Rapid Adaptation to Prevent Drug Use (RAPD)

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

Tracking Information

• First Submitted Date: March 2, 2023
• First Posted Date: April 10, 2023
• Last Update Posted Date: April 10, 2023
• Estimated Study Start Date: August 2023
• Estimated Primary Completion Date: June 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 6, 2023)

• 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.
• 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.
• 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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: April 6, 2023)

MMH Fidelity [ Time Frame: 9 Months ]

The investigators use an MMH fidelity tracking form to assess dose delivered by summing the total lessons delivered.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Rapid Adaptation to Prevent Drug Use
• Official Title: Enhancing the Impact of Evidence-Based Prevention for Youth: The Rapid Adaptation to Prevent Drug Use (RAPD) Implementation Study
• 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

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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Substance Use

Intervention

• 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.
• 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.

Study Arms

• 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.
  Intervention: Behavioral: Standard Implementation
• 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.
  Intervention: Behavioral: Rapid Adaptation to Prevent Drug Use (RAPD)

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: April 6, 2023): 12
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 2024
• Estimated Primary Completion Date: June 2024 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 11 Years to 99 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Andria B Eisman, PhD, MPH, MS; 313-649-7477; aeisman@wayne.edu

Contact: Christine R Koffkey, MPH; ckoffkey@wayne.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05806840
• Other Study ID Numbers: IRB-23-01-5434; R34DA056777 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Andria B Eisman, Wayne State University
• Original Responsible Party: Same as current
• Current Study Sponsor: Wayne State University
• Original Study Sponsor: Same as current
• Collaborators: National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Andria Eisman, PhD; Wayne State University

• PRS Account: Wayne State University
• Verification Date: April 2023