Skip to main content
OpenTrials
Completed

NCT Number: NCT05178290

Back to ECE Safely With SAGE: Reducing COVID-19 Transmission in Hispanic and Low-income Preschoolers

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

3 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona State University-Downtown Campus

Phoenix, Arizona, 85004, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

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.

Primary outcomes

  1. Viable sample

    Time frame: Within six weeks from the start of school (varies by site and semester)

    Proportion of viable saliva samples obtained from children

  2. Proportion of Children Attending ECE

    Time frame: 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.

  3. Progressive Aerobic Cardiovascular Endurance Run (PACER)

    Time frame: Baseline pre-intervention

    Product-based quantitative, locomotor skills test

  4. Progressive Aerobic Cardiovascular Endurance Run (PACER)

    Time frame: Post-test up to four weeks after intervention

    Product-based quantitative, locomotor skills test

  5. Children's Activity and Movement in Preschool Study (CHAMPS) motor skill protocol

    Time frame: Baseline pre-intervention

    Process-based quantitative, locomotor skills test that tests skills of running, broad jumping, sliding, galloping, leaping, and hopping

  6. Children's Activity and Movement in Preschool Study (CHAMPS) motor skill protocol

    Time frame: 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

  7. Eating in the absence of hunger

    Time frame: Baseline pre-intervention

    Behavioral, quantitative test of eating when one is not hungry

  8. Eating in the absence of hunger

    Time frame: Posttest up to four weeks post-intervention

    Behavioral, quantitative test of eating when one is not hungry

Secondary outcomes

  1. Acceptability and feasibility of saliva COVID-19 test

    Time frame: 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.

  2. Cost to obtain a sample

    Time frame: 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

  3. Parent reports of COVID-19 household incidence

    Time frame: 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

Other outcomes

  1. Demographics

    Time frame: Time 1 Baseline start of the semester

    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)

  2. Vulnerability and Exposure to COVID-19 and Vaccine Acceptance

    Time frame: Time 1 Baseline start of the semester

    RADx-UP measure from the PhenX Toolkit of Vulnerability and Exposure to COVID-19 and Vaccine Acceptance

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Registry information

Acronym: BESAGE

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 5, 2022
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.