Preventing Substance Use Among Youth
torstai 28. heinäkuuta 2022 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Valmis
Ehdot
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
6
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Michigan
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Detroit, Michigan, Yhdysvallat, 48202
- Wayne State University
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
14 vuotta - 99 vuotta (Lapsi, Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Joo
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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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
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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.
Muut nimet:
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Kokeellinen: 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.
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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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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Curriculum Feasibility
Aikaikkuna: 9 months
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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.
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9 months
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Curriculum Acceptability
Aikaikkuna: 9 months
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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
|
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Curriculum Appropriateness
Aikaikkuna: 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.
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9 months
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Cost-Effectiveness
Aikaikkuna: 9 months
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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
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Substance Use
Aikaikkuna: 9 months
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The investigators will assess past substance use using items from Monitoring the Future (MTF) with adapted response options and timeframe.
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9 months
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Student Engagement
Aikaikkuna: 9 months
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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.
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9 months
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Dose Delivered
Aikaikkuna: 9 months
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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.
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9 months
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Yleiset julkaisut
- Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.
- Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
- Stirman SW, Miller CJ, Toder K, Calloway A. Development of a framework and coding system for modifications and adaptations of evidence-based interventions. Implement Sci. 2013 Jun 10;8:65. doi: 10.1186/1748-5908-8-65.
- O'neill JM, Clark JK, Jones JA. Promoting mental health and preventing substance abuse and violence in elementary students: a randomized control study of the Michigan Model for Health. J Sch Health. 2011 Jun;81(6):320-30. doi: 10.1111/j.1746-1561.2011.00597.x.
- Eisman AB, Kilbourne AM, Greene D Jr, Walton M, Cunningham R. The User-Program Interaction: How Teacher Experience Shapes the Relationship Between Intervention Packaging and Fidelity to a State-Adopted Health Curriculum. Prev Sci. 2020 Aug;21(6):820-829. doi: 10.1007/s11121-020-01120-8.
- Kilbourne AM, Neumann MS, Pincus HA, Bauer MS, Stall R. Implementing evidence-based interventions in health care: application of the replicating effective programs framework. Implement Sci. 2007 Dec 9;2:42. doi: 10.1186/1748-5908-2-42.
- Eisman AB, Palinkas LA, Koffkey C, Herrenkohl TI, Abbasi U, Fridline J, Lundahl L, Kilbourne AM. Michigan Model for HealthTM Learning to Enhance and Adapt for Prevention (Mi-LEAP): protocol of a pilot randomized trial comparing Enhanced Replicating Effective Programs versus standard implementation to deliver an evidence-based drug use prevention curriculum. Pilot Feasibility Stud. 2022 Sep 10;8(1):204. doi: 10.1186/s40814-022-01145-6.
Opintojen ennätyspäivät
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Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Keskiviikko 4. elokuuta 2021
Ensisijainen valmistuminen (Todellinen)
Torstai 14. heinäkuuta 2022
Opintojen valmistuminen (Todellinen)
Torstai 14. heinäkuuta 2022
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Lauantai 23. tammikuuta 2021
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Maanantai 8. helmikuuta 2021
Ensimmäinen Lähetetty (Todellinen)
Perjantai 12. helmikuuta 2021
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Perjantai 29. heinäkuuta 2022
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Torstai 28. heinäkuuta 2022
Viimeksi vahvistettu
Perjantai 1. heinäkuuta 2022
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- IRB-20-10-2821
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
JOO
IPD-suunnitelman kuvaus
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-jaon aikakehys
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-jaon käyttöoikeuskriteerit
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-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
- MAHLA
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