Psychological Interventions in Children After Road Traffic Accidents or Burns (PICARTA-B)
Primary Purpose
Acute Stress Disorder
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 Acute Stress Disorder focused on measuring posttraumatic stress, prevention, children, acute stress disorder due to burn injury or injuries associated with road traffic accidents
Eligibility Criteria
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
Sites / Locations
- Unviersity Children's Hospital, Psychosomatic and Psychiatry
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Group
Intervention group
Arm Description
standard medical care only
2 sessions with early psychological interventions
Outcomes
Primary Outcome Measures
Clinician administered PTSD Scale for Children/Adolescents (CAPS-CA) and Child Posttraumatic Stress Disorder Semistructured Interview and Observational Scale (PTSDSSI)
Secondary Outcome Measures
KIDSCREEN-Questionnaire / TAPQOL-Questionnaire (health-related quality of life)
Child behavior Child Behavior Checklist (CBCL)
Child Depression Inventory (CDI)
Full Information
NCT ID
NCT01085370
First Posted
March 10, 2010
Last Updated
March 17, 2014
Sponsor
University Children's Hospital, Zurich
1. Study Identification
Unique Protocol Identification Number
NCT01085370
Brief Title
Psychological Interventions in Children After Road Traffic Accidents or Burns
Acronym
PICARTA-B
Official Title
Psychological Interventions in Children After Road Traffic Accidents or Burns: a Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Children's Hospital, Zurich
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Stress Disorder
Keywords
posttraumatic stress, prevention, children, acute stress disorder due to burn injury or injuries associated with road traffic accidents
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
standard medical care only
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
2 sessions with early psychological interventions
Intervention Type
Other
Intervention Name(s)
Early psychological intervention
Intervention Description
3 modules: psychoeducation, reconstruction of the trauma, coping skills
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
KIDSCREEN-Questionnaire / TAPQOL-Questionnaire (health-related quality of life)
Time Frame
Baseline, 3 months, 6 months post intervention
Title
Child behavior Child Behavior Checklist (CBCL)
Time Frame
Baseline, 3 months, 6 months post intervention
Title
Child Depression Inventory (CDI)
Time Frame
Baseline, 3 months, 6 months post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus A Landolt, PhD
Organizational Affiliation
University Children's Hospital Zurich, Psychosomatic and Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unviersity Children's Hospital, Psychosomatic and Psychiatry
City
Zurich
ZIP/Postal Code
CH-8032
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
24062371
Citation
Kramer DN, Hertli MB, Landolt MA. Evaluation of an early risk screener for PTSD in preschool children after accidental injury. Pediatrics. 2013 Oct;132(4):e945-51. doi: 10.1542/peds.2013-0713. Epub 2013 Sep 23.
Results Reference
derived
Learn more about this trial
Psychological Interventions in Children After Road Traffic Accidents or Burns
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