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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03722745
Other study ID # 18-00792
Secondary ID 5K23MH104697-03
Status Withdrawn
Phase N/A
First received
Last updated
Start date July 17, 2019
Est. completion date July 17, 2019

Study information

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

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date July 17, 2019
Est. primary completion date July 17, 2019
Accepts healthy volunteers No
Gender All
Age group 13 Years to 17 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
NYU Langone Health National Institute of Mental Health (NIMH)

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Youth PTSD re-arrest Number of times subject is arrested during study participation 8 Weeks
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