- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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?
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Georgia
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Atlanta, Georgia, Stati Uniti, 30322
- Emory University
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Illinois
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Bloomington, Illinois, Stati Uniti, 61701
- Chestnut Health Systems
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Kentucky
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Lexington, Kentucky, Stati Uniti, 40508
- University of Kentucky
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Maryland
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Rockville, Maryland, Stati Uniti, 20892
- National Institute on Drug Abuse
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Mississippi
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Starkville, Mississippi, Stati Uniti, 39759
- Mississippi State University
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New York
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New York, New York, Stati Uniti, 10032
- Columbia University
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19122
- Temple University
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Texas
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Fort Worth, Texas, Stati Uniti, 76129
- Texas Christian University
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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..
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Nessun intervento: 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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Comparatore attivo: 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. |
Altri nomi:
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Sperimentale: 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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Altri nomi:
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Service Cascade: % Referred to Substance Use Treatment
Lasso di tempo: 120 weeks
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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
Lasso di tempo: 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 treatment services.
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120 weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Service Cascade: % Screened for Substance Use Problems
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 120 weeks
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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
Lasso di tempo: 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
Lasso di tempo: 120 weeks
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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
Lasso di tempo: 120 weeks
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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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Christy K Scott, Ph.D., Chestnut Health Systems
- Investigatore principale: Danica K Knight, Ph.D., Texas Christian University
- Investigatore principale: Michael L Dennis, Ph.D., Chestnut Health Systems
- Investigatore principale: Tisha R Wiley, Ph.D., National Institute on Drug Abuse (NIDA)
- Investigatore principale: Gail A Wasserman, Ph.D., Columbia University
- Investigatore principale: Ralph DiClemente, Ph.D., Emory University
- Investigatore principale: Gene H Brody, Ph.D., Emory University
- Investigatore principale: Angela A Robertson, Ph.D., Mississippi State University
- Investigatore principale: Steven R Belenko, Ph.D., Temple University
- Investigatore principale: Carl G Leukefeld, Ph.D., University of Kentucky
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Collegamenti utili
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- JJ-TRIALS
- U01DA036221 (Sovvenzione/contratto NIH degli Stati Uniti)
- U01DA036226 (Sovvenzione/contratto NIH degli Stati Uniti)
- U01DA036233 (Sovvenzione/contratto NIH degli Stati Uniti)
- U01DA036176 (Sovvenzione/contratto NIH degli Stati Uniti)
- U01DA036225 (Sovvenzione/contratto NIH degli Stati Uniti)
- U01DA036224 (Sovvenzione/contratto NIH degli Stati Uniti)
- U01DA036158 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .