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ReSET Aim 1a: Restarting Safe Education and Testing for Children With Medical Complexity - Feasibility of In-home Cohort COVID-19 Testing Strategies, and Associations With CMC Parent Perceptions About In-person School Attendance

ReSET Aim 1a: Restarting Safe Education and Testing for Children With Medical Complexity - Feasibility of In-home Cohort SARS-CoV-2 Testing Strategies, and Associations With CMC Parent Perceptions About In-person School Attendance

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04895085
Enrollment
51
Registered
2021-05-20
Start date
2021-04-27
Completion date
2023-09-15
Last updated
2024-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children With Medical Complexity (CMC), COVID-19

Keywords

Caregiver, in-person school attendance, In-home COVID testing

Brief summary

The purpose of this research study is to learn about the factors parents consider when deciding whether their child will go to school in-person or attend from home. Investigators are also interested in learning whether access to in-home COVID testing is of value to parents and also whether it affects decision-making about returning to school. This study is being done at UW-Madison in partnership between the Department of Pediatrics and the Department of Industrial and Systems Engineering. A total of 50 caregivers (plus their children with medical complexity) will participate in this study. Additionally, 20 caregivers involved in the study may also be invited to participate in a one-hour, virtual visit in which the caregiver demonstrates and discusses how they perform in-home COVID testing with their child. The results of the study may help researchers advance their understanding of in-home testing strategies for children with medical complexity.

Detailed description

During the first three months of the study, caregivers will be asked to perform the BinaxNOW Rapid Antigen test on their child twice-weekly. After the first three months of the study, the testing schedule will depend on the statewide (WI) community spread rate. If the rate of spread is above the threshold for higher risk of transmission in schools (defined by the CDC as ≥ 25 new cases per 100,000 population in past 7 days) caregivers will be asked to continue twice-weekly surveillance. If it is below the threshold, caregivers will be offered the option to continue twice-weekly testing or switch to symptomatic-only testing. The study staff will notify caregivers of changes in testing frequency during their weekly communication. Caregivers will be asked to document their testing activities, results, and any possible COVID-19 symptoms on a Parent Testing Log. If testing produces a negative result, the caregiver will be instructed to document the test result on their testing log. While false negative tests are possible with asymptomatic individuals, there will be no change in standard mitigation measures based on the test results (mandatory masks in school, social distancing, hand hygiene, etc.). If testing produces a positive result from an asymptomatic individual, the caregiver will be instructed to contact the study team immediately and then obtain a PCR (polymerase chain reaction) test within 48 hours. The study staff will assist the caregiver in making arrangements for this test. In the case of positive tests, children will be restricted from school activities per public health guidelines until the results of the PCR testing are known. If the PCR test returns as a negative result and the child is attending school in-person, they will be allowed to return to school the next day (or if symptomatic, once symptoms resolve). If the PCR returns as positive, the caregiver will be instructed to keep the child at home per public health guidelines. To support families and ensure these steps occur, the study staff will call families daily following positive tests.

Interventions

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.

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

This is a single site study taking place over 24 months and involving (50) caregivers and their children with medical complexity. Additionally, (20) of these caregivers will be invited to participate in an hour-long, virtual contextual inquiry session.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

In order to be eligible to participate in this study, the caregiver/child must meet the following criteria: * The caregiver is willing to comply with all study procedures and expects to be available for the duration of the study. * The caregiver is at least 18 years of age. * The caregiver is proficient in English. * The caregiver is self-identified as the primary caregiver (parent, foster parent, legal guardian) of a CMC who is aged 5-16 years at the start of the study and who is enrolled in the Pediatric Complex Care Program (PCCP) at the University of WI-Madison. * The caregiver is currently providing care on an ongoing basis to their CMC. The child may not be housed in a skilled nursing facility, an acute care or transitional facility, a rehabilitative hospital, a medical group home or in a foster home (unless the primary caregiver for the study is the foster parent). * The caregiver has access to a web-enabled device (phone, tablet, or computer). * Caregiver and child are residents of Wisconsin. * The child attended in-person school pre-pandemic. (Child can currently be attending school in-person, remotely or a hybrid combination). * The caregiver provides a written informed consent form.

Exclusion criteria

* Failure to meet all inclusion criteria. * The child is hospitalized at the time of enrollment (visit may be rescheduled) * Children not currently enrolled in public or private school and whose caregiver has no plan to enroll them in the Fall of 2021 (e.g., children currently homeschooling with plans to homeschool in the Fall of 2021 are ineligible).

Design outcomes

Primary

MeasureTime frameDescription
Change in Protocol Uptake: Number of Participants Consented Compared to Number of Participants ApproachedStudy duration (up to 21 months)Feasibility of home based COVID-19 testing will be evaluated by protocol uptake. Data will be retrieved from the study log.
Change in Mean Number of Weekly in Home COVID-19 TestsEvery week up to 21 monthsFeasibility of home based COVID-19 testing will be evaluated by the mean number of weekly in home COVID-19 tests run by parents/caregivers. Data will be collected by survey.
Change in COVID Test Rate at Home: Number of Total Tests Completed as Compared to Number of Tests ExpectedStudy duration (up to 21 months)Data will be collected by survey. * Tests expected: Various scenarios factor into the tests expected value. Caregivers were expected to test their child twice a week every week for the first three months. After that time, caregivers could opt-in to surveillance testing (expected testing twice a week every week) or proceed with symptomatic-only testing (no expected tests for caregivers). Additionally, caregivers were not expected to test for 90 days after their child tested positive. * Tests completed: Caregivers were allowed to test more often than twice a week if appropriate (e.g., exposure to COVID-19). All symptomatic-only tests were not considered expected tests. These factors allowed the number of tests completed to exceed the number of tests expected.
Change in Symptomatic Test Rate: Number of Symptomatic Tests CompletedStudy duration (up to 21 months)Data will be collected from parents via survey.
Change in Positive Rate: Number of Positive COVID-19 Tests Compared to Total Number of Tests PerformedStudy duration (up to 21 months)Data will be collected from parents via survey.
Change in False-positive Rate: Number of Negative Confirmatory Polymerase Chain Reaction (PCR) as Compared to Total PCR Run for COVID-19 TestingStudy duration (up to 21 months)Data will be collected from parents via survey.
Surveillance Opt in: Number of Participants Opting Into Surveillance Compared to Total Number of Enrolled ParticipantsAt month 3Data will be collected from parents via survey. \- Caregivers were expected to test their child twice a week every week for the first three months. After that time, caregivers could opt-in to surveillance testing (expected testing twice a week every week) or proceed with symptomatic-only testing (no expected tests for caregivers).
Change in Susceptibility: Number of Fully Vaccinated People Who Interact With Participant's Child at Schoolbaseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 monthHow 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)
Change in Susceptibility: School Takes Precautionsbaseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 monthThe 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)
Change in Susceptibility: Likely to Get COVID-19baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 monthFollowing 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)
Change in Percentage of Participants for Perceived Severity Survey Question: Health Severely Affected15 month, 18 month, 21 month, 24 monthParent 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)
Change in Percentage of Participants to the Perceived Severity Survey Question: Health Permanently Reduced15 month, 18 month, 21 month, 24 monthParent 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)
Change in Percentage of Participants to the Perceived Severity Survey Question: Grave Health Consequences15 month, 18 month, 21 month, 24 monthParent 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)
Change in Motivation to Attend School (Quite a Bit / A Great Deal vs. Not)Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 monthParticipants 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?
Change in Perceived Benefits to Attend School: Important to HealthBaseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 monthParent 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)
Change in Perceived Benefits to Attend School: In-person SchoolingBaseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 monthParent 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)
Change in Perceived Benefits to Attend School: Therapy NeedsBaseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 monthParent 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)
Change in Perceived Benefits to Attend School: Positive for FamilyBaseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 monthParent 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)
Change in Perceived Benefits to Attend School: Positive for StaffBaseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 monthParent 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)
Change in Perceived Benefits to Attend School: Keep JobsBaseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 monthParent 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
Change in Barriers to School Attendance: Number of Peoplebaseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 monthSurvey 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)
Change in Barriers to School Attendance: ProximityBaseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 monthSurvey 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)
Change in Barriers to School Attendance: PPEBaseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 monthSurvey 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)
Change in Barriers to School Attendance: TestingBaseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 monthSurvey 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)
Change in Barriers to School Attendance: Following RecommendationsBaseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 monthSurvey 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)
Change in Barriers to School Attendance: TransportationBaseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 monthSurvey 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)
Change in Barriers to School Attendance: WashBaseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 monthSurvey 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)
Change in Barriers to School Attendance: Close ContactBaseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 monthSurvey 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)
Change in Barriers to School Attendance: MaskingBaseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 monthSurvey 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)
Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 monthParticipants will answer the following survey question in Yes/No: * Teachers/staff have asked for my child to attend school.- Y/N
Change in Option and Practice: Currently, is Child Attending School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/Nbaseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 monthParticipant will be asked the attendance question in survey. It will be answered in Yes/No
Change in Option and Practice: Currently, if Participant Wanted, Could the Child Attend School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/Nbaseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 monthParticipant will be asked the attendance question in survey. It will be answered in Yes/No. 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.

Countries

United States

Participant flow

Pre-assignment details

The protocol enrollment, started, and completed values reflect caregiver/child dyads. All dyads assigned to the intervention had one caregiver to one child (n = 51 caregivers, n = 51 children). All participants were assigned to the intervention group.

Participants by arm

ArmCount
Caregiver of Children With Medical Complexity (CMC)
BinaxNOW Rapid Antigen System: BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes. The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more.
51
Child With Medical Complexity
BinaxNOW Rapid Antigen System: BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes. The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more.
51
Total102

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyDeath1
Overall StudyNo longer eligible: Moved from area1
Overall StudyWithdrawal by Subject1

Baseline characteristics

CharacteristicCaregiver of Children With Medical Complexity (CMC)Child With Medical ComplexityTotal
Age, Categorical
<=18 years
0 Participants51 Participants51 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
51 Participants0 Participants51 Participants
Age, Continuous39 years9 yearsNA years
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants6 Participants10 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
46 Participants44 Participants90 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants1 Participants2 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Asian
2 Participants1 Participants3 Participants
Race (NIH/OMB)
Black or African American
0 Participants1 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants4 Participants4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants2 Participants5 Participants
Race (NIH/OMB)
White
46 Participants42 Participants88 Participants
Region of Enrollment
United States
51 Participants51 Participants102 Participants
Sex: Female, Male
Female
48 Participants20 Participants68 Participants
Sex: Female, Male
Male
3 Participants31 Participants34 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
1 / 51
other
Total, other adverse events
0 / 51
serious
Total, serious adverse events
0 / 51

Outcome results

Primary

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)

Time frame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Close ContactBaselineYes, all of the time or Yes, most of the time47 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Close ContactBaselineSome of the time, Rarely, or Not at all4 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Close Contact3 monthYes, all of the time or Yes, most of the time42 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Close Contact3 monthSome of the time, Rarely, or Not at all6 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Close Contact6 monthYes, all of the time or Yes, most of the time41 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Close Contact6 monthSome of the time, Rarely, or Not at all5 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Close Contact9 monthYes, all of the time or Yes, most of the time44 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Close Contact9 monthSome of the time, Rarely, or Not at all1 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Close Contact15 monthYes, all of the time or Yes, most of the time36 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Close Contact15 monthSome of the time, Rarely, or Not at all3 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Close Contact18 monthYes, all of the time or Yes, most of the time36 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Close Contact18 monthSome of the time, Rarely, or Not at all3 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Close Contact21 monthYes, all of the time or Yes, most of the time40 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Close Contact21 monthSome of the time, Rarely, or Not at all3 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Close Contact24 monthYes, all of the time or Yes, most of the time43 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Close Contact24 monthSome of the time, Rarely, or Not at all1 Participants
Primary

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)

Time frame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Following Recommendations18 monthVery or Extremely comfortable13 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Following Recommendations18 monthNot at all, A little, or Somewhat comfortable26 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Following RecommendationsBaselineVery or Extremely comfortable13 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Following RecommendationsBaselineNot at all, A little, or Somewhat comfortable38 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Following Recommendations3 monthVery or Extremely comfortable15 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Following Recommendations3 monthNot at all, A little, or Somewhat comfortable33 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Following Recommendations6 monthVery or Extremely comfortable14 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Following Recommendations6 monthNot at all, A little, or Somewhat comfortable32 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Following Recommendations9 monthVery or Extremely comfortable14 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Following Recommendations9 monthNot at all, A little, or Somewhat comfortable31 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Following Recommendations15 monthVery or Extremely comfortable9 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Following Recommendations15 monthNot at all, A little, or Somewhat comfortable30 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Following Recommendations21 monthVery or Extremely comfortable11 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Following Recommendations21 monthNot at all, A little, or Somewhat comfortable32 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Following Recommendations24 monthVery or Extremely comfortable14 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Following Recommendations24 monthNot at all, A little, or Somewhat comfortable31 Participants
Primary

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)

Time frame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: MaskingBaselineYes, all of the time or Yes, most of the time24 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: MaskingBaselineSome of the time, Rarely, or Not at all27 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Masking3 monthYes, all of the time or Yes, most of the time23 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Masking24 monthSome of the time, Rarely, or Not at all28 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Masking3 monthSome of the time, Rarely, or Not at all25 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Masking6 monthYes, all of the time or Yes, most of the time21 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Masking6 monthSome of the time, Rarely, or Not at all25 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Masking9 monthYes, all of the time or Yes, most of the time19 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Masking9 monthSome of the time, Rarely, or Not at all26 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Masking15 monthYes, all of the time or Yes, most of the time18 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Masking15 monthSome of the time, Rarely, or Not at all21 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Masking18 monthYes, all of the time or Yes, most of the time16 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Masking18 monthSome of the time, Rarely, or Not at all23 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Masking21 monthYes, all of the time or Yes, most of the time14 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Masking21 monthSome of the time, Rarely, or Not at all29 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Masking24 monthYes, all of the time or Yes, most of the time16 Participants
Primary

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)

Time frame: baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Number of People6 monthNot at all, A little, or Somewhat comfortable29 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Number of People9 monthVery or Extremely comfortable19 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Number of PeopleBaselineVery or Extremely comfortable21 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Number of PeopleBaselineNot at all, A little, or Somewhat comfortable30 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Number of People3 monthVery or Extremely comfortable14 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Number of People3 monthNot at all, A little, or Somewhat comfortable34 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Number of People6 monthVery or Extremely comfortable17 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Number of People9 monthNot at all, A little, or Somewhat comfortable26 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Number of People15 monthVery or Extremely comfortable12 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Number of People15 monthNot at all, A little, or Somewhat comfortable27 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Number of People18 monthVery or Extremely comfortable14 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Number of People18 monthNot at all, A little, or Somewhat comfortable25 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Number of People21 monthVery or Extremely comfortable13 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Number of People21 monthNot at all, A little, or Somewhat comfortable30 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Number of People24 monthVery or Extremely comfortable15 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Number of People24 monthNot at all, A little, or Somewhat comfortable30 Participants
Primary

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)

Time frame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: PPEBaselineNot at all, A little, or Somewhat comfortable27 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: PPE3 monthVery or Extremely comfortable20 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: PPE9 monthNot at all, A little, or Somewhat comfortable25 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: PPEBaselineVery or Extremely comfortable24 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: PPE3 monthNot at all, A little, or Somewhat comfortable28 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: PPE6 monthVery or Extremely comfortable25 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: PPE6 monthNot at all, A little, or Somewhat comfortable21 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: PPE9 monthVery or Extremely comfortable20 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: PPE15 monthVery or Extremely comfortable10 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: PPE15 monthNot at all, A little, or Somewhat comfortable29 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: PPE18 monthVery or Extremely comfortable21 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: PPE18 monthNot at all, A little, or Somewhat comfortable18 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: PPE21 monthVery or Extremely comfortable19 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: PPE21 monthNot at all, A little, or Somewhat comfortable24 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: PPE24 monthVery or Extremely comfortable21 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: PPE24 monthNot at all, A little, or Somewhat comfortable24 Participants
Primary

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)

Time frame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Proximity21 monthNot at all, A little, or Somewhat comfortable31 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Proximity24 monthVery or Extremely comfortable18 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Proximity24 monthNot at all, A little, or Somewhat comfortable27 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: ProximityBaselineVery or Extremely comfortable18 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: ProximityBaselineNot at all, A little, or Somewhat comfortable32 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Proximity3 monthVery or Extremely comfortable12 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Proximity3 monthNot at all, A little, or Somewhat comfortable36 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Proximity6 monthVery or Extremely comfortable18 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Proximity6 monthNot at all, A little, or Somewhat comfortable28 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Proximity9 monthVery or Extremely comfortable17 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Proximity9 monthNot at all, A little, or Somewhat comfortable28 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Proximity15 monthVery or Extremely comfortable11 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Proximity15 monthNot at all, A little, or Somewhat comfortable28 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Proximity18 monthVery or Extremely comfortable13 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Proximity18 monthNot at all, A little, or Somewhat comfortable26 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Proximity21 monthVery or Extremely comfortable12 Participants
Primary

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)

Time frame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Testing6 monthNot at all, A little, or Somewhat comfortable29 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Testing9 monthVery or Extremely comfortable18 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: TestingBaselineVery or Extremely comfortable11 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: TestingBaselineNot at all, A little, or Somewhat comfortable40 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Testing3 monthVery or Extremely comfortable14 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Testing3 monthNot at all, A little, or Somewhat comfortable34 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Testing6 monthVery or Extremely comfortable16 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Testing9 monthNot at all, A little, or Somewhat comfortable26 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Testing15 monthVery or Extremely comfortable10 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Testing15 monthNot at all, A little, or Somewhat comfortable29 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Testing18 monthVery or Extremely comfortable13 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Testing18 monthNot at all, A little, or Somewhat comfortable26 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Testing21 monthVery or Extremely comfortable13 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Testing21 monthNot at all, A little, or Somewhat comfortable30 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Testing24 monthVery or Extremely comfortable15 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Testing24 monthNot at all, A little, or Somewhat comfortable30 Participants
Primary

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)

Time frame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Transportation21 monthVery or Extremely difficult2 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Transportation3 monthNot at all, A little, or Somewhat difficult47 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: TransportationBaselineVery or Extremely difficult5 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: TransportationBaselineNot at all, A little, or Somewhat difficult46 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Transportation3 monthVery or Extremely difficult1 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Transportation6 monthVery or Extremely difficult3 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Transportation6 monthNot at all, A little, or Somewhat difficult43 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Transportation9 monthVery or Extremely difficult4 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Transportation9 monthNot at all, A little, or Somewhat difficult41 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Transportation15 monthVery or Extremely difficult4 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Transportation15 monthNot at all, A little, or Somewhat difficult35 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Transportation18 monthVery or Extremely difficult2 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Transportation18 monthNot at all, A little, or Somewhat difficult35 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Transportation21 monthNot at all, A little, or Somewhat difficult41 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Transportation24 monthVery or Extremely difficult1 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Transportation24 monthNot at all, A little, or Somewhat difficult44 Participants
Primary

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)

Time frame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: WashBaselineYes, all of the time or Yes, most of the time43 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: WashBaselineSome of the time, Rarely, or Not at all8 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Wash3 monthYes, all of the time or Yes, most of the time45 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Wash3 monthSome of the time, Rarely, or Not at all3 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Wash6 monthYes, all of the time or Yes, most of the time41 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Wash6 monthSome of the time, Rarely, or Not at all5 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Wash9 monthYes, all of the time or Yes, most of the time40 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Wash9 monthSome of the time, Rarely, or Not at all5 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Wash15 monthYes, all of the time or Yes, most of the time33 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Wash15 monthSome of the time, Rarely, or Not at all6 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Wash18 monthYes, all of the time or Yes, most of the time32 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Wash18 monthSome of the time, Rarely, or Not at all7 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Wash21 monthYes, all of the time or Yes, most of the time37 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Wash21 monthSome of the time, Rarely, or Not at all6 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Wash24 monthYes, all of the time or Yes, most of the time39 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Barriers to School Attendance: Wash24 monthSome of the time, Rarely, or Not at all6 Participants
Primary

Change in COVID Test Rate at Home: Number of Total Tests Completed as Compared to Number of Tests Expected

Data will be collected by survey. * Tests expected: Various scenarios factor into the tests expected value. Caregivers were expected to test their child twice a week every week for the first three months. After that time, caregivers could opt-in to surveillance testing (expected testing twice a week every week) or proceed with symptomatic-only testing (no expected tests for caregivers). Additionally, caregivers were not expected to test for 90 days after their child tested positive. * Tests completed: Caregivers were allowed to test more often than twice a week if appropriate (e.g., exposure to COVID-19). All symptomatic-only tests were not considered expected tests. These factors allowed the number of tests completed to exceed the number of tests expected.

Time frame: Study duration (up to 21 months)

ArmMeasureGroupValue (NUMBER)
Caregiver of Children With Medical Complexity (CMC)Change in COVID Test Rate at Home: Number of Total Tests Completed as Compared to Number of Tests ExpectedNumber of tests completed3254 BinaxNOW Rapid Antigen COVID-19 Tests
Caregiver of Children With Medical Complexity (CMC)Change in COVID Test Rate at Home: Number of Total Tests Completed as Compared to Number of Tests ExpectedNumber of tests expected2572 BinaxNOW Rapid Antigen COVID-19 Tests
Primary

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

Time frame: baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Caregiver of Children With Medical Complexity (CMC)Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)BaselineYes29 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)BaselineNo22 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)18-monthNo9 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)21-monthYes33 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)3-monthYes31 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)3-monthNo17 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)6-monthYes34 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)6-monthNo12 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)9-monthYes32 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)9-monthNo13 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)15-monthYes25 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)15-monthNo14 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)18-monthYes30 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)21-monthNo10 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)24-monthYes36 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Cues: Has a Teacher or Staff Member Encouraged Child to Attend School In-person? (Y/N)24-monthNo8 Participants
Primary

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 collected from parents via survey.

Time frame: Study duration (up to 21 months)

ArmMeasureGroupValue (NUMBER)
Caregiver of Children With Medical Complexity (CMC)Change in False-positive Rate: Number of Negative Confirmatory Polymerase Chain Reaction (PCR) as Compared to Total PCR Run for COVID-19 TestingNumber of negative confirmatory PCR tests1 Polymerase chain reaction for COVID-19
Caregiver of Children With Medical Complexity (CMC)Change in False-positive Rate: Number of Negative Confirmatory Polymerase Chain Reaction (PCR) as Compared to Total PCR Run for COVID-19 TestingTotal COVID-19 PCR tests109 Polymerase chain reaction for COVID-19
Primary

Change in Mean Number of Weekly in Home COVID-19 Tests

Feasibility of home based COVID-19 testing will be evaluated by the mean number of weekly in home COVID-19 tests run by parents/caregivers. Data will be collected by survey.

Time frame: Every week up to 21 months

ArmMeasureValue (MEAN)Dispersion
Caregiver of Children With Medical Complexity (CMC)Change in Mean Number of Weekly in Home COVID-19 Tests1.8 BinaxNow Antigen COVID-19 Tests per weekStandard Deviation 0.3
Primary

Change in Motivation 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?

Time frame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Caregiver of Children With Medical Complexity (CMC)Change in Motivation to Attend School (Quite a Bit / A Great Deal vs. Not)BaselineQuite a bit or A great deal33 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Motivation to Attend School (Quite a Bit / A Great Deal vs. Not)BaselineSomewhat, A little, or Not at all18 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Motivation to Attend School (Quite a Bit / A Great Deal vs. Not)3 monthSomewhat, A little, or Not at all19 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Motivation to Attend School (Quite a Bit / A Great Deal vs. Not)21 monthQuite a bit or A great deal33 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Motivation to Attend School (Quite a Bit / A Great Deal vs. Not)3 monthQuite a bit or A great deal29 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Motivation to Attend School (Quite a Bit / A Great Deal vs. Not)6 monthQuite a bit or A great deal29 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Motivation to Attend School (Quite a Bit / A Great Deal vs. Not)6 monthSomewhat, A little, or Not at all17 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Motivation to Attend School (Quite a Bit / A Great Deal vs. Not)9 monthQuite a bit or A great deal35 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Motivation to Attend School (Quite a Bit / A Great Deal vs. Not)9 monthSomewhat, A little, or Not at all10 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Motivation to Attend School (Quite a Bit / A Great Deal vs. Not)15 monthQuite a bit or A great deal28 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Motivation to Attend School (Quite a Bit / A Great Deal vs. Not)15 monthSomewhat, A little, or Not at all11 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Motivation to Attend School (Quite a Bit / A Great Deal vs. Not)18 monthQuite a bit or A great deal27 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Motivation to Attend School (Quite a Bit / A Great Deal vs. Not)18 monthSomewhat, A little, or Not at all12 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Motivation to Attend School (Quite a Bit / A Great Deal vs. Not)21 monthSomewhat, A little, or Not at all9 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Motivation to Attend School (Quite a Bit / A Great Deal vs. Not)24 monthQuite a bit or A great deal35 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Motivation to Attend School (Quite a Bit / A Great Deal vs. Not)24 monthSomewhat, A little, or Not at all10 Participants
Primary

Change in Option and Practice: Currently, if Participant Wanted, Could the Child Attend School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N

Participant will be asked the attendance question in survey. It will be answered in Yes/No. 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.

Time frame: baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Caregiver of Children With Medical Complexity (CMC)Change in Option and Practice: Currently, if Participant Wanted, Could the Child Attend School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N6-monthYes8 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Option and Practice: Currently, if Participant Wanted, Could the Child Attend School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N6-monthNo3 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Option and Practice: Currently, if Participant Wanted, Could the Child Attend School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N24-monthYes4 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Option and Practice: Currently, if Participant Wanted, Could the Child Attend School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/NBaselineYes14 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Option and Practice: Currently, if Participant Wanted, Could the Child Attend School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/NBaselineNo8 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Option and Practice: Currently, if Participant Wanted, Could the Child Attend School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N3-monthYes9 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Option and Practice: Currently, if Participant Wanted, Could the Child Attend School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N3-monthNo4 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Option and Practice: Currently, if Participant Wanted, Could the Child Attend School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N9-monthYes7 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Option and Practice: Currently, if Participant Wanted, Could the Child Attend School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N9-monthNo1 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Option and Practice: Currently, if Participant Wanted, Could the Child Attend School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N15-monthYes4 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Option and Practice: Currently, if Participant Wanted, Could the Child Attend School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N15-monthNo3 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Option and Practice: Currently, if Participant Wanted, Could the Child Attend School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N18-monthYes3 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Option and Practice: Currently, if Participant Wanted, Could the Child Attend School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N18-monthNo3 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Option and Practice: Currently, if Participant Wanted, Could the Child Attend School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N21-monthYes4 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Option and Practice: Currently, if Participant Wanted, Could the Child Attend School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N21-monthNo2 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Option and Practice: Currently, if Participant Wanted, Could the Child Attend School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N24-monthNo3 Participants
Primary

Change in Option and Practice: Currently, is Child Attending School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N

Participant will be asked the attendance question in survey. It will be answered in Yes/No

Time frame: baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Caregiver of Children With Medical Complexity (CMC)Change in Option and Practice: Currently, is Child Attending School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/NBaselineYes29 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Option and Practice: Currently, is Child Attending School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/NBaselineNo22 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Option and Practice: Currently, is Child Attending School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N3-monthYes35 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Option and Practice: Currently, is Child Attending School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N3-monthNo13 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Option and Practice: Currently, is Child Attending School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N6-monthYes35 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Option and Practice: Currently, is Child Attending School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N6-monthNo11 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Option and Practice: Currently, is Child Attending School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N9-monthYes37 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Option and Practice: Currently, is Child Attending School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N9-monthNo8 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Option and Practice: Currently, is Child Attending School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N15-monthYes32 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Option and Practice: Currently, is Child Attending School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N15-monthNo7 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Option and Practice: Currently, is Child Attending School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N18-monthYes33 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Option and Practice: Currently, is Child Attending School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N18-monthNo6 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Option and Practice: Currently, is Child Attending School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N21-monthYes37 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Option and Practice: Currently, is Child Attending School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N21-monthNo6 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Option and Practice: Currently, is Child Attending School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N24-monthYes38 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Option and Practice: Currently, is Child Attending School In-person, Either Full-time or as Part of a Hybrid or Part-time Schedule? Y/N24-monthNo7 Participants
Primary

Change in Perceived Benefits to Attend 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)

Time frame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Important to Health9 monthNot at all important, A little important, or Somewhat important11 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Important to Health15 monthVery important or Extremely important29 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Important to HealthBaselineVery important or Extremely important37 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Important to HealthBaselineNot at all important, A little important, or Somewhat important14 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Important to Health3 monthVery important or Extremely important29 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Important to Health3 monthNot at all important, A little important, or Somewhat important19 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Important to Health6 monthVery important or Extremely important31 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Important to Health6 monthNot at all important, A little important, or Somewhat important15 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Important to Health9 monthVery important or Extremely important34 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Important to Health15 monthNot at all important, A little important, or Somewhat important10 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Important to Health18 monthVery important or Extremely important31 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Important to Health18 monthNot at all important, A little important, or Somewhat important8 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Important to Health21 monthVery important or Extremely important32 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Important to Health21 monthNot at all important, A little important, or Somewhat important10 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Important to Health24 monthVery important or Extremely important29 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Important to Health24 monthNot at all important, A little important, or Somewhat important15 Participants
Primary

Change in Perceived Benefits to Attend 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)

Time frame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: In-person Schooling3 monthQuite a bit worse, Somewhat worse, A little bit worse, or Neither better nor worse15 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: In-person SchoolingBaselineQuite a bit worse, Somewhat worse, A little bit worse, or Neither better nor worse15 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: In-person Schooling3 monthA little bit better, Somewhat better, or Quite a bit better33 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: In-person Schooling6 monthQuite a bit worse, Somewhat worse, A little bit worse, or Neither better nor worse14 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: In-person Schooling9 monthQuite a bit worse, Somewhat worse, A little bit worse, or Neither better nor worse10 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: In-person Schooling15 monthA little bit better, Somewhat better, or Quite a bit better32 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: In-person Schooling21 monthA little bit better, Somewhat better, or Quite a bit better37 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: In-person SchoolingBaselineA little bit better, Somewhat better, or Quite a bit better35 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: In-person Schooling6 monthA little bit better, Somewhat better, or Quite a bit better32 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: In-person Schooling9 monthA little bit better, Somewhat better, or Quite a bit better35 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: In-person Schooling15 monthQuite a bit worse, Somewhat worse, A little bit worse, or Neither better nor worse7 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: In-person Schooling18 monthA little bit better, Somewhat better, or Quite a bit better29 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: In-person Schooling18 monthQuite a bit worse, Somewhat worse, A little bit worse, or Neither better nor worse10 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: In-person Schooling21 monthQuite a bit worse, Somewhat worse, A little bit worse, or Neither better nor worse6 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: In-person Schooling24 monthA little bit better, Somewhat better, or Quite a bit better36 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: In-person Schooling24 monthQuite a bit worse, Somewhat worse, A little bit worse, or Neither better nor worse9 Participants
Primary

Change in Perceived Benefits to Attend 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

Time frame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Keep JobsBaselineYes32 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Keep JobsBaselineNo19 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Keep Jobs3 monthYes29 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Keep Jobs3 monthNo19 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Keep Jobs6 monthYes26 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Keep Jobs6 monthNo20 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Keep Jobs9 monthYes24 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Keep Jobs9 monthNo21 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Keep Jobs15 monthYes22 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Keep Jobs15 monthNo17 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Keep Jobs18 monthYes25 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Keep Jobs18 monthNo14 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Keep Jobs21 monthYes29 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Keep Jobs21 monthNo14 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Keep Jobs24 monthYes28 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Keep Jobs24 monthNo17 Participants
Primary

Change in Perceived Benefits to Attend 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)

Time frame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Positive for FamilyBaselineVery negative, Somewhat negative, or A little negative, Neutral13 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Positive for Family3 monthA little positive, Somewhat positive, or Very positive37 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Positive for Family3 monthVery negative, Somewhat negative, or A little negative, Neutral11 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Positive for Family9 monthA little positive, Somewhat positive, or Very positive38 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Positive for Family21 monthA little positive, Somewhat positive, or Very positive36 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Positive for Family24 monthVery negative, Somewhat negative, or A little negative, Neutral8 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Positive for FamilyBaselineA little positive, Somewhat positive, or Very positive37 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Positive for Family6 monthA little positive, Somewhat positive, or Very positive38 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Positive for Family6 monthVery negative, Somewhat negative, or A little negative, Neutral8 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Positive for Family9 monthVery negative, Somewhat negative, or A little negative, Neutral7 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Positive for Family15 monthA little positive, Somewhat positive, or Very positive31 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Positive for Family15 monthVery negative, Somewhat negative, or A little negative, Neutral8 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Positive for Family18 monthA little positive, Somewhat positive, or Very positive30 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Positive for Family18 monthVery negative, Somewhat negative, or A little negative, Neutral9 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Positive for Family21 monthVery negative, Somewhat negative, or A little negative, Neutral7 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Positive for Family24 monthA little positive, Somewhat positive, or Very positive37 Participants
Primary

Change in Perceived Benefits to Attend 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)

Time frame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Positive for Staff18 monthA little positive, Somewhat positive, or Very positive30 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Positive for Staff18 monthVery negative, Somewhat negative, or A little negative, Neutral9 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Positive for Staff21 monthA little positive, Somewhat positive, or Very positive36 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Positive for StaffBaselineA little positive, Somewhat positive, or Very positive34 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Positive for StaffBaselineVery negative, Somewhat negative, or A little negative, Neutral16 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Positive for Staff3 monthA little positive, Somewhat positive, or Very positive36 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Positive for Staff3 monthVery negative, Somewhat negative, or A little negative, Neutral11 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Positive for Staff6 monthA little positive, Somewhat positive, or Very positive32 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Positive for Staff6 monthVery negative, Somewhat negative, or A little negative, Neutral14 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Positive for Staff9 monthA little positive, Somewhat positive, or Very positive38 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Positive for Staff9 monthVery negative, Somewhat negative, or A little negative, Neutral7 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Positive for Staff15 monthA little positive, Somewhat positive, or Very positive28 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Positive for Staff15 monthVery negative, Somewhat negative, or A little negative, Neutral11 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Positive for Staff21 monthVery negative, Somewhat negative, or A little negative, Neutral7 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Positive for Staff24 monthA little positive, Somewhat positive, or Very positive36 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Positive for Staff24 monthVery negative, Somewhat negative, or A little negative, Neutral9 Participants
Primary

Change in Perceived Benefits to Attend 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)

Time frame: Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Therapy Needs3 monthMost, All32 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Therapy Needs3 monthNone, A few, Some16 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Therapy Needs21 monthMost, All29 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Therapy Needs9 monthMost, All31 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Therapy NeedsBaselineMost, All38 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Therapy NeedsBaselineNone, A few, Some13 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Therapy Needs6 monthMost, All33 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Therapy Needs6 monthNone, A few, Some13 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Therapy Needs9 monthNone, A few, Some14 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Therapy Needs15 monthMost, All26 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Therapy Needs15 monthNone, A few, Some13 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Therapy Needs18 monthMost, All27 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Therapy Needs18 monthNone, A few, Some12 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Therapy Needs21 monthNone, A few, Some14 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Therapy Needs24 monthMost, All30 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Perceived Benefits to Attend School: Therapy Needs24 monthNone, A few, Some15 Participants
Primary

Change in Percentage of Participants 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)

Time frame: 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Caregiver of Children With Medical Complexity (CMC)Change in Percentage of Participants for Perceived Severity Survey Question: Health Severely Affected24 monthNot at all, A little, or Somewhat likely19 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Percentage of Participants for Perceived Severity Survey Question: Health Severely Affected15 monthVery or Extremely likely20 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Percentage of Participants for Perceived Severity Survey Question: Health Severely Affected15 monthNot at all, A little, or Somewhat likely18 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Percentage of Participants for Perceived Severity Survey Question: Health Severely Affected18 monthVery or Extremely likely25 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Percentage of Participants for Perceived Severity Survey Question: Health Severely Affected18 monthNot at all, A little, or Somewhat likely14 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Percentage of Participants for Perceived Severity Survey Question: Health Severely Affected21 monthVery or Extremely likely29 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Percentage of Participants for Perceived Severity Survey Question: Health Severely Affected21 monthNot at all, A little, or Somewhat likely14 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Percentage of Participants for Perceived Severity Survey Question: Health Severely Affected24 monthVery or Extremely likely26 Participants
Primary

Change in Percentage of Participants 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)

Time frame: 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Caregiver of Children With Medical Complexity (CMC)Change in Percentage of Participants to the Perceived Severity Survey Question: Grave Health Consequences15 monthVery or Extremely likely17 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Percentage of Participants to the Perceived Severity Survey Question: Grave Health Consequences18 monthVery or Extremely likely21 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Percentage of Participants to the Perceived Severity Survey Question: Grave Health Consequences24 monthNot at all, A little, or Somewhat likely24 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Percentage of Participants to the Perceived Severity Survey Question: Grave Health Consequences15 monthNot at all, A little, or Somewhat likely21 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Percentage of Participants to the Perceived Severity Survey Question: Grave Health Consequences18 monthNot at all, A little, or Somewhat likely18 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Percentage of Participants to the Perceived Severity Survey Question: Grave Health Consequences21 monthVery or Extremely likely19 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Percentage of Participants to the Perceived Severity Survey Question: Grave Health Consequences21 monthNot at all, A little, or Somewhat likely24 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Percentage of Participants to the Perceived Severity Survey Question: Grave Health Consequences24 monthVery or Extremely likely20 Participants
Primary

Change in Percentage of Participants 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)

Time frame: 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Caregiver of Children With Medical Complexity (CMC)Change in Percentage of Participants to the Perceived Severity Survey Question: Health Permanently Reduced24-monthVery or Extremely likely19 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Percentage of Participants to the Perceived Severity Survey Question: Health Permanently Reduced24-monthNot at all, A little, or Somewhat likely26 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Percentage of Participants to the Perceived Severity Survey Question: Health Permanently Reduced15-monthVery or Extremely likely17 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Percentage of Participants to the Perceived Severity Survey Question: Health Permanently Reduced15-monthNot at all, A little, or Somewhat likely21 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Percentage of Participants to the Perceived Severity Survey Question: Health Permanently Reduced18-monthVery or Extremely likely20 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Percentage of Participants to the Perceived Severity Survey Question: Health Permanently Reduced18-monthNot at all, A little, or Somewhat likely19 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Percentage of Participants to the Perceived Severity Survey Question: Health Permanently Reduced21-monthVery or Extremely likely18 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Percentage of Participants to the Perceived Severity Survey Question: Health Permanently Reduced21-monthNot at all, A little, or Somewhat likely25 Participants
Primary

Change in Positive Rate: Number of Positive COVID-19 Tests Compared to Total Number of Tests Performed

Data will be collected from parents via survey.

Time frame: Study duration (up to 21 months)

ArmMeasureGroupValue (NUMBER)
Caregiver of Children With Medical Complexity (CMC)Change in Positive Rate: Number of Positive COVID-19 Tests Compared to Total Number of Tests PerformedNumber of positive COVID-19 tests39 BinaxNow Rapid Antigen COVID-19 Tests
Caregiver of Children With Medical Complexity (CMC)Change in Positive Rate: Number of Positive COVID-19 Tests Compared to Total Number of Tests PerformedTotal number of tests performed3254 BinaxNow Rapid Antigen COVID-19 Tests
Primary

Change in Protocol Uptake: Number of Participants Consented Compared to Number of Participants Approached

Feasibility of home based COVID-19 testing will be evaluated by protocol uptake. Data will be retrieved from the study log.

Time frame: Study duration (up to 21 months)

Population: The number of participants analyzed must reflect the number of participants approached in addition to those consented.

ArmMeasureGroupValue (NUMBER)
Caregiver of Children With Medical Complexity (CMC)Change in Protocol Uptake: Number of Participants Consented Compared to Number of Participants ApproachedNumber approached, consented51 Caregiver/child dyads
Caregiver of Children With Medical Complexity (CMC)Change in Protocol Uptake: Number of Participants Consented Compared to Number of Participants ApproachedNumber approached, not consented33 Caregiver/child dyads
Primary

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)

Time frame: baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: Likely to Get COVID-1924 monthsVery or Extremely likely25 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: Likely to Get COVID-196 monthsNot at all, A little, or Somewhat likely24 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: Likely to Get COVID-19BaselineVery or Extremely likely22 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: Likely to Get COVID-19BaselineNot at all, A little, or Somewhat likely29 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: Likely to Get COVID-193 monthsVery or Extremely likely18 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: Likely to Get COVID-193 monthsNot at all, A little, or Somewhat likely30 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: Likely to Get COVID-196 monthsVery or Extremely likely21 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: Likely to Get COVID-199 monthsVery or Extremely likely16 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: Likely to Get COVID-199 monthsNot at all, A little, or Somewhat likely28 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: Likely to Get COVID-1915 monthsVery or Extremely likely19 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: Likely to Get COVID-1915 monthsNot at all, A little, or Somewhat likely20 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: Likely to Get COVID-1918 monthsVery or Extremely likely23 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: Likely to Get COVID-1918 monthsNot at all, A little, or Somewhat likely16 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: Likely to Get COVID-1921 monthsVery or Extremely likely23 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: Likely to Get COVID-1921 monthsNot at all, A little, or Somewhat likely19 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: Likely to Get COVID-1924 monthsNot at all, A little, or Somewhat likely20 Participants
Primary

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)

Time frame: baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: Number of Fully Vaccinated People Who Interact With Participant's Child at School9-monthMost or All of the people who interact with their child at school have been fully vaccinated10 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: Number of Fully Vaccinated People Who Interact With Participant's Child at School21-monthNone, A few, Some, Don't Know26 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: Number of Fully Vaccinated People Who Interact With Participant's Child at School24-monthMost or All of the people who interact with their child at school have been fully vaccinated17 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: Number of Fully Vaccinated People Who Interact With Participant's Child at School24-monthNone, A few, Some, Don't Know27 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: Number of Fully Vaccinated People Who Interact With Participant's Child at SchoolBaselineMost or All of the people who interact with their child at school have been fully vaccinated12 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: Number of Fully Vaccinated People Who Interact With Participant's Child at SchoolBaselineNone, A few, Some, Don't Know39 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: Number of Fully Vaccinated People Who Interact With Participant's Child at School3-monthMost or All of the people who interact with their child at school have been fully vaccinated9 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: Number of Fully Vaccinated People Who Interact With Participant's Child at School3-monthNone, A few, Some, Don't Know39 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: Number of Fully Vaccinated People Who Interact With Participant's Child at School6-monthMost or All of the people who interact with their child at school have been fully vaccinated12 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: Number of Fully Vaccinated People Who Interact With Participant's Child at School6-monthNone, A few, Some, Don't Know34 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: Number of Fully Vaccinated People Who Interact With Participant's Child at School9-monthNone, A few, Some, Don't Know35 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: Number of Fully Vaccinated People Who Interact With Participant's Child at School15-monthMost or All of the people who interact with their child at school have been fully vaccinated16 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: Number of Fully Vaccinated People Who Interact With Participant's Child at School15-monthNone, A few, Some, Don't Know23 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: Number of Fully Vaccinated People Who Interact With Participant's Child at School18-monthMost or All of the people who interact with their child at school have been fully vaccinated15 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: Number of Fully Vaccinated People Who Interact With Participant's Child at School18-monthNone, A few, Some, Don't Know24 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: Number of Fully Vaccinated People Who Interact With Participant's Child at School21-monthMost or All of the people who interact with their child at school have been fully vaccinated15 Participants
Primary

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)

Time frame: baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month

Population: The number analyzed varies per row due to varied response rates per question at each time point.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: School Takes Precautions9-12 monthsNot at all, A little, or Somewhat comfortable21 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: School Takes PrecautionsBaselineVery or Extremely comfortable24 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: School Takes PrecautionsBaselineNot at all, A little, or Somewhat comfortable27 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: School Takes Precautions3 monthsVery or Extremely comfortable17 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: School Takes Precautions3 monthsNot at all, A little, or Somewhat comfortable31 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: School Takes Precautions6 monthsVery or Extremely comfortable20 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: School Takes Precautions6 monthsNot at all, A little, or Somewhat comfortable26 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: School Takes Precautions9-12 monthsVery or Extremely comfortable24 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: School Takes Precautions15 monthsVery or Extremely comfortable16 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: School Takes Precautions15 monthsNot at all, A little, or Somewhat comfortable23 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: School Takes Precautions18 monthsVery or Extremely comfortable16 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: School Takes Precautions18 monthsNot at all, A little, or Somewhat comfortable21 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: School Takes Precautions21 monthsVery or Extremely comfortable13 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: School Takes Precautions21 monthsNot at all, A little, or Somewhat comfortable30 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: School Takes Precautions24 monthsVery or Extremely comfortable21 Participants
Caregiver of Children With Medical Complexity (CMC)Change in Susceptibility: School Takes Precautions24 monthsNot at all, A little, or Somewhat comfortable24 Participants
Primary

Change in Symptomatic Test Rate: Number of Symptomatic Tests Completed

Data will be collected from parents via survey.

Time frame: Study duration (up to 21 months)

ArmMeasureValue (NUMBER)
Caregiver of Children With Medical Complexity (CMC)Change in Symptomatic Test Rate: Number of Symptomatic Tests Completed729 Symptomatic BinaxNow Rapid Antigen Tests
Primary

Surveillance Opt in: Number of Participants Opting Into Surveillance Compared to Total Number of Enrolled Participants

Data will be collected from parents via survey. \- Caregivers were expected to test their child twice a week every week for the first three months. After that time, caregivers could opt-in to surveillance testing (expected testing twice a week every week) or proceed with symptomatic-only testing (no expected tests for caregivers).

Time frame: At month 3

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Caregiver of Children With Medical Complexity (CMC)Surveillance Opt in: Number of Participants Opting Into Surveillance Compared to Total Number of Enrolled ParticipantsParticipants opting into surveillance testing32 Participants
Caregiver of Children With Medical Complexity (CMC)Surveillance Opt in: Number of Participants Opting Into Surveillance Compared to Total Number of Enrolled ParticipantsParticipants not opting into surveillance testing19 Participants

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026