Cluster-RCT Collective Nasopharyngeal COVID-19 Testing Amongst Pupils

NCT ID: NCT04993547

Last Updated: 2021-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 952 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-31
• Study Completion Date: 2021-06-10

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.

Conditions

Peer Group; Parents

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Parent and peer presence

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Parent and peer presence

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Parent and peer presence

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Parent and peer presence

Intervention Type: OTHER

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

Interventions

Parent and peer presence

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• undergoing a nasopharyngeal COVID-19 swab test

Exclusion Criteria

-

• Minimum Eligible Age: 30 Months
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Simon Malfait

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

Ghent University Hospital

Ghent, , Belgium

Countries

Belgium

Other Identifiers

BUN6702021000301

Identifier Type: OTHER

Identifier Source: secondary_id

BAD/DV/2021/BC-09709

Identifier Type: -

Identifier Source: org_study_id