Cluster-RCT Collective Nasopharyngeal COVID-19 Testing Amongst Pupils

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

Detailed Description
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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.

Official Title
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Peers' and Parent's Presence During Collective Nasopharyngeal COVID-19 Testing Amongst Pupils: A Cluster-Randomized Controlled Trial

Conditions
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Peer Group, Parents

Intervention / Treatment
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* Other: Parent and peer presence


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: undergoing a nasopharyngeal COVID-19 swab test Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 30 Months
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parents present, peers present<br>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. | Other: Parent and peer presence<br>* Does the presence of fellow pupils and parents improves a pupil's resistance to undergo a nasopharyngeaal swab test?<br>|
| Active Comparator: Parent present, peers absent<br>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. | Other: Parent and peer presence<br>* Does the presence of fellow pupils and parents improves a pupil's resistance to undergo a nasopharyngeaal swab test?<br>|
| Active Comparator: Parents absent, peers present<br>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. | Other: Parent and peer presence<br>* Does the presence of fellow pupils and parents improves a pupil's resistance to undergo a nasopharyngeaal swab test?<br>|
| Active Comparator: Parents absent, peers absent<br>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. | Other: Parent and peer presence<br>* Does the presence of fellow pupils and parents improves a pupil's resistance to undergo a nasopharyngeaal swab test?<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| test resistance | resistance for swab testing | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Public Health, Pediatric, Nasopharyngeal, Collective testing