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

This study is currently recruiting participants.
Information provided by National Institute of Mental Health (NIMH)

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Descriptive Information Fields
Brief Title  Effectiveness of Trauma-Focused Cognitive Behavioral Therapy in Treating Children With Post-Traumatic Stress Disorder
Official Title  Creating a Collaborative Field Research Organization
Brief Summary

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

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.

Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment
Primary Outcome Measure  University of California Los Angeles- Post-Traumatic Stress Disorder (UCLA-PTSD) Reaction Index [ Time Frame: Measured at baseline and Month 3 ] [ Designated as safety issue: No ]
Secondary Outcome Measure 
Condition  Post-Traumatic Stress Disorder
Intervention  Behavioral: Trauma-focused cognitive behavioral therapy (TF-CBT)
Behavioral: Treatment as usual (TAU)
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  40
Start Date  January 2007
Completion Date
Eligibility Criteria 

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
Gender Both
Ages 8 Years to 18 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Joseph Rubacka, BA     212-987-0030 ext 5     joselh.rubacka@mssm.edu    
Contact: Rohini Luthra, PhD     212-987-0030 ext 3     rohini.luthra@mssm.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00614068
Organization ID R24 MH63910
Secondary IDs †† DSIR SE-CE
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Principal Investigator:     Claude M. Chemtob, PhD     Mount Sinai School of Medicine    
Study Director:     Rohini Luthra, PhD     Mount Sinai School of Medicine    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date March 2008
First Received Date  February 11, 2008
Last Updated Date March 13, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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