Back to ECE Safely With SAGE: Reducing COVID-19 Transmission in Hispanic and Low-income Preschoolers
- Conditions
- COVID-19 TestingChildren, PreschoolSelf-ControlExerciseDiet, HealthyParentsChild Development
- Interventions
- Behavioral: CHILD back-to-ECE COVID-19 saliva testingBehavioral: ECE personnel back-to-ECE COVID-19 saliva screeningBehavioral: SAGE garden programming
- Registration Number
- NCT05178290
- Lead Sponsor
- Arizona State University
- Brief Summary
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.
- Detailed Description
This study aims to get children safely back to school with a three strategy approach.
1. Child and Family Testing. Investigators will determine acceptability, feasibility, efficacy and scalability of testing children and families as a pre-screening strategy for re-entry to 40 CACFP-eligible ECE sites for fall 2021. Our trained bilingual ASU team (vaccinated staff and nursing students) will provide onsite testing ECE sites. Investigators will assess acceptability and feasibility via brief parent surveys and developmentally appropriate icon ratings for children, and assess efficacy as the proportion of viable samples obtained, coaching time needed to obtain one sample, and proportion of successfully obtained samples. Investigators will document costs of delivering the screening strategy (e.g., personnel, time, materials) to determine scalability. For participants testing positive for COVID-19, community health workers from Equality Health Services will provide follow-up care.
2. ECE Personnel Testing. Investigators will determine the acceptability, feasibility, efficacy and scalability of routine ECE screening of ECE personnel (teachers and aides) who have direct contact with children. Investigators will determine the acceptability of screening by 6-8 focus groups with teachers (N=80) from the 40 ECE sites above in July. Investigators will measure feasibility and efficacy (agree to test, proportion of viable samples obtained) of bi-weekly ECE site-based testing with school personnel from half (20) of the sites for fall 2021. Investigators will survey teachers to determine how acceptability toward testing relates to importance for back to ECE safety changes as vaccine uptake increases and vaccine hesitancy decreases over time. Investigators will record costs (e.g., personnel, time, materials) to determine scalability. Investigators will determine the additive efficacy of both child testing (see #1) and ECE personnel testing on attendance and enrollment. For participants testing positive for COVID-19, community health workers from Equality Health Services will provide follow-up care.
3. Outdoor Learning via Garden Education. Investigators will determine the efficacy of enhanced outdoor learning opportunities for closing the gap from the lack of in person based ECE on motor development and eating in the absence of hunger in 4 and 5 year olds. Investigators will randomize participating sites to engage in an adapted Sustainability via Active Garden Education (SAGE) garden curriculum in Spring of 2022 or wait list. Wait list sites will receive the garden and curriculum in Fall 2022. Investigators will install or enhance existing gardens in ECE sites to promote outdoor learning opportunities linked to NAEYC guidelines, and expect children in those sites to gain more rapid improvements following the learning gap. Using established protocols Investigators will test children on motor behavior and eating in the absence of hunger in Fall of 2021 (T1, baseline), prior to implementing SAGE, in Spring 2022, following SAGE implementation, and then a follow up in Fall of 2022 to determine ongoing effects.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1356
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CHILD testing CHILD back-to-ECE COVID-19 saliva testing 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. CHILD+ personnel testing ECE personnel back-to-ECE COVID-19 saliva screening This arm receives the CHILD condition plus ECE site personnel are screened biweekly for COVID-19 using the ASU saliva test. SAGE garden SAGE garden programming 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. Wait list ECE personnel back-to-ECE COVID-19 saliva screening Those in the wait list condition will receive SAGE in year two. SAGE garden CHILD back-to-ECE COVID-19 saliva testing 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. CHILD+ personnel testing CHILD back-to-ECE COVID-19 saliva testing This arm receives the CHILD condition plus ECE site personnel are screened biweekly for COVID-19 using the ASU saliva test. Wait list CHILD back-to-ECE COVID-19 saliva testing Those in the wait list condition will receive SAGE in year two. SAGE garden ECE personnel back-to-ECE COVID-19 saliva screening 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.
- Primary Outcome Measures
Name Time Method Viable sample Within six weeks from the start of school (varies by site and semester) Proportion of viable saliva samples obtained from children
Progressive Aerobic Cardiovascular Endurance Run (PACER) Post-test up to four weeks after intervention Product-based quantitative, locomotor skills test
Children's Activity and Movement in Preschool Study (CHAMPS) motor skill protocol Posttest up to four week post-intervention Process-based quantitative, locomotor skills test that tests skills of running, broad jumping, sliding, galloping, leaping, and hopping
Eating in the absence of hunger Posttest up to four weeks post-intervention Behavioral, quantitative test of eating when one is not hungry
Proportion of Children Attending ECE within four weeks of the end of school (varies by site and semester) Aggregated weekly attendance of children in ECE sites and comparison (non-participating) sites.
- Secondary Outcome Measures
Name Time Method Parent reports of COVID-19 household incidence Approximately once per month following time 1, up to 10 months following time 1 (varies by site and semester) Brief questionnaire that measures self-report of COVID-19 cases in households enrolled in the project completed by parents approximately once per month
Acceptability and feasibility of saliva COVID-19 test At time of COVID-19 test within six weeks from the start of school (varies by site and semester) Self-report survey scale that measures difficulty, satisfaction and repeatability of COVID-19 test.
Cost 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) Cost including personnel, time, materials, space to obtain a sample
Trial Locations
- Locations (1)
Arizona State University-Downtown Campus
🇺🇸Phoenix, Arizona, United States