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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04850924
Other study ID # 21-HPNCL-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 18, 2021
Est. completion date February 26, 2021

Study information

Verified date April 2021
Source Fondation Lenval
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Alex storm hits France, especially the French Riviera, from September 30, 2020 to October 3, 2020. A lot of people have been impacted by this event. Among these people, 116 children have been taking care by the medico-psychological emergency unit and have been assessed by child psychiatrists or by psychologists.


Description:

Alex storm hits France from September 30, 2020 to October 3, 2020. On October 2, several valley in the Nice hinterland were devastated by this natural disaster. Nine people died during this storm and hundreds of families were affected (house washed away or uninhabitable). This led to emergency evacuations on October 3 of several families. The inhabitants of some villages have been subjected to prolonged stress (lack of water and electricity, difficulty in supplying food, fear of another storm). These villages were isolated for a period varying from fifteen days to over three months. These people are particularly exposed to psychological consequences. Between October 3 and October 30, the CUMP (medico-psychological emergency unit) was mobilized to provide psychological first aid to these families. Among those seen in emergency 116 children were taken care of. In order to assess the immediate symptoms of the children, the investigators used an assessment sheet specific to the developmental ages of the children. All children seen in an emergency between October 3 and October 30, 2020 were assessed by child psychiatrists or by psychologists trained in emergency and pediatric psychological trauma.


Recruitment information / eligibility

Status Completed
Enrollment 116
Est. completion date February 26, 2021
Est. primary completion date February 26, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria: - children impacted by the Alex storm - children seen in an emergency between October 3 and October 30, 2020 - children were assessed by child psychiatrists or by psychologists trained in emergency and pediatric psychological trauma Exclusion Criteria: - children whose parents refused to the processing of their data

Study Design


Related Conditions & MeSH terms


Intervention

Other:
evaluation psychological trauma
9 classes of symptoms to be evaluated

Locations

Country Name City State
France Hôpitaux Pédiatriques de Nice CHU-Lenval Nice

Sponsors (1)

Lead Sponsor Collaborator
Fondation Lenval

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary measure of risk developing post-traumatic stress disorder A questionnaire assessing symptoms in the acute phase. 9 classes of symptoms to be evaluated..
Anxiety - Sadness / Cries - Mutism / Apartness - Passiveness - Agitation / Panic / Disorganization - Somatization - Developmental regression / Excessive attachment to caregiver - Verbalization of fear - Sleep disorders All symptoms are assessed by scoring presence (1) or absence (0). The total score is calculated out of 9 and refers to the risk of later developing post-traumatic stress disorder (PTSD) (0 = very low risk; 9 = very high risk)
at inclusion
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