Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

Preventing Substance Use Among Youth

28 lipca 2022 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

6

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • Michigan
      • Detroit, Michigan, Stany Zjednoczone, 48202
        • Wayne State University

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

14 lat do 99 lat (Dziecko, Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny 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
Behawioralne: 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.
Inne nazwy:
  • Standard REP
Eksperymentalny: 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.
Behawioralne: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Curriculum Feasibility
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Substance Use
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Wayne State University

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

4 sierpnia 2021

Zakończenie podstawowe (Rzeczywisty)

14 lipca 2022

Ukończenie studiów (Rzeczywisty)

14 lipca 2022

Daty rejestracji na studia

Pierwszy przesłany

23 stycznia 2021

Pierwszy przesłany, który spełnia kryteria kontroli jakości

8 lutego 2021

Pierwszy wysłany (Rzeczywisty)

12 lutego 2021

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

29 lipca 2022

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

28 lipca 2022

Ostatnia weryfikacja

1 lipca 2022

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • IRB-20-10-2821

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

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.

Ramy czasowe udostępniania IPD

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.

Kryteria dostępu do udostępniania IPD

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.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Standard implementation

Wyszukaj podobne próby

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

CROs by country

CROs in Zambia

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje

3
Subskrybuj