Emotional and Social Impact on the Relatives of Hospitalized Children for Severe Trauma

NCT04168827 | Completed

• 2 other identifiers: APHP1904152019-A01076-51
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Severe Trauma

Keywords

Severe trauma; Post-traumatic stress; Anxiety; Depression; Intensive care

Outcome Measures

Primary Outcomes (1)

• 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.

  18 months

Secondary Outcomes (3)

• Socio-demographic analysis

  18 months

• Predictive factors for the occurrence of mental disorders

  18 months

• Feeling of hospitalization

  18 months

Study Arms (1)

Relatives of severe traumatized child

Relatives of a child who has been hospitalized in intensive care of Necker hospital following a severe trauma

Behavioral: Questionnaire

Interventions

Questionnaire BEHAVIORAL

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

Relatives of severe traumatized child

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

MeSH Terms

Conditions

Wounds and Injuries; Anxiety Disorders; Depression

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Philippe Meyer

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Florian Prevost

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: November 19, 2019
• Study Start: December 9, 2019
• Primary Completion: June 9, 2021
• Study Completion: June 9, 2021
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)