Peer GroupNCT04993547
Cluster-RCT Collective Nasopharyngeal COVID-19 Testing Amongst Pupils
A study testing Parent and peer presence in people with Peer Group and Parents, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Does the presence of fellow pupils and parents improves a pupil's resistance to undergo a nasopharyngeaal swab test? Read more about this study
- Who is it for?
- Ages 30 months to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Peer Group, Parents
- What is being tested?
- Parent and peer presence
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 952 participants
- Where
- 1 siteBelgium
- Study dates
- 31 Mar 2021to 10 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 months to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- undergoing a nasopharyngeal COVID-19 swab test
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
Read the 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
- Being tested
- Parent and peer presence
- Keywords
- Public Health, Pediatric, Nasopharyngeal, Collective testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent and peer presenceOther
Does the presence of fellow pupils and parents improves a pupil's resistance to undergo a nasopharyngeaal swab test?
| Study group | Role | What they receive |
|---|---|---|
| Parents present, peers present | Experimental | 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. Receives: Other: Parent and peer presence |
| Parent present, peers absent | Active comparator | 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. Receives: Other: Parent and peer presence |
| Parents absent, peers present | Active comparator | 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. Receives: Other: Parent and peer presence |
| Parents absent, peers absent | Active comparator | 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. Receives: Other: Parent and peer presence |
What is being measured
The primary outcome is the main question the study is designed to answer.
test resistance
resistance for swab testing
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start31 Mar 2021
- Primary completion9 Jun 2021
- Study completion10 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peer GroupStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 952 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Malfait, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04993547
- Sponsor's protocol ID
- BAD/DV/2021/BC-09709
- Other IDs
- BUN6702021000301
- Status last verified
- Mar 2021
- First submitted
- 4 Aug 2021
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peers' and Parent's Presence During Collective Nasopharyngeal COVID-19 Testing Amongst Pupils: A Cluster-Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04993547
- Acronym / sponsor ID
- BAD/DV/2021/BC-09709
- Conditions
- Peer Group, Parents
- Keywords
- Public Health, Pediatric, Nasopharyngeal, Collective testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 952 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 9 Jun 2021 (actual)
- Study completion
- 10 Jun 2021 (actual)
- First posted
- 6 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Parents present, peers present | Experimental | Other: Parent and peer presenceThe 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. |
| Parent present, peers absent | Active comparator | Other: Parent and peer presenceThe 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 absent, peers present | Active comparator | Other: Parent and peer presenceParents 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 | Active comparator | Other: Parent and peer presenceParents 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. |
Who may qualify
- Ages
- 30 months to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- undergoing a nasopharyngeal COVID-19 swab test
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parent and peer presenceDoes the presence of fellow pupils and parents improves a pupil's resistance to undergo a nasopharyngeaal swab test? | Other | Parent present, peers absent, Parents absent, peers absent, Parents absent, peers present, Parents present, peers present |
Primary outcome
test resistance
Time frame: 1 day
resistance for swab testing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Peer Group
Enrolling by invitation
PATH to Reducing Burnout Among Peers Who Deliver Overdose Prevention Services (R33 Phase Clinical Trial)
Burnout, Secondary Trauma
Not yet recruitingObservational study
Phase 1: Thrive Together
Attention-Deficit/Hyperactivity Disorder (ADHD)
Recruiting
Developing a Recovery-Oriented Suicide Prevention Program for Young People at Clinical High Risk for Psychosis
Clinical High Risk for Psychosis (CHR), Suicidal Ideation
Active, not recruiting
Feasibility and Acceptability of Peer Intervention for Improving Mental Health Among People Accessing Hormone Care
Hormone Care, Mild Depression
Recruiting
PeerScreen Trial - Reducing Screen Media Use in Peer-groups of Young People
Mental Health, Social Interaction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Malfait principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent and peer presence in people with Peer Group and Parents, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
test resistance (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2021.