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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Children's Hospital, Zurich
ClinicalTrials.gov Identifier:
NCT01085370
First received: March 10, 2010
Last updated: March 17, 2014
Last verified: March 2014
  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:


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 ]

Enrollment: 108
Study Start Date: April 2010
Study Completion Date: August 2013
Primary Completion Date: March 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by University Children's Hospital, Zurich

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: March 17, 2014
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 August 19, 2014