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

NCT ID: NCT03722745

Last Updated: 2019-07-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-17
• Study Completion Date: 2019-07-17

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

TARGET

Intervention Type: BEHAVIORAL

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

study group 2

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

Group Type: ACTIVE_COMPARATOR

TAU

Intervention Type: 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).

Interventions

TARGET

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

Intervention Type: 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).

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Branson

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Other Identifiers

5K23MH104697-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

18-00792

Identifier Type: -

Identifier Source: org_study_id