Back to School COVID-19 Simulation Study

The Hospital for Sick Children

Status: Completed

Conditions: Covid19; Schools

Treatments: Behavioral: Wearing a face mask at all times

Study type: Interventional

Funder types: Other

Identifiers

NCT04531254

1000071861

Details and patient eligibility

About

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.

Full 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.

Enrollment: 174 patients

Sex: All

Ages: 4 to 18 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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174 participants in 2 patient groups

Masking at all times

Experimental group

Description:

Children in this group will be asked to wear a face mask/covering in the classroom and common areas during the simulation

Treatment:

Behavioral: Wearing a face mask at all times

No mask/masking when physical distancing is not maintained

No Intervention group

Description:

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