NCT04850924

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 20, 2021

Completed
Last Updated

April 20, 2021

Status Verified

April 1, 2021

Enrollment Period

1 month

First QC Date

April 12, 2021

Last Update Submit

April 19, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

children impact by the Alex storm

Other: evaluation psychological trauma

Interventions

9 classes of symptoms to be evaluated

children impact by the Alex storm

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children aged between 0 to 18 years. Impacted by the Alex Storm and evacuated to Nice airport

You may qualify if:

  • 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

You may not qualify if:

  • children whose parents refused to the processing of their data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpitaux Pédiatriques de Nice CHU-Lenval

Nice, France

Location

Related Publications (1)

  • Richez A, Gindt M, Battista M, Nachon O, Menard ML, Askenazy F, Fernandez A, Thummler S. Storm Alex: acute stress responses in the pediatric population. Eur J Psychotraumatol. 2022 May 11;13(1):2067297. doi: 10.1080/20008198.2022.2067297. eCollection 2022.

MeSH Terms

Conditions

Psychological Trauma

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2021

First Posted

April 20, 2021

Study Start

January 18, 2021

Primary Completion

February 26, 2021

Study Completion

February 26, 2021

Last Updated

April 20, 2021

Record last verified: 2021-04

Locations