Psychological Interventions in Children After Road Traffic Accidents or Burns

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Stress Disorder

Intervention / Treatment
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* Other: Early psychological intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>standard medical care only | |
| Experimental: Intervention group<br>2 sessions with early psychological interventions | Other: Early psychological intervention<br>* 3 modules: psychoeducation, reconstruction of the trauma, coping skills<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician administered PTSD Scale for Children/Adolescents (CAPS-CA) and Child Posttraumatic Stress Disorder Semistructured Interview and Observational Scale (PTSDSSI) |  | Baseline, 3 months, 6 months post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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posttraumatic stress, prevention, children, acute stress disorder due to burn injury or injuries associated with road traffic accidents