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Bringing What Works to Youth in Corrections: A Trauma Intervention

Primary Purpose

Post-Traumatic Stress Disorder

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Trauma-Focused Cognitive Behavioral Therapy
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Traumatic Stress Disorder focused on measuring Post Traumatic Stress Disorder, Major Depressive Disorder, Dysthymia, Generalized Anxiety Disorder, Social Phobia, Panic Disorder

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Evidence of one or more significant traumatic life events

  • Current diagnosis of one of the following:

    • Post Traumatic Stress Disorder
    • Major Depressive Disorder
    • Dysthymia
    • Generalized Anxiety Disorder
    • Social Phobia
    • Panic Disorder
  • Trauma symptom severity scores of 25 or greater.

Exclusion Criteria:

  • Expected release date or transfer date within 5 months from study enrollment date
  • Current inclusion in the Sex Offender Treatment Program
  • Intellectual Quotient (IQ) less than 70
  • Current high risk of suicidality
  • Current symptoms of active psychosis

Sites / Locations

  • Ron Jackson State Juvenile Correctional Facility
  • Giddings State School
  • McClennan County State Juvenile Correctional Facility

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Trauma-Focused CBT

Wait list

Arm Description

Adapted or modified Trauma-Focused Cognitive Behavioral Therapy

Monitored while waiting for intervention

Outcomes

Primary Outcome Measures

Rate of change in UCLA PTSD Reaction Index (UCLA PTSD RI) Trauma Symptom Severity
Reduction in traumatic stress symptom severity

Secondary Outcome Measures

Rate of change in Child Behavioral Checklist Youth Self-Report Total Score
Reduction in self-reported emotional and behavioral problem scores

Full Information

First Posted
March 19, 2012
Last Updated
March 15, 2016
Sponsor
University of Texas at Austin
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01560728
Brief Title
Bringing What Works to Youth in Corrections: A Trauma Intervention
Official Title
Bringing What Works to Youth in Prison: An Evidence-Based Trauma Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas at Austin
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Youth with mental illnesses are disproportionately represented in juvenile correctional facilities and limited evidence exists about effective treatments in this setting. This study will adapt Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), a treatment found to be efficacious in community settings, to the correctional setting and study the feasibility of its implementation. Conducted within Texas youth correctional facilities, the findings will be rapidly disseminated in the state. The goal is to enhance the TF-CBT approach to meet the unique needs of incarcerated youth and the correctional system, one of the priorities outlined in the National Institute of Mental Health Strategic Plan.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder
Keywords
Post Traumatic Stress Disorder, Major Depressive Disorder, Dysthymia, Generalized Anxiety Disorder, Social Phobia, Panic Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trauma-Focused CBT
Arm Type
Experimental
Arm Description
Adapted or modified Trauma-Focused Cognitive Behavioral Therapy
Arm Title
Wait list
Arm Type
No Intervention
Arm Description
Monitored while waiting for intervention
Intervention Type
Behavioral
Intervention Name(s)
Trauma-Focused Cognitive Behavioral Therapy
Intervention Description
Individual psychotherapeutic approach occurring once per week for 12 to 20 weeks
Primary Outcome Measure Information:
Title
Rate of change in UCLA PTSD Reaction Index (UCLA PTSD RI) Trauma Symptom Severity
Description
Reduction in traumatic stress symptom severity
Time Frame
Participants will be assessed at baseline and every 2 weeks for an average of 6 months
Secondary Outcome Measure Information:
Title
Rate of change in Child Behavioral Checklist Youth Self-Report Total Score
Description
Reduction in self-reported emotional and behavioral problem scores
Time Frame
Participants will be assessed at baseline and every 2 weeks for an average of 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Evidence of one or more significant traumatic life events Current diagnosis of one of the following: Post Traumatic Stress Disorder Major Depressive Disorder Dysthymia Generalized Anxiety Disorder Social Phobia Panic Disorder Trauma symptom severity scores of 25 or greater. Exclusion Criteria: Expected release date or transfer date within 5 months from study enrollment date Current inclusion in the Sex Offender Treatment Program Intellectual Quotient (IQ) less than 70 Current high risk of suicidality Current symptoms of active psychosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Molly M Lopez, Ph.D.
Organizational Affiliation
University of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ron Jackson State Juvenile Correctional Facility
City
Brownwood
State/Province
Texas
ZIP/Postal Code
76804
Country
United States
Facility Name
Giddings State School
City
Giddings
State/Province
Texas
ZIP/Postal Code
78942
Country
United States
Facility Name
McClennan County State Juvenile Correctional Facility
City
Mart
State/Province
Texas
ZIP/Postal Code
76664
Country
United States

12. IPD Sharing Statement

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Bringing What Works to Youth in Corrections: A Trauma Intervention

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