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

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.

Study Overview

• Status: Completed
• Conditions: Exercise; Parents; Child Development; Diet, Healthy; COVID-19 Testing; Children, Preschool; Self-Control
• Intervention / Treatment: Behavioral: CHILD back-to-ECE COVID-19 saliva testing; Behavioral: ECE personnel back-to-ECE COVID-19 saliva screening; Behavioral: SAGE garden programming

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.

• Study Type: Interventional
• Enrollment (Actual): 1356
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Arizona State University-Downtown Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CHILD 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.	Behavioral: CHILD back-to-ECE COVID-19 saliva testing; 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.
Experimental: CHILD+ personnel testing; This arm receives the CHILD condition plus ECE site personnel are screened biweekly for COVID-19 using the ASU saliva test.	Behavioral: CHILD back-to-ECE COVID-19 saliva testing; 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.; Behavioral: ECE personnel back-to-ECE COVID-19 saliva screening; 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
Experimental: SAGE garden; 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.	Behavioral: CHILD back-to-ECE COVID-19 saliva testing; 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.; Behavioral: ECE personnel back-to-ECE COVID-19 saliva screening; 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; Behavioral: SAGE garden programming; 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.
Sham Comparator: Wait list; Those in the wait list condition will receive SAGE in year two.	Behavioral: CHILD back-to-ECE COVID-19 saliva testing; 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.; Behavioral: ECE personnel back-to-ECE COVID-19 saliva screening; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Secondary Outcome Measures

Outcome Measure	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	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)

Other Outcome Measures

Outcome Measure	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	RADx-UP measure from the PhenX Toolkit of Vulnerability and Exposure to COVID-19 and Vaccine Acceptance	Time 1 Baseline start of the semester

Collaborators and Investigators

• Sponsor: Arizona State University
• Investigators: Principal Investigator: Rebecca Lee, PhD, Arizona State University

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2021
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: July 28, 2021
• First Submitted That Met QC Criteria: January 3, 2022
• First Posted (Actual): January 5, 2022

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 19, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: STUDY00014151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All de-identified data is to be shared with the RADx-UP CDCC per the DTA.
• IPD Sharing Time Frame: Data will be available through the RADx-UP CDCC per their governing principles.
• IPD Sharing Access Criteria: Access is through the RADx-UP CDCC.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No