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Rapid Adaptation to Prevent Drug Use (RAPD)

Primary Purpose

Substance Use

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rapid Adaptation to Prevent Drug Use (RAPD)
Standard Implementation
Sponsored by
Wayne State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance Use

Eligibility Criteria

11 Years - 99 Years (Child, Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Wayne State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Michigan Model for Health (MMH) Curriculum Implementation

Rapid Adaptation to Prevent Drug Use (RAPD)

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
March 2, 2023
Last Updated
April 6, 2023
Sponsor
Wayne State University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT05806840
Brief Title
Rapid Adaptation to Prevent Drug Use
Acronym
RAPD
Official Title
Enhancing the Impact of Evidence-Based Prevention for Youth: The Rapid Adaptation to Prevent Drug Use (RAPD) Implementation Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Michigan Model for Health (MMH) Curriculum Implementation
Arm Type
Active Comparator
Arm 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.
Arm Title
Rapid Adaptation to Prevent Drug Use (RAPD)
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Rapid Adaptation to Prevent Drug Use (RAPD)
Intervention Description
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
Intervention Name(s)
Standard Implementation
Intervention Description
Standard implementation of the Michigan Model for Health (MMH) includes curriculum materials and as-needed technical assistance provided by a school health coordinator.
Primary Outcome Measure Information:
Title
RAPD Strategy Feasibility
Description
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.
Time Frame
9 Months
Title
RAPD Strategy Acceptability
Description
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.
Time Frame
9 Months
Title
RAPD Strategy Appropriateness
Description
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.
Time Frame
9 Months
Secondary Outcome Measure Information:
Title
MMH Fidelity
Description
The investigators use an MMH fidelity tracking form to assess dose delivered by summing the total lessons delivered.
Time Frame
9 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andria B Eisman, PhD, MPH, MS
Phone
313-649-7477
Email
aeisman@wayne.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Christine R Koffkey, MPH
Email
ckoffkey@wayne.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andria Eisman, PhD
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andria B Eisman, PhD, MPH, MS
Phone
313-649-7477
Email
aeisman@wayne.edu
First Name & Middle Initial & Last Name & Degree
Andria B Eisman, PhD, MPH, MS

12. IPD Sharing Statement

Citations:
PubMed Identifier
28851459
Citation
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.
Results Reference
background
PubMed Identifier
31171014
Citation
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.
Results Reference
background

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Rapid Adaptation to Prevent Drug Use

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