Efficacy of the SAFE Program to Promote Preventative Behaviors of Airborne Diseases (COVID-19) and Improve Well-Being for People With Intellectual and Developmental Disabilities in the Workplace
Phase: NA
Conditions: Communicable Diseases, Prevention, Workplace Intervention
Sponsor: Temple University

 
 
 
 
 
 
Study Protocol with Statistical Analysis Plan  
SAFE Workplace Intervention for People With IDD 
 
 
 
 
Official Title: Efficacy of the SAFE Program to Promote Preventative Behaviors of Airborne 
Diseases (COVID-19) and Improve Well-Being for People with Intellectual and 
Developmental Disabilities in the Workplace   
 
NCT06112249 
 
 
 
 
November 6, 2025 
 
 

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August 2024 
1) Abstract of the study 
The purpose of this study is to examine the feasibility and efficacy of a 
systematic training approach targeting behaviors to increase safety and 
prevention of airborne diseases such as COVID-19 in the workplace for 
individuals with Intellectual and Developmental Disabilities (IDD).  This 
project is designed to determine proof of concept and proof of product for a 
peer support intervention, the SAFE program, to increase knowledge and safe 
workplace practices. There is an identified immediate need for individuals 
with IDD to receive training in an accessible format.  The SAFE program has 
been developed in an accessible format for those with IDD.  It focuses on 
education regarding actionable behaviors that reduce the risk of acquiring and 
transmitting COVID-19 and other airborne diseases.  The study will 
implement a peer-mediated and occupational therapy lead program, SAFE, to 
identify and address potential implementation issues and further refine the 
program curriculum. Additionally, the efficacy of the program on perceived 
safety and well-being, observable preventative behaviors and self-advocacy 
will be examined. 
2) Protocol Title 
Efficacy of the SAFE Program to Promote Preventative Behaviors of Airborne Diseases 
(COVID-19) and Improve Well-Being for People with Intellectual and Developmental 
Disabilities in the Workplace 
 
3) Investigator  
Beth Pfeiffer, PhD, OTR/L, BCP, FAOTA 
Sarah Bass, PhD 
 
4) Sponsor:   
PA Department of Health 
 
5) Objectives 
It is hypothesized that the SAFE program will have a positive effect on perceived well-
being and knowledge of the actionable behaviors for the prevention of COVID-19 and 
other airborne diseases. The program will have a larger effect on outcomes when 
provided using peer support compared to staff training. Individuals with IDD will 
demonstrate increased knowledge and safe behaviors after completing the SAFE 
program. Peer-interventionists will report perceived benefits and limitations of 
participating in training and providing peer-mediated travel training interventions to 
identify potential outcomes for future research. 
 
 
The research intends to answer these questions: 
1. Does participation in the SAFE program increase perceived safety and well-being in 
the workplace for people with ASD and/or IDD? 

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2. Does participation in the SAFE program increase knowledge of actionable behaviors 
to prevent transmission of airborne diseases (i.e. COVID-19) in the workplace for 
people with IDD?  
3. When implemented through peer support, does the SAFE program have a larger 
increase in perceived well-being and knowledge of actionable behaviors to prevent 
transmission of airborne diseases (i.e. COVID-19) than when implemented through 
staff training and supports? 
 
The research further intends to: 
• Develop health communication messages related to safe interactions 
and the prevention of COVID-19 and other infectious airborne 
diseases for autistic adults 
• Refine and expand the SAFE program based on stakeholder priorities 
and input Evaluate the SAFE program training with Autistic adults 
 
Phase 2 
1: Identify stakeholder priorities for additional health communication content related 
to staying safe from infectious airborne diseases.  
 
2: Develop new content based on the identified needs and incorporate it into the 
SAFE program for individuals with IDD.  
 
3: Pilot the new curriculum with direct care providers and refine materials based on 
feedback to ensure effectiveness. 
 
 
 
6) Rationale and Significance  
Employment is emerging as a significant socioeconomic factor that influences health 
outcomes. As a social determinant of health, employment is closely linked to income and 
subsequent access to goods, services, and environments that promote health. The 
COVID-19 pandemic sweeping the nation and protective stay-home orders have had a 
significant impact on the economy, impacting the employment status of millions. Many 
of those fortunate enough to retain employment have shifted to remote work from home, 
while others continue to work onsite providing “essential” services. Essential 
employment includes but is not limited to work in healthcare facilities, the food service 
industry, commercial retail (including grocery, pharmacy, and convenience stores), and 
maintenance and sanitation services. All essential workers are facing new policies and 
procedures intended to promote health and safety. Our ongoing work on supportive 
community-based employment for people with intellectual and developmental disabilities 
(IDD) highlights the unique needs of this population as we navigate unprecedented 
workplace challenges introduced by COVID-19, especially as many people with IDD 
find themselves employed in some of these essential positions. People with IDD are a 
vulnerable population facing increased health risks and disparities due to their 
disabilities.  

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People with ASD and/or IDD are also believed to be at increased risk for COVID-19 and 
other airborne diseases due to unavoidable close contact with direct care providers, 
difficulty communicating that they are experiencing symptoms, and difficulty 
understanding and following Centers for Disease Control and Prevention (CDC) 
recommendations for protective practices like social distancing, handwashing, and use of 
personal protective equipment (PPE). These recommendations, especially for workplace 
precautions, are not in formats that are readily accessible to people with IDD. Training 
and interventions are rapidly emerging to meet the needs of essential workers with IDD 
and their employers. There is a need to create accessibly trainings for individuals with 
IDD. 
 
Peer-mediated interventions are identified as effective and are provided in natural social 
contexts (Zhang & Wheeler, 2011). Peers act as intervention agents to model or reinforce 
a particular skill and facilitate social interactions. This is an essential component in 
learning the skills needed for implementation of new safety procedures due to Covid-19. 
Much of the research on peer-mediated interventions has focused on developing social 
and academic skills (Chan et al., 2009; Wong et al., 2015). The majority of research 
targets the pediatric population. Although social skills and supports are important for safe 
workplace habits, there are additional skills that the peer-mediator needs to model and 
target for proper workplace precautions. This project expands the use of peer-mediated 
interventions to adult populations and specific skills necessary for consistently 
participating in proper workplace procedures.  
 
 
7) Resources and Settings 
 
Research staff for this study will receive extensive training, including completion of the 
Temple University CITI social and behavioral health human subjects training program 
and the research lab’s interviewer training. The lab’s interviewer training includes: 
regulations and assessing risk, the informed consent process, upholding privacy and 
confidentiality, unanticipated problems and how to report them, cultural competency and 
project management (procedures for recruitment, consent, data collection, retention, data 
entry, data storage and debriefing study participants).  Weekly staff meetings, as well as 
individual and group supervision, are utilized to ensure procedures are followed and 
issues are addressed appropriately. 
Participants will complete the SAFE program course, focus groups and qualitative 
interview in a place that is private, quiet and convenient for the participant. This could 
include remote meetings using programs like Zoom or FaceTime, or in person sites such 
as private conference room or office at Temple University, the person’s home, or a 
community setting such as the recruitment site. For example, if potential participants are 
identified or recruited through a specific organization or agency where private rooms are 
available, researchers can use these sites to discuss the study and also to conduct the 
consent and interview process. Individuals will also be able to call research staff at our 
research offices to discuss the study and to set up a time to meet in person at one of the 

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identified locations. All data collection activities will comply with the recommended 
social distancing requirements currently in place at the time. 
Quantitative study measures will be implemented through the use of on-line REDCAP 
survey software and is available to interested individuals through an on-line link. 
Participants can complete the survey in any environment in which they have access to the 
Internet (i.e., public library; home; work). If the interested participant does not have a 
device to access the Internet and the survey or communicate with the researcher to 
indicate their responses, the primary researcher will meet them a place identified as 
convenient for the participant with the necessary equipment to complete the survey (i.e., 
laptop computer with Internet connectivity). 
 
8) Prior Approvals 
N/A 
 
9) Study Design 
 
Recruitment Methods 
 
Recruitment will occur through local community partners, which include Philadelphia 
Independence Network, Community Integrated Services, Carousel Connection GRASP, 
ASERT, Philadelphia the Institute of Disability at Temple University, and the 
Philadelphia Area Charter School. We have an established relationship with all of these 
organizations. An introductory recruitment e-mail (see materials submitted with IRB 
protocol) will be sent to potential participants through the organization, which includes a 
link to the survey questions on  REDCAP.  
 
Phase 1  
We intend to recruit 20 employed individuals with ASD and 20 employed individuals 
with IDD to complete in depth qualitative interviews, 100 employed individuals with 
ASD and 100 employed with IDD to complete quantitative perceptual mapping surveys.  
We will recruit 40 individuals 10 ASD 10 IDD, 10 vocational staff, and 10 from the 
project Advisory Board to conduct vector modeling analysis with and complete sample 
messaging. We aim to recruit at least 120 participants with ASD and 120 participants 
with IDD for the pilot SAFE program, which we anticipate will yield a total of 96 
participants in the final sample when accounting for 20% attrition rates commonly 
identified in prior intervention studies of people with ASD and/or IDD.  
 
Phase 2 
We will recruit 60 individuals—30 with IDD and 30 vocational staff—to participate in 
focus groups aimed at identifying stakeholder priorities for additional health 
communication related to staying safe from infectious airborne diseases and ensuring 
workplace safety. Focus groups will ideally include 5-10 people, but that they may be as 
small as 1, thus turning it into an interview instead. 
The project team will recruit 5-10 staff members from community partners listed 
above to participate in a pilot training session. Following the training, staff 

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member participants will provide feedback to inform any necessary revisions to 
the training materials or processes, ensuring the content is effective and practical 
for future use. The additional lessons will be developed based on feedback from 
the focus group. Once completed, the materials (including recruitment materials) 
will be submitted as an amendment to the IRB and will not be used until approval 
is granted. After IRB approval, the materials will be provided to the staff and used 
in the training. 
This will require between 2-3 one to two hour sessions. 
 
a) Inclusion and Exclusion Criteria 
We anticipate recruiting young adults 18years old and over with ASD or IDD who are 
currently employed or actively looking for employment to participate in the study. 
Participants will have a diagnosis of ASD or IDD. Participants will self-report their ASD 
or IDD diagnosis. Additionally, the community agencies have access to documentation 
that identifies their consumer’s diagnoses. Based on this, we will ask them to only 
provide information to those individuals who have a diagnosis of IDD.  Potentially 
eligible participants with documented intellectual and developmental disabilities will be 
recruited through large vocational rehabilitation organizations (Community Integration 
Services [CIS] and Project Search) that together serve over 1200 adults with IDD. 
Participants must be working a minimum of 10 hours a week outside the home and/or 
receive vocational rehabilitation services. We aim to recruit at least 120 participants, 
which we anticipate will yield a total of 96 participants in the final sample when 
accounting for 20% attrition rates commonly identified in prior intervention studies of 
people with ASD/IDD. 
  
The participants must have communication skills or a system to engage in the learning 
process, which will be determined during the initial meeting and assessment. All 
participants must speak English. For those participants who are nonverbal, visual and 
communication systems can be used, although participants must be able to cognitively 
answer questions on their own and provide consent/assent. These devices can also be 
used during the initial interview process to provide yes or no answers to formal interview 
questions. Participants with ASD or IDD can have assistance completing the 
questionnaire if they need help in reading and understanding the questions or checking 
the appropriate answer box. For any participants that are not able to participate in the 
SAFE program methodology or qualitative interviews, a support staff, parents or 
caregiver proxy can be used.  
 
Phase 2 
For phase 2, we will recruit young adults aged 18 and over with ASD or IDD who are 
currently employed or seeking employment, as well as staff who support young adults 
with ASD or IDD in employment settings. Participants must either self-report their 
diagnosis. Additionally,  community agencies have access to documentation that 
identifies their consumer’s diagnoses and, based on this, research personnel will ask 
them to only provide information to those individuals who have a diagnosis of 
IDDRecruitment will occur through large vocational rehabilitation organizations that serve 
over 1,200 adults with IDD. Eligible participants must work at least 10 hours per week 

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and/or receive vocational rehabilitation services. We aim to recruit 60 participants. All 
participants must have communication skills or systems to engage in the focus groups 
and be able to provide consent. 
 
Project team members will include 5-10 staff members from a selected service provider 
organization to participate in a pilot training session. Staff will directly support young 
adults with IDD with their employment goals.  
 
 
 
b) Study Timelines 
 
Phase 1 
We intend to complete the SAFE program and interviews over the course of three years 
starting as soon as IRB approval is obtained. We intend to complete the qualitative 
interviews and quantitative surveys in the first year. We intend to implement the SAFE 
program until approximately 120 participants have completed the program and data 
collection during year two and three. Recruitment will occur throughout the course of the 
study until the targeted number of participants is obtained.  We will use block 
randomization, which will allow us to have continuous enrollment in the study. 
Participation in the SAFE program is completed over the course of 2-4 weeks. 
Participants will meet 2-3 times a week for approximately 60 minutes with either staff, a 
peer support specialist peer, or occupational therapy graduate students.  The meetings 
will provide direct instruction and role play experiences covering the main concepts and 
proper use of preventable behaviors to protect against COVID-19 and other airborne 
diseases in the workplace.  
 
Phase 2 
Phase 2 will be completed over the course of one year following IRB approval. During 
the first two months, recruitment for the focus groups will take place. In months 2-4, 
focus groups will be conducted, and their feedback will be analyzed. Months 4-8 will 
involve revising the SAFE curriculum by adding lessons based on the focus group 
feedback. The final months will focus on recruitment and training. 
 
Study Procedures and Data Analysis 
 
Procedures. 
To assess perceptions of peer-support interventions and use of preventative 
decision-making practices for individuals with ASD and or IDD in the workplace  we 
will conduct in-depth qualitative interviews with individuals with ASD and or IDD 
working 10 hours or more a week (n=20 or until data saturation) who receive 
employment services or supports in order to: 1) understand the barriers and facilitators of 
implementing preventative decision-making practices for IADs and individuals with IDD 
in the workplace; 2) examine the perceptions and acceptability of peer support 
intervention strategies; and 3) develop a perceptual mapping survey instrument based on 
these findings.  

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Perceptual Mapping Survey Development. Once qualitative data is analyzed, we 
will develop a perceptual mapping survey using the themes from the interviews. Surveys 
are constructed using statement blocks with 5 to 7 related statements each. Participants 
indicate how much they agree or disagree with a statement using a 0 to 10 scale 
(0=totally disagree, 10=totally agree). For example, barriers statements may include “I do 
not think I am at risk of getting an infectious airborne disease” or “I don’t trust that 
masks really protect me.” Other statement groups might include facilitators to or beliefs 
about preventive behaviors, such as “I believe that standing six feet from someone can 
protect me”. These surveys are set up to reflect how study elements are conceptualized 
relative to each other and relative to “Self”, based on the mean scores of the group being 
studied. Then perceptual maps are constructed for each block. 
 
Refine peer-support components of the SAFE program intervention and 
assess feasibility and acceptability of program components based on vector 
modeling findings. We will: 1) Conduct surveys with individuals with ASD and or IDD 
working 10 or more hours a week  (n=100); 2) Conduct vector modeling analysis to 
identify: a. acceptable and feasible peer-support strategies and b. messages around 
preventative decision-making processes for airborne diseases in the workplace; 3) 
Concept-test refined strategies and messages with individuals with ASD and IDD 
working 10 hours a week (n=10), vocational rehabilitation staff (n=10), and the project 
Advisory Board (n=10) for feedback on acceptability; and 4) Refine intervention 
materials, fidelity processes and conduct usability testing with the same groups to assess 
potential feasibility of the intervention.    
Perceptual Mapping Survey Analysis and Vector Message Modeling. We will 
be responsible for the analysis of quantitative data from the survey to construct 
perceptual maps. These maps will be created using multidimensional scaling (MDS) 
software developed based on the Galileo system (The Galileo Company, 2018). Input 
associations among the risks/benefits are derived from the inter-item correlations. The 
software then performs a metric MDS analysis and produces graphic arrays of the 
distances among the elements to produce a 3-dimensional map (Figure B). A percentage 
of explained variance is calculated as an index of the explanatory power of the map, 
showing validity of the method. The software is highly valid; if you enter distances 
between American cities into the program, a map that shows the cities in proper relative 
positions to each other, including longitude and latitude, is constructed with very little 
error (SSTRESS = .003). Possible differences in perceptual maps by subgroup will be 
assessed using k-mean cluster analyses. This “segmentation”, usually by psychographic 
variables such as perception variables or demographics (gender, age etc.), is important to 
understand potential perceptual differences by segment.  Should differences exist, maps 
will be generated separately for subgroups to assess whether significant differences 
would impact message design and incorporated into the SAFE program. Surveying 150-
200 people with ASD and IDD should be adequate to do this sub-analysis if needed.  
 
Once perceptual maps are constructed, we will conduct vector analyses to design 
messages that optimize the fit between people with ASD’s perceptual maps and the 
SAFE program intervention content. These messages will be embedded in the 
intervention to help people with ASD and IDD make positive, protection decisions about 
measures that will reduce their risk of IAD transmission. To do this, the software 

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determines optimum strategies to emphasize in a message, including both the positive 
and negative attributes that should be moved and where in the space they should be 
repositioned to “pull” the group (see dotted lines in Figure B) toward the behavior (in this 
case, mask wearing). Mathematically, this defines the “target vector”. This is then used to 
create message strategies to use in an intervention. For this study we will construct maps 
with multiple targeted vectors, including mask wearing, social distancing, and hand 
washing/hand sanitizing. While the construction of the message is left to the researcher, 
the content of the messages is made clear by the modeling. Once these messages are 
constructed, we will integrate them into the existing SAFE program intervention and 
develop processes to evaluate fidelity to the intervention. We will then “concept test” 
these with our advisory board to assess salience, acceptability and understanding.   
 
Concept testing.  To confirm whether the mapping strategies are salient to 
individuals with IDD and/or ASD, we will conduct concept testing with participants 
including working individuals with ASD (n=10) and IDD (n=10), vocational 
rehabilitation staff (n=20), and the project Advisory Board (n=20). The project Advisory 
Board is made up of 10 stakeholders including working individuals with ASD, family or 
caregivers, researchers and staff or administrators from employment service providers. 
We will develop a testing interview guide based on the Feedback Sessions Toolkit80 for 
testing health communication messages. These groups will assess salience, understanding 
and acceptability. All interviews will be audio-recorded and analyzed. Once these 
messages are constructed study staff to integrate messages into the SAFE program 
content.  
 
 
We will collect data using quantitative and qualitative interviews.  We will use surveys to 
obtain demographic, general COVID-19 knowledge, self-advocacy/self-determination 
and workplace safety information.  We will conduct qualitative interviews to determine 
acceptability and feasibility of intervention. Participants will be asked to discuss their 
experiences during the intervention specific to their assigned intervention group. 
 
Potential participants will be provided with an introductory email with the link to 
research staff or administrative contacts of our community contacts identified under 
recruitment methods. Participants support staff will also be contacted with an 
introductory email to identify their role in the research process.  Organizational 
administrators will provide information on the study to individuals that meet the inclusion 
criteria. Interested individuals will contact the project research coordinator to determine 
inclusion and provide consent/assent prior to participation in a qualitative interview or 
focus groups. Research procedures will occur in a format and location convenient for the 
participant. Although in-person interviews are the preferred method, participants can 
engage in the research procedures through audio-video conferencing or other web-based 
platforms. We will complete inclusion, consent and interviews in locations and methods 
that ensure privacy for the participant (e.g., a private room or area available to the 
primary investigators at Temple University, the participants jobsite, or the recruiting 
organization; HIPPA compliant Zoom room). All participants will receive a $25 gift card.  
 

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We will use similar recruitment methods as proposed for the quantitative 
perceptual mapping survey, qualitative interviews and focus groups.  We will leverage 
current relationships with community organizations to recruit 100 participants with ASD 
and or IDD who are employed 10 hours or more a week and receiving employment 
services or supports. Organizational administrators will provide information on the study 
to individuals that meet the inclusion criteria. Interested individuals will contact the 
project research coordinator to determine inclusion. Eligible participants will receive a 
survey link to complete consent and the on line Perceptual Mapping Survey. The 
survey will confirm eligibility again before the consent will appear.  The visible consent 
will highlight key areas including study purpose, procedure, confidentiality, risks and 
benefits, and participants’ rights.  In addition a pdf link will allow participants to see the 
complete consent form before agreeing to participate.  Participants are prompted 
throughout the online survey to check a box if support is needed or they have any 
questions.  If a participant checks this they will then be linked to a research staff member 
to finish completing the consent and/or survey.  The consent/assent from will be 
completed prior to participation. Participants must check that they understand and agree 
to participate in the study prior to the actual survey being open. We will implement data 
collection procedures successfully used in prior studies with individuals with IDD and 
ASD. When participants ask for support research staff will read survey questions out loud 
to the participant and document responses. Participants will have a hard copy of the 
survey and response options in an accessible format to follow along with the verbal 
administration.   
 
 If the participant is assigned to the staff intervention support staff will be contacted with 
an email or phone call.  Staff members will be required to complete human subjects 
training.  Researchers will obtain informed consent for all participants. During the first 
contact made with participants, written information will be provided remotely using 
Zoom/FaceTime or in person to all participants explaining the following in simple terms: 
1) the criteria for participation, 2) the purpose of the research and the procedures 
involved, 3) the subject’s right to withdraw at any time without penalty of any sort, 4) 
potential benefits to the subject, 5) potential risks, 6) assurance of anonymity, and 7) 
terms of remuneration. All research staff will complete training about the informed 
consent process prior to consenting subjects.  The information described above will be 
reviewed and any questions answered. Participants will be obtained signed or a printed 
signature box used for signature when electronic signatures are unable to be obtained for 
consent either in person or virtually.  
 
 
We will collect data from young adults or transitional aged-youth with ASD or IDD to 
determine the efficacy and feasibility of the intervention. Recruitment occurs through the 
sites identified in the participant recruitment section of this proposal. Participants 
interested in the study will contact the primary investigator or research staff who will 
schedule an initial physical or virtual meeting at a place and time convenient for the 
participant to determine inclusion and obtain consent/assent. Participants are randomly 
assigned to either peer-support intervention, staff intervention or a control group. We will 
randomize in blocks of 12 (4 to each group) until we reach the targeted number of 120 or 

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40 participants in each group.  Pre-test and post-test measures will be administered by 
researcher staff prior to the start of the intervention (Pre-test) and at the end of the 
intervention 4 weeks (Post-test ). Key stakeholders, including the participants and 
interventionists (occupational therapists and peer mediators), will complete qualitative 
interviews at the end of the intervention period for each participant. The information 
gathered will determine acceptability and feasibility of intervention. Participants will be 
asked to discuss their experiences during the intervention specific to their assigned 
intervention group.  
 
A member from the research team will then contact interested individuals to set 
up a convenient meeting time and place for the SAFE program training. These meetings 
will occur remotely or in a private location convenient to the participant. The SAFE 
program course training will occur in small group settings or individually. The course 
trainings will occur 2-3 times per week for between 45-60 minutes. An appropriate 
curriculum has been developed by Temple University Researchers and Occupational 
therapy students based on many qualitative interviews, research of proper education 
methods, and COVID-19 practices. The curriculum is based on a series of classes 
designed to create an understanding of best practices and behaviors to prevent the spread 
of COVID-19 in the workplace. The curriculum will be adapted to meet the needs of this 
project and study population.  The course will provides instruction in the following areas: 
1) COVID-19 and how it spreads 2) PPE and How to use it properly 3) Social Distancing 
4) Community Participation 5) Employment 6) Self Efficacy.  
 
Participants will complete the SAFE program sessions remotely or in person in a private, 
quiet and convenient setting.. Participants will be randomized into two treatment arms 
and a control group. The first treatment arm will receive the SAFE program implemented 
through a staff training model. The second group will receive the program using a peer 
support model. The control group will continue to receive their standard vocational 
rehabilitation supports.  
 
Training of the SAFE program will occur remotely or person by staff who are trained 
within our research team or we will implement it in collaboration with staff or a peer 
specialist remotely as part of their current services. If it is in person it will be 
implemented at their vocational rehabilitation centers or places of employment. Research 
staff will be available to support the process after the training is complete.  
 
We will use a questionnaire to assess knowledge of actionable behaviors to prevent 
COVID-19, which reflect the core components of the SAFE program (social distancing, 
proper use of PPE, personal hygiene practices, and self-advocacy in the workplace). We 
will also administer measures to determine the degree of self-advocacy and self-efficacy 
in the work place reported by staff and self-reported by participants. We will determine 
how well a participant follows workplace procedures. Data will be collected either in 
person or virtually both at pre-test and post-test for all outcome measures.  Finally, we 
will assess perceived anxiety. 
 
Phase 2 

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Focus Group Participation 
Recruited and consented participants will take part in focus groups consisting of 5-10 
people. These focus groups will be held in convenient, private locations such as agency 
centers or conducted via Zoom to ensure both accessibility and privacy for all participants. 
During the focus groups, participants will be presented with a summarized and accessible 
version of the SAFE program. After reviewing the material, participants will share their 
experiences, priorities, and concerns, specifically focusing on any important priorities that 
they feel are missing from the current SAFE program curriculum. Research staff will 
facilitate these discussions. Each session will be recorded and transcribed using Zoom built 
in features to accurately capture the data. Focus groups will last no longer than two hours. 
Participants will be compensated $30 for their participation. 
 
Content Development for the SAFE Program 
• Once the focus group analysis is completed, research staff will proceed with the creation of 
new content for the SAFE program. The team will draft educational materials that address 
the priorities identified during the focus groups. The draft content will undergo a rigorous 
review process through an advisory board involving subject matter experts, stakeholders, 
and individuals with lived experiences to ensure the content's accuracy and relevance. Five 
to ten stakeholders will review the new content developed for the SAFE program. They 
will receive the newly developed content and provide feedback on its accessibility, 
clarity, and overall engagement. The content will be sent via email, and stakeholders 
will be asked to provide their feedback either through email or during a scheduled 
group Zoom meeting.  
Based on the feedback received, research staff will make any necessary revisions to ensure 
the materials are both effective and accessible. 
Once finalized, the new content will be integrated into the existing SAFE program 
materials. Research staff will adapt the content into various formats, including written 
guides, videos, and infographics, to meet the diverse learning needs of participants. 
 
Pilot Testing for Service Providers 
• Research staff will recruit 5-10 staff members from a large service provider organization to 
participate in pilot testing of the training materials. This pilot testing will occur over a 1-2 
month period, during which staff will be trained on the new SAFE materials and additional 
content. The trainings will occur using Zoom meetings. The training sessions will be 
conducted either in groups or individually, depending on scheduling availability. Feedback 
will be collected from participants through surveys, interviews, or debriefing sessions to 
evaluate the effectiveness of the training. The training feedback will be audio recorded to 
ensure that we capture all important information you share. The audio recordings will be 
transcribed by the project team using Zoom's transcription feature. By signing the consent 
form, you are giving permission to be recorded. 
• 
Only people working on this project will have access to the recordings. 
• 
Information and transcripts will be stored securely in locked filing cabinets or on 
password-protected computers. 
Based on this feedback, research staff will refine the training materials and curriculum, 
making necessary adjustments to improve clarity, accessibility, and applicability. These 

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trainings will not be recorded. Feedback will only be collected using FIM surveys, AIM 
surveys and exit interview. 
 
Once these refinements are complete, the finalized curriculum will be prepared for broader 
implementation within service-based organizations that support individuals with IDD. 
Participants will receive $50 for the training. Participant will receive $25 after the first 
training sessions and an additional $25 after completion.  
 
Data Analysis. Descriptive statistics including mean, median, standard deviation, 
skewness, frequencies, and percentages will be computed on demographic and measures 
as appropriate. We will complete ANOVAs to determine if there were significant 
changes in scores on outcome measures within and between groups. We will use SPSS to 
complete the analyses.  
 
Qualitative data analysis will utilize the Kruegar method of analyzing narrative 
data: familiarization, identifying a thematic framework, indexing, charting, mapping and 
interpretation.75 We will use the cross-platform app, Dedoose,76 for analysis. Transcribed, 
verbatim digital recordings of focus groups and interviews will be read by study staff to 
become familiar with what participants said. A thematic framework will be developed to 
create categories and quotes and will be indexed according to categories to reduce data. 
Charting of quotes to enable analysis will then occur.77 During the indexing/coding steps, 
data will be coded by at least 2 coders and intercoder reliability rates will be randomly 
assessed. Once this is achieved, interpretation of the thematic framework and supporting 
quotes will be conducted, accessing context, internal consistency, frequency of 
comments, specificity of comments, intensity of comments and “big ideas” (Krueger, 
Casey 2000). Results will inform survey development.   
 
Measures 
We anticipate that some of the participants will need assistance to complete the 
assessments (i.e. reading questions, marking answers). Researchers, family or support 
persons will provide assistance as needed.  
 
Qualitative Data collection- Qualitative interviews will be administered prior to the SAFE 
program completion remotely or in person, 1:1 and privately.  The interviews will be 30 
minutes and will be completed in one meeting.  Individual interviews will be completed 
by one of the primary investigators, research assistant, or OT graduate student and will be 
audio recorded and transcribed for further review. Transcriptions will be cross checked to 
ensure accuracy.  Each person facilitating the interviews will use guiding questions 
determined by the research team and practice interview techniques prior to implementing 
interviews. There will be one interview per participant completed.  
 
Qualitative interviews will be transcribed and cross-checked. Per the methods described 
by Creswell and Plano Clark (2011), qualitative data will be analyzed using constant 
comparison. Specifically, transcripts will be coded (i.e., horizontalization) and collapsed 
into clusters of meaning (i.e., themes) by at least 3 analysts. Analysts will 1) meet to 

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review codes, 2) identify areas of disagreement, 3) recode data until consensus is reached, 
and 4) collapse initial codes into a preliminary framework of interrelated themes. The 
transcripts will be reanalyzed until a final thematic structure is reached. The research 
team will implement a number of methodological actions to strengthen the data collection 
process and trustworthiness including reflexivity, triangulation, and stakeholder checks.  
 
Demographics and Potential Moderators.  
The research team, primary investigators or research assistant, will collect demographic 
data including age, gender, ethnicity, education, type of area lived in, and primary and 
other diagnosis. The demographic form is completed only during pre-test data collection. 
Additionally, we will track participants who acquire an infectious airborne disease (IAD) 
during the course of participation in the study. This is not considered a primary outcome 
as we are not able to incorporate contact tracing within the scope of this project. 
Therefore, it is unlikely that we can confidently identify whether the participant acquired 
the IAD in the workplace.  We will rely on self or caregiver report to acquire this 
information. The process of collecting this information will help in determining if it is 
feasible to include this as an outcome in future research. 
 
Primary Outcomes Measure will be collected by the research team, primary 
investigators or research assistant.  
Workplace Health and Safety Assessment.  The Workplace Health and Safety 
Assessment assesses both knowledge and actionable behaviors participants exhibit to 
prevent IADs. The items for the tool were developed from recommendations provided by 
the CDC to reduce exposure to IADs including use of personal protective equipment, 
personal hygiene and social distancing. The assessment includes 20 items and takes 
approximately 15-20 minutes to complete through both administrator observations in the 
workplace environment (8 items) and questions completed by the participant (12 items). 
Response options are “rarely, never, sometimes, most of the time, always” and are scaled 
from 1 to 5 respectively.  A total raw score is provided for data analysis. 
 
PROMIS General Self-Efficacy Item Bank. This measure assesses a person’s belief in 
their capacity to manage daily stressors and have control over meaningful events. 
Participants will complete the 10-question tool which is designed for people 18 years and 
older. It has established acceptable reliability and validity.81 The responses are on a 5 
point scale from “I am a little confident” (1) to “I am very confident” (5) with higher 
scores reflecting greater general self-efficacy. A total standard T-score will be used to 
analyze the data.  
 
VocFit Safety Subscale.  The VocFit is an assessment tool used to measure the best fit 
for a worker with a job.8 The tool was specifically developed for individuals with 
developmental disabilities and has strong psychometric properties for this population.82 
The VocFit safety subscale consists of 8 questions asking to what degree the participant 
demonstrates the ability to engage in safety protocol at their employment.  The tool 
identifies the degree to which the participant is able to follow safety protocols and 
precautions in their work setting.  The response options include “high”, “some”, and 
“low”.  

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Workplace Health and Safety Self-Advocacy Scale (WHSSS). This measure was 
adapted from employment-centered items on the Self-Determination and Self-Advocacy 
Questionnaire, which assesse the degree of self-advocacy in the workplace as reported by 
staff and self-reported by participants. The measure has ten question and takes 5-10 
minutes to complete. The modified WHSSS assesses the skills used to advocate for 
preventative practices for IADs in the workplace and the degree to which the person uses 
these skills. The response options range from “none of the time” (1) to “all of the time.”  
 
Perceptual Survey Items. To assess perceptions of IADs and protective behaviors, we 
will utilize the perceptual mapping items developed in the formative phase. These will be 
determinmed at baseline and the one-month follow-up to see if perceptions have changed 
based on intervention content. We will be able to compare perceptual maps of 
interventions groups to see if specific messaging affected the relationship between the 
group and the target protective behavior. 
 
NIH Toolbox Item Bank/Fixed Form v2.0 – Perceived Stress (Ages 18+). This measure 
assesses “perceptions about the nature of events and their relationship to the values and 
perceived coping resources of an individual” for adults 18 years and older. This self-
report measure has 14 items with a response range from “Never” (1) to “Very Often” (5). 
Higher scores reflect greater levels of perceived stress. The tool has established 
acceptable reliability and validity. A total standard T-score will be used to analyze the 
data. 
 
PROMIS Item Bank v1.0 – Anxiety Short Form 8. This measure assesses anxiety for 
adults 18 years and older. This self-report measure has 8 items with a response range 
from “Never” (1) to “Very Often” (5). Higher scores reflect greater levels of anxiety. It 
has established acceptable psychometrics and is sensitive to change.  A total standard T-
score will be used to analyze the data. 
 
Acceptability of Intervention Measure (AIM) and Feasibility of Intervention Measure 
(FIM). These measures were developed concurrently as the constructs are highly related. 
The AIM measures the acceptability of the intervention defined as “the perception among 
stakeholders that a given intervention is agreeable, palatable, or satisfactory” (Weiner et 
al., 2017). The FIM measures the feasibility of the intervention as defined as “the extent 
to which a new intervention can be successfully used or carried out within a given agency 
or setting (Weiner et al., 2017). Both tools demonstrated substantive and discriminant 
content validity and moderate to good test/re-test reliability. Preliminary research 
identified that the tools are sensitive to change in either direction. The tools take less than 
5 minutes to complete and have a Flesch reading ease score at a 5th grade level. Response 
options range from completely disagree (1) to completely agree (5) with higher scores 
indicating greater acceptability or feasibility. A total raw score is provided.  
 
Feasibility Data. The research team will evaluate the feasibility of the intervention and 
research methodology. Methods and benchmarks for evaluating feasibility include 
recruitment and retention rates, data about assessment procedures, feasibility survey 

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questionnaires, and qualitative exit interviews of interventionists and 
participants.Theparticipants and  will complete the Acceptability of Intervention measure 
(AIM) and the interventionist the Feasibility of Intervention Measure (FIM) at post-test 
1.   
 
In Phase 2, feasibility data will be collected exclusively by the staff completing the 
SAFE curriculum training. They will assess how feasible and acceptable the SAFE 
program, including the new lesson, is for their clients or students. This phase will not 
involve a pilot study with participants. 
 
 
c) Withdrawal of Subjects 
Participation is voluntary and there is no penalty if a person chooses not to join the 
research study. They will continue to receive services as usual. If a person enrolls in 
the study and later chooses to withdraw from the study, they may do so at any time 
without any penalty. They can withdraw from the study by contacting the primary 
researcher through telephone or email.  
 
d) Privacy & Confidentiality 
The study team has placed safeguards to maintain the confidentiality of participants’ 
personal information.  
Phase 1: Personal information will be kept electronically in password protected files 
and hard copies will be stored in locked cabinets at the TU Collaborative on 
Community Inclusion, located at 1913 North Broad Street, Mitten Hall, Philadelphia. 
Except for the legal requirements described below, only research staff will have 
access to personal information.  By law, however, the Temple University Institutional 
Review Board (IRB), National Institute of Disability, Independence Living and 
Rehabilitation Research (NIDLRR), the Office for Human Research Protections, and 
the Philadelphia Department of Public Health IRB, are required to have access as 
well. Study files will be kept for seven years after the last publication of the data. Any 
information about child abuse or intent to harm oneself or others will be reported to 
authorities, as is required by law. Efforts will be made to limit personal information 
access to people who have a need to review this information.  
Phase 2: Personal information will be kept electronically in password protected files 
and hard copies will be stored in locked cabinets at the Reach Lab, located at 1913 
North Broad Street, Mitten Hall, Philadelphia. Except for the legal requirements 
described below, only research staff will have access to personal information.  By 
law, however, the Temple University Institutional Review Board (IRB), and PA 
Department of Health, , are required to have access as well. Study files will be kept 
for seven years after the last publication of the data. Any information about child 
abuse or intent to harm oneself or others will be reported to authorities, as is required 
by law. Efforts will be made to limit personal information access to people who have 
a need to review this information.  
 
 

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All research funded by NIDILRR falls within the ACL requirements for public access 
to scientific data. The data must be publicly available no later than 24 months after 
award’s end date. Data must be stored in such a way that enables retrieval and use at 
no cost to users. All scientific data resulting from a NIDLRR award must be 
made publicly available. Each data set must have a Digital Object Identifier (DOI) 
for future reference and citation. Final Report must include DOIs and data release 
date. The data will be deposited in Inter-university Consortium for Political and 
Social Research (ICPSR).  All data will be de-identified before it is deposited. ICPSR 
is the preferred repository for NIDILRR-funded research. Within Institute for 
Social Research at the University of Michigan. Established in 1962. ICPSR contains 
over 10,000 achieved studies. This does not apply to Phase 2 of the study as it is not 
funded by NIDILLR . 
 
 
The study does not use or disclose participants’ Protected Health Information and 
therefore a HIPPA Authorization Form is not included in this proposal. 
 
All information gathered about participants for this study is confidential, except as 
may be required by law. For example, confidentiality would not be honored if a 
person expressed a current plan to harm themselves or others, or if they report they 
have committed child abuse or neglect. Completed interviews will contain a coded 
identification number to prevent loss of confidentiality. Confidentiality of data files 
will be achieved by separating code numbers from individual identifying information. 
Information taken about participants will be kept electronically only in password 
protected files on an encrypted network and hard copies will be stored in locked 
cabinets.  Research investigators will be the only people with access to this data, with 
the exception of authorized representatives of the Temple University Institutional 
Review Board (IRB), who are required to have access by law. For phase 2, No hard 
copies will be retained. If a person is unable to sign electronically and a physical 
signature is required, the document will be scanned, stored as a PDF in the 
confidential digital system, and the hard copy will be destroyed.Protected health 
information will not be collected for participants during the qualitative interviews.  
Participant contact information will always be kept separate from the data. Participant 
information will be password protected and stored on an encrypted network. 
Whenever feasible, identifiers will be removed from study-related information.  All 
published reports will contain data reported either in aggregate form (where no 
individual responses can be identified), or in composite individual examples that are 
constructed so that identification is impossible.   
During the consent process, individuals will be informed that they can stop the 
interview at any time should they feel uncomfortable.  They will also be told that they 
do not have to answer any question that they do not want to answer. All data will be 
assigned a number for data management purposes. Data collected from participants 
will only be kept electronically in password-protected files on an encrypted network.  
Research investigators will be the only people with access to this data, with the 
exception of authorized representatives of the Temple University Institutional Review 

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Board (IRB), who are required to have access by law. All published reports will 
contain data reported either in aggregate form (where no individual responses can be 
identified), or in composite individual examples that are constructed so that 
identification is impossible.   
 
 
11) Risks to Subjects 
Participants will receive the SAFE program training and may interact with peers, 
occupational therapists, community members, and researchers directly.  This 
interaction may be perceived as stressful for the participants, especially for the 
participants who have social and communicative challenges.  Participants do not need 
to answer any questions that make them uncomfortable. Participation in the study 
requires a commitment of a 4 week time period for the course and additional time for 
inclusion and consent processes.  
 
12) Potential Benefits to Subjects 
There are direct benefits to participating in the study. Participants will contribute to 
society through the knowledge gained in the research process in an area that is 
meaningful and important to them. After participants have completed the SAFE 
program, participants will have gained knowledge and behaviors to assist them as 
they work and properly implement safety precautions and procedures.  Participants in 
Phase 1 will receive a $25 gift card electronically or in person when the qualitative 
interview or focus group is complete. Participants in Phase 2 will receive a $30 gift 
card electronically or in person when the qualitative interview or focus group is 
complete. Participants will receive $20 gift card electronically or in person if they 
complete the quantitative survey.  Participants invited to be a part of the intervention 
will receive a $50 gift card electronically or in person when complete. Staff 
completing the SAFE pilot training for future implementation will receive $50 
electronic gift card.  
 
13) Costs to Subjects 
There are no anticipated costs associated with participation in the study.  
 
14) Informed Consent  
All adult participants in the study will provide informed consent. Consent will be 
obtained remotely and through electronic signatures until it is safe to meet one on one 
with participants.   Individuals will meet remotely with research staff to review and 
obtain informed consent in REDCAP via a zoom meeting or comparable. The primary 
investigator or a research assistant will obtain informed consent and when needed assent 
when possible for each participant. The research assistant will obtain training in the 
consent process to ensure that there is no coercion and proper procedures are followed. 
During the first contact made with adult participants (either in person, electronically, or 
over the phone), written information will be provided in person or through electronic 
formats. Researchers will explain the following in simple terms to all participants: 1) the 
criteria for participation, 2) the purpose of the research and the procedures involved, 3) 
the subject’s right to withdraw at any time without penalty of any sort, 4) potential 

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benefits to the subject, 5) potential risks, 6) assurance of anonymity, and 7) terms of 
remuneration. Although it is anticipated that many participants will be able to provide 
informed consent, a process for obtaining informed consent from a legally authorized 
representative (i.e. parent, caregiver, or another individual with legal guardianship) and 
assent from the participant will be used if the individual is under guardianship or not able 
to provide consent. Some participants may not have a legally authorized representative.  
In those cases investigators will take special care for all participants who have an 
intellectual or developmental disability to ensure that participants understand the consent 
process by going over the information slowly with them and asking them to repeat back 
to the investigator each aspect of the consent process. Accommodations will be made to 
ensure that communication between the participant and the investigator is as clear as 
possible (i.e., use of sign language interpreter, assistive communication devices as 
needed). 
 
The following format will be used to obtain informed consent/assent process and to 
assess each potential participants understanding of that to which they are agreeing.  
 (A) Each potential participant will be provided with a copy of the informed 
consent/assent form and askes to read the form. 
(B) Each section of the form will be read to the potential participant if they are an 
individual with a disability.  
(C) When an individual has completed reading through each section of the form or the 
section of the form has been read to them, they will first be asked if they have any 
questions. Once these general questions have been answered, those individuals obtaining 
consent/assent will ask the following questions to ensure comprehension of content: 
(1) Please tell me what you will be asked to do if you take part in this study? 
(2) Tell me what might go wrong or the potential risks/negative things that might happen 
to you if you take part in this study? 
(3) If you do not want to take part in the the study what will happen? 
(4) If you say "yes" you want to be a part of the study, but change your mind, what can 
you do? 
(5) What can you do if someone asks you a question as part of the study that you do not 
feel comfortable answering? 
(6) Will the people running the study share information they get from you with anyone 
else? 
(7) How will the people running the study keep the information you provide them private 
or confidential? 
(8) Who can you call or tell if something you don't like happens during the study?  
(9) What do you remember about what I told you about the study? 
 
Phase 1: If the person is not able to accurately answer the questions above, they will not 
be able to participate in the study unless there is a parent or legal representative that can 
provide consent. If the person has a parent or representative, then researchers will attempt 
to obtain assent. Informed consent from parents or guardians will be obtained for all 
participants under the age of 18.  

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Informed consent is obtained by the participant or the legally authorized representative 
signing the informed consent form. The research specialist will read the assent form to 
the adult participant who cannot provide informed consent and obtain a signature, verbal, 
or non-verbal indication of consent from the participant. If the person is not able to 
complete a signature, the research specialist will document on the assent form if the 
person provided verbal assent or how non-verbal assent was provided. Individuals who 
are not able to provide assent will not be included in the study, as identified in the 
inclusion/exclusion criteria. We will follow the policy “Legally Authorized 
Representatives Children and Guardians (HRP-021)” to guide procedures to obtain 
consent for adults who are not able to provide consent.  
 
Phase 2: If individuals are unable to answer the questions in the section above, they will 
be excluded from Phase 2. 
 
All participants will receive a copy of the signed or electronic version of the consent form 
and assent form if applicable. Please see attached Informed Consent Forms and Assent 
Form. 
 
15) Vulnerable Populations 
For Phase 1, some of the adult participants may have cognitive impairments, which 
would require informed consent to be obtained by a legally authorized representative. For 
these individuals, assent will also be obtained through written, verbal or non-verbal 
methods as described above. Phase 2 will not enroll any participant who cannot provide 
consent.  
 
Adolescents and adults with developmental disabilities are the population for the study. 
This population is at risk for decreased access to health and employment services, along 
with reduced community participation and therefore is the targeted population for 
inclusion in the study. No pregnant women or prisoners will participate in the study.