Cluster-RCT Collective Nasopharyngeal COVID-19 Testing Amongst Pupils

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

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

Study Overview

• Status: Completed
• Conditions: Parents; Peer Group
• Intervention / Treatment: Other: Parent and peer presence

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 Type: Interventional
• Enrollment (Actual): 952
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Ghent University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• undergoing a nasopharyngeal COVID-19 swab test

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Parents present, peers present; 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; Does the presence of fellow pupils and parents improves a pupil's resistance to undergo a nasopharyngeaal swab test?
Active Comparator: Parent present, peers absent; 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; Does the presence of fellow pupils and parents improves a pupil's resistance to undergo a nasopharyngeaal swab test?
Active Comparator: Parents absent, peers present; 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; Does the presence of fellow pupils and parents improves a pupil's resistance to undergo a nasopharyngeaal swab test?
Active Comparator: Parents absent, peers absent; 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; Does the presence of fellow pupils and parents improves a pupil's resistance to undergo a nasopharyngeaal swab test?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Investigators: Principal Investigator: Simon Malfait, University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2021
• Primary Completion (Actual): June 9, 2021
• Study Completion (Actual): June 10, 2021

Study Registration Dates

• First Submitted: August 4, 2021
• First Submitted That Met QC Criteria: August 5, 2021
• First Posted (Actual): August 6, 2021

Study Record Updates

• Last Update Posted (Actual): August 6, 2021
• Last Update Submitted That Met QC Criteria: August 5, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Pediatric; Public Health; Nasopharyngeal; Collective testing
• Other Study ID Numbers: BAD/DV/2021/BC-09709; BUN6702021000301 (Other Identifier: Ghent University Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No