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CompletedNCT01031615CFTSIUpdated Jun 16, 2011

Evaluation of the Child and Family Traumatic Stress Intervention

A Phase 1/2 interventional study of Child and Family Traumatic Stress Interv (CFTSI) and Psychoeducational Comparison in Posttraumatic Stress Disorder, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 7 Years to 17 Years. Per ClinicalTrials.gov, last updated 2011-06-16.

Sponsored by Yale University · Phase 1/2, Interventional, and Prevention

Phase
Phase 1/2
Study type
Interventional
Enrollment
112
Allocation
Randomized
Ages
7 Years to 17 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Posttraumatic Stress Disorder

Keywords

  • School age children and adolescents exposed to a potentially traumatic event
03

In context

Stress Disorders, Post-Traumatic

2,239 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 554 are open to participants now.

This study's enrollment of 112 is above the median of 70 across 1,858 interventional studies indexed under Stress Disorders, Post-Traumatic.

Browse Stress Disorders, Post-Traumatic studies →

Lead sponsor

Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.

Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Already receiving mental health treatment
  • Autism or Developmental Disability
  • Diagnosed with psychosis or bipolar disorder
  • Non-english speaking
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
112 participants (actual)

Study arms

  • 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)

  • Active comparator
    Psychoeducational Comparison

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

    Behavioral: Psychoeducational Comparison

Interventions

  • BehavioralChild and Family Traumatic Stress Interv (CFTSI)

    4 sessions involving both the target child and a parent/caregiver

  • BehavioralPsychoeducational Comparison

    4 individually focused sessions including psychoeducation and relaxation.

06

What researchers measure

Primary outcomes

  1. UCLA Posttraumatic Reaction Index (PTSD-RI)

    Time frame: 3 months post-intervention

Secondary outcomes

  1. Trauma Symptom Checklist for Children (TSCC)

    Time frame: 3 Months post-intervention

07

Study locations

1 site
  • Yale University Child Study Center
    New Haven, Connecticut 06520, United States
08

References and documents

Publications

  • 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. PubMed 20868370 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01031615
Lead sponsor
Yale University
First posted
Dec 14, 2009
Start date
Oct 2005
Primary completion
Sep 2009
Completion
Sep 2009
Last update
Jun 16, 2011

Study contacts

Steven Berkowitz, M.D.
study director · University of Pennsylvania

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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