Treating Post Traumatic Stress Disorder in Children Exposed to Domestic Violence
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|ClinicalTrials.gov Identifier: NCT00183326|
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : July 22, 2015
|Condition or disease||Intervention/treatment||Phase|
|Stress Disorders, Post-Traumatic Anxiety Depression||Behavioral: Trauma-focused cognitive behavioral therapy (TF-CBT) Behavioral: Child-centered supportive therapy (CCT)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||124 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treating PTSD in Children Exposed to Domestic Violence|
|Study Start Date :||May 2004|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
Participants will receive trauma-focused cognitive behavioral therapy
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.
Active Comparator: 2
Participants will receive child-centered supportive therapy
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.
- PTSD symptoms [ Time Frame: Measured before and after treatment and Months 6 and 12 of follow-up ]
- Anxiety [ Time Frame: Measured before and after treatment and Months 6 and 12 of follow-up ]
- Depression [ Time Frame: Measured before and after treatment and Months 6 and 12 of follow-up ]
- Behavior [ Time Frame: Measured before and after treatment and Months 6 and 12 of follow-up ]
- Contact with perpetrator [ Time Frame: Measured at every treatment session ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00183326
|United States, Pennsylvania|
|Women's Center and Shelter of Greater Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15224|
|Principal Investigator:||Judith A. Cohen, MD||Allegheny Singer Research Institute|