Treating Post Traumatic Stress Disorder in Children Exposed to Domestic Violence

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dawnmarie DeFazio, Allegheny Singer Research Institute
ClinicalTrials.gov Identifier:
NCT00183326
First received: September 12, 2005
Last updated: July 20, 2015
Last verified: July 2015

September 12, 2005
July 20, 2015
May 2004
July 2015   (final data collection date for primary outcome measure)
  • PTSD symptoms [ Time Frame: Measured before and after treatment and Months 6 and 12 of follow-up ] [ Designated as safety issue: No ]
  • Anxiety [ Time Frame: Measured before and after treatment and Months 6 and 12 of follow-up ] [ Designated as safety issue: No ]
  • Depression [ Time Frame: Measured before and after treatment and Months 6 and 12 of follow-up ] [ Designated as safety issue: No ]
  • Behavior [ Time Frame: Measured before and after treatment and Months 6 and 12 of follow-up ] [ Designated as safety issue: No ]
  • PTSD symptoms
  • anxiety
  • depression
  • behavior
Complete list of historical versions of study NCT00183326 on ClinicalTrials.gov Archive Site
Contact with perpetrator [ Time Frame: Measured at every treatment session ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Treating Post Traumatic Stress Disorder in Children Exposed to Domestic Violence
Treating PTSD in Children Exposed to Domestic Violence

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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Stress Disorders, Post-Traumatic
  • Anxiety
  • Depression
  • 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.
  • 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.
  • Experimental: 1
    Participants will receive trauma-focused cognitive behavioral therapy
    Intervention: Behavioral: Trauma-focused cognitive behavioral therapy (TF-CBT)
  • Active Comparator: 2
    Participants will receive child-centered supportive therapy
    Intervention: Behavioral: Child-centered supportive therapy (CCT)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
124
July 2015
July 2015   (final data collection date for primary outcome measure)

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
Both
7 Years to 14 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00183326
R01 MH072590, R01MH072590, DDTR B3-PDS
Yes
Dawnmarie DeFazio, Allegheny Singer Research Institute
Allegheny Singer Research Institute
National Institute of Mental Health (NIMH)
Principal Investigator: Judith A. Cohen, MD Allegheny Singer Research Institute
Allegheny Singer Research Institute
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP