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NCT00296842 Clinical Trial

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

Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00296842
Other study ID # PICARTA-1
Secondary ID
Status Completed
Phase N/A
First received February 24, 2006
Last updated December 8, 2011
Start date November 2004
Est. completion date February 2008

Study information
Verified date December 2011
Source University Children's Hospital, Zurich
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 99
Est. completion date February 2008
Est. primary completion date February 2008
Accepts healthy volunteers No
Gender Both
Age group 7 Years to 16 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Behavioral:
• Early psychological intervention
Psychoeducation, trauma narrative, provision of coping skills

Locations
Country Name City State
Switzerland University Children's Hospital, Psychosomatic and Psychiatry Zurich

Sponsors (1)
Lead Sponsor Collaborator
University Children's Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Zehnder D, Meuli M, Landolt MA. Effectiveness of a single-session early psychological intervention for children after road traffic accidents: a randomised controlled trial. Child Adolesc Psychiatry Ment Health. 2010 Feb 8;4:7. doi: 10.1186/1753-2000-4-7. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary CAPS-CA 10 days, 2 months, 6 months after intervention No
Primary CBCL 10 days, 2 months, 6 months after intervention No
Primary DIKJ 10 days, 2 months, 6 months after intervention No
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