Rapid Adaptation to Prevent Drug Use

NCT ID: NCT05806840

Last Updated: 2024-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-06

Study Completion Date

2025-07-31

Brief Summary

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

Detailed Description

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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 Healthâ„¢ (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.

Conditions

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Substance Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Standard Michigan Model for Health (MMH) Curriculum Implementation

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.

Group Type ACTIVE_COMPARATOR

Standard Implementation

Intervention Type BEHAVIORAL

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

Rapid Adaptation to Prevent Drug Use (RAPD)

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.

Group Type EXPERIMENTAL

Rapid Adaptation to Prevent Drug Use (RAPD)

Intervention Type 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.

Interventions

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Rapid Adaptation to Prevent Drug Use (RAPD)

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.

Intervention Type BEHAVIORAL

Standard Implementation

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

11 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Wayne State University

OTHER

Sponsor Role lead

Responsible Party

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Andria B Eisman

Assistant Professor of Community Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andria Eisman, PhD

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

Locations

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Wayne State University

Detroit, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 28851459 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31171014 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39930106 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39838453 (View on PubMed)

Other Identifiers

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R34DA056777

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-23-01-5434

Identifier Type: -

Identifier Source: org_study_id

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