Trial Outcomes & Findings for Supporting the Health and Well-being of Children With Intellectual and Developmental Disability During COVID-19 Pandemic (NCT NCT04565509)
NCT ID: NCT04565509
Last Updated: 2026-02-23
Results Overview
Assuming the binomial distribution for each primary outcome, generalized estimating equation (GEE) models with logit link function were utilized to investigate the primary outcome changes across the weeks. The denominators for the enrollment and test rate per school were the total number of staff and students; and the total number of consented participants for a specific week, respectively. For the weeks after randomization, the GEE model included the indicator of week, group indicator, and the interaction term between week and group indicator. P-values of the interaction term from type-3 test were used to test the difference between 2 groups across the weeks. At Kennedy, GEE models were conducted separately using participants with non-missing data and participants with missing data to assess the impact of missing data. The reported values reflect the percentage of participants enrolled per week.
COMPLETED
NA
1143 participants
22 months
2026-02-23
Participant Flow
All students and staff in the schools were eligible.
Focus Groups and Fuzzy Cognitive Mapping only completed during Phase 1. SCD = Special School District. KKI = Kennedy Krieger Institute. FCM = Fuzzy Cognitive Mapping.
Unit of analysis: Schools
Participant milestones
| Measure |
SSD: Standard Messaging - Enhanced Messaging
In phase 1, all received standard messaging. In phase 2, three schools were randomized to a messaging strategy that was developed from focus groups that targeted to address specific concerns of the different communities.
|
KKI: Standard Messaging - Standard Messaging
In phase 1, all schools received standard messaging. In Phase 2, two school were randomized to receive standard messaging.
|
SSD: Standard Messaging-Standard Messaging
In phase 1, all schools received standard messaging. In Phase 2, three school were randomized to receive standard messaging.
|
KKI: Standard Messaging - Enhanced Messaging
In phase 1, all received standard messaging. In phase 2, two schools were randomized to a messaging strategy that was developed from focus groups that targeted to address specific concerns of the different communities.
|
Focus Groups
Focus group were completed in Phase 1 to develop enhanced messaging. Focus group participants were not required to be enrolled in testing.
|
Fuzzy Cognitive Mapping
FCMs were completed to assess the facilitators and barriers to testing. FCM participants were not required to be enrolled testing.
Participants in the FCM only participated in Phase 1.
|
|---|---|---|---|---|---|---|
|
Phase 1
STARTED
|
352 3
|
133 2
|
284 3
|
194 2
|
86 0
|
94 0
|
|
Phase 1
COMPLETED
|
352 3
|
133 2
|
284 3
|
194 2
|
86 0
|
94 0
|
|
Phase 1
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Phase 2
STARTED
|
352 3
|
133 2
|
284 3
|
194 2
|
0 0
|
0 0
|
|
Phase 2
COMPLETED
|
352 2
|
133 2
|
284 3
|
194 2
|
0 0
|
0 0
|
|
Phase 2
NOT COMPLETED
|
0 1
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Missing data
Baseline characteristics by cohort
| Measure |
SSD: Standard Messaging - Standard Messaging
n=284 Participants
In phase 1, all schools received standard messaging. In phase 2, three schools were randomized to standard messaging.
|
SSD: Standard Messaging - Enhanced Messaging
n=352 Participants
In phase 1, all schools received standard messaging. In phase 2, three schools were randomized to a messaging strategy that was developed from focus groups that were targeted to address specific concerns of the different communities.
|
KKI: Standard Messaging-Standard Messaging
n=133 Participants
In phase1, all schools received standard messaging. In phase 2 two schools were randomized to standard messaging.
|
KKI: Standard Messaging - Enhanced Messaging
n=194 Participants
In phase 1, all schools received standard messaging. In phase 2, two schools were randomized to a messaging strategy that was developed from focus groups that were targeted to address specific concerns of the different communities.
|
Focus Group Participants
n=86 Participants
Parents/caregivers and school staff in participating schools.
|
Fuzzy Cognitive Mapping Participants
n=94 Participants
Parents/caregivers of a child (children) with IDD in Missouri and Maryland.
|
Total
n=1143 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Sex: Female, Male
Male
|
68 Participants
n=283 Participants • Missing data
|
96 Participants
n=349 Participants • Missing data
|
40 Participants
n=131 Participants • Missing data
|
41 Participants
n=188 Participants • Missing data
|
4 Participants
n=69 Participants • Missing data
|
9 Participants
n=93 Participants • Missing data
|
258 Participants
n=1113 Participants • Missing data
|
|
Age, Continuous
|
38 years
n=284 Participants • median age was calculated for the COVID-19 testing participants only. Most participants were adult staff, students were also included in this calculation
|
41 years
n=352 Participants • median age was calculated for the COVID-19 testing participants only. Most participants were adult staff, students were also included in this calculation
|
35 years
n=133 Participants • median age was calculated for the COVID-19 testing participants only. Most participants were adult staff, students were also included in this calculation
|
30 years
n=194 Participants • median age was calculated for the COVID-19 testing participants only. Most participants were adult staff, students were also included in this calculation
|
—
|
—
|
35 years
n=963 Participants • median age was calculated for the COVID-19 testing participants only. Most participants were adult staff, students were also included in this calculation
|
|
Age, Customized
25 to 34 years of age
|
—
|
—
|
—
|
—
|
16 Participants
n=86 Participants • These age categories were calculated for focus groups only
|
—
|
16 Participants
n=86 Participants • These age categories were calculated for focus groups only
|
|
Age, Customized
35 to 44 years of age
|
—
|
—
|
—
|
—
|
13 Participants
n=86 Participants • These age categories were calculated for focus groups only
|
—
|
13 Participants
n=86 Participants • These age categories were calculated for focus groups only
|
|
Age, Customized
45 to 54 years of age
|
—
|
—
|
—
|
—
|
26 Participants
n=86 Participants • These age categories were calculated for focus groups only
|
—
|
26 Participants
n=86 Participants • These age categories were calculated for focus groups only
|
|
Age, Customized
>/= 55 years of age
|
—
|
—
|
—
|
—
|
12 Participants
n=86 Participants • These age categories were calculated for focus groups only
|
—
|
12 Participants
n=86 Participants • These age categories were calculated for focus groups only
|
|
Age, Customized
Unknown
|
—
|
—
|
—
|
—
|
19 Participants
n=86 Participants • These age categories were calculated for focus groups only
|
—
|
19 Participants
n=86 Participants • These age categories were calculated for focus groups only
|
|
Age, Customized
25 to 30 years of age
|
—
|
—
|
—
|
—
|
—
|
3 Participants
n=94 Participants • These age categories were calculated for Fuzzy Cognitive Mapping (FCM) group only
|
3 Participants
n=94 Participants • These age categories were calculated for Fuzzy Cognitive Mapping (FCM) group only
|
|
Age, Customized
30 to 39 years of age
|
—
|
—
|
—
|
—
|
—
|
21 Participants
n=94 Participants • These age categories were calculated for Fuzzy Cognitive Mapping (FCM) group only
|
21 Participants
n=94 Participants • These age categories were calculated for Fuzzy Cognitive Mapping (FCM) group only
|
|
Age, Customized
40 to 49 years of age
|
—
|
—
|
—
|
—
|
—
|
43 Participants
n=94 Participants • These age categories were calculated for Fuzzy Cognitive Mapping (FCM) group only
|
43 Participants
n=94 Participants • These age categories were calculated for Fuzzy Cognitive Mapping (FCM) group only
|
|
Age, Customized
50 to 59 years of age
|
—
|
—
|
—
|
—
|
—
|
19 Participants
n=94 Participants • These age categories were calculated for Fuzzy Cognitive Mapping (FCM) group only
|
19 Participants
n=94 Participants • These age categories were calculated for Fuzzy Cognitive Mapping (FCM) group only
|
|
Age, Customized
60 to 64 years of age
|
—
|
—
|
—
|
—
|
—
|
6 Participants
n=94 Participants • These age categories were calculated for Fuzzy Cognitive Mapping (FCM) group only
|
6 Participants
n=94 Participants • These age categories were calculated for Fuzzy Cognitive Mapping (FCM) group only
|
|
Age, Customized
other or missing
|
—
|
—
|
—
|
—
|
—
|
2 Participants
n=94 Participants • These age categories were calculated for Fuzzy Cognitive Mapping (FCM) group only
|
2 Participants
n=94 Participants • These age categories were calculated for Fuzzy Cognitive Mapping (FCM) group only
|
|
Sex: Female, Male
Female
|
215 Participants
n=283 Participants • Missing data
|
253 Participants
n=349 Participants • Missing data
|
91 Participants
n=131 Participants • Missing data
|
147 Participants
n=188 Participants • Missing data
|
65 Participants
n=69 Participants • Missing data
|
84 Participants
n=93 Participants • Missing data
|
855 Participants
n=1113 Participants • Missing data
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=284 Participants
|
12 Participants
n=352 Participants
|
5 Participants
n=133 Participants
|
9 Participants
n=194 Participants
|
1 Participants
n=86 Participants
|
2 Participants
n=94 Participants
|
40 Participants
n=1143 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
255 Participants
n=284 Participants
|
316 Participants
n=352 Participants
|
116 Participants
n=133 Participants
|
167 Participants
n=194 Participants
|
66 Participants
n=86 Participants
|
90 Participants
n=94 Participants
|
1010 Participants
n=1143 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
18 Participants
n=284 Participants
|
24 Participants
n=352 Participants
|
12 Participants
n=133 Participants
|
18 Participants
n=194 Participants
|
19 Participants
n=86 Participants
|
2 Participants
n=94 Participants
|
93 Participants
n=1143 Participants
|
|
Race/Ethnicity, Customized
White
|
203 Participants
n=284 Participants
|
244 Participants
n=352 Participants
|
86 Participants
n=133 Participants
|
120 Participants
n=194 Participants
|
59 Participants
n=86 Participants
|
70 Participants
n=94 Participants
|
782 Participants
n=1143 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
62 Participants
n=284 Participants
|
83 Participants
n=352 Participants
|
37 Participants
n=133 Participants
|
55 Participants
n=194 Participants
|
8 Participants
n=86 Participants
|
15 Participants
n=94 Participants
|
260 Participants
n=1143 Participants
|
|
Race/Ethnicity, Customized
Other / Mixed
|
10 Participants
n=284 Participants
|
15 Participants
n=352 Participants
|
8 Participants
n=133 Participants
|
18 Participants
n=194 Participants
|
2 Participants
n=86 Participants
|
9 Participants
n=94 Participants
|
62 Participants
n=1143 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
9 Participants
n=284 Participants
|
10 Participants
n=352 Participants
|
2 Participants
n=133 Participants
|
1 Participants
n=194 Participants
|
17 Participants
n=86 Participants
|
0 Participants
n=94 Participants
|
39 Participants
n=1143 Participants
|
|
Region of Enrollment
United States
|
284 participants
n=284 Participants
|
352 participants
n=352 Participants
|
133 participants
n=133 Participants
|
194 participants
n=194 Participants
|
86 participants
n=86 Participants
|
94 participants
n=94 Participants
|
1143 participants
n=1143 Participants
|
PRIMARY outcome
Timeframe: 22 monthsPopulation: Comparison of enrollment rate between standard and enhanced messages.
Assuming the binomial distribution for each primary outcome, generalized estimating equation (GEE) models with logit link function were utilized to investigate the primary outcome changes across the weeks. The denominators for the enrollment and test rate per school were the total number of staff and students; and the total number of consented participants for a specific week, respectively. For the weeks after randomization, the GEE model included the indicator of week, group indicator, and the interaction term between week and group indicator. P-values of the interaction term from type-3 test were used to test the difference between 2 groups across the weeks. At Kennedy, GEE models were conducted separately using participants with non-missing data and participants with missing data to assess the impact of missing data. The reported values reflect the percentage of participants enrolled per week.
Outcome measures
| Measure |
Special School District
n=636 Participants
Special School District in St. Louis, MO
|
Teachers/Staff
Teachers/staff employed at Special School District
|
|---|---|---|
|
Enrollment Into Weekly Testing by Each Participant - Special School District
Standard messaging
|
0.47 % of participants enrolled per week
Interval 0.46 to 0.47
|
—
|
|
Enrollment Into Weekly Testing by Each Participant - Special School District
Enhanced messaging
|
0.49 % of participants enrolled per week
Interval 0.49 to 0.5
|
—
|
PRIMARY outcome
Timeframe: 22 monthsPopulation: All testing participants
Assuming the binomial distribution for each primary outcome, generalized estimating equation (GEE) models with logit link function were utilized to investigate the primary outcome changes across the weeks. The denominators for the enrollment and test rate per school were the total number of staff and students; and the total number of consented participants for a specific week, respectively. For the weeks after randomization, the GEE model included the indicator of week, group indicator, and the interaction term between week and group indicator. P-values of the interaction term from type-3 test were used to test the difference between 2 groups across the weeks. At Kennedy, GEE models were conducted separately using participants with non-missing data and participants with missing data to assess the impact of missing data. The outcome measure reflects the percentage of participants tested per week.
Outcome measures
| Measure |
Special School District
n=636 Participants
Special School District in St. Louis, MO
|
Teachers/Staff
Teachers/staff employed at Special School District
|
|---|---|---|
|
Overall Testing Rate - Special School District
Standard messaging
|
0.57 % of participants tested per week
Interval 0.56 to 0.58
|
—
|
|
Overall Testing Rate - Special School District
Enhanced messaging
|
0.46 % of participants tested per week
Interval 0.45 to 0.46
|
—
|
PRIMARY outcome
Timeframe: 22 monthsPopulation: Comparison of enrollment rate between standard and enhanced messages.
Assuming the binomial distribution for each primary outcome, generalized estimating equation (GEE) models with logit link function were utilized to investigate the primary outcome changes across the weeks. The denominators for the enrollment and test rate per school were the total number of staff and students; and the total number of consented participants for a specific week, respectively. For the weeks after randomization, the GEE model included the indicator of week, group indicator, and the interaction term between week and group indicator. P-values of the interaction term from type-3 test were used to test the difference between 2 groups across the weeks. At Kennedy, GEE models were conducted separately using participants with non-missing data and participants with missing data to assess the impact of missing data. The outcome measure reflects the percentage of participants enrolled per week.
Outcome measures
| Measure |
Special School District
n=327 Participants
Special School District in St. Louis, MO
|
Teachers/Staff
Teachers/staff employed at Special School District
|
|---|---|---|
|
Enrollment Into Weekly Testing by Each Participant - Kennedy Krieger Institute
Standard messaging
|
0.25 % of participants enrolled per week
Interval 0.25 to 0.26
|
—
|
|
Enrollment Into Weekly Testing by Each Participant - Kennedy Krieger Institute
Enhanced messaging
|
0.36 % of participants enrolled per week
Interval 0.35 to 0.37
|
—
|
PRIMARY outcome
Timeframe: 22 monthsPopulation: All testing participants
Assuming the binomial distribution for each primary outcome, generalized estimating equation (GEE) models with logit link function were utilized to investigate the primary outcome changes across the weeks. The denominators for the enrollment and test rate per school were the total number of staff and students; and the total number of consented participants for a specific week, respectively. For the weeks after randomization, the GEE model included the indicator of week, group indicator, and the interaction term between week and group indicator. P-values of the interaction term from type-3 test were used to test the difference between 2 groups across the weeks. At Kennedy, GEE models were conducted separately using participants with non-missing data and participants with missing data to assess the impact of missing data. The outcome measure reflects the percentage of participants tested per week.
Outcome measures
| Measure |
Special School District
n=327 Participants
Special School District in St. Louis, MO
|
Teachers/Staff
Teachers/staff employed at Special School District
|
|---|---|---|
|
Overall Testing Rate - Kennedy Krieger Institute
Standard messaging
|
0.43 % of participants tested per week
Interval 0.41 to 0.45
|
—
|
|
Overall Testing Rate - Kennedy Krieger Institute
Enhanced messaging
|
0.63 % of participants tested per week
Interval 0.61 to 0.64
|
—
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: Parents/caregivers of students enrolled in Special School District and teachers/staff employed at Special School District who participated in the focus group sessions. The presence of a theme resulting from focus groups is represented as "1" each group. Zeros represent the absence of themes.
Key themes and subthemes of participants' perceptions of returning to in-person learning
Outcome measures
| Measure |
Special School District
n=29 Participants
Special School District in St. Louis, MO
|
Teachers/Staff
n=57 Participants
Teachers/staff employed at Special School District
|
|---|---|---|
|
Key Themes and Subthemes: Perceptions of Returning to In-person Learning
Feeling guilty about transmitting COVID-19 at school
|
1 Themes reported
|
1 Themes reported
|
|
Key Themes and Subthemes: Perceptions of Returning to In-person Learning
Anxiety about transmission of COVID-19 for high-risk students
|
1 Themes reported
|
0 Themes reported
|
|
Key Themes and Subthemes: Perceptions of Returning to In-person Learning
Level of comfort unchanged because it does not eliminate the risk of exposure
|
1 Themes reported
|
1 Themes reported
|
|
Key Themes and Subthemes: Perceptions of Returning to In-person Learning
Benefits of in-person outweigh risks
|
1 Themes reported
|
0 Themes reported
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: Parents/caregivers of students enrolled in Special School District and teachers/staff employed at Special School District who participated in the focus group sessions. The presence of a theme resulting from focus groups is represented as "1" each group. Zeros represent the absence of themes.
Key Themes and Subthemes: Facilitators to Participation in SARS-CoV-2 Screening Testing
Outcome measures
| Measure |
Special School District
n=29 Participants
Special School District in St. Louis, MO
|
Teachers/Staff
n=57 Participants
Teachers/staff employed at Special School District
|
|---|---|---|
|
Key Themes and Subthemes: Facilitators to Participation in SARS-CoV-2 Screening Testing
Ability to adapt to child's limited ability to communicate symptoms
|
1 Themes reported
|
0 Themes reported
|
|
Key Themes and Subthemes: Facilitators to Participation in SARS-CoV-2 Screening Testing
Maintain consistency for student schedule
|
1 Themes reported
|
0 Themes reported
|
|
Key Themes and Subthemes: Facilitators to Participation in SARS-CoV-2 Screening Testing
Importance of flexibility during student testing
|
1 Themes reported
|
0 Themes reported
|
|
Key Themes and Subthemes: Facilitators to Participation in SARS-CoV-2 Screening Testing
Students need social stories to prepare for testing
|
1 Themes reported
|
1 Themes reported
|
|
Key Themes and Subthemes: Facilitators to Participation in SARS-CoV-2 Screening Testing
Parents administering test at home
|
1 Themes reported
|
0 Themes reported
|
|
Key Themes and Subthemes: Facilitators to Participation in SARS-CoV-2 Screening Testing
Ability to identify asymptomatic COVID-19 cases
|
1 Themes reported
|
1 Themes reported
|
|
Key Themes and Subthemes: Facilitators to Participation in SARS-CoV-2 Screening Testing
Ability to quickly isolate affected individuals
|
1 Themes reported
|
1 Themes reported
|
|
Key Themes and Subthemes: Facilitators to Participation in SARS-CoV-2 Screening Testing
Provide details about the accuracy of the saliva-based test
|
1 Themes reported
|
1 Themes reported
|
|
Key Themes and Subthemes: Facilitators to Participation in SARS-CoV-2 Screening Testing
Desire for in-person facilitated by regular testing
|
1 Themes reported
|
0 Themes reported
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: Parents/caregivers of students enrolled in Special School District and teachers/staff employed at Special School District who participated in the focus group sessions. The presence of a theme resulting from focus groups is represented as "1" each group. Zeros represent the absence of themes.
Key Themes and Subthemes: Communication (messages)
Outcome measures
| Measure |
Special School District
n=29 Participants
Special School District in St. Louis, MO
|
Teachers/Staff
n=57 Participants
Teachers/staff employed at Special School District
|
|---|---|---|
|
Key Themes and Subthemes: Communication (Messages)
Preferred methods of communication for receiving COVID-19 information
|
1 Themes reported
|
1 Themes reported
|
|
Key Themes and Subthemes: Communication (Messages)
Frequent and consistent messaging
|
1 Themes reported
|
0 Themes reported
|
|
Key Themes and Subthemes: Communication (Messages)
Concerns about frequency of COVID-19 dashboard updates
|
0 Themes reported
|
1 Themes reported
|
|
Key Themes and Subthemes: Communication (Messages)
House regularly updated COVID-19 info in 1 place
|
1 Themes reported
|
0 Themes reported
|
|
Key Themes and Subthemes: Communication (Messages)
Communicate the testing protocol with caregivers, staff, and students
|
1 Themes reported
|
1 Themes reported
|
|
Key Themes and Subthemes: Communication (Messages)
Provide test results quickly
|
0 Themes reported
|
1 Themes reported
|
SECONDARY outcome
Timeframe: 2 monthPopulation: Parents/caregivers of students enrolled in Special School District and teachers/staff employed at Special School District who participated in the focus group sessions. The presence of a theme resulting from focus groups is represented as "1" each group. Zeros represent the absence of themes.
Key themes and subthemes: Communication (messengers)
Outcome measures
| Measure |
Special School District
n=29 Participants
Special School District in St. Louis, MO
|
Teachers/Staff
n=57 Participants
Teachers/staff employed at Special School District
|
|---|---|---|
|
Key Themes and Subthemes: Communication (Messengers)
Medical professionals were identified as trusted sources of information related to COVID-19
|
1 Themes reported
|
1 Themes reported
|
|
Key Themes and Subthemes: Communication (Messengers)
Teachers and case managers were identified as reliable messengers
|
1 Themes reported
|
0 Themes reported
|
|
Key Themes and Subthemes: Communication (Messengers)
School nurses and principals were identified as trusted sources for information related to COVID-19
|
1 Themes reported
|
1 Themes reported
|
SECONDARY outcome
Timeframe: up to 52 weeksPopulation: This outcome measure was assessed only in the Fuzzy Cognitive Mapping group and the Facilitators and Barriers groups represent two separate interventions. Zero's Number Analyzed indicates that facilitator themes were not assessed in the "Barriers" arm and barrier themes were not assessed in the "Facilitators" arm.
Structural equation modeling (SEM) was used to confirm the results of the FCM analyses. SEM is a combination of confirmatory factor analysis (CFA) and multiple regression that identifies the relationships among latent constructs. For the purpose of the current study, SEM analyses examined the effects of facilitators and barriers related to a Successful SARS-COV-2 Test. The factor loadings in the tables can be interpreted on the following scale: 0.70+ -\> Strong 0.50 -\> Moderate 0.30 -\> Weak but acceptable
Outcome measures
| Measure |
Special School District
n=94 Participants
Special School District in St. Louis, MO
|
Teachers/Staff
n=94 Participants
Teachers/staff employed at Special School District
|
|---|---|---|
|
Structural Equation Modeling (SEM) for Effects of Facilitators and Barriers Related to a Successful SARS-COV-2 Test
Preparing the Child
|
0.75 unitless
|
—
|
|
Structural Equation Modeling (SEM) for Effects of Facilitators and Barriers Related to a Successful SARS-COV-2 Test
Good Environment
|
0.25 unitless
|
—
|
|
Structural Equation Modeling (SEM) for Effects of Facilitators and Barriers Related to a Successful SARS-COV-2 Test
Incentives/motivators/reinforcers
|
0.43 unitless
|
—
|
|
Structural Equation Modeling (SEM) for Effects of Facilitators and Barriers Related to a Successful SARS-COV-2 Test
Poor Environment
|
—
|
0.58 unitless
|
|
Structural Equation Modeling (SEM) for Effects of Facilitators and Barriers Related to a Successful SARS-COV-2 Test
Poor Test Administrator
|
—
|
0.59 unitless
|
|
Structural Equation Modeling (SEM) for Effects of Facilitators and Barriers Related to a Successful SARS-COV-2 Test
Mode of Test (painful/invasive)
|
—
|
0.38 unitless
|
|
Structural Equation Modeling (SEM) for Effects of Facilitators and Barriers Related to a Successful SARS-COV-2 Test
Child Needs
|
—
|
0.38 unitless
|
SECONDARY outcome
Timeframe: up to 52 weeksPopulation: This outcome measure was assessed only in the Fuzzy Cognitive Mapping group
In the one-factor model, Structural equation modeling (SEM) was used for pinpointing key items that loaded onto Successful SARS-COV-2 Test The factor loadings in the tables can be interpreted on the following scale: 0.70+ -\> Strong 0.50 -\> Moderate 0.30 -\> Weak but acceptable
Outcome measures
| Measure |
Special School District
n=94 Participants
Special School District in St. Louis, MO
|
Teachers/Staff
Teachers/staff employed at Special School District
|
|---|---|---|
|
Structural Equation Modeling (SEM) for Successful SARS-COV-2 Test
Preparing the Child
|
0.31 unitless
|
—
|
|
Structural Equation Modeling (SEM) for Successful SARS-COV-2 Test
Good Environment
|
0.36 unitless
|
—
|
|
Structural Equation Modeling (SEM) for Successful SARS-COV-2 Test
Poor Environment
|
0.55 unitless
|
—
|
|
Structural Equation Modeling (SEM) for Successful SARS-COV-2 Test
Poor Test Administrator
|
0.62 unitless
|
—
|
|
Structural Equation Modeling (SEM) for Successful SARS-COV-2 Test
Mode of Test (painful/invasive)
|
0.35 unitless
|
—
|
|
Structural Equation Modeling (SEM) for Successful SARS-COV-2 Test
Child Needs
|
0.37 unitless
|
—
|
Adverse Events
SSD: Standard Messaging
SSD: Enhanced Messaging
KKI: Standard Messaging
KKI: Enhanced Messaging
Focus Group Participants
Fuzzy Cognitive Mapping Participants
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