NCT05747638

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
315

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Mar 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Mar 2023Mar 2027

First Submitted

Initial submission to the registry

February 27, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 28, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

March 14, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Expected
Last Updated

December 5, 2023

Status Verified

December 1, 2023

Enrollment Period

3 months

First QC Date

February 27, 2023

Last Update Submit

December 4, 2023

Conditions

Keywords

Primary schools

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Interventions

All participants will be invited to complete a paper questionnaire.

Also known as: Hospital Anxiety and Depression Scale (HAD)

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • All children between the ages of 6 and 12 years and all school attenders from selected primary schools were invited to participate.

You may not qualify if:

  • Refusal or absence of written informed consent before enrolment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLouvain

Brussels, 1200, Belgium

Location

Related Links

MeSH Terms

Interventions

4-amino-4'-hydroxylaminodiphenylsulfone

Study Officials

  • Annie Robert, Pr

    Université Catholique de Louvain

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2023

First Posted

February 28, 2023

Study Start

March 14, 2023

Primary Completion

June 1, 2023

Study Completion (Estimated)

March 1, 2027

Last Updated

December 5, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations