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

Primary Purpose

Stress Disorders, Post-Traumatic

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

TARGET

TAU

About this trial

This is an interventional health services research trial for Stress Disorders, Post-Traumatic

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study group 1

study group 2

Arm Description

Juvenile offenders will attend 4-session Trauma Affect Regulation: Guide for Education & Treatment (TARGET) groups led by one or two juvenile staff members

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

Outcomes

Primary Outcome Measures

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).

Youth PTSD re-arrest

Number of times subject is arrested during study participation

Secondary Outcome Measures

Full Information

NCT ID

NCT03722745

First Posted

October 19, 2018

Last Updated

July 19, 2019

Sponsor

NYU Langone Health

Collaborators

National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT03722745

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Withdrawn

Why Stopped

Participant recruitment due to high rates of staff turn over at three of the four recruitment sites

Study Start Date

July 17, 2019 (Actual)

Primary Completion Date

July 17, 2019 (Actual)

Study Completion Date

July 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NYU Langone Health

Collaborators

National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stress Disorders, Post-Traumatic

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study group 1

Arm Type

Experimental

Arm Description

Juvenile offenders will attend 4-session Trauma Affect Regulation: Guide for Education & Treatment (TARGET) groups led by one or two juvenile staff members

Arm Title

study group 2

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

TARGET

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

TAU

Intervention Description

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).

Primary Outcome Measure Information:

Title

Youth PTSD symptoms

Description

Time Frame

8 Weeks

Title

Youth PTSD re-arrest

Description

Number of times subject is arrested during study participation

Time Frame

8 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christopher Branson

Organizational Affiliation

NYU Langone Health

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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).

Learn more about this trial

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

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