Preventing Substance Use Among Youth

Wayne State University

Status: Completed

Conditions: Substance Abuse

Treatments: Behavioral: Standard implementation; Behavioral: Enhanced Replicating Effective Programs (Enhanced REP)

Study type: Interventional

Funder types: Other

Identifiers

NCT04752189

IRB-20-10-2821

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 825 patients

Sex: All

Ages: 14 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Schools which fail to meet state standards for implementation (less than 80% of curriculum) and/or face one or more barriers to MMH implementation

Exclusion criteria

• None

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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825 participants in 2 patient groups

Standard MMH Curriculum Implementation

Active Comparator group

Description:

Teachers will receive the MMH curriculum manual, standard training and as-needed technical assistance, provided to them by the health coordinators; consistent with standard REP.

Treatment:

Behavioral: Standard implementation

Enhanced Replicating Effective Programs (REP)

Experimental group

Description:

We will deploy Enhanced REP to include additional tailoring of the MMH curriculum to include trauma-informed approaches, tailored trauma-focused curriculum training, and implementation facilitation, ongoing specialized implementation support.

Treatment:

Behavioral: Enhanced Replicating Effective Programs (Enhanced REP)