NCT00183326

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

July 5, 2018

Status Verified

July 1, 2018

Enrollment Period

11.2 years

First QC Date

September 12, 2005

Last Update Submit

July 3, 2018

Conditions

Stress Disorders, Post-TraumaticAnxietyDepression

Keywords

Posttraumatic Stress DisorderDomestic ViolenceChildrenCognitive Behavioral TherapyCBT

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (1)

  • Contact with perpetrator

    Measured at every treatment session

Study Arms (2)

1

EXPERIMENTAL

Participants will receive trauma-focused cognitive behavioral therapy

Behavioral: Trauma-focused cognitive behavioral therapy (TF-CBT)

2

ACTIVE COMPARATOR

Participants will receive child-centered supportive therapy

Behavioral: Child-centered supportive therapy (CCT)

Interventions

Trauma-focused cognitive behavioral therapy (TF-CBT)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.

1
Child-centered supportive therapy (CCT)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.

2

Eligibility Criteria

Age7 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Certain psychiatric disorders which preclude participation in cognitive-based treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's Center and Shelter of Greater Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Related Publications (1)

  • 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.

    PMID: 21199975BACKGROUND

Related Links

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Judith A. Cohen, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

May 1, 2004

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

July 5, 2018

Record last verified: 2018-07

Locations

US(1)