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

June 14, 2011 updated by: Yale University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
UCLA Posttraumatic Reaction Index (PTSD-RI)
Time Frame: 3 months post-intervention
3 months post-intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Trauma Symptom Checklist for Children (TSCC)
Time Frame: 3 Months post-intervention
3 Months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Study Director: Steven Berkowitz, M.D., University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (ACTUAL)

September 1, 2009

Study Completion (ACTUAL)

September 1, 2009

Study Registration Dates

First Submitted

December 10, 2009

First Submitted That Met QC Criteria

December 11, 2009

First Posted (ESTIMATE)

December 14, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

June 16, 2011

Last Update Submitted That Met QC Criteria

June 14, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0504027679
  • SAMHSA U79SM54318 (OTHER_GRANT: SAMHSA U79SM54318)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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