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

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00183326

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)

MedlinePlus related topics: Anxiety Depression Domestic Violence Injuries Post-Traumatic Stress Disorder Wounds

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Treating PTSD in Children Exposed to Domestic Violence

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
1: Experimental 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.
2: Active Comparator 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.

Arms

Assigned Interventions

1: Experimental

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.

2: Active Comparator

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

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

Contacts

Contact: Judith A. Cohen, MD	412-330-4312	jcohen1@wpahs.org
Contact: Anthony P. Mannarino, PhD	412-330-4312	amannari@wpahs.org

Locations

United States, Pennsylvania
Women's Center and Shelter of Greater Pittsburgh	Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Leslie Slagle, PhD 412-687-8005
Contact: Melissa DeBernardi, MSW 412-687-8005 mdeberna@wpahs.org
Principal Investigator: Judith A. Cohen, MD

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Judith A. Cohen, MD

Allegheny Singer Research Institute

More Information

Click here to learn more about the National Child Traumatic Stress Network This link exits the ClinicalTrials.gov site

Responsible Party:	Allegheny Singer Research Institute ( Judith A. Cohen, MD, Principal Investigator )
Study ID Numbers:	R01 MH72590, DDTR B3-PDS
Study First Received:	September 12, 2005
Last Updated:	September 19, 2008
ClinicalTrials.gov Identifier:	NCT00183326
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

Study placed in the following topic categories:

Depression
Anxiety Disorders
Mental Disorders
Stress Disorders, Post-Traumatic

Stress
Depressive Disorder
Stress Disorders, Traumatic
Behavioral Symptoms

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 30, 2009