Back to resultsPrevention of Posttraumatic Stress Symptoms and Behavioral Problems in Children After Road Traffic Accidents: a Randomized Controlled Trial
Primary Purpose
Injury
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Early psychological intervention
Sponsored by
About this trial
This is an interventional prevention trial for Injury focused on measuring posttraumatic stress disorder, children, injury, road traffic accident
Eligibility 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
Sites / Locations
- University Children's Hospital, Psychosomatic and Psychiatry
Outcomes
Primary Outcome Measures
CAPS-CA
CBCL
DIKJ
Secondary Outcome Measures
Full Information
NCT ID
NCT00296842
First Posted
February 24, 2006
Last Updated
December 8, 2011
Sponsor
University Children's Hospital, Zurich
1. Study Identification
Unique Protocol Identification Number
NCT00296842
Brief Title
Prevention of Posttraumatic Stress Symptoms and Behavioral Problems in Children After Road Traffic Accidents: a Randomized Controlled Trial
Official Title
Prevention of Posttraumatic Stress Symptoms and Behavioral Problems in Children and Adolescents After Road Traffic Accidents: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Children's Hospital, Zurich
4. Oversight
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injury
Keywords
posttraumatic stress disorder, children, injury, road traffic accident
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Early psychological intervention
Intervention Description
Psychoeducation, trauma narrative, provision of coping skills
Primary Outcome Measure Information:
Title
CAPS-CA
Time Frame
10 days, 2 months, 6 months after intervention
Title
CBCL
Time Frame
10 days, 2 months, 6 months after intervention
Title
DIKJ
Time Frame
10 days, 2 months, 6 months after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus A Landolt, PhD
Organizational Affiliation
University Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Children's Hospital, Psychosomatic and Psychiatry
City
Zurich
ZIP/Postal Code
CH-8032
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
20181120
Citation
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.
Results Reference
result
Learn more about this trial
Prevention of Posttraumatic Stress Symptoms and Behavioral Problems in Children After Road Traffic Accidents: a Randomized Controlled Trial
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