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临床试验/NCT05178290
NCT05178290已完成不适用

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

Arizona State University2 个研究点 分布在 1 个国家目标入组 1,356 人开始时间: 2021年11月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,356
试验地点
2
主要终点
Viable sample

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

盲法说明

As this is community engaged research, full transparency is required.

入排标准

年龄范围
3 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Viable sample

时间窗: Within six weeks from the start of school (varies by site and semester)

Proportion of viable saliva samples obtained from children

Progressive Aerobic Cardiovascular Endurance Run (PACER)

时间窗: 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

时间窗: 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

时间窗: Posttest up to four weeks post-intervention

Behavioral, quantitative test of eating when one is not hungry

Proportion of Children Attending ECE

时间窗: 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.

次要结局

  • 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))
  • 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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rebecca Lee

Principal Investigator

Arizona State University

研究点 (2)

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