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

NCT ID: NCT04899245

Last Updated: 2024-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-04
• Study Completion Date: 2023-09-01

Brief Summary

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.

Conditions

Children With Medical Complexity (CMC); COVID-19

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

School Staff

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.

Group Type: EXPERIMENTAL

BinaxNOW Rapid Antigen System

Intervention Type: DIAGNOSTIC_TEST

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.

Parent/Child with Children with medical complexity (CMC)

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.

Group Type: EXPERIMENTAL

BinaxNOW Rapid Antigen System

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

BinaxNOW Rapid Antigen System

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

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

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ryan Coller, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

A536771

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/PEDIATRICS

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 7/11/22

Identifier Type: OTHER

Identifier Source: secondary_id

1OT2HD107558-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2022-0810

Identifier Type: OTHER

Identifier Source: secondary_id

2021-0488

Identifier Type: -

Identifier Source: org_study_id