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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02693249
Other study ID # PB_2016-00275
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2016
Est. completion date September 2018

Study information

Verified date March 2018
Source University Children's Hospital, Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Background: Dysfunctional trauma-related cognitions play an important role in the aftermath of a traumatic event. Children and adolescents, who think that the experienced trauma has a permanent and disturbing impact on their actual life and their future, feel threatened. Study results show that dysfunctional posttraumatic cognitions correlate highly with posttraumatic stress symptoms (PTSS), depression, and anxiety. In addition, children and adolescents with a posttraumatic stress disorder (PTSD) have significantly more dysfunctional trauma-related cognitions than those without PTSD. Especially for children and adolescents it is important to consider interacting developmental and environmental factors. A developmental approach, nevertheless, has not been investigated yet.

Aims: The aims of the proposed study are to achieve a better understanding of dysfunctional trauma-related cognitions considering child and environmental factors in a cross-sectional and a longitudinal design.

Method: The sample consists of two different subsamples: 1) A hospital sample consisting of children and adolescents (school age: 7-18 years), who experienced an accidental trauma (either acute traffic accident or burn injury) assessed at three times: in the acute phase (7-14 days), 3 months, and 6 months after the trauma occurred. 2) An already existing clinical sample of 159 children and adolescents (TreatChildTrauma study), who mostly experienced an interpersonal trauma such as sexual or physical abuse. The total sample will be used to investigate the impact of child and environmental factors including trauma type, trauma frequency, age, gender, risk status pre trauma (psychopathological status pre trauma and traumatic events pre trauma), psychopathological status post trauma, and parental trauma-related cognitions. In addition, the hospital sample will be used for assessing the naturalistic time course of dysfunctional trauma-related cognitions as well as the association between cognitions, PTSS, depression, and anxiety over time. Moreover, the association between parental dysfunctional trauma-related cognitions and altered parenting as well as their impact on the child's cognitions will be investigated.

Relevance: Dysfunctional trauma-related cognitions have an important impact on coping with a traumatic event in childhood and adolescence. Nevertheless, no study has investigated the interaction between several child and environmental factors so far. A gain of knowledge in this area is important to improve treatments of trauma-related disorders.


Recruitment information / eligibility

Status Completed
Enrollment 130
Est. completion date September 2018
Est. primary completion date September 2018
Accepts healthy volunteers No
Gender All
Age group 7 Years to 18 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Switzerland University Children's Hospital 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 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 University of California at Los Angeles Post-Traumatic Stress Disorder Reaction Index DSM-5 version (UCLA PTSD RI DSM-5) The UCLA PTSD RI DSM-5 is a widely used and well validated questionnaire assessing posttraumatic stress symptoms in children and adolescents ages 7-18 years. Both self-report and proxy-report will be used. 6 months
Secondary Children`s Depression Inventory (CDI) The CDI is a 29-item self-report measure assessing depression symptoms in children ages 8-16 years. The questionnaire showing good psychometric properties yields a total score. 6 months
Secondary Screen for Child Anxiety Related Disorders (SCARED) The SCARED is a 41-item self-report measure assessing anxiety symptoms in children ages 8-18 years which shows good psychometric properties. 6 months
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