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Juvenile Justice Translational Research on Interventions for Adolescents in the Legal System ((JJ-TRAILS))

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02672150
Recruitment Status : Completed
First Posted : February 3, 2016
Last Update Posted : July 23, 2019
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Columbia University
Emory University
Mississippi State University
Temple University
Texas Christian University
University of Kentucky
Information provided by (Responsible Party):
Michael L. Dennis, Ph.D., Chestnut Health Systems

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.

Condition or disease Intervention/treatment Phase
Substance Use Disorders Behavioral: Core Behavioral: Enhanced Not Applicable

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?

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 839 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Pairs of sites were optimally randomize based on 10,000 trials to the two conditions by the coordinating center. The assignment (to core or core+enhanced) was not revealed to the local research center or site until after completion of the core. Thus it is double blind.
Primary Purpose: Health Services Research
Official Title: Juvenile Justice Translational Research on Interventions for Adolescents in the Legal System: Multi-site Implementation Study
Actual Study Start Date : July 1, 2013
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : June 30, 2019

Arm Intervention/treatment
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.
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.

Behavioral: Core
Other Name: GAT, DDDM

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).
Behavioral: Core
Other Name: GAT, DDDM

Behavioral: Enhanced
Other Name: DDDM, Facilitation




Primary Outcome Measures :
  1. Service Cascade: % Referred to Substance Use Treatment [ Time Frame: 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.

  2. Staff Perception: Value of Evidenced Based Substance Use Treatment [ Time Frame: 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.


Secondary Outcome Measures :
  1. Service Cascade: % Screened for Substance Use Problems [ Time Frame: 120 weeks ]
    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.

  2. Service Cascade: % Clinically Assessed for Substance Use Problems [ Time Frame: 120 weeks ]
    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.

  3. Service Cascade: % In Need of Substance Use Treatment [ Time Frame: 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.

  4. Service Cascade: % Initiating Substance Use Treatment [ Time Frame: 120 weeks ]
    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.

  5. Service Cascade: % Engaged in Substance Use Treatment [ Time Frame: 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.

  6. Service Cascade: % With Substance Use Treatment Continuing Care [ Time Frame: 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.

  7. Service Quality: Timing of Screening or Clinical Assessment [ Time Frame: 120 weeks ]
    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.

  8. Service Quality: Timing of Substance Use Treatment Initiation [ Time Frame: 120 weeks ]
    Calculated from juvenile justice and substance use treatment agency records as the mean days from referral to and initiation of substance use treatment.

  9. Service Quality: Number of Evidence Based Practices [ Time Frame: 120 Weeks ]
    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.

  10. Staff Perception: Value of Evidenced Based Screening [ Time Frame: 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 screening.

  11. Staff Perception: Value of Evidenced Based Clinical Assessment [ Time Frame: 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 clinical assessment.

  12. Staff Perception: Value of Evidenced Based Substance Use Prevention [ Time Frame: 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 prevention.

  13. Staff Perception: Value of Evidenced Based HIV Risk Prevention [ Time Frame: 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 HIV Risk prevention.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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..


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672150


Locations
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United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Chestnut Health Systems
Bloomington, Illinois, United States, 61701
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40508
United States, Maryland
National Institute on Drug Abuse
Rockville, Maryland, United States, 20892
United States, Mississippi
Mississippi State University
Starkville, Mississippi, United States, 39759
United States, New York
Columbia University
New York, New York, United States, 10032
United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States, 19122
United States, Texas
Texas Christian University
Fort Worth, Texas, United States, 76129
Sponsors and Collaborators
Chestnut Health Systems
National Institute on Drug Abuse (NIDA)
Columbia University
Emory University
Mississippi State University
Temple University
Texas Christian University
University of Kentucky
Investigators
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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: Danica K Knight, Ph.D. Texas Christian University
Principal Investigator: Carl G Leukefeld, Ph.D. University of Kentucky
Principal Investigator: Michael L Dennis, Ph.D. Chestnut Health Systems
Principal Investigator: Christy K Scott, Ph.D. Chestnut Health Systems
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Michael L. Dennis, Ph.D., Coordinating Center Multi-PI, Chestnut Health Systems
ClinicalTrials.gov Identifier: NCT02672150    
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 )
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The coordinating center is charged with creating de-identified versions of agency, staff and client level service data available at the end of the study.
Keywords provided by Michael L. Dennis, Ph.D., Chestnut Health Systems:
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
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders