Back to ECE Safely With SAGE: Reducing COVID-19 Transmission in Hispanic and Low-income Preschoolers (BESAGE)
Status
Completed
Conditions
Child Development
Children, Preschool
Parents
COVID-19 Testing
Diet, Healthy
Exercise
Self-Control
Treatments
Behavioral: SAGE garden programming
Behavioral: CHILD back-to-ECE COVID-19 saliva testing
Behavioral: ECE personnel back-to-ECE COVID-19 saliva screening
Details and patient eligibility
About
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.
Full description
This study aims to get children safely back to school with a three strategy approach.
- 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.
- 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.
- 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.
Enrollment
1,356 patients
Sex
All
Ages
3+ years old
Volunteers
Accepts Healthy Volunteers
Inclusion and exclusion criteria
Inclusion
- Adult parents and their minor children (age 3-5)
- Children and their parents who are attending eligible early care and education (ECE) sites
- ECE site personnel (adults 18 and older) with direct contact of children attending ECE sites.
Exclusion
-Children with health-compromising conditions (e.g., food allergies) that study activities might aggravate.
Trial design
Primary purpose
Prevention
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
1,356 participants in 4 patient groups
CHILD testing
Experimental group
Description:
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.
Treatment:
Behavioral: CHILD back-to-ECE COVID-19 saliva testing
CHILD+ personnel testing
Experimental group
Description:
This arm receives the CHILD condition plus ECE site personnel are screened biweekly for COVID-19 using the ASU saliva test.
Treatment:
Behavioral: ECE personnel back-to-ECE COVID-19 saliva screening
Behavioral: CHILD back-to-ECE COVID-19 saliva testing
SAGE garden
Experimental group
Description:
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.
Treatment:
Behavioral: ECE personnel back-to-ECE COVID-19 saliva screening
Behavioral: CHILD back-to-ECE COVID-19 saliva testing
Behavioral: SAGE garden programming
Wait list
Sham Comparator group
Description:
Those in the wait list condition will receive SAGE in year two.
Treatment:
Behavioral: ECE personnel back-to-ECE COVID-19 saliva screening
Behavioral: CHILD back-to-ECE COVID-19 saliva testing
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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