Covid19NCT04531254
Back to School COVID-19 Simulation Study
A study testing Wearing a face mask at all times in people with Covid19 and Schools, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
This will be a prospective study simulating return to school for two full days prior to the start of the school year in September. Volunteer students and teachers from six grade ranges will be recruited to participate in the study. Read more about this study
- Who is it for?
- Ages 4 to 18 yearsHealthy volunteers can take part
- What is being tested?
- Wearing a face mask at all times
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteCanada
- Study dates
- 10 Aug 2020to 31 Aug 2020
- 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 4 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- To be included in the study, students must have attended a structure learning environment during 2019-2020 school year and provide informed consent (student in Grade 7 or older) or parental consent (SK - Grade 6) and assent (if appropriate). To be included in the study, teachers must be certified teachers and provide informed consent to participate.
Who cannot join
- require additional resources or support beyond what can be provided by the single class teacher
- have been exposed to an individual that has tested positive for COVID-19 in the 14 days prior to the simulation
- test positive for COVID-19 in the 14 days prior to the simulation
- have signs or symptoms of COVID-19, as identified on the screening form (See Screening Form) before the simulations
- travel outside Canada in the last 14 days
- known hypersensitivity or allergy to the biological indicator (Fluorescein dye/GloGerm)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Understanding the Impact of Public Health Measures Planned for School Reopening During COVID-19 Using Simulation Exercises
This will be a prospective study simulating return to school for two full days prior to the start of the school year in September. Volunteer students and teachers from six grade ranges will be recruited to participate in the study. In each grade range, there will be two classes that will participate, one that will be assigned to wear face masks/coverings at all times (experimental group/class) and the other that will not wear face masks/coverings at all times (control group/class). Students will be randomized to either the masking at all times (experimental across all grades) or no masking (control across JK-Grade 4) / masking only when physical distance can be maintained (control across Grade 5-Grade 12) class in their appropriate grade. Personal behaviours and person-to-person interactions will be recorded using video cameras. In addition, a safe biological indicator will be applied to the hands to simulate potential asymptomatic infection in a subset of students. Other students will have sanitizer applied so that students are blinded to who has the indicator. Cameras will be used to document how the indicator moves throughout the classroom.
Read the detailed description
Grade ranges will include 1) Senior Kindergarten (children who have just completed JK or SK in the 2019-2020 year), 2) Grades 1-2, 3) Grades 3-4, 4) Grades 5-6, 5) Grades 7-8 and 6) high school. A total of 14 teachers and up to 240 students will be recruited. Final class sizes will be in accordance with Ministry of Education and public health guidelines.
- Being tested
- Wearing a face mask at all times
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearing a face mask at all timesBehavioural
Children in this group will be asked to wear a face mask in the classroom and common areas during the simulation
| Study group | Role | What they receive |
|---|---|---|
| Masking at all times | Experimental | Children in this group will be asked to wear a face mask/covering in the classroom and common areas during the simulation Receives: Behavioral: Wearing a face mask at all times |
| No mask/masking when physical distancing is not maintained | No intervention | Children in this group will not be asked to wear a mask (JK-Grade 4) or only asked to wear a mask when physical distancing in the classroom cannot be maintained (Grade 5-Grade 12) during the simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of hand-to-face contacts per participant per hour
The number of touches to the face made per hour in the simulated school environment
Measured: Day 2
Secondary outcomes (15)
Total number of hand-to-mucus membrane contacts per participant per hour
The number of touches to the eyes, nose, mouth made per hour in the simulated school environment
Measured: Day 2
Total number of hand-to-non-mucus membrane contacts per participant per hour
The number of touches to the skin (not eyes, nose, mouth) made per hour in the simulated school environment
Measured: Day 2
Total number of instances where participants are within 1 and 2 meters of each other
The number of instances where 1 and 2 meter distance between participants is breached in the classroom
Measured: Day 2
Total number of glo germ transfers to another person
The number of children within a classroom with Glo Germ on the hands/face
Measured: Day 2
Total number of glo germ transfers to teacher
The presence of Glo Germ on the hands/face of teacher within the same classroom
Measured: Day 2
Total number of glo germ transfers to a surface
The number of surfaces in the classroom with Glo Germ
Measured: Day 2
Total number of instances of hand holding per participant per hour
The count of hand holding instances with another person per hour in the simulated school environment
Measured: Day 2
Total number of touches to another person per participant per hour
The count of touches to another person per hour in the simulated school environment
Measured: Day 2
Total number of hand hygiene actions per participant per hour
The count of hand hygiene actions (i.e., hand washing, hand sanitizer) per participant per hour
Measured: Day 2
Total number of mask removals per participant per hour
The number of times a participant in a masking group removes their mask per hour in the simulated school environment
Measured: Day 2
Teacher concerns measured using study-specific post-simulation questionnaire
A study specific questionnaire that examines teacher anxiety and mental health
Measured: Day 2
Teacher concerns measured using semi-structured group interviews
A study specific semi-structured interview examining the factors throughout the day (hand hygiene, mask use, physical distancing) that impacted the teaching experience
Measured: Day 2
Student concerns measured using study-specific post-simulation questionnaire
A study specific questionnaire that examines student anxiety and mental health
Measured: Day 2
Student concerns measured using semi-structured group interviews
A study specific semi-structured interview examining the factors throughout the day (hand hygiene, mask use, physical distancing) that impacted the learning experience
Measured: Day 2
Identify activity types that influence touching behaviour
The count of each type of activity participants are engaged in while touching others or surfaces in the simulated school environment
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start10 Aug 2020
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Science, The Hospital for Sick Children
- Investigators
- Michelle Science, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04531254
- Sponsor's protocol ID
- 1000071861
- Status last verified
- Nov 2022
- First submitted
- 24 Aug 2020
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Science M, Caldeira-Kulbakas M, Parekh RS, Maguire BR, Carroll S, Anthony SJ, Bitnun A, Bourns LE, Campbell DM, Cohen E, Dodds A, Dubey V, Friedman JN, Greenwood JL, Hopkins JP, Imgrund R, Korczak DJ, Looi T, Louca E, Mertz D, Nashid J, Panzera G, Schneiderman JE, Schwartz KL, Streitenberger L, Vuppal S, Walsh CM, Juni P, Matava CT; Back-to-School COVID-19 School Study Group. Effect of Wearing a Face Mask on Hand-to-Face Contact by Children in a Simulated School Environment: The Back-to-School COVID-19 Simulation Randomized Clinical Trial. JAMA Pediatr. 2022 Dec 1;176(12):1169-1175. doi: 10.1001/jamapediatrics.2022.3833.
PubMed 36279142
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Impact of Public Health Measures Planned for School Reopening During COVID-19 Using Simulation Exercises
- ClinicalTrials.gov ID
- NCT04531254
- Acronym / sponsor ID
- 1000071861
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 28 Aug 2020 (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.
This will be a prospective study simulating return to school for two full days prior to the start of the school year in September. Volunteer students and teachers from six grade ranges will be recruited to participate in the study. In each grade range, there will be two classes that will participate, one that will be assigned to wear face masks/coverings at all times (experimental group/class) and the other that will not wear face masks/coverings at all times (control group/class). Students will be randomized to either the masking at all times (experimental across all grades) or no masking (control across JK-Grade 4) / masking only when physical distance can be maintained (control across Grade 5-Grade 12) class in their appropriate grade. Personal behaviours and person-to-person interactions will be recorded using video cameras. In addition, a safe biological indicator will be applied to the hands to simulate potential asymptomatic infection in a subset of students. Other students will have sanitizer applied so that students are blinded to who has the indicator. Cameras will be used to document how the indicator moves throughout the classroom.
Detailed description
Grade ranges will include 1) Senior Kindergarten (children who have just completed JK or SK in the 2019-2020 year), 2) Grades 1-2, 3) Grades 3-4, 4) Grades 5-6, 5) Grades 7-8 and 6) high school. A total of 14 teachers and up to 240 students will be recruited. Final class sizes will be in accordance with Ministry of Education and public health guidelines.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Masking at all times | Experimental | Behavioral: Wearing a face mask at all timesChildren in this group will be asked to wear a face mask/covering in the classroom and common areas during the simulation |
| No mask/masking when physical distancing is not maintained | No intervention | –Children in this group will not be asked to wear a mask (JK-Grade 4) or only asked to wear a mask when physical distancing in the classroom cannot be maintained (Grade 5-Grade 12) during the simulation |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- To be included in the study, students must have attended a structure learning environment during 2019-2020 school year and provide informed consent (student in Grade 7 or older) or parental consent (SK - Grade 6) and assent (if appropriate). To be included in the study, teachers must be certified teachers and provide informed consent to participate.
Key exclusion criteria (6 listed)
- require additional resources or support beyond what can be provided by the single class teacher
- have been exposed to an individual that has tested positive for COVID-19 in the 14 days prior to the simulation
- test positive for COVID-19 in the 14 days prior to the simulation
- have signs or symptoms of COVID-19, as identified on the screening form (See Screening Form) before the simulations
- travel outside Canada in the last 14 days
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 |
|---|---|---|
| Wearing a face mask at all timesChildren in this group will be asked to wear a face mask in the classroom and common areas during the simulation | Behavioural | Masking at all times |
Primary outcome
Total number of hand-to-face contacts per participant per hour
Time frame: Day 2
The number of touches to the face made per hour in the simulated school environment
15 secondary outcomes
Total number of hand-to-mucus membrane contacts per participant per hour
Time frame: Day 2
Total number of hand-to-non-mucus membrane contacts per participant per hour
Time frame: Day 2
Total number of instances where participants are within 1 and 2 meters of each other
Time frame: Day 2
Total number of glo germ transfers to another person
Time frame: Day 2
Total number of glo germ transfers to teacher
Time frame: Day 2
Total number of glo germ transfers to a surface
Time frame: Day 2
Total number of instances of hand holding per participant per hour
Time frame: Day 2
Total number of touches to another person per participant per hour
Time frame: Day 2
Total number of hand hygiene actions per participant per hour
Time frame: Day 2
Total number of mask removals per participant per hour
Time frame: Day 2
Teacher concerns measured using study-specific post-simulation questionnaire
Time frame: Day 2
Teacher concerns measured using semi-structured group interviews
Time frame: Day 2
Student concerns measured using study-specific post-simulation questionnaire
Time frame: Day 2
Student concerns measured using semi-structured group interviews
Time frame: Day 2
Identify activity types that influence touching behaviour
Time frame: Day 2
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 30 Nov 2022.
- Derived from this study: PubMed 36279142Science M, Caldeira-Kulbakas M, Parekh RS, Maguire BR, Carroll S, Anthony SJ, Bitnun A, Bourns LE, Campbell DM, Cohen E, Dodds A, Dubey V, Friedman JN, Greenwood JL, Hopkins JP, Imgrund R, Korczak DJ, Looi T, Louca E, Mertz D, Nashid J, Panzera G, Schneiderman JE, Schwartz KL, Streitenberger L, Vuppal S, Walsh CM, Juni P, Matava CT; Back-to-School COVID-19 School Study Group. Effect of Wearing a Face Mask on Hand-to-Face Contact by Children in a Simulated School Environment: The Back-to-School COVID-19 Simulation Randomized Clinical Trial. JAMA Pediatr. 2022 Dec 1;176(12):1169-1175. doi: 10.1001/jamapediatrics.2022.3833.
- Individual participant dataSharing planned: Undecided
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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.
Michelle Science principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearing a face mask at all times in people with Covid19 and Schools, run by The Hospital for Sick Children at 1 site in Canada.
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 6 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 30 Nov 2022. 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 Canada. 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?
Total number of hand-to-face contacts per participant per hour (time frame: Day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04531254, which also lists 1 linked publication.
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 30 Nov 2022.