Covid19NCT04565509

Supporting the Health and Well-being of Children With Intellectual and Developmental Disability During COVID-19 Pandemic

A study testing Standard Messaging, Enhanced Messaging and COVID-19 Testing in people with Covid19 and Intellectual Disability, run by Washington University School of Medicine at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 5 to 90 yearsHealthy volunteers can take part
Conditions the study is for: Covid19, Intellectual Disability, Developmental Disability
What is being tested?: Standard Messaging, Enhanced Messaging and COVID-19 Testing
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,143 participants
Where: 3 sitesUnited States
Study dates: 20 Nov 2020to 29 Mar 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 5 to 90 years
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Students enrolled in the St. Louis Special School District or the Kennedy Krieger Institutes/Sheppard Pratt Schools in Maryland.
Teachers/Staff working at the St. Louis Special Schools or the Kennedy Krieger Institutes/Sheppard Pratt Schools in Maryland dedicated to teaching children with IDD.
or
Parents/ of students, teachers and/or staff employed by the St. Louis Special School District or Kennedy Krieger Institute/Sheppard Pratt schools in Maryland or
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).

Who cannot join

Members of the research team will not be eligible to participate in the focus groups.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Baltimore, Maryland, 21205
University of Missouri
Kansas City, Missouri, 64110
Special School District
St Louis, Missouri, 63131

Other trials in United States

About this study

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.

Read the detailed description

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.

Conditions: Covid19, Intellectual Disability, Developmental Disability, Child Development Disorder
Being tested: Standard Messaging, Enhanced Messaging, COVID-19 Testing, Focus Groups, Fuzzy Cognitive Mapping
Medical subject headings: COVID-19, Intellectual Disability, Developmental Disabilities

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Standard MessagingBehavioural
A messaging strategy will be developed from focus groups that generally describes COVID-19 and the importance of testing.
Enhanced MessagingBehavioural
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 TestingDiagnostic test
Weekly surveillance COVID-19 testing.
Focus GroupsBehavioural
Focus groups to develop enhanced messaging.
Fuzzy Cognitive MappingBehavioural
FCMs to assess facilitators and barriers to COVID-19 testing.

Study groups in NCT04565509
Study group	Role	What they receive
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. Receives: Behavioral: Standard Messaging; Diagnostic Test: COVID-19 Testing
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. Receives: Behavioral: Standard Messaging; Behavioral: Enhanced Messaging; Diagnostic Test: COVID-19 Testing
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. Receives: Behavioral: Standard Messaging; Diagnostic Test: COVID-19 Testing
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. Receives: Behavioral: Standard Messaging; Behavioral: Enhanced Messaging; Diagnostic Test: COVID-19 Testing
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. Receives: Behavioral: Focus Groups
Fuzzy Cognitive Mapping	Experimental	FCMs were completed to assess the facilitators and barriers to testing. FCM participants were not required to be enrolled testing. Receives: Behavioral: Fuzzy Cognitive Mapping

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 22 months

Secondary outcomes (6)

Key Themes and Subthemes: Perceptions of Returning to In-person Learning
Key themes and subthemes of participants' perceptions of returning to in-person learning
Measured: 2 months
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
Measured: 2 months
Key Themes and Subthemes: Communication (Messages)
Key Themes and Subthemes: Communication (messages)
Measured: 2 months
Key Themes and Subthemes: Communication (Messengers)
Key themes and subthemes: Communication (messengers)
Measured: 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
Measured: 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
Measured: up to 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Nov 202029 Mar 2024

First posted25 Sep 2020
Study start20 Nov 2020
Primary completion29 Mar 2024
Study completion29 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (17)Papers the sponsor has linked to this study.
Other trials for Covid19Studies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Single group
Model description: 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.
Masking: None (open label)
Enrolment: 1,143 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04565509
Sponsor's protocol ID: 202009060
Other IDs: 3P50HD103525-01S1
Status last verified: Jan 2026
First submitted: 24 Sep 2020
Last updated: 23 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 32600948
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.
PubMed 19664226
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.
PubMed 32690063
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.
PubMed 20235862
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.
PubMed 31036028
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.
PubMed 32412064
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.
PubMed 33098427
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.
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.
PubMed 32345686
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.
PubMed 17763914
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.
PubMed 28851459
Jetter AJ, Schweinfort W. Building scenarios with Fuzzy Cognitive Mapping: An exploratory study of solar energy. Futures. 2011;43(1):52-66.
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.
PubMed 37853427
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.
PubMed 37704799
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.
PubMed 36404403

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Supporting the Health and Well-being of Children With Intellectual and Developmental Disability During COVID-19 Pandemic
ClinicalTrials.gov ID: NCT04565509
Acronym / sponsor ID: 202009060
Conditions: Covid19, Intellectual Disability, Developmental Disability, Child Development Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,143 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: 20 Nov 2020 (actual)
Primary completion: 29 Mar 2024 (actual)
Study completion: 29 Mar 2024 (actual)
First posted: 25 Sep 2020 (actual)
Results: Posted 23 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 6
Model description: 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.

Arm	Type	Receives
SSD: Standard Messaging - Standard Messaging	Active comparator	Behavioral: Standard Messaging, Diagnostic Test: COVID-19 TestingIn phase 1, all schools received standard messaging. In phase 2, three schools were randomized to standard messaging.
SSD: Standard Messaging - Enhanced Messaging	Active comparator	Behavioral: Standard Messaging, Behavioral: Enhanced Messaging, Diagnostic Test: COVID-19 TestingIn 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	Behavioral: Standard Messaging, Diagnostic Test: COVID-19 TestingIn phase 1, all schools received standard messaging. In phase 2, two schools were randomized to standard messaging.
KKI: Standard Messaging - Enhanced Messaging	Active comparator	Behavioral: Standard Messaging, Behavioral: Enhanced Messaging, Diagnostic Test: COVID-19 TestingIn 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 Groups	Experimental	Behavioral: Focus GroupsFocus 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	Behavioral: Fuzzy Cognitive MappingFCMs were completed to assess the facilitators and barriers to testing. FCM participants were not required to be enrolled testing.

Who may qualify

Ages: 5 to 90 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

Students enrolled in the St. Louis Special School District or the Kennedy Krieger Institutes/Sheppard Pratt Schools in Maryland.
Teachers/Staff working at the St. Louis Special Schools or the Kennedy Krieger Institutes/Sheppard Pratt Schools in Maryland dedicated to teaching children with IDD.
or
Parents/ of students, teachers and/or staff employed by the St. Louis Special School District or Kennedy Krieger Institute/Sheppard Pratt schools in Maryland or
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).

Key exclusion criteria (1 listed)

Members of the research team will not be eligible to participate in the focus groups.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Standard MessagingA messaging strategy will be developed from focus groups that generally describes COVID-19 and the importance of testing.	Behavioural	KKI: Standard Messaging - Enhanced Messaging, KKI: Standard Messaging - Standard Messaging, SSD: Standard Messaging - Enhanced Messaging, SSD: Standard Messaging - Standard Messaging
Enhanced MessagingA 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.	Behavioural	KKI: Standard Messaging - Enhanced Messaging, SSD: Standard Messaging - Enhanced Messaging
COVID-19 TestingWeekly surveillance COVID-19 testing.	Diagnostic test	KKI: Standard Messaging - Enhanced Messaging, KKI: Standard Messaging - Standard Messaging, SSD: Standard Messaging - Enhanced Messaging, SSD: Standard Messaging - Standard Messaging
Focus GroupsFocus groups to develop enhanced messaging.	Behavioural	Focus Groups
Fuzzy Cognitive MappingFCMs to assess facilitators and barriers to COVID-19 testing.	Behavioural	Fuzzy Cognitive Mapping

Primary outcome

Enrollment Into Weekly Testing by Each Participant - Special School District
Time frame: 22 months
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.
Overall Testing Rate - Special School District
Time frame: 22 months
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.
Enrollment Into Weekly Testing by Each Participant - Kennedy Krieger Institute
Time frame: 22 months
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.
Overall Testing Rate - Kennedy Krieger Institute
Time frame: 22 months
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.

6 secondary outcomes

Key Themes and Subthemes: Perceptions of Returning to In-person Learning
Time frame: 2 months
Key Themes and Subthemes: Facilitators to Participation in SARS-CoV-2 Screening Testing
Time frame: 2 months
Key Themes and Subthemes: Communication (Messages)
Time frame: 2 months
Key Themes and Subthemes: Communication (Messengers)
Time frame: 2 month
Structural Equation Modeling (SEM) for Effects of Facilitators and Barriers Related to a Successful SARS-COV-2 Test
Time frame: up to 52 weeks
Structural Equation Modeling (SEM) for Successful SARS-COV-2 Test
Time frame: up to 52 weeks

Results and safety

Results posted to the registry on 23 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SSD: Standard Messaging-Standard Messaging	284	284
SSD: Standard Messaging - Enhanced Messaging	352	352
KKI: Standard Messaging - Standard Messaging	133	133
KKI: Standard Messaging - Enhanced Messaging	194	194
Focus Groups	86	86
Fuzzy Cognitive Mapping	94	94

Primary outcome: Enrollment Into Weekly Testing by Each Participant - Special School District

Time frame: 22 months. Least squares mean (95% Confidence Interval). Unit: % of participants enrolled per week

Measure	Special School District n = 636
Standard messaging	0.47 (0.46 to 0.47)
Enhanced messaging	0.49 (0.49 to 0.50)

Special School District: p >0.99, generalized estimating equations

Population analysed: Comparison of enrollment rate between standard and enhanced messages.

Primary outcome: Overall Testing Rate - Special School District

Time frame: 22 months. Least squares mean (95% Confidence Interval). Unit: % of participants tested per week

Measure	Special School District n = 636
Standard messaging	0.57 (0.56 to 0.58)
Enhanced messaging	0.46 (0.45 to 0.46)

Special School District: p = 0.90, generalized estimating equations

Population analysed: All testing participants

Primary outcome: Enrollment Into Weekly Testing by Each Participant - Kennedy Krieger Institute

Time frame: 22 months. Least squares mean (95% Confidence Interval). Unit: % of participants enrolled per week

Measure	Kennedy Krieger Institute n = 327
Standard messaging	0.25 (0.25 to 0.26)
Enhanced messaging	0.36 (0.35 to 0.37)

Kennedy Krieger Institute: p >0.99, generalized estimating equations

Population analysed: Comparison of enrollment rate between standard and enhanced messages.

Primary outcome: Overall Testing Rate - Kennedy Krieger Institute

Time frame: 22 months. Least squares mean (95% Confidence Interval). Unit: % of participants tested per week

Measure	Kennedy Krieger Institute n = 327
Standard messaging	0.43 (0.41 to 0.45)
Enhanced messaging	0.63 (0.61 to 0.64)

Kennedy Krieger Institute: p = 0.71, generalized estimating equations

Population analysed: All testing participants

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year, 10 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SSD: Standard Messaging	0 of 636 (0%)	0 of 636 (0%)	0 of 636
SSD: Enhanced Messaging	0 of 352 (0%)	0 of 352 (0%)	0 of 352
KKI: Standard Messaging	0 of 327 (0%)	0 of 327 (0%)	0 of 327
KKI: Enhanced Messaging	0 of 194 (0%)	0 of 194 (0%)	0 of 194
Focus Group Participants	0 of 86 (0%)	0 of 86 (0%)	0 of 86
Fuzzy Cognitive Mapping Participants	0 of 94 (0%)	0 of 94 (0%)	0 of 94

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 32600948Landes 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.
Background: PubMed 19664226Damschroder 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.
Background: PubMed 32690063Zhou 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.
Background: PubMed 20235862Ross 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.
Background: PubMed 31036028Waltz 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.
Background: PubMed 32412064Rader 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.
Background: PubMed 33098427Lalli 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.
BackgroundWylie 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.
Background: PubMed 32345686Silliman 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.
Background: PubMed 17763914Steiner 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.
Background: PubMed 28851459Weiner 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.
BackgroundJetter AJ, Schweinfort W. Building scenarios with Fuzzy Cognitive Mapping: An exploratory study of solar energy. Futures. 2011;43(1):52-66.
Brown School Evaluation Center at Washington University in St. LouisLink provided by the sponsor.
Health Communication Research Laboratory at Washington University in St. LouisLink provided by the sponsor.
Intellectual and Developmental Disabilities Research Center at Washington University in St. LouisLink provided by the sponsor.
Kennedy Krieger Institute Intellectual and Developmental Disabilities Research CenterLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jason G. Newland, MD principal investigator

Washington University School of Medicine

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Enrollment Into Weekly Testing by Each Participant - Special School District (time frame: 22 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04565509, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.