Clinical trial NCT04899245: ReSET Aim 1b: Restarting Safe Education and Testing for Children With Medical Complexity - COVID-19 Testing in School With Children and Staff
Official title: ReSET Aim 1b: Restarting Safe Education and Testing for Children With Medical Complexity - SARS-CoV-2 Testing in School With Children and Staff
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children With Medical Complexity (CMC)
COVID-19
Keywords: In-school COVID testing
Caregiver
School staff
In-person school attendance
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-05-24
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single site study taking place over 24 months and involving (65) caregivers and their children, and (50) school staff.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Change in Protocol Uptake: Number of Children and Staff Consented Compared to Number of Approached
timeFrame: Study duration (up to 21 months)
measure: Change in COVID Test Rate at School: Number of Total Child and Staff Tests Completed as Compared to Number of Tests Expected
timeFrame: Every week up to 21 months
measure: Change in Symptomatic Test Rate: Number of Symptomatic Tests Completed
timeFrame: Study duration (up to 21 months)
measure: Change in Positive Rate: Number of Positive COVID-19 Tests Compared to Total Number of Tests Performed
timeFrame: Study duration (up to 21 months)
measure: Change in False-positive Rate: Number of Negative Confirmatory Polymerase Chain Reaction (PCR) as Compared to Total PCR Run for COVID-19 Testing
timeFrame: Study duration (up to 21 months)
measure: Caregiver Change in Susceptibility: Number of Fully Vaccinated People Who Interact With Participant's Child at School
timeFrame: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
measure: Caregiver Change in Susceptibility: School Takes Precautions
timeFrame: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
measure: Caregiver Change in Susceptibility: Likely to Get COVID-19
timeFrame: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
measure: Change in Percentage of Caregivers for Perceived Severity Survey Question: Health Severely Affected
timeFrame: 15 month, 18 month, 21 month, 24 month
measure: Change in Percentage of Caregivers to the Perceived Severity Survey Question: Health Permanently Reduced
timeFrame: 15 month, 18 month, 21 month, 24 month
measure: Change in Percentage of Caregivers to the Perceived Severity Survey Question: Grave Health Consequences
timeFrame: 15 month, 18 month, 21 month, 24 month
measure: Caregiver Change in Motivation for Child to Attend School (Quite a Bit / a Great Deal vs Not)
timeFrame: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
measure: Caregiver Change in Perceived Benefits to Child Attending School: Important to Health
timeFrame: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
measure: Caregiver Change in Perceived Benefits to Child Attending School: In-person Schooling
timeFrame: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
measure: Caregiver Change in Perceived Benefits to Child Attending School: Therapy Needs
timeFrame: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
measure: Caregiver Change in Perceived Benefits to Child Attending School: Positive for Family
timeFrame: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
measure: Caregiver Change in Perceived Benefits to Child Attending School: Positive for Staff
timeFrame: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
measure: Caregiver Change in Perceived Benefits to Child Attending School: Keep Jobs
timeFrame: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
measure: Caregiver Change in Barriers to School Attendance: Number of People
timeFrame: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
measure: Caregiver Change in Barriers to School Attendance: Proximity
timeFrame: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
measure: Caregiver Change in Barriers to School Attendance: PPE
timeFrame: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
measure: Caregiver Change in Barriers to School Attendance: Testing
timeFrame: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
measure: Caregiver Change in Barriers to School Attendance: Following Recommendations
timeFrame: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
measure: Caregiver Change in Barriers to School Attendance: Transportation
timeFrame: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
measure: Caregiver Change in Barriers to School Attendance: Wash
timeFrame: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
measure: Caregiver Change in Barriers to School Attendance: Close Contact
timeFrame: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
measure: Caregiver Change in Barriers to School Attendance: Masking
timeFrame: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
measure: Caregiver Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)
timeFrame: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
measure: Caregiver Change in Option and Practice: School Attendance
timeFrame: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
measure: Caregiver Change in Option and Practice: Option to Attend School
timeFrame: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin School of Medicine and Public Health
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Ryan Coller, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: