Trial Outcomes & Findings for Reopening Schools Safely and Educating Youth Research Study (ROSSEY) (NCT NCT04859699)
NCT ID: NCT04859699
Last Updated: 2025-10-08
Results Overview
How many school days missed due to symptoms of respiratory illness (only include index child).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1095 participants
Primary outcome timeframe
Up to nine months
Results posted on
2025-10-08
Participant Flow
Participants (Child and parent dyad) were recruited from Yakima School District elementary schools from January 17, 2022 and November 4, 2022.
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.
Unit of analysis: schools
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
524 7
|
571 7
|
|
Overall Study
T2 Follow-up
|
441 7
|
525 7
|
|
Overall Study
T3 Follow-up
|
454 7
|
482 7
|
|
Overall Study
COMPLETED
|
454 7
|
482 7
|
|
Overall Study
NOT COMPLETED
|
70 0
|
89 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Row categories are divided by age and parent, child
Baseline characteristics by cohort
| Measure |
Control Group
n=524 Participants
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.
|
Health Communication Strategy
n=571 Participants
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
|
Total
n=1095 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<=18 Years · Child
|
307 Participants
n=307 Participants • Row categories are divided by age and parent, child
|
325 Participants
n=325 Participants • Row categories are divided by age and parent, child
|
632 Participants
n=632 Participants • Row categories are divided by age and parent, child
|
|
Age, Customized
<=18 Years · Parent
|
0 Participants
n=307 Participants • Row categories are divided by age and parent, child
|
0 Participants
n=325 Participants • Row categories are divided by age and parent, child
|
0 Participants
n=632 Participants • Row categories are divided by age and parent, child
|
|
Age, Customized
Between 18-65 Years · Child
|
0 Participants
Row categories are divided by age and parent, child
|
0 Participants
Row categories are divided by age and parent, child
|
0 Participants
Row categories are divided by age and parent, child
|
|
Age, Customized
Between 18-65 Years · Parent
|
0 Participants
Row categories are divided by age and parent, child
|
0 Participants
Row categories are divided by age and parent, child
|
0 Participants
Row categories are divided by age and parent, child
|
|
Age, Customized
>=65 Years · Child
|
0 Participants
Row categories are divided by age and parent, child
|
0 Participants
Row categories are divided by age and parent, child
|
0 Participants
Row categories are divided by age and parent, child
|
|
Age, Customized
>=65 Years · Parent
|
0 Participants
Row categories are divided by age and parent, child
|
0 Participants
Row categories are divided by age and parent, child
|
0 Participants
Row categories are divided by age and parent, child
|
|
Age, Customized
Unknown or Not Reported · Child
|
0 Participants
n=217 Participants • Row categories are divided by age and parent, child
|
0 Participants
n=246 Participants • Row categories are divided by age and parent, child
|
0 Participants
n=463 Participants • Row categories are divided by age and parent, child
|
|
Age, Customized
Unknown or Not Reported · Parent
|
217 Participants
n=217 Participants • Row categories are divided by age and parent, child
|
246 Participants
n=246 Participants • Row categories are divided by age and parent, child
|
463 Participants
n=463 Participants • Row categories are divided by age and parent, child
|
|
Sex/Gender, Customized
Male · Child
|
145 Participants
n=172 Participants • The total is divided between category and parent, child
|
146 Participants
n=171 Participants • The total is divided between category and parent, child
|
291 Participants
n=343 Participants • The total is divided between category and parent, child
|
|
Sex/Gender, Customized
Male · Parent
|
27 Participants
n=172 Participants • The total is divided between category and parent, child
|
25 Participants
n=171 Participants • The total is divided between category and parent, child
|
52 Participants
n=343 Participants • The total is divided between category and parent, child
|
|
Sex/Gender, Customized
Female · Child
|
161 Participants
n=322 Participants • The total is divided between category and parent, child
|
179 Participants
n=369 Participants • The total is divided between category and parent, child
|
340 Participants
n=691 Participants • The total is divided between category and parent, child
|
|
Sex/Gender, Customized
Female · Parent
|
161 Participants
n=322 Participants • The total is divided between category and parent, child
|
190 Participants
n=369 Participants • The total is divided between category and parent, child
|
351 Participants
n=691 Participants • The total is divided between category and parent, child
|
|
Sex/Gender, Customized
Prefer not to Answer · Child
|
1 Participants
n=3 Participants • The total is divided between category and parent, child
|
0 Participants
n=2 Participants • The total is divided between category and parent, child
|
1 Participants
n=5 Participants • The total is divided between category and parent, child
|
|
Sex/Gender, Customized
Prefer not to Answer · Parent
|
2 Participants
n=3 Participants • The total is divided between category and parent, child
|
2 Participants
n=2 Participants • The total is divided between category and parent, child
|
4 Participants
n=5 Participants • The total is divided between category and parent, child
|
|
Sex/Gender, Customized
Unknown or Not Reported · Child
|
0 Participants
n=27 Participants • The total is divided between category and parent, child
|
0 Participants
n=29 Participants • The total is divided between category and parent, child
|
0 Participants
n=56 Participants • The total is divided between category and parent, child
|
|
Sex/Gender, Customized
Unknown or Not Reported · Parent
|
27 Participants
n=27 Participants • The total is divided between category and parent, child
|
29 Participants
n=29 Participants • The total is divided between category and parent, child
|
56 Participants
n=56 Participants • The total is divided between category and parent, child
|
|
Ethnicity (NIH/OMB)
Child · Hispanic or Latino
|
242 Participants
n=307 Participants • The total is divided between category and parent, child
|
267 Participants
n=325 Participants • The total is divided between category and parent, child
|
509 Participants
n=632 Participants • The total is divided between category and parent, child
|
|
Ethnicity (NIH/OMB)
Child · Not Hispanic or Latino
|
58 Participants
n=307 Participants • The total is divided between category and parent, child
|
57 Participants
n=325 Participants • The total is divided between category and parent, child
|
115 Participants
n=632 Participants • The total is divided between category and parent, child
|
|
Ethnicity (NIH/OMB)
Child · Unknown or Not Reported
|
7 Participants
n=307 Participants • The total is divided between category and parent, child
|
1 Participants
n=325 Participants • The total is divided between category and parent, child
|
8 Participants
n=632 Participants • The total is divided between category and parent, child
|
|
Ethnicity (NIH/OMB)
Parent · Hispanic or Latino
|
143 Participants
n=217 Participants • The total is divided between category and parent, child
|
167 Participants
n=246 Participants • The total is divided between category and parent, child
|
310 Participants
n=463 Participants • The total is divided between category and parent, child
|
|
Ethnicity (NIH/OMB)
Parent · Not Hispanic or Latino
|
40 Participants
n=217 Participants • The total is divided between category and parent, child
|
45 Participants
n=246 Participants • The total is divided between category and parent, child
|
85 Participants
n=463 Participants • The total is divided between category and parent, child
|
|
Ethnicity (NIH/OMB)
Parent · Unknown or Not Reported
|
34 Participants
n=217 Participants • The total is divided between category and parent, child
|
34 Participants
n=246 Participants • The total is divided between category and parent, child
|
68 Participants
n=463 Participants • The total is divided between category and parent, child
|
|
Race/Ethnicity, Customized
RACE (NIH/OMB) Child · American Indian or Alaska Native
|
6 Participants
n=307 Participants • The total is divided between category and parent, child
|
1 Participants
n=325 Participants • The total is divided between category and parent, child
|
7 Participants
n=632 Participants • The total is divided between category and parent, child
|
|
Race/Ethnicity, Customized
RACE (NIH/OMB) Child · Asian American, Native Hawaiian or Other PI
|
1 Participants
n=307 Participants • The total is divided between category and parent, child
|
0 Participants
n=325 Participants • The total is divided between category and parent, child
|
1 Participants
n=632 Participants • The total is divided between category and parent, child
|
|
Race/Ethnicity, Customized
RACE (NIH/OMB) Child · Black or African American
|
1 Participants
n=307 Participants • The total is divided between category and parent, child
|
1 Participants
n=325 Participants • The total is divided between category and parent, child
|
2 Participants
n=632 Participants • The total is divided between category and parent, child
|
|
Race/Ethnicity, Customized
RACE (NIH/OMB) Child · White
|
41 Participants
n=307 Participants • The total is divided between category and parent, child
|
48 Participants
n=325 Participants • The total is divided between category and parent, child
|
89 Participants
n=632 Participants • The total is divided between category and parent, child
|
|
Race/Ethnicity, Customized
RACE (NIH/OMB) Child · More than One Race
|
4 Participants
n=307 Participants • The total is divided between category and parent, child
|
7 Participants
n=325 Participants • The total is divided between category and parent, child
|
11 Participants
n=632 Participants • The total is divided between category and parent, child
|
|
Race/Ethnicity, Customized
RACE (NIH/OMB) Child · Other
|
5 Participants
n=307 Participants • The total is divided between category and parent, child
|
0 Participants
n=325 Participants • The total is divided between category and parent, child
|
5 Participants
n=632 Participants • The total is divided between category and parent, child
|
|
Race/Ethnicity, Customized
RACE (NIH/OMB) Child · Prefer Not to Answer
|
7 Participants
n=307 Participants • The total is divided between category and parent, child
|
0 Participants
n=325 Participants • The total is divided between category and parent, child
|
7 Participants
n=632 Participants • The total is divided between category and parent, child
|
|
Race/Ethnicity, Customized
RACE (NIH/OMB) Child · Unknown or Not Reported
|
242 Participants
n=307 Participants • The total is divided between category and parent, child
|
268 Participants
n=325 Participants • The total is divided between category and parent, child
|
510 Participants
n=632 Participants • The total is divided between category and parent, child
|
|
Race/Ethnicity, Customized
RACE (NIH/OMB) Parent · American Indian or Alaska Native
|
3 Participants
n=217 Participants • The total is divided between category and parent, child
|
3 Participants
n=246 Participants • The total is divided between category and parent, child
|
6 Participants
n=463 Participants • The total is divided between category and parent, child
|
|
Race/Ethnicity, Customized
RACE (NIH/OMB) Parent · Asian American, Native Hawaiian or Other PI
|
0 Participants
n=217 Participants • The total is divided between category and parent, child
|
1 Participants
n=246 Participants • The total is divided between category and parent, child
|
1 Participants
n=463 Participants • The total is divided between category and parent, child
|
|
Race/Ethnicity, Customized
RACE (NIH/OMB) Parent · Black or African American
|
1 Participants
n=217 Participants • The total is divided between category and parent, child
|
2 Participants
n=246 Participants • The total is divided between category and parent, child
|
3 Participants
n=463 Participants • The total is divided between category and parent, child
|
|
Race/Ethnicity, Customized
RACE (NIH/OMB) Parent · White
|
35 Participants
n=217 Participants • The total is divided between category and parent, child
|
36 Participants
n=246 Participants • The total is divided between category and parent, child
|
71 Participants
n=463 Participants • The total is divided between category and parent, child
|
|
Race/Ethnicity, Customized
RACE (NIH/OMB) Parent · More than One Race
|
1 Participants
n=217 Participants • The total is divided between category and parent, child
|
3 Participants
n=246 Participants • The total is divided between category and parent, child
|
4 Participants
n=463 Participants • The total is divided between category and parent, child
|
|
Race/Ethnicity, Customized
RACE (NIH/OMB) Parent · Other
|
5 Participants
n=217 Participants • The total is divided between category and parent, child
|
0 Participants
n=246 Participants • The total is divided between category and parent, child
|
5 Participants
n=463 Participants • The total is divided between category and parent, child
|
|
Race/Ethnicity, Customized
RACE (NIH/OMB) Parent · Prefer Not to Answer
|
9 Participants
n=217 Participants • The total is divided between category and parent, child
|
0 Participants
n=246 Participants • The total is divided between category and parent, child
|
9 Participants
n=463 Participants • The total is divided between category and parent, child
|
|
Race/Ethnicity, Customized
RACE (NIH/OMB) Parent · Unknown or Not Reported
|
163 Participants
n=217 Participants • The total is divided between category and parent, child
|
201 Participants
n=246 Participants • The total is divided between category and parent, child
|
364 Participants
n=463 Participants • The total is divided between category and parent, child
|
|
Region of Enrollment
United States
|
217 participants
n=524 Participants
|
246 participants
n=571 Participants
|
463 participants
n=1095 Participants
|
PRIMARY outcome
Timeframe: Up to nine monthsPopulation: 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)
How many school days missed due to symptoms of respiratory illness (only include index child).
Outcome measures
| Measure |
Control Group
n=191 Participants
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.
|
COVID-19 Comic Books and Videos
n=217 Participants
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
|
|---|---|---|
|
School Attendance
|
6.57 Mean # days missed
Standard Deviation 7.72
|
7.34 Mean # days missed
Standard Deviation 8.45
|
SECONDARY outcome
Timeframe: Completed at baseline (T1)Population: Overall ppts analyzed 463 index children, which is 217 at Control and 246 Intervention
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.
Outcome measures
| Measure |
Control Group
n=217 Participants
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.
|
COVID-19 Comic Books and Videos
n=246 Participants
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
|
|---|---|---|
|
Emotional Regulation of Index Children at Baseline (T1)
Anxiety
|
45.7 score on a scale
Standard Deviation 9.65
|
45.4 score on a scale
Standard Deviation 10.2
|
|
Emotional Regulation of Index Children at Baseline (T1)
Stress
|
49.2 score on a scale
Standard Deviation 9.24
|
48.4 score on a scale
Standard Deviation 9.07
|
|
Emotional Regulation of Index Children at Baseline (T1)
Physical Activity
|
48.8 score on a scale
Standard Deviation 8.36
|
48.1 score on a scale
Standard Deviation 8.02
|
|
Emotional Regulation of Index Children at Baseline (T1)
Sleep Disturbance
|
51.7 score on a scale
Standard Deviation 10.0
|
51.0 score on a scale
Standard Deviation 9.94
|
|
Emotional Regulation of Index Children at Baseline (T1)
Depression
|
43.9 score on a scale
Standard Deviation 10.1
|
43.3 score on a scale
Standard Deviation 9.76
|
SECONDARY outcome
Timeframe: Completed at baseline (T1)Population: Total number of Parents assessed for anxiety, sleep disturbance, depression, and stress
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. .
Outcome measures
| Measure |
Control Group
n=217 Participants
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.
|
COVID-19 Comic Books and Videos
n=246 Participants
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
|
|---|---|---|
|
Perceived Stress of Parents at Baseline (T1)
Anxiety
|
52.6 score on a scale
Standard Deviation 10.2
|
52.2 score on a scale
Standard Deviation 10.6
|
|
Perceived Stress of Parents at Baseline (T1)
Sleep distubance
|
51.1 score on a scale
Standard Deviation 9.73
|
50.5 score on a scale
Standard Deviation 8.78
|
|
Perceived Stress of Parents at Baseline (T1)
Depression
|
48.4 score on a scale
Standard Deviation 9.68
|
48.3 score on a scale
Standard Deviation 10.1
|
|
Perceived Stress of Parents at Baseline (T1)
Stress
|
51.0 score on a scale
Standard Deviation 8.51
|
51.0 score on a scale
Standard Deviation 9.74
|
SECONDARY outcome
Timeframe: Post survey 1 (T2)Population: Overall ppts analyzed 408 index children, which is 191 at Control and 217 Intervention
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.
Outcome measures
| Measure |
Control Group
n=191 Participants
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.
|
COVID-19 Comic Books and Videos
n=217 Participants
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
|
|---|---|---|
|
Emotional Regulation of Index Children at Post Survey 1 (T2)
Stress
|
51.7 score on a scale
Standard Deviation 8.97
|
51.7 score on a scale
Standard Deviation 9.03
|
|
Emotional Regulation of Index Children at Post Survey 1 (T2)
Physical Activity
|
50.2 score on a scale
Standard Deviation 7.46
|
50.1 score on a scale
Standard Deviation 8.20
|
|
Emotional Regulation of Index Children at Post Survey 1 (T2)
Sleep Disturbance
|
52.6 score on a scale
Standard Deviation 9.90
|
51.7 score on a scale
Standard Deviation 10.5
|
|
Emotional Regulation of Index Children at Post Survey 1 (T2)
Anxiety
|
45.9 score on a scale
Standard Deviation 9.00
|
45.8 score on a scale
Standard Deviation 10.0
|
|
Emotional Regulation of Index Children at Post Survey 1 (T2)
Depression
|
43.6 score on a scale
Standard Deviation 9.50
|
42.4 score on a scale
Standard Deviation 9.82
|
SECONDARY outcome
Timeframe: Completed at Post survey 1 (T2)Population: Total number of Parents assessed for anxiety, sleep disturbance, depression, and stress
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. .
Outcome measures
| Measure |
Control Group
n=191 Participants
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.
|
COVID-19 Comic Books and Videos
n=217 Participants
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
|
|---|---|---|
|
Perceived Stress of Parents at Post Survey 1 (T2)
Anxiety
|
53.1 score on a scale
Standard Deviation 10.2
|
52.6 score on a scale
Standard Deviation 10.5
|
|
Perceived Stress of Parents at Post Survey 1 (T2)
Sleep distubance
|
50.9 score on a scale
Standard Deviation 9.25
|
49.2 score on a scale
Standard Deviation 9.15
|
|
Perceived Stress of Parents at Post Survey 1 (T2)
Depression
|
48.9 score on a scale
Standard Deviation 10.4
|
48.8 score on a scale
Standard Deviation 10.2
|
|
Perceived Stress of Parents at Post Survey 1 (T2)
Stress
|
52.0 score on a scale
Standard Deviation 10.2
|
51.0 score on a scale
Standard Deviation 10.0
|
Adverse Events
Control Group -Parent
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Health Communication Strategies Parent
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group - Child
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Health Communication Strategies - Child
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place