Evaluation of the Child and Family Traumatic Stress Intervention

NCT ID: NCT01031615

Last Updated: 2011-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2009-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Posttraumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Child and Family Traumatic Stress Interv

4-session secondary prevention model that focuses on family communication about symptoms of a child aged 7-16.

Group Type EXPERIMENTAL

Child and Family Traumatic Stress Interv (CFTSI)

Intervention Type BEHAVIORAL

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

Psychoeducational Comparison

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

Group Type ACTIVE_COMPARATOR

Psychoeducational Comparison

Intervention Type BEHAVIORAL

4 individually focused sessions including psychoeducation and relaxation.

Interventions

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Child and Family Traumatic Stress Interv (CFTSI)

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

Intervention Type BEHAVIORAL

Psychoeducational Comparison

4 individually focused sessions including psychoeducation and relaxation.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Yale University School of Medicine Child Study Center

Principal Investigators

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Steven Berkowitz, M.D.

Role: STUDY_DIRECTOR

University of Pennsylvania

Locations

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Yale University Child Study Center

New Haven, Connecticut, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 20868370 (View on PubMed)

Other Identifiers

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SAMHSA U79SM54318

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

0504027679

Identifier Type: -

Identifier Source: org_study_id

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