Examine the Preliminary Effect of an Evidence-Based Practice (EBP) Consultation Model on Staff Fidelity to EBP

Youth involved in the juvenile justice system report high rates of exposure to traumatic events (>90%) and posttraumatic stress disorder (PTSD; 20-50%). Although youth offenders are routinely assessed and referred for mental health services, few receive evidence-based interventions for PTSD. The current study evaluates an innovative approach to overcoming this problem: train front-line juvenile justice staff to deliver PTSD treatment groups. To determine the preliminary effectiveness and safety of PTSD groups delivered by juvenile justice staff, investigators will compare outcomes for youth offenders randomly assigned to receive evidence-based PTSD group treatment or treatment as usual (i.e., referral to community mental health clinic). Investigators hypothesize that PTSD groups led by justice staff will lead to significantly better youth outcomes (mental health symptoms, re-arrest) compared to treatment as usual.

Study Overview

• Status: Withdrawn
• Conditions: Stress Disorders, Post-Traumatic
• Intervention / Treatment: Behavioral: TARGET; Behavioral: TAU

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Juvenile offender participants must

• be able to assent
• be between the ages of 13 and 17,
• currently involved with the local juvenile justice system (i.e., have an active court case),
• currently receiving services from one of the four participating agencies, and - meet DSM5 criteria for a full or partial diagnosis of Posttraumatic Stress Disorder (assessed during baseline eligibility screening with the eMINI-KID) or report moderate or greater PTSD symptoms on the UCLA PTSD-Reaction Index (score > 25).

Exclusion Criteria:

• unable to provide consent/assent
• Currently meet DSM5 criteria for Alcohol Use Disorder-Severe or any substance use disorders other than Cannabis or Nicotine (assessed with the eMINI-KID). This criterion is intended to exclude youth whose substance use is severe enough to require a higher level of care such as inpatient treatment;
• Currently meet DSM5 criteria for a psychotic disorder, pervasive developmental disorder, or other serious cognitive impairment (assessed with the eMINI-KID) that would prevent them from fully participating in the TARGET treatment groups;
• Report recent suicidal or homicidal ideation (i.e., past 6 months) or a past year suicide attempt unless the youth is currently receiving treatment from a licensed mental health professional (i.e., we will accept youth with recent SI/HI or past year suicide attempts if they are currently in treatment).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group 1; Juvenile offenders will attend 4-session Trauma Affect Regulation: Guide for Education & Treatment (TARGET) groups led by one or two juvenile staff members	Behavioral: TARGET; TARGET is manualized cognitive-behavioral treatment designed to help adolescents and adults with symptoms of posttraumatic stress
Active Comparator: study group 2; Juvenile offenders will receive treatment-as-usual (TAU).	Behavioral: TAU; It involves referral to an offsite community mental health provider with no attempt to control the treatment modality-type-quality (i.e., evidence-based-treatment or not).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Youth PTSD symptoms	University of California at Los Angeles (UCLA) Posttraumatic Stress Disorder Reaction Index-Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 version will be administered to assess youth symptom severity (range 0-124).	8 Weeks
Youth PTSD re-arrest	Number of times subject is arrested during study participation	8 Weeks

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Christopher Branson, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2019
• Primary Completion (Actual): July 17, 2019
• Study Completion (Actual): July 17, 2019

Study Registration Dates

• First Submitted: October 19, 2018
• First Submitted That Met QC Criteria: October 25, 2018
• First Posted (Actual): October 29, 2018

Study Record Updates

• Last Update Posted (Actual): July 23, 2019
• Last Update Submitted That Met QC Criteria: July 19, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 18-00792; 5K23MH104697-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

All of the individual participant data collected during the trial, after deidentification will be shared for any purpose.

Researchers who provide a methodologically sound proposal will have access to the data.

• IPD Sharing Time Frame: Immediately following publication. No end date
• IPD Sharing Access Criteria: We will make the raw, de-identified final dataset publicly-available through the Inter-University Consortium for Political and Social Research (ICPSR) at the University of Michigan (http://www.icpsr.umich.edu). Investigators who wish to download our dataset will be required to first complete a standard data sharing agreement that includes: (1) a commitment to use the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. We are taking these steps to protect the confidentiality of study participants, given the restricted sample (justice-involved teens in NYC) and highly sensitive nature of the data (i.e., criminal record).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No