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OpenTrials
Completed

NCT Number: NCT04531254

Back to School COVID-19 Simulation Study

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Schools Virus Diseases

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Wearing a face mask at all times

Behavioral

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

Primary outcomes

  1. Total number of hand-to-face contacts per participant per hour

    Time frame: Day 2

    The number of touches to the face made per hour in the simulated school environment

Secondary outcomes

  1. Total number of hand-to-mucus membrane contacts per participant per hour

    Time frame: Day 2

    The number of touches to the eyes, nose, mouth made per hour in the simulated school environment

  2. Total number of hand-to-non-mucus membrane contacts per participant per hour

    Time frame: Day 2

    The number of touches to the skin (not eyes, nose, mouth) made per hour in the simulated school environment

  3. Total number of instances where participants are within 1 and 2 meters of each other

    Time frame: Day 2

    The number of instances where 1 and 2 meter distance between participants is breached in the classroom

  4. Total number of glo germ transfers to another person

    Time frame: Day 2

    The number of children within a classroom with Glo Germ on the hands/face

  5. Total number of glo germ transfers to teacher

    Time frame: Day 2

    The presence of Glo Germ on the hands/face of teacher within the same classroom

  6. Total number of glo germ transfers to a surface

    Time frame: Day 2

    The number of surfaces in the classroom with Glo Germ

  7. Total number of instances of hand holding per participant per hour

    Time frame: Day 2

    The count of hand holding instances with another person per hour in the simulated school environment

  8. Total number of touches to another person per participant per hour

    Time frame: Day 2

    The count of touches to another person per hour in the simulated school environment

  9. Total number of hand hygiene actions per participant per hour

    Time frame: Day 2

    The count of hand hygiene actions (i.e., hand washing, hand sanitizer) per participant per hour

  10. Total number of mask removals per participant per hour

    Time frame: Day 2

    The number of times a participant in a masking group removes their mask per hour in the simulated school environment

  11. Teacher concerns measured using study-specific post-simulation questionnaire

    Time frame: Day 2

    A study specific questionnaire that examines teacher anxiety and mental health

  12. Teacher concerns measured using semi-structured group interviews

    Time frame: Day 2

    A study specific semi-structured interview examining the factors throughout the day (hand hygiene, mask use, physical distancing) that impacted the teaching experience

  13. Student concerns measured using study-specific post-simulation questionnaire

    Time frame: Day 2

    A study specific questionnaire that examines student anxiety and mental health

  14. Student concerns measured using semi-structured group interviews

    Time frame: Day 2

    A study specific semi-structured interview examining the factors throughout the day (hand hygiene, mask use, physical distancing) that impacted the learning experience

  15. Identify activity types that influence touching behaviour

    Time frame: Day 2

    The count of each type of activity participants are engaged in while touching others or surfaces in the simulated school environment

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

Understanding the Impact of Public Health Measures Planned for School Reopening During COVID-19 Using Simulation Exercises

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 28, 2020
Registry last updated
Nov 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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