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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
University Children's Hospital, Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

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

2 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

First Posted
March 10, 2010
Last Updated
March 17, 2014
Sponsor
University Children's Hospital, Zurich
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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

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Psychological Interventions in Children After Road Traffic Accidents or Burns

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