NCT00296842

Brief Summary

The purpose of this study is to study the effectiveness of an early psychological intervention 7-10 days after a road traffic accident on posttraumatic stress and behavior of children and adolescents

Trial Health

87
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2004

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

Study Start

First participant enrolled

November 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 27, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

December 9, 2011

Status Verified

December 1, 2011

Enrollment Period

3.3 years

First QC Date

February 24, 2006

Last Update Submit

December 8, 2011

Conditions

Injury

Keywords

posttraumatic stress disorderchildreninjuryroad traffic accident

Outcome Measures

Primary Outcomes (3)

  • CAPS-CA

    10 days, 2 months, 6 months after intervention

  • CBCL

    10 days, 2 months, 6 months after intervention

  • DIKJ

    10 days, 2 months, 6 months after intervention

Interventions

Early psychological interventionBEHAVIORAL

Psychoeducation, trauma narrative, provision of coping skills

Eligibility Criteria

Age7 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 7-16 y Command of German language Road traffic accident inpatient or outpatient treatment at the University Children's Hospital Zurich no pretraumatic developmental delay

You may not qualify if:

  • severe head injury No command of the German language Age below 7 y or above 16 y Other major systemic illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Children's Hospital, Psychosomatic and Psychiatry

Zurich, CH-8032, Switzerland

Location

Related Publications (1)

  • Zehnder D, Meuli M, Landolt MA. Effectiveness of a single-session early psychological intervention for children after road traffic accidents: a randomised controlled trial. Child Adolesc Psychiatry Ment Health. 2010 Feb 8;4:7. doi: 10.1186/1753-2000-4-7.

    PMID: 20181120RESULT

MeSH Terms

Conditions

Wounds and InjuriesStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Markus A Landolt, PhD

    University Children's Hospital

    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

February 24, 2006

First Posted

February 27, 2006

Study Start

November 1, 2004

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

December 9, 2011

Record last verified: 2011-12

Locations

CH(1)