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| Descriptive Information Fields | |||||||||
| Brief Title † | Treating Post Traumatic Stress Disorder in Children Exposed to Domestic Violence | ||||||||
| Official Title † | Treating PTSD in Children Exposed to Domestic Violence | ||||||||
| Brief Summary | This study will determine whether trauma-focused cognitive behavioral therapy (TF-CBT) is more effective than child-centered therapy (CCT) in reducing post traumatic stress disorder (PTSD) in children exposed to domestic violence (DV). |
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| Detailed Description | Up to 10 million children in the United States are exposed to DV directed at their mothers by intimate partners. DV exposure puts these children at an increased risk for developing behavioral problems, depression, anxiety, and PTSD. While studies targeting PTSD in DV-exposed children are limited, data indicates that TF-CBT is effective in improving PTSD as well as depression, anxiety, and behavioral symptoms. This study will determine the effectiveness of TF-CBT in reducing PTSD and other DV-related psychological symptoms in children from a community DV agency in Pittsburgh, Pennsylvania. This study will last 8 weeks. Children and their mothers will be randomly assigned to receive 8 weeks of either TF-CBT or CCT. In TF-CBT, patients recall the events of their trauma and try to deal with the emotions that arise. Supportive treatment empowers children to deal with their emotions in general. Both the children and their mothers will complete questionnaires at study entry and at Week 8. Children will also complete self-report scales at study entry and at Week 8. The questionnaires and self-report scales will be used to assess symptoms of PTSD, depression, anxiety, and behavioral problems. Children and their mothers will be contacted 6 and 12 months after study completion for follow-up interviews. |
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| Study Phase | |||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | PTSD symptoms [ Time Frame: Measured before and after treatment and Months 6 and 12 of follow-up ] [ Designated as safety issue: No ] Anxiety [ Time Frame: Measured before and after treatment and Months 6 and 12 of follow-up ] [ Designated as safety issue: No ] Depression [ Time Frame: Measured before and after treatment and Months 6 and 12 of follow-up ] [ Designated as safety issue: No ] Behavior [ Time Frame: Measured before and after treatment and Months 6 and 12 of follow-up ] [ Designated as safety issue: No ] |
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| Secondary Outcome Measure † | Contact with perpetrator [ Time Frame: Measured at every treatment session ] [ Designated as safety issue: Yes ] | ||||||||
| Condition † | Stress Disorders, Post-Traumatic Anxiety Depression |
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| Intervention † | Behavioral: Trauma-focused cognitive behavioral therapy (TF-CBT) Behavioral: Child-centered supportive therapy (CCT) |
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| MEDLINE PMIDs | |||||||||
| Links | Click here to learn more about the National Child Traumatic Stress Network  |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 80 | ||||||||
| Start Date † | May 2004 | ||||||||
| Completion Date | May 2009 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 7 Years to 14 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00183326 | ||||||||
| Organization ID | R01 MH72590 | ||||||||
| Secondary IDs †† | DDTR B3-PDS | ||||||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | February 2008 | ||||||||
| First Received Date † | September 12, 2005 | ||||||||
| Last Updated Date | February 12, 2008 | ||||||||
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