- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04475484
Online Survey on Psychological Impact of COVID-19 Epidemic on School-age Children (PSICOcs)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Pauline Espi
- Phone Number: +33 4 72 12 95 62
- Email: pauline.espi@chu-lyon.fr
Study Contact Backup
- Name: Pierre Pierre Fourneret
- Phone Number: +33 4 72 12 95 62
- Email: pierre.fourneret@chu-lyon.fr
Study Locations
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-
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Bron, France, 69500
- Recruiting
- Hopital Femme Mere Enfant
-
Contact:
- Pauline Espi
- Phone Number: +33 4 72 12 95 62
- Email: pauline.espi@chu-lyon.fr
-
Contact:
- Pierre Fourneret
- Phone Number: +33 4 72 12 95 62
- Email: pierre.fourneret@chu-lyon.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- school-age children in the Academy of Lyon
- parental consent
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
School-age children
School-age children from primary school to high school (about age 6 to 18) in the Academy of Lyon
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of children presenting signs of psychological suffering during confinement.
Time Frame: 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.
|
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.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PSICOcs_2020
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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