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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.
Verified by National Institute of Mental Health (NIMH), March 2008
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00614068
  Purpose

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


Condition Intervention Phase
Post-Traumatic Stress Disorder
Behavioral: Trauma-focused cognitive behavioral therapy (TF-CBT)
Behavioral: Treatment as usual (TAU)
Phase III

MedlinePlus related topics: Injuries Post-Traumatic Stress Disorder Wounds
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment
Official Title: Creating a Collaborative Field Research Organization

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: January 2007
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
Participants will receive 12 sessions of trauma-focused cognitive behavioral therapy over 3 months.
Behavioral: Trauma-focused cognitive behavioral therapy (TF-CBT)
TF-CBT sessions will include trauma-focused treatment and will teach participants behavioral management and coping skills to overcome their PTSD.
B: Active Comparator
Participants will receive 12 sessions of treatment as usual over 3 months.
Behavioral: Treatment as usual (TAU)
TAU outpatient sessions will include routine community care and nontrauma-focused therapy.

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.

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00614068

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

Locations
United States, New York
Jewish Board of Family and Children's Services (Pelham) Recruiting
New York, New York, United States, 10467
Contact: Julie List     718-882-5000 ext 220     jlist@jbfcs.org    
Contact: Michael Upston     718-882-5000 ext 222     muptston@jbfcs.org    
Jewish Board of Family and Children's Services (Pride) Recruiting
New York, New York, United States, 11362
Contact: Shoshana Garber     718-423-6200 ext 211     sgarber@jbfcs.org    
Jewish Board of Family and Children's Services (Staten Island) Recruiting
New York, New York, United States, 10314
Contact: John Jannes     718-761-9800 ext 210     jjannes@jbfcs.org    
Jewish Board of Family and Children's Services (BoroPark) Recruiting
New York, New York, United States, 11219
Contact: Faye Wilbur     718-435-5700     fwilbur@jbfcs.org    
Jewish Board of Family and Children's Services (Yeshiva Chanoch Lenaar) Recruiting
New York, New York, United States, 10019
Contact: Joan Adams     212-481-2500 ext 248     jadams@jbfcs.org    
Jewish Board of Family and Children's Services (Break-Free Adolescent Services) Recruiting
New York, New York, United States, 11223
Contact: Arnold Markowitz     718-676-4280 ext 281     amarkowitz@jbfcs.org    
Jewish Board of Family and Children's Services (South Brooklyn) Recruiting
New York, New York, United States, 11223
Contact: Jeanne Murphy     718-339-5300 ext 218     jmurphy@jbfcs.org    
Jewish Board of Family and Children's Services (Beatman) Recruiting
New York, New York, United States, 10463
Contact: Karen Cwalinski     718-601-2280     kcwalinski@jbfcs.org    
Sponsors and Collaborators
Investigators
Principal Investigator: Claude M. Chemtob, PhD Mount Sinai School of Medicine
Study Director: Rohini Luthra, PhD Mount Sinai School of Medicine
  More Information

Responsible Party: Mount Sinai School of Medicine ( Claude Chemtob )
Study ID Numbers: R24 MH63910, DSIR SE-CE
Study First Received: February 11, 2008
Last Updated: March 13, 2008
ClinicalTrials.gov Identifier: NCT00614068  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Treatment
PTSD

Study placed in the following topic categories:
Anxiety Disorders
Mental Disorders
Wounds and Injuries
Stress Disorders, Post-Traumatic
Stress
Stress Disorders, Traumatic

Additional relevant MeSH terms:
Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 14, 2009