Substance Abuse
Conditions
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.
Detailed description
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.
Interventions
BEHAVIORALEnhanced Replicating Effective Programs (Enhanced REP)
Enhanced REP includes 1. a tailored MMH curriculum, 2. tailored training, and 3. ongoing provider consultation or facilitation to support implementation.
BEHAVIORALStandard implementation
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.
Sponsors
Wayne State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Schools which fail to meet state standards for implementation (less than 80% of curriculum) and/or face one or more barriers to MMH implementation
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Indicators of Feasibility | 9 months | 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). |
| Indicators of Acceptability | 9 months | 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). |
| Indicators of Appropriateness | 9 months | 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). |
| Incremental Implementation Strategy Cost | 9 months | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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) | 369 |
| 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) | 5 |
| 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. | 456 |
| 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. | 4 |
| Total | 834 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 261 | 126 |
| Overall Study | Withdrawal by Subject | 0 | 150 |
Baseline characteristics
| Characteristic | Enhanced Replicating Effective Programs (REP) | Standard MMH Curriculum Implementation | Total |
|---|---|---|---|
| Age, Categorical Students <=18 years | 451 Participants | 364 Participants | 815 Participants |
| Age, Categorical Students >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Students Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Teachers <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Teachers >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Teachers Between 18 and 65 years | 5 Participants | 5 Participants | 10 Participants |
| Free Reduced Lunch Percentage (>50%) | 1 Schools | 1 Schools | 2 Schools |
| Race/Ethnicity, Customized Asian American Students | 9 Participants | 9 Participants | 18 Participants |
| Race/Ethnicity, Customized Asian American Teachers | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black Students | 211 Participants | 166 Participants | 377 Participants |
| Race/Ethnicity, Customized Black Teachers | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Latino/a Students | 15 Participants | 8 Participants | 23 Participants |
| Race/Ethnicity, Customized Latino/a Teachers | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Multiracial Students | 48 Participants | 40 Participants | 88 Participants |
| Race/Ethnicity, Customized Multiracial Teachers | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Native American Students | 8 Participants | 6 Participants | 14 Participants |
| Race/Ethnicity, Customized Native American Teachers | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Unsure Students | 60 Participants | 77 Participants | 137 Participants |
| Race/Ethnicity, Customized Unsure Teachers | 5 Participants | 5 Participants | 10 Participants |
| Race/Ethnicity, Customized White Students | 100 Participants | 58 Participants | 158 Participants |
| Race/Ethnicity, Customized White Teachers | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 4 Schools | 5 Schools | 9 Schools |
| School Size (>1000) | 3 Schools | 4 Schools | 7 Schools |
| Sex/Gender, Customized Man Students | 226 Participants | 158 Participants | 384 Participants |
| Sex/Gender, Customized Man Teachers | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Non-binary Students | 8 Participants | 12 Participants | 20 Participants |
| Sex/Gender, Customized Non-binary Teachers | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Not collected Students | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Not collected Teachers | 5 Participants | 5 Participants | 10 Participants |
| Sex/Gender, Customized Other Students | 6 Participants | 8 Participants | 14 Participants |
| Sex/Gender, Customized Other Teachers | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Prefer not to say Students | 4 Participants | 9 Participants | 13 Participants |
| Sex/Gender, Customized Prefer not to say Teachers | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Woman Students | 207 Participants | 177 Participants | 384 Participants |
| Sex/Gender, Customized Woman Teachers | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 9 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard REP | Incremental Implementation Strategy Cost | 11,903 Dollars |
| Enhanced REP | Incremental Implementation Strategy Cost | 0 Dollars |
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).
Time frame: 9 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard REP | Indicators of Acceptability | Acceptability of Implementation Facilitation and Support | 6 Coded interview segments |
| Standard REP | Indicators of Acceptability | Inner setting influences on curriculum acceptability | 19 Coded interview segments |
| Standard REP | Indicators of Acceptability | Curriculum materials acceptably met student needs | 46 Coded interview segments |
| Enhanced REP | Indicators of Acceptability | Curriculum materials acceptably met student needs | 36 Coded interview segments |
| Enhanced REP | Indicators of Acceptability | Acceptability of Implementation Facilitation and Support | 5 Coded interview segments |
| Enhanced REP | Indicators of Acceptability | Inner setting influences on curriculum acceptability | 13 Coded interview segments |
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).
Time frame: 9 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard REP | Indicators of Appropriateness | Appropriateness of curriculum for students | 24 Coded interview segments |
| Standard REP | Indicators of Appropriateness | Appropriateness of implementation facilitation | 6 Coded interview segments |
| Enhanced REP | Indicators of Appropriateness | Appropriateness of curriculum for students | 29 Coded interview segments |
| Enhanced REP | Indicators of Appropriateness | Appropriateness of implementation facilitation | 4 Coded interview segments |
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).
Time frame: 9 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard REP | Indicators of Feasibility | Impact of implementation climate on feasibility | 6 Coded interview segments |
| Standard REP | Indicators of Feasibility | Impact of strategic implementation leadership on feasibility | 5 Coded interview segments |
| Enhanced REP | Indicators of Feasibility | Impact of strategic implementation leadership on feasibility | 5 Coded interview segments |
| Enhanced REP | Indicators of Feasibility | Impact of implementation climate on feasibility | 6 Coded interview segments |