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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04475484
Other study ID # PSICOcs_2020
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 10, 2020
Est. completion date December 31, 2020

Study information

Verified date July 2020
Source Hospices Civils de Lyon
Contact Pauline Espi
Phone 4 72 12 95 62
Email pauline.espi@chu-lyon.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The coronavirus outbreak is a stressful event for the whole population. Confinement measures are protective against the risk of dissemination of the virus, but they can also lead to several psychological symptoms. In children, a study in China has reported about 20% of depressive or anxious troubles in school-age children after a 4-week period of confinement.

In France, confinement lasted about 8 weeks. School resumed on May 11th for primary school children and on June 2nd for secondary school children.

In this survey, we aim at exploring the psychological status of these children and the impact on their schooling, for better understanding, support and prevention. Through this online questionnaire, we also aim at giving some psycho-education advices. Finally, we could identify some subgroups of children particularly vulnerable, and organise some specific support for them in coming months.


Recruitment information / eligibility

Status Recruiting
Enrollment 30000
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 18 Years
Eligibility Inclusion Criteria:

- school-age children in the Academy of Lyon

- parental consent

Exclusion Criteria:

-

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Online questionnaire
Parents will receive a link to an online questionnaire through computing services of Lyon's Academy. They have to give their consent to allow their child to participate in the study. Then, children can complete the online questionnaire. The questionnaire starts with few explanations on the context of the study, and ends with psycho-education advices and what to do in the event of psychological distress.

Locations

Country Name City State
France hôpital Femme Mère Enfant Bron

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of children presenting signs of psychological suffering during confinement. We plan to assess the psychological status of children during coronavirus outbreak : negative and positive feeling during confinement, worries and expectations about school resumption.
We also aim at correlating high stress levels with environmental or/and temperamental factors.
We plan to address a first online questionnaire in June 2020 (school resumption after confinement), and a follow-up questionnaire 3 months later, in September 2020.
See also
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