Preventing Substance Use Among Youth

NCT04752189 | Completed Results DMC

• 1 other identifier: IRB-20-10-2821
• Study Type: interventional
• Target: 825
• Locations: 1 country
• Sites: 1

Brief Summary

Using a 2-group, mixed method group randomized trial design, this pilot study will compare standard implementation versus Enhanced Replicating Effective Programs (Enhanced REP) to deliver Michigan Model for Health (MMH) in Michigan high schools.

Conditions

Substance Abuse

Outcome Measures

Primary Outcomes (4)

• Indicators of Feasibility

  To evaluate comprehensively curriculum feasibility, the investigators used the Consolidated Framework for Implementation Research (CFIR) interview guide to guide the qualitative investigation of using Standard MMH Implementation or MI-LEAP for MMH delivery. The semi-structured interview guide was designed to elicit specific feedback on REP and Enhanced REP components (manual, training, and facilitation) and their feasibility to deliver MMH. We used reflexive thematic analysis to generate initial codes guided by the CFIR constructs. To ensure data extracts illustrated the themes and identified the subthemes, we reviewed the themes and subthemes against the original transcripts after the review sessions to ensure the analysis provided a well-organized and thorough view of the data. The number of coded interview segments identified during teacher interviews reported here indicate the number of segments from the teacher interviews which align with the identified theme (row title).

  9 months

• Indicators of Acceptability

  To evaluate comprehensively curriculum acceptability, the investigators used the Consolidated Framework for Implementation Research (CFIR) interview guide to guide the qualitative investigation of using Standard MMH Implementation or MI-LEAP for MMH delivery. The semi-structured interview guide was designed to elicit specific feedback on REP and Enhanced REP components (manual, training, and facilitation) and their feasibility to deliver MMH. We used reflexive thematic analysis to generate initial codes guided by the CFIR constructs. To ensure data extracts illustrated the themes and identified the subthemes, we reviewed the themes and subthemes against the original transcripts after the review sessions to ensure the analysis provided a well-organized and thorough view of the data. The number of coded interview segments identified during teacher interviews reported here indicate the number of segments from the teacher interviews which align with the identified theme (row title).

  9 months

• Indicators of Appropriateness

  To evaluate comprehensively curriculum appropriateness, the investigators used the Consolidated Framework for Implementation Research (CFIR) interview guide to guide the qualitative investigation of using Standard MMH Implementation or MI-LEAP for MMH delivery. The semi-structured interview guide was designed to elicit specific feedback on REP and Enhanced REP components (manual, training, and facilitation) and their feasibility to deliver MMH. We used reflexive thematic analysis to generate initial codes guided by the CFIR constructs. To ensure data extracts illustrated the themes and identified the subthemes, we reviewed the themes and subthemes against the original transcripts after the review sessions to ensure the analysis provided a well-organized and thorough view of the data. The number of coded interview segments identified during teacher interviews reported here indicate the number of segments from the teacher interviews which align with the identified theme (row title).

  9 months

• Incremental Implementation Strategy Cost

  We used an activity-based micro-costing approach mapping key activities of Enhanced REP across implementation phases. We used the EPIS (Exploration, Preparation, Implementation, and Sustainment) framework to guide implementation phases and to guide the determination of implementation strategy costs. To accurately assess the time spent on each activity, and therefore the cost, individuals (health coordinators and research staff) recorded time spent on tasks throughout the strategy deployment and documented those activities using an activity log. Because the cost of Enhanced REP is on top of the current practices of Standard REP, we report the incremental cost of Enhanced REP.

  9 months

Study Arms (2)

Standard MMH Curriculum Implementation

ACTIVE COMPARATOR

Teachers will receive the MMH curriculum manual, standard training and as-needed technical assistance, provided to them by the health coordinators; consistent with standard REP.

Behavioral: Standard implementation

Enhanced Replicating Effective Programs (REP)

EXPERIMENTAL

We will deploy Enhanced REP to include additional tailoring of the MMH curriculum to include trauma-informed approaches, tailored trauma-focused curriculum training, and implementation facilitation, ongoing specialized implementation support.

Behavioral: Enhanced Replicating Effective Programs (Enhanced REP)

Interventions

Enhanced Replicating Effective Programs (Enhanced REP) BEHAVIORAL

Enhanced REP includes 1. a tailored MMH curriculum, 2. tailored training, and 3. ongoing provider consultation or facilitation to support implementation.

Enhanced Replicating Effective Programs (REP)

Standard implementation BEHAVIORAL

The standard implementation of the Michigan Model for Health is consistent with Standard REP and includes the curriculum materials, standard training, and as-needed technical assistance.

Also known as: Standard REP

Standard MMH Curriculum Implementation

Eligibility Criteria

• Age: 14 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Schools which fail to meet state standards for implementation (less than 80% of curriculum) and/or face one or more barriers to MMH implementation

You may not qualify if:

• None

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

Wayne State University

Detroit, Michigan, 48202, United States

Location

Related Publications (8)

• 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.

  PMID: 28851459 BACKGROUND

• Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.

  PMID: 19664226 BACKGROUND

• O'neill JM, Clark JK, Jones JA. Promoting mental health and preventing substance abuse and violence in elementary students: a randomized control study of the Michigan Model for Health. J Sch Health. 2011 Jun;81(6):320-30. doi: 10.1111/j.1746-1561.2011.00597.x.

  PMID: 21592127 BACKGROUND

• Stirman SW, Miller CJ, Toder K, Calloway A. Development of a framework and coding system for modifications and adaptations of evidence-based interventions. Implement Sci. 2013 Jun 10;8:65. doi: 10.1186/1748-5908-8-65.

  PMID: 23758995 BACKGROUND

• Eisman AB, Kilbourne AM, Greene D Jr, Walton M, Cunningham R. The User-Program Interaction: How Teacher Experience Shapes the Relationship Between Intervention Packaging and Fidelity to a State-Adopted Health Curriculum. Prev Sci. 2020 Aug;21(6):820-829. doi: 10.1007/s11121-020-01120-8.

  PMID: 32307625 BACKGROUND

• Kilbourne AM, Neumann MS, Pincus HA, Bauer MS, Stall R. Implementing evidence-based interventions in health care: application of the replicating effective programs framework. Implement Sci. 2007 Dec 9;2:42. doi: 10.1186/1748-5908-2-42.

  PMID: 18067681 BACKGROUND

• Eisman AB, Whitman J, Palinkas LA, Fridline J, Harvey C, Kilbourne AM, Hutton DW. A mixed methods partner-focused cost and budget impact analysis to deploy implementation strategies for school-based prevention. Implement Sci Commun. 2023 Nov 9;4(1):133. doi: 10.1186/s43058-023-00511-6.

  PMID: 37946235 DERIVED

• Eisman AB, Palinkas LA, Koffkey C, Herrenkohl TI, Abbasi U, Fridline J, Lundahl L, Kilbourne AM. Michigan Model for HealthTM Learning to Enhance and Adapt for Prevention (Mi-LEAP): protocol of a pilot randomized trial comparing Enhanced Replicating Effective Programs versus standard implementation to deliver an evidence-based drug use prevention curriculum. Pilot Feasibility Stud. 2022 Sep 10;8(1):204. doi: 10.1186/s40814-022-01145-6.

  PMID: 36088351 DERIVED

Related Links

• This website contains the resources for the intervention group and access to the surveys which teachers use to track their lesson fidelity.

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Andria Eisman, Principal Investigator
• Organization: Wayne State University

aeisman@wayne.edu

313-649-7477

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 23, 2021
• First Posted: February 12, 2021
• Study Start: August 4, 2021
• Primary Completion: July 14, 2022
• Study Completion: July 14, 2022
• Last Updated: November 18, 2024
• Results First Posted: November 18, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: De-identified primary participant (i.e., student) -level data will be available through an appropriate data repository, such as the NIH HEAL Initiative central data repository. The data will be available upon acceptance for publication of the main findings from the final student-level dataset. Data will be available in the NIH HEAL repository per HEAL guidelines.
• Access Criteria: Access criteria will be determined by the NIH HEAL guidelines. Access to individual-level data will require entering into a data-sharing agreement that includes requirements to protect participants' privacy and data confidentiality.

Locations

US (1)