COVID-19 TestingBESAGENCT05178290
Back to ECE Safely With SAGE: Reducing COVID-19 Transmission in Hispanic and Low-income Preschoolers
A study testing CHILD back-to-ECE COVID-19 saliva testing, ECE personnel back-to-ECE COVID-19 saliva screening and SAGE garden programming in people with COVID-19 Testing and Children, Preschool, run by Arizona State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Testing, Children, Preschool, Parents
- What is being tested?
- CHILD back-to-ECE COVID-19 saliva testing, ECE personnel back-to-ECE COVID-19 saliva screening and SAGE garden programming
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,356 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2021to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -Children with health-compromising conditions (e.g., food allergies) that study activities might aggravate.
Trial locations and contacts
1 site in 1 country.
United States1 site
Arizona State University-Downtown Campus
Phoenix, Arizona, 85004
About this study
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.
Read the 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.
- Conditions
- COVID-19 Testing, Children, Preschool, Parents, Child Development, Self-Control, Exercise
- Being tested
- CHILD back-to-ECE COVID-19 saliva testing, ECE personnel back-to-ECE COVID-19 saliva screening, SAGE garden programming
- Medical subject headings
- Self-Control, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHILD back-to-ECE COVID-19 saliva testingBehavioural
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 screeningBehavioural
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 programmingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: CHILD back-to-ECE COVID-19 saliva testing; Behavioral: ECE personnel back-to-ECE COVID-19 saliva screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viable sample
Proportion of viable saliva samples obtained from children
Measured: 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.
Measured: 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
Measured: Baseline pre-intervention
Progressive Aerobic Cardiovascular Endurance Run (PACER)
Product-based quantitative, locomotor skills test
Measured: 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
Measured: 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
Measured: Posttest up to four week post-intervention
Eating in the absence of hunger
Behavioral, quantitative test of eating when one is not hungry
Measured: Baseline pre-intervention
Eating in the absence of hunger
Behavioral, quantitative test of eating when one is not hungry
Measured: Posttest up to four weeks post-intervention
Secondary outcomes (3)
Acceptability and feasibility of saliva COVID-19 test
Self-report survey scale that measures difficulty, satisfaction and repeatability of COVID-19 test.
Measured: 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
Measured: 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
Measured: Approximately once per month following time 1, up to 10 months following time 1 (varies by site and semester)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start22 Nov 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19 TestingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 1,356 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecca Lee, Arizona State University
- Investigators
- Rebecca Lee, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05178290
- Sponsor's protocol ID
- STUDY00014151
- Acronym
- BESAGE
- Status last verified
- Apr 2025
- First submitted
- 28 Jul 2021
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified data is to be shared with the RADx-UP CDCC per the DTA.
Publications
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.
PubMed 37394507
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Back to ECE Safely With SAGE: Reducing COVID-19 Transmission in Hispanic and Low-income Preschoolers
- ClinicalTrials.gov ID
- NCT05178290
- Acronym / sponsor ID
- BESAGE / STUDY00014151
- Conditions
- COVID-19 Testing, Children, Preschool, Parents, Child Development, Self-Control, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,356 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 5 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| CHILD testing | Experimental | Behavioral: CHILD back-to-ECE COVID-19 saliva testingOne 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. |
| CHILD+ personnel testing | Experimental | Behavioral: CHILD back-to-ECE COVID-19 saliva testing, Behavioral: ECE personnel back-to-ECE COVID-19 saliva screeningThis arm receives the CHILD condition plus ECE site personnel are screened biweekly for COVID-19 using the ASU saliva test. |
| SAGE garden | Experimental | Behavioral: CHILD back-to-ECE COVID-19 saliva testing, Behavioral: ECE personnel back-to-ECE COVID-19 saliva screening, Behavioral: SAGE garden programmingThe 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. |
| Wait list | Sham comparator | Behavioral: CHILD back-to-ECE COVID-19 saliva testing, Behavioral: ECE personnel back-to-ECE COVID-19 saliva screeningThose in the wait list condition will receive SAGE in year two. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- -Children with health-compromising conditions (e.g., food allergies) that study activities might aggravate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHILD back-to-ECE COVID-19 saliva testingPreschool 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. | Behavioural | CHILD testing, CHILD+ personnel testing, SAGE garden, Wait list |
| ECE personnel back-to-ECE COVID-19 saliva screeningECE 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 | Behavioural | CHILD+ personnel testing, SAGE garden, Wait list |
| SAGE garden programmingThe 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. | Behavioural | SAGE garden |
Primary outcome
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
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.
Progressive Aerobic Cardiovascular Endurance Run (PACER)
Time frame: Baseline pre-intervention
Product-based quantitative, locomotor skills test
Progressive Aerobic Cardiovascular Endurance Run (PACER)
Time frame: Post-test up to four weeks after intervention
Product-based quantitative, locomotor skills test
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
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
Eating in the absence of hunger
Time frame: Baseline pre-intervention
Behavioral, quantitative test of eating when one is not hungry
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
3 secondary outcomes
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Derived from this study: PubMed 37394507Lee 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.
- Individual participant dataSharing planned: Yes. All de-identified data is to be shared with the RADx-UP CDCC per the DTA.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Lee, PhD principal investigator
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHILD back-to-ECE COVID-19 saliva testing, ECE personnel back-to-ECE COVID-19 saliva screening and SAGE garden programming in people with COVID-19 Testing and Children, Preschool, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viable sample (time frame: Within six weeks from the start of school (varies by site and semester)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05178290, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.