Treating Post Traumatic Stress Disorder in Children Exposed to Domestic Violence

Depression Clinical Trial

Official title:

Treating PTSD in Children Exposed to Domestic Violence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00183326
• Other study ID #: R01MH072590
• Secondary ID: R01MH072590DDTR
• Status: Completed
• Phase: N/A
• Start date: May 2004
• Est. completion date: July 2015

Study information

• Verified date: July 2018
• Source: Allegheny Singer Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Women's Center and Shelter of Greater Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Allegheny Singer Research Institute	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD symptoms		Measured before and after treatment and Months 6 and 12 of follow-up
Primary	Anxiety		Measured before and after treatment and Months 6 and 12 of follow-up
Primary	Depression		Measured before and after treatment and Months 6 and 12 of follow-up
Primary	Behavior		Measured before and after treatment and Months 6 and 12 of follow-up
Secondary	Contact with perpetrator		Measured at every treatment session

External Links

•   Click here to learn more about the National Child Traumatic Stress Network