Bringing What Works to Youth in Corrections: A Trauma Intervention

NCT01560728 | Completed Phase 1 DMC

• 1 other identifier: 1R34MH095210-01
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 3

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.

Conditions

Post-Traumatic Stress Disorder

Keywords

Post Traumatic Stress Disorder; Major Depressive Disorder; Dysthymia; Generalized Anxiety Disorder; Social Phobia; Panic Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Rate of change in Child Behavioral Checklist Youth Self-Report Total Score

  Participants will be assessed at baseline and every 2 weeks for an average of 6 months

Study Arms (2)

Trauma-Focused CBT

EXPERIMENTAL

Adapted or modified Trauma-Focused Cognitive Behavioral Therapy

Behavioral: Trauma-Focused Cognitive Behavioral Therapy

Wait list

NO INTERVENTION

Monitored while waiting for intervention

Interventions

Trauma-Focused Cognitive Behavioral Therapy BEHAVIORAL

Individual psychotherapeutic approach occurring once per week for 12 to 20 weeks

Trauma-Focused CBT

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas at Austin: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (3)

Ron Jackson State Juvenile Correctional Facility

Brownwood, Texas, 76804, United States

Location

Giddings State School

Giddings, Texas, 78942, United States

Location

McClennan County State Juvenile Correctional Facility

Mart, Texas, 76664, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depressive Disorder, Major; Dysthymic Disorder; Generalized Anxiety Disorder; Phobia, Social; Panic Disorder

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Depressive Disorder; Mood Disorders; Anxiety Disorders; Phobic Disorders

Study Officials

• Molly M Lopez, Ph.D.

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2012
• First Posted: March 22, 2012
• Study Start: November 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: March 17, 2016

Record last verified: 2016-03

Locations

US (3)