NCT01085370

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 11, 2010

Completed
21 days until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

March 18, 2014

Status Verified

March 1, 2014

Enrollment Period

2.9 years

First QC Date

March 10, 2010

Last Update Submit

March 17, 2014

Conditions

Acute Stress Disorder

Keywords

posttraumatic stresspreventionchildrenacute stress disorder due to burn injury or injuries associated with road traffic accidents

Outcome Measures

Primary Outcomes (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 Outcomes (3)

  • KIDSCREEN-Questionnaire / TAPQOL-Questionnaire (health-related quality of life)

    Baseline, 3 months, 6 months post intervention

  • Child behavior Child Behavior Checklist (CBCL)

    Baseline, 3 months, 6 months post intervention

  • Child Depression Inventory (CDI)

    Baseline, 3 months, 6 months post intervention

Study Arms (2)

Control Group

NO INTERVENTION

standard medical care only

Intervention group

EXPERIMENTAL

2 sessions with early psychological interventions

Other: Early psychological intervention

Interventions

Early psychological interventionOTHER

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

Intervention group

Eligibility Criteria

Age2 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 2-16 years
  • Glasgow Coma Scale (GCS) \> 8
  • German speaking
  • Burn accident or road traffic accident

You may not qualify if:

  • Glasgow Coma Scale (GCS) \< 9
  • more than 2 weeks in the Pediatric Intensive Care Unit
  • no command of German
  • previous mental retardation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unviersity Children's Hospital, Psychosomatic and Psychiatry

Zurich, CH-8032, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 24062371DERIVED

MeSH Terms

Conditions

Stress Disorders, Traumatic, Acute

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Markus A Landolt, PhD

    University Children's Hospital Zurich, Psychosomatic and Psychiatry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2010

First Posted

March 11, 2010

Study Start

April 1, 2010

Primary Completion

March 1, 2013

Study Completion

August 1, 2013

Last Updated

March 18, 2014

Record last verified: 2014-03

Locations

CH(1)