Preventing Substance Use Among Youth

Sponsor
Wayne State University (Other)
Overall Status
Completed
CT.gov ID
NCT04752189
Collaborator
(none)
6
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2
11.3
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Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Enhanced Replicating Effective Programs (Enhanced REP)
  • Behavioral: Standard implementation
N/A

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, there is 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 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Preventing Substance Use Among Youth: Behavioral and Economic Impact of Enhanced Implementation Strategies for Communities
Actual Study Start Date :
Aug 4, 2021
Actual Primary Completion Date :
Jul 14, 2022
Actual Study Completion Date :
Jul 14, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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

Behavioral: 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.
Other Names:
  • Standard REP
  • Experimental: 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.

    Behavioral: 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.

    Outcome Measures

    Primary Outcome Measures

    1. Curriculum Feasibility [9 months]

      To evaluate comprehensively curriculum feasibility, the investigators adopt a convergent mixed methods design. The purpose of a convergent design is to obtain complementary, though different, data on the same topic. Weiner et al.'s measures will be used to assess feasibility. Each construct has 4 items (e.g., REP is appealing, REP seems suitable), from 1: Strongly disagree to 5: Strongly agree. The investigators will use the Consolidated Framework for Implementation Research (CFIR) interview guide to guide the qualitative investigation of using Enhanced REP for MMH. The interview guide will be designed to elicit specific feedback on Enhanced REP components (manual, training, and facilitation) and their feasibility to deliver MMH.

    2. Curriculum Acceptability [9 months]

      To evaluate comprehensively curriculum acceptability, the researchers adopt a convergent mixed methods design. The purpose of a convergent design is to obtain complementary, though different, data on the same topic. Weiner et al.'s measures will be used to assess acceptability. Each construct has 4 items (e.g., REP is appealing, REP seems suitable), from 1: Strongly disagree to 5: Strongly agree. The investigators will use the Consolidated Framework for Implementation Research (CFIR) interview guide to guide the qualitative investigation of using Enhanced REP for MMH. The interview guide will be designed to elicit specific feedback on Enhanced REP components (manual, training, and facilitation) and their acceptability to deliver MMH.

    3. Curriculum Appropriateness [9 months]

      To evaluate comprehensively appropriateness the investigators adopt a convergent mixed methods design. The purpose of a convergent design is to obtain complementary, though different, data on the same topic. Weiner et al.'s measures will be used to assess appropriateness. Each construct has 4 items (e.g., REP is appealing, REP seems suitable), from 1: Strongly disagree to 5: Strongly agree. The investigators will use the Consolidated Framework for Implementation Research (CFIR) interview guide to guide the qualitative investigation of using Enhanced REP for MMH. The interview guide will be designed to elicit specific feedback on Enhanced REP components (manual, training, and facilitation) and their appropriateness to deliver MMH.

    4. Cost-Effectiveness [9 months]

      Implementation cost measures are guided by Costs of Implementing New Strategies (COINS) and include implementation strategy costs across phases of implementation relevant for replication. The investigators will measure implementation costs using a micro-costing approach to assess labor and non-labor costs. The investigators will also use available cost data from the school district as needed, summary data from previous empirical studies on implementation costs, and routinely available cost data using market prices. Net costs (net increase in costs from the Enhanced REP condition versus standard implementation) and net effectiveness (net decrease in substance use from the Enhanced REP condition versus standard implementation) will be used to calculate the incremental cost-effectiveness ratio.

    Secondary Outcome Measures

    1. Substance Use [9 months]

      The investigators will assess past substance use using items from Monitoring the Future (MTF) with adapted response options and timeframe.

    2. Student Engagement [9 months]

      The investigators will assess student engagement using student satisfaction and key intervention skills. The satisfaction measure will be adapted based on a scale developed by Giles et al. for another drug prevention intervention with good psychometric properties that will include 4 items. The investigators will evaluate key intervention skills: assertive communication, refusal skills, and decision making. These dimensions are identified in the curriculum summative evaluation materials identified by the MMH curriculum and assessed in previous MMH studies and based on National Health Education Standards. The current study will assess secondary behavioral outcomes including poly-drug use using an item from the National Survey on Drug Use and Health (NSDUH). Substance use consequences (e.g., missed school due to substance use) will be ascertained using items from the Problem Oriented Screening Instrument for Teenagers.

    3. Dose Delivered [9 months]

      The investigators will assess dose or amount of program delivered using a curriculum fidelity tracking from. Teachers will be asked to complete a brief form following each lesson/unit included in the study. These units/lessons include the alcohol, tobacco and other drug prevention unit, the skills unit, and the social and emotional learning unit. The investigators will assess dose delivered by calculating the total number of lessons completed within each unit (10 lessons/unit). As part of the tracking form, teachers will report any adaptations or modifications, guided by the framework proposed by Wiltsey-Stirman et.al. This includes adding, removing and changing content, substituting activities and changing activity formats.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Wayne State University Detroit Michigan United States 48202

    Sponsors and Collaborators

    • Wayne State University

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Andria B Eisman, Assistant Professor, Wayne State University
    ClinicalTrials.gov Identifier:
    NCT04752189
    Other Study ID Numbers:
    • IRB-20-10-2821
    First Posted:
    Feb 12, 2021
    Last Update Posted:
    Jul 29, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 29, 2022