: Behavioral and Economic Impact of Enhanced Implementation Strategies for Communities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 825
- 试验地点
- 2
- 主要终点
- Indicators of Feasibility
研究概览
简要总结
Using a 2-group, mixed method group randomized trial design, this pilot study will compare standard implementation versus Enhanced Replicating Effective Programs (Enhanced REP) to deliver Michigan Model for Health (MMH) in Michigan high schools.
详细描述
Background: Drug use remains a major public health problem among youth in the United States. Effective implementation of evidence-based interventions for youth is critical for reducing the burden of drug use and its consequences. The Michigan Model for Health (MMH) is an intervention that has demonstrated efficacy in reducing adolescent substance use. Yet, youth rarely receive evidence-based interventions (EBIs) as intended; this is, in part, due to a poor fit between the intervention and the context. The disconnect between the EBI and context is especially pronounced among underserved and vulnerable populations, including among youth exposed to trauma. Trauma is a potent risk factor for substance use, abuse, and the development of substance use disorders. Consequently, we have a critical need to design and test effective, cost-efficient implementation strategies to optimize the fidelity of school-based drug use prevention to better meet the needs of youth exposed to trauma. The objective of this study is to design and test a multi-component implementation strategy to improve intervention-context fit and enhance fidelity and effectiveness.
Methods: Using a 2-group, mixed method, randomized trial design, this pilot study will compare standard implementation (Replicating Effective Programs: REP) versus enhanced Enhanced Replicating Effective Programs (Enhanced REP) to deliver MMH. REP is a previously established implementation strategy that promotes EBI fidelity through a combination of curriculum packaging, training, and as-needed technical assistance. Enhanced REP incorporates tailoring of the EBI package and training and deploys customized implementation support (i.e., implementation facilitation).
This research designs and tests an implementation strategy deployed to systematically enhance the fit between the intervention and the context for a universal drug use prevention curriculum. The proposed research will focus on youth at heightened risk of drug use and its consequences due to trauma exposure. The proposed research is significant because of its potential to have a positive public health impact by preventing and reducing youth drug use and its consequences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Schools which fail to meet state standards for implementation (less than 80% of curriculum) and/or face one or more barriers to MMH implementation
排除标准
- 未提供
结局指标
主要结局
Indicators of Feasibility
时间窗: 9 months
To evaluate comprehensively curriculum feasibility, the investigators used the Consolidated Framework for Implementation Research (CFIR) interview guide to guide the qualitative investigation of using Standard MMH Implementation or MI-LEAP for MMH delivery. The semi-structured interview guide was designed to elicit specific feedback on REP and Enhanced REP components (manual, training, and facilitation) and their feasibility to deliver MMH. We used reflexive thematic analysis to generate initial codes guided by the CFIR constructs. To ensure data extracts illustrated the themes and identified the subthemes, we reviewed the themes and subthemes against the original transcripts after the review sessions to ensure the analysis provided a well-organized and thorough view of the data. The number of coded interview segments identified during teacher interviews reported here indicate the number of segments from the teacher interviews which align with the identified theme (row title).
Indicators of Acceptability
时间窗: 9 months
To evaluate comprehensively curriculum acceptability, the investigators used the Consolidated Framework for Implementation Research (CFIR) interview guide to guide the qualitative investigation of using Standard MMH Implementation or MI-LEAP for MMH delivery. The semi-structured interview guide was designed to elicit specific feedback on REP and Enhanced REP components (manual, training, and facilitation) and their feasibility to deliver MMH. We used reflexive thematic analysis to generate initial codes guided by the CFIR constructs. To ensure data extracts illustrated the themes and identified the subthemes, we reviewed the themes and subthemes against the original transcripts after the review sessions to ensure the analysis provided a well-organized and thorough view of the data. The number of coded interview segments identified during teacher interviews reported here indicate the number of segments from the teacher interviews which align with the identified theme (row title).
Indicators of Appropriateness
时间窗: 9 months
To evaluate comprehensively curriculum appropriateness, the investigators used the Consolidated Framework for Implementation Research (CFIR) interview guide to guide the qualitative investigation of using Standard MMH Implementation or MI-LEAP for MMH delivery. The semi-structured interview guide was designed to elicit specific feedback on REP and Enhanced REP components (manual, training, and facilitation) and their feasibility to deliver MMH. We used reflexive thematic analysis to generate initial codes guided by the CFIR constructs. To ensure data extracts illustrated the themes and identified the subthemes, we reviewed the themes and subthemes against the original transcripts after the review sessions to ensure the analysis provided a well-organized and thorough view of the data. The number of coded interview segments identified during teacher interviews reported here indicate the number of segments from the teacher interviews which align with the identified theme (row title).
Incremental Implementation Strategy Cost
时间窗: 9 months
We used an activity-based micro-costing approach mapping key activities of Enhanced REP across implementation phases. We used the EPIS (Exploration, Preparation, Implementation, and Sustainment) framework to guide implementation phases and to guide the determination of implementation strategy costs. To accurately assess the time spent on each activity, and therefore the cost, individuals (health coordinators and research staff) recorded time spent on tasks throughout the strategy deployment and documented those activities using an activity log. Because the cost of Enhanced REP is on top of the current practices of Standard REP, we report the incremental cost of Enhanced REP.
次要结局
未报告次要终点
研究者
Andria B Eisman
Assistant Professor
Wayne State University