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

University of Wisconsin (UW)

Status: Completed

Conditions: COVID-19; Children With Medical Complexity (CMC)

Treatments: Diagnostic Test: BinaxNOW Rapid Antigen System

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04899245

2021-0488

1OT2HD107558-01 (U.S. NIH Grant/Contract)

A536771 (Other Identifier)

2022-0810 (Other Identifier)

Protocol Version 7/11/22 (Other Identifier)

SMPH/PEDIATRICS (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 112 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

School Staff

Experimental group

Description:

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.

Treatment:

Diagnostic Test: BinaxNOW Rapid Antigen System

Parent/Child with Children with medical complexity (CMC)

Experimental group

Description:

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.

Treatment:

Diagnostic Test: BinaxNOW Rapid Antigen System