Back to School COVID-19 Simulation Study

NCT ID: NCT04531254

Last Updated: 2022-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-10
• Study Completion Date: 2020-08-31

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.

Conditions

Covid19; Schools

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Wearing a face mask at all times

Intervention Type: BEHAVIORAL

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

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Michelle Science

Infectious Disease Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michelle Science

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 36279142 (View on PubMed)

Other Identifiers

1000071861

Identifier Type: -

Identifier Source: org_study_id