Cluster-RCT Collective Nasopharyngeal COVID-19 Testing Amongst Pupils

Not Applicable

Completed

• Conditions: Peer Group; Parents
• Interventions: Other: Parent and peer presence

• Registration Number: NCT04993547
• Lead Sponsor: University Hospital, Ghent

Brief Summary

Does the presence of fellow pupils and parents improves a pupil's resistance to undergo a nasopharyngeaal swab test?

Detailed Description

In order to control the outbreak of cluster infections on school during the COVID-19 pandemic, regular rounds of collective nasopharyngeal swab testing were organized. However, it is unclear under which circumstances nasopharyngeal swab testing is better accepted by young children. Due to the closing of schools, and the different logistic situations in schools, a natural pragmatic RCT formed. In some cases, children could observe their peers before having their own test, while for others the view was blocked. Also, sometimes parents would be present during a test procedure when the school was closed, while they were not present when the school was open. To date, it is unclear whether these two variable elements influence a child's resistance to be tested. Therefore a cluster-randomized controlled trial with testing site as the unit of randomisation will be set-up. Four conditions will be tested. On the individual level, the resistance of their peers before their own testing will be taken into account. The aim of the study is to compare whether (1) the visibility of nasopharyngeal swab testing on their peers and (2) the presence of their parents impacts a child's resistance towards the test. Additionally, the impact of whether or not their peers resisted the test impact predicts the likelihood of their own resisting behaviour.

Study Timeline

• Status Verified: 2021-03
• Study Start: 2021-03-31
• Primary Completion: 2021-06-09
• Study Completion: 2021-06-10
• Study First Submitted: 2021-08-04
• Study First Submitted QC: 2021-08-05
• Last Update Submitted: 2021-08-05
• Study First Posted: 2021-08-06
• Last Update Posted: 2021-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 952

Inclusion Criteria

• undergoing a nasopharyngeal COVID-19 swab test

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parent present, peers absent	Parent and peer presence	The children are also accompanied by their parents, but a covered COVID-19 swab test waiting line is set-up whereby the children are unable to observe their peers being tested.
Parents present, peers present	Parent and peer presence	The children are accompanied by their parents during the COVID-19 testing, and a visible covid-19 swab test waiting line is set-up enabling the children to observe their peers being tested.
Parents absent, peers present	Parent and peer presence	Parents are absent during the COVID-19 testing, and a visible COVID-19 swab test waiting line is set-up enabling the children to observe their peers being tested.
Parents absent, peers absent	Parent and peer presence	Parents are absent, and a covered COVID-19 swab test waiting line is set-up whereby the children are not able to observe their peers being tested.

Primary Outcome Measures

Name	Time	Method
test resistance	1 day	resistance for swab testing

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Ghent, Belgium