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Preventing Substance Use Among Youth

28. juli 2022 opdateret af: Andria B Eisman, Wayne State University

Preventing Substance Use Among Youth: Behavioral and Economic Impact of Enhanced Implementation Strategies for Communities

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

6

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48202
        • Wayne State University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

14 år til 99 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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
Adfærdsmæssigt: 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.
Andre navne:
  • Standard REP
Eksperimentel: 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.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Curriculum Feasibility
Tidsramme: 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.
9 months
Curriculum Acceptability
Tidsramme: 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.
9 months
Curriculum Appropriateness
Tidsramme: 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.
9 months
Cost-Effectiveness
Tidsramme: 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.
9 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Substance Use
Tidsramme: 9 months
The investigators will assess past substance use using items from Monitoring the Future (MTF) with adapted response options and timeframe.
9 months
Student Engagement
Tidsramme: 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.
9 months
Dose Delivered
Tidsramme: 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.
9 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Wayne State University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

4. august 2021

Primær færdiggørelse (Faktiske)

14. juli 2022

Studieafslutning (Faktiske)

14. juli 2022

Datoer for studieregistrering

Først indsendt

23. januar 2021

Først indsendt, der opfyldte QC-kriterier

8. februar 2021

Først opslået (Faktiske)

12. februar 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. juli 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. juli 2022

Sidst verificeret

1. juli 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRB-20-10-2821

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

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.

IPD-delingsadgangskriterier

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.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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