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| Tracking Information | |||||||||
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| First Received Date ICMJE | February 11, 2008 | ||||||||
| Last Updated Date | March 13, 2008 | ||||||||
| Start Date ICMJE | January 2007 | ||||||||
| Estimated Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00614068 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effectiveness of Trauma-Focused Cognitive Behavioral Therapy in Treating Children With Post-Traumatic Stress Disorder | ||||||||
| Official Title ICMJE | 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. |
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| 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. |
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| Study Phase | Phase III | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment | ||||||||
| Condition ICMJE | Post-Traumatic Stress Disorder | ||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||
| Completion Date | |||||||||
| Estimated Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 8 Years to 18 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00614068 | ||||||||
| Responsible Party | Claude Chemtob, Mount Sinai School of Medicine | ||||||||
| Study ID Numbers ICMJE | R24 MH63910, DSIR SE-CE | ||||||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | March 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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