Back to School COVID-19 Simulation Study

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.

Study Overview

• Status: Completed
• Conditions: Covid19; Schools
• Intervention / Treatment: Behavioral: Wearing a face mask at all times

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 Type: Interventional
• Enrollment (Actual): 174
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Masking at all times; 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; Children in this group will be asked to wear a face mask in the classroom and common areas during the simulation
NO_INTERVENTION: No mask/masking when physical distancing is not maintained; 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?

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

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Investigators: Principal Investigator: Michelle Science, The Hospital for Sick Children

Publications and helpful links

General 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.

Helpful Links

• 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

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 10, 2020
• Primary Completion (ACTUAL): August 31, 2020
• Study Completion (ACTUAL): August 31, 2020

Study Registration Dates

• First Submitted: August 24, 2020
• First Submitted That Met QC Criteria: August 27, 2020
• First Posted (ACTUAL): August 28, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 25, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 1000071861

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No