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Treating Post Traumatic Stress Disorder in Children Exposed to Domestic Violence

Primary Purpose

Stress Disorders, Post-Traumatic, Anxiety, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trauma-focused cognitive behavioral therapy (TF-CBT)
Child-centered supportive therapy (CCT)
Sponsored by
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post-Traumatic focused on measuring Posttraumatic Stress Disorder, Domestic Violence, Children, Cognitive Behavioral Therapy, CBT

Eligibility Criteria

7 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Women's Center and Shelter of Greater Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Participants will receive trauma-focused cognitive behavioral therapy

Participants will receive child-centered supportive therapy

Outcomes

Primary Outcome Measures

PTSD symptoms
Anxiety
Depression
Behavior

Secondary Outcome Measures

Contact with perpetrator

Full Information

First Posted
September 12, 2005
Last Updated
July 3, 2018
Sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00183326
Brief Title
Treating Post Traumatic Stress Disorder in Children Exposed to Domestic Violence
Official Title
Treating PTSD in Children Exposed to Domestic Violence
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic, Anxiety, Depression
Keywords
Posttraumatic Stress Disorder, Domestic Violence, Children, Cognitive Behavioral Therapy, CBT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive trauma-focused cognitive behavioral therapy
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will receive child-centered supportive therapy
Intervention Type
Behavioral
Intervention Name(s)
Trauma-focused cognitive behavioral therapy (TF-CBT)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Child-centered supportive therapy (CCT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
PTSD symptoms
Time Frame
Measured before and after treatment and Months 6 and 12 of follow-up
Title
Anxiety
Time Frame
Measured before and after treatment and Months 6 and 12 of follow-up
Title
Depression
Time Frame
Measured before and after treatment and Months 6 and 12 of follow-up
Title
Behavior
Time Frame
Measured before and after treatment and Months 6 and 12 of follow-up
Secondary Outcome Measure Information:
Title
Contact with perpetrator
Time Frame
Measured at every treatment session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith A. Cohen, MD
Organizational Affiliation
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women's Center and Shelter of Greater Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21199975
Citation
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.
Results Reference
background
Links:
URL
https://www.nctsn.org
Description
Click here to learn more about the National Child Traumatic Stress Network

Learn more about this trial

Treating Post Traumatic Stress Disorder in Children Exposed to Domestic Violence

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