AbsenteeismNCT04859699
Reopening Schools Safely and Educating Youth Research Study (ROSSEY)
A study testing COVID-19 Health Education Comic Books and Videos in people with Absenteeism, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Absenteeism
- What is being tested?
- COVID-19 Health Education Comic Books and Videos
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,095 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reopening Schools Safely and Educating Youth Research Study
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.
Read the 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.
- Conditions
- Absenteeism
- Being tested
- COVID-19 Health Education Comic Books and Videos
- Keywords
- SARS-CoV-2, School re-opening, Rural communities, Risk communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 Health Education Comic Books and VideosBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | 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. |
| COVID-19 Comic Books and Videos | Active comparator | 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. Receives: Behavioral: COVID-19 Health Education Comic Books and Videos |
What is being measured
The primary outcome is the main question the study is designed to answer.
School Attendance
How many school days missed due to symptoms of respiratory illness (only include index child).
Measured: Up to nine months
Secondary outcomes (4)
Emotional Regulation of Index Children at Baseline (T1)
Index children will be assessed for physical activity, perceived stress, COVID-related stress, and depressive symptomatology from the PROMIS measures of Index Child Only (n=463) PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. PROMIS scores are typically reported on a T-score metric, with a mean of 50 and a standard deviation of 10. Higher T-scores indicate moderate to severe symptoms. T-scores above 60 are considered moderate, and those above 70 indicate severe symptoms.
Measured: Completed at baseline (T1)
Perceived Stress of Parents at Baseline (T1)
Parents of enrolled children will be assessed for perceived stress, sleep disturbance, and emotional regulation using PROMIS measure.
PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. PROMIS scores are typically reported on a T-score metric, with a mean of 50 and a standard deviation of 10. Higher T-scores indicate moderate to severe symptoms. T-scores above 60 are considered moderate, and those above 70 indicate severe symptoms.
.
Measured: Completed at baseline (T1)
Emotional Regulation of Index Children at Post Survey 1 (T2)
Post Survey assessment using PROMIS measures will evaluate physical activity, perceived stress, COVID-related stress, and depressive symptoms among 408 index children, out of an original cohort of 463, with 55 lost to follow-up. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. PROMIS scores are typically reported on a T-score metric, with a mean of 50 and a standard deviation of 10. Higher T-scores indicate moderate to severe symptoms. T-scores above 60 are considered moderate, and those above 70 indicate severe symptoms.
Measured: Post survey 1 (T2)
Perceived Stress of Parents at Post Survey 1 (T2)
Parents of enrolled children will be assessed for perceived stress, sleep disturbance, and emotional regulation using PROMIS measure.
PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. PROMIS scores are typically reported on a T-score metric, with a mean of 50 and a standard deviation of 10. Higher T-scores indicate moderate to severe symptoms. T-scores above 60 are considered moderate, and those above 70 indicate severe symptoms.
.
Measured: Completed at Post survey 1 (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start17 Jan 2022
- Primary completion8 May 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AbsenteeismStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,095 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Linda Ko, University of Washington
- Investigators
- Linda Ko, PhD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859699
- Sponsor's protocol ID
- STUDY00014531-A
- Other IDs
- 1OT2HD107544-01
- Status last verified
- Sep 2025
- First submitted
- 16 Apr 2021
- Last updated
- 8 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pascoe KM, Bishop S, Ci X, Ramirez M, Perez G, Ibarra G, Garza L, Linde S, Duran MC, Chae HY, Quigley T, Hassell L, Garrison MM, Drain PK, Shah PD, Ko LK. Factors that shape COVID-19 pediatric vaccine decision-making in rural agricultural communities: A qualitative study. Vaccine. 2024 Dec 2;42(26):126389. doi: 10.1016/j.vaccine.2024.126389. Epub 2024 Oct 4.
PubMed 39368130Constantin AM, Noertjojo K, Sommer I, Pizarro AB, Persad E, Durao S, Nussbaumer-Streit B, McElvenny DM, Rhodes S, Martin C, Sampson O, Jorgensen KJ, Bruschettini M. Workplace interventions to reduce the risk of SARS-CoV-2 infection outside of healthcare settings. Cochrane Database Syst Rev. 2024 Apr 10;4(4):CD015112. doi: 10.1002/14651858.CD015112.pub3.
PubMed 38597249Ramirez M, Shah PD, Chu HY, Garza L, Linde S, Garrison MM, Zhou C, Bishop S, Ibarra G, Ko LK. Reopening schools safely and educating youth (ROSSEY) study: Protocol for a community-based, cluster randomized controlled trial. Contemp Clin Trials. 2024 Apr;139:107480. doi: 10.1016/j.cct.2024.107480. Epub 2024 Feb 19.
PubMed 38382823
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reopening Schools Safely and Educating Youth Research Study
- ClinicalTrials.gov ID
- NCT04859699
- Acronym / sponsor ID
- STUDY00014531-A
- Conditions
- Absenteeism
- Keywords
- SARS-CoV-2, School re-opening, Rural communities, Risk communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,095 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- 8 May 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 26 Apr 2021 (actual)
- Results
- Posted 8 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –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. |
| COVID-19 Comic Books and Videos | Active comparator | Behavioral: COVID-19 Health Education Comic Books and VideosThis 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. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 Health Education Comic Books and VideosComic 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 | Behavioural | COVID-19 Comic Books and Videos |
Primary outcome
School Attendance
Time frame: Up to nine months
How many school days missed due to symptoms of respiratory illness (only include index child).
4 secondary outcomes
Emotional Regulation of Index Children at Baseline (T1)
Time frame: Completed at baseline (T1)
Perceived Stress of Parents at Baseline (T1)
Time frame: Completed at baseline (T1)
Emotional Regulation of Index Children at Post Survey 1 (T2)
Time frame: Post survey 1 (T2)
Perceived Stress of Parents at Post Survey 1 (T2)
Time frame: Completed at Post survey 1 (T2)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39368130Pascoe KM, Bishop S, Ci X, Ramirez M, Perez G, Ibarra G, Garza L, Linde S, Duran MC, Chae HY, Quigley T, Hassell L, Garrison MM, Drain PK, Shah PD, Ko LK. Factors that shape COVID-19 pediatric vaccine decision-making in rural agricultural communities: A qualitative study. Vaccine. 2024 Dec 2;42(26):126389. doi: 10.1016/j.vaccine.2024.126389. Epub 2024 Oct 4.
- Derived from this study: PubMed 38597249Constantin AM, Noertjojo K, Sommer I, Pizarro AB, Persad E, Durao S, Nussbaumer-Streit B, McElvenny DM, Rhodes S, Martin C, Sampson O, Jorgensen KJ, Bruschettini M. Workplace interventions to reduce the risk of SARS-CoV-2 infection outside of healthcare settings. Cochrane Database Syst Rev. 2024 Apr 10;4(4):CD015112. doi: 10.1002/14651858.CD015112.pub3.
- Derived from this study: PubMed 38382823Ramirez M, Shah PD, Chu HY, Garza L, Linde S, Garrison MM, Zhou C, Bishop S, Ibarra G, Ko LK. Reopening schools safely and educating youth (ROSSEY) study: Protocol for a community-based, cluster randomized controlled trial. Contemp Clin Trials. 2024 Apr;139:107480. doi: 10.1016/j.cct.2024.107480. Epub 2024 Feb 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Ko, PhD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COVID-19 Health Education Comic Books and Videos in people with Absenteeism, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
School Attendance (time frame: Up to nine months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04859699, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2025.