| 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. | The number of participants analyzed must reflect the number of participants approached in addition to those consented. | Posted | | Number | | Caregiver/child dyads | | Study duration (up to 21 months) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| | | Title | Denominators | Categories |
|---|
| Number approached, consented | | | | Number approached, not consented | | |
| |
| 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. | | Posted | | Mean | Standard Deviation | BinaxNow Antigen COVID-19 Tests per week | | Every week up to 21 months | BinaxNOW Rapid Antigen COVID-19 Tests | BinaxNOW Rapid Antigen COVID-19 Tests | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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.
| | Posted | | Number | | BinaxNOW Rapid Antigen COVID-19 Tests | | Study duration (up to 21 months) | BinaxNOW Rapid Antigen COVID-19 Tests | BinaxNOW Rapid Antigen COVID-19 Tests | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| Primary | Change in Symptomatic Test Rate: Number of Symptomatic Tests Completed | Data will be collected from parents via survey. | | Posted | | Number | | Symptomatic BinaxNow Rapid Antigen Tests | | Study duration (up to 21 months) | BinaxNOW Rapid Antigen COVID-19 Tests | BinaxNOW Rapid Antigen COVID-19 Tests | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | | Posted | | Number | | BinaxNow Rapid Antigen COVID-19 Tests | | Study duration (up to 21 months) | BinaxNOW Rapid Antigen COVID-19 Tests | BinaxNOW Rapid Antigen COVID-19 Tests | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | | Posted | | Number | | Polymerase chain reaction for COVID-19 | | Study duration (up to 21 months) | COVID-19 PCR Tests | COVID-19 PCR Tests | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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). | | Posted | | Count of Participants | | Participants | | At month 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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) | The number analyzed varies per row due to varied response rates per question at each time point. | Posted | | Count of Participants | | Participants | | baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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")
| The number analyzed varies per row due to varied response rates per question at each time point. | Posted | | Count of Participants | | Participants | | baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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")
| The number analyzed varies per row due to varied response rates per question at each time point. | Posted | | Count of Participants | | Participants | | baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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")
| The number analyzed varies per row due to varied response rates per question at each time point. | Posted | | Count of Participants | | Participants | | 15 month, 18 month, 21 month, 24 month | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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")
| The number analyzed varies per row due to varied response rates per question at each time point. | Posted | | Count of Participants | | Participants | | 15 month, 18 month, 21 month, 24 month | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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")
| The number analyzed varies per row due to varied response rates per question at each time point. | Posted | | Count of Participants | | Participants | | 15 month, 18 month, 21 month, 24 month | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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?"
| The number analyzed varies per row due to varied response rates per question at each time point. | Posted | | Count of Participants | | Participants | | Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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")
| The number analyzed varies per row due to varied response rates per question at each time point. | Posted | | Count of Participants | | Participants | | Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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")
| The number analyzed varies per row due to varied response rates per question at each time point. | Posted | | Count of Participants | | Participants | | Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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")
| The number analyzed varies per row due to varied response rates per question at each time point. | Posted | | Count of Participants | | Participants | | Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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")
| The number analyzed varies per row due to varied response rates per question at each time point. | Posted | | Count of Participants | | Participants | | Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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")
| The number analyzed varies per row due to varied response rates per question at each time point. | Posted | | Count of Participants | | Participants | | Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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
| The number analyzed varies per row due to varied response rates per question at each time point. | Posted | | Count of Participants | | Participants | | Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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")
| The number analyzed varies per row due to varied response rates per question at each time point. | Posted | | Count of Participants | | Participants | | baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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")
| The number analyzed varies per row due to varied response rates per question at each time point. | Posted | | Count of Participants | | Participants | | Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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")
| The number analyzed varies per row due to varied response rates per question at each time point. | Posted | | Count of Participants | | Participants | | Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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")
| The number analyzed varies per row due to varied response rates per question at each time point. | Posted | | Count of Participants | | Participants | | Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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")
| The number analyzed varies per row due to varied response rates per question at each time point. | Posted | | Count of Participants | | Participants | | Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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")
| The number analyzed varies per row due to varied response rates per question at each time point. | Posted | | Count of Participants | | Participants | | Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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")
| The number analyzed varies per row due to varied response rates per question at each time point. | Posted | | Count of Participants | | Participants | | Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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")
| The number analyzed varies per row due to varied response rates per question at each time point. | Posted | | Count of Participants | | Participants | | Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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")
| The number analyzed varies per row due to varied response rates per question at each time point. | Posted | | Count of Participants | | Participants | | Baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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
| The number analyzed varies per row due to varied response rates per question at each time point. | Posted | | Count of Participants | | Participants | | baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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 | The number analyzed varies per row due to varied response rates per question at each time point. | Posted | | Count of Participants | | Participants | | baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | The number analyzed varies per row due to varied response rates per question at each time point. | Posted | | Count of Participants | | Participants | | baseline, 3 month, 6 month, 9-12 month, 15 month, 18 month, 21 month, 24 month | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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