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Clinical Trials/NCT01085370
NCT01085370
Completed
Not Applicable

Psychological Interventions in Children After Road Traffic Accidents or Burns: a Randomized Controlled Study

University Children's Hospital, Zurich1 site in 1 country108 target enrollmentApril 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Stress Disorder
Sponsor
University Children's Hospital, Zurich
Enrollment
108
Locations
1
Primary Endpoint
Clinician administered PTSD Scale for Children/Adolescents (CAPS-CA) and Child Posttraumatic Stress Disorder Semistructured Interview and Observational Scale (PTSDSSI)
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2010
End Date
August 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Children's Hospital, Zurich
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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 Outcomes

  • KIDSCREEN-Questionnaire / TAPQOL-Questionnaire (health-related quality of life)(Baseline, 3 months, 6 months post intervention)
  • Child behavior Child Behavior Checklist (CBCL)(Baseline, 3 months, 6 months post intervention)
  • Child Depression Inventory (CDI)(Baseline, 3 months, 6 months post intervention)

Study Sites (1)

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