Treating Post Traumatic Stress Disorder in Children Exposed to Domestic Violence

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Treating PTSD in Children Exposed to Domestic Violence

Conditions
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Stress Disorders, Post-Traumatic, Anxiety, Depression

Intervention / Treatment
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* Behavioral: Trauma-focused cognitive behavioral therapy (TF-CBT)
* Behavioral: Child-centered supportive therapy (CCT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of PTSD related to exposure to DV, defined as their mother having been the victim of intimate partner violence within 1 year prior to study entry Able to read and understand English Parent or guardian able to read and understand English Parent or guardian willing to give informed consent Exclusion Criteria: Certain psychiatric disorders which preclude participation in cognitive-based treatment

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Participants will receive trauma-focused cognitive behavioral therapy | Behavioral: Trauma-focused cognitive behavioral therapy (TF-CBT)<br>* 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.<br>|
| Active Comparator: 2<br>Participants will receive child-centered supportive therapy | Behavioral: Child-centered supportive therapy (CCT)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD symptoms |  | Measured before and after treatment and Months 6 and 12 of follow-up | 
| Anxiety |  | Measured before and after treatment and Months 6 and 12 of follow-up | 
| Depression |  | Measured before and after treatment and Months 6 and 12 of follow-up | 
| Behavior |  | Measured before and after treatment and Months 6 and 12 of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contact with perpetrator |  | Measured at every treatment session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CBT, Posttraumatic Stress Disorder, Domestic Violence, Children, Cognitive Behavioral Therapy