search
Back to results

Evaluation of the Child and Family Traumatic Stress Intervention (CFTSI)

Primary Purpose

Posttraumatic Stress Disorder

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Child and Family Traumatic Stress Interv (CFTSI)
Psychoeducational Comparison
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Posttraumatic Stress Disorder focused on measuring School age children and adolescents exposed to a potentially traumatic event

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Youth exposed to a potentially traumatic event within the last 30 days who have one new symptom on the Posttraumatic Checklist (PCL)

Exclusion Criteria:

  • Already receiving mental health treatment
  • Autism or Developmental Disability
  • Diagnosed with psychosis or bipolar disorder
  • Non-english speaking

Sites / Locations

  • Yale University Child Study Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Child and Family Traumatic Stress Interv

Psychoeducational Comparison

Arm Description

4-session secondary prevention model that focuses on family communication about symptoms of a child aged 7-16.

4-sessions focused on individual child using psychoeducation and relaxation skills

Outcomes

Primary Outcome Measures

UCLA Posttraumatic Reaction Index (PTSD-RI)

Secondary Outcome Measures

Trauma Symptom Checklist for Children (TSCC)

Full Information

First Posted
December 10, 2009
Last Updated
June 14, 2011
Sponsor
Yale University
search

1. Study Identification

Unique Protocol Identification Number
NCT01031615
Brief Title
Evaluation of the Child and Family Traumatic Stress Intervention
Acronym
CFTSI
Official Title
Evaluation of the Child and Family Traumatic Stress Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Yale University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the efficacy of the Child and Family Traumatic Stress Intervention (CFTSI) in preventing the development of Posttraumatic Stress Disorder (PTSD) when implemented within 30 days of a potentially traumatic event.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
School age children and adolescents exposed to a potentially traumatic event

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Child and Family Traumatic Stress Interv
Arm Type
Experimental
Arm Description
4-session secondary prevention model that focuses on family communication about symptoms of a child aged 7-16.
Arm Title
Psychoeducational Comparison
Arm Type
Active Comparator
Arm Description
4-sessions focused on individual child using psychoeducation and relaxation skills
Intervention Type
Behavioral
Intervention Name(s)
Child and Family Traumatic Stress Interv (CFTSI)
Intervention Description
4 sessions involving both the target child and a parent/caregiver
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducational Comparison
Intervention Description
4 individually focused sessions including psychoeducation and relaxation.
Primary Outcome Measure Information:
Title
UCLA Posttraumatic Reaction Index (PTSD-RI)
Time Frame
3 months post-intervention
Secondary Outcome Measure Information:
Title
Trauma Symptom Checklist for Children (TSCC)
Time Frame
3 Months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Youth exposed to a potentially traumatic event within the last 30 days who have one new symptom on the Posttraumatic Checklist (PCL) Exclusion Criteria: Already receiving mental health treatment Autism or Developmental Disability Diagnosed with psychosis or bipolar disorder Non-english speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Berkowitz, M.D.
Organizational Affiliation
University of Pennsylvania
Official's Role
Study Director
Facility Information:
Facility Name
Yale University Child Study Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20868370
Citation
Berkowitz SJ, Stover CS, Marans SR. The Child and Family Traumatic Stress Intervention: secondary prevention for youth at risk of developing PTSD. J Child Psychol Psychiatry. 2011 Jun;52(6):676-85. doi: 10.1111/j.1469-7610.2010.02321.x. Epub 2010 Sep 24.
Results Reference
background

Learn more about this trial

Evaluation of the Child and Family Traumatic Stress Intervention

We'll reach out to this number within 24 hrs