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

NCT03722745 | Withdrawn

• 2 other identifiers: 18-007925K23MH104697-03
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stress Disorders, Post-Traumatic

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Study group 1

EXPERIMENTAL

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

study group 2

ACTIVE COMPARATOR

Juvenile offenders will receive treatment-as-usual (TAU).

Behavioral: TAU

Interventions

TARGET BEHAVIORAL

TARGET is manualized cognitive-behavioral treatment designed to help adolescents and adults with symptoms of posttraumatic stress

Study group 1

TAU BEHAVIORAL

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).

study group 2

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute of Mental Health (NIMH): collaborator

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

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

Study Officials

• Christopher Branson

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2018
• First Posted: October 29, 2018
• Study Start: July 17, 2019
• Primary Completion: July 17, 2019
• Study Completion: July 17, 2019
• Last Updated: July 23, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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).