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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by National Institute of Mental Health (NIMH).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00614068
First received: February 11, 2008
Last updated: October 5, 2010
Last verified: April 2009
  Purpose

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


Condition Intervention Phase
Post-Traumatic Stress Disorder
Behavioral: Trauma-focused cognitive behavioral therapy (TF-CBT)
Behavioral: Treatment as usual (TAU)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Creating a Collaborative Field Research Organization

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • University of California Los Angeles- Post-Traumatic Stress Disorder (UCLA-PTSD) Reaction Index [ Time Frame: Measured at baseline and Month 3 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2007
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Participants will receive 12 sessions of trauma-focused cognitive behavioral therapy over 3 months.
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.
Active Comparator: B
Participants will receive 12 sessions of treatment as usual over 3 months.
Behavioral: Treatment as usual (TAU)
TAU outpatient sessions will include routine community care and nontrauma-focused therapy.

Detailed 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.

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00614068

Locations
United States, New York
Jewish Board of Family and Children's Services (Beatman)
New York, New York, United States, 10463
Jewish Board of Family and Children's Services (BoroPark)
New York, New York, United States, 11219
Jewish Board of Family and Children's Services (Break-Free Adolescent Services)
New York, New York, United States, 11223
Jewish Board of Family and Children's Services (Pelham)
New York, New York, United States, 10467
Jewish Board of Family and Children's Services (Pride)
New York, New York, United States, 11362
Jewish Board of Family and Children's Services (South Brooklyn)
New York, New York, United States, 11223
Jewish Board of Family and Children's Services (Staten Island)
New York, New York, United States, 10314
Jewish Board of Family and Children's Services (Yeshiva Chanoch Lenaar)
New York, New York, United States, 10019
Sponsors and Collaborators
Investigators
Principal Investigator: Claude M. Chemtob, PhD Mount Sinai School of Medicine
Study Director: Rohini Luthra, PhD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Claude Chemtob, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00614068     History of Changes
Other Study ID Numbers: R24 MH063910, DSIR SE-CE
Study First Received: February 11, 2008
Last Updated: October 5, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Treatment
PTSD

Additional relevant MeSH terms:
Disease
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014