- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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?
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University
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Illinois
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Bloomington, Illinois, United States, 61701
- Chestnut Health Systems
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Kentucky
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Lexington, Kentucky, United States, 40508
- University of Kentucky
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Maryland
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Rockville, Maryland, United States, 20892
- National Institute on Drug Abuse
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Mississippi
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Starkville, Mississippi, United States, 39759
- Mississippi State University
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New York
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New York, New York, United States, 10032
- Columbia University
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19122
- Temple University
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Texas
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Fort Worth, Texas, United States, 76129
- Texas Christian University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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..
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: 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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Active Comparator: 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. |
Other Names:
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Experimental: 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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Other Names:
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Service Cascade: % Referred to Substance Use Treatment
Time Frame: 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
Time Frame: 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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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Service Cascade: % Screened for Substance Use Problems
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christy K Scott, Ph.D., Chestnut Health Systems
- Principal Investigator: Danica K Knight, Ph.D., Texas Christian University
- Principal Investigator: Michael L Dennis, Ph.D., Chestnut Health Systems
- Principal Investigator: Tisha R Wiley, Ph.D., National Institute on Drug Abuse (NIDA)
- Principal Investigator: Gail A Wasserman, Ph.D., Columbia University
- Principal Investigator: Ralph DiClemente, Ph.D., Emory University
- Principal Investigator: Gene H Brody, Ph.D., Emory University
- Principal Investigator: Angela A Robertson, Ph.D., Mississippi State University
- Principal Investigator: Steven R Belenko, Ph.D., Temple University
- Principal Investigator: Carl G Leukefeld, Ph.D., University of Kentucky
Publications and helpful links
General Publications
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- JJ-TRIALS
- U01DA036221 (U.S. NIH Grant/Contract)
- U01DA036226 (U.S. NIH Grant/Contract)
- U01DA036233 (U.S. NIH Grant/Contract)
- U01DA036176 (U.S. NIH Grant/Contract)
- U01DA036225 (U.S. NIH Grant/Contract)
- U01DA036224 (U.S. NIH Grant/Contract)
- U01DA036158 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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