Clinical trial NCT00183326: Treating Post Traumatic Stress Disorder in Children Exposed to Domestic Violence
Official title: Treating PTSD in Children Exposed to Domestic Violence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Anxiety
Depression
Keywords: Posttraumatic Stress Disorder
Domestic Violence
Children
Cognitive Behavioral Therapy
CBT
Lead sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-09-16
Enrollment: 124
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: PTSD symptoms
timeFrame: Measured before and after treatment and Months 6 and 12 of follow-up
measure: Anxiety
timeFrame: Measured before and after treatment and Months 6 and 12 of follow-up
measure: Depression
timeFrame: Measured before and after treatment and Months 6 and 12 of follow-up
measure: Behavior
timeFrame: Measured before and after treatment and Months 6 and 12 of follow-up
Secondary outcomes:
measure: Contact with perpetrator
timeFrame: Measured at every treatment session
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Women's Center and Shelter of Greater Pittsburgh
state: Pennsylvania
Study officials:
affiliation: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
name: Judith A. Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cohen JA, Mannarino AP, Iyengar S. Community treatment of posttraumatic stress disorder for children exposed to intimate partner violence: a randomized controlled trial. Arch Pediatr Adolesc Med. 2011 Jan;165(1):16-21. doi: 10.1001/archpediatrics.2010.247.