Prevention of Posttraumatic Stress Symptoms and Behavioral Problems in Children After Road Traffic Accidents: a Randomized Controlled Trial
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| First Received Date ICMJE | February 24, 2006 | ||||
| Last Updated Date | December 8, 2011 | ||||
| Start Date ICMJE | November 2004 | ||||
| Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00296842 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Prevention of Posttraumatic Stress Symptoms and Behavioral Problems in Children After Road Traffic Accidents: a Randomized Controlled Trial | ||||
| Official Title ICMJE | Prevention of Posttraumatic Stress Symptoms and Behavioral Problems in Children and Adolescents After Road Traffic Accidents: a Randomized Controlled Trial | ||||
| 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 |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE | Injury | ||||
| Intervention ICMJE | Behavioral: Early psychological intervention
Psychoeducation, trauma narrative, provision of coping skills |
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| Study Arm (s) | Not Provided | ||||
| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 99 | ||||
| Completion Date | February 2008 | ||||
| Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Both | ||||
| Ages | 7 Years to 16 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Switzerland | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00296842 | ||||
| Other Study ID Numbers ICMJE | PICARTA-1 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | University Children's Hospital, Zurich | ||||
| Study Sponsor ICMJE | University Children's Hospital, Zurich | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University Children's Hospital, Zurich | ||||
| Verification Date | December 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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