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Prevention of Posttraumatic Stress Symptoms and Behavioral Problems in Children After Road Traffic Accidents: a Randomized Controlled Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Children's Hospital, Zurich
ClinicalTrials.gov Identifier:
NCT00296842
First received: February 24, 2006
Last updated: December 8, 2011
Last verified: December 2011
History of Changes
  Purpose

The purpose of this study is to study the effectiveness of an early psychological intervention 7-10 days after a road traffic accident on posttraumatic stress and behavior of children and adolescents


Condition Intervention
Injury
 Behavioral: Early psychological intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Posttraumatic Stress Symptoms and Behavioral Problems in Children and Adolescents After Road Traffic Accidents: a Randomized Controlled Trial

Further study details as provided by University Children's Hospital, Zurich:

Primary Outcome Measures:
  • CAPS-CA [ Time Frame: 10 days, 2 months, 6 months after intervention ] [ Designated as safety issue: No ]
  • CBCL [ Time Frame: 10 days, 2 months, 6 months after intervention ] [ Designated as safety issue: No ]
  • DIKJ [ Time Frame: 10 days, 2 months, 6 months after intervention ] [ Designated as safety issue: No ]

Enrollment: 99
Study Start Date: November 2004
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Early psychological intervention
    Psychoeducation, trauma narrative, provision of coping skills
Detailed Description:

Within a randomized controlled design the effects of a brief psychological intervention (child, parents) after a road traffic accident shall be examined in a sample of 100 children and adolescents. After a baseline assessment 7-10 days after the accident participants are randomly assigned to an intervention or a control group. Both are re-assessed at 2 and 6 months after the accident by means of standardized questionnaires assessing posttraumatic stress symptoms, depression, and behavior.

  Eligibility

Ages Eligible for Study:   7 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Age 7-16 y Command of German language Road traffic accident inpatient or outpatient treatment at the University Children's Hospital Zurich no pretraumatic developmental delay

Exclusion Criteria:

severe head injury No command of the German language Age below 7 y or above 16 y Other major systemic illness

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00296842

Locations
Switzerland
University Children's Hospital, Psychosomatic and Psychiatry
Zurich, Switzerland, CH-8032
Sponsors and Collaborators
University Children's Hospital, Zurich
Investigators
Principal Investigator: Markus A Landolt, PhD University Children's Hospital
  More Information

Publications:

Responsible Party: University Children's Hospital, Zurich
ClinicalTrials.gov Identifier: NCT00296842     History of Changes
Other Study ID Numbers: PICARTA-1
Study First Received: February 24, 2006
Last Updated: December 8, 2011
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Children's Hospital, Zurich:
posttraumatic stress disorder
children
injury
road traffic accident

ClinicalTrials.gov processed this record on May 19, 2013