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CHILD back-to-ECE COVID-19 saliva testing for COVID-19 Testing (BESAGE Trial)

N/A
Waitlist Available
Led By Rebecca Lee, PhD
Research Sponsored by Arizona State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately once per month following time 1, up to 10 months following time 1 (varies by site and semester)
Awards & highlights

BESAGE Trial Summary

This trial will test different ways of getting children back to school safely during the pandemic.

Eligible Conditions
  • COVID-19 Testing
  • Preschoolers
  • Parenting
  • Child Development
  • Self-Discipline
  • Exercise
  • Healthy Eating

BESAGE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately once per month following time 1, up to 10 months following time 1 (varies by site and semester)
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately once per month following time 1, up to 10 months following time 1 (varies by site and semester) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Children's Activity and Movement in Preschool Study (CHAMPS) motor skill protocol
Eating in the absence of hunger
Progressive Aerobic Cardiovascular Endurance Run (PACER)
+2 more
Secondary outcome measures
Acceptability and feasibility of saliva COVID-19 test
Cost to obtain a sample
Parent reports of COVID-19 household incidence
Other outcome measures
Demographics
Vulnerability and Exposure to COVID-19 and Vaccine Acceptance

BESAGE Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: SAGE gardenExperimental Treatment3 Interventions
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.
Group II: CHILD+ personnel testingExperimental Treatment2 Interventions
This arm receives the CHILD condition plus ECE site personnel are screened biweekly for COVID-19 using the ASU saliva test.
Group III: CHILD testingExperimental Treatment1 Intervention
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.
Group IV: Wait listPlacebo Group2 Interventions
Those in the wait list condition will receive SAGE in year two.

Find a Location

Who is running the clinical trial?

Arizona State UniversityLead Sponsor
278 Previous Clinical Trials
103,867 Total Patients Enrolled
Rebecca Lee, PhDPrincipal InvestigatorArizona State University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any new participants being recruited for this research endeavor?

"According to clinicaltrials.gov, this medical trial is momentarily not recruiting new subjects. The study was first advertised on November 22nd 2021 and last revised January 3rd 2022. While this investigation cannot be joined presently, there are 1331 other trials that currently have open enrollment options for patients."

Answered by AI
~984 spots leftby Mar 2025