N/A N=112 Health Services Research

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

Children With Medical Complexity (CMC) · COVID-19

Bottom Line

View on ClinicalTrials.gov: NCT04899245 ↗

Enrolled (actual)

112

Serious AEs

0.0%

Results posted

Jul 2024

Primary outcome: Primary: Change in Protocol Uptake: Number of Children and Staff Consented Compared to Number of Approached — 71; 17 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: BinaxNOW Rapid Antigen System (Diagnostic_test)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Wisconsin, Madison
Primary completion: Jun 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Protocol Uptake: Number of Children and Staff Consented Compared to Number of Approached	71; 17	—
PRIMARY Change in COVID Test Rate at School: Number of Total Child and Staff Tests Completed as Compared to Number of Tests Expected	2368; 2688	—
PRIMARY Change in Symptomatic Test Rate: Number of Symptomatic Tests Completed	195; 39	—
PRIMARY Change in Positive Rate: Number of Positive COVID-19 Tests Compared to Total Number of Tests Performed	30; 5	—
PRIMARY Change in False-positive Rate: Number of Negative Confirmatory Polymerase Chain Reaction (PCR) as Compared to Total PCR Run for COVID-19 Testing	22; 1	—
PRIMARY Caregiver Change in Susceptibility: Number of Fully Vaccinated People Who Interact With Participant's Child at School	21; 18; 11; 18; 15; 12	—
PRIMARY Caregiver Change in Susceptibility: School Takes Precautions	27; 13; 19; 10; 19; 8	—
PRIMARY Caregiver Change in Susceptibility: Likely to Get COVID-19	6; 33; 5; 24; 3; 25	—
PRIMARY Change in Percentage of Caregivers for Perceived Severity Survey Question: Health Severely Affected	1; 7; 1; 7; 0; 13	—
PRIMARY Change in Percentage of Caregivers to the Perceived Severity Survey Question: Health Permanently Reduced	1; 7; 1; 7; 0; 13	—
PRIMARY Change in Percentage of Caregivers to the Perceived Severity Survey Question: Grave Health Consequences	1; 7; 1; 7; 0; 13	—
PRIMARY Caregiver Change in Motivation for Child to Attend School (Quite a Bit / a Great Deal vs Not)	30; 9; 26; 4; 26; 1	—
PRIMARY Caregiver Change in Perceived Benefits to Child Attending School: Important to Health	32; 8; 21; 9; 21; 7	—
PRIMARY Caregiver Change in Perceived Benefits to Child Attending School: In-person Schooling	36; 2; 27; 2; 26; 2	—
PRIMARY Caregiver Change in Perceived Benefits to Child Attending School: Therapy Needs	9; 22; 9; 14; 10; 10	—
PRIMARY Caregiver Change in Perceived Benefits to Child Attending School: Positive for Family	39; 1; 29; 0; 27; 1	—
PRIMARY Caregiver Change in Perceived Benefits to Child Attending School: Positive for Staff	32; 8; 23; 6; 22; 6	—
PRIMARY Caregiver Change in Perceived Benefits to Child Attending School: Keep Jobs	31; 8; 24; 5; 23; 5	—
PRIMARY Caregiver Change in Barriers to School Attendance: Number of People	21; 19; 10; 19; 15; 12	—
PRIMARY Caregiver Change in Barriers to School Attendance: Proximity	20; 20; 9; 20; 13; 14	—
PRIMARY Caregiver Change in Barriers to School Attendance: PPE	27; 13; 16; 13; 16; 10	—
PRIMARY Caregiver Change in Barriers to School Attendance: Testing	30; 10; 19; 10; 13; 13	—
PRIMARY Caregiver Change in Barriers to School Attendance: Following Recommendations	23; 17; 10; 19; 14; 12	—
PRIMARY Caregiver Change in Barriers to School Attendance: Transportation	1; 39; 0; 29; 1; 27	—
PRIMARY Caregiver Change in Barriers to School Attendance: Wash	39; 0; 29; 0; 28; 0	—
PRIMARY Caregiver Change in Barriers to School Attendance: Close Contact	24; 16; 21; 8; 24; 4	—
PRIMARY Caregiver Change in Barriers to School Attendance: Masking	30; 10; 23; 6; 23; 5	—
PRIMARY Caregiver Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)	7; 31; 7; 22; 7; 20	—
PRIMARY Caregiver Change in Option and Practice: School Attendance	38; 2; 29; 1; 25; 2	—
PRIMARY Caregiver Change in Option and Practice: Option to Attend School	1; 0; 1; 0; 1; 0	—

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.

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.

Exclusion Criteria

Failure to meet all inclusion criteria

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04899245). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.