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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on July 26, 2014