Evaluation of the Child and Family Traumatic Stress Intervention
CFTSI
2 other identifiers
interventional
112
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2005
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 10, 2009
CompletedFirst Posted
Study publicly available on registry
December 14, 2009
CompletedJune 16, 2011
June 1, 2011
3.9 years
December 10, 2009
June 14, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
UCLA Posttraumatic Reaction Index (PTSD-RI)
3 months post-intervention
Secondary Outcomes (1)
Trauma Symptom Checklist for Children (TSCC)
3 Months post-intervention
Study Arms (2)
Child and Family Traumatic Stress Interv
EXPERIMENTAL4-session secondary prevention model that focuses on family communication about symptoms of a child aged 7-16.
Psychoeducational Comparison
ACTIVE COMPARATOR4-sessions focused on individual child using psychoeducation and relaxation skills
Interventions
4 sessions involving both the target child and a parent/caregiver
4 individually focused sessions including psychoeducation and relaxation.
Eligibility Criteria
You may qualify if:
- Youth exposed to a potentially traumatic event within the last 30 days who have one new symptom on the Posttraumatic Checklist (PCL)
You may not qualify if:
- Already receiving mental health treatment
- Autism or Developmental Disability
- Diagnosed with psychosis or bipolar disorder
- Non-english speaking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
Study Sites (1)
Yale University Child Study Center
New Haven, Connecticut, 06520, United States
Related Publications (1)
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.
PMID: 20868370BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Steven Berkowitz, M.D.
University of Pennsylvania
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 10, 2009
First Posted
December 14, 2009
Study Start
October 1, 2005
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
June 16, 2011
Record last verified: 2011-06