Reopening Schools Safely and Educating Youth Research Study (ROSSEY)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1095 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-17

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comprehensive Program to Improve Reading and Writing Skills in At-Risk and Dyslexic Children

NCT00061412

Dyslexia Learning Disorders

COMPLETED NA

Efficacy of a Two-Year Intensive Reading Intervention for Middle School English Learners With Reading Difficulties

NCT03695068

Learning Disorders Dyslexia

UNKNOWN NA

Testing for COVID-19 in High Risk Children With Intellectual and Developmental Disabilities (COV-IDD)

NCT04887129

Covid19

COMPLETED NA

Preventing Learning Problems in Young Children: A Public Health and Physician-Based Outreach

NCT00110292

Developmental Disabilities Language Development Disorders

UNKNOWN PHASE1

Literacy Promotion for Latinos Study

NCT04609553

Language Development Behavior, Child Parenting +1 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Absenteeism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control Group

This arm will include schools(n=7) and the enrolled families from those schools assigned as the control group, who will not receive the COVID-19 health education comic books and video intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

COVID-19 Comic Books and Videos

This arm will include schools (n=7) and enrolled families from those schools that are randomized to receive the health education with comic books and videos focused on the benefits of preventive measures for COVID-19.

Group Type ACTIVE_COMPARATOR

COVID-19 Health Education Comic Books and Videos

Intervention Type BEHAVIORAL

Comic books and videos will be shared with intervention students and their parents to provide education on COVID-19 topics such as masking, social distancing and COVID-19 testing

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

COVID-19 Health Education Comic Books and Videos

Comic books and videos will be shared with intervention students and their parents to provide education on COVID-19 topics such as masking, social distancing and COVID-19 testing

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes