Motor Vehicle AccidentPTCNCT02693249
Dysfunctional Posttraumatic Cognitions in Children and Adolescents
An observational study of Motor Vehicle Accident and Burns, run by University Children's Hospital, Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Motor Vehicle Accident, Burns
- How many people
- 130 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2016to Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Motor Vehicle Accident, Burns
- Keywords
- accidents, adolescents, children, posttraumatic cognitions
- Medical subject headings
- Burns
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor Vehicle AccidentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Markus A. Landolt, Prof. Dr., Principal investigator, University Children's Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02693249
- Sponsor's protocol ID
- PB_2016-00275
- Acronym
- PTC
- Status last verified
- Mar 2018
- First submitted
- 15 Feb 2016
- Last updated
- 26 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dysfunctional Posttraumatic Cognitions in Children and Adolescents
- ClinicalTrials.gov ID
- NCT02693249
- Acronym / sponsor ID
- PTC / PB_2016-00275
- Conditions
- Motor Vehicle Accident, Burns
- Keywords
- accidents, adolescents, children, posttraumatic cognitions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 26 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Child Posttraumatic Cognitions Inventory (CPTCI)
Time frame: 6 months
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.
3 secondary outcomes
University of California at Los Angeles Post-Traumatic Stress Disorder Reaction Index DSM-5 version (UCLA PTSD RI DSM-5)
Time frame: 6 months
Children's Depression Inventory (CDI)
Time frame: 6 months
Screen for Child Anxiety Related Disorders (SCARED)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus A. Landolt, Prof. Dr. principal investigator
University Children's Hospital, Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Motor Vehicle Accident and Burns, run by University Children's Hospital, Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Posttraumatic Cognitions Inventory (CPTCI) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2018.