Clinical trial NCT01085370: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Stress Disorder
Keywords: posttraumatic stress
prevention
children
acute stress disorder due to burn injury or injuries associated with road traffic accidents
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
First posted: 2010-03-11
Enrollment: 108
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Clinician administered PTSD Scale for Children/Adolescents (CAPS-CA) and Child Posttraumatic Stress Disorder Semistructured Interview and Observational Scale (PTSDSSI)
timeFrame: Baseline, 3 months, 6 months post intervention
Secondary outcomes:
measure: KIDSCREEN-Questionnaire / TAPQOL-Questionnaire (health-related quality of life)
timeFrame: Baseline, 3 months, 6 months post intervention
measure: Child behavior Child Behavior Checklist (CBCL)
timeFrame: Baseline, 3 months, 6 months post intervention
measure: Child Depression Inventory (CDI)
timeFrame: Baseline, 3 months, 6 months post intervention
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Unviersity Children's Hospital, Psychosomatic and Psychiatry
Study officials:
affiliation: University Children's Hospital Zurich, Psychosomatic and Psychiatry
name: Markus A Landolt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.