- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02672150
Juvenile Justice Translational Research on Interventions for Adolescents in the Legal System ((JJ-TRAILS))
Juvenile Justice Translational Research on Interventions for Adolescents in the Legal System: Multi-site Implementation Study
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Background: The Juvenile Justice-Translational Research on Interventions for Adolescents in the Legal System (JJ-TRIALS) study is a cooperative implementation science initiative involving the National Institute on Drug Abuse, six Research Centers, a Coordinating Center, and Juvenile Justice Partners representing seven U.S. states. The pooling of resources across Centers enables a robust implementation study design involving 36 juvenile justice agencies and their behavioral health partner agencies, coproducing a study protocol that has potential to advance implementation science, meets the needs of all constituencies (funding agency, researchers, partners, study sites), and can be implemented with fidelity across the cooperative can be challenging.
Methods/design: The JJ-TRIALS primary study uses a head-to-head cluster randomized trial with a phased rollout to evaluate the differential effectiveness of two conditions (Core and Enhanced) in 36 sites located in 7 states. Core strategies for promoting change are compared to an Enhanced strategy that incorporate all core strategies plus active facilitation. Target outcomes include improvements in evidence-based screening, assessment, and linkage to substance use treatment.
Primary Research Questions:
- Does the Core and/or Enhanced Intervention reduce unmet need by increasing Cascade retention related to screening, assessment, treatment initiation, engagement and continuing care?
- Does the addition of the Enhanced Intervention components further increase the percentage of youth retained in the Cascade relative to the Core components?
- Does the addition of the Enhanced Intervention components improve service quality relative to Core sites?
- Do staff perceptions of the value of best practices increase over time, and are increases more pronounced in Enhanced sites?
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Georgia
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Atlanta, Georgia, Spojené státy, 30322
- Emory University
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Illinois
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Bloomington, Illinois, Spojené státy, 61701
- Chestnut Health Systems
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Kentucky
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Lexington, Kentucky, Spojené státy, 40508
- University of Kentucky
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Maryland
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Rockville, Maryland, Spojené státy, 20892
- National Institute on Drug Abuse
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Mississippi
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Starkville, Mississippi, Spojené státy, 39759
- Mississippi State University
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New York
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New York, New York, Spojené státy, 10032
- Columbia University
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Pennsylvania
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Philadelphia, Pennsylvania, Spojené státy, 19122
- Temple University
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Texas
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Fort Worth, Texas, Spojené státy, 76129
- Texas Christian University
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Specific site inclusion criteria include: (a) ability to provide youth service records, (b) service to youth under community supervision, (c) access to treatment provider(s) if treatment is not provided directly by the JJ agency, (d) participation in requisite intervention training/activities,(e) minimum average case flow of 10 youth per month, (f) minimum of 10 staff per site, and (g) a senior JJ staff member who agrees to serve as site leader/liaison during the study. Study sites are geographically dispersed and were identified by state JJ agencies (and not selected for particular substance use or related BH service needs).
Youth inclusion criteria include: all youth entering the juvenile justice system during the period within the exception of those who are already in treatment at the time that they are referred to the juvenile justice agency.
Staff inclusion criteria include: all staff actively working with the youth under community supervision in the site with exclusion only of higher level administrative or regional staff over multiple units..
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Žádný zásah: Control
During the Baseline Control data is collected in all 36 sites at the agency, staff, and youth level on the 6 months prior to the interventions in Arms 2 & 3 to document what practice was before the study.
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Aktivní komparátor: Core
In the second phase (after baseline) all 36 sites receive a Core condition that includes five interventions: (1) JJ-TRIALS Orientation Meetings, (2) Needs Assessment, (3) Behavioral Health Training, (4) Site Feedback Report, (5) Goal Achievement Training, (6) Monthly Site Check-ins, and (7) Quarterly Reports. As part of Goal Achievement Training, sites receive assistance in using their Site Feedback Reports to select goals to meet their local needs. Sites are trained on using Data-Driven Decision Making (DDDM) to inform decisions (e.g., selecting a goal, monitoring progress) and enlisting DDDM templates and tools (developed as part of the project) to plan and implement proposed changes. these principles to their improvement efforts during the implementation phase. |
Ostatní jména:
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Experimentální: Enhanced
While the core intervention and DDDM are expected to facilitate change, organizations may need additional support to apply these principles to their improvement efforts during the implementation phase.
In the third phase (after Core), 1/2 of the sites are randomly assigned to an Enhanced condition that provides continuing support for the use of DDDM tools by adding research staff facilitation of DDDM over a 12-month period and formalized Local Change Teams (LCTs) featuring representation from the JJ agency and a local BH provider, with meetings facilitated by research staff).
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Ostatní jména:
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Service Cascade: % Referred to Substance Use Treatment
Časové okno: 120 weeks
|
Calculated from juvenile justice and substance use treatment agency records as the number of youth referred to substance use treatment divided by the number of youth identified as need of substance use treatment.
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120 weeks
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Staff Perception: Value of Evidenced Based Substance Use Treatment
Časové okno: 120 weeks
|
Calculated from staff surveys at juvenile justice and substance use treatment agencies as the average staff ranking of the perceived "value" of using of evidence-based substance use treatment services.
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120 weeks
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Service Cascade: % Screened for Substance Use Problems
Časové okno: 120 weeks
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Calculated from juvenile justice and substance use treatment agency records as the number of youth "Screened" for substance use problems divided by the number of youth entering the juvenile justice system.
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120 weeks
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Service Cascade: % Clinically Assessed for Substance Use Problems
Časové okno: 120 weeks
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Calculated from juvenile justice and substance use treatment agency records as the number of youth "Clinically Assessed" for substance use problems divided by the number of youth entering the juvenile justice system.
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120 weeks
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Service Cascade: % In Need of Substance Use Treatment
Časové okno: 120 weeks
|
Calculated from juvenile justice and substance use treatment agency records as the number of youth identified (via screening, clinical assessment or other sources) as "In Need of Substance Use Treatment" divided by the number of youth entering the juvenile justice system.
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120 weeks
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Service Cascade: % Initiating Substance Use Treatment
Časové okno: 120 weeks
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Calculated from juvenile justice and substance use treatment agency records as the number of youth "Initiating" Substance Use Treatment within 90 days of referral" divided by the number referred to treatment from the juvenile justice system.
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120 weeks
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Service Cascade: % Engaged in Substance Use Treatment
Časové okno: 120 weeks
|
Calculated from juvenile justice and substance use treatment agency records as the number of youth "Engaged" in Substance Use Treatment for 6 weeks or more weeks divided by the number initiating treatment.
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120 weeks
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Service Cascade: % With Substance Use Treatment Continuing Care
Časové okno: 120 weeks
|
number of youth "Continuing" to receive substance use treatment services forCalculated from juvenile justice and substance use treatment agency records as the 90 days or more divided by the number initiating treatment.
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120 weeks
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Service Quality: Timing of Screening or Clinical Assessment
Časové okno: 120 weeks
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Calculated from juvenile justice and substance use treatment agency records as the mean days from entry into the justice system to the first of screening or clinical assessment for substance use problems.
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120 weeks
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Service Quality: Timing of Substance Use Treatment Initiation
Časové okno: 120 weeks
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Calculated from juvenile justice and substance use treatment agency records as the mean days from referral to and initiation of substance use treatment.
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120 weeks
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Service Quality: Number of Evidence Based Practices
Časové okno: 120 Weeks
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Based on agency surveys and youth records from juvenile justice and substance use treatment agencies, the number of steps using 1 or more evidenced based practices in each of the following steps along the service cascade: screening, clinical assessment, referral, substance use treatment.
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120 Weeks
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Staff Perception: Value of Evidenced Based Screening
Časové okno: 120 weeks
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Calculated from staff surveys at juvenile justice and substance use treatment agencies as the average staff ranking of the perceived "value" of using of evidence-based screening.
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120 weeks
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Staff Perception: Value of Evidenced Based Clinical Assessment
Časové okno: 120 weeks
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Calculated from staff surveys at juvenile justice and substance use treatment agencies as the average staff ranking of the perceived "value" of using of evidence-based clinical assessment.
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120 weeks
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Staff Perception: Value of Evidenced Based Substance Use Prevention
Časové okno: 120 weeks
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Calculated from staff surveys at juvenile justice and substance use treatment agencies as the average staff ranking of the perceived "value" of using of evidence-based substance use prevention.
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120 weeks
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Staff Perception: Value of Evidenced Based HIV Risk Prevention
Časové okno: 120 weeks
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Calculated from staff surveys at juvenile justice and substance use treatment agencies as the average staff ranking of the perceived "value" of using of evidence-based HIV Risk prevention.
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120 weeks
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Christy K Scott, Ph.D., Chestnut Health Systems
- Vrchní vyšetřovatel: Danica K Knight, Ph.D., Texas Christian University
- Vrchní vyšetřovatel: Michael L Dennis, Ph.D., Chestnut Health Systems
- Vrchní vyšetřovatel: Tisha R Wiley, Ph.D., National Institute on Drug Abuse (NIDA)
- Vrchní vyšetřovatel: Gail A Wasserman, Ph.D., Columbia University
- Vrchní vyšetřovatel: Ralph DiClemente, Ph.D., Emory University
- Vrchní vyšetřovatel: Gene H Brody, Ph.D., Emory University
- Vrchní vyšetřovatel: Angela A Robertson, Ph.D., Mississippi State University
- Vrchní vyšetřovatel: Steven R Belenko, Ph.D., Temple University
- Vrchní vyšetřovatel: Carl G Leukefeld, Ph.D., University of Kentucky
Publikace a užitečné odkazy
Obecné publikace
- Belenko S, Dembo R, Knight DK, Elkington KS, Wasserman GA, Robertson AA, Welsh WN, Schmeidler J, Joe GW, Wiley T. Using structured implementation interventions to improve referral to substance use treatment among justice-involved youth: Findings from a multisite cluster randomized trial. J Subst Abuse Treat. 2022 Sep;140:108829. doi: 10.1016/j.jsat.2022.108829. Epub 2022 Jun 19.
- Marks KR, Leukefeld CG, Dennis ML, Scott CK, Funk R; JJ-TRIALS Cooperative. Geographic differences in substance use screening for justice-involved youth. J Subst Abuse Treat. 2019 Jul;102:40-46. doi: 10.1016/j.jsat.2019.04.005. Epub 2019 Apr 13.
- Fisher JH, Becan JE, Harris PW, Nager A, Baird-Thomas C, Hogue A, Bartkowski JP, Wiley T; JJ-TRIALS Cooperative. Using Goal Achievement Training in juvenile justice settings to improve substance use services for youth on community supervision. Health Justice. 2018 Apr 30;6(1):10. doi: 10.1186/s40352-018-0067-4.
- Becan JE, Bartkowski JP, Knight DK, Wiley TRA, DiClemente R, Ducharme L, Welsh WN, Bowser D, McCollister K, Hiller M, Spaulding AC, Flynn PM, Swartzendruber A, Dickson MF, Fisher JH, Aarons GA. A model for rigorously applying the Exploration, Preparation, Implementation, Sustainment (EPIS) framework in the design and measurement of a large scale collaborative multi-site study. Health Justice. 2018 Apr 13;6(1):9. doi: 10.1186/s40352-018-0068-3.
- Belenko S, Knight D, Wasserman GA, Dennis ML, Wiley T, Taxman FS, Oser C, Dembo R, Robertson AA, Sales J. The Juvenile Justice Behavioral Health Services Cascade: A new framework for measuring unmet substance use treatment services needs among adolescent offenders. J Subst Abuse Treat. 2017 Mar;74:80-91. doi: 10.1016/j.jsat.2016.12.012. Epub 2016 Dec 31.
- Knight DK, Belenko S, Wiley T, Robertson AA, Arrigona N, Dennis M, Bartkowski JP, McReynolds LS, Becan JE, Knudsen HK, Wasserman GA, Rose E, DiClemente R, Leukefeld C; JJ-TRIALS Cooperative. Juvenile Justice-Translational Research on Interventions for Adolescents in the Legal System (JJ-TRIALS): a cluster randomized trial targeting system-wide improvement in substance use services. Implement Sci. 2016 Apr 29;11:57. doi: 10.1186/s13012-016-0423-5.
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- JJ-TRIALS
- U01DA036221 (Grant/smlouva NIH USA)
- U01DA036226 (Grant/smlouva NIH USA)
- U01DA036233 (Grant/smlouva NIH USA)
- U01DA036176 (Grant/smlouva NIH USA)
- U01DA036225 (Grant/smlouva NIH USA)
- U01DA036224 (Grant/smlouva NIH USA)
- U01DA036158 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
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Popis plánu IPD
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