Treating Post Traumatic Stress Disorder in Children Exposed to Domestic Violence - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 12, 2005

Last Updated Date

March 25, 2009

Start Date ^†

May 2004

Current 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 ]

Original Primary Outcome Measures ^†

PTSD symptoms
anxiety
depression
behavior

Change History

Complete list of historical versions of study NCT00183326 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Treating Post Traumatic Stress Disorder in Children Exposed to Domestic Violence

Official Title ^†

Treating PTSD in Children Exposed to Domestic Violence

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.

Study Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^†

Stress Disorders, Post-Traumatic
Anxiety
Depression

Intervention ^†

Behavioral: Trauma-focused cognitive behavioral therapy (TF-CBT)
Behavioral: Child-centered supportive therapy (CCT)

Study Arms / Comparison Groups

Experimental: Participants will receive trauma-focused cognitive behavioral therapy
Active Comparator: Participants will receive child-centered supportive therapy

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Estimated Enrollment ^†

Estimated Completion Date

May 2009

Estimated Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

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

Gender

Both

Ages

7 Years to 14 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00183326

Responsible Party

Judith A. Cohen, MD, Principal Investigator, Allegheny Singer Research Institute

Secondary IDs ^††

DDTR B3-PDS

Study Sponsor ^†

National Institute of Mental Health (NIMH)

Collaborators ^††

Investigators ^†

Principal Investigator:

Judith A. Cohen, MD

Allegheny Singer Research Institute

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

March 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.