- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05747638
Study of Children's Well-being After the COVID-19 Pandemic in Belgian French-speaking Primary Schools (DYNAtracs)
Children's Well-being After the COVID-19 Pandemic in French-speaking Primary Schools of the Federation Wallonia - Brussels in Belgium - (DYNAtracs)
In order to limit the transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), a significant numbers of measures were taken worldwide. It has been shown that the pandemic and its consequences, such as lockdown and isolation, can have a significant long-term impact on the well-being of children.
This study follows the initial DYNAtracs study on SARS-CoV-2 transmission in primary schools. In Belgium, 2488 children and 444 school attenders in 11 primary schools of the Federation Wallonia Brussels are invited. Every participant will be invited to answer a well-being questionnaire. This study aimed to document the children and workers well-being in the primary schools of Belgium after the COVID-19 pandemic. The results of the study should contribute to improved decision making regarding measures for schools and children well-being in the context of current and future pandemics.
The objective of this study is to document the well-being of children and workers after the COVID 19 pandemic in primary schools of the Federation Wallonia-Brussels.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Brussels, Belgium, 1200
- UCLouvain
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Sampling procedure for the initial study Eight schools will be chosen by purposive sampling on three criteria: either high or low size of the school, a school within an area with either a high or a low incidence of SARS-CoV-2 on 06/05/2020, the first wave of COVID-19 in Belgium, and a school with either a high or a low socioeconomic level (Belgian 20-point-scale ISE index superior to thirteen or inferior to seven). As direct partners in the project, the ONE ("Office de la naissance et de l'enfance") and the PSE teams ("Promotion de la Santé à l'Ecole") will give a list of schools corresponding to these three criteria.
In this present study, the investigators will return to the same schools as in the previous DYNAtracs study.
All participants will be invited to complete a paper questionnaire.
Description
Inclusion Criteria:
- All children between the ages of 6 and 12 years and all school attenders from selected primary schools were invited to participate.
Exclusion Criteria:
- Refusal or absence of written informed consent before enrolment
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety symptoms in children
Time Frame: Once
|
Anxiety symptoms measured by the "Revised Children's Manifest Anxiety Scale" after the COVID-19 pandemic.
A total anxiety score can be calculated by counting 28 items.
The minimum score is 0 and the maximum is 28.
The higher the score the greater the susceptibility to anxiety.
|
Once
|
|
Anxiety and depression symptoms in school staff.
Time Frame: Once
|
Anxiety and depression symptoms measured by the "Hospital Anxiety and Depression" Scale in adults after the COVID-19 pandemic.The person is invited to choose between 4 responses for each question and the score varies between 0 to 3. A total anxiety and depression score can be calculated for a total of 21 points each.
The minimum value is 0 and the maximum is 21.
A score under or equal 7 was considered with an absence of anxiety and depression; between 8 to 10 corresponds to an anxious or depressive symptoms; and over 11 indicates a definite state of anxiety or depression.
|
Once
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Annie Robert, Pr, Université Catholique de Louvain
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
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
- 2022/06DEC/469
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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