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Back to School COVID-19 Simulation Study

Primary Purpose

Covid19, Schools

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Wearing a face mask at all times
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Covid19

Eligibility Criteria

4 Years - 18 Years (Child, Adult)All SexesAccepts 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)

Sites / Locations

  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Masking at all times

No mask/masking when physical distancing is not maintained

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
Total number of glo germ transfers to another person
The number of children within a classroom with Glo Germ on the hands/face
Total number of glo germ transfers to teacher
The presence of Glo Germ on the hands/face of teacher within the same classroom
Total number of glo germ transfers to a surface
The number of surfaces in the classroom with Glo Germ
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
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
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
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
Teacher concerns measured using study-specific post-simulation questionnaire
A study specific questionnaire that examines teacher anxiety and mental health
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
Student concerns measured using study-specific post-simulation questionnaire
A study specific questionnaire that examines student anxiety and mental health
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
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

Full Information

First Posted
August 24, 2020
Last Updated
November 25, 2022
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT04531254
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
August 10, 2020 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Schools

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
174 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Masking at all times
Arm Type
Experimental
Arm Description
Children in this group will be asked to wear a face mask/covering in the classroom and common areas during the simulation
Arm Title
No mask/masking when physical distancing is not maintained
Arm Type
No Intervention
Arm 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
Intervention Type
Behavioral
Intervention Name(s)
Wearing a face mask at all times
Intervention Description
Children in this group will be asked to wear a face mask in the classroom and common areas during the simulation
Primary Outcome Measure Information:
Title
Total number of hand-to-face contacts per participant per hour
Description
The number of touches to the face made per hour in the simulated school environment
Time Frame
Day 2
Secondary Outcome Measure Information:
Title
Total number of hand-to-mucus membrane contacts per participant per hour
Description
The number of touches to the eyes, nose, mouth made per hour in the simulated school environment
Time Frame
Day 2
Title
Total number of hand-to-non-mucus membrane contacts per participant per hour
Description
The number of touches to the skin (not eyes, nose, mouth) made per hour in the simulated school environment
Time Frame
Day 2
Title
Total number of instances where participants are within 1 and 2 meters of each other
Description
The number of instances where 1 and 2 meter distance between participants is breached in the classroom
Time Frame
Day 2
Title
Total number of glo germ transfers to another person
Description
The number of children within a classroom with Glo Germ on the hands/face
Time Frame
Day 2
Title
Total number of glo germ transfers to teacher
Description
The presence of Glo Germ on the hands/face of teacher within the same classroom
Time Frame
Day 2
Title
Total number of glo germ transfers to a surface
Description
The number of surfaces in the classroom with Glo Germ
Time Frame
Day 2
Title
Total number of instances of hand holding per participant per hour
Description
The count of hand holding instances with another person per hour in the simulated school environment
Time Frame
Day 2
Title
Total number of touches to another person per participant per hour
Description
The count of touches to another person per hour in the simulated school environment
Time Frame
Day 2
Title
Total number of hand hygiene actions per participant per hour
Description
The count of hand hygiene actions (i.e., hand washing, hand sanitizer) per participant per hour
Time Frame
Day 2
Title
Total number of mask removals per participant per hour
Description
The number of times a participant in a masking group removes their mask per hour in the simulated school environment
Time Frame
Day 2
Title
Teacher concerns measured using study-specific post-simulation questionnaire
Description
A study specific questionnaire that examines teacher anxiety and mental health
Time Frame
Day 2
Title
Teacher concerns measured using semi-structured group interviews
Description
A study specific semi-structured interview examining the factors throughout the day (hand hygiene, mask use, physical distancing) that impacted the teaching experience
Time Frame
Day 2
Title
Student concerns measured using study-specific post-simulation questionnaire
Description
A study specific questionnaire that examines student anxiety and mental health
Time Frame
Day 2
Title
Student concerns measured using semi-structured group interviews
Description
A study specific semi-structured interview examining the factors throughout the day (hand hygiene, mask use, physical distancing) that impacted the learning experience
Time Frame
Day 2
Title
Identify activity types that influence touching behaviour
Description
The count of each type of activity participants are engaged in while touching others or surfaces in the simulated school environment
Time Frame
Day 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Science
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36279142
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.
Results Reference
derived
Links:
URL
https://jamanetwork.com/journals/jamapediatrics/fullarticle/2797601
Description
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

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Back to School COVID-19 Simulation Study

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