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

This study has been completed.
Sponsor:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT01031615
First received: December 10, 2009
Last updated: June 14, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Posttraumatic Stress Disorder
 Behavioral: Child and Family Traumatic Stress Interv (CFTSI)
Behavioral: Psychoeducational Comparison
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of the Child and Family Traumatic Stress Intervention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • UCLA Posttraumatic Reaction Index (PTSD-RI) [ Time Frame: 3 months post-intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Trauma Symptom Checklist for Children (TSCC) [ Time Frame: 3 Months post-intervention ] [ Designated as safety issue: No ]

Enrollment: 112
Study Start Date: October 2005
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Child and Family Traumatic Stress Interv
4-session secondary prevention model that focuses on family communication about symptoms of a child aged 7-16.
 Behavioral: Child and Family Traumatic Stress Interv (CFTSI)
4 sessions involving both the target child and a parent/caregiver
Active Comparator: Psychoeducational Comparison
4-sessions focused on individual child using psychoeducation and relaxation skills
 Behavioral: Psychoeducational Comparison
4 individually focused sessions including psychoeducation and relaxation.

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01031615

Locations
United States, Connecticut
Yale University Child Study Center
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
Investigators
Study Director: Steven Berkowitz, M.D. University of Pennsylvania
  More Information

Publications:

Responsible Party: Carla S. Stover/Assistant Professor, Yale University School of Medicine Child Study Center
ClinicalTrials.gov Identifier: NCT01031615     History of Changes
Other Study ID Numbers: 0504027679, SAMHSA U79SM54318
Study First Received: December 10, 2009
Last Updated: June 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
School age children and adolescents exposed to a potentially traumatic event

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

ClinicalTrials.gov processed this record on May 19, 2013