- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04850924
Emergency Psychological Intervention With Children: Alex Storm (ALEX)
Alex Storm: Acute Stress Manifestations' Description in French Pediatric Population
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Nice, France
- Hôpitaux Pédiatriques de Nice CHU-Lenval
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
children impact by the Alex storm
|
9 classes of symptoms to be evaluated
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
measure of risk developing post-traumatic stress disorder
Time Frame: at inclusion
|
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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-HPNCL-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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