Supporting the Health and Well-being of Children With Intellectual and Developmental Disability During COVID-19 Pandemic
Phase: NA
Conditions: Covid19, Intellectual Disability, Developmental Disability, Child Development Disorder
Sponsor: Washington University School of Medicine

 
  
 
 
Supporting the health and well-being of children with intellectual and 
developmental disability during COVID-19 pandemic 
 
 
Short title:  Children with IDD during COVID 
 
 
 
Principal Investigator:  Jason Newland, MD, MEd 
 
 
 
 
 
 
 
Version Date: 23September2021 
 
 

 
2 
 
TABLE OF CONTENTS 
 
 
A. INTRODUCTION 
 
 
 
 
 
 
 
 
  3 
 
B. BACKGROUND 
 
 
 
 
 
 
 
 
  4 
 
C. STUDY OBJECTIVIES 
 
 
 
 
 
 
 
10 
 
D. STUDY DESIGN 
 
 
 
 
 
 
 
 
11 
 
E. STUDY PROCEDURES 
 
 
 
 
 
 
 
17 
 
F. STATISTICAL PLAN  
 
 
 
 
 
 
 
19 
 
G. STUDY MONITORING 
 
 
 
 
 
 
 
20 
 
H. REFERENCES 
 
 
 
 
 
 
 
 
21 
 
I. APPENDIX 
 
 
 
 
 
 
 
 
 
24 
Data Points 
 
 
 
 
 
 
 
 
 
 
 
 

 
3 
 
A 
Introduction 
The COVID-19 pandemic resulted in school closures that negatively impact children. In 
December 2019, a novel coronavirus, now termed SARS-CoV-2, was identified to cause a severe 
acute respiratory syndrome (SARS) in Wuhan, China.1 The virus quickly and inexorably spread to six 
continents, and in the US alone has now caused over 4.5 million infections and 150,000 deaths.2 
Without proven treatments or an effective vaccine, the actual timetable for when this crisis will end is 
unknown. Non-pharmaceutical public health interventions, including social distancing, limiting 
gatherings of individuals, and face coverings, are the key strategies being used to limit ongoing 
transmission of SARS-CoV-2. In March, as the cases began to rise in the US, schools were closed 
and virtual learning commenced. While this temporarily reduced the spread of disease, the negative 
consequences of school closures include an increase in adverse child experiences such as child 
abuse and neglect, food insecurity, and lack of essential services that are particularly acute for 
children with IDD.3  
Individuals with IDD are disproportionately affected by the COVID-19 pandemic. Children less 
than 17 years of age with IDD are much more likely to become infected and have a greater case-
fatality rate than children without IDD.4 Children and adults who live in residential facilities have a 5–
fold higher rate of COVID-19 and a 6% greater case fatality.5 Furthermore, individuals with IDD have 
additional disparities including higher rates of obesity and cardiovascular disease which are both 
significant risk factors for severe COVID-19, higher rates of poverty with household income less than 
$15,000, lack of internet access, and inadequate transportation.6  
Children with IDD rely on schools for many services besides an educational curriculum. Schools 
provide an opportunity for socialization, work skills development, and receipt of therapy services that 
are not available outside the home. Furthermore, reports have suggested children with IDD have 
experienced behavioral and developmental regression, resulting in significant struggles for the 
families. Ensuring a safe return to school for this vulnerable group of children is essential and will 
require the successful implementation of new mitigation strategies including readily available SARS-
CoV-2 testing and vaccinations. 
 
Purpose of the Study Protocol 
Access to COVID-19 diagnostic testing for children with IDD and their teachers is a critical 
step toward ensuring a safe return to school. Children with IDD are likely at higher risk of 
contracting and transmitting SARS-CoV-2 as they are often unable to wear a face covering, maintain 
social distance, and practice effective hand hygiene. Throughout the pandemic, access to SARS-
CoV-2 testing and timely results reporting have remained a major barrier to safely reopening the 
workplace and schools. In underserved communities, these barriers are magnified due to lack of 
access to testing sites within close proximity.7 Since many children with IDD live in poverty and lack 
transportation, access to an easily administered test within the school setting is essential for the 
safety of the child and school staff.   
Safe return to school relies on convenient access and use of SARS-CoV-2 testing. However, reports 
suggest that SARS-CoV-2 testing is not supported by all individuals. Lack of trust in the healthcare 
system due to centuries of systemic racism and discrimination on the basis of disability may result in 
poor participation by this population. Refusal of testing is also possible when individuals do not have a 
social or financial safety net to provide for their families if they are subsequently unable to work due to 
being quarantined. The stigma of SARS-CoV-2 infection, fear of a positive test and the implications to 
their health, lack of health insurance, and risk of deportment also contribute to test refusal.8  
Understanding the barriers to and optimal approaches for implementing testing of children with IDD in 
the school setting is essential and is likely to inform the best strategies for vaccine delivery to this 
vulnerable population of children with IDD. 

 
4 
 
 
B 
Background 
Children with IDD have an increased risk of COVID-19 and are at particularly high risk for severe 
disease. Additionally, children with IDD are more adversely impacted by the loss of access to critical 
school-based services including nutritional, social, therapy and healthcare services. Because 
mitigation strategies such as masking, social distancing and effective hand hygiene cannot be reliably 
performed by many children with IDD, a safe school environment for children with IDD, their teachers, 
and caregivers will require frequent SARS-CoV-2 virus testing. The best implementation strategies to 
achieve SARS-CoV-2 testing in children with IDD in a school setting are unknown. Geographic, 
socioeconomic, and racial differences in public attitudes toward COVID-19 prevention for children with 
IDD are also unknown. By identifying the most effective methods for SARS-CoV-2 testing in children 
with IDD, we will establish a blueprint for wide adoption of school testing that will also guide future 
COVID-19 mitigation strategies, such as vaccination. 
 
Overview. The primary goal of this study is to enable successful implementation of saliva-based 
SARS-CoV-2 testing for children with IDD and staff so that schools can operate as safely as possible. 
Utilizing community partners within the St. Louis region and nationally, our multidisciplinary research 
team will conduct a cluster randomized adaptive trial of different strategies to maximize delivery of 
weekly SARS-CoV-2 tests to this vulnerable population. Over the course of the study, we will perform 
a minimum of 52,000 diagnostic tests on saliva. As testing capacity expands locally and nationally, 
widespread use of testing within a school setting may become an essential tool to mitigate the impact 
of COVID-19, therefore we will assess national attitudes toward SARS-CoV-2 testing and the COVID-
19 pandemic to guide sustainable testing and vaccination strategies.  
 
Saliva-Based Diagnostic Testing. Investigators at Washington University (WUSTL) recognized early 
on in the pandemic that establishing rapid and widespread SARS-CoV-2 testing is essential to safely 
resume social and commercial activity. Therefore, the McDonnell Genome Institute (GTAC@MGI) 
deployed its expertise in high-throughput sequencing capabilities, enhanced technology development, 
and large-scale data processing to develop a saliva-based SARS-CoV-2 diagnostic test [Washington 
University SARS-CoV-2 Ultrasensitive-High-Throughput-Saliva assay (WUSC2-UHT-S)]. To address 
the limited supply of swabs and reagents needed for RNA isolation and the need for safe and 
acceptable collection method for use in children, we developed methods to detect virus directly from 
saliva. The non-invasive nature of saliva collection also facilitates its use in community settings, such 
as schools because it does not require special training to collect and minimizes aerosolization. In 
addition, saliva contains more viral particles than nasopharyngeal (NP) samples. Because it contains 
an inhibitor of reverse transcriptase that prevents detection of RNA genomes like SARS-CoV-2.9-11, 
the WUSC2-UHT-S test includes novel treatment steps to allow viral detection directly from saliva 
without the need for RNA-extraction.12 This is a major advantage of this new method. Because NP 
swabs and RNA-extraction reagents have become difficult to procure during the pandemic because of 
demand, removing these steps makes the assay robust to supply chain disruptions. In addition, saliva 
samples can sit for 5 days at ambient temperature without impacting assay sensitivity. This 
dramatically simplifies transport, storage, and handling of samples. 
The WUSC2-UHT-S test is processed and run at GTAC@MGI on the WUSTL campus with a turn-
around time of less than 3 hours. The test had 100% positive and 100% negative agreement with gold 
standard NP swab tests during validation and in the FDA submission. Application of microfluidics and 
adaptation of our existing sample-handling robotics has resulted in a capacity to test 4000 samples 
per week as of August 1, 2020. With capital investments already allocated by WUSTL, GTAC@MGI 
should reach a throughput of 20-30,000 samples per week by Fall 2020.  . Through a commercial 
partnership, the technology has been implemented commercially (Advanta Dx SARS-CoV-2 RT-PCR 
Assay) and will soon be available nationwide.  

 
5 
 
 
SARS-CoV-2 Testing Capacity and Process. Our overall strategy builds upon testing and 
associated informatics infrastructure that is rapidly being ramped up to test thousands of WUSTL staff 
and students every week. As the current project leverages existing infrastructure, we will be able to 
rapidly role out a similar test for the SSD.  
Strategy for Sample Collection and Processing. We will use a standardized sample collection kit 
developed for WUSTL. Kits contain barcoded sample collection tube, CLIA/CAP compliant label, and 
ziplock biohazard bag. 500 uls of saliva will be collected from each subject in the classroom under the 
supervision of a trained research coordinator. For students unable to spit because of poor motor 
control, we will use disposable transfer pipette under the tongue to collect a sample. Some will also 
have the option of providing the sample at home and bringing it to the school.  We will provide what is 
needed to obtain the sample at home. If a participant becomes symptomatic while at school, the 
research coordinator and/or school nurse will be able to obtain additional samples from those 
individuals in addition to their weekly testing. 
Scanning of corresponding barcode and data-entry into a HIPAA compatible Research Electronic 
Data Capture (REDCap) database will occur at time of collection (or return of sample), and will include 
all information needed for eventual National level reporting and contact tracing (e.g. demographics, 
communal housing status, pregnancy status, etc.).19 Labeled samples are transferred to a ziplock bag 
which is externally sterilized with an alcohol wipe, then sent to Vault or couriered en masse to 
GTAC@MGI on the WUSTL medical campus.  Limit of detection on this assay is <10 particles/ul, with 
no cross reactivity to any other viruses tested to date.  Leveraging the rapid run-time, sample 
collection to return of results is expected to be <2-3 d at Vault or <24 hours at GTAC@MGI.  
Return of Results. Results from the diagnostic test will be transferred into a study-specific REDCap 
database for research and communication to the RADx-UP Coordinating and Data Collection Center 
(CDCC), and provided as a HIPAA compliant report to the requisitioning physician (Drs. Newland or 
Fritz). Under their guidance, research coordinators will return results to parents/guardians using 
standardized algorithms developed by Dr. Newland that provide training on appropriate responses 
reporting to the appropriate health department, referral for medical monitoring and care, as well as 
referrals for social supports (e.g. food aid or financial assistance). Dr. Newland will coordinate with the 
health department and the school medical staff to ensure appropriate contact tracing and 
quarantining. Contact tracing will be done by trained individuals. To remove administrative burden 
from the schools, reporting to state and county agencies will be handled directly by the Consortium 
Data Reporting Unit (CDRU)(see below) and medical team. The CDRU, which has extensive 
experience developing similar reporting systems, will adapt an existing pipeline. 
 
Implementation Research for Diagnostics in a Pandemic. The application of implementation 
science tools to promote the use of a new diagnostic method, particularly in the face of a worldwide 
pandemic in which both the speed and scale required are unprecedented, represents a remarkable 
opportunity to demonstrate their effectiveness in a public health emergency. The Center for 
Dissemination and Implementation (CDI) in the Institute of Public Health at WUSTL is a national and 
international leader in this field of research.13  The CDI is directed by Dr. Elvin Geng, a member of our 
Scientific Advisory Board (see below), who also coordinates the Washington University Network for 
Dissemination and Implementation Research (WUNDIR).14 This university-wide, transdisciplinary 
network of over 80 researchers meets regularly to develop new and ongoing research efforts including 
an Agency for Healthcare Research and Quality funded R01 study of the de-implementation of 
antibiotics led by three investigators on this proposal, Drs. Newland (co-PI), McKay (co-I), and Powell 
(co-I) (NCT04366440). In addition, the Brown School at Washington University, whose mission is to 
advance social work, public health, and social policy, is on the front lines of social change both 
regionally and nationally. By engaging with investigators in their Health Communications Research 
Laboratory (HCRL) and Evaluation Center, we have access to the highest caliber investigators for this 
community-engaged research.     

 
6 
 
 
Community Partner Program 
Special School District of St Louis County. Our primary community partner for COVID-19 testing in 
Aim 1 is the Special School District (SSD) of St Louis County. IDDRC@WUSTL investigators have a 
long-standing relationship with SSD and have 
worked closely with them on past and current 
projects,15-17 including the Center for Disease 
Control-funded Autism and Developmental 
Disabilities Monitoring (ADDM) Network and the 
Study to Explore Early Development (SEED). St 
Louis County consists of more than 20 
communities surrounding the city of St Louis City 
(Figure 2) that together have a population of 
996,945 and are economically (9.8% poverty rate) 
and racially diverse (65.5% White, 24.4% Black, 
4.5% Asian, and 2.1% Hispanic). Nearly 10% 
speak a non-English language. The SSD provides 
special education and related services for more 
than 23,000 students within 22 school districts in 
St Louis County. While the vast majority of 
students receive special education and related 
services in their home school in the district in 
which they live, 909 children with disabilities are 
educated in one of the District’s six special 
education schools, of which 48% of students are 
Black. Students served by the SSD make up 
approximately 20% of the total population of students with disabilities in the state of Missouri. 
 
 This project will leverage six racially diverse special education schools at SSD that serve 909 children 
age 5-21 years (Table 1), and employs 590 teachers, staff, and administrators. Children who attend 
these schools are bussed from their homes daily. The students' medical needs are complex, including 
54 with non-progressive neuromuscular disorder, 8 with progressive 
neuromuscular disorder, 90 with permanent orthopedic disabilities, 42 
receiving gastric-tube feedings, and 11 with tracheostomies. 
 
Our partners at the SSD of St Louis County include Superintendent 
Elizabeth Keenan, PhD; Kelly Grigsby, PhD, Executive Director of 
Schools and Programs, and the principals of each school where the 
project will take place. The SSD project co-leads are Maureen McCoy, 
Area Coordinator for Nursing and Health Services, and Matthew 
Traughber, PhD, Evaluation and Research Administrator. The SSD also 
has a Parent Advisory Council, and an active Family and Community Resource Center that is led by 
Michelle Levi Perez, who is also a member of our Community Advisory Board (see below).  
The School Project Implementation Team will consist of Maureen McCoy and Matthew Traughber, 
Michelle Levi Perez, a nurse from each school, principals (or designee) from each school, as well as 
Drs. Newland, Gurnett, Fritz, Morris, and 4 research coordinators employed by Washington University 
embedded within the SSD. This team will meet weekly throughout the study to discuss any concerns 
as they arise. The research coordinators will work closely with teachers and administrators at each of 
the six schools to solve local problems, with oversight by the School Project Implementation Team. 
The SSD is an equal partner in the decision-making structure of this project, therefore any 
Table 1: Racial demographics 
of students in Special School 
District of St Louis schools 
Number  (%) 
Black 
440 (48.4%) 
White 
403 (44.3%) 
Asian 
18 (4.4%) 
Multiracial 
27 (2.9%) 
Hispanic 
20 (2.2%) 
Total 
909 
Figure 2: Community Partner for the IDDR COVID-19 
project. Special School District of St Louis County (non-gray) 
and the 6 special education schools (red) where the project will 
take place, and corresponding SARS-CoV-2 infection rate by 
ZIP code (as of 6/16/20).
*

 
7 
 
modifications of the proposal will require approval of (a) Maureen McCoy and Matthew Traughber, if 
minor, or (b) the SSD Executive Leadership Team, if deemed major. 
University Centers for Excellence in Developmental Disabilities (UCEDDs). Our national 
community partner for Aim 2 is the Association of University Centers on Disabilities (AUCD), which 
sponsors a network of 67 University Centers for Excellence in Developmental Disabilities (UCEDDs) 
that are housed in every US state and territory.18 Intellectual and Developmental Disabilities Research 
Centers (IDDRCs), which are funded by NICHD, are closely aligned with the UCEDDs. Centers work 
with people with disabilities and their families, state and local agencies, and community providers to 
provide training, technical assistance, community service, research, and information sharing, with a 
focus on building capacity of communities. The national network of UCEDDs is authorized by law and 
their core funding is administered by the Office of Intellectual and Developmental Disabilities (OIDD). 
Thus, the UCEDDs are an ideal partner for this project. The nationwide reach of the UCEDDs will 
allow us to assess and disseminate successful strategies for reducing healthcare disparities in SARS-
CoV-2 testing in schools and communities across the US.  We will initially partner with two UCEDDS: 
The University of Missouri-Kansas City Institute of Human Development (IHD)(directed by co-I 
George Gotto) and the Maryland Center for Developmental Disabilities (MCDD)(directed by co-I 
Maureen van Stone) at Kennedy Krieger Institute (KKI) led by Co-I and CEO Dr. Brad Schlaggar.  
The KKI School Program uniquely comprises 4 publicly funded nonpublic schools providing special 
education and related services to >480 children from across the state of Maryland. We will leverage 
the UCEDDs large network of professional and community partners to distribute a national survey in 
Aim 2, and to disseminate results of our study for impact on local and national policy.  
Consortium Data Reporting Unit (CDRU) 
The CDRU will coordinate the submission of common evaluation metrics on SARS-CoV-2 testing and 
implementation outcomes to the RADx-UP CDCC. The CDRU will be led by Albert Lai, the Deputy 
Director for the Institute for Informatics and the Chief Research Information Officer for the School of 
Medicine at WUSTL. We will comply with data sharing as mandated by the NIH and follow the 
guidance provided by the CDCC for data acquisition, collection and curation, including appropriate 
consent for data sharing and implementation of the schemas proposed under the ABOUT ML effort. 
The CDRU will also coordinate data safety monitoring board (DSMB) activities with the CDCC and 
ensure compliance with federal, state, and local requirements on testing, reporting, and surveillance 
policies. The CDRU will also work closely with the CDCC to employ a common set of tools to promote 
collection of comparable data on social determinants of health, including measures from the PhenX 
Toolkit. Effective implementation strategies for rapid adoption will be disseminated through the CDCC 
as well as by IDDRC/UCEDD community partners to spread best practices nationally. 
 
Community and Scientific Advisory Board 
We have already convened our Community Advisory Board (CAB) to discuss this proposed project on 
July 9, 2020, with the goal of assimilating their perceptions of barriers and facilitators of school-based 
COVID-19 testing for children with IDD. During the hour-long conversation led by Co-PI Christina 
Gurnett, the CAB strongly encouraged our team to consider: (1) effective communication strategies 
tailored to the culture and demographics of each school, (2) providing resources to parents if their 
child tests positive for COVID-19 (“a big blanket that will catch you”), and (3) contingency plans based 
on infection rates in the community and transmission within the school. Given the fluidity of the 
pandemic and its effect on our community, the CAB will meet quarterly (Sept, Dec, Mar, Jun).  

 
8 
 
 
CAB. The CAB consists of members of our 
IDDRC CAB, the Institute of Public 
Health/Institute of Clinical and Translational 
Science CAB, and several community 
members who were asked to join due to their 
expertise in educational settings (e.g. as 
school nurses) or healthcare in underserved 
populations.  The CAB is comprised of 
representatives of our parents of children with 
IDD, child advocates, teachers, school nurses, 
medical providers, and leaders of community 
health organizations. Many of our board 
members have completed a 15-week training 
through the Community Research Fellows 
Training program 
(https://beckerguides.wustl.edu/fellows), and 
have participated in other COVID-19 CAB 
meetings, including those discussing return of 
genetic results to vulnerable infected patients, 
and vaccine recruitment strategies. Thus, our 
CAB is actively committed to improving public 
health through research participation. 
 
SAB. Our Scientific Advisory Board (SAB) is comprised of local experts in infectious diseases, 
genetics, community outreach and engagement, social determinants of health, and implementation 
science with local expertise to guide the clinical trial.  Due to the rapid timeline for achieving results, 
the SAB will meet monthly during the start-up period of this project (Sept-Nov 2020), then quarterly.  
 
Human Subjects Unit (HSU) 
The HSU be supported by Drs. DuBois and Balls-Berry who bring extensive knowledge of research 
ethics, community engagement, and social science research methods. Dr DuBois also leads the 
Bioethics Research Center (BRC), a Clinical & Translational Science Award (CTSA) core that 
provides consultative services on demand. The HSU will provide three services for the proposed 
project:  
1. Ethical Guidance. First, the HSU will provide the project team with consultation access to 
either of the two faculty who will respond to requests within 48 hours. HSU faculty and staff will 
conduct literature reviews and consult with stakeholders or experts as needed to address 
ethical questions. Second, a HSU faculty member will attend all meetings of the CAB and SAB 
to provide “embedded ethics” services 20 which we have used previously and will adapt for this 
project.21 
Scientific Advisory Board: 
 Katie Plax, MD, Ferring Family Chair in Pediatrics, Medical Director of the SPOT (Supporting Positive Opportunities 
with Teens) 
 Cynthia Rogers, MD, Assoc Prof of Child Psychiatry 
 Hillary Babcock, MD, MPH, Medical Director, Occupational Health, BJC and St Louis Children’s Hospitals  
 Elvin Geng, MD MPH, Director, Center for Dissemination and Implementation 
 Alex Ramsey, PhD, Assist Prof of Psychiatry, expert in organizational psychology 
 Joseph Dougherty, PhD, Professor of Genetics 
 
Community Advisory Board: 
 Michelle Levi Perez, Family and Community Resource Center, 
Special School District of St Louis County 
 Will and Tricia Bolster, Autism Speaks St Louis, Chairman of the 
Board, IDDRC@WUSTL Board 
 David and Mary Steward, IDDRC@WUSTL Board 
 Pat Fox, Missouri Family Partnership, Bureau of Special Health 
Care, Dept of Health and Senior Services 
 Diane Southard, Community Support Southwest Regional 
Director, National Fragile X Foundation, mother of four children 
with special needs 
 Judy Bentley, Founder, Community Health in Partnership 
(provides healthcare for uninsured and underserved populations) 
 Linda Neumann, Consultant, Former Lead Nurse, Webster 
Groves School District 
 Felice McClendon, Byrne Criminal Justice Innovation Project 
Manager, Urban Strategies 
 Stacey G Newman, Director and Founder of 
ProgressWomen.com, Retired Missouri State Legislator 
 Doug Lindsay, Keynote Speaker, Workshop Designer, and 
Personal Medical Consultant, survivor of rare disease 
 Sherrill Jackson, CPNP, President and Founder, The Breakfast 
Club, Inc, Retired Certified Pediatric Nurse Practitioner 
 Nancy Spargo, Dennis Lane, Maxine McBride Jackson 
 Krista Peyton, St Louis Housing Authority, General Counsel 

 
9 
 
2. Cooperation with the Social, Ethical, and Behavioral Implications (SEBI) RADx-UP Program. 
Dr. DuBois will serve as a liaison to this SEBI program (NOT-OD-20-119) program, and will 
participate in calls and coordinate activities that require multi-site collaboration. Dr. DuBois 
spent 6 years on the NIH Societal and Ethical Issues in Research (SEIR) study section, has 
been engaged with the CTSA ethics network since its inception, and currently chairs the 
External Scientific Panel for the NHGRI Center for ELSI Resources and Analysis. He is in an 
excellent position to serve as a liaison for SEBI work.  
3. Formative Ethical Evaluation.  We will support the community-based participatory research 
activities by holding Community Engagement Studios described by Joosten et al. but modified 
for a virtual Zoom platform.22. This approach encourages respect, facilitates recruitment, 
increases trust, and buy in from communities, and makes communities more willing to 
engage.23  
 
The Consolidated Framework for Implementation Research (CFIR) will be used to evaluate facilitators 
and barriers, and identify strategies to increase participant adoption of weekly SARS-CoV-2 testing. 
This framework is widely accepted and allows systematic assessment of contextual factors important 
for implementation. CFIR has 39 constructs in five domains: innovation characteristics (e.g. saliva-
based test), outer setting (e.g. home, culture challenges), inner setting (e.g. school culture), 
participant characteristics, and process (e.g. planning and stakeholder engagement).24 Furthermore, 
implementation strategies are linked to barriers and facilitators in CFIR domains.25 Our 
implementation experts (Drs. Newland, McKay, and Powell) along with Dr. Fritz have extensive 
experience with this framework and in conducting successful clinical trials in settings outside of 
healthcare. 26-33  
 
Dissemination Plan for the Entire Project 
Community Conversations.  We will employ a World Café process to share qualitative and 
quantitative data from the FCM, FG, and survey findings to our key stakeholders of parents/guardians 
and school staff.  In our experience, these conversations spur creative thinking that will lead to the 
identification of parent-driven strategies that draw upon the ideas, insights, relationships, and 
resources of the wider community to generate creative solutions to issues.61,62 Individuals who 
participated will be invited to attend these zoom meetings.  Following each Community Conversation, 
researchers from UMKC and KKI will organize the developed strategies and share them with the full 
research team for final review and dissemination. 
Sustainability. The SARS-CoV-2 testing paradigm described here is designed to be acceptable and 
sustainable, particularly as schools are increasingly recognized as sites of essential health care 
delivery. Further, the relationships built across the research team, AUCDs and IDDRC, CAB, SAB, 
and our community partners will be maintained through the regular meetings and reports as described 
above. Thus, we are prepared to pivot the same team and network to enhance adoption of vaccines 
or other therapeutics for this vulnerable population and have laid the groundwork for those efforts 
through the aims described here. 
Data sharing and dissemination. We will deposit the IDD-specific measure that we develop to 
identify barriers and facilitators to COVID-19 testing and vaccination into the PhenX Toolkit.  FG, 
FCM, testing and survey results will be shared through the RADx-UP CDCC, and participants with 
COVID-19 complications such as MIS-C will be entered into national registries. Results of the national 
survey will be widely disseminated to our community partners to guide local policy and decision-
making. Academic manuscripts will be submitted simultaneously as preprints on MedRxiv to facilitate 
rapid dissemination of relevant data while under peer review.  Finally, as we proceed through this 
adaptive clinical trial, we will share the most effective messaging and implementation strategies 
developed through this project with the national IDDRC and AUCD network to enhance diagnostic 
testing uptake for children with IDD and school staff nationwide. We anticipate that our results will 

 
10 
 
serve as a template to aid enhanced diagnostic testing, and eventual vaccination, for this uniquely 
vulnerable population. 
Publicly Available Information. We will make the aggregate results of the surveys, discussion 
sessions, and testing results publicly available on the following website: 
https://sites.wustl.edu/safereturn. Additionally, we will provide a quarterly Newsletter to participants 
sharing aggregate results, provide study updates, and include relevent information regarding the 
pandemic. 
 
Description of milestones and timeline completion 
 
Year 1
Year 2
Site(s)
S
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N
D
J
F
M
A
M
J
J
A
S
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N
D
J
F
M
A
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J
J
A
Diagnostic Testing 
SSD
R1
R2 
CAB and SAB Mtg 
WUSTL
 
 
Aim 1: Determine the most effective messaging and implementation strategies to maximize SARS-CoV-2 testing with IDD and school staff using an adaptive trial design
Messaging: Develop 
and test entere
SSD 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
FGs: Parents 
SSD 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
FGs: Staff 
SSD 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Aim 2: Assess national perspectives among parents of children with IDD and school staff regarding the impact of COVID-19 and the importance of SARS-CoV-2 testing
FCM: Parents 
SSD 
KKI
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Local Survey 
SSD 
KKI
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
National Survey  
All 
Dissemination and Utilization
Community 
conversations
SSD 
KKI
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
C 
Study Objectives 
AIM 1: Determine the most effective implementation strategies to maximize SARS-CoV-2 testing for 
children with IDD and school staff using an adaptive trial design. 
AIM 1.1: Develop messaging and implementation strategies for parents/guardians and staff based on 
the local identification of facilitators and barriers to weekly SARS-CoV-2 testing in a school setting. 
AIM 1.2. Evaluate the impact of implementation strategies on the uptake of weekly SARS-CoV-2 
testing in children with IDD and school staff through a cluster randomized adaptive clinical trial. 
AIM 2: Assess the local and national perspectives among parents/guardians of children with IDD and 
school staff regarding the impact of COVID-19 and the role of frequent SARS-CoV-2 testing.   
 
D 
Study Design  
AIM 1: Determine the most effective implementation strategies to maximize SARS-CoV-2 
testing for children with IDD and school staff using an adaptive trial design. 
Our first practical goal is to test all students, staff, and research team membersweekly for SARS-CoV-
2 in the St. Louis and Baltimore area schools that serve student with IDD so that they can operate as 
normally and safely as possible. Beyond the weekly monitoring, we will also provide prompt testing to 
any staff, students, and research team members who develop COVID-19 like symptoms. Over the 
course of the study, we will perform at minimum 52,000 diagnostic tests on saliva. Those with 
negative test results will continue to attend school or work, while those with positive results can rapidly 

 
11 
 
be home-quarantined, undergo contact tracing, and be referred for additional medical and social 
services as needed.  
Study Setting and Populations. All research activities for this aim will occur among the students, 
parents/guardians, staff (teachers, aides, nurses, administrators) of our primary community partners, 
SSD, Kennedy Krieger and Sheppard Pratt schools, and research team members.  These schools 
that only serve children with IDD. All students (5-21 years old), school staff, and research team 
members are eligible for inclusion in the study. Individuals will be excluded if they (or their 
parents/guardians) do not provide consent or are unable to provide saliva for testing. 
Recruitment and Consent for AIM 1. Informational emails and zoom meetings will occur at each site 
to recruit staff and students for the study. Informed consent will be obtained from the 
parents/guardians, school staff, or research team members by the research coordinator after 
discussing the benefits and risk of the study. A time to answer questions regarding the study will 
always be provided regardless of the consent process used. If a student is 18 to 21 years of age and 
is not cognitively able to provide consent/assent, consent will be obtained from the legally authorized 
representative.  Children 8-17 years of age who are developmentally able will provide assent.   
Children age 5-7 will not be providing assent due to their age and development.  The 
consenting/assenting process will be done electronically via REDCap, virtually, in person or by phone.  
 
Research Design. A cluster randomized adaptive trial with 2 phases will be conducted at six schools 
dedicated to children with IDD (Figure 3). An adaptive trial provides the capability to assess multiple 
interventions and modify the trial based on data obtained during the trial. Adaptive trial designs have 
been used in a wide range of studies from improving adoption of suicide risk screening to optimizing 
use of mosquito nets to prevent malaria.34,35 Based on our initial focus group (FG) and prior work, 
messaging that educates the participants about COVID-19, explains the benefits of frequent SARS-
CoV-2 testing will likely have the greatest impact on the participation of students, parents/guardians 
and staff of the SSD schools in SARS-CoV-2 virus testing. Additionally, we will utilize FGs and 
surveys to develop/enhance messaging and other implementation strategies to maximize testing of 
children and school staff.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 3: Research design and study aims. Clinical trial is in orange 
box. Timeline is indicated at the bottom. FG=focus groups, R1=Phase 1 
randomization, R2=phase 2 randomization, FCM=fuzzy cognitive 
mapping.  

 
12 
 
 
Each school will be randomized 1:1 at the beginning of the study to one of two messaging strategies 
(Phase 1) that are informed by FGs involving parents/guardians and staff. Messaging strategies will 
include either (a) a general message that is inexpensive and easy to disseminate or (b) focused 
message that address specific concerns of the different communities. Messages may target groups 
being tested (staff versus students) or sociodemographic or racial differences between schools 
depending on the FG input. Analysis will occur after 5 months of weekly testing to determine which of 
the two initial messages is correlated with the highest uptake of testing among eligible subjects. After 
the testing begins, additional FGs will be conducted to assess factors that promote or discourage 
testing. After 6 months, each school will be randomized a second time to either the best initial 
messaging strategy (general v. focused) as determined by the analysis or the best message plus an 
augmented messaging or implementation strategy (Phase 2) to further promote the adoption of 
testing. Such strategies might include a specific type/role of person delivering the message or the type 
of content (factual versus narrative). Other implementation strategies will be informed by the barriers 
and facilitators identified based on the CFIR domains and results of focus groups and surveys in Aim 
2. For example, if participants feel there is a lack of communication regarding the importance of 
testing, local consensus discussions may be added as an additional strategy.25 
AIM 1.1: Develop messaging and implementation strategies for parents/guardians and staff 
based on the local identification of facilitators and barriers to weekly SARS-CoV-2 testing in a 
school setting.  
Focus Groups to capture stakeholder perceptions. To develop effective messaging strategies for 
recruitment, we will use the CFIR domains to understand local views on: 1) SARS-CoV-2 testing and 
COVID-19 (e.g. risk, symptoms); 2) facilitators and barriers to testing; and 3) messaging and 
implementation strategies to encourage the adoption of weekly testing for children and staff. The 
Brown School Evaluation Center will collaborate with the CAB to develop FG and interview guides. 
FGs will be conducted with parents/guardians and school staff using a virtual Zoom platform. A total of 
21 staff FGs will occur across three time points (pre-, midpoint, and post SARS-CoV-2 testing). 
Twenty-four parent/guardian focus groups will occur over two time points (pre- and post SARS-CoV-2 
testing). Recruitment of stakeholders will occur via their school with the assistance of the School 
Project Implementation Team, CAB, and SSD Parent Resource Center. FGs and interviews will be 
conducted by Evaluation Center team members who are experienced qualitative methodologists. FGs 
(8-10 participants/FG) will last approximately 60 minutes and will be recorded and transcribed. 
Parents/guardians and school staff will receive $20 gift cards per FG. 
 
Video Interviews to assess the perceptions and the practices for safe return to school for students 
and staff. Video interviews will be conducted by Washington University researchers. Approximately 
35 people will take part in the video interviews. The video interviews will last roughly 30 minutes 
each. Participants will receive a $50 gift card for their participation in the video interview. In 
coordination with media services the videos will be turned into sound clips. These video/sound clips 
will be shared with participants for their review and approval. Upon participant review and approval 
the video/sound clips will be submitted for IRB approval before dissemination. 
 
Recruitment and Consent for AIM 1.1. The SSD will share project description through multiple 
methods (e.g., email, electronic platforms, meetings) with parents/caregivers and school staff. One of 
the methods will be to share project description handout. (ProjectOverview).   
 

 
13 
 
SSD will share recruitment flyers for discussion sessions through multiple methods (e.g., email, 
electronic platforms, meetings) with parents/caregivers and school staff (DSRecruitmentFlyerParents 
or attachment: DSRecruitmentFlyerStaff).   
 
Individuals interested in participating in discussion sessions will contact the research team to enroll. 
 
 
Within approximately 2 business days of contacting research team, interested individuals will be:  
a. Emailed project description (ProjectOverview) 
b. Emailed consent cover page and consent information sheet (DSConsentCoverPage and 
DSConsentInformationForm)  
 
Within approximately 1-2 business days after initial contact the research team will follow-up with a 
phone call (DSInfoPhoneScript) 
a) If agree to participate, research team will follow up with discussion session information 
email and/or phone call (DSConfirmation and DSDemographicForm) 
b) Reminders will be sent between 2-7 days prior to the discussion session date via email 
and/or phone 
 
Participants that attend discussion sessions will provide verbal consent at the beginning of the 
session.  Discussion sessions will be conducted virtually (via Zoom) with approximately 1-15 
participants.  Sessions will be led by at least one facilitator and at least one note taker. Facilitators will 
use a guide to assist with facilitating the discussion session: (DSGuide). 
 
Information about the video interviews will be shared using a phone call script. Interested participants 
will consent before video interviews are conducted. 
 
Message Development. The Health Communication Research Laboratory (HCRL) will use an 
iterative process of environmental scan and pre-testing of initial message concepts to translate well-
received concepts into prototype messages. We will rely heavily on input from the FGs and our CAB, 
which has already emphasized the importance of trust. The HCRL will conduct an environmental scan 
of communication messages about SARS-CoV-2 testing, including headlines, taglines, and calls to 
action designed for a variety of audiences, further differentiated for delivery on specific platforms (e.g., 
policy briefs, report, social media, schools, etc.). Results of this environmental scan, as well as 
conversations with our CAB and data collected in the FGs by the Brown School Evaluation Center, 
will be used to create an initial set of 30 messages focused on promoting SARS-CoV-2 testing. 
Messages will be pre-tested among a variety of audiences, including the CAB and key stakeholders. 
Pre-testing identifies messages that are truthful, interesting, original, informative, clear and easy to 
understand, emotionally evocative, memorable, stimulate self-reflection and are perceived by 
audiences as personally relevant.37,38 Participants will evaluate these messages through cognitive 
response interviews, paraphrase tasks, thinking exercises and thought listing,39 and their reactions 
and responses will be captured for analysis (described below). These methods not only assess 
participants’ understanding of content, but also capture the natural language they use to express 
questions about and barriers to frequent SARS-CoV-2 testing, identify points of confusion, and reveal 
how this information is processed cognitively, emotionally and for personal relevance.  
Participants (n=15) will be key influencers or stakeholders such as parents, teachers, and school 
administrators, and we will recruit at least 5 participants from each subgroup. Pre-testing will be 
iterative in blocks of five participants, as recommended for user-centered design.40,41 After each block, 

 
14 
 
content is revised before the next iteration of testing. The Brown School Evaluation Center will assist 
in recruitment and participants will receive a $20 gift card for their time. 
 
AIM 1.2. Evaluate the impact of implementation strategies on the uptake of weekly SARS-CoV-
2 testing in children with IDD and school staff through a cluster randomized adaptive clinical 
trial.   
Clinical Trial Data Collection. Demographic data will be collected on each participant who consents to 
weekly SARS-CoV-2 testing in the cluster randomized adaptive trial and stored in a REDCap 
database. This will include age, gender, race/ethnicity, insurance status and type, medical history, 
housing characteristics, employment characteristics,  income and educational level, type of work, and 
all county-level reporting data required for the SARS-CoV-2 diagnostic test.   The number of missed 
days of school or work will be recorded as well as the reason for the absence. Additionally, if a 
student or staff is infected with SARS-CoV-2, the following data will be obtained: signs and symptoms, 
duration of symptoms, possible exposure(s) and location of exposure, contacts of the student or 
teacher, and outcome of the infection (e.g. resolution, hospitalization, complications, and death). We 
will also collect the mitigation strategies (e.g. social distancing, school schedule, PPE use by staff, 
etc.) being employed at each school and whether masks are provided and worn by students 
participating in the study. 
Primary Outcome. Adoption of diagnostic testing for each participant will be the primary outcome for 
this study. Adoption, a common implementation outcome, will be defined as the ratio of the total 
number of tests to the number of weeks during the study period. For example, in Phase 1 the analysis 
will occur at 20 weeks.  
Secondary Outcomes. Acceptability, feasibility and appropriateness will be secondary outcomes 
assessed for each strategy through validated surveys prior to each randomization and at the 
conclusion of the study.51 Secondary clinical outcomes will include the number of missed school or 
work days, the percentage of students or staff who test positive for SARS-CoV-2, and number of 
possible SARS-CoV-2 transmission events per student or staff within the school setting.   
AIM 2: Assess the local and national perspectives among parents/guardians of children with 
IDD and school staff regarding the impact of COVID-19 and the role of frequent SARS-CoV-2 
testing.   
As testing capacity expands locally and nationally, the next major roadblock is gaining widespread 
acceptance of testing so that even the most vulnerable students can resume access to special 
education and related services. We will take two separate approaches to gain broad insight into the 
stakeholders’ perceptions of the pandemic, the need for and barriers to frequent testing, and attitudes 
toward future COVID-19 interventions, such as vaccination. First, to understand the conceptual and 
causal relationships that parents attribute to issues surrounding SARS-CoV-2 testing strategies, we 
will utilize Fuzzy Cognitive Mapping (FCM) to understand how stakeholders make complex decisions.     
Custom IDD surveys along with standard PhenX surveys will also be deployed through email and 
captured via REDCap or Qualtrics.  Second, we will deploy national surveys through AUCD and 
additional community partners. These nationwide surveys will allow us to assess geographical, 
sociodemographic, and racial differences in attitudes that will inform the feasibility and sustainability of 
strategies to resume safe special education and related services for children with IDD, including 
vaccination strategies for this vulnerable population.  
 
Recruitment and Consent for AIM 2.    
The team will share recruitment flyers for focus groups through multiple methods (e.g., email, 
electronic platforms, meetings) with parents/caregivers (KKI and KC family recruit flyer B).   
 

 
15 
 
Individuals interested in participating in focus groups will contact the research team to enroll.  
Informed consent will be sent via email/mail, if preferred by the interested potential participant for 
review prior to the focus group (informed consent KKI and KC).   
 
Participants that attend focus groups will provide verbal consent at the beginning of the session after 
the consent has been reviewed with all.  Focus groups will be conducted virtually (via Zoom) with 
approximately 1-10 participants.  Facilitators will use a guide to assist with facilitating the focus 
groups.  (Fuzzy cognitive mapping script). 
 
FCM participants will receive a $50 gift card for their time. 
 
Fuzzy Cognitive Mapping to Understand Decision-Making.  FCM is a reliable knowledge-based 
model that facilitates democratic discourse to understand how stakeholders make decisions.52-54 We 
have demonstrated its effectiveness in our prior study of veterans’ participation in higher education.55 
This methodology is highly participatory and fosters social learning among participants. For the 
current project, we anticipate that FCM will generate community-specific, testable strategies to 
address factors impacting the uptake and effectiveness of SARS-CoV-2 testing. The FCM sessions 
will take place with 10 groups of 10 parents/guardians (100 total). The sessions will be organized at 
the community level in partnership with the  SSD of St Louis County schools,  Kennedy Krieger 
School Programs schools, The Maryland Association of Nonpublic Special Education Facilities 
(MANSEF)and/or the Sheppard Pratt School. Leadership from each school will work with our team to 
recruit parents/guardians who are representative of the gender, ethnic/racial, and social/economic 
diversity in the school. A second round of FCM sessions will be conducted at the beginning of the 
school year to learn from parents of students with disabilities concerns about returning to in-person 
learning during COVID-19 in order to inform national level strategies to safely return children with 
disabilities to school. FCM sessions will take place in an online Zoom format using a program called 
Draw Chat and all sessions will be recorded. This whiteboard program allows collaborators to work on 
a document in real time via audio and video conference systems. Each participant will have their own 
template to draw their own maps (Figure 4A). The UMKC UCEDD has extensive experience in 
leading FCM sessions and will provide written instructions, a tutorial, and will work with the MCDD 
team to implement this at KKl. In each FCM session, participants will be asked to list up to five 
important facilitators and five barriers to COVID-19 testing in children with IDD. Participants will apply 
directional (arrows) and weighted (e.g. negative to positive) connections that quantify the relationships 
between the items on their maps. A facilitated discussion of the ideas presented on the maps will then 
Figure 4: Fuzzy Cognitive Mapping (FCM). A. Individual hand written FCM. B. Synthesized and modeled FCM. 

 
16 
 
take place (Petri & Corwin, 2015). A minimum of three members of the research team will be present 
for each FCM session.  
 
National Surveys to Assess COVID-19 Impact and Mitigation Strategies. Because there are no 
accepted measures for understanding parent or school staff concerns around COVID-19 or any IDD-
specific measures regarding SARS-CoV-2 testing and vaccination, a series of surveys will be 
developed to evaluate stakeholders’ perceptions and impacts of the COVID-19 pandemic, 
acceptability of COVID-19 testing, perceptions of risk and appropriate strategies to mitigate risk, and 
acceptability of and attitudes toward COVID-19 vaccinations. The team at KKI has substantive and 
methodological expertise with survey-based research, including assessing the impact of COVID-19 on 
mental health.59,60 Custom surveys will be deployed across two stakeholder groups: parenst/guardians 
and school staff.  
The initial local and national survey will be informed by the FGs that take place prior to onset of the 
trial in Aim 1. For parents, we expect items to assess domains such as: 1) trust in the healthcare 
systems, 2) transportation, 3) beliefs about COVID-19 testing and vaccines, and 4) access to social 
and community resources in the event of exposure and quarantine. For school staff, we expect items 
to address: 1) concerns about infection; 2) conditions that facilitate and/or inhibit testing; 3) 
perceptions of hybrid educational models; and 4) trust in educational leadership. Both surveys will 
build on extant resource that are not currently tailored to the IDD population (see below for details). 
After baseline data from our survey is collected, we will conduct preliminary psychometric analyses to 
revise our custom measure. Both reliability (Cronbach’s α) and validity (correlations between our 
novel measure and standard COVID-19 measures, as listed below) will be evaluated. We will also 
integrate results from the FCM to ensure items comprehensively cover parental concerns. Ultimately, 
this effort will yield the first, IDD-specific measure that identifies barriers and facilitators to COVID-19 
testing and vaccination. This revised measure will be launched at the end of the trial across our 
national network of partners (Table 3). This national survey will allow identification of regional 
populations that may face major barriers to testing or vaccination. 
Beyond our custom survey, we will also use several NIH-recommended parent-report surveys from 
the PhenX Toolkit during each survey administration. This includes the Psychological Stress 
Associated with the COVID-19 Crisis Scale. This measure includes standard demographics and social 
determinants of health, the Perceived Stress Scale, exposure to COVID-19, impacts of COVID on 
daily life and work as well as disruption to sleep and exercise. We will also deploy the COVID impact 
questionnaires developed as part of the NIH Director’s Environmental Influences on Children’s Health 
Outcomes (ECHO) initiative, which addresses multiple research questions in school-age children and 
their parents/guardians. These specific ECHO questionnaires assess the impact of COVID-19 on child 
and family life. In total, these external surveys were selected to ensure we are following 
recommended measurement protocols, promote future data sharing efforts (i.e. through the CDCC), 
and validate our novel measure.  
 
Table 3: Community Partners Who Will Distribute IDD Focused COVID-19 Survey
Stakeholder
Description
Association of University 
Centers for Disability (AUCD) 
AUCD is national network of interdisciplinary centers that advance policy and practice for and with 
individuals IDD, their families, and communities.  
Council of Parent Attorneys 
and Advocates (COPAA) 
COPAA’s mission is to protect and enforce the legal and civil rights of students with disabilities and 
their families.  
National Community of 
Practice for Supporting 
Families with IDD 
The Community of Practice for Supporting Families of Individuals is a national network that works 
towards developing systems of support for families supporting individuals with IDD throughout the 
lifespan.  
Parents’ Place of Maryland 
The Parents’ Place of Maryland is a state-wide, grass-roots effort of families, professionals, and 
community leaders determined to provide resources, support, and information to parents of children 
special health care needs.  

 
17 
 
 
 
E 
Study Procedures  
This research study will occur at six schools that are a part of the Special School Districts in St. Louis, 
MO as well as the Kennedy Krieger School Programs and Sheppard Pratt school in Baltimore that 
serve children with intellectual and developmental disabilities (IDD). Additionally, surveys, focus 
groups, and fuzzy cognitive mapping sessions will be conducted at these six schools and at the 
Baltimore schools. 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), along with other national listserv’s.  
 
The primary goal of this project is to identify the best messaging and implementation strategies to 
maximize SARS-CoV-2 testing for children with 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. The first aim will involve focus 
groups of parents/guardians, teachers, and school staff to identify the barriers and facilitators of 
testing, impressions of COVID-19, and best messages and implementation strategies for improving 
testing and vaccinations.  A formal process for developing the message will be performed using focus 
group data and involving key stakeholders to test the messages. Additionally, in the first aim we will 
conduct a cluster randomized adaptive clinical trial. The schools will be randomized initially to either a 
general message or focused message to promote the adoption of weekly SARS-CoV-2 testing by the 
students and teachers. A second randomization will occur for the schools and phase 2 of the study 
will start at 7 months. In the second phase, each school will be randomized to either the best 
message determined from phase 1 analysis or the best message plus an augmented strategy.  
 
For aim 1, focus groups will be conducted and recorded. Participants will provide consent prior to 
participating. The recorded focus groups will be transcribed and the analyzed using NVIVO. The 
community advisory board and key stakeholders will pre-test the general and focus messages. 
Following the development of the messaging which will also be informed by FCM and the local 
surveys done in aim 2, each school will be randomized to either the general of focused message. 
Testing will commence and adoption of the weekly testing by the students and teachers will be 
assessed through a REDCap database. Once consented, testing will be completed weekly. If a 
participant is unable to test in a given week, reasons for missing the test will be obtained by the 
research team.  The study team will follow-up with the participant to assess how we could help them 
complete the weekly testing.  . To assess transmission in schools a REDCap database will be used to 
examine the percentage of students or staff who test positive for SARS-CoV-2 each week, prevalence 
and incidence of COVID-19 within the school, create an epi curve, and obtain symptomology. 
Research coordinators will return results to parent/guardian using standardized algorithms  for both 
positive and negative test results developed by Dr. Newland that provide education on appropriate 
Maryland Developmental 
Disabilities Council  
The Maryland Developmental Disabilities Council is an independent, self-governing organization 
dedicated to advancing the inclusion of Marylanders with developmental disabilities in all facets of 
community life. The Council is 100% federally funded.  
Community Advisory Council 
for the Maryland Center for 
Developmental Disabilities 
(MCDD) 
The Community Advisory Council for the MCDD is federally required under the Developmental 
Disabilities Act. The CAC is comprised of a diverse group of stakeholders including self-advocates, 
family members, representatives from local and state agencies and organizations, and MCDD staff.  
Maryland’s Community of 
Practice for Supporting 
Families  
The Maryland Community of Practice for Supporting Families is our statewide network that works 
toward developing systems of support for supporting individuals with IDD throughout the lifespan. It 
is housed within the Maryland Developmental Disabilities Administration within the Maryland 
Department of Health.     
People on the Go 
People on the Go are self-advocates with IDD that pattern with KKI and the MCEDD. 
 

 
18 
 
responses including criteria for immediately contacting the appropriate health department, referral for 
medical monitoring and care, as well as further referrals for social supports as needed (e.g. food aid). 
Dr. Newland will coordinate with the health department and the school medical staff the appropriate 
contact tracing and quarantining that is required.   
Each school will be randomized 1:1 at the beginning of the study to one of two messaging strategies 
(Phase 1) that are informed by FGs involving parent/guardians and staff. Messaging strategies will 
include either (a) a general message that is inexpensive and easy to disseminate or (b) focused 
message that addresses specific concerns of different groups. Messages may target groups being 
tested (staff versus students) or sociodemographic differences between schools depending on the FG 
input. Analysis will occur after 5 months of weekly testing to determine which of the two initial 
messages resulted in the highest percentage of eligible testing to be performed. After the testing 
begins, additional FGs will be conducted to assess factors that promote or discourage testing. After 6 
months, each school will be randomized a second time to either the best initial messaging strategy 
(general v. focused) as determined by the analysis or the best message plus an augmented 
messaging or implementation strategy (Phase 2) to further promote the adoption of testing. Additional 
messaging could be the type of person delivering the message or the type of content (factual versus 
narrative). Other implementation strategies will be informed by the barriers and facilitators identified 
based on the CFIR domains and results of focus groups and surveys (Aim 2). 
For Aim 2, FCM sessions will occur by zoom with 10 groups of 10 parents that are from the St. Louis 
Special School District schools and the Baltimore area schools.  The program Draw map will be 
utilized in real time to help create the map and the audio from these session will be recorded. In each 
FCM session, participants will be asked to list up to five important facilitators and five barriers to 
COVID-19 testing in children with IDD. Participants will apply directional (arrows) and weighted (e.g. 
negative to positive) connections that quantify the relationships between the items on their maps. A 
facilitated discussion of the ideas presented on the maps will then take place (Petri & Corwin, 2015). 
A minimum of three members of the research team will be present for each FCM session. Qualitative 
analysis with coding and network mapping are then performed followed by confirmatory factor 
analysis. 
A second round of FCM sessions will be conducted at the beginning of the school year to learn from 
parents of students with disabilities concerns about returning to in-person learning during COVID-19 
in order to inform national level strategies to safely return children with disabilities to school. 
Additionally, in Aim 2 local and national surveys will be constructed and administered. For parents, we 
expect items to assess domains like: 1) trust in the healthcare systems, 2) transportation, 3) beliefs 
about COVID-19 testing and vaccines, and d) access to social and community resources in the event 
of exposure and quarantine. For school staff, we expect items to address: 1) concerns about infection; 
2) conditions that facilitate and/or inhibit testing; 3) perceptions of hybrid educational models; and d) 
trust in educational leadership. Both surveys will build on extant resource that are not currently 
tailored to the IDD population (see below for details). 
 
The second aim involves FCM and the administration of local and national surveys. FCM will involve 
in-person sessions at the 6 schools in aim 1 and Kennedy Krieger Schools. These sessions will help 
identify important factors that will support SARS-CoV-2 testing and other mitigation strategies 
including vaccinations. Since no accepted measures have been developed for understanding parent 
and school staff concerns for children with IDD around COVID-19, local 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 and various 
other national listserv’s. 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 

 
19 
 
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 impact questionnaires. 
 
After baseline data from our survey is collected, we will conduct preliminary psychometric analyses to 
revise our custom measure. Both reliability (Cronbach’s α) and validity (correlations between our 
novel measure and standard COVID-19 measures, as listed above) will be evaluated. We will also 
integrate results from the FCM to ensure items comprehensively cover concerns parental concerns. 
Ultimately, this effort will result in the first, IDD-specific measure that identifies barriers and facilitators 
to COVID-19 testing and vaccination. This revised measure will be launched at the end of the trial 
across our national network of partners (Table 3). This national survey will allow identification of 
regional populations that may face major barriers to testing or vaccination. 
Beyond our custom survey, we will also use several NIH-recommended parent-report surveys from 
the PhenX Toolkit during each survey administration. This includes the Psychological Stress 
Associated with the COVID-19 Crisis Scale. This measure includes standard demographics and social 
determinants of health, the Perceived Stress Scale, exposure to COVID-19, impacts of COVID on 
daily life and work as well as disruption to sleep and exercise. We will also deploy the COVID impact 
questionnaires developed as part of the NIH Office of the Director Environmental Influences on 
Children’s Health Outcomes (ECHO) initiative, which was developed for school age children and their 
parents/guardians. This survey assesses the impact of COVID-19 on child and family life. These 
broad surveys were selected to ensure we are following recommended measurement protocols, 
promote future data sharing efforts, and validate our novel measure. 
 
 
F 
Statistical Plan  
AIM 1.1: Develop messaging and implementation strategies for parents/guardians and staff 
based on the local identification of facilitators and barriers to weekly SARS-CoV-2 testing in a 
school setting. 
Focus Group Analysis. A directed thematic analysis of the qualitative data will be conducted.36 
Transcripts will be independently coded by the qualitative leads and research assistants. Coders will 
discuss codes to resolve discrepancies and analyses will be based on consensus codes. NVivo will 
be used for the analysis.  
Message Development Analysis. Qualitative analysis methods will be used to identify specific content 
revisions. Audio recordings of pre-testing interviews will be transcribed, reviewed for accuracy, and 
analyzed using a hybrid deductive/inductive thematic approach.42,43 A priori codes will come from 
health communication and behavior theories.44-46 Emergent codes will be added after reviewing 
representative transcripts.47 The HCRL will code transcripts and results will be discussed with the 
larger study team to challenge perceptions and explore potential negative responses.48-50 At the 
conclusion of the pre-testing activities and qualitative analysis, the HCRL will use these findings to 
create prototype messages to support SARS-CoV-2 testing. 
 
AIM 1.2.  Evaluate the impact of implementation strategies on the uptake of weekly SARS-CoV-
2 testing in children with IDD and school staff through a cluster randomized adaptive clinical 
trial. 
Sample size calculation. Assuming the percentage of testing in the group of general message (P0) is 
0.60 and the intracluster correlation (ICC) is 0.05, 64 participants per school with 3 schools per group 
will achieve 80% power to detect a 25% difference between two groups when the percentage of 

 
20 
 
testing in the group of focused message (P1) is 0.85 using the two-sided Z-Test at the significance 
level of 5%. 
Analyses. The generalized estimating equation (GEE) model with appropriate link function (e.g. 
identity for primary outcome, logit for test positive) will be used to analyze the cluster randomized trial 
data at the end of phase 1 and again at the end of phase 2, in which the correlation among the 
participants within each school need to be considered. The autoregressive of first order as working 
correlation structure will be used and the participants with missing values will be excluded from GEE 
analysis. The GEE model will include the group indicator and other factors including race/ethnicity, 
insurance state, age, gender, underlying diagnoses. Least square means for each outcome per group 
will be estimated and the standard errors will be calculated with the use of GEE sandwich method 
when accounting for within-school correlation. All analyses will be conducted using SAS at the two-
sided 5% significance level.  
 
AIM 2: Assess the local and national perspectives among parents/guardians of children with IDD 
and school staff regarding the impact of COVID-19 and the role of frequent SARS-CoV-2 testing.   
Fuzzy Cognitive Mapping (FCM) to Understand Decision-Making. 
Analysis.  Using the added directional and weighted relationships, the maps from multiple responders 
can be integrated to show a dynamic display of direct and indirect effects. An item level analysis will 
be used to code the mapping data.56 An adjacency matrix will then be created for each map 
representing a network-type diagram or graph, directed (with arrows) or non-directed (without arrows). 
We use the directionality of the connecting arrows and the strength score assigned to each 
connection to develop the adjacency matrix and merge individual matrices into one data set for export 
to R for the final analysis. Confirmatory factor analysis (CFA) will be employed to examine latent 
constructs within the mapping data (Figure 4B). As a part of the structural equation modeling family, 
CFA plays an essential role in model validation.57,58  CFA will allow us understand the relationships 
between the mapping concepts and the underlying factor structure supporting SARS-CoV-2 testing 
strategies among children with IDD. The data will also be analyzed using FCMapper that aggregates 
maps and uses the values of weight and direction of the relationships between major and minor 
factors to provide if-then scenarios for hypothesis generating and simulated testing.  
 
The informatics team at WU will deploy the electronic surveys via REDCap. KKI will assist with survey 
development and dissemination. Best practices will be used throughout to ensure responses are valid. 
Survey data will be analyzed using a series of descriptive, bivariate, and multivariate methods to 
understand unadjusted and adjusted associations between beliefs about testing and vaccines, COVID-
19 related stressors, and Aim 1 outcomes. 
 
Data Management.  
All data, including FG transcriptions, will be managed utilizing REDCap and stored on secure servers.   
 
G Study Monitoring 
Study Monitoring Plan  
The proposed study will evaluate the impact of messaging and potentially other implementation 
strategies to maximize the adoption of frequent SARS-CoV-2 testing for students with IDD and their 
teachers. Frequent testing has been a recommended strategy by experts to help prevent outbreaks of 
COVID-19. Performing the test does not provide any risk to the participants, as it is saliva-based. For 
this reason, a Data and Safety Monitoring Plan, rather than a formal board is appropriate. Monitors for 

 
21 
 
this study will include the co-PIs, Drs. Gurnett and Newland, independent monitors, Drs. David 
Hunstad (Division Chief of Pediatric Infectious Diseases) and Greg Storch (Pediatric ID physician and 
virologist), and the trial statistician, Esther Lu, PhD. The co-PIs will monitor the number of SARS-CoV-
2 tests being obtained at the schools, rate of SARS-CoV-2 positivity in all schools, and the number of 
potential transmission events within the schools on a continuous basis and is responsible for providing 
the monitors with new safety information relevant to the study. This group will meet quarterly during 
the testing phase of the study and will review interim and cumulative data for the measures 
mentioned. Interim reports will be developed for these meetings by the trial statistician.  Ad hoc 
meetings may occur at the request of the monitors or the WU HRPO.   
 
 

 
22 
 
H 
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26 
 
Data Points 
 
Focus groups and the FCM sessions will be recorded and transcribed. Local and national surveys 
will be developed and administered using REDCap and Qualtrics 
 
For the students/parents/guardians and teachers in the randomized clustered adaptive clinical trial 
we will collect: 
Age 
Gender 
Race/ethnicity 
Insurance status and type 
Medical conditions 
Number of individuals in the home 
Income and educational level of parent/guardians or teachers 
Type of work 
County-level reporting data required for the SARS-CoV-2 diagnostic test 
Reason for missed tests  
Mitigation strategies being followed by the individual 
 
Information collected from the schools 
Mitigation strategies utilized (e.g. social distancing, school schedule, PPE use by staff, etc.)  
Whether masks are provided and worn by students participating in the study. 
Number of days of missed school work 
Reason for missed days 
Percentage of students and teachers that are SARS-CoV-2 positive 
Number of SARS-CoV-2 transmission events by the students or teachers.    
 
Student or staff is infected with SARS-CoV-2, the following data will be obtained:  
Signs and symptoms 
Duration of symptoms 
Possible exposure(s) and location of exposure 
Contacts of the student or teacher 
Outcome of the infection (e.g. resolution, hospitalization, complications, and death)  
Mitigation strategies being followed by the individual