Severe TraumaRESPETNCT04168827
Emotional and Social Impact on the Relatives of Hospitalized Children for Severe Trauma
An observational study of Severe Trauma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This research aims to study the occurrence of post-traumatic stress, anxiety or depression in the parents of a child who has been hospitalized in intensive care unit following a severe trauma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Trauma
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- 9 Dec 2019to 9 Jun 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Holder of the parental authority of a patient under 18 who has been hospitalized in the surgical intensive care unit of Necker University Hospital for severe trauma (Abbreviated Injury Scale greater than or equal to 3 in one of the anatomical regions) at the admission in the service and regardless of the ending of hospitalization.
Who may be able to join
- Holder of the parental authority of a patient under 18 who has been hospitalized in the surgical intensive care unit of Necker University Hospital for severe trauma (Abbreviated Injury Scale greater than or equal to 3 in one of the anatomical regions) at the admission in the service and regardless of the ending of hospitalization.
- Holder of parental authority over 18 years.
- Holder of parental authority speaking French.
Who cannot join
- Holder of parental authority refusing to participate in the study, after submission of the information document.
- Holder of parental authority unable to answer the questionnaire.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Emotional and Social Impact on the Relatives of Hospitalized Children for Severe Trauma of 3 to 6 Months After the Intensive Care Unit Leaving
This research aims to study the occurrence of post-traumatic stress, anxiety or depression in the parents of a child who has been hospitalized in intensive care unit following a severe trauma.
Read the detailed description
With nearly 25% of trauma deaths, trauma is one of the leading causes of death in the world for children aged 5 to 14 years. In children under 4, it is responsible for 6% of deaths.
Severe trauma is defined by an Abbreviated Injury Scale > 3 score in at least one anatomical region.
In case of multiple traumas, the Injury Severity Score is used to define severe polytrauma if it is > 15.
Cranial trauma is the most common lesion found in polytraumatized children and is present in 80% of cases.
Serious head trauma is defined as the existence of a cranial trauma in a patient whose Glasgow score is less than or equal to 8.
Severe trauma is a source of high mortality and severe disability in surviving children. Due to the context of sudden onset, a prolonged length of hospitalization in intensive care, as well as the occurrence of often severe sequelae, the severe trauma causes a real upheaval for the child's relatives.
In adults, the occurrence of post-traumatic stress, anxiety and depression is relatively well described in patients and relatives of patients who have been hospitalized in intensive care unit. However, there is currently no pediatric study focusing on this subject, apart from neonatology where the traumatological context remains exceptional.
This research aims to study the occurrence of post-traumatic stress, anxiety or depression in the parents of a child who has been hospitalized in intensive care unit following a severe trauma.
- Conditions
- Severe Trauma
- Being tested
- Questionnaire
- Keywords
- Severe trauma, Post-traumatic stress, Anxiety, Depression, Intensive care
- Medical subject headings
- Wounds and Injuries, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Questionnaire completed by the parents of severe traumatized child, between 3 to 6 months after the leaving of the child out of intensive care unit
| Study group | Role | What they receive |
|---|---|---|
| Relatives of severe traumatized child | Relatives of a child who has been hospitalized in intensive care of Necker hospital following a severe trauma Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression, post traumatic stress disorder, anxiety
Composite criterion considered positive if :
The subject obtains a score greater than or equal to 13 in the Hospital Anxiety and Depression Scale questionnaire, thus defining a state of anxiety and depression. Hospital Anxiety and Depression Scale score range from 0 to 42 with higher scores indicating worse symptoms.
and / or The subject obtains a score greater than or equal to 8 on one of the of the Hospital Anxiety and Depression Scale score. The Hospital Anxiety and Depression Scale score is separated in two section, one for Anxiety and one for depression. Each subscales range from 0 to 21 with higher scores indicating worse symptoms.
and / or The subject obtains a score greater than or equal to 30 in the Impact of Event Scale Revised questionnaire defining high risk of presence of a post-traumatic stress disorder. The Impact of Event Scale Revised scores range from 0 to 88, with higher scores indicating worse symptoms.
Measured: 18 months
Secondary outcomes (3)
Socio-demographic analysis
A socio-demographic analysis of the population with data collected by a questionnaire focusing on :
- Parent's age (in years)
- The presence of a chronic disease (Yes/No)
- The presence of psychiatric follow-up (Yes/No)
- Taking antidepressant, neuroleptic or anxiolytic drugs (Yes/No)
- Modification of marital status (Yes/No)
- The presence of difficulties in the relationship with the spouse (Yes/No)
- The evolution of professional status (No change / Loss of employment / Sickness leave / Decrease in professional activity)
- The presence of financial difficulties (Yes/No)
Measured: 18 months
Predictive factors for the occurrence of mental disorders
A search for predictive factors of the occurrence of a mental disorder will be conducted using the questionnaire and medical data from the child's file.
Sub-group analyses will be carried out according to the results.
Measured: 18 months
Feeling of hospitalization
The experience of relatives of hospitalization will be studied on the basis of the questionnaire focusing on :
- Sufficient medical information by the team (Yes/No)
- Suffering from the following situation:
- Visiting hours too restricted (Yes/No)
- Visits limited to parents (Yes/No)
- Insufficient availability of the medical team (Yes/No)
- Lack of availability of psychologists (Yes/No)
- Misunderstanding of the child's health problem (Yes/No)
- Follow-up by a psychologist (Yes/No)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start9 Dec 2019
- Primary completion9 Jun 2021
- Study completion9 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe TraumaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Philippe Meyer, Principal investigator, Assistance Publique - Hôpitaux de ParisFlorian Prevost, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168827
- Sponsor's protocol ID
- APHP190415
- Other IDs
- 2019-A01076-51
- Acronym
- RESPET
- Status last verified
- Sep 2025
- First submitted
- 4 Jun 2019
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional and Social Impact on the Relatives of Hospitalized Children for Severe Trauma of 3 to 6 Months After the Intensive Care Unit Leaving
- ClinicalTrials.gov ID
- NCT04168827
- Acronym / sponsor ID
- RESPET / APHP190415
- Conditions
- Severe Trauma
- Keywords
- Severe trauma, Post-traumatic stress, Anxiety, Depression, Intensive care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 9 Jun 2021 (actual)
- Study completion
- 9 Jun 2021 (actual)
- First posted
- 19 Nov 2019 (actual)
- 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.
This research aims to study the occurrence of post-traumatic stress, anxiety or depression in the parents of a child who has been hospitalized in intensive care unit following a severe trauma.
Detailed description
With nearly 25% of trauma deaths, trauma is one of the leading causes of death in the world for children aged 5 to 14 years. In children under 4, it is responsible for 6% of deaths.
Severe trauma is defined by an Abbreviated Injury Scale > 3 score in at least one anatomical region.
In case of multiple traumas, the Injury Severity Score is used to define severe polytrauma if it is > 15.
Cranial trauma is the most common lesion found in polytraumatized children and is present in 80% of cases.
Serious head trauma is defined as the existence of a cranial trauma in a patient whose Glasgow score is less than or equal to 8.
Severe trauma is a source of high mortality and severe disability in surviving children. Due to the context of sudden onset, a prolonged length of hospitalization in intensive care, as well as the occurrence of often severe sequelae, the severe trauma causes a real upheaval for the child's relatives.
In adults, the occurrence of post-traumatic stress, anxiety and depression is relatively well described in patients and relatives of patients who have been hospitalized in intensive care unit. However, there is currently no pediatric study focusing on this subject, apart from neonatology where the traumatological context remains exceptional.
This research aims to study the occurrence of post-traumatic stress, anxiety or depression in the parents of a child who has been hospitalized in intensive care unit following a severe trauma.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Relatives of severe traumatized child | – | Behavioral: QuestionnaireRelatives of a child who has been hospitalized in intensive care of Necker hospital following a severe trauma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Holder of the parental authority of a patient under 18 who has been hospitalized in the surgical intensive care unit of Necker University Hospital for severe trauma (Abbreviated Injury Scale greater than or equal to 3 in one of the anatomical regions) at the admission in the service and regardless of the ending of hospitalization.
Key inclusion criteria (3 listed)
- Holder of the parental authority of a patient under 18 who has been hospitalized in the surgical intensive care unit of Necker University Hospital for severe trauma (Abbreviated Injury Scale greater than or equal to 3 in one of the anatomical regions) at the admission in the service and regardless of the ending of hospitalization.
- Holder of parental authority over 18 years.
- Holder of parental authority speaking French.
Key exclusion criteria (2 listed)
- Holder of parental authority refusing to participate in the study, after submission of the information document.
- Holder of parental authority unable to answer the questionnaire.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireQuestionnaire completed by the parents of severe traumatized child, between 3 to 6 months after the leaving of the child out of intensive care unit | Behavioural | Relatives of severe traumatized child |
Primary outcome
Depression, post traumatic stress disorder, anxiety
Time frame: 18 months
Composite criterion considered positive if : The subject obtains a score greater than or equal to 13 in the Hospital Anxiety and Depression Scale questionnaire, thus defining a state of anxiety and depression. Hospital Anxiety and Depression Scale score range from 0 to 42 with higher scores indicating worse symptoms. and / or The subject obtains a score greater than or equal to 8 on one of the of the Hospital Anxiety and Depression Scale score. The Hospital Anxiety and Depression Scale score is separated in two section, one for Anxiety and one for depression. Each subscales range from 0 to 21 with higher scores indicating worse symptoms. and / or The subject obtains a score greater than or equal to 30 in the Impact of Event Scale Revised questionnaire defining high risk of presence of a post-traumatic stress disorder. The Impact of Event Scale Revised scores range from 0 to 88, with higher scores indicating worse symptoms.
3 secondary outcomes
Socio-demographic analysis
Time frame: 18 months
Predictive factors for the occurrence of mental disorders
Time frame: 18 months
Feeling of hospitalization
Time frame: 18 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 3 Apr 2026.
- 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.
Philippe Meyer principal investigator
Assistance Publique - Hôpitaux de Paris
Florian Prevost study director
Assistance Publique - Hôpitaux de Paris
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 Severe Trauma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 2 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 3 Apr 2026. 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 France. 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?
Depression, post traumatic stress disorder, anxiety (time frame: 18 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 3 Apr 2026.