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Rapid Adaptation to Prevent Drug Use (RAPD)

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ClinicalTrials.gov Identifier: NCT05806840
Recruitment Status : Not yet recruiting
First Posted : April 10, 2023
Last Update Posted : April 10, 2023
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Andria B Eisman, Wayne State University

Study Description
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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

Condition or disease Intervention/treatment Phase
Substance Use Behavioral: Rapid Adaptation to Prevent Drug Use (RAPD) Behavioral: Standard Implementation Not Applicable

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Enhancing the Impact of Evidence-Based Prevention for Youth: The Rapid Adaptation to Prevent Drug Use (RAPD) Implementation Study
Estimated Study Start Date : August 2023
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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.
 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.
Experimental: 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.
 Behavioral: 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.


Outcome Measures
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Primary Outcome Measures :
  1. RAPD Strategy Feasibility [ Time Frame: 9 Months ]
    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.

  2. RAPD Strategy Acceptability [ Time Frame: 9 Months ]
    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.

  3. RAPD Strategy Appropriateness [ Time Frame: 9 Months ]
    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.


Secondary Outcome Measures :
  1. MMH Fidelity [ Time Frame: 9 Months ]
    The investigators use an MMH fidelity tracking form to assess dose delivered by summing the total lessons delivered.


Eligibility Criteria
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Ages Eligible for Study:   11 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05806840


Contacts
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Contact: Andria B Eisman, PhD, MPH, MS 313-649-7477 aeisman@wayne.edu
Contact: Christine R Koffkey, MPH ckoffkey@wayne.edu

Locations
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United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48202
Contact: Andria B Eisman, PhD, MPH, MS    313-649-7477    aeisman@wayne.edu   
Principal Investigator: Andria B Eisman, PhD, MPH, MS         
Sponsors and Collaborators
Wayne State University
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Andria Eisman, PhD Wayne State University
More Information
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Publications:

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Responsible Party: Andria B Eisman, Assistant Professor of Community Health, Wayne State University
ClinicalTrials.gov Identifier: NCT05806840    
Other Study ID Numbers: IRB-23-01-5434
R34DA056777 ( U.S. NIH Grant/Contract )
First Posted: April 10, 2023    Key Record Dates
Last Update Posted: April 10, 2023
Last Verified: April 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders