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NCT01031615 Clinical Trial

Evaluation of the Child and Family Traumatic Stress Intervention

Posttraumatic Stress Disorder Clinical Trial

— CFTSI  

Official title:
Evaluation of the Child and Family Traumatic Stress Intervention

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01031615
Other study ID # 0504027679
Secondary ID SAMHSA U79SM5431
Status Completed
Phase Phase 1/Phase 2
First received December 10, 2009
Last updated June 14, 2011
Start date October 2005
Est. completion date September 2009

Study information
Verified date June 2011
Source Yale University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 112
Est. completion date September 2009
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender Both
Age group 7 Years to 17 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Behavioral:
• Child and Family Traumatic Stress Interv (CFTSI)
4 sessions involving both the target child and a parent/caregiver
• Psychoeducational Comparison
4 individually focused sessions including psychoeducation and relaxation.

Locations
Country Name City State
United States Yale University Child Study Center New Haven Connecticut

Sponsors (1)
Lead Sponsor Collaborator
Yale University

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary UCLA Posttraumatic Reaction Index (PTSD-RI) 3 months post-intervention No
Secondary Trauma Symptom Checklist for Children (TSCC) 3 Months post-intervention No
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