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| ID | Type | Description | Link |
|---|---|---|---|
| 3P50HD103525-01S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The primary goal of this project is to identify the best messaging and implementation strategies to maximize SARS-CoV-2 testing for children with intellectual and developmental disabilities (IDD) and their teachers to help ensure a safe school environment. Additionally, we will understand nationally the perceptions of COVID-19 and identify facilitators and barriers to help with the adoption of testing in other parts of the US and the necessary strategies to address other mitigation strategies including vaccination.
This research study will occur at six schools dedicated to children with IDD that are a part of the Special School Districts in St. Louis, MO.
Additionally, surveys, focus groups, and fuzzy cognitive mapping sessions will be conducted at these six schools and at schools within the Kennedy Krieger School Programs in Baltimore, MD. Finally, a national survey will be administered to families, teachers, and staff of the 67 University Centers for Excellence in Developmental Disabilities (UCEDD) which is sponsored by the Association of University Centers for Disability (AUCD).
The first aim will involve focus groups of parents/guardians, teachers, and school staff to identify the barriers and facilitators to frequent SARS-CoV-2 testing, impressions of COVID-19, and best messages and implementation strategies to promote increase testing and vaccination. A formal process for developing two types of messages (general versus focused) will be performed using focus group data and involving key stakeholders to test the messages. A cluster randomized adaptive clinical trial will then occur at the six special school district schools. In phase 1, the schools will be randomized initially to either the general or focused message to promote the adoption of weekly SARS-CoV-2 testing by the students and teachers. After 5 months, data analysis will be conducted to determine which strategy led to the highest percentage of testing. Phase 2 will begin at 7 months after the schools are randomized to either the best message determined from phase 1 or best message plus an augmented implementation strategy.
Beginning in April 2021 the first aim was expanded to include weekly testing and message development at the Kennedy Krieger Institutes and Sheppard Pratt Schools in Baltimore, MD. In phase 1, these schools will be randomized initially to either the general or focused message to promote the adoption of weekly SARS-CoV-2 testing by the students and teachers. After 5 months, data analysis will be conducted to determine which strategy led to the highest percentage of testing. Phase 2 will begin at 7 months after these schools are randomized to either the best message determined from phase 1 or best message plus an augmented implementation strategy.
The second aim will assess the national perspectives among parents of children with IDD and school staff regarding the impact of COVID-19 and importance of SARS-CoV-2 testing. Fuzzy cognitive mapping (FCM) and the administration of local and national surveys will be used to accomplish this aim. FCM will involve in-person sessions with parents from the schools in aim 1 and Kennedy Krieger Institute/Sheppard Pratt schools in Baltimore, MD for children with IDD. These sessions will help identify the facilitators and barriers SARS-CoV-2 testing and other mitigation strategies including COVID-19 vaccine. Since no accepted measures have been developed for understanding parent and school staff concerns for children with IDD around COVID-19, local (St. Louis and Baltimore) and national surveys will be conducted. Custom surveys will be deployed across two stakeholder groups: parent/guardians and school staff. We will administer the survey at baseline and during the trial across school settings (St. Louis and Baltimore).
A national survey will also be administered across the UCEDDs. Psychometric analysis will be performed to help identify the questions for a national survey at the end of the study period. In addition to the custom surveys, NIH recommended parent-report surveys from the PhenX Toolkit will be used. The surveys to be used include the Psychological Stress Associated with the COVID-19 Crisis Scale and COVID-19 impact questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SSD: Standard Messaging - Standard Messaging | Active Comparator | In phase 1, all schools received standard messaging. In phase 2, three schools were randomized to standard messaging. |
|
| SSD: Standard Messaging - Enhanced Messaging | Active Comparator | 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 | Active Comparator | In phase 1, all schools received standard messaging. In phase 2, two schools were randomized to standard messaging. |
|
| KKI: Standard Messaging - Enhanced Messaging | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Messaging | Behavioral | A messaging strategy will be developed from focus groups that generally describes COVID-19 and the importance of testing. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Enrollment Into Weekly Testing by Each Participant - Special School District | 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. | 22 months |
| Overall Testing Rate - Special School District | 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. | 22 months |
| Enrollment Into Weekly Testing by Each Participant - Kennedy Krieger Institute | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Key Themes and Subthemes: Perceptions of Returning to In-person Learning | Key themes and subthemes of participants' perceptions of returning to in-person learning | 2 months |
| Key Themes and Subthemes: Facilitators to Participation in SARS-CoV-2 Screening Testing |
Not provided
Inclusion Criteria:
or
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason G. Newland, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hugo W. Moser Research Institute at Kennedy Krieger, Inc. | Baltimore | Maryland | 21205 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32600948 | Background | Landes SD, Turk MA, Formica MK, McDonald KE, Stevens JD. COVID-19 outcomes among people with intellectual and developmental disability living in residential group homes in New York State. Disabil Health J. 2020 Oct;13(4):100969. doi: 10.1016/j.dhjo.2020.100969. Epub 2020 Jun 24. | |
| 19664226 | Background | Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50. |
| Label | URL |
|---|---|
| Brown School Evaluation Center at Washington University in St. Louis | View source |
Not provided
Not provided
Not provided
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Focus Groups and Fuzzy Cognitive Mapping only completed during Phase 1.
SCD = Special School District. KKI = Kennedy Krieger Institute. FCM = Fuzzy Cognitive Mapping.
All students and staff in the schools were eligible.
| ID | Title | Description |
|---|---|---|
| FG000 | SSD: Standard Messaging-Standard Messaging | In phase 1, all schools received standard messaging. In Phase 2, three school were randomized to receive standard messaging. |
| FG001 | SSD: Standard Messaging - Enhanced Messaging |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Phase 1 |
|
Not provided
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 23, 2021 |
Not provided
A cluster randomized adaptive trial will be conducted. The first phase will randomize the 6 Special School District schools to either a general message or focus/targeted message. Data analysis will occur and then the schools will be randomized to the best message strategy from phase 1 alone or best message plus and augmented message or implementation strategy.
The same process will take place independently at the Kennedy Krieger Institutes/Sheppard Pratt Schools.
Not provided
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| Focus Groups | Experimental | 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 | Experimental | FCMs were completed to assess the facilitators and barriers to testing. FCM participants were not required to be enrolled testing. |
|
| Enhanced Messaging | Behavioral | A messaging strategy that is developed from focus groups that is targeted to address specific concerns of the different communities. Messages may target groups being tested (staff versus students) or sociodemographic or race/ethnicity differences between schools depending on the focus groups input. |
|
| COVID-19 Testing | Diagnostic Test | Weekly surveillance COVID-19 testing. |
|
| Focus Groups | Behavioral | Focus groups to develop enhanced messaging. |
|
| Fuzzy Cognitive Mapping | Behavioral | FCMs to assess facilitators and barriers to COVID-19 testing. |
|
| 22 months |
| Overall Testing Rate - Kennedy Krieger Institute | 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. | 22 months |
Key Themes and Subthemes: Facilitators to Participation in SARS-CoV-2 Screening Testing |
| 2 months |
| Key Themes and Subthemes: Communication (Messages) | Key Themes and Subthemes: Communication (messages) | 2 months |
| Key Themes and Subthemes: Communication (Messengers) | Key themes and subthemes: Communication (messengers) | 2 month |
| Structural Equation Modeling (SEM) for Effects of Facilitators and Barriers Related to a Successful SARS-COV-2 Test | 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 | up to 52 weeks |
| Structural Equation Modeling (SEM) for Successful SARS-COV-2 Test | 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 | up to 52 weeks |
| University of Missouri |
| Kansas City |
| Missouri |
| 64110 |
| United States |
| Special School District | St Louis | Missouri | 63131 | United States |
| 32690063 | Background | Zhou G, Lee MC, Atieli HE, Githure JI, Githeko AK, Kazura JW, Yan G. Adaptive interventions for optimizing malaria control: an implementation study protocol for a block-cluster randomized, sequential multiple assignment trial. Trials. 2020 Jul 20;21(1):665. doi: 10.1186/s13063-020-04573-y. |
| 20235862 | Background | Ross LF, Loup A, Nelson RM, Botkin JR, Kost R, Smith GR, Gehlert S. Nine key functions for a human subjects protection program for community-engaged research: points to consider. J Empir Res Hum Res Ethics. 2010 Mar;5(1):33-47. doi: 10.1525/jer.2010.5.1.33. |
| 31036028 | Background | Waltz TJ, Powell BJ, Fernandez ME, Abadie B, Damschroder LJ. Choosing implementation strategies to address contextual barriers: diversity in recommendations and future directions. Implement Sci. 2019 Apr 29;14(1):42. doi: 10.1186/s13012-019-0892-4. |
| 32412064 | Background | Rader B, Astley CM, Sy KTL, Sewalk K, Hswen Y, Brownstein JS, Kraemer MUG. Geographic access to United States SARS-CoV-2 testing sites highlights healthcare disparities and may bias transmission estimates. J Travel Med. 2020 Nov 9;27(7):taaa076. doi: 10.1093/jtm/taaa076. No abstract available. |
| 33098427 | Background | Lalli MA, Langmade JS, Chen X, Fronick CC, Sawyer CS, Burcea LC, Wilkinson MN, Fulton RS, Heinz M, Buchser WJ, Head RD, Mitra RD, Milbrandt J. Rapid and Extraction-Free Detection of SARS-CoV-2 from Saliva by Colorimetric Reverse-Transcription Loop-Mediated Isothermal Amplification. Clin Chem. 2021 Jan 30;67(2):415-424. doi: 10.1093/clinchem/hvaa267. |
| Background | Wylie AL, Fourneir J, Casanovas-Massana A, et al. Saliva is more sensitive for SARS-CoV-2 detection in COVID-19 patients than nasopharyngeal swabs. medRxiv. 2020. |
| 32345686 | Background | Silliman Cohen RI, Bosk EA. Vulnerable Youth and the COVID-19 Pandemic. Pediatrics. 2020 Jul;146(1):e20201306. doi: 10.1542/peds.2020-1306. Epub 2020 Apr 28. No abstract available. |
| 17763914 | Background | Steiner JF. Using stories to disseminate research: the attributes of representative stories. J Gen Intern Med. 2007 Nov;22(11):1603-7. doi: 10.1007/s11606-007-0335-9. Epub 2007 Sep 1. |
| 28851459 | Background | Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3. |
| Background | Jetter AJ, Schweinfort W. Building scenarios with Fuzzy Cognitive Mapping: An exploratory study of solar energy. Futures. 2011;43(1):52-66. |
| 37853427 | Derived | Vestal LE, Schmidt AM, Dougherty NL, Rolf L, Newland JG, Mueller NB; COMPASS-T Study Group. COVID-19 Related Facilitators and Barriers to In-Person Learning for Children With Intellectual and Development Disabilities: A Follow-Up. J Sch Health. 2024 Feb;94(2):105-116. doi: 10.1111/josh.13404. Epub 2023 Oct 18. |
| 37704799 | Derived | Gemmell M, Walsh T, Sherby M, Imbeah A, Bono K, Baldenweck M, Gurnett C, Newland JG. Clusters of SARS-CoV-2 Infection Across Six Schools for Students with Intellectual and Developmental Disabilities. Infect Dis Ther. 2023 Sep;12(9):2289-2294. doi: 10.1007/s40121-023-00855-5. Epub 2023 Sep 13. |
| 36404403 | Derived | Vestal LE, Schmidt AM, Dougherty NL, Sherby MR, Newland JG, Mueller NB; COMPASS-T Study Group. COVID-19-Related Facilitators and Barriers to In-Person Learning for Children With Intellectual and Development Disabilities. J Sch Health. 2023 Mar;93(3):176-185. doi: 10.1111/josh.13262. Epub 2022 Nov 20. |
| 34465306 | Derived | Sherby MR, Walsh TJ, Lai AM, Neidich JA, Balls-Berry JE, Morris SM, Head R, Prener CG, Newland JG, Gurnett CA; COMPASS-T Study Group. SARS-CoV-2 screening testing in schools for children with intellectual and developmental disabilities. J Neurodev Disord. 2021 Sep 1;13(1):31. doi: 10.1186/s11689-021-09376-z. |
| 34312616 | Derived | Sherby MR, Walsh T, Lai AM, Neidich JA, Balls-Berry JE, Morris SM, Head R, Prener C, Newland JG, Gurnett CA; COMPASS-T Study Group. SARS-CoV-2 Screening Testing in Schools for Children with Intellectual and Developmental Disabilities. Res Sq [Preprint]. 2021 Jul 20:rs.3.rs-700296. doi: 10.21203/rs.3.rs-700296/v1. |
| Health Communication Research Laboratory at Washington University in St. Louis | View source |
| Intellectual and Developmental Disabilities Research Center at Washington University in St. Louis | View source |
| Kennedy Krieger Institute Intellectual and Developmental Disabilities Research Center | View source |
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.
| FG002 | KKI: Standard Messaging - Standard Messaging | In phase 1, all schools received standard messaging. In Phase 2, two school were randomized to receive standard messaging. |
| FG003 | 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. |
| FG004 | Focus Groups | Focus group were completed in Phase 1 to develop enhanced messaging. Focus group participants were not required to be enrolled in testing. |
| FG005 | 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. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Phase 2 |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SSD: Standard Messaging - Standard Messaging | In phase 1, all schools received standard messaging. In phase 2, three schools were randomized to standard messaging. |
| BG001 | SSD: Standard Messaging - Enhanced Messaging | 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. |
| BG002 | KKI: Standard Messaging-Standard Messaging | In phase1, all schools received standard messaging. In phase 2 two schools were randomized to standard messaging. |
| BG003 | KKI: Standard Messaging - Enhanced Messaging | 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. |
| BG004 | Focus Group Participants | Parents/caregivers and school staff in participating schools. |
| BG005 | Fuzzy Cognitive Mapping Participants | Parents/caregivers of a child (children) with IDD in Missouri and Maryland. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | median age was calculated for the COVID-19 testing participants only. Most participants were adult staff, students were also included in this calculation | Median | Inter-Quartile Range | years |
| |||||||||
| Age, Customized | These age categories were calculated for focus groups only | Count of Participants | Participants |
| ||||||||||
| Age, Customized | These age categories were calculated for Fuzzy Cognitive Mapping (FCM) group only | Count of Participants | Participants |
| ||||||||||
| Sex: Female, Male | Missing data | Count of Participants | Participants |
| ||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Enrollment Into Weekly Testing by Each Participant - Special School District | 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. | Comparison of enrollment rate between standard and enhanced messages. | Posted | Least Squares Mean | 95% Confidence Interval | % of participants enrolled per week | 22 months |
|
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| Primary | Overall Testing Rate - Special School District | 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. | All testing participants | Posted | Least Squares Mean | 95% Confidence Interval | % of participants tested per week | 22 months |
|
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| Primary | Enrollment Into Weekly Testing by Each Participant - Kennedy Krieger Institute | 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. | Comparison of enrollment rate between standard and enhanced messages. | Posted | Least Squares Mean | 95% Confidence Interval | % of participants enrolled per week | 22 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Overall Testing Rate - Kennedy Krieger Institute | 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. | All testing participants | Posted | Least Squares Mean | 95% Confidence Interval | % of participants tested per week | 22 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Key Themes and Subthemes: Perceptions of Returning to In-person Learning | Key themes and subthemes of participants' perceptions of returning to in-person learning | 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. | Posted | Number | Themes reported | 2 months |
|
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| Secondary | Key Themes and Subthemes: Facilitators to Participation in SARS-CoV-2 Screening Testing | Key Themes and Subthemes: Facilitators to Participation in SARS-CoV-2 Screening Testing | 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. | Posted | Number | Themes reported | 2 months |
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| Secondary | Key Themes and Subthemes: Communication (Messages) | Key Themes and Subthemes: Communication (messages) | 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. | Posted | Number | Themes reported | 2 months |
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| Secondary | Key Themes and Subthemes: Communication (Messengers) | Key themes and subthemes: Communication (messengers) | 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. | Posted | Number | Themes reported | 2 month |
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| Secondary | Structural Equation Modeling (SEM) for Effects of Facilitators and Barriers Related to a Successful SARS-COV-2 Test | 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 | 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. | Posted | Number | unitless | up to 52 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Structural Equation Modeling (SEM) for Successful SARS-COV-2 Test | 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 | This outcome measure was assessed only in the Fuzzy Cognitive Mapping group | Posted | Number | unitless | up to 52 weeks |
|
|
1 year, 10 months
Not provided
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 | SSD: Standard Messaging | In phase 1, all schools received standard messaging. In phase 2, three schools were randomized to standard messaging. | 0 | 636 | 0 | 636 | 0 | 636 |
| EG001 | SSD: Enhanced Messaging | 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. | 0 | 352 | 0 | 352 | 0 | 352 |
| EG002 | KKI: Standard Messaging | In phase 1, all schools received standard messaging. In phase 2, two schools were randomized to standard messaging. | 0 | 327 | 0 | 327 | 0 | 327 |
| EG003 | KKI: Enhanced Messaging | 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. | 0 | 194 | 0 | 194 | 0 | 194 |
| EG004 | Focus Group Participants | Parents/caregivers and school staff in participating schools. | 0 | 86 | 0 | 86 | 0 | 86 |
| EG005 | Fuzzy Cognitive Mapping Participants | Parents/caregivers of a child (children) with IDD in Missouri and Maryland. | 0 | 94 | 0 | 94 | 0 | 94 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason Newland, MD | Nationwide Children's Hospital | 614-722-3416 | Jason.Newland@nationwidechildrens.org |
| Feb 11, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D008607 | Intellectual Disability |
| D002658 | Developmental Disabilities |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000086742 | COVID-19 Testing |
| D017144 | Focus Groups |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
Not provided
Not provided
|
|
| 35 to 44 years of age |
|
|
| 45 to 54 years of age |
|
|
| >/= 55 years of age |
|
|
| Unknown |
|
|
|
| 30 to 39 years of age |
|
|
| 40 to 49 years of age |
|
|
| 50 to 59 years of age |
|
|
| 60 to 64 years of age |
|
|
| other or missing |
|
|
|
|
|
| Black/African American |
|
|
| Other / Mixed |
|
|
| Not Reported |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|