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Completed

NCT Number: NCT00614068

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

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

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Key information

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jewish Board of Family and Children's Services (Beatman), New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)

Behavioral

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)

Behavioral

TAU outpatient sessions will include routine community care and nontrauma-focused therapy.

Primary outcomes

  1. University of California Los Angeles- Post-Traumatic Stress Disorder (UCLA-PTSD) Reaction Index

    Time frame: Measured at baseline and Month 3

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Creating a Collaborative Field Research Organization

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Feb 13, 2008
Registry last updated
Apr 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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