Treating Post Traumatic Stress Disorder in Children Exposed to Domestic Violence

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by National Institute of Mental Health (NIMH).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00183326
First received: September 12, 2005
Last updated: March 25, 2009
Last verified: March 2009
  Purpose

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).


Condition Intervention
Stress Disorders, Post-Traumatic
Anxiety
Depression
Behavioral: Trauma-focused cognitive behavioral therapy (TF-CBT)
Behavioral: Child-centered supportive therapy (CCT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treating PTSD in Children Exposed to Domestic Violence

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Contact with perpetrator [ Time Frame: Measured at every treatment session ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: May 2004
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.

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

Ages Eligible for Study:   7 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00183326

Locations
United States, Pennsylvania
Women's Center and Shelter of Greater Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
Sponsors and Collaborators
Investigators
Principal Investigator: Judith A. Cohen, MD Allegheny Singer Research Institute
  More Information

Additional Information:
No publications provided by National Institute of Mental Health (NIMH)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Judith A. Cohen, MD, Principal Investigator, Allegheny Singer Research Institute
ClinicalTrials.gov Identifier: NCT00183326     History of Changes
Other Study ID Numbers: R01 MH072590, DDTR B3-PDS
Study First Received: September 12, 2005
Last Updated: March 25, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Posttraumatic Stress Disorder
Domestic Violence
Children
Cognitive Behavioral Therapy
CBT

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Mental Disorders
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on August 21, 2014