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Psychological Interventions in Children After Road Traffic Accidents or Burns (PICARTA-B)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Children's Hospital, Zurich
ClinicalTrials.gov Identifier:
NCT01085370
First received: March 10, 2010
Last updated: February 13, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Acute Stress Disorder
 Other: Early psychological intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Psychological Interventions in Children After Road Traffic Accidents or Burns: a Randomized Controlled Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Children's Hospital, Zurich:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • KIDSCREEN-Questionnaire / TAPQOL-Questionnaire (health-related quality of life) [ Time Frame: Baseline, 3 months, 6 months post intervention ] [ Designated as safety issue: No ]
  • Child behavior Child Behavior Checklist (CBCL) [ Time Frame: Baseline, 3 months, 6 months post intervention ] [ Designated as safety issue: No ]
  • Child Depression Inventory (CDI) [ Time Frame: Baseline, 3 months, 6 months post intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: April 2010
Estimated Study Completion Date: April 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control Group
standard medical care only
Experimental: Intervention group
2 sessions with early psychological interventions
 Other: Early psychological intervention
3 modules: psychoeducation, reconstruction of the trauma, coping skills

  Eligibility

Ages Eligible for Study:   2 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01085370

Locations
Switzerland
Unviersity Children's Hospital, Psychosomatic and Psychiatry
Zurich, Switzerland, CH-8032
Sponsors and Collaborators
University Children's Hospital, Zurich
Investigators
Principal Investigator: Markus A Landolt, PhD University Children's Hospital Zurich, Psychosomatic and Psychiatry
  More Information

No publications provided

Responsible Party: University Children's Hospital, Zurich
ClinicalTrials.gov Identifier: NCT01085370     History of Changes
Other Study ID Numbers: PICARTA-B
Study First Received: March 10, 2010
Last Updated: February 13, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Children's Hospital, Zurich:
posttraumatic stress
prevention
children
acute stress disorder due to burn injury or injuries associated with road traffic accidents

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Traumatic, Acute
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013