Clinical trial NCT02672150: Juvenile Justice Translational Research on Interventions for Adolescents in the Legal System
Official title: Juvenile Justice Translational Research on Interventions for Adolescents in the Legal System: Multi-site Implementation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorders
Keywords: evidence-based practice implementation
system change
interagency collaboration
substance use
treatment services
data-driven decision making
juvenile justice
adolescents
justice-involved youth
cluster randomized trial
Lead sponsor: Chestnut Health Systems
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Columbia University
name: Emory University
name: Mississippi State University
name: Temple University
name: Texas Christian University
name: University of Kentucky
First posted: 2016-02-03
Enrollment: 839
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Staff from 34 juvenile community supervision agencies were observed for a 6 month baseline period than trained over 4 months on using a behavioral health service cascade model to screen, identify, and refer youth to substance use treatment. Half the sites were randomized to 12 additional months of facilitation. Sites were then monitored for an additional 4 month maintenance phase.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a multi site experiment to evaluate the impact of various strategies for increasing the use of evidence based screening, assessment and linkage to substance use treatment. All sites collect baseline data and receive a core intervention. Half are then randomly assigned to get an additional year of coaching to facilitate implementation.

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:

1. Does the Core and/or Enhanced Intervention reduce unmet need by increasing Cascade retention related to screening, assessment, treatment initiation, engagement and continuing care?
2. Does the addition of the Enhanced Intervention components further increase the percentage of youth retained in the Cascade relative to the Core components?
3. Does the addition of the Enhanced Intervention components improve service quality relative to Core sites?
4. Do staff perceptions of the value of best practices increase over time, and are increases more pronounced in Enhanced sites?

Eligibility criteria: 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..

Primary outcomes:
measure: Service Cascade: % Referred to Substance Use Treatment
timeFrame: 120 weeks
measure: Staff Perception: Value of Evidenced Based Substance Use Treatment
timeFrame: 120 weeks
Secondary outcomes:
measure: Service Cascade: % Screened for Substance Use Problems
timeFrame: 120 weeks
measure: Service Cascade: % Clinically Assessed for Substance Use Problems
timeFrame: 120 weeks
measure: Service Cascade: % In Need of Substance Use Treatment
timeFrame: 120 weeks
measure: Service Cascade: % Initiating Substance Use Treatment
timeFrame: 120 weeks
measure: Service Cascade: % Engaged in Substance Use Treatment
timeFrame: 120 weeks
measure: Service Cascade: % With Substance Use Treatment Continuing Care
timeFrame: 120 weeks
measure: Service Quality: Timing of Screening or Clinical Assessment
timeFrame: 120 weeks
measure: Service Quality: Timing of Substance Use Treatment Initiation
timeFrame: 120 weeks
measure: Service Quality: Number of Evidence Based Practices
timeFrame: 120 Weeks
measure: Staff Perception: Value of Evidenced Based Screening
timeFrame: 120 weeks
measure: Staff Perception: Value of Evidenced Based Clinical Assessment
timeFrame: 120 weeks
measure: Staff Perception: Value of Evidenced Based Substance Use Prevention
timeFrame: 120 weeks
measure: Staff Perception: Value of Evidenced Based HIV Risk Prevention
timeFrame: 120 weeks
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Bloomington
country: United States
facility: Chestnut Health Systems
state: Illinois
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Rockville
country: United States
facility: National Institute on Drug Abuse
state: Maryland
city: Starkville
country: United States
facility: Mississippi State University
state: Mississippi
city: New York
country: United States
facility: Columbia University
state: New York
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Fort Worth
country: United States
facility: Texas Christian University
state: Texas
Study officials:
affiliation: National Institute on Drug Abuse (NIDA)
name: Tisha R Wiley, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Gail A Wasserman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Ralph DiClemente, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Gene H Brody, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mississippi State University
name: Angela A Robertson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Temple University
name: Steven R Belenko, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Texas Christian University
name: Danica K Knight, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kentucky
name: Carl G Leukefeld, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chestnut Health Systems
name: Michael L Dennis, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chestnut Health Systems
name: Christy K Scott, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.