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临床试验/NCT04859699
NCT04859699已完成不适用

Reopening Schools Safely and Educating Youth Research Study

University of Washington2 个研究点 分布在 1 个国家目标入组 1,095 人开始时间: 2022年1月17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
1,095
试验地点
2
主要终点
School Attendance

研究概览

简要总结

The study has three aims and involves a clustered randomized controlled trial (RCT) where K-5 schools will be the unit of randomization. Aim 1 involves a qualitative assessment of rural Latino community's social, ethical, behavioral needs and resources for students to return to school and maintain onsite learning. Aim 2 includes a clustered RCT in schools. Aim 3 involves qualitative assessment of implementation outcomes of the Yakima School District (YSD) testing program and risk communication intervention with school stakeholders, parents, and children.

详细描述

OBJECTIVE:

Aim 1. Identify the rural Latino community's social, ethical, behavioral needs and resources for students to return to school and maintain onsite learning using qualitative assessments with school stakeholders, parents, and students.

Aim 2. Evaluate the effectiveness of risk communication on student attendance and participation in SARS-CoV-2 testing using a cluster randomized controlled trial (RCT) with two intervention arms: intervention (SARS-CoV-2 Risk Communication) and comparison (control group) arm.

Aim 3. Assess implementation outcomes of the Yakima School District testing program and risk communication intervention with school stakeholders, parents, and children guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework.

OVERVIEW:

研究设计

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

入排标准

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

入选标准

  • Participant attends or works in a participating school for at least 2 days/week.
  • Participant must be willing to comply with all study procedures, including weekly online check-ins and phone interviews.
  • Participant should have consistent and reliable Internet access, either by smart phone or computer.
  • Participant must be comfortable speaking English or Spanish.
  • Participant must be able to provide online informed consent and/or legal guardian assent.

排除标准

  • Individuals unable to provide informed consent / assent, except in cases where the participant has an available legal authorized representative and/or parent
  • Individuals who are incarcerated
  • Individuals with conditions that may preclude or limit the participant's ability to comply with study procedures, according to the investigators
  • Children who are wards of the state and who have clinically-diagnosed dementia, terminal (<5 years) illness, major psychiatric illness, severe hearing impairment, and inability to move, which will be assessed during the distribution of the study recruitment packets to families.

结局指标

主要结局

School Attendance

时间窗: Up to nine months

How many school days missed due to symptoms of respiratory illness (only include index child).

次要结局

  • Emotional Regulation of Index Children at Baseline (T1)(Completed at baseline (T1))
  • Perceived Stress of Parents at Baseline (T1)(Completed at baseline (T1))
  • Emotional Regulation of Index Children at Post Survey 1 (T2)(Post survey 1 (T2))
  • Perceived Stress of Parents at Post Survey 1 (T2)(Completed at Post survey 1 (T2))

研究者

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

Linda Ko

Professor, School of Public Health

University of Washington

研究点 (2)

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