ReSET Aim 1b: Restarting Safe Education and Testing for Children With Medical Complexity - COVID-19 Testing in School With Children and Staff

Study Overview
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Brief Summary
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The Coronavirus Disease 2019 (COVID-19), caused by the SARS-CoV-2 virus, is a worldwide pandemic that has resulted in large-scale quarantines in cities, states, and countries throughout the world. SARS-CoV-2 is a respiratory virus that is most commonly spread via contact with infective respiratory droplets and aerosols produced by coughing, sneezing, talking, and singing. Children with medical complexity (CMC), i.e., children with multiple severe chronic conditions, high resource use, severe functional limitations, and substantial family-identified service needs, are a medically vulnerable population for the development of severe COVID-19. Deciding to send CMC to school poses a major dilemma to families wanting to minimize severe COVID-19 risk. School personnel also face risks when CMC attend school. Despite these challenges, achieving in-person school attendance is critical for CMC. Compared to non-CMC, academic and social development for most CMC hinges on being at school. Severe intellectual and developmental disability impairs one's ability to engage with online platforms. Health-promoting services delivered at school, e.g., physical, occupational, and speech therapy, are likely less effective when delivered virtually. Parents of CMC, already disproportionately unemployed due to their child's care needs, experience added employment strain when their child is out of school. The study objective is to increase the safe return to school for CMC by 1) evaluating the feasibility of school-based COVID-19 testing strategies and 2) identifying parent and staff perceptions of testing and school attendance. A related study (ReSET Aim 1a, NCT04895085) will evaluate the same factors in home-based testing strategies in CMC exclusively.

Official Title
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ReSET Aim 1b: Restarting Safe Education and Testing for Children With Medical Complexity - SARS-CoV-2 Testing in School With Children and Staff

Conditions
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COVID-19, Children With Medical Complexity (CMC)

Intervention / Treatment
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* Diagnostic Test: BinaxNOW Rapid Antigen System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parents and staff must be at least 18 years of age. Staff must have a classroom role (e.g., teacher, aide, playground assistant) Parents and staff must be proficient in English. Parents and staff must have access to a web-enabled device (phone, tablet, or computer). Staff, parent and child must be residents of Wisconsin. Parent/child must be enrolled at WECP for the 2021 and/or 2022 school year. Exclusion Criteria: Failure to meet all inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a single site study taking place over 24 months and involving (65) caregivers and their children, and (50) school staff.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: School Staff<br>50 school staff from Waisman Early Childhood Program (WECP) will be recruited to participate in this study. School staff will send a letter to all WECP staff inviting them to participate. Staff new to the school or who initially decline participation and then reconsider may join at any time. Additionally, staff who are vaccinated will be asked to participate in testing. | Diagnostic Test: BinaxNOW Rapid Antigen System<br>* BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes. The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more.<br>|
| Experimental: Parent/Child with Children with medical complexity (CMC)<br>65 children and their parents will be recruited to participate. School staff will send a letter to all parents with children enrolled in the Waisman Early Childhood Program (WECP) inviting them to participate. Families new to the school or who initially decline participation and then reconsider may join at any time. Participants will also be offered the option of as needed symptomatic home testing. Additionally, parents who are vaccinated will be asked to participate in testing. Siblings may be enrolled in the study. | Diagnostic Test: BinaxNOW Rapid Antigen System<br>* BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes. The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Protocol uptake: Number of Participants Consented Compared to Number of participants approached | Feasibility of school based COVID-19 testing will be evaluated by protocol uptake. Data will be retrieved from the study log. | Study duration (up to 21 months) | 
| Change in COVID test rate at school: Number of total tests completed as compared to number of tests expected | Data will be retrieved from study log. | Every week up to 21 months | 
| Change in Symptomatic test rate: number of symptomatic tests completed compared to total number of participants enrolled | Data will be retrieved from study log. | Study duration (up to 21 months) | 
| Change in Positive rate: Number of positive COVID-19 tests compared to total number of tests performed | Data will be retrieved from study log. | Study duration (up to 21 months) | 
| Change in False-positive rate: number of negative confirmatory Polymerase chain reaction (PCR) as compared to total PCR run for COVID-19 testing | Data will be retrieved from study log. | Study duration (up to 21 months) | 
| Change in susceptibility: Number of fully vaccinated people who interact with participant's child at school |  | baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month | 
| Change in susceptibility: Survey items answered dichotomously (agree or disagree) | Following questions from the Participant's perceived susceptibility survey will be answered dichotomously (agree or disagree) and presented qualitatively. How comfortable are you with...the ability of your child's school to take all precautions to stop the spread of COVID-19? In your opinion, how likely is your child to get sick with COVID-19 by attending school in-person? | baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month | 
| Change in percentage of participants who chose each option in response to the perceived severity survey question | Parent survey perceived severity construct variables will be: If my child was sick with COVID-19, their health would be severely affected. If my child was sick with COVID-19, they would have grave health consequences. If my child was sick with COVID-19, their health would be permanently reduced. | baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month | 
| Change in motivation to attend school (quite a bit / a great deal vs not) | Participants will answer the following survey question in quite a bit / a great deal vs not: Based on the situation right now, how much do you want your child to attend school in-person at least some of the time? | baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month | 
| Change in perceived benefits to attend school | Parent survey perceived benefits construct survey will be having 6 questions ranging from benefits to child's overall health, therapy needs, impact on family. Survey will be analyzed qualitatively. | baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month | 
| Change in barriers to school attendance: Survey answered dichotomously very/extremely [comfortable] vs not. | Survey will have following questions which will be answered dichotomously very/extremely [comfortable] vs not. It How comfortable are you with... the number of people around your child at school? how close people have to be to your child at school? the amount personal protective equipment (PPE), such as masks and gloves, available at school? the amount of COVID-19 testing among school staff and classmates? how closely parents of classmates follow recommendations to keep your child safe? How difficult is it to transport your child to or from school as a result of COVID-19? In your child's school, do they have access to necessary facilities to wash? While in school, is your child required to be in close contact (i.e., within 6 ft) with others? 'Others' includes teachers, aides, nurses, and classmates. While in school, is your child able to wear a mask? | baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month | 
| Change in Cues: Has a teacher or staff member encouraged child to attend school in-person? (Y/N) | Participants will answer the following survey question in Yes/No: Teachers/staff have asked for my child to attend school.- Y/N | baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month | 
| Change in option and practice: Currently, if participant wanted, could the child attend school in-person, either full-time or as part of a hybrid or part-time schedule? Y/N | Participant will be asked the attendance question in survey. It will be answered in Yes/No | baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month | 
| Change in option and practice: Currently, is child attending school in-person, either full-time or as part of a hybrid or part-time schedule? Y/N | Participant will be asked the attendance question in survey. It will be answered in Yes/No | baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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In-school COVID testing, Caregiver, School staff, In-person school attendance