Effectiveness of Trauma-Focused Cognitive Behavioral Therapy in Treating Children With Post-Traumatic Stress Disorder

Post-Traumatic Stress Disorder Clinical Trial

Official title:

Creating a Collaborative Field Research Organization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00614068
• Other study ID #: GCO 00-0996
• Secondary ID: R24MH063910DSIR
• Status: Completed
• Phase: N/A
• First received: February 11, 2008
• Last updated: April 3, 2015
• Start date: January 2007
• Est. completion date: February 2009

Study information

• Verified date: April 2015
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study will compare the effectiveness of trauma-focused cognitive behavioral therapy versus standard care in treating children with post-traumatic stress disorder.

Description:

Each year approximately 5 million children in the United States are exposed to some form of traumatic event, and nearly 40% of these children will go on to develop post-traumatic stress disorder (PTSD). There are a number of traumatic events that have been shown to cause PTSD in children, including natural disaster, physical or sexual abuse, loss of a loved one, and witnessing an act of violence. Children with PTSD may experience persistent generalized fear and anxiety, recurrent nightmares, mood swings, withdrawal, and depression. If left untreated, PTSD can cause serious distress for those affected, resulting in emotional, academic, and social problems. Trauma-focused cognitive behavioral therapy (TF-CBT), a form of psychotherapy that focuses on trauma, may be the most effective means of improving PTSD screening and treatment in community-based mental health services. Although TF-CBT has shown success in treating children with PTSD in the research setting, its use in community clinics remains limited. This study will compare the effectiveness of TF-CBT versus treatment as usual (TAU) in treating children with PTSD in community clinics. The study will also develop a community collaboration between a community mental health agency and an academic institution, both in New York City, to address childhood trauma and PTSD and to enhance research in community clinics.

Participation in this study will last about 3 months. Potential parent and child participants will first undergo initial assessments, which will include interviews and questionnaires concerning symptoms of PTSD. Eligible participants will then be assigned randomly to receive TF-CBT or TAU. Participants in both groups will attend 12 sessions over 3 months. TF-CBT sessions will include trauma-focused treatment and will teach participants behavioral management and coping skills to overcome their PTSD. TAU sessions will include routine community clinic care and will not involve a trauma-focused treatment component. Upon completion of treatment, participants will complete repeat interviews and questionnaires.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

Inclusion Criteria:

• Seeking services at Jewish Board of Family and Children's Services outpatient clinics

• Meets DSM-IV criteria for PTSD

• Stable on medication for 1 month before study entry

• English-speaking

Exclusion Criteria:

• Active suicidality or anyone whose life circumstances might be considered peri-traumatic (e.g., active current abuse)

• Uncontrolled psychosis

• Severe mental retardation or severe brain damage

• Severe language comprehension barriers

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Trauma-focused cognitive behavioral therapy (TF-CBT)
TF-CBT sessions will include trauma-focused treatment and will teach participants behavioral management and coping skills to overcome their PTSD.
• Treatment as usual (TAU)
TAU outpatient sessions will include routine community care and nontrauma-focused therapy.

Locations

Country	Name	City	State
United States	Jewish Board of Family and Children's Services (Beatman)	New York	New York
United States	Jewish Board of Family and Children's Services (BoroPark)	New York	New York
United States	Jewish Board of Family and Children's Services (Break-Free Adolescent Services)	New York	New York
United States	Jewish Board of Family and Children's Services (Pelham)	New York	New York
United States	Jewish Board of Family and Children's Services (Pride)	New York	New York
United States	Jewish Board of Family and Children's Services (South Brooklyn)	New York	New York
United States	Jewish Board of Family and Children's Services (Staten Island)	New York	New York
United States	Jewish Board of Family and Children's Services (Yeshiva Chanoch Lenaar)	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	University of California Los Angeles- Post-Traumatic Stress Disorder (UCLA-PTSD) Reaction Index		Measured at baseline and Month 3	No