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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02672150
Other study ID # JJ-TRIALS
Secondary ID U01DA036221U01DA
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2013
Est. completion date June 30, 2019

Study information

Verified date July 2019
Source Chestnut Health Systems
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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?


Recruitment information / eligibility

Status Completed
Enrollment 839
Est. completion date June 30, 2019
Est. primary completion date January 31, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Core

Enhanced


Locations

Country Name City State
United States Emory University Atlanta Georgia
United States Chestnut Health Systems Bloomington Illinois
United States Texas Christian University Fort Worth Texas
United States University of Kentucky Lexington Kentucky
United States Columbia University New York New York
United States Temple University Philadelphia Pennsylvania
United States National Institute on Drug Abuse Rockville Maryland
United States Mississippi State University Starkville Mississippi

Sponsors (8)

Lead Sponsor Collaborator
Chestnut Health Systems Columbia University, Emory University, Mississippi State University, National Institute on Drug Abuse (NIDA), Temple University, Texas Christian University, University of Kentucky

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Service Cascade: % Referred to Substance Use Treatment 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. 120 weeks
Primary Staff Perception: Value of Evidenced Based Substance Use Treatment 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. 120 weeks
Secondary Service Cascade: % Screened for Substance Use Problems 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. 120 weeks
Secondary Service Cascade: % Clinically Assessed for Substance Use Problems 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. 120 weeks
Secondary Service Cascade: % In Need of Substance Use Treatment 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. 120 weeks
Secondary Service Cascade: % Initiating Substance Use Treatment 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. 120 weeks
Secondary Service Cascade: % Engaged in Substance Use Treatment 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. 120 weeks
Secondary Service Cascade: % With Substance Use Treatment Continuing Care 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. 120 weeks
Secondary Service Quality: Timing of Screening or Clinical Assessment 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. 120 weeks
Secondary Service Quality: Timing of Substance Use Treatment Initiation Calculated from juvenile justice and substance use treatment agency records as the mean days from referral to and initiation of substance use treatment. 120 weeks
Secondary Service Quality: Number of Evidence Based Practices 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. 120 Weeks
Secondary Staff Perception: Value of Evidenced Based Screening 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. 120 weeks
Secondary Staff Perception: Value of Evidenced Based Clinical Assessment 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. 120 weeks
Secondary Staff Perception: Value of Evidenced Based Substance Use Prevention 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. 120 weeks
Secondary Staff Perception: Value of Evidenced Based HIV Risk Prevention 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. 120 weeks
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