Rapid Adaptation to Prevent Drug Use (RAPD)

Wayne State University

Status: Active, not recruiting

Conditions: Substance Use

Treatments: Behavioral: Standard Implementation; Behavioral: Rapid Adaptation to Prevent Drug Use (RAPD)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05806840

R34DA056777 (U.S. NIH Grant/Contract)

IRB-23-01-5434

Details and patient eligibility

About

Using a 2-group, mixed method cluster randomized trial design, this study will compare standard implementation versus RAPD implementation strategy in Michigan Middle Schools

Full description

Background: Drug use trends change rapidly among youth, leaving intervention experts struggling to respond to emerging drugs promptly. There is a critical need to advance implementation strategies to optimize system responsiveness to these emerging issues. COVID-19 has increased the urgency for implementation science to facilitate rapid, equitable responses using existing treatment and prevention efforts. Tier 1 evidence-based interventions (EBIs), such as the Michigan Model for Health™ (MMH) lend themselves to addressing emerging trends. The overall objectives of this study are to 1) improve the responsiveness of school-based EBIs in addressing urgent issues and 2) find ways to support educators and education systems in implementing updated EBIs, attending to unique considerations of low-resource settings.

Methods: Using a 2-group, mixed method, randomized controlled trial design, this pilot study will compare standard implementation versus the RAPD implementation strategy to deliver MMH.

The RAPD implementation strategy was designed based on an After Action Review (AAR) approach in collaboration with community partners to analyze gaps and best practices and identify and test suitable implementation strategies to improve responsiveness to the next urgent drug event.

Enrollment: 12 estimated patients

Sex: All

Ages: 11 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Schools that fail to meet state standards for implementation (less than 80% of curriculum) and/or face one or more barriers to Michigan Model for Health (MMH) curriculum implementation
• Schools that have a minimum of 25% of students eligible for free and reduced meals
• Schools must include 7th-grade classes/students

Exclusion criteria

• Schools that meet state identified fidelity standards (i.e., teaching 80% or more of the curriculum) and do not face barriers to MMH implementation
• Schools that have fewer than 25% of students eligible for free and reduced meals
• Schools that do not include 7th-grade education level

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Standard Michigan Model for Health (MMH) Curriculum Implementation

Active Comparator group

Description:

Standard implementation of the MMH (Michigan Model for Health), a universal prevention intervention includes curriculum materials, foundational curriculum training and as-needed technical assistance, provided by the regional school health coordinators.

Treatment:

Behavioral: Standard Implementation

Rapid Adaptation to Prevent Drug Use (RAPD)

Experimental group

Description:

RAPD is a novel bundle of implementation strategies to improve the responsiveness of an existing evidence-based intervention (EBI), the Michigan Model for Health (MMH) for urgent drug events. These implementation strategies will be deployed in addition to standard implementation components.

Treatment:

Behavioral: Rapid Adaptation to Prevent Drug Use (RAPD)