AbsenteeismNCT05965323

Reopening Schools Safely and Educating Youth Research- Early Learning Ancillary Study

A study testing Health Education in people with Absenteeism, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a single arm, pre/post intervention study to a larger trial that will examine the effect of health education with comic books and videos on COVID-19 preventive behaviors (masking, social distancing, testing and vaccine uptake). The participants are students, ages 3-5 years old and their parents. Read more about this study

Who is it for?: Ages 3 to 5 yearsHealthy volunteers can take part
Conditions the study is for: Absenteeism
What is being tested?: Health Education
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 97 participants
Where: 1 siteUnited States
Study dates: 22 Sep 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 3 to 5 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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.
Must speak English or Spanish.

Who cannot join

Not in Early Learning program in Yakima School District

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Washington
Seattle, Washington, 98109

Other trials in United States

About this study

Read the detailed description

Students will receive the intervention from November 2023 to March 2024.

Conditions: Absenteeism
Being tested: Health Education
Keywords: SARS-coV-2, School re-opening, Rural Communities, Early Education - pre School, Risk communication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Health EducationBehavioural
Health education with comic books and videos

Study groups in NCT05965323
Study group	Role	What they receive
Intervention	Experimental	The students in this arm will receive comic books and their parents videos on the benefits of preventive measures of COVID-19 Receives: Behavioral: Health Education

What is being measured

The primary outcome is the main question the study is designed to answer.

Testing
Percentage of early learning students testing for COVID-19
Measured: Up to eleven months
Masking
Percentage of early learning students masking for COVID-19
Measured: Up to eleven months
Wash Hands
Percentage of early learning students washing hands for COVID-19
Measured: Up to eleven months
Hide Cough
Percentage of early learning students who hide cough during COVID-19
Measured: Up to eleven months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Sep 202231 Dec 2024

First posted28 Jul 2023
Study start22 Sep 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.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 97 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05965323
Sponsor's protocol ID: STUDY00014531-B
Other IDs: 1OT2HD107544-01
Status last verified: May 2025
First submitted: 19 Jul 2023
Last updated: 8 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Reopening Schools Safely and Educating Youth Research- Early Learning Ancillary Study
ClinicalTrials.gov ID: NCT05965323
Acronym / sponsor ID: STUDY00014531-B
Conditions: Absenteeism
Keywords: SARS-coV-2, School re-opening, Rural Communities, Early Education - pre School, Risk communication
Study type: Interventional
Recruitment status: Completed
Enrolment: 97 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: 22 Sep 2022 (actual)
Primary completion: 8 May 2024 (actual)
Study completion: 31 Dec 2024 (actual)
First posted: 28 Jul 2023 (actual)
Results: Posted 8 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Students will receive the intervention from November 2023 to March 2024.

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Intervention	Experimental	Behavioral: Health EducationThe students in this arm will receive comic books and their parents videos on the benefits of preventive measures of COVID-19

Who may qualify

Ages: 3 to 5 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

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.
Must speak English or Spanish.

Key exclusion criteria (1 listed)

Not in Early Learning program in Yakima School District

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
Health EducationHealth education with comic books and videos	Behavioural	Intervention

Primary outcome

Testing
Time frame: Up to eleven months
Percentage of early learning students testing for COVID-19
Masking
Time frame: Up to eleven months
Percentage of early learning students masking for COVID-19
Wash Hands
Time frame: Up to eleven months
Percentage of early learning students washing hands for COVID-19
Hide Cough
Time frame: Up to eleven months
Percentage of early learning students who hide cough during COVID-19

Results and safety

Results posted to the registry on 8 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Students	49	49
Parent	48	48

Primary outcome: Testing

Time frame: Up to eleven months. Count of participants. Unit: Participants

Measure	Early Learning n = 49
Enrollment: Test Yes	41
Enrollment: Testing No	8
Enrollment: Prefer not to Respond	0
Enrollment: Unknown Not Reported	0
Follow Up: Test Yes	22
Follow Up: Testing No	20
Follow Up: Prefer not to Respond	1
Follow Up: Unknown Not Reported	6

Population analysed: Early Learning Students age 3-5 years old

Primary outcome: Masking

Time frame: Up to eleven months. Count of participants. Unit: Participants

Measure	Early Learning n = 49
Enrollment: Frequently	7
Enrollment: Never	21
Enrollment: Sometimes	21
Enrollment: Missing	0
Follow Up: Frequently	21
Follow Up: Never	15
Follow Up: Sometimes	7
Follow Up: Missing	6

Population analysed: Early Learning Students age 3-5 years old

Primary outcome: Wash Hands

Time frame: Up to eleven months. Count of participants. Unit: Participants

Measure	Early Learning n = 49
Enrollment: Frequenty	42
Enrollment: Sometimes	7
Enrollment: Missing	0
Follow Up: Frequenty	35
Follow Up: Sometimes	8
Follow Up: Missing	6

Population analysed: Early Learning Students age 3-5 years old

Primary outcome: Hide Cough

Time frame: Up to eleven months. Count of participants. Unit: Participants

Measure	Early Learning n = 49
Enrollment: Frequently	13
Enrollment: Sometimes	24
Enrollment: Never	7
Enrollment: Prefer not to Answer	1
Enrollment: Missing	4
Follow Up: Frequently	14
Follow Up: Sometimes	24
Follow Up: Never	5

Population analysed: Early Learning Students age 3-5 years old

Adverse events

Time frame: Parent,(n=48), student (n=49) dyads were enrolled from 9/22/22 through 2/16/24.Adverse events were monitored for 1 year 5 months from baseline assessment through Post Survey.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single Arm Pre and Post Intervention Study - Parent	0 of 48 (0%)	0 of 48 (0%)	0 of 48
Single Arm Pre and Post Intervention Study - Child	0 of 49 (0%)	0 of 49 (0%)	0 of 49

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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 Health Education 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 4 inclusion and 1 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 Jun 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 Jun 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?

Testing (time frame: Up to eleven months). The study lists 4 primary outcomes in all. 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 NCT05965323.

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 Jun 2025.