Substance UseRAPDNCT05806840
Rapid Adaptation to Prevent Drug Use
A study testing Rapid Adaptation to Prevent Drug Use (RAPD) and Standard Implementation in people with Substance Use, run by Wayne State University at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 11 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use
- What is being tested?
- Rapid Adaptation to Prevent Drug Use (RAPD) and Standard Implementation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2023to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing the Impact of Evidence-Based Prevention for Youth: The Rapid Adaptation to Prevent Drug Use (RAPD) Implementation Study
Using a 2-group, mixed method cluster randomized trial design, this study will compare standard implementation versus RAPD implementation strategy in Michigan Middle Schools
Read the 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.
- Conditions
- Substance Use
- Being tested
- Rapid Adaptation to Prevent Drug Use (RAPD), Standard Implementation
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid Adaptation to Prevent Drug Use (RAPD)Behavioural
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.
Standard ImplementationBehavioural
Standard implementation of the Michigan Model for Health (MMH) includes curriculum materials and as-needed technical assistance provided by a school health coordinator.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Rapid Adaptation to Prevent Drug Use (RAPD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 9 Months
Secondary outcomes (1)
MMH Fidelity
The investigators use an MMH fidelity tracking form to assess dose delivered by summing the total lessons delivered.
Measured: 9 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start6 Sep 2023
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Substance UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Andria B Eisman, Wayne State University
- Investigators
- Andria Eisman, PhD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806840
- Sponsor's protocol ID
- IRB-23-01-5434
- Other IDs
- R34DA056777
- Acronym
- RAPD
- Status last verified
- Jun 2024
- First submitted
- 2 Mar 2023
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 28851459Wiltsey 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.
PubMed 31171014Eisman 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.
PubMed 39930106Eisman 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.
PubMed 39838453
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing the Impact of Evidence-Based Prevention for Youth: The Rapid Adaptation to Prevent Drug Use (RAPD) Implementation Study
- ClinicalTrials.gov ID
- NCT05806840
- Acronym / sponsor ID
- RAPD / IRB-23-01-5434
- Conditions
- Substance Use
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 6 Sep 2023 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 10 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Michigan Model for Health (MMH) Curriculum Implementation | Active comparator | Behavioral: Standard ImplementationStandard 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. |
| Rapid Adaptation to Prevent Drug Use (RAPD) | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 11 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Rapid Adaptation to Prevent Drug Use (RAPD) |
| Standard ImplementationStandard implementation of the Michigan Model for Health (MMH) includes curriculum materials and as-needed technical assistance provided by a school health coordinator. | Behavioural | Standard Michigan Model for Health (MMH) Curriculum Implementation |
Primary outcome
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.
1 secondary outcome
MMH Fidelity
Time frame: 9 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Background: PubMed 28851459Weiner 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.
- Background: PubMed 31171014Wiltsey 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.
- Derived from this study: PubMed 39930106Eisman 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.
- Derived from this study: PubMed 39838453Eisman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andria Eisman, PhD principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid Adaptation to Prevent Drug Use (RAPD) and Standard Implementation in people with Substance Use, run by Wayne State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RAPD Strategy Feasibility (time frame: 9 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05806840, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.