Absenteeism
Conditions
Keywords
SARS-CoV-2, School re-opening, Rural communities, Risk communication
Brief 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. 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.
Interventions
BEHAVIORALCOVID-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
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| School Attendance | Up to nine months | How many school days missed due to symptoms of respiratory illness (only include index child). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Emotional Regulation of Index Children at Baseline (T1) | Completed 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. |
| Perceived Stress of Parents at Baseline (T1) | Completed 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. . |
| Emotional Regulation of Index Children at Post Survey 1 (T2) | 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. |
| Perceived Stress of Parents at Post Survey 1 (T2) | Completed 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. . |
Countries
United States
Participant flow
Recruitment details
Participants (Child and parent dyad) were recruited from Yakima School District elementary schools from January 17, 2022 and November 4, 2022.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 524 |
| Health Communication Strategy 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 | 571 |
| Total | 1,095 |
Baseline characteristics
| Characteristic | Control Group | Health Communication Strategy | Total |
|---|---|---|---|
| Age, Customized <=18 Years Child | 307 Participants | 325 Participants | 632 Participants |
| Age, Customized <=18 Years Parent | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized >=65 Years Child | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized >=65 Years Parent | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Between 18-65 Years Child | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Between 18-65 Years Parent | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Unknown or Not Reported Child | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Unknown or Not Reported Parent | 217 Participants | 246 Participants | 463 Participants |
| Ethnicity (NIH/OMB) Child Hispanic or Latino | 242 Participants | 267 Participants | 509 Participants |
| Ethnicity (NIH/OMB) Child Not Hispanic or Latino | 58 Participants | 57 Participants | 115 Participants |
| Ethnicity (NIH/OMB) Child Unknown or Not Reported | 7 Participants | 1 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Parent Hispanic or Latino | 143 Participants | 167 Participants | 310 Participants |
| Ethnicity (NIH/OMB) Parent Not Hispanic or Latino | 40 Participants | 45 Participants | 85 Participants |
| Ethnicity (NIH/OMB) Parent Unknown or Not Reported | 34 Participants | 34 Participants | 68 Participants |
| Race/Ethnicity, Customized RACE (NIH/OMB) Child American Indian or Alaska Native | 6 Participants | 1 Participants | 7 Participants |
| Race/Ethnicity, Customized RACE (NIH/OMB) Child Asian American, Native Hawaiian or Other PI | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized RACE (NIH/OMB) Child Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized RACE (NIH/OMB) Child More than One Race | 4 Participants | 7 Participants | 11 Participants |
| Race/Ethnicity, Customized RACE (NIH/OMB) Child Other | 5 Participants | 0 Participants | 5 Participants |
| Race/Ethnicity, Customized RACE (NIH/OMB) Child Prefer Not to Answer | 7 Participants | 0 Participants | 7 Participants |
| Race/Ethnicity, Customized RACE (NIH/OMB) Child Unknown or Not Reported | 242 Participants | 268 Participants | 510 Participants |
| Race/Ethnicity, Customized RACE (NIH/OMB) Child White | 41 Participants | 48 Participants | 89 Participants |
| Race/Ethnicity, Customized RACE (NIH/OMB) Parent American Indian or Alaska Native | 3 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized RACE (NIH/OMB) Parent Asian American, Native Hawaiian or Other PI | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized RACE (NIH/OMB) Parent Black or African American | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized RACE (NIH/OMB) Parent More than One Race | 1 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized RACE (NIH/OMB) Parent Other | 5 Participants | 0 Participants | 5 Participants |
| Race/Ethnicity, Customized RACE (NIH/OMB) Parent Prefer Not to Answer | 9 Participants | 0 Participants | 9 Participants |
| Race/Ethnicity, Customized RACE (NIH/OMB) Parent Unknown or Not Reported | 163 Participants | 201 Participants | 364 Participants |
| Race/Ethnicity, Customized RACE (NIH/OMB) Parent White | 35 Participants | 36 Participants | 71 Participants |
| Region of Enrollment United States | 217 participants | 325 participants | 632 participants |
| Sex/Gender, Customized Female Child | 161 Participants | 179 Participants | 340 Participants |
| Sex/Gender, Customized Female Parent | 161 Participants | 190 Participants | 351 Participants |
| Sex/Gender, Customized Male Child | 145 Participants | 146 Participants | 291 Participants |
| Sex/Gender, Customized Male Parent | 27 Participants | 25 Participants | 52 Participants |
| Sex/Gender, Customized Prefer not to Answer Child | 1 Participants | 0 Participants | 1 Participants |
| Sex/Gender, Customized Prefer not to Answer Parent | 2 Participants | 2 Participants | 4 Participants |
| Sex/Gender, Customized Unknown or Not Reported Child | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Unknown or Not Reported Parent | 27 Participants | 29 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 217 | 0 / 246 | 0 / 307 | 0 / 325 |
| other Total, other adverse events | 0 / 217 | 0 / 246 | 0 / 307 | 0 / 325 |
| serious Total, serious adverse events | 0 / 217 | 0 / 246 | 0 / 307 | 0 / 325 |
Outcome results
Primary
School Attendance
How many school days missed due to symptoms of respiratory illness (only include index child).
Time frame: Up to nine months
Population: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | School Attendance | 6.57 Mean # days missed | Standard Deviation 7.72 |
| COVID-19 Comic Books and Videos | School Attendance | 7.34 Mean # days missed | Standard Deviation 8.45 |
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.
Time frame: Completed at baseline (T1)
Population: Overall ppts analyzed 463 index children, which is 217 at Control and 246 Intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Emotional Regulation of Index Children at Baseline (T1) | Stress | 49.2 score on a scale | Standard Deviation 9.24 |
| Control Group | Emotional Regulation of Index Children at Baseline (T1) | Sleep Disturbance | 51.7 score on a scale | Standard Deviation 10 |
| Control Group | Emotional Regulation of Index Children at Baseline (T1) | Physical Activity | 48.8 score on a scale | Standard Deviation 8.36 |
| Control Group | Emotional Regulation of Index Children at Baseline (T1) | Depression | 43.9 score on a scale | Standard Deviation 10.1 |
| Control Group | Emotional Regulation of Index Children at Baseline (T1) | Anxiety | 45.7 score on a scale | Standard Deviation 9.65 |
| COVID-19 Comic Books and Videos | Emotional Regulation of Index Children at Baseline (T1) | Depression | 43.3 score on a scale | Standard Deviation 9.76 |
| COVID-19 Comic Books and Videos | Emotional Regulation of Index Children at Baseline (T1) | Anxiety | 45.4 score on a scale | Standard Deviation 10.2 |
| COVID-19 Comic Books and Videos | Emotional Regulation of Index Children at Baseline (T1) | Stress | 48.4 score on a scale | Standard Deviation 9.07 |
| COVID-19 Comic Books and Videos | Emotional Regulation of Index Children at Baseline (T1) | Physical Activity | 48.1 score on a scale | Standard Deviation 8.02 |
| COVID-19 Comic Books and Videos | Emotional Regulation of Index Children at Baseline (T1) | Sleep Disturbance | 51.0 score on a scale | Standard Deviation 9.94 |
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.
Time frame: Post survey 1 (T2)
Population: Overall ppts analyzed 408 index children, which is 191 at Control and 217 Intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Emotional Regulation of Index Children at Post Survey 1 (T2) | Stress | 51.7 score on a scale | Standard Deviation 8.97 |
| Control Group | Emotional Regulation of Index Children at Post Survey 1 (T2) | Sleep Disturbance | 52.6 score on a scale | Standard Deviation 9.9 |
| Control Group | Emotional Regulation of Index Children at Post Survey 1 (T2) | Physical Activity | 50.2 score on a scale | Standard Deviation 7.46 |
| Control Group | Emotional Regulation of Index Children at Post Survey 1 (T2) | Depression | 43.6 score on a scale | Standard Deviation 9.5 |
| Control Group | Emotional Regulation of Index Children at Post Survey 1 (T2) | Anxiety | 45.9 score on a scale | Standard Deviation 9 |
| COVID-19 Comic Books and Videos | Emotional Regulation of Index Children at Post Survey 1 (T2) | Depression | 42.4 score on a scale | Standard Deviation 9.82 |
| COVID-19 Comic Books and Videos | Emotional Regulation of Index Children at Post Survey 1 (T2) | Anxiety | 45.8 score on a scale | Standard Deviation 10 |
| COVID-19 Comic Books and Videos | Emotional Regulation of Index Children at Post Survey 1 (T2) | Stress | 51.7 score on a scale | Standard Deviation 9.03 |
| COVID-19 Comic Books and Videos | Emotional Regulation of Index Children at Post Survey 1 (T2) | Physical Activity | 50.1 score on a scale | Standard Deviation 8.2 |
| COVID-19 Comic Books and Videos | Emotional Regulation of Index Children at Post Survey 1 (T2) | Sleep Disturbance | 51.7 score on a scale | Standard Deviation 10.5 |
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. .
Time frame: Completed at baseline (T1)
Population: Total number of Parents assessed for anxiety, sleep disturbance, depression, and stress
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Perceived Stress of Parents at Baseline (T1) | Anxiety | 52.6 score on a scale | Standard Deviation 10.2 |
| Control Group | Perceived Stress of Parents at Baseline (T1) | Sleep distubance | 51.1 score on a scale | Standard Deviation 9.73 |
| Control Group | Perceived Stress of Parents at Baseline (T1) | Depression | 48.4 score on a scale | Standard Deviation 9.68 |
| Control Group | Perceived Stress of Parents at Baseline (T1) | Stress | 51.0 score on a scale | Standard Deviation 8.51 |
| COVID-19 Comic Books and Videos | Perceived Stress of Parents at Baseline (T1) | Stress | 51.0 score on a scale | Standard Deviation 9.74 |
| COVID-19 Comic Books and Videos | Perceived Stress of Parents at Baseline (T1) | Anxiety | 52.2 score on a scale | Standard Deviation 10.6 |
| COVID-19 Comic Books and Videos | Perceived Stress of Parents at Baseline (T1) | Depression | 48.3 score on a scale | Standard Deviation 10.1 |
| COVID-19 Comic Books and Videos | Perceived Stress of Parents at Baseline (T1) | Sleep distubance | 50.5 score on a scale | Standard Deviation 8.78 |
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. .
Time frame: Completed at Post survey 1 (T2)
Population: Total number of Parents assessed for anxiety, sleep disturbance, depression, and stress
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Perceived Stress of Parents at Post Survey 1 (T2) | Anxiety | 53.1 score on a scale | Standard Deviation 10.2 |
| Control Group | Perceived Stress of Parents at Post Survey 1 (T2) | Sleep distubance | 50.9 score on a scale | Standard Deviation 9.25 |
| Control Group | Perceived Stress of Parents at Post Survey 1 (T2) | Depression | 48.9 score on a scale | Standard Deviation 10.4 |
| Control Group | Perceived Stress of Parents at Post Survey 1 (T2) | Stress | 52.0 score on a scale | Standard Deviation 10.2 |
| COVID-19 Comic Books and Videos | Perceived Stress of Parents at Post Survey 1 (T2) | Stress | 51.0 score on a scale | Standard Deviation 10 |
| COVID-19 Comic Books and Videos | Perceived Stress of Parents at Post Survey 1 (T2) | Anxiety | 52.6 score on a scale | Standard Deviation 10.5 |
| COVID-19 Comic Books and Videos | Perceived Stress of Parents at Post Survey 1 (T2) | Depression | 48.8 score on a scale | Standard Deviation 10.2 |
| COVID-19 Comic Books and Videos | Perceived Stress of Parents at Post Survey 1 (T2) | Sleep distubance | 49.2 score on a scale | Standard Deviation 9.15 |