Rapid Adaptation to Prevent Drug Use

NCT05806840 | Active Not Recruiting DMC

• 2 other identifiers: IRB-23-01-5434R34DA056777
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Substance Use

Outcome Measures

Primary Outcomes (3)

• RAPD Strategy Feasibility

  The investigators use a mixed methods approach to determine teacher perceived feasibility of the RAPD implementation strategy (Feasibility of Implementation Measure). Feasibility is defined as the extent to which the innovation (RAPD) can be practically used in a given setting.

  9 Months

• RAPD Strategy Acceptability

  The investigators use a mixed methods approach to determine teacher perceived acceptability of the RAPD implementation strategy (Acceptability of Implementation Measure). Acceptability is defined as the view among stakeholders that a given innovation (RAPD) is agreeable or satisfactory.

  9 Months

• RAPD Strategy Appropriateness

  The investigators use a mixed methods approach to determine teacher perceived appropriateness of the RAPD implementation strategy (Implementation Appropriateness Measure). Appropriateness is defined as the perceived compatibility of an innovation (RAPD) with needs and practices of the setting and the perceived utility in addressing a given problem.

  9 Months

Secondary Outcomes (1)

• MMH Fidelity

  9 Months

Study Arms (2)

Standard Michigan Model for Health (MMH) Curriculum Implementation

ACTIVE COMPARATOR

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.

Behavioral: Standard Implementation

Rapid Adaptation to Prevent Drug Use (RAPD)

EXPERIMENTAL

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.

Behavioral: Rapid Adaptation to Prevent Drug Use (RAPD)

Interventions

Rapid Adaptation to Prevent Drug Use (RAPD) BEHAVIORAL

RAPD will include a novel bundle of implementation strategies to support rapid responses to urgent drug use events. The strategies deployed will be based on the first step of the After Action Review: critical analysis and reflection.

Rapid Adaptation to Prevent Drug Use (RAPD)

Standard Implementation BEHAVIORAL

Standard implementation of the Michigan Model for Health (MMH) includes curriculum materials and as-needed technical assistance provided by a school health coordinator.

Standard Michigan Model for Health (MMH) Curriculum Implementation

Eligibility Criteria

• Age: 11 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wayne State University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Wayne State University

Detroit, Michigan, 48202, United States

Location

Related Publications (4)

• Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.

  PMID: 28851459 BACKGROUND

• Wiltsey Stirman S, Baumann AA, Miller CJ. The FRAME: an expanded framework for reporting adaptations and modifications to evidence-based interventions. Implement Sci. 2019 Jun 6;14(1):58. doi: 10.1186/s13012-019-0898-y.

  PMID: 31171014 BACKGROUND

• Eisman AB, Koffkey C, Brown S, Holmes C, Schmidt B, Swihart E, Robinson T, Kim B. Using After Action Review to Identify Rapid Response Implementation Strategies for Emerging Drugs Among Youth. Prev Sci. 2025 Feb;26(2):258-270. doi: 10.1007/s11121-025-01787-x. Epub 2025 Feb 10.

  PMID: 39930106 DERIVED

• Eisman AB, Koffkey C, Partridge RT, Brown S, Kim B. Rapid Adaptation to Prevent Drug Use (RAPD): protocol of a pilot randomized trial to enhance the impact of an evidence-based intervention for youth. Pilot Feasibility Stud. 2025 Jan 21;11(1):8. doi: 10.1186/s40814-024-01581-6.

  PMID: 39838453 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Andria Eisman, PhD

  Wayne State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Community Health

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: April 10, 2023
• Study Start: September 6, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2025
• Last Updated: June 14, 2024

Record last verified: 2024-06

Locations

US (1)