- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01560728
Bringing What Works to Youth in Corrections: A Trauma Intervention
March 15, 2016 updated by: University of Texas at Austin
Bringing What Works to Youth in Prison: An Evidence-Based Trauma Intervention
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
57
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
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Brownwood, Texas, United States, 76804
- Ron Jackson State Juvenile Correctional Facility
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Giddings, Texas, United States, 78942
- Giddings State School
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Mart, Texas, United States, 76664
- McClennan County State Juvenile Correctional Facility
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Trauma-Focused CBT
Adapted or modified Trauma-Focused Cognitive Behavioral Therapy
|
Individual psychotherapeutic approach occurring once per week for 12 to 20 weeks
|
No Intervention: Wait list
Monitored while waiting for intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of change in UCLA PTSD Reaction Index (UCLA PTSD RI) Trauma Symptom Severity
Time Frame: Participants will be assessed at baseline and every 2 weeks for an average of 6 months
|
Reduction in traumatic stress symptom severity
|
Participants will be assessed at baseline and every 2 weeks for an average of 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of change in Child Behavioral Checklist Youth Self-Report Total Score
Time Frame: Participants will be assessed at baseline and every 2 weeks for an average of 6 months
|
Reduction in self-reported emotional and behavioral problem scores
|
Participants will be assessed at baseline and every 2 weeks for an average of 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Molly M Lopez, Ph.D., University of Texas at Austin
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
March 19, 2012
First Submitted That Met QC Criteria
March 20, 2012
First Posted (Estimate)
March 22, 2012
Study Record Updates
Last Update Posted (Estimate)
March 17, 2016
Last Update Submitted That Met QC Criteria
March 15, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R34MH095210-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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