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Completed

NCT Number: NCT01085370

Psychological Interventions in Children After Road Traffic Accidents or Burns

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.

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Key information

Age range

2 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unviersity Children's Hospital, Psychosomatic and Psychiatry

Zurich, CH-8032, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early psychological intervention

Other

3 modules: psychoeducation, reconstruction of the trauma, coping skills

Primary outcomes

  1. 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

  1. KIDSCREEN-Questionnaire / TAPQOL-Questionnaire (health-related quality of life)

    Time frame: Baseline, 3 months, 6 months post intervention

  2. Child behavior Child Behavior Checklist (CBCL)

    Time frame: Baseline, 3 months, 6 months post intervention

  3. Child Depression Inventory (CDI)

    Time frame: Baseline, 3 months, 6 months post intervention

Sponsors and collaborators

Lead sponsor

University Children's Hospital, Zurich

Other

Registry information

Official study title

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

Acronym: PICARTA-B

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Mar 11, 2010
Registry last updated
Mar 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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