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

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ClinicalTrials.gov Identifier: NCT01031615
Recruitment Status : Completed
First Posted : December 14, 2009
Last Update Posted : June 16, 2011
Sponsor:
Information provided by:
Yale University

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of the Child and Family Traumatic Stress Intervention
Study Start Date : October 2005
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. UCLA Posttraumatic Reaction Index (PTSD-RI) [ Time Frame: 3 months post-intervention ]

Secondary Outcome Measures :
  1. Trauma Symptom Checklist for Children (TSCC) [ Time Frame: 3 Months post-intervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( Other Grant/Funding Number: SAMHSA U79SM54318 )
First Posted: December 14, 2009    Key Record Dates
Last Update Posted: June 16, 2011
Last Verified: June 2011

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
Trauma and Stressor Related Disorders
Mental Disorders