Clinical trial NCT04859699: Reopening Schools Safely and Educating Youth Research Study
Official title: Reopening Schools Safely and Educating Youth Research Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Absenteeism
Keywords: SARS-CoV-2
School re-opening
Rural communities
Risk communication
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-04-26
Enrollment: 1095
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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:

The study has three aims and involves a clustered randomized controlled trial (RCT) where K-5 elementary schools will be the unit of randomization. Aim 1 will involve conducting qualitative assessments with school stakeholders, parents and students to to assess social, ethical, cultural, and behavioral concerns related to COVID-19 in the community. This data will be used to guide the development of the risk communication strategies (e.g., comic books and videos). Aim 2 includes a clustered RCT conducted in Yakima School District elementary schools to evaluate the effect of risk communication on testing uptake. We will assess primary outcome on students; parent/guardian will provide informed consent through either an online, paper, or telephone process to enroll in the study. Following consent, parent/guardians of participants will receive instructions on study procedures and complete the enrollment questionnaire either via online, on paper, or over the telephone with a study staff member. If the students attend a school that is randomized into the intervention group, they will receive the risk communication as three comic books and their parents will receive two videos at regular intervals throughout the study in English and Spanish. The communication intervention will highlight benefits of and address barriers to preventative behaviors, SARS-CoV-2 testing, and COVID-19 vaccines. Participants in the comparison group will receive the risk communication comic books and videos at the end of the study as part of the delayed intervention. Secondary outcome measures will be assessed for one index child in all families who have children enrolled in the study.

To prepare for this large trial, the study will institute a pilot study conducting weekly novel coronavirus surveillance testing in one school during April - June 2021 to understand the implementation steps and the workflow of working with schools. The larger RCT trial will be implemented in 14 K-5 schools in Fall 2021 - Spring 2023 school year.

All students in the Yakima School District has access to the Yakima School District's COVID-19 static testing site. Screening and symptomatic testing will be available (but not mandated) to Yakima School District students through the static site. School attendance and SARS-CoV-2 test results on students enrolled in our research study will come from schools.

STUDY POPULATION:

The schools participating in the study come from an agricultural region of Washington state.

STUDY TIME PERIOD:

August 2021-March 2023.

STATISTICAL ANALYSES: The primary analysis will be based on the average number of onsite learning hours per week over the study period for each student. The data will be analyzed using a linear mixed effects model with district and randomization arm as fixed effects, and school and classroom within school as random effects. Analyses will test for any difference between the randomization arms using α = 0.05 and report the comparisons between arms.

STUDY OUTCOMES:

The primary outcome for children will be absenteeism (hours per week missing onsite learning).

The secondary outcome will be assessed in parent/child dyads. Parents will share their child's physical activity and emotional regulation; and will be assessed for perceived stress, COVID-related stress, and depressive symptomatology for parents.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: School absenteeism
timeFrame: Up to nine months
Secondary outcomes:
measure: Emotional regulation of children
timeFrame: Up to once per month over a nine month period
measure: Perceived stress of parents and staff
timeFrame: Up to once per month over a nine month period
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Linda Ko, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: