- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01085370
Psychological Interventions in Children After Road Traffic Accidents or Burns (PICARTA-B)
March 17, 2014 updated by: University Children's Hospital, Zurich
Psychological Interventions in Children After Road Traffic Accidents or Burns: a Randomized Controlled Study
Within a randomized controlled design the effects of a brief early psychological intervention (child, parents) after road traffic accidents or burns shall be examined in a sample of 120 children and adolescents (aged 2 to 16 years).
During the first seven days after the accident a screening for the risk of developing a posttraumatic stress disorder is conducted to divide the participants into a "high risk" and a "low risk" group.
Participants with a low risk are excluded from the intervention study but reassessed six months after their accident to validate the screening instrument.
After a baseline assessment within 14 days after the accident participants of the high risk group are randomly assigned to an intervention group (n = 60) or a control group (n = 60).
The latter receive standard medical care.
Children of the intervention group are provided with a brief age appropriate two-session intervention that includes a detailed reconstruction of the accident, psychoeducation and discussion of helpful coping strategies.
Both the control and the intervention group are reassessed by blind raters at 3 and 6 months after the accident.
Assessment of outcome includes measures of posttraumatic stress symptoms, depression, anxiety, behavior, and health-related quality of life.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
108
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Zurich, Switzerland, CH-8032
- Unviersity Children's Hospital, Psychosomatic and Psychiatry
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 2-16 years
- Glasgow Coma Scale (GCS) > 8
- German speaking
- Burn accident or road traffic accident
Exclusion Criteria:
- Glasgow Coma Scale (GCS) < 9
- more than 2 weeks in the Pediatric Intensive Care Unit
- no command of German
- previous mental retardation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control Group
standard medical care only
|
|
Experimental: Intervention group
2 sessions with early psychological interventions
|
3 modules: psychoeducation, reconstruction of the trauma, coping skills
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinician administered PTSD Scale for Children/Adolescents (CAPS-CA) and Child Posttraumatic Stress Disorder Semistructured Interview and Observational Scale (PTSDSSI)
Time Frame: Baseline, 3 months, 6 months post intervention
|
Baseline, 3 months, 6 months post intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
KIDSCREEN-Questionnaire / TAPQOL-Questionnaire (health-related quality of life)
Time Frame: Baseline, 3 months, 6 months post intervention
|
Baseline, 3 months, 6 months post intervention
|
Child behavior Child Behavior Checklist (CBCL)
Time Frame: Baseline, 3 months, 6 months post intervention
|
Baseline, 3 months, 6 months post intervention
|
Child Depression Inventory (CDI)
Time Frame: Baseline, 3 months, 6 months post intervention
|
Baseline, 3 months, 6 months post intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Markus A Landolt, PhD, University Children's Hospital Zurich, Psychosomatic and Psychiatry
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2010
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
August 1, 2013
Study Registration Dates
First Submitted
March 10, 2010
First Submitted That Met QC Criteria
March 10, 2010
First Posted (Estimate)
March 11, 2010
Study Record Updates
Last Update Posted (Estimate)
March 18, 2014
Last Update Submitted That Met QC Criteria
March 17, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PICARTA-B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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