Treating Post Traumatic Stress Disorder in Children Exposed to Domestic Violence

NCT ID: NCT00183326

Last Updated: 2018-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-31
• Study Completion Date: 2015-07-31

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.

Conditions

Stress Disorders, Post-Traumatic; Anxiety; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Participants will receive trauma-focused cognitive behavioral therapy

Group Type: EXPERIMENTAL

Trauma-focused cognitive behavioral therapy (TF-CBT)

Intervention Type: BEHAVIORAL

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

Participants will receive child-centered supportive therapy

Group Type: ACTIVE_COMPARATOR

Child-centered supportive therapy (CCT)

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Judith Cohen

Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Judith A. Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Women's Center and Shelter of Greater Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21199975 (View on PubMed)

Related Links

https://www.nctsn.org

Click here to learn more about the National Child Traumatic Stress Network

Other Identifiers

R01MH072590

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DDTR B3-PDS

Identifier Type: -

Identifier Source: secondary_id

R01MH072590

Identifier Type: NIH

Identifier Source: org_study_id

View Link