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

NCT05178290 | Completed

• 1 other identifier: STUDY00014151
• Study Type: interventional
• Target: 1,356
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Testing; Children, Preschool; Parents; Child Development; Self-Control; Exercise; Diet, Healthy

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (3)

• 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)

• 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)

• 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)

Other Outcomes (2)

• Demographics

  Time 1 Baseline start of the semester

• Vulnerability and Exposure to COVID-19 and Vaccine Acceptance

  Time 1 Baseline start of the semester

Study Arms (4)

CHILD testing

EXPERIMENTAL

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

CHILD+ personnel testing

EXPERIMENTAL

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; Behavioral: ECE personnel back-to-ECE COVID-19 saliva screening

SAGE garden

EXPERIMENTAL

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; Behavioral: ECE personnel back-to-ECE COVID-19 saliva screening; Behavioral: SAGE garden programming

Wait list

SHAM COMPARATOR

Those in the wait list condition will receive SAGE in year two.

Behavioral: CHILD back-to-ECE COVID-19 saliva testing; Behavioral: ECE personnel back-to-ECE COVID-19 saliva screening

Interventions

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.

CHILD testing; CHILD+ personnel testing; SAGE garden; Wait list

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

CHILD+ personnel testing; SAGE garden; Wait list

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.

SAGE garden

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Children with health-compromising conditions (e.g., food allergies) that study activities might aggravate.

Sponsors & Collaborators

• Arizona State University: lead

Study Sites (1)

Arizona State University-Downtown Campus

Phoenix, Arizona, 85004, United States

Location

Related Publications (1)

• Lee RE, Todd M, Oh H, Han S, Santana M, Aguilar-Troncoso J, Bruening M, Kramer JL, Leon T, Murugan V, Valdez H, Villegas-Gold M. Acceptability and Feasibility of Saliva-delivered PCR Coronavirus 2019 Tests for Young Children. Pediatrics. 2023 Jul 1;152(Suppl 1):e2022060352D. doi: 10.1542/peds.2022-060352D.

  PMID: 37394507 DERIVED

MeSH Terms

Conditions

Self-Control; Motor Activity

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Rebecca Lee, PhD

  Arizona State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: As this is community engaged research, full transparency is required.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: January 5, 2022
• Study Start: November 22, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available through the RADx-UP CDCC per their governing principles.
• Access Criteria: Access is through the RADx-UP CDCC.

Locations

US (1)