Trial Outcomes & Findings for Preventing Substance Use Among Youth (NCT NCT04752189)
NCT ID: NCT04752189
Last Updated: 2024-11-18
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
825 participants
Primary outcome timeframe
9 months
Results posted on
2024-11-18
Participant Flow
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.
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.
Unit of analysis: Schools
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
369 5
|
456 4
|
|
Overall Study
Teacher Participants- Completed Pre-implementation Interview
|
5 5
|
5 4
|
|
Overall Study
Student Participants- Completed Baseline Student Survey
|
364 4
|
451 4
|
|
Overall Study
Teacher Participants - Participated in Interim Interview
|
1 1
|
2 2
|
|
Overall Study
Student Participants- Completed Post-implementation Survey Matched to Baseline Survey
|
104 4
|
178 2
|
|
Overall Study
Teacher Participants- Completed Post-implementation Interview
|
4 4
|
2 2
|
|
Overall Study
COMPLETED
|
108 4
|
180 2
|
|
Overall Study
NOT COMPLETED
|
261 1
|
276 2
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
150
|
|
Overall Study
Lost to Follow-up
|
261
|
126
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Standard MMH Curriculum Implementation
n=5 Schools
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)
|
Enhanced Replicating Effective Programs (REP)
n=4 Schools
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.
|
Total
n=9 Schools
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
Students · <=18 years
|
364 Participants
n=364 Participants • 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
|
451 Participants
n=451 Participants • 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
|
815 Participants
n=815 Participants • 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
|
|
Age, Categorical
Students · Between 18 and 65 years
|
0 Participants
n=364 Participants • 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
|
0 Participants
n=451 Participants • 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
|
0 Participants
n=815 Participants • 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
|
|
Age, Categorical
Students · >=65 years
|
0 Participants
n=364 Participants • 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
|
0 Participants
n=451 Participants • 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
|
0 Participants
n=815 Participants • 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
|
|
Age, Categorical
Teachers · <=18 years
|
0 Participants
n=5 Participants • 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
|
0 Participants
n=5 Participants • 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
|
0 Participants
n=10 Participants • 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
|
|
Age, Categorical
Teachers · Between 18 and 65 years
|
5 Participants
n=5 Participants • 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
|
5 Participants
n=5 Participants • 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
|
10 Participants
n=10 Participants • 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
|
|
Age, Categorical
Teachers · >=65 years
|
0 Participants
n=5 Participants • 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
|
0 Participants
n=5 Participants • 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
|
0 Participants
n=10 Participants • 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
|
|
Sex/Gender, Customized
Man · Students
|
158 Participants
n=158 Participants • 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
|
226 Participants
n=226 Participants • 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
|
384 Participants
n=384 Participants • 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
|
|
Sex/Gender, Customized
Man · Teachers
|
0 Participants
n=158 Participants • 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
|
0 Participants
n=226 Participants • 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
|
0 Participants
n=384 Participants • 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
|
|
Sex/Gender, Customized
Woman · Students
|
177 Participants
n=177 Participants • 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
|
207 Participants
n=207 Participants • 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
|
384 Participants
n=384 Participants • 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
|
|
Sex/Gender, Customized
Woman · Teachers
|
0 Participants
n=177 Participants • 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
|
0 Participants
n=207 Participants • 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
|
0 Participants
n=384 Participants • 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
|
|
Sex/Gender, Customized
Non-binary · Students
|
12 Participants
n=12 Participants • 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
|
8 Participants
n=8 Participants • 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
|
20 Participants
n=20 Participants • 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
|
|
Sex/Gender, Customized
Non-binary · Teachers
|
0 Participants
n=12 Participants • 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
|
0 Participants
n=8 Participants • 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
|
0 Participants
n=20 Participants • 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
|
|
Sex/Gender, Customized
Other · Students
|
8 Participants
n=8 Participants • 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
|
6 Participants
n=6 Participants • 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
|
14 Participants
n=14 Participants • 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
|
|
Sex/Gender, Customized
Other · Teachers
|
0 Participants
n=8 Participants • 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
|
0 Participants
n=6 Participants • 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
|
0 Participants
n=14 Participants • 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
|
|
Sex/Gender, Customized
Prefer not to say · Students
|
9 Participants
n=9 Participants • 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
|
4 Participants
n=4 Participants • 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
|
13 Participants
n=13 Participants • 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
|
|
Sex/Gender, Customized
Prefer not to say · Teachers
|
0 Participants
n=9 Participants • 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
|
0 Participants
n=4 Participants • 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
|
0 Participants
n=13 Participants • 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
|
|
Sex/Gender, Customized
Not collected · Students
|
0 Participants
n=5 Participants • 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
|
0 Participants
n=5 Participants • 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
|
0 Participants
n=10 Participants • 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
|
|
Sex/Gender, Customized
Not collected · Teachers
|
5 Participants
n=5 Participants • 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
|
5 Participants
n=5 Participants • 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
|
10 Participants
n=10 Participants • 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
|
|
Race/Ethnicity, Customized
Black · Students
|
166 Participants
n=166 Participants • 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
|
211 Participants
n=211 Participants • 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
|
377 Participants
n=377 Participants • 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
|
|
Race/Ethnicity, Customized
Black · Teachers
|
0 Participants
n=166 Participants • 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
|
0 Participants
n=211 Participants • 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
|
0 Participants
n=377 Participants • 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
|
|
Race/Ethnicity, Customized
White · Students
|
58 Participants
n=58 Participants • 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
|
100 Participants
n=100 Participants • 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
|
158 Participants
n=158 Participants • 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
|
|
Race/Ethnicity, Customized
White · Teachers
|
0 Participants
n=58 Participants • 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
|
0 Participants
n=100 Participants • 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
|
0 Participants
n=158 Participants • 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
|
|
Race/Ethnicity, Customized
Latino/a · Students
|
8 Participants
n=8 Participants • 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
|
15 Participants
n=15 Participants • 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
|
23 Participants
n=23 Participants • 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
|
|
Race/Ethnicity, Customized
Latino/a · Teachers
|
0 Participants
n=8 Participants • 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
|
0 Participants
n=15 Participants • 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
|
0 Participants
n=23 Participants • 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
|
|
Race/Ethnicity, Customized
Native American · Students
|
6 Participants
n=6 Participants • 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
|
8 Participants
n=8 Participants • 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
|
14 Participants
n=14 Participants • 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
|
|
Race/Ethnicity, Customized
Native American · Teachers
|
0 Participants
n=6 Participants • 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
|
0 Participants
n=8 Participants • 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
|
0 Participants
n=14 Participants • 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
|
|
Race/Ethnicity, Customized
Asian American · Students
|
9 Participants
n=9 Participants • 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
|
9 Participants
n=9 Participants • 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
|
18 Participants
n=18 Participants • 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
|
|
Race/Ethnicity, Customized
Asian American · Teachers
|
0 Participants
n=9 Participants • 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
|
0 Participants
n=9 Participants • 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
|
0 Participants
n=18 Participants • 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
|
|
Race/Ethnicity, Customized
Multiracial · Students
|
40 Participants
n=40 Participants • 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
|
48 Participants
n=48 Participants • 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
|
88 Participants
n=88 Participants • 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
|
|
Race/Ethnicity, Customized
Multiracial · Teachers
|
0 Participants
n=40 Participants • 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
|
0 Participants
n=48 Participants • 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
|
0 Participants
n=88 Participants • 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
|
|
Race/Ethnicity, Customized
Unsure · Students
|
77 Participants
n=82 Participants • 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
|
60 Participants
n=65 Participants • 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
|
137 Participants
n=147 Participants • 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
|
|
Race/Ethnicity, Customized
Unsure · Teachers
|
5 Participants
n=82 Participants • 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
|
5 Participants
n=65 Participants • 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
|
10 Participants
n=147 Participants • 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
|
|
Region of Enrollment
United States
|
5 Schools
n=5 Schools
|
4 Schools
n=4 Schools
|
9 Schools
n=9 Schools
|
|
School Size (>1000)
|
4 Schools
n=5 Schools • Publicly available school-level data was used to identify schools with more than 1000 students. Teachers in each school are considered the participants analyzed.
|
3 Schools
n=4 Schools • Publicly available school-level data was used to identify schools with more than 1000 students. Teachers in each school are considered the participants analyzed.
|
7 Schools
n=9 Schools • Publicly available school-level data was used to identify schools with more than 1000 students. Teachers in each school are considered the participants analyzed.
|
|
Free Reduced Lunch Percentage (>50%)
|
1 Schools
n=5 Schools • 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.
|
1 Schools
n=4 Schools • 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.
|
2 Schools
n=9 Schools • 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.
|
PRIMARY outcome
Timeframe: 9 monthsPopulation: 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.
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).
Outcome measures
| Measure |
Standard REP
n=4 Schools
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.
|
Enhanced REP
n=2 Schools
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.
|
|---|---|---|
|
Indicators of Feasibility
Impact of implementation climate on feasibility
|
6 Coded interview segments
|
6 Coded interview segments
|
|
Indicators of Feasibility
Impact of strategic implementation leadership on feasibility
|
5 Coded interview segments
|
5 Coded interview segments
|
PRIMARY outcome
Timeframe: 9 monthsPopulation: 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.
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).
Outcome measures
| Measure |
Standard REP
n=5 Schools
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.
|
Enhanced REP
n=4 Schools
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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Indicators of Acceptability
Curriculum materials acceptably met student needs
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46 Coded interview segments
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36 Coded interview segments
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Indicators of Acceptability
Acceptability of Implementation Facilitation and Support
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6 Coded interview segments
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5 Coded interview segments
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Indicators of Acceptability
Inner setting influences on curriculum acceptability
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19 Coded interview segments
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13 Coded interview segments
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PRIMARY outcome
Timeframe: 9 monthsPopulation: 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.
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).
Outcome measures
| Measure |
Standard REP
n=5 Schools
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.
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Enhanced REP
n=4 Schools
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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|---|---|---|
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Indicators of Appropriateness
Appropriateness of curriculum for students
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24 Coded interview segments
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29 Coded interview segments
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Indicators of Appropriateness
Appropriateness of implementation facilitation
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6 Coded interview segments
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4 Coded interview segments
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PRIMARY outcome
Timeframe: 9 monthsWe 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.
Outcome measures
| Measure |
Standard REP
n=4 Schools
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.
|
Enhanced REP
n=4 Schools
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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|---|---|---|
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Incremental Implementation Strategy Cost
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11,903 Dollars
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0 Dollars
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Adverse Events
Standard MMH Curriculum Implementation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Michigan Model for Health: Learning to Enhance and Adapt for Prevention (MI-LEAP)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Andria Eisman, Principal Investigator
Wayne State University
Phone: 313-649-7477
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place