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

Primary Purpose

COVID-19 Testing, Children, Preschool, Parents

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CHILD back-to-ECE COVID-19 saliva testing
ECE personnel back-to-ECE COVID-19 saliva screening
SAGE garden programming
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19 Testing

Eligibility Criteria

3 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Arizona State University-Downtown Campus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Sham Comparator

Arm Label

CHILD testing

CHILD+ personnel testing

SAGE garden

Wait list

Arm 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.

This arm receives the CHILD condition plus ECE site personnel are screened biweekly for COVID-19 using the ASU saliva test.

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.

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

Outcomes

Primary Outcome Measures

Viable sample
Proportion of viable saliva samples obtained from children
Proportion of Children Attending ECE
Aggregated weekly attendance of children in ECE sites and comparison (non-participating) sites.
Progressive Aerobic Cardiovascular Endurance Run (PACER)
Product-based quantitative, locomotor skills test
Progressive Aerobic Cardiovascular Endurance Run (PACER)
Product-based quantitative, locomotor skills test
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
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
Eating in the absence of hunger
Behavioral, quantitative test of eating when one is not hungry
Eating in the absence of hunger
Behavioral, quantitative test of eating when one is not hungry

Secondary Outcome Measures

Acceptability and feasibility of saliva COVID-19 test
Self-report survey scale that measures difficulty, satisfaction and repeatability of COVID-19 test.
Cost to obtain a sample
Cost including personnel, time, materials, space to obtain a sample
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

Full Information

First Posted
July 28, 2021
Last Updated
January 3, 2022
Sponsor
Arizona State University
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1. Study Identification

Unique Protocol Identification Number
NCT05178290
Brief Title
Back to ECE Safely With SAGE: Reducing COVID-19 Transmission in Hispanic and Low-income Preschoolers
Acronym
BESAGE
Official Title
Back to ECE Safely With SAGE: Reducing COVID-19 Transmission in Hispanic and Low-income Preschoolers
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 22, 2021 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Arizona State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Testing, Children, Preschool, Parents, Child Development, Self-Control, Exercise, Diet, Healthy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Masking Description
As this is community engaged research, full transparency is required.
Allocation
Randomized
Enrollment
3280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CHILD testing
Arm Type
Experimental
Arm 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.
Arm Title
CHILD+ personnel testing
Arm Type
Experimental
Arm Description
This arm receives the CHILD condition plus ECE site personnel are screened biweekly for COVID-19 using the ASU saliva test.
Arm Title
SAGE garden
Arm Type
Experimental
Arm 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.
Arm Title
Wait list
Arm Type
Sham Comparator
Arm Description
Those in the wait list condition will receive SAGE in year two.
Intervention Type
Behavioral
Intervention Name(s)
CHILD back-to-ECE COVID-19 saliva testing
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
ECE personnel back-to-ECE COVID-19 saliva screening
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
SAGE garden programming
Intervention Description
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 Outcome Measure Information:
Title
Viable sample
Description
Proportion of viable saliva samples obtained from children
Time Frame
Within six weeks from the start of school (varies by site and semester)
Title
Proportion of Children Attending ECE
Description
Aggregated weekly attendance of children in ECE sites and comparison (non-participating) sites.
Time Frame
within four weeks of the end of school (varies by site and semester)
Title
Progressive Aerobic Cardiovascular Endurance Run (PACER)
Description
Product-based quantitative, locomotor skills test
Time Frame
Baseline pre-intervention
Title
Progressive Aerobic Cardiovascular Endurance Run (PACER)
Description
Product-based quantitative, locomotor skills test
Time Frame
Post-test up to four weeks after intervention
Title
Children's Activity and Movement in Preschool Study (CHAMPS) motor skill protocol
Description
Process-based quantitative, locomotor skills test that tests skills of running, broad jumping, sliding, galloping, leaping, and hopping
Time Frame
Baseline pre-intervention
Title
Children's Activity and Movement in Preschool Study (CHAMPS) motor skill protocol
Description
Process-based quantitative, locomotor skills test that tests skills of running, broad jumping, sliding, galloping, leaping, and hopping
Time Frame
Posttest up to four week post-intervention
Title
Eating in the absence of hunger
Description
Behavioral, quantitative test of eating when one is not hungry
Time Frame
Baseline pre-intervention
Title
Eating in the absence of hunger
Description
Behavioral, quantitative test of eating when one is not hungry
Time Frame
Posttest up to four weeks post-intervention
Secondary Outcome Measure Information:
Title
Acceptability and feasibility of saliva COVID-19 test
Description
Self-report survey scale that measures difficulty, satisfaction and repeatability of COVID-19 test.
Time Frame
At time of COVID-19 test within six weeks from the start of school (varies by site and semester)
Title
Cost to obtain a sample
Description
Cost including personnel, time, materials, space 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)
Title
Parent reports of COVID-19 household incidence
Description
Brief questionnaire that measures self-report of COVID-19 cases in households enrolled in the project completed by parents approximately once per month
Time Frame
Approximately once per month following time 1, up to 10 months following time 1 (varies by site and semester)
Other Pre-specified Outcome Measures:
Title
Demographics
Description
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 Frame
Time 1 Baseline start of the semester
Title
Vulnerability and Exposure to COVID-19 and Vaccine Acceptance
Description
RADx-UP measure from the PhenX Toolkit of Vulnerability and Exposure to COVID-19 and Vaccine Acceptance
Time Frame
Time 1 Baseline start of the semester

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Lee, PhD
Organizational Affiliation
Arizona State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona State University-Downtown Campus
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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