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| ID | Type | Description | Link |
|---|---|---|---|
| 1OT2HD107544-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
Students will receive the intervention from November 2023 to March 2024.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | The students in this arm will receive comic books and their parents videos on the benefits of preventive measures of COVID-19 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health Education | Behavioral | Health education with comic books and videos |
|
| Measure | Description | Time Frame |
|---|---|---|
| Testing | Percentage of early learning students testing for COVID-19 | Up to eleven months |
| Masking | Percentage of early learning students masking for COVID-19 | Up to eleven months |
| Wash Hands | Percentage of early learning students washing hands for COVID-19 | Up to eleven months |
| Hide Cough | Percentage of early learning students who hide cough during COVID-19 | Up to eleven months |
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Inclusion Criteria:
Exclusion Criteria:
- Not in Early Learning program in Yakima School District
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| Name | Affiliation | Role |
|---|---|---|
| Linda Ko, PhD, MPH | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98109 | United States |
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Recruitment of parent, child dyads in Early Learning anxillary study 09/22/2022 through 12/30/2022
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| ID | Title | Description |
|---|---|---|
| FG000 | Students | Assented students enrolled in Early Learning study |
| FG001 | Parent | Consented parents of Early Learning Students |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Recruitment of Early Learning students (3, 4 and 5 years old) and their parent or Guardian(s) regardless of their participation in SARS-CoV-2 testing provided by the Yakima School District.
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm Pre and Post Intervention Study | We want to learn if health education (COVID-19 Health Education Comic Books and Videos) 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Parent (n=48), Child (n=49) dyads, totaling (n=97) enrolled participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Testing | Percentage of early learning students testing for COVID-19 | Early Learning Students age 3-5 years old | Posted | Count of Participants | Participants | Up to eleven months |
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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.
Definition is any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm Pre and Post Intervention Study - Parent | We want to learn if health education (COVID-19 Health Education Comic Books and Videos) 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linda K Ko, PhD, Principal Investigator | University of Washington | 2062568261 | lindako@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 3, 2024 | Mar 3, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 30, 2022 | Jun 5, 2025 | SAP_001.pdf |
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| Count of Participants |
| Participants |
|
| Sex/Gender, Customized | Parent (n=48), Child (n=49) dyads, totaling (n=97) enrolled participants | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Parent (n=48), Child (n=49) dyads, totaling (n=97) enrolled participants | Count of Participants | Participants |
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| Race (NIH/OMB) | Parent (n=48), Child (n=49) dyads, totaling (n=97) enrolled participants | Count of Participants | Participants |
|
| Region of Enrollment | Number | Student Participants |
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| Region of Enrollment | Parent (n=48), Child (n=49) dyads, totaling (n=97) enrolled participants | Number | Parent Participants |
|
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| Primary | Masking | Percentage of early learning students masking for COVID-19 | Early Learning Students age 3-5 years old | Posted | Count of Participants | Participants | Up to eleven months |
|
|
|
| Primary | Wash Hands | Percentage of early learning students washing hands for COVID-19 | Early Learning Students age 3-5 years old | Posted | Count of Participants | Participants | Up to eleven months |
|
|
|
| Primary | Hide Cough | Percentage of early learning students who hide cough during COVID-19 | Early Learning Students age 3-5 years old | Posted | Count of Participants | Participants | Up to eleven months |
|
|
|
| 0 |
| 48 |
| 0 |
| 48 |
| 0 |
| 48 |
| EG001 | Single Arm Pre and Post Intervention Study - Child | We want to learn if health education (COVID-19 Health Education Comic Books and Videos) 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. | 0 | 49 | 0 | 49 | 0 | 49 |
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| Unknown not reported |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Missing |
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| Follow Up |
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| Follow Up |
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| Prefer not to Answer |
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| Missing |
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| Follow Up |
|