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

• Sponsor: University Children's Hospital, Zurich (Other)
• Overall Status: Completed
• CT.gov ID: NCT01085370
• Collaborator: (none)
• Enrollment: 108
• Location: 1
• Arms: 2
• Duration (Months): 40
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Stress Disorder	Other: Early psychological intervention	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 108 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Psychological Interventions in Children After Road Traffic Accidents or Burns: a Randomized Controlled Study
• Study Start Date: Apr 1, 2010
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. 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

1. KIDSCREEN-Questionnaire / TAPQOL-Questionnaire (health-related quality of life) [Baseline, 3 months, 6 months post intervention]

2. Child behavior Child Behavior Checklist (CBCL) [Baseline, 3 months, 6 months post intervention]

3. Child Depression Inventory (CDI) [Baseline, 3 months, 6 months post intervention]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 16 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Children's Hospital, Zurich
• ClinicalTrials.gov Identifier: NCT01085370
• Other Study ID Numbers: PICARTA-B
• First Posted: Mar 11, 2010
• Last Update Posted: Mar 18, 2014
• Last Verified: Mar 1, 2014

• 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

Study Results

No Results Posted as of Mar 18, 2014