Clinical trial NCT04531254: Back to School COVID-19 Simulation Study
Official title: Understanding the Impact of Public Health Measures Planned for School Reopening During COVID-19 Using Simulation Exercises
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Schools
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2020-08-28
Enrollment: 174
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Total number of hand-to-face contacts per participant per hour
timeFrame: Day 2
Secondary outcomes:
measure: Total number of hand-to-mucus membrane contacts per participant per hour
timeFrame: Day 2
measure: Total number of hand-to-non-mucus membrane contacts per participant per hour
timeFrame: Day 2
measure: Total number of instances where participants are within 1 and 2 meters of each other
timeFrame: Day 2
measure: Total number of glo germ transfers to another person
timeFrame: Day 2
measure: Total number of glo germ transfers to teacher
timeFrame: Day 2
measure: Total number of glo germ transfers to a surface
timeFrame: Day 2
measure: Total number of instances of hand holding per participant per hour
timeFrame: Day 2
measure: Total number of touches to another person per participant per hour
timeFrame: Day 2
measure: Total number of hand hygiene actions per participant per hour
timeFrame: Day 2
measure: Total number of mask removals per participant per hour
timeFrame: Day 2
measure: Teacher concerns measured using study-specific post-simulation questionnaire
timeFrame: Day 2
measure: Teacher concerns measured using semi-structured group interviews
timeFrame: Day 2
measure: Student concerns measured using study-specific post-simulation questionnaire
timeFrame: Day 2
measure: Student concerns measured using semi-structured group interviews
timeFrame: Day 2
measure: Identify activity types that influence touching behaviour
timeFrame: Day 2
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Michelle Science
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.