Back to School COVID-19 Simulation Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Understanding the Impact of Public Health Measures Planned for School Reopening During COVID-19 Using Simulation Exercises

Conditions
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Covid19, Schools

Intervention / Treatment
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* Behavioral: Wearing a face mask at all times


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • 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. Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Masking at all times<br>Children in this group will be asked to wear a face mask/covering in the classroom and common areas during the simulation | Behavioral: Wearing a face mask at all times<br>* Children in this group will be asked to wear a face mask in the classroom and common areas during the simulation<br>|
| No Intervention: No mask/masking when physical distancing is not maintained<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | Day 2 | 
| Total number of glo germ transfers to a surface | The number of surfaces in the classroom with Glo Germ | 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 | 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 | 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 | 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 | Day 2 | 
| Teacher concerns measured using study-specific post-simulation questionnaire | A study specific questionnaire that examines teacher anxiety and mental health | 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 | Day 2 | 
| Student concerns measured using study-specific post-simulation questionnaire | A study specific questionnaire that examines student anxiety and mental health | 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 | 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 | Day 2 |