Online Survey on Psychological Impact of COVID-19 Epidemic on School-age Children (PSICOcs)

July 16, 2020 updated by: Hospices Civils de Lyon

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

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

School-age children from primary school to high school (about age 6 to 18) in the Academy of Lyon

Description

Inclusion Criteria:

  • school-age children in the Academy of Lyon
  • parental consent

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.

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

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2020

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

July 6, 2020

First Submitted That Met QC Criteria

July 16, 2020

First Posted (Actual)

July 17, 2020

Study Record Updates

Last Update Posted (Actual)

July 17, 2020

Last Update Submitted That Met QC Criteria

July 16, 2020

Last Verified

July 1, 2020

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

No

Studies a U.S. FDA-regulated device product

No

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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