NCT02693249

Brief Summary

The purpose of this study is to investigate the psychological consequences of motor vehicle accidents and burn accidents in 7-18 years old children and adolescents. The impact of posttraumatic cognitions on developing psychological symptoms are of particular interest.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2016

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 26, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

September 26, 2018

Status Verified

March 1, 2018

Enrollment Period

2.6 years

First QC Date

February 15, 2016

Last Update Submit

September 25, 2018

Conditions

Motor Vehicle AccidentBurns

Keywords

accidentsadolescentschildrenposttraumatic cognitions

Outcome Measures

Primary Outcomes (1)

  • Child Posttraumatic Cognitions Inventory (CPTCI)

    The CPTCI is a 25-item self-report measure assessing dysfunctional posttraumatic cognitions in children ages 6-18 years. The questionnaire showing good psychometric properties yields scores for two subscales "Permanent and disturbing change" and "Fragile person in a scary world" as well as a total score.

    6 months

Secondary Outcomes (3)

  • University of California at Los Angeles Post-Traumatic Stress Disorder Reaction Index DSM-5 version (UCLA PTSD RI DSM-5)

    6 months

  • Children's Depression Inventory (CDI)

    6 months

  • Screen for Child Anxiety Related Disorders (SCARED)

    6 months

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children and adolescents (ages 7-18 years), who experienced an accidental trauma (either traffic accident or burn accident) and at least one parent.

You may qualify if:

  • child age between 7.0 and 18.0
  • outpatient or inpatient medical care at the University Children's Hospital Zurich because of an injury after a traffic accident or a burn accident
  • at least one parent participating

You may not qualify if:

  • a severe comorbid head injury (Glasgow Coma Scale \< 9)
  • any previous evidence of pervasive developmental disorder
  • an insufficient command of the German language of the participant or of the parents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Children's Hospital

Zurich, 8032, Switzerland

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Markus A. Landolt, Prof. Dr.

    University Children's Hospital, Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2016

First Posted

February 26, 2016

Study Start

February 1, 2016

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

September 26, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)