Children With Medical Complexity (CMC)NCT04899245
ReSET Aim 1b: Restarting Safe Education and Testing for Children With Medical Complexity - COVID-19 Testing in School With Children and Staff
A study testing BinaxNOW Rapid Antigen System in people with Children With Medical Complexity (CMC) and COVID-19, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Children With Medical Complexity (CMC), COVID-19
- What is being tested?
- BinaxNOW Rapid Antigen System
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2021to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Failure to meet all inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 53792-4108
About this study
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
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
- Being tested
- BinaxNOW Rapid Antigen System
- Keywords
- In-school COVID testing, Caregiver, School staff, In-person school attendance
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BinaxNOW Rapid Antigen SystemDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: BinaxNOW Rapid Antigen System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Every week up to 21 months
Change in Symptomatic Test Rate: Number of Symptomatic Tests Completed
Data will be retrieved from study log.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start4 May 2021
- Primary completion15 Jun 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Children With Medical Complexity (CMC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a single site study taking place over 24 months and involving (65) caregivers and their children, and (50) school staff.
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Ryan Coller, MD, MPH, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899245
- Sponsor's protocol ID
- 2021-0488
- Other IDs
- A536771, SMPH/PEDIATRICS, Protocol Version 7/11/22, 1OT2HD107558-01, 2022-0810
- Status last verified
- Jun 2024
- First submitted
- 19 May 2021
- Last updated
- 17 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04899245
- Acronym / sponsor ID
- 2021-0488
- Conditions
- Children With Medical Complexity (CMC), COVID-19
- Keywords
- In-school COVID testing, Caregiver, School staff, In-person school attendance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 4 May 2021 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 24 May 2021 (actual)
- Results
- Posted 17 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a single site study taking place over 24 months and involving (65) caregivers and their children, and (50) school staff.
| Arm | Type | Receives |
|---|---|---|
| School Staff | Experimental | Diagnostic Test: BinaxNOW Rapid Antigen System50 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. |
| Parent/Child with Children with medical complexity (CMC) | Experimental | Diagnostic Test: BinaxNOW Rapid Antigen System65 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- Failure to meet all inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BinaxNOW Rapid Antigen SystemBinaxNOW 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. | Diagnostic test | Parent/Child with Children with medical complexity (CMC), School Staff |
Primary outcome
Change in Protocol Uptake: Number of Children and Staff Consented Compared to Number of Approached
Time frame: Study duration (up to 21 months)
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.
Change in COVID Test Rate at School: Number of Total Child and Staff Tests Completed as Compared to Number of Tests Expected
Time frame: Every week up to 21 months
* 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.
Change in Symptomatic Test Rate: Number of Symptomatic Tests Completed
Time frame: Study duration (up to 21 months)
Data will be retrieved from study log.
Change in Positive Rate: Number of Positive COVID-19 Tests Compared to Total Number of Tests Performed
Time frame: Study duration (up to 21 months)
Data will be retrieved from study log.
Change in False-positive Rate: Number of Negative Confirmatory Polymerase Chain Reaction (PCR) as Compared to Total PCR Run for COVID-19 Testing
Time frame: Study duration (up to 21 months)
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.
Caregiver Change in Susceptibility: Number of Fully Vaccinated People Who Interact With Participant's Child at School
Time frame: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
* "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.
Caregiver Change in Susceptibility: School Takes Precautions
Time frame: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
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.
Caregiver Change in Susceptibility: Likely to Get COVID-19
Time frame: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
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.
Change in Percentage of Caregivers for Perceived Severity Survey Question: Health Severely Affected
Time frame: 15 month, 18 month, 21 month, 24 month
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.
Change in Percentage of Caregivers to the Perceived Severity Survey Question: Health Permanently Reduced
Time frame: 15 month, 18 month, 21 month, 24 month
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.
Change in Percentage of Caregivers to the Perceived Severity Survey Question: Grave Health Consequences
Time frame: 15 month, 18 month, 21 month, 24 month
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.
Caregiver Change in Motivation for Child to Attend School (Quite a Bit / a Great Deal vs Not)
Time frame: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
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.
Caregiver Change in Perceived Benefits to Child Attending School: Important to Health
Time frame: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
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.
Caregiver Change in Perceived Benefits to Child Attending School: In-person Schooling
Time frame: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
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.
Caregiver Change in Perceived Benefits to Child Attending School: Therapy Needs
Time frame: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
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.
Caregiver Change in Perceived Benefits to Child Attending School: Positive for Family
Time frame: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
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.
Caregiver Change in Perceived Benefits to Child Attending School: Positive for Staff
Time frame: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
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.
Caregiver Change in Perceived Benefits to Child Attending School: Keep Jobs
Time frame: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
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.
Caregiver Change in Barriers to School Attendance: Number of People
Time frame: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
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.
Caregiver Change in Barriers to School Attendance: Proximity
Time frame: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
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.
Caregiver Change in Barriers to School Attendance: PPE
Time frame: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
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.
Caregiver Change in Barriers to School Attendance: Testing
Time frame: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
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.
Caregiver Change in Barriers to School Attendance: Following Recommendations
Time frame: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
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.
Caregiver Change in Barriers to School Attendance: Transportation
Time frame: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
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.
Caregiver Change in Barriers to School Attendance: Wash
Time frame: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
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.
Caregiver Change in Barriers to School Attendance: Close Contact
Time frame: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
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.
Caregiver Change in Barriers to School Attendance: Masking
Time frame: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
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.
Caregiver Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)
Time frame: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
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.
Caregiver Change in Option and Practice: School Attendance
Time frame: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
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.
Caregiver Change in Option and Practice: Option to Attend School
Time frame: Baseline, 3 month, 6 month, 9 month, 15 month, 18 month, 21 month, 24 month
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Coller, MD, MPH principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BinaxNOW Rapid Antigen System in people with Children With Medical Complexity (CMC) and COVID-19, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Protocol Uptake: Number of Children and Staff Consented Compared to Number of Approached (time frame: Study duration (up to 21 months)). The study lists 30 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.