Back to School COVID-19 Simulation Study
Understanding the Impact of Public Health Measures Planned for School Reopening During COVID-19 Using Simulation Exercises
1 other identifier
interventional
174
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable covid19
Started Aug 2020
Shorter than P25 for not_applicable covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 10, 2020
CompletedFirst Submitted
Initial submission to the registry
August 24, 2020
CompletedFirst Posted
Study publicly available on registry
August 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2020
CompletedNovember 30, 2022
November 1, 2022
21 days
August 24, 2020
November 25, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Day 2
Secondary Outcomes (15)
Total number of hand-to-mucus membrane contacts per participant per hour
Day 2
Total number of hand-to-non-mucus membrane contacts per participant per hour
Day 2
Total number of instances where participants are within 1 and 2 meters of each other
Day 2
Total number of glo germ transfers to another person
Day 2
Total number of glo germ transfers to teacher
Day 2
- +10 more secondary outcomes
Study Arms (2)
Masking at all times
EXPERIMENTALChildren 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 INTERVENTIONChildren 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
Interventions
Children in this group will be asked to wear a face mask in the classroom and common areas during the simulation
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
Related Publications (1)
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.
PMID: 36279142DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michelle Science
The Hospital for Sick Children
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Infectious Disease Physician
Study Record Dates
First Submitted
August 24, 2020
First Posted
August 28, 2020
Study Start
August 10, 2020
Primary Completion
August 31, 2020
Study Completion
August 31, 2020
Last Updated
November 30, 2022
Record last verified: 2022-11