NCT01031615

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2005

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 14, 2009

Completed
Last Updated

June 16, 2011

Status Verified

June 1, 2011

Enrollment Period

3.9 years

First QC Date

December 10, 2009

Last Update Submit

June 14, 2011

Conditions

Keywords

School age children and adolescents exposed to a potentially traumatic event

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

EXPERIMENTAL

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)

Psychoeducational Comparison

ACTIVE COMPARATOR

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

Behavioral: Psychoeducational Comparison

Interventions

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

Child and Family Traumatic Stress Interv

4 individually focused sessions including psychoeducation and relaxation.

Psychoeducational Comparison

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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

Study Sites (1)

Yale University Child Study Center

New Haven, Connecticut, 06520, United States

Location

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

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Steven Berkowitz, M.D.

    University of Pennsylvania

    STUDY DIRECTOR

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

Locations