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

NCT04899245 | Completed Results FDA Device

• 6 other identifiers: 2021-0488A536771SMPH/PEDIATRICSProtocol Version 7/11/221OT2HD107558-012022-0810
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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

Keywords

In-school COVID testing; Caregiver; School staff; In-person school attendance

Outcome Measures

Primary Outcomes (30)

• Change in Protocol Uptake: Number of Children and Staff Consented Compared to Number of Approached

  Feasibility of school based COVID-19 testing will be evaluated by protocol uptake. Data will be retrieved from the study log. Two data limitations to note: * The enrollment rate was not stratified by caregiver and child number at the time of data collection. The data was collected at the level of the child. * The enrollment rate was not stratified by caregiver/child dyad and staff at the time of data collection. This is a limitation of our data. It is not possible to stratify this outcome and it is therefore analyzed together.

  Study duration (up to 21 months)

• Change in COVID Test Rate at School: Number of Total Child and Staff Tests Completed as Compared to Number of Tests Expected

  * Tests expected: Children and staff in this study will have nasal swab testing performed at school twice weekly (as well as anytime they have symptoms) for the first 3 months of the study. After 3 months, the twice-weekly testing may decrease to symptom-only testing if the rate of COVID spread decreases in Wisconsin. Symptom-only testing is not included as an "expected" test. * The number of tests expected was assessed specifically for this outcome measure to determine if testing was proceeding as expected. This value was based on the number of children and staff enrolled at a given time, whether surveillance or symptom-only testing was being conducted, and if any of the participants had COVID-19 (excluding them from testing). This value was not created at baseline, but was dynamic over the course of the study dependent upon the aforementioned factors. * The tests expected value was not stratified by child and staff at the time of data collection. It is a limitation of the data.

  Every week up to 21 months

• Change in Symptomatic Test Rate: Number of Symptomatic Tests Completed

  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. All children and staff (n = 71) were included in this outcome. However, participants were not required to and were sometimes unable to complete a confirmatory PCR test after a positive in-home rapid test. This explains the difference between the number of positive at-home COVID-19 tests and the number of PCR tests. Some participants completed multiple confirmatory PCR tests over the study time frame. This explains why the PCR quantity is greater than the number of participants.

  Study duration (up to 21 months)

• Caregiver Change in Susceptibility: Number of Fully Vaccinated People Who Interact With Participant's Child at School

  * "How many of the people who interact with your child at school have been fully vaccinated?" * Response options: "None", "A few", "Some" "Most", "All", "Don't Know" * Dichotomized into: ("Most" or "All") vs. ("None", "A few", "Some", "Don't Know) * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

  Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month

• Caregiver Change in Susceptibility: School Takes Precautions

  The following question from the Participant's perceived susceptibility survey will be answered dichotomously 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? * Response options: "Not at all", "A little", "Somewhat", "Very", "Extremely" * Dichotomized into: ("Not at all", "A little", "Somewhat") vs. ("Very", "Extremely") * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

  Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month

• Caregiver Change in Susceptibility: Likely to Get COVID-19

  Following questions from the Participant's perceived susceptibility survey will be answered dichotomously (agree or disagree) and presented qualitatively. * In your opinion, how likely is your child to get sick with COVID-19 by attending school in-person? * Response options: "Not at all", "A little", "Somewhat", "Very", "Extremely" * Dichotomized into: ("Not at all", "A little", "Somewhat") vs. ("Very", "Extremely") * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

  Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month

• Change in Percentage of Caregivers for Perceived Severity Survey Question: Health Severely Affected

  Parent survey perceived severity construct variables will include: * If your child was sick with COVID-19, how likely would...their health be severely affected * Response options: "Not at all", "A little", "Somewhat", "Very", "Extremely" * Dichotomized into: ("Not at all", "A little", "Somewhat") vs. ("Very", "Extremely") * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

  15 month, 18 month, 21 month, 24 month

• Change in Percentage of Caregivers to the Perceived Severity Survey Question: Health Permanently Reduced

  Parent survey perceived severity construct variables will be: * "If your child was sick with COVID-19, how likely would...their health be permanently reduced" * Response options: "Not at all", "A little", "Somewhat", "Very", "Extremely" * Dichotomized into: ("Not at all", "A little", "Somewhat") vs. ("Very", "Extremely") * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

  15 month, 18 month, 21 month, 24 month

• Change in Percentage of Caregivers to the Perceived Severity Survey Question: Grave Health Consequences

  Parent survey perceived severity construct variables will be: * "If my child was sick with COVID-19, they would have grave health consequences." * Response options: "Not at all", "A little", "Somewhat", "Very", "Extremely" * Dichotomized into: ("Not at all", "A little", "Somewhat") vs. ("Very", "Extremely") * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

  15 month, 18 month, 21 month, 24 month

• Caregiver Change in Motivation for Child 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?" * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

  Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month

• Caregiver Change in Perceived Benefits to Child Attending School: Important to Health

  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. * How important is attending school in-person to your child's overall health? * Dichotomized into: ("Not at all important", "A little important", "Somewhat important") vs. ("Very important", "Extremely important") * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

  Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month

• Caregiver Change in Perceived Benefits to Child Attending School: In-person Schooling

  Parent survey perceived benefits construct survey will be having 6 questions ranging from benefits to child's overall health, therapy needs, and impact on family. Survey will be analyzed qualitatively. * Compared to fully virtual school, how much better or worse is attending any school in-person for your child? * Dichotomized into: ("Quite a bit worse", "Somewhat worse", "A little bit worse", "Neither better nor worse") vs. ("A little bit better", "Somewhat better", "Quite a bit better") * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

  Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month

• Caregiver Change in Perceived Benefits to Child Attending School: Therapy Needs

  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. * How much of your child's therapy needs are only met by attending school in-person? * Dichotomized into: ("None", "A few", "Some" vs. "Most", "All") * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

  Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month

• Caregiver Change in Perceived Benefits to Child Attending School: Positive for Family

  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. * How positive or negative is your child attending school in-person for...your family * Dichotomized into: ("Very negative", "Somewhat negative", "A little negative", "Neutral") vs. ("A little positive", "Somewhat positive", "Very positive") * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

  Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month

• Caregiver Change in Perceived Benefits to Child Attending School: Positive for Staff

  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. * How positive or negative is your child attending school in-person for...the staff and teachers * Dichotomized into: ("Very negative", "Somewhat negative", "A little negative", "Neutral") vs. ("A little positive", "Somewhat positive", "Very positive") * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

  Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month

• Caregiver Change in Perceived Benefits to Child Attending School: Keep Jobs

  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. * Does your child attending school in-person help the adults in your family to keep their jobs? * Response options: Yes / No * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

  Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month

• Caregiver Change in Barriers to School Attendance: Number of People

  Survey will have following questions which will be answered dichotomously very/extremely \[comfortable\] vs not. * How comfortable are you with the number of people around your child at school? * Dichotomized into: ("Not at all", "A little", "Somewhat") vs. ("Very", "Extremely") * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

  Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month

• Caregiver Change in Barriers to School Attendance: Proximity

  Survey will have following questions which will be answered dichotomously very/extremely \[comfortable\] vs not. * How comfortable are you with how close people have to be to your child at school? * Dichotomized into: ("Not at all", "A little", "Somewhat") vs. ("Very", "Extremely") * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

  Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month

• Caregiver Change in Barriers to School Attendance: PPE

  Survey will have following questions which will be answered dichotomously very/extremely \[comfortable\] vs not. * How comfortable are you with the amount personal protective equipment (PPE), such as masks and gloves, available at school? * Dichotomized into: ("Not at all", "A little", "Somewhat") vs. ("Very", "Extremely") * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

  Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month

• Caregiver Change in Barriers to School Attendance: Testing

  Survey will have following questions which will be answered dichotomously very/extremely \[comfortable\] vs not. * How comfortable are you with the amount of COVID-19 testing among school staff and classmates? * Dichotomized into: ("Not at all", "A little", "Somewhat") vs. ("Very", "Extremely") * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

  Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month

• Caregiver Change in Barriers to School Attendance: Following Recommendations

  Survey will have following questions which will be answered dichotomously very/extremely \[comfortable\] vs not. * How comfortable are you with how closely parents of classmates follow recommendations to keep your child safe? * Dichotomized into: ("Not at all", "A little", "Somewhat") vs. ("Very", "Extremely") * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

  Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month

• Caregiver Change in Barriers to School Attendance: Transportation

  Survey will have following questions which will be answered dichotomously very/extremely vs not. * How difficult is it to transport your child to or from school as a result of COVID-19? * Dichotomized as: ("Not at all", "A little", "Somewhat") vs. ("Very", "Extremely") * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

  Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month

• Caregiver Change in Barriers to School Attendance: Wash

  Survey will have following questions which will be answered dichotomously very/extremely vs not. * In your child's school, do they have access to necessary facilities to wash? * Dichotomized as: ("Yes, all of the time", "Yes, most of the time") vs. ("Some of the time", "Rarely", "Not at all") * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

  Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month

• Caregiver Change in Barriers to School Attendance: Close Contact

  Survey will have following questions which will be answered dichotomously very/extremely \[comfortable\] vs not. * 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. * Dichotomized as: ("Yes, all of the time", "Yes, most of the time") vs. ("Some of the time", "Rarely", "Not at all") * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

  Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month

• Caregiver Change in Barriers to School Attendance: Masking

  Survey will have following questions which will be answered dichotomously very/extremely vs not. * While in school, is your child able to wear a mask? * Dichotomized as: ("Yes, all of the time", "Yes, most of the time") vs. ("Some of the time", "Rarely", "Not at all") * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

  Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month

• Caregiver 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 * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

  Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month

• Caregiver Change in Option and Practice: School Attendance

  Participant will be asked the attendance question in survey. It will be answered in Yes/No. * Currently, is child attending school in-person, either full-time or as part of a hybrid or part-time schedule? Y/N * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

  Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month

• Caregiver Change in Option and Practice: Option to Attend School

  Participant will be asked the attendance question in survey. It will be answered in Yes/No * Currently, if participant wanted, could the child attend school in-person, either full-time or as part of a hybrid or part-time schedule? * Survey branching logic asked this question only to participants whose child was not currently attending school in person, either full-time or as part of a hybrid or part-time schedule. The number analyzed represents the number of participants that answered this question. * This question was only asked to caregivers. * Caregivers with multiple children enrolled completed a survey for each child.

  Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month

Study Arms (2)

School Staff

EXPERIMENTAL

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

Parent/Child with Children with medical complexity (CMC)

EXPERIMENTAL

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

Interventions

BinaxNOW Rapid Antigen System 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); School Staff

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53792-4108, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Ryan Coller
• Organization: University of Wisconsin School of Medicine and Public Health

rcoller@pediatrics.wisc.edu

608-263-9408

Study Officials

• Ryan Coller, MD, MPH

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single site study taking place over 24 months and involving (65) caregivers and their children, and (50) school staff.

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 24, 2021
• Study Start: May 4, 2021
• Primary Completion: June 15, 2023
• Study Completion: September 1, 2023
• Last Updated: July 17, 2024
• Results First Posted: July 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)