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This study aims to get children safely back to school by (1) Child and Family Testing, (2) ECE Personnel Testing, and (3) Outdoor Learning via Garden Education.
This study aims to get children safely back to school with a three strategy approach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHILD testing | Experimental | One child and parent dyad will be tested for COVID-19 using the ASU saliva test as part of back-to-ECE safely programming. All sites will receive this condition. |
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| CHILD+ personnel testing | Experimental | This arm receives the CHILD condition plus ECE site personnel are screened biweekly for COVID-19 using the ASU saliva test. |
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| SAGE garden | Experimental | The SAGE arm is a garden-based curriculum that emphasizes outdoor learning opportunities such as active games, songs, and garden-activities. About half of the original 40 sites (roughly evenly divided by CHILD and CHILD+) will receive this in year one, and the remaining sites will receive this condition in year two. |
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| Wait list | Sham Comparator | Those in the wait list condition will receive SAGE in year two. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHILD back-to-ECE COVID-19 saliva testing | Behavioral | Preschool children and their parent will complete saliva COVID-19 tests at the start of the school year and after winter break as part of a back-to-ECE safely intervention. Tests may be completed during pick up, at drop off, or during school, depending on local on-campus regulations. |
| Measure | Description | Time Frame |
|---|---|---|
| Viable sample | Proportion of viable saliva samples obtained from children | Within six weeks from the start of school (varies by site and semester) |
| Proportion of Children Attending ECE | Aggregated weekly attendance of children in ECE sites and comparison (non-participating) sites. | within four weeks of the end of school (varies by site and semester) |
| Progressive Aerobic Cardiovascular Endurance Run (PACER) | Product-based quantitative, locomotor skills test | Baseline pre-intervention |
| Progressive Aerobic Cardiovascular Endurance Run (PACER) | Product-based quantitative, locomotor skills test | Post-test up to four weeks after intervention |
| Children's Activity and Movement in Preschool Study (CHAMPS) motor skill protocol | Process-based quantitative, locomotor skills test that tests skills of running, broad jumping, sliding, galloping, leaping, and hopping | Baseline pre-intervention |
| Children's Activity and Movement in Preschool Study (CHAMPS) motor skill protocol | Process-based quantitative, locomotor skills test that tests skills of running, broad jumping, sliding, galloping, leaping, and hopping | Posttest up to four week post-intervention |
| Eating in the absence of hunger | Behavioral, quantitative test of eating when one is not hungry |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability and feasibility of saliva COVID-19 test | Self-report survey scale that measures difficulty, satisfaction and repeatability of COVID-19 test. | At time of COVID-19 test within six weeks from the start of school (varies by site and semester) |
| Cost to obtain a sample |
| Measure | Description | Time Frame |
|---|---|---|
| Demographics | Tier 1 Common Data Element (PhenX Toolkit): Age (Demo), Annual Family Income (Demo), Employment Status (Demo), Educational Attainment (Demo), Gender (Demo), Ethnicity/Race (Demo), Health Insurance Coverage (Demo) | Time 1 Baseline start of the semester |
| Vulnerability and Exposure to COVID-19 and Vaccine Acceptance |
Inclusion
Exclusion
-Children with health-compromising conditions (e.g., food allergies) that study activities might aggravate.
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Lee, PhD | Arizona State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona State University-Downtown Campus | Phoenix | Arizona | 85004 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37394507 | Derived | Lee RE, Todd M, Oh H, Han S, Santana M, Aguilar-Troncoso J, Bruening M, Kramer JL, Leon T, Murugan V, Valdez H, Villegas-Gold M. Acceptability and Feasibility of Saliva-delivered PCR Coronavirus 2019 Tests for Young Children. Pediatrics. 2023 Jul 1;152(Suppl 1):e2022060352D. doi: 10.1542/peds.2022-060352D. |
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All de-identified data is to be shared with the RADx-UP CDCC per the DTA.
Data will be available through the RADx-UP CDCC per their governing principles.
Access is through the RADx-UP CDCC.
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Participating ECE sites (N=40) will be block randomized to receive child and family back-to-ECE testing OR child and family testing plus ECE personnel biweekly testing. Of this same group of sites, half will be block randomized to complete an outdoor learning garden condition (SAGE) and have will receive waitlist. Waitlist sites will receive the garden condition delayed by one year.
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As this is community engaged research, full transparency is required.
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| ECE personnel back-to-ECE COVID-19 saliva screening | Behavioral | ECE personnel will complete saliva COVID-19 tests biweekly through the school year as part of a back-to-ECE safely intervention. Tests may be completed on the ECE campus or in the parking lot, depending on local on-campus regulations |
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| SAGE garden programming | Behavioral | The SAGE garden programming includes installation of a garden; teacher training via Zoom and/or short videos, a binder and website support along with other accompanying materials and teacher technical support (email, text, phone); gardening supplies and gear (e.g., hats, watering cans, gloves); and delivers active songs, games, science experiments and other outdoor learning opportunities. |
|
| Baseline pre-intervention |
| Eating in the absence of hunger | Behavioral, quantitative test of eating when one is not hungry | Posttest up to four weeks post-intervention |
Cost including personnel, time, materials, space to obtain a sample |
| Time 1 at the time of COVID-19 test, Within six weeks from the start of school (varies by site and semester) |
| Parent reports of COVID-19 household incidence | Brief questionnaire that measures self-report of COVID-19 cases in households enrolled in the project completed by parents approximately once per month | Approximately once per month following time 1, up to 10 months following time 1 (varies by site and semester) |
RADx-UP measure from the PhenX Toolkit of Vulnerability and Exposure to COVID-19 and Vaccine Acceptance |
| Time 1 Baseline start of the semester |
| ID | Term |
|---|---|
| D000068356 | Self-Control |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
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