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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.
Background: Drug use remains a major public health problem among youth in the United States. Effective implementation of evidence-based interventions for youth is critical for reducing the burden of drug use and its consequences. The Michigan Model for Health (MMH) is an intervention that has demonstrated efficacy in reducing adolescent substance use. Yet, youth rarely receive evidence-based interventions (EBIs) as intended; this is, in part, due to a poor fit between the intervention and the context. The disconnect between the EBI and context is especially pronounced among underserved and vulnerable populations, including among youth exposed to trauma. Trauma is a potent risk factor for substance use, abuse, and the development of substance use disorders. Consequently, we have a critical need to design and test effective, cost-efficient implementation strategies to optimize the fidelity of school-based drug use prevention to better meet the needs of youth exposed to trauma. The objective of this study is to design and test a multi-component implementation strategy to improve intervention-context fit and enhance fidelity and effectiveness.
Methods: Using a 2-group, mixed method, randomized trial design, this pilot study will compare standard implementation (Replicating Effective Programs: REP) versus enhanced Enhanced Replicating Effective Programs (Enhanced REP) to deliver MMH. REP is a previously established implementation strategy that promotes EBI fidelity through a combination of curriculum packaging, training, and as-needed technical assistance. Enhanced REP incorporates tailoring of the EBI package and training and deploys customized implementation support (i.e., implementation facilitation).
This research designs and tests an implementation strategy deployed to systematically enhance the fit between the intervention and the context for a universal drug use prevention curriculum. The proposed research will focus on youth at heightened risk of drug use and its consequences due to trauma exposure. The proposed research is significant because of its potential to have a positive public health impact by preventing and reducing youth drug use and its consequences.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wayne State University | Detroit | Michigan | 48202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28851459 | Background | 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. | |
| 19664226 | 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. |
| Label | URL |
|---|---|
| This website contains the resources for the intervention group and access to the surveys which teachers use to track their lesson fidelity. | View source |
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From NIH HEAL (Helping to End Addiction Long-term) Public Access and Data Sharing (https://heal.nih.gov/about/public-access-data) information: Electronic copies of publications will be deposited within 4 weeks of acceptance by a journal in PubMed Central with proper metadata to be discoverable and accessible upon publication. Publications will be published under the Creative Commons Attribution 4.0 Generic License (CC BY 4.0) or otherwise dedicated to the public domain. Publications will be made publicly available immediately without an embargo period. Underlying Primary Data for the Publications will be made available through an suitable data repository, such as the NIH HEAL central data repository. To meet program goals, NIH requires broad sharing of Underlying Primary Data from NIH-Supported NIH HEAL Initiative Research Projects in a way that is responsive to concerns about protecting confidential and proprietary data and is consistent with other applicable laws and regulations.
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 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.
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10 schools were assessed for eligibility. 1 school was excluded due to lack of response to eligibility survey and 9 schools were randomized to receive Standard Replicating Effective Programs (REP) or Enhanced REP.
Schools which failed to meet state standards for implementation (<80% of curriculum) and/or faced one or more barrier to implementation were recruited by Regional School Health Coordinators. Participating teachers taught high school health class.
| ID | Title | Description |
|---|---|---|
| FG000 | Standard REP | Teachers received the digital MMH curriculum, standard training, and as-needed technical assistance, provided to them by the regional school health coordinators. Standard implementation: Standard implementation of the Michigan Model for Health is akin to Standard REP and includes the curriculum materials, standard training and as-needed technical assistance. |
| FG001 | Enhanced REP | Teachers in the Enhanced REP group received a tailored MMH curriculum to include trauma-informed approaches, tailored trauma-focused curriculum training, and implementation facilitation (ongoing specialized implementation support). Enhanced Replicating Effective Programs (Enhanced REP): Deploy Enhanced REP to optimize the delivery of a drug use prevention intervention in community schools and test its feasibility, acceptability, and appropriateness; Enhanced REP includes tailoring the curriculum, training, and providing ongoing provider consultation, or facilitation, to support implementation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard MMH Curriculum Implementation | Standard MMH implementation includes 1. MMH curriculum manual, 2. standard training, and 3. as-needed technical assistance provided by the statewide network of school health coordinators. Standard implementation of the Michigan Model for Health is consistent with Standard REP (Replicating Effective Programs) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | This study includes two separate populations of participants (i.e., teachers and students). We include a separate row for each population group, which adds to the total number of baseline participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Teachers who completed the study and participated in interviews. Data collected is from interim- and post-implementation interviews as they pertain directly to the outcome measure. | Posted | Number | Coded interview segments | 9 months | Schools | Schools |
9 Months
AE data was not collected for any group.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard MMH Curriculum Implementation | Teachers will receive the MMH curriculum manual, standard training and as-needed technical assistance, provided to them by the health coordinators Standard implementation: Standard implementation of the Michigan Model for Health is akin to Standard REP and includes the curriculum materials, standard training and as-needed technical assistance. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andria Eisman, Principal Investigator | Wayne State University | 313-649-7477 | aeisman@wayne.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 20, 2020 | Jul 6, 2023 | Prot_SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form: Teacher Informed Consent | Aug 15, 2021 | Sep 21, 2021 | ICF_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Adolescent Informed Assent | Aug 15, 2021 | Sep 21, 2021 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Parent Information Letter | Aug 15, 2021 | Sep 21, 2021 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| 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. |
|
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| 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 |
| 21592127 | 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. |
| 23758995 | 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. |
| 32307625 | 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. |
| 18067681 | 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. |
| 41924170 | Derived | Eisman A, Whitman J, Palinkas L, Fridline J, Harvey C, Kilbourne AM, Hutton D. Economic Evaluation of Implementation Strategies for School-Based Universal Prevention: Insights from a Pilot Study. Ment Health Prev. 2026 Jun;42:200498. doi: 10.1016/j.mhp.2026.200498. Epub 2026 Mar 11. |
| 37946235 | Derived | 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. |
| 36088351 | 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. |
| BG001 |
| Enhanced Replicating Effective Programs (REP) |
Enhanced REP includes 1. tailored MMH curriculum to include trauma-sensitive content, 2. tailored curriculum training, and 3. implementation facilitation. Enhanced Replicating Effective Programs (Enhanced REP): We deploy Enhanced REP to optimize the delivery of a drug use prevention intervention in community schools and test its feasibility, acceptability, and appropriateness. |
| BG002 | Total | Total of all reporting groups |
| Schools |
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| Count of Participants |
| Participants |
| Participants |
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| Sex/Gender, Customized | This study includes two separate populations of participants (i.e., teachers and students). We include a separate row for each population group, which adds to the total number of baseline participants | Count of Participants | Participants | Participants |
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| Race/Ethnicity, Customized | This study includes two separate populations of participants (i.e., teachers and students). We include a separate row for each population group, which adds to the total number of baseline participants | Count of Participants | Participants | Participants |
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| Region of Enrollment | Number | Schools | Schools |
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| School Size (>1000) | Number of schools with more than 1000 students. | Publicly available school-level data was used to identify schools with more than 1000 students. Teachers in each school are considered the participants analyzed. | Count of Units | Schools | Schools |
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| Free Reduced Lunch Percentage (>50%) | Number of schools where greater than 50% of students receive free and/or reduced lunches. | School-level data was used to determine the number of schools in the study which had greater than 50% of students who are eligible to receive free and/or reduced lunches, according to state-level data. | Count of Units | Schools | Schools |
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| ID | Title | Description |
|---|---|---|
| OG000 | Standard REP | Teachers received the digital MMH curriculum, standard training, and as-needed technical assistance, provided to them by the regional school health coordinators. Standard implementation: Standard implementation of the Michigan Model for Health is akin to Standard REP and includes the curriculum materials, standard training and as-needed technical assistance. |
| OG001 | Enhanced REP | Teachers in the Enhanced REP group received a tailored MMH curriculum to include trauma-informed approaches, tailored trauma-focused curriculum training, and implementation facilitation (ongoing specialized implementation support). Enhanced Replicating Effective Programs (Enhanced REP): Deploy Enhanced REP to optimize the delivery of a drug use prevention intervention in community schools and test its feasibility, acceptability, and appropriateness; Enhanced REP includes tailoring the curriculum, training, and providing ongoing provider consultation, or facilitation, to support implementation. |
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| Primary | 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). | Teachers who completed the study and participated in interviews. Data collected is from interim- and post-implementation interviews as they pertain directly to the outcome measure. | Posted | Number | Coded interview segments | 9 months | Schools | Schools |
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| Primary | 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). | Teachers who completed the study and participated in interviews. Data collected is from interim- and post-implementation interviews as they pertain directly to the outcome measure. | Posted | Number | Coded interview segments | 9 months | Schools | Schools |
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| Primary | 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. | Posted | Number | Dollars | 9 months | Schools | Schools |
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| EG001 | Michigan Model for Health: Learning to Enhance and Adapt for Prevention (MI-LEAP) | 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. Enhanced Replicating Effective Programs (Enhanced REP): Deploy Enhanced REP to optimize the delivery of a drug use prevention intervention in community schools and test its feasibility, acceptability, and appropriateness; Enhanced REP includes tailoring the curriculum, training, and providing ongoing provider consultation, or facilitation, to support implementation. | 0 | 0 | 0 | 0 | 0 | 0 |
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| >=65 years |
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| Inner setting influences on curriculum acceptability |
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