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

• ClinicalTrials.gov Identifier: NCT03722745
• Recruitment Status: Withdrawn
• First Posted: October 29, 2018
• Last Update Posted: July 23, 2019
• Sponsor: NYU Langone Health
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): NYU Langone Health

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Stress Disorders, Post-Traumatic	Behavioral: TARGET; Behavioral: TAU	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Health Services Research
• Official Title: Examine the Preliminary Effect of an Evidence-Based Practice (EBP) Consultation Model on Staff Fidelity to EBP
• Actual Study Start Date: July 17, 2019
• Actual Primary Completion Date: July 17, 2019
• Actual Study Completion Date: July 17, 2019

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures :

1. Youth PTSD symptoms [ Time Frame: 8 Weeks ]
   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).
2. Youth PTSD re-arrest [ Time Frame: 8 Weeks ]
   Number of times subject is arrested during study participation

Eligibility Criteria

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

Criteria

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).

Contacts and Locations

Sponsors and Collaborators

NYU Langone Health

National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Christopher Branson; NYU Langone Health

More Information

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT03722745
• Other Study ID Numbers: 18-00792; 5K23MH104697-03 ( U.S. NIH Grant/Contract )
• First Posted: October 29, 2018
• Last Update Posted: July 23, 2019
• Last Verified: July 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

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.

• Supporting Materials: Study Protocol
• Time Frame: Immediately following publication. No end date
• 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).

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Stress Disorders, Post-Traumatic; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders