Reopening Schools Safely and Educating Youth Research- Early Learning Ancillary Study
Phase: NA
Conditions: Absenteeism
Sponsor: University of Washington

Protocol version: 1 
 
Date updated: 1/03/24 
 
Reopening Schools Safely and Educating Youth (ROSSEY): Early Learning Ancillary 
Study  
 
Investigator List  
Principal PI: 
Linda K. Ko, PhD 
Department of Health Systems and Population 
Health 
University of Washington (UW)  
Hans Rosling Center for Population Health 3980 
15th AVE NE, UW Mailbox 351621 
Seattle, WA 98195 
Phone: 206-685-4978 
lindako@uw.edu 
 
Co-Investigator:  
Allison Cole, MD, MS 
UW Medicine/Family Medicine 
University of Washington 
Phone: 206-685-9879 
Acole2@uw.edu  
Site PI/Co-Investigator:  
Parth Shah, Pharm D, PhD  
Division of Public Health Sciences  
Fred Hutchinson Cancer Research Center  
1100 Fairview AVE, N 
M3-B232 
Seattle, WA 98109  
pshah@fredhutch.org 
 
Co-Investigator/Biostatistician:  
Chuan Zhou, PhD 
Seattle Children’s Hospital/ Department of Health 
Systems and Population Health 
1920 Terry Ave, Building Cure, #04-228M/S 
CURE-4, PO Box 5371 
Seattle, WA 98145 
Phone: 206-854-128 
Chuan.zhou@seattlechidlrens.org 
Co-Investigator:  
Michelle M. Garrison, PhD 
College of Health and Human Services 
Purdue University 
Matthews 229 
812 W. State Street 
West Lafayette, IN 47907 
mmgarris@purdue.edu  
 
Co-Investigator:  
Magaly Ramirez, PhD 
Department of Health Systems and Population 
Health 
University of Washington (UW)  
Hans Rosling Center for Population Health 3980 
15th AVE NE, UW Mailbox 351621 
Seattle, WA 98195 
maggiera@uw.edu 
Co-Investigator:  
Paul Drain, MD, MPH 
Department of Global Health 
Hans Rosling Center for Population Health 3980 
15th AVE NE, UW Mailbox 351620 
Seattle, WA 98195 
Phone: 206-520-3820 
pkdrain@uw.edu  
 
 
Funding: National Institute of Child Health and Human Development 
Role of funders: The funders had a role in the design of this study.  
 
 

I. 
Study Design 
This ancillary study incorporates one primary aim which is meant to help students return to school 
safely by providing free health education to families and their children. Simultaneously, free 
COVID-19 testing will be offered to families for their children at schools through the Yakima 
School District. We want to learn if health education can increase the uptake of COVID-19 
mitigation measures, improve children’s school attendance, and increase families’ physical and 
mental well-being using single-arm pre/post-study. 
 
The ancillary study runs parallel with the larger ROSSEY RCT.  Recruitment, enrollment, and 
baseline assessment are expected to last two months (September-November 2022).  Enrolled 
participants will not receive the comic book and parent video series until after completion of the 
ROSSEY RCT Post 1 follow-up Survey to not bias the data of older siblings participating in the 
ROSSEY RCT.  A follow-up assessment for Early Learning participants is anticipated to take 
place 10 months after the launch of recruitment (July-August 2023) 
 
II. 
Aim 1 
Evaluate if risk communication health education can increase uptake of COVID-19 mitigation 
measures, improve children’s school attendance, and increase families’ physical and mental 
well-being using a single-arm pre/post study. 
 
III. 
Study Population 
We will collaborate with the Yakima School District to recruit Early Learning students (3, 4 and 5 
years old) and their parent or Guardian(s) into the research study. We will recruit Early Learning 
students into the study regardless of their participation in SARS-CoV-2 testing provided by the 
Yakima School District. This will allow us to evaluate the effect of the risk communication 
strategies on the uptake of SARS-CoV-2 testing and other mitigation measures. 
 
IV. 
Sample Size 
Early Learning is an ancillary study with no defined sample size.  We will enroll and recruit 
participants for a total of eight weeks. 
 
V. 
Enrollment Criteria 
Parent/Guardian eligibility criteria for participation in the study include: 
● Must have a child attending the Early Learning Program in the Yakima School District  
● Must be able to provide informed consent and legal guardian assent either virtually, on 
the telephone, or in-person. 
● Must have a permanent mailing address available for study staff to mail necessary 
materials OR a working email address. 
 
VI. 
Study Procedures 
Recruitment, Screening and Consent 

Enrollment and recruitment of the Early Learning ancillary study will start the second academic 
year of the RCT (2022-2023). Study information in the form of a flyer will be sent home with 
students to parents through school email by the principal and posted 
on the school Parent Square site in September of 2022. In addition, 
ROSSEY staff will attend the Early Learning Open House to hand out 
study information and obtain the phone number or email address of 
interested parents. ROSSEY staff will follow up with interested parents 
and provide further information about the study.   
 
Families will have two options to enroll children in the study: online 
through a website portal (Project REDCap), or with assistance from 
study staff over the phone.  
 
• 
Parents/guardians who choose to enroll children in the study 
online will provide informed consent by reading and e-signing 
consent and assent forms through a web-based REDCap 
portal, and then the participant’s parent/legal guardian will 
complete a baseline survey (same enrollment and secondary 
outcomes survey from the RCT of the main study). 
• 
Parents/guardians who choose to enroll with staff assistance 
over the phone will be verbally guided through the REDCap 
consent/assent forms, enrollment questionnaire and 
secondary outcomes questionnaire. 
 
Parents who choose online enrollment will be screened for eligibility via the REDCap web-based 
portal. Parents who choose enrollment with staff assistance will be screened over the telephone.  
The online consent portal will encourage parents/legal guardians to contact research staff by 
phone or email to review the risks and benefits of study participation, or to review the study 
procedures outlined in the consent form. Since all children are under the age of 7, the parent or 
legal guardian will sign the consent form, and the child will provide verbal assent if able. Electronic 
copies of the e-signed consent and assent documents will be automatically emailed to 
participants. For those who enrolled by telephone, copies of the consent and assent documents 
will be sent to the participants either via e-mail, through the mail, or in person.  
 
NEEDS A SECTION ON BASELINE SURVEY.  
 
After enrollment is complete, parents/guardians of study participants will take part in the 
following study procedures:  
 
Risk Communication: Risk communication, in the form of comic books with accompanying read-
along videos for the children (n=3) and videos for the parents (n=2) will be distributed in English 
and Spanish to all enrolled students within two weeks of completion of the ROSSEY RCT final 
assessment (December 2023). Three comic books will be distributed by mail and parents will be 
sent a password-protected link with the mailed comic to access the parent videos and comic book 
read-along videos. All intervention materials (i.e., children’s comic books and parent videos) will 
be distributed after the final assessment of the larger ROSSEY RCT study is complete.  The delay 
is to eliminate possible contamination of the RCT by siblings of comparison students who will 
receive the comic books as part of this ancillary study. 
 

Follow-up Survey:  We will contact parents  6 weeks after the risk communication intervention 
distribution.  Parents will be asked to complete the follow-up survey either online or by phone. 
The surveys will ask for updates to their contact and demographic information, child’s COVID-19 
vaccination status, and child’s SARS-CoV-2 mitigation behaviors and the secondary outcome 
measures.  
 
Following the protocol from the ROSSEY RCT, the post assessment will take place over 6 weeks, 
allowing two weeks for final contact prior to closure.  For EL participants with missing or phone 
numbers no longer in service, ROSSEY staff will contact the YSD to 1) determine if the student 
is still attending YSD, 2) find out school and teachers name to send a notice through the school 
to the parent letting them know we are trying to reach them. Students determined to still be 
enrolled at YSD, and are non-responders to the follow up survey, will receive an at home visit by 
ROSSEY staff as a final attempt to reach student and parent to complete survey.  Follow-up 
assessment closure will take place one week after completion of home visits.