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

Primary Purpose

Post-Traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trauma-focused cognitive behavioral therapy (TF-CBT)
Treatment as usual (TAU)
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Traumatic Stress Disorder focused on measuring Treatment, PTSD

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jewish Board of Family and Children's Services (Yeshiva Chanoch Lenaar)
  • Jewish Board of Family and Children's Services (Staten Island)
  • Jewish Board of Family and Children's Services (Beatman)
  • Jewish Board of Family and Children's Services (Pelham)
  • Jewish Board of Family and Children's Services (BoroPark)
  • Jewish Board of Family and Children's Services (Break-Free Adolescent Services)
  • Jewish Board of Family and Children's Services (South Brooklyn)
  • Jewish Board of Family and Children's Services (Pride)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

Participants will receive 12 sessions of trauma-focused cognitive behavioral therapy over 3 months.

Participants will receive 12 sessions of treatment as usual over 3 months.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 11, 2008
Last Updated
April 3, 2015
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00614068
Brief Title
Effectiveness of Trauma-Focused Cognitive Behavioral Therapy in Treating Children With Post-Traumatic Stress Disorder
Official Title
Creating a Collaborative Field Research Organization
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder
Keywords
Treatment, PTSD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Participants will receive 12 sessions of trauma-focused cognitive behavioral therapy over 3 months.
Arm Title
B
Arm Type
Active Comparator
Arm Description
Participants will receive 12 sessions of treatment as usual over 3 months.
Intervention Type
Behavioral
Intervention Name(s)
Trauma-focused cognitive behavioral therapy (TF-CBT)
Intervention Description
TF-CBT sessions will include trauma-focused treatment and will teach participants behavioral management and coping skills to overcome their PTSD.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual (TAU)
Intervention Description
TAU outpatient sessions will include routine community care and nontrauma-focused therapy.
Primary Outcome Measure Information:
Title
University of California Los Angeles- Post-Traumatic Stress Disorder (UCLA-PTSD) Reaction Index
Time Frame
Measured at baseline and Month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claude M. Chemtob, PhD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rohini Luthra, PhD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Study Director
Facility Information:
Facility Name
Jewish Board of Family and Children's Services (Yeshiva Chanoch Lenaar)
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Jewish Board of Family and Children's Services (Staten Island)
City
New York
State/Province
New York
ZIP/Postal Code
10314
Country
United States
Facility Name
Jewish Board of Family and Children's Services (Beatman)
City
New York
State/Province
New York
ZIP/Postal Code
10463
Country
United States
Facility Name
Jewish Board of Family and Children's Services (Pelham)
City
New York
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Jewish Board of Family and Children's Services (BoroPark)
City
New York
State/Province
New York
ZIP/Postal Code
11219
Country
United States
Facility Name
Jewish Board of Family and Children's Services (Break-Free Adolescent Services)
City
New York
State/Province
New York
ZIP/Postal Code
11223
Country
United States
Facility Name
Jewish Board of Family and Children's Services (South Brooklyn)
City
New York
State/Province
New York
ZIP/Postal Code
11223
Country
United States
Facility Name
Jewish Board of Family and Children's Services (Pride)
City
New York
State/Province
New York
ZIP/Postal Code
11362
Country
United States

12. IPD Sharing Statement

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

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