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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00614068 |
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 |
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Post-Traumatic Stress Disorder |
Behavioral: Trauma-focused cognitive behavioral therapy (TF-CBT) Behavioral: Treatment as usual (TAU) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment |
Official Title: | Creating a Collaborative Field Research Organization |
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 |
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A: Experimental
Participants will receive 12 sessions of trauma-focused cognitive behavioral therapy over 3 months.
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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.
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B: Active Comparator
Participants will receive 12 sessions of treatment as usual over 3 months.
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Behavioral: Treatment as usual (TAU)
TAU outpatient sessions will include routine community care and nontrauma-focused therapy.
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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.
Ages Eligible for Study: | 8 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Principal Investigator: | Claude M. Chemtob, PhD | Mount Sinai School of Medicine |
Study Director: | Rohini Luthra, PhD | Mount Sinai School of Medicine |
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 |
Treatment PTSD |
Anxiety Disorders Mental Disorders Wounds and Injuries |
Stress Disorders, Post-Traumatic Stress Stress Disorders, Traumatic |
Pathologic Processes Disease |