Clinical trial NCT05178290: Back to ECE Safely With SAGE: Reducing COVID-19 Transmission in Hispanic and Low-income Preschoolers
Official title: Back to ECE Safely With SAGE: Reducing COVID-19 Transmission in Hispanic and Low-income Preschoolers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19 Testing
Children, Preschool
Parents
Child Development
Self-Control
Exercise
Diet, Healthy
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2022-01-05
Enrollment: 1356
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Viable sample
timeFrame: Within six weeks from the start of school (varies by site and semester)
measure: Proportion of Children Attending ECE
timeFrame: within four weeks of the end of school (varies by site and semester)
measure: Progressive Aerobic Cardiovascular Endurance Run (PACER)
timeFrame: Baseline pre-intervention
measure: Progressive Aerobic Cardiovascular Endurance Run (PACER)
timeFrame: Post-test up to four weeks after intervention
measure: Children's Activity and Movement in Preschool Study (CHAMPS) motor skill protocol
timeFrame: Baseline pre-intervention
measure: Children's Activity and Movement in Preschool Study (CHAMPS) motor skill protocol
timeFrame: Posttest up to four week post-intervention
measure: Eating in the absence of hunger
timeFrame: Baseline pre-intervention
measure: Eating in the absence of hunger
timeFrame: Posttest up to four weeks post-intervention
Secondary outcomes:
measure: Acceptability and feasibility of saliva COVID-19 test
timeFrame: At time of COVID-19 test within six weeks from the start of school (varies by site and semester)
measure: Cost to obtain a sample
timeFrame: Time 1 at the time of COVID-19 test, Within six weeks from the start of school (varies by site and semester)
measure: Parent reports of COVID-19 household incidence
timeFrame: Approximately once per month following time 1, up to 10 months following time 1 (varies by site and semester)
Other outcomes:
measure: Demographics
timeFrame: Time 1 Baseline start of the semester
measure: Vulnerability and Exposure to COVID-19 and Vaccine Acceptance
timeFrame: Time 1 Baseline start of the semester
Locations:
city: Phoenix
country: United States
facility: Arizona State University-Downtown Campus
state: Arizona
Study officials:
affiliation: Arizona State University
name: Rebecca Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References: