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).

Study Overview

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 Type

Interventional

Enrollment (Actual)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Women's Center and Shelter of Greater Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Participants will receive trauma-focused cognitive behavioral therapy
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PTSD symptoms
Time Frame: Measured before and after treatment and Months 6 and 12 of follow-up
Measured before and after treatment and Months 6 and 12 of follow-up
Anxiety
Time Frame: Measured before and after treatment and Months 6 and 12 of follow-up
Measured before and after treatment and Months 6 and 12 of follow-up
Depression
Time Frame: Measured before and after treatment and Months 6 and 12 of follow-up
Measured before and after treatment and Months 6 and 12 of follow-up
Behavior
Time Frame: Measured before and after treatment and Months 6 and 12 of follow-up
Measured before and after treatment and Months 6 and 12 of follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Contact with perpetrator
Time Frame: Measured at every treatment session
Measured at every treatment session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Actual)

July 5, 2018

Last Update Submitted That Met QC Criteria

July 3, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • R01MH072590 (U.S. NIH Grant/Contract)
  • DDTR B3-PDS (Other Identifier: FDAAA)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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