Psychological Interventions in Children After Road Traffic Accidents or Burns

Acute Stress Disorder Clinical Trial

— PICARTA-B  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01085370
• Other study ID #: PICARTA-B
• Status: Completed
• Phase: N/A
• First received: March 10, 2010
• Last updated: March 17, 2014
• Start date: April 2010
• Est. completion date: August 2013

Study information

• Verified date: March 2014
• Source: University Children's Hospital, Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: August 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 16 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Stress Disorder
• Stress Disorders, Traumatic
• Stress Disorders, Traumatic, Acute

Intervention

Other:
• Early psychological intervention
3 modules: psychoeducation, reconstruction of the trauma, coping skills

Locations

Country	Name	City	State
Switzerland	Unviersity Children's Hospital, Psychosomatic and Psychiatry	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University Children's Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	KIDSCREEN-Questionnaire / TAPQOL-Questionnaire (health-related quality of life)		Baseline, 3 months, 6 months post intervention	No
Secondary	Child behavior Child Behavior Checklist (CBCL)		Baseline, 3 months, 6 months post intervention	No
Secondary	Child Depression Inventory (CDI)		Baseline, 3 months, 6 months post intervention	No