Effectiveness of Trauma-Focused Cognitive Behavioral Therapy in Treating Children With Post-Traumatic Stress Disorder

Study Overview
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Brief Summary
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This study will compare the effectiveness of trauma-focused cognitive behavioral therapy versus standard care in treating children with post-traumatic stress disorder.

Detailed Description
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Each year approximately 5 million children in the United States are exposed to some form of traumatic event, and nearly 40% of these children will go on to develop post-traumatic stress disorder (PTSD). There are a number of traumatic events that have been shown to cause PTSD in children, including natural disaster, physical or sexual abuse, loss of a loved one, and witnessing an act of violence. Children with PTSD may experience persistent generalized fear and anxiety, recurrent nightmares, mood swings, withdrawal, and depression. If left untreated, PTSD can cause serious distress for those affected, resulting in emotional, academic, and social problems. Trauma-focused cognitive behavioral therapy (TF-CBT), a form of psychotherapy that focuses on trauma, may be the most effective means of improving PTSD screening and treatment in community-based mental health services. Although TF-CBT has shown success in treating children with PTSD in the research setting, its use in community clinics remains limited. This study will compare the effectiveness of TF-CBT versus treatment as usual (TAU) in treating children with PTSD in community clinics. The study will also develop a community collaboration between a community mental health agency and an academic institution, both in New York City, to address childhood trauma and PTSD and to enhance research in community clinics. Participation in this study will last about 3 months. Potential parent and child participants will first undergo initial assessments, which will include interviews and questionnaires concerning symptoms of PTSD. Eligible participants will then be assigned randomly to receive TF-CBT or TAU. Participants in both groups will attend 12 sessions over 3 months. TF-CBT sessions will include trauma-focused treatment and will teach participants behavioral management and coping skills to overcome their PTSD. TAU sessions will include routine community clinic care and will not involve a trauma-focused treatment component. Upon completion of treatment, participants will complete repeat interviews and questionnaires.

Official Title
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Creating a Collaborative Field Research Organization

Conditions
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Post-Traumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Trauma-focused cognitive behavioral therapy (TF-CBT)
* Behavioral: Treatment as usual (TAU)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Seeking services at Jewish Board of Family and Children's Services outpatient clinics Meets DSM-IV criteria for PTSD Stable on medication for 1 month before study entry English-speaking Exclusion Criteria: Active suicidality or anyone whose life circumstances might be considered peri-traumatic (e.g., active current abuse) Uncontrolled psychosis Severe mental retardation or severe brain damage Severe language comprehension barriers

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Participants will receive 12 sessions of trauma-focused cognitive behavioral therapy over 3 months. | Behavioral: Trauma-focused cognitive behavioral therapy (TF-CBT)<br>* TF-CBT sessions will include trauma-focused treatment and will teach participants behavioral management and coping skills to overcome their PTSD.<br>|
| Active Comparator: B<br>Participants will receive 12 sessions of treatment as usual over 3 months. | Behavioral: Treatment as usual (TAU)<br>* TAU outpatient sessions will include routine community care and nontrauma-focused therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| University of California Los Angeles- Post-Traumatic Stress Disorder (UCLA-PTSD) Reaction Index |  | Measured at baseline and Month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD, Treatment