Psychological Interventions in Children After Road Traffic Accidents or Burns

Official Title: “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.

Intervention(s) in this Clinical Trial

• Other: Early psychological intervention
  • 3 modules: psychoeducation, reconstruction of the trauma, coping skills

Arms, Groups and Cohorts in this Clinical Trial

• No Intervention: Control Group
  • standard medical care only
• Experimental: Intervention group
  • 2 sessions with early psychological interventions

Primary Measures

• 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
    Safety Issue?: No

Secondary Measures

• KIDSCREEN-Questionnaire / TAPQOL-Questionnaire (health-related quality of life)
  • Time Frame: Baseline, 3 months, 6 months post intervention
    Safety Issue?: No
• Child behavior Child Behavior Checklist (CBCL)
  • Time Frame: Baseline, 3 months, 6 months post intervention
    Safety Issue?: No
• Child Depression Inventory (CDI)
  • Time Frame: Baseline, 3 months, 6 months post intervention
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 2 Years

Maximum Age for this Clinical Trial: 16 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: University Children's Hospital, Zurich Other

Overall Clinical Trial Officials and Contacts

Markus A Landolt, PhD Principal Investigator University Children's Hospital Zurich, Psychosomatic and Psychiatry  

Overall Contact: Markus A Landolt, PhD +41442667396 markus.landolt@kispi.uzh.ch

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01085370

Study ID Number: PICARTA-B

ClinicalTrials.gov Identifier: NCT01085370

Health Authority: Switzerland: Ethikkommission