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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: | NCT00183326 |
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).
Condition | Intervention |
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Stress Disorders, Post-Traumatic Anxiety Depression |
Behavioral: Trauma-focused cognitive behavioral therapy (TF-CBT) Behavioral: Child-centered supportive therapy (CCT) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Treating PTSD in Children Exposed to Domestic Violence |
Estimated Enrollment: | 80 |
Study Start Date: | May 2004 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will receive trauma-focused cognitive behavioral therapy
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Behavioral: Trauma-focused cognitive behavioral therapy (TF-CBT)
TF-CBT is a psychotherapeutic intervention designed to help children, youth, and their parents overcome the negative effects of traumatic life events. It was developed by integrating cognitive and behavioral interventions with traditional child abuse therapies that focus on enhancement of interpersonal trust and empowerment. It targets PTSD symptoms, which often co-occur with depression and behavioral problems. TF-CBT also targets other issues experienced by those suffering a trauma including poor self-esteem, mood instability, and difficulty trusting others.
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2: Active Comparator
Participants will receive child-centered supportive therapy
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Behavioral: Child-centered supportive therapy (CCT)
CCT demonstrates an empathic approach to healing. An environment consisting of empathy, unconditional positive regard and acceptance are key elements in this mode of therapy.
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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.
Ages Eligible for Study: | 7 Years to 14 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Judith A. Cohen, MD | 412-330-4312 | jcohen1@wpahs.org |
Contact: Anthony P. Mannarino, PhD | 412-330-4312 | amannari@wpahs.org |
United States, Pennsylvania | |
Women's Center and Shelter of Greater Pittsburgh | Recruiting |
Pittsburgh, Pennsylvania, United States, 15224 | |
Contact: Leslie Slagle, PhD 412-687-8005 | |
Contact: Melissa DeBernardi, MSW 412-687-8005 mdeberna@wpahs.org | |
Principal Investigator: Judith A. Cohen, MD |
Principal Investigator: | Judith A. Cohen, MD | Allegheny Singer Research Institute |
Responsible Party: | Allegheny Singer Research Institute ( Judith A. Cohen, MD, Principal Investigator ) |
Study ID Numbers: | R01 MH72590, DDTR B3-PDS |
Study First Received: | September 12, 2005 |
Last Updated: | September 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00183326 |
Health Authority: | United States: Federal Government |
Posttraumatic Stress Disorder Domestic Violence Children Cognitive Behavioral Therapy CBT |
Depression Anxiety Disorders Mental Disorders Stress Disorders, Post-Traumatic |
Stress Depressive Disorder Stress Disorders, Traumatic Behavioral Symptoms |
Pathologic Processes Disease |