Well-beingDYNAtracsNCT05747638
Study of Children's Well-being After the COVID-19 Pandemic in Belgian French-speaking Primary Schools
An observational study of Well-being, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Well-being
- What is being tested?
- Revised Children's Manifest Anxiety Scale (RCMAS)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 315 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Mar 2023to 1 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- All children between the ages of 6 and 12 years and all school attenders from selected primary schools were invited to participate.
Who cannot join
- Refusal or absence of written informed consent before enrolment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Well-being
- Being tested
- Revised Children's Manifest Anxiety Scale (RCMAS)
- Keywords
- Primary schools
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revised Children's Manifest Anxiety Scale (RCMAS)Behavioural
Also called Hospital Anxiety and Depression Scale (HAD)
All participants will be invited to complete a paper questionnaire.
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety symptoms in children
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.
Measured: Once
Anxiety and depression symptoms in school staff.
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.
Measured: Once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start14 Mar 2023
- Primary completion1 Jun 2023
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Well-beingStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annie Robert, Pr, Study director, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747638
- Sponsor's protocol ID
- 2022/06DEC/469
- Acronym
- DYNAtracs
- Status last verified
- Dec 2023
- First submitted
- 27 Feb 2023
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children's Well-being After the COVID-19 Pandemic in French-speaking Primary Schools of the Federation Wallonia - Brussels in Belgium - (DYNAtracs)
- ClinicalTrials.gov ID
- NCT05747638
- Acronym / sponsor ID
- DYNAtracs / 2022/06DEC/469
- Conditions
- Well-being
- Keywords
- Primary schools
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 28 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All children between the ages of 6 and 12 years and all school attenders from selected primary schools were invited to participate.
Key exclusion criteria (1 listed)
- Refusal or absence of written informed consent before enrolment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Revised Children's Manifest Anxiety Scale (RCMAS)Also: Hospital Anxiety and Depression Scale (HAD)All participants will be invited to complete a paper questionnaire. | Behavioural | – |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annie Robert, Pr study director
Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Well-being, run by Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety symptoms in children (time frame: Once). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.