Bringing What Works to Youth in Corrections: A Trauma Intervention

Post-Traumatic Stress Disorder Clinical Trial

Official title:

Bringing What Works to Youth in Prison: An Evidence-Based Trauma Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01560728
• Other study ID #: 1R34MH095210-01
• Secondary ID: 1R34MH095210-01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 19, 2012
• Last updated: March 15, 2016
• Start date: November 2012
• Est. completion date: July 2015

Study information

• Verified date: March 2016
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 18 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Trauma-Focused Cognitive Behavioral Therapy
Individual psychotherapeutic approach occurring once per week for 12 to 20 weeks

Locations

Country	Name	City	State
United States	Ron Jackson State Juvenile Correctional Facility	Brownwood	Texas
United States	Giddings State School	Giddings	Texas
United States	McClennan County State Juvenile Correctional Facility	Mart	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas at Austin	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of change in UCLA PTSD Reaction Index (UCLA PTSD RI) Trauma Symptom Severity	Reduction in traumatic stress symptom severity	Participants will be assessed at baseline and every 2 weeks for an average of 6 months	No
Secondary	Rate of change in Child Behavioral Checklist Youth Self-Report Total Score	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	No