Children's Well-being After the COVID-19 Pandemic in French-speaking Primary Schools of the Federation Wallonia - Brussels in Belgium - (DYNAtracs)
Conditions: Well-being
Sponsor: Université Catholique de Louvain

 
 
 
 
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Children’s well-being in primary schools after the COVID-19 pandemic Study Protocol Version 
2.0 – 09-01-2023 
 
 
 
 
 
 
 
 
 
 
 
Children’s well-being after the COVID-19 pandemic in French-speaking 
primary schools of the Federation Wallonia-Brussels in Belgium 
 
Protocol version 2.0, January 9th, 2023 
NCT05747638 
 
 
 
 

 
 
 
 
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Children’s well-being in primary schools after the COVID-19 pandemic Study Protocol Version 
2.0 – 09-01-2023 
 
Sponsor  
UCLouvain 
 
Sponsor’s representative 
Pr. Annie Robert. Institut de Recherche Expérimentale et Clinique, Responsable du pôle de 
recherche Epidémiologie et biostatistique (EPID) – UCLouvain  
 
Principal Investigator 
Pr Dimitri Van der Linden. Institut de Recherche Expérimentale et Clinique, PEDI – UCLouvain, 
Pediatric Task Force spokesperson. 
 
Subinvestigators 
Dr. Julie Frère. Pédiatre-infectiologue au CHU Liège, Pediatric Task force member. 
Dr. Olga Chatzis. Pédiatre-infectiologue aux Cliniques universitaires Saint-Luc, Institut de 
Recherche Expérimentale et Clinique, PEDI, UCLouvain, Pediatric Task force member. 
Dr Florence Renard. Médecin scolaire et de santé publique, Conseillère Médicale Promotion 
de la Santé à l'école (PSE). 
Dr Mathilde de Keukeleire. Chercheur qualifié, Institut de Recherche Expérimentale et 
Clinique, EPID-UCLouvain. 
Mme Kelly Cremer. Infirmière, Master en santé publique, Doctorante en EPID (supervision 
Pr. Annie Robert) 
 
 
 

 
 
 
 
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Children’s well-being in primary schools after the COVID-19 pandemic Study Protocol Version 
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1. Background and rational  
We have conducted a study named DYNAmic TRAnsmission of Coronavirus in Schools 
(DYNAtracs) from January 14 to May 18, 2021, in 11 primary schools in the Federation 
Wallonia – Brussels. 11 primary schools were selected according to 3 extreme criteria : a low 
or a high SARS-CoV-2 local incidence level (incidence < or ≥5.0/1000 persons during the 1st 
wave in May 2020), a small or a large school (< or ≥230 children), and a low or a high 
socioeconomic status (SES) (SES ≤7 or ≥13). 
We enrolled 932 children (932/2488=38%) and 242 staff (242/444=55%). In each school, we 
went 6 times. At the inclusion, every participant was tested by a serological test. Each 
participant was asked to perform a salivary PCR test and to complete a questionnaire at each 
visit. 
21% of children and 25% staff had a positive (IgG+) serological test.(1) PCR results have shown 
a low positive rate among participants : 3% in children and 2% in staff.(2) 
The well-being data collected during the COVID-19 is still under analysis. 
 
1.1 References and previously obtained results or data related to the study and used as a basis 
for the study 
- 
Frère, J.; Chatzis, O.; Cremer, K.; Merckx, J.; De Keukeleire, M.; Renard, F.; Ribesse, N.; 
Minner, F.; Ruelle, J.; Kabamba, B.; Rodriguez-Villalobos, H.; Bearzatto, B.; Delforge, M.-
L.; Henin, C.; Bureau, F.; Gillet, L.; Robert, A.; Van der Linden, D. SARS-CoV-2 Transmission 
in Belgian French-Speaking Primary Schools: An Epidemiological Pilot Study. Viruses 2022, 
14, 2199. https://doi.org/10.3390/v14102199 SARS-CoV-2 transmission in Belgian 
primary schools of the Federation Wallonie - Bruxelles. An epidemiological pilot study (2); 
 
- 
Kelly Cremer, Julie Frère, Olga Chatzis et al. SARS-CoV-2 antibody seroprevalence in 
children and workers from Belgian French-speaking primary schools, 13 July 2022, 
PREPRINT (Version 1) available at Research Square [https://doi.org/10.21203/rs.3.rs-
1781857/v1](1) 
 
- 
Study protocol DYNAtracs « SARS-CoV-2 Transmission in Belgian Primary Schools of the 
Federation Wallonia - Brussels: An Epidemiological Pilot Study (DYNAtracs) » published 
on September 16th, 2021 (identification number NCT05046470); 
 
- 
Study protocol DYNAtracs « Study of COVID-19 transmission in Belgian French-speaking 
primary schools of the Federation Wallonia – Brussels in Belgium» published on April 20th, 
2022 (identification number ISRCTN16837012). 
 

 
 
 
 
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Children’s well-being in primary schools after the COVID-19 pandemic Study Protocol Version 
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2. Objectives and outcomes 
The general objective of our initial study was to describe the transmission dynamics of SARS-
CoV-2 in primary schools in Federation Wallonia-Brussels. 
The general objective of this present study is to document children and staff well-being after 
the COVID-19 pandemic in primary schools in Federation Wallonia-Brussels.  
The aim of this study is to propose concrete public health actions to help manage and develop 
tools to limit longer-term damage of the COVID-19 pandemic. 
 
3. Methodology 
3.1 Study design 
We will conduct a cross-sectional observational study.  
 
3.2 Study period 
This study will be conducted in February 2023. Participants will be involved for no more than 
one day. 
 
3.3 Study population 
All children attending the 11 primary schools in Federation Wallonia-Brussels selected in the 
initial study in 2021.  
 
All adults working in the 11 primary schools in Federation Wallonia-Brussels selected in the 
initial study in 2021. 
 
3.4 Inclusion criteria 
All children registered and attended the selected primary schools of the Federation Wallonia-
Brussels and all adults working in the same selected schools  
Participants were enrolled into the study if the consent was signed by both parents and the 
child or by the staff. 
 
3.5 Exclusion criteria 
Refusal or absence to provide written informed consent before enrolment. 
 

 
 
 
 
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Children’s well-being in primary schools after the COVID-19 pandemic Study Protocol Version 
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3.6 Expected number 
There will be approximately 2488 children in 125 classes and 444 workers in the 11 schools of 
the Federation Wallonia-Brussels. 
 
3.7 Stop or continuation rules 
This is a cross-sectional observational study, there are no drop-out criteria or stopping rules.  
 
3.8 Research question and variables definition  
Has the COVID-19 pandemic impacted children’s well-being in primary schools of the 
Federation Wallonia-Brussels, according to the perception of well-being or anxiety of the 
children and staff who supervise them? 
 
Well-being :  
According to the who definition: “Health is a state of complete physical, mental and social 
well-being and not merely the absence of disease or infirmity.”(3) 
Mental health is : “a state of mental well-being that enables people to cope with the stresses 
of life, realize their abilities, learn well and work well, and contribute to their community.”(3) 
Well-being is defined as a : “pleasant state resulting from the satisfaction of the body’s needs 
and the calm of the mind.”(4)  
 
Well-being in this study will be evaluated by « The Revised Children’s Manifest Anxiety Scale » 
(RCMAS)(5,6) and « Hospital Anxiety and Depression Scale » (HAD).(7,8) 
 
COVID-19 : Disease caused by the SARS-CoV-2 virus. 
 
SARS-CoV-2 : Severe Acute Respiratory Syndrome Coronavirus 2. 
 
Children in primary schools : Children from the 1st to 6th primary. 
 
Staff: Adults working in schools. 
 

 
 
 
 
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Anxiety : “Painful concern, nervous tension, caused by uncertainty, expectation, anguish.”(9) 
 
4. Conduct of the study 
We have developed questionnaires and informed consent. We will hire students and train 
them on the questionnaires. We will contact schools that we initially went in the previous 
DYNAtracs study. We will provide the protocol and informed consent before the beginning of 
the study. 
Within the 11 schools, there are approximatively 2488 children and 444 school attenders. 
Then, we will go to each school one day for data collection. The questionnaires will be given 
to each participant who has returned a signed consent form. Each participant will be invited 
to answer the questionnaire anonymously and data will be collected in panel form. 
Each child in grade 3 and 6 (n=830) will be invited to draw 3 pictures expressing their feelings 
about the COVID-19 pandemic. In order to achieve this task, 2 persons will supervise each 
child. 
 
5. Statistical analyses plan 
The proportions will be analyzed by chi-square tests. 
The associations of these proportions with the characteristics of the child or adult will be 
analyzed by logistic regression. 
 
6. Subject confidentiality 
The child’s or staff identity and participation to this study will remain strictly confidential. 
He/she will not be identified by name or in any other recognizable way in any of the records, 
results or publications related to the study. The protection of personal data is ensured by the 
Belgian law of July 30th, 2018 on the protection of individuals with regard to the treatment of 
personal data. Data will be processed in accordance with the General Data Protection 
Regulation (GDPR of May 25th, 2018) and the Belgian law of August 22nd, 2002 on the rights 
participants in a health study. UCLouvain will be responsible for the processing of this data. 
Participation in the study means that the nurse investigator collects data and that the study 
sponsor uses them for research purposes and for scientific and public health publications for 

 
 
 
 
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the community. The nurse investigator has a duty of confidentiality regarding the data 
collected. This means that not only will she never disclose the name of the child or staff 
member in any publication or conference, but she will also code (that the identity of the child 
or staff member will be replace by a 12-digit study identification code) the data before passing 
it on to the manager of the collected database (Pr. Annie Robert). The personal data 
transmitted will not contained any association of elements that would allow to identify the 
child or the staff member. For the research data manager appointed by the sponsor (Pr. Annie 
Robert), the data submitted will not allow to identify the child or the staff member. The 
sponsor is responsible for the collection, processing, and protection of the data collected by 
all investigators involved in the research in accordance with requirements of the Belgian 
privacy law. The sponsor undertakes to use data collected only for the purpose of the study in 
which the child or staff member is participating. Any use of the child’s or staff member’s data 
outside the context described in this document could only be conducted after approval by the 
Ethics committee. 
 
 
7. Ethics committee 
The study is subject to the approval of the “Comité d’Ethique Hospitalo-Facultaire Saint- Luc 
– UCLouvain”.  
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
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Children’s well-being in primary schools after the COVID-19 pandemic Study Protocol Version 
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8. References  
1. Cremer K, Frère J, Chatzis O, De Mendonca R, Minner F, Kabamba B, et al. SARS-CoV-
2 antibody seroprevalence in children and workers from Belgian French-speaking primary 
schools [Internet]. In Review; 2022 Jul [cited 2022 Nov 8]. Available from: 
https://www.researchsquare.com/article/rs-1781857/v1 
2. Frère J, Chatzis O, Cremer K, Merckx J, De Keukeleire M, Renard F, et al. SARS-CoV-2 
Transmission in Belgian French-Speaking Primary Schools: An Epidemiological Pilot 
Study. Viruses. 2022 Oct 6;14(10):2199.  
3. Mental health: strengthening our response [Internet]. World Health Organization. [cited 
2022 Nov 11]. Available from: https://www.who.int/news-room/fact-sheets/detail/mental-
health-strengthening-our-response 
4. Bien-être [Internet]. Larousse. [cited 2022 Oct 22]. Available from: 
https://www.larousse.fr/dictionnaires/francais/bien-%C3%AAtre/9159 
5. Reynolds CR. Factor Structure and Construct Validty of the Revised. :10.  
6. Bouvard M. Échelles et questionnaires d’évaluation chez l’enfant et l’adolescent. Elsevier 
Masson. Vol. 1. 2008. 192 p.  
7. Zigmond AS, Snaith RP. Échelle HAD : Hospital Anxiety and Depression scale. 
1983;67:361–70.  
8. Guelfi JD. L’évaluation clinique standardisée en psychiatrie. Editions Médicales Pierre 
Fabre. Vol. 2. 1997. 376 p.  
9. Anxiété [Internet]. Larousse. [cited 2022 Oct 22]. Available from: 
https://www.larousse.fr/dictionnaires/francais/anxi%C3%A9t%C3%A9/4369 
10. Sciensano. Fact Sheet Covid-19 disease (SARS-CoV-2 virus). [Internet]. Sciensano; 2020 
Sep [cited 2020 Oct 25]. Available from: https://covid-
19.sciensano.be/sites/default/files/Covid19/COVID-19_fact_sheet_ENG.pdf 
 
 

 
 
 
 
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9. Annexes  
A) Children’s well-being questionnaire 
B) Children’s drawings questionnaire 
C) Staff questionnaire 
D) Informed consent form for children 
E) Informed consent form for parents 
F) Informed consent form for staff