Psychological Interventions in Children After Road Traffic Accidents or Burns

NCT ID: NCT01085370

Last Updated: 2014-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2013-08-31

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.

Conditions

Acute Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control Group

standard medical care only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention group

2 sessions with early psychological interventions

Group Type: EXPERIMENTAL

Early psychological intervention

Intervention Type: OTHER

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

Interventions

Early psychological intervention

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Children's Hospital, Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Markus A Landolt, PhD

Role: PRINCIPAL_INVESTIGATOR

University Children's Hospital Zurich, Psychosomatic and Psychiatry

Locations

Unviersity Children's Hospital, Psychosomatic and Psychiatry

Zurich, , Switzerland

Countries

Switzerland

References

Kramer DN, Hertli MB, Landolt MA. Evaluation of an early risk screener for PTSD in preschool children after accidental injury. Pediatrics. 2013 Oct;132(4):e945-51. doi: 10.1542/peds.2013-0713. Epub 2013 Sep 23.

Reference Type: DERIVED

PMID: 24062371 (View on PubMed)

Other Identifiers

PICARTA-B

Identifier Type: -

Identifier Source: org_study_id