Treating Post Traumatic Stress Disorder in Children Exposed to Domestic Violence

Sponsor

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) (Other)

Overall Status

Completed

CT.gov ID

NCT00183326

Collaborator

National Institute of Mental Health (NIMH) (NIH)

124

Enrollment

Location

Arms

134

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Stress Disorders, Post-Traumatic Anxiety Depression	Behavioral: Trauma-focused cognitive behavioral therapy (TF-CBT) Behavioral: Child-centered supportive therapy (CCT)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

124 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Treating PTSD in Children Exposed to Domestic Violence

Study Start Date :

May 1, 2004

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 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.
Active Comparator: 2 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.

Arm

Intervention/Treatment

Experimental: 1

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.

Active Comparator: 2

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.

Outcome Measures

Primary Outcome Measures

PTSD symptoms [Measured before and after treatment and Months 6 and 12 of follow-up]
Anxiety [Measured before and after treatment and Months 6 and 12 of follow-up]
Depression [Measured before and after treatment and Months 6 and 12 of follow-up]
Behavior [Measured before and after treatment and Months 6 and 12 of follow-up]

Secondary Outcome Measures

Contact with perpetrator [Measured at every treatment session]

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 14 Years

Sexes Eligible for Study:

All

Accepts 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