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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05747638
Other study ID # 2022/06DEC/469
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 14, 2023
Est. completion date March 1, 2027

Study information

Verified date December 2023
Source Université Catholique de Louvain
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 315
Est. completion date March 1, 2027
Est. primary completion date June 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Revised Children's Manifest Anxiety Scale (RCMAS)
All participants will be invited to complete a paper questionnaire.

Locations

Country Name City State
Belgium UCLouvain Brussels

Sponsors (1)

Lead Sponsor Collaborator
Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Once
Primary 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. Once
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