- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00183326
Treating Post Traumatic Stress Disorder in Children Exposed to Domestic Violence
Treating PTSD in Children Exposed to Domestic Violence
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15224
- Women's Center and Shelter of Greater Pittsburgh
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 1
Participants will receive trauma-focused cognitive behavioral therapy
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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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Active Comparator: 2
Participants will receive child-centered supportive therapy
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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PTSD symptoms
Time Frame: Measured before and after treatment and Months 6 and 12 of follow-up
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Measured before and after treatment and Months 6 and 12 of follow-up
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Anxiety
Time Frame: Measured before and after treatment and Months 6 and 12 of follow-up
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Measured before and after treatment and Months 6 and 12 of follow-up
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Depression
Time Frame: Measured before and after treatment and Months 6 and 12 of follow-up
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Measured before and after treatment and Months 6 and 12 of follow-up
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Behavior
Time Frame: Measured before and after treatment and Months 6 and 12 of follow-up
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Measured before and after treatment and Months 6 and 12 of follow-up
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Contact with perpetrator
Time Frame: Measured at every treatment session
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Measured at every treatment session
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01MH072590 (U.S. NIH Grant/Contract)
- DDTR B3-PDS (Other Identifier: FDAAA)
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