Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1OT2HD107544-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID-19 Health Education Comic Books and Videos | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| School Attendance | How many school days missed due to symptoms of respiratory illness (only include index child). | Up to nine months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39368130 | Derived | 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. | |
| 38597249 | Derived | Constantin 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. |
Not provided
Not provided
Parent-child dyads were counted individually and the number of participants reflects each individual in the study. Some parents had more than one child (siblings) included in the study.
Participants (Child and parent dyad) were recruited from Yakima School District elementary schools from January 17, 2022 and November 4, 2022.
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Health Communication Strategy | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Consented kindergarten through 5th grade students and parents enrolled in participating school district; children includes index and siblings. Children in the intervention arm = 325 (246 index and 79 siblings); Children in the control group = 307 (217 index and 90 siblings).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | This arm will include schools and the enrolled families assigned as the control group, who will not receive the COVID-19 health education comic books and video intervention. |
| BG001 | Health Communication Strategy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Row categories are divided by age and parent, child |
| 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 | School Attendance | How many school days missed due to symptoms of respiratory illness (only include index child). | Total number of school days missed by students (index child only) due to symptoms of respiratory illness at Post Survey 1 (Control = 191; Intervention = 217) | Posted | Mean | Standard Deviation | Mean # days missed | Up to nine months |
|
1 year, 9 months
Same as clinical trials
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group -Parent | This arm will include schools and the enrolled families assigned as the control group, who will not receive the COVID-19 health education comic books and video intervention. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linda K. Ko | University of Washington | +1 206 707-5624 | lindako@uw.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 18, 2024 | Feb 26, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 26, 2024 | Apr 14, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D014743 | Videotape Recording |
| ID | Term |
|---|---|
| D013637 | Tape Recording |
| D001296 | Audiovisual Aids |
| D018961 | Educational Technology |
| D013672 | Technology |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. . | 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. | 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. . | Completed at Post survey 1 (T2) |
| 38382823 | Derived | Ramirez 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. |
This arm will include schools that are randomized to receive the health education with comic books and videos focused on the benefits of preventive measures for COVID-19.
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
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex/Gender, Customized | The total is divided between category and parent, child | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | The total is divided between category and parent, child | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | The total is divided between category and parent, child | Count of Participants | Participants |
|
| Region of Enrollment | Region of Enrollment Children | Number | participants |
|
| Region of Enrollment | Region of Enrollment Parent | Number | participants |
|
|
|
| Secondary | 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. | Overall ppts analyzed 463 index children, which is 217 at Control and 246 Intervention | Posted | Mean | Standard Deviation | score on a scale | Completed at baseline (T1) |
|
|
|
| Secondary | 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. . | Total number of Parents assessed for anxiety, sleep disturbance, depression, and stress | Posted | Mean | Standard Deviation | score on a scale | Completed at baseline (T1) |
|
|
|
| Secondary | 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. | Overall ppts analyzed 408 index children, which is 191 at Control and 217 Intervention | Posted | Mean | Standard Deviation | score on a scale | Post survey 1 (T2) |
|
|
|
| Secondary | 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. . | Total number of Parents assessed for anxiety, sleep disturbance, depression, and stress | Posted | Mean | Standard Deviation | score on a scale | Completed at Post survey 1 (T2) |
|
|
|
| 0 |
| 217 |
| 0 |
| 217 |
| 0 |
| 217 |
| EG001 | Health Communication Strategies Parent | This arm will include schools that are randomized to receive the health education with comic books and videos focused on the benefits of preventive measures for COVID-19. 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 | 0 | 246 | 0 | 246 | 0 | 246 |
| EG002 | Control Group - Child | This arm will include schools and the enrolled families assigned as the control group, who will not receive the COVID-19 health education comic books and video intervention. | 0 | 307 | 0 | 307 | 0 | 307 |
| EG003 | Health Communication Strategies - Child | This arm will include schools that are randomized to receive the health education with comic books and videos focused on the benefits of preventive measures for COVID-19. 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 | 0 | 325 | 0 | 325 | 0 | 325 |
Not provided
Not provided
| D013676 |
| Technology, Industry, and Agriculture |
| D013690 | Television |
| Parent |
|
| Parent |
|
| Parent |
|
| Parent |
|
| Parent |
|
| Parent |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| White |
|
| More than One Race |
|
| Other |
|
| Prefer Not to Answer |
|
| Unknown or Not Reported |
|
| Asian American, Native Hawaiian or Other PI |
|
| Black or African American |
|
| White |
|
| More than One Race |
|
| Other |
|
| Prefer Not to Answer |
|
| Unknown or Not Reported |
|
| Physical Activity |
|
| Sleep Disturbance |
|
| Depression |
|
| Depression |
|
| Stress |
|
| Physical Activity |
|
| Sleep Disturbance |
|
| Depression |
|
| Depression |
|
| Stress |
|