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Developmental DisabilityD2/R3NCT07220837

Online Learning Module to Advance Research Related to People With Disabilities

A study testing eLearning module in people with Developmental Disability and Intellectual Disability, run by Albert Einstein College of Medicine at 1 site in United States.

Completed

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

Official record
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Trial summary

This study will measure the effects of a brief one-time eLearning intervention on researcher Knowledge, Attitudes, and Perceptions (KAP) of including people with disabilities (PWDs) in biomedical \& behavioral research. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
eLearning module
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteUnited States
Study dates
16 Dec 2025to 15 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

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

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Aged >=18
  • Conducts non-disability focused research (in the past 3 years)
  • Conducts (primarily) research with/on adults
  • Affirms their understanding that eligibility and data must pass quality assurance checks before compensation is disbursed

Who cannot join

  • Participant in Aim1/Aim2 of D2/R3 study
  • Respondent fails to provide a valid US-based personal institutional email

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Albert Einstein College of Medicine

    The Bronx, New York, 10461

Other trials in United States

About this study

Official title: Randomized Control Trial (RCT) of Online Learning Module to Advance Research Related to People With Disabilities (D2/R3)

This study will measure the effects of a brief one-time eLearning intervention on researcher Knowledge, Attitudes, and Perceptions (KAP) of including people with disabilities (PWDs) in biomedical \& behavioral research. Researchers will be recruited from across the Einstein/Montefiore network, and other medical centers with a focus on CTSAs.

Read the detailed description

According to the Centers for Disease Control and Prevention (CDC), 1 in 4 adults in the U.S. has a disability, approximately 29% of the overall population. Adults with (vs. without) disabilities have higher rates of obesity (41.6% v. 29.6%), smoking (21.9% v. 10.9%), heart disease (9.6% v. 3.4%), and diabetes (15.9% v. 7.6%), and lower rates of preventive care (e.g., mammograms, cervical cancer screening).

Disability may present as salient to others or be non-visible (e.g., autism, Long COVID). Non-visible disabilities comprise 70-80% of all disabilities; robust data finds stronger negative attitudes towards non-visible (vs. visible) disabilities.

People with Disabilities (PWDs) are under-represented in health research. Reasons include: a) structural elements of research: poorly justified exclusion criteria, PWDs not designated as a vulnerable group, b) access barriers: physical, sensory, literacy; and c) PWDs skepticism due to researcher bias, lack of perceived benefit, focus on cure vs. quality of life. Data on provider attitudes towards people with disabilities (PWDs) is scant.

KAP of barriers and benefits are modifiable roadblocks to including PWDs in research. The research team will develop and test tools to increase researcher motivation and capacity to mitigate perceived barriers. For Aims 1 and 2 of D2/R3, the research team engaged the 10 US sites (Einstein is one) that are Clinical and Translational Science Awards (CTSAs) and Intellectual and Developmental Disabilities Research Centers (IDDRCs) for basic/clinical research and University Centers of Excellence in Developmental Disabilities (UCEDDs).

Timeliness - This study is timely and novel as the perception of disability in research settings has shifted in recent years. Made apparent by the NIHs designation of PWDs as a health disparities population and changes to the Research, Condition, and Disease Categories (RCDCs) (i.e., disability research is now included on the list).

This registration is exclusive to Aim 3 of the D2/R3 study.

Being tested
eLearning module, Control
Keywords
Bias, Attitudes, Perceptions, Inclusion, Translational Science, Representation
Medical subject headings
Developmental Disabilities, Intellectual Disability, Behavior

What participants receive

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

  • eLearning moduleOther

    • Baseline pre-survey (15 minutes)
    • Baseline learning module (30 minutes)
    • Baseline post-survey (15 minutes)
    • Follow-up survey (3-4 weeks later)

    Components of KAP survey:

    Demographics-research experience/role, disability status, exposure to PWDs, etc. (baseline pre-survey only; e.g. not asked at post follow-up survey) Knowledge-short-answer, clinical scenarios, items focused on historical/legislative context, etc.

    Attitudes-validated "Attitudes to Disability Scale" (ADS) developed by a World Health Organization (WHO) working group Perceptions-questions developed by Prosci's Awareness, Desire, Knowledge, Ability, Reinforcement (ADKAR) framework.

  • ControlOther

    Also called Disability Statistics Training

    Disability Statistics Training (University of New Hampshire Link). Modules identify disability data sources via US surveys and measurement hurdles in disability research:

    1. Module 2/Topic 1 (13m:44s):

    Operationalization of Disability in Surveys- covers the two common operationalization methods, the 6 Question Sequence (6QS) and the Washington Group Short Set (WGSS), and the challenges of collecting disability data

    1. Module 3/Topic 1 (13m:48s):

    Disablement Models- conceptually defines models, such as Nagi's Disablement Model, Work Disability, Verbrugge and Jette, and WHO's Definition.

Study groups in NCT07220837
Study groupRoleWhat they receive
eLearning moduleExperimentalParticipants (n=100) will view one interactive 30-minute module aimed at increasing KAP of including PWDs in research.
Receives: Other: eLearning module
ControlOtherParticipants (n=100) will view two 15-min modules (total~30 mins) one focusing on disability data sources and the other on the medical/social model of disability. Participants will retake the KAP survey again immediately after completing the 2 modules.
Receives: Other: Control

What is being measured

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

  1. Change in Attitudes Towards Disability

    Change in Attitudes will be assessed using the 16 item Attitudes to Disability Scale (ADS). Scoring range on a 5-point Likert scale ranging from 1-5, yielding an overall possible scoring range of 16-80. Participants for whom a single item is inapplicable (i.e., N/A) will have data removed for that item. Lower scores indicate less favorable attitudes towards people with disabilities, while higher scores indicate more favorable attitudes.

    *Note: Questions 1-6 \& 11-16 are reverse coded.

    Measured: Pre-intervention at baseline and 3-4 weeks post intervention

Secondary outcomes (2)

  1. Change in Knowledge Scores

    Change in Knowledge scores from baseline will be assessed using a 10 item multiple choice scale which assesses how disability is conceptualized, historical and legislative context, etc. Scoring range: 0%-100%, whereby the percentage correct indicates comprehension towards factual items and best practices for engaging people with disabilities. Questions 4, 8, and 10 can be scored for partial credit. Percentage correct scores will be summarized by study arm.

    Measured: Pre-intervention at baseline and 3-4 weeks post intervention

  2. Change in Perception Scores

    Change in Perception from baseline will be assessed using a 17 item Change in Perception scale. Scores are based on 5 domains (i.e. Awareness, Desire, Knowledge, Ability, Reinforcement). Scoring range for each domain includes: Awareness (1-5), Desire (2-10), Knowledge (4-20), Ability (4-20), Reinforcement (6-30). An overall composite score of 17-85 for all 5 of these domains. Participants for whom a single item is inapplicable (i.e., N/A) will have data removed for that item. Higher scores indicate greater awareness of, willingness and motivation to include, understanding about, ability to include, and reinforcement of inclusive behavior, respectively, regarding inclusion of people with disabilities in research.

    Measured: Pre-intervention at baseline, and 3-4 weeks post intervention

Timeline

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

  1. First posted24 Oct 2025
  2. Study start16 Dec 2025
  3. Primary completion15 Jun 2026
  4. Study completion15 Jun 2026

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Assignment RCT with block randomization by research team role within each arm: * n=65 Principal or Co-investigators * n=35 other study personnel (i.e. coordinator, interventionist, etc.) Participating researchers (n=200) will be randomly assigned to either of 2 arms (i.e. Experimental- eLearning module or Control- module on disability data sources). Participants will begin their respective intervention modules after completing the baseline KAP survey.
Masking
Single blind
Who is masked
Participant
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07220837
Sponsor's protocol ID
2025-17152
Other IDs
1UM1TR004400, 2025
Acronym
D2/R3
Status last verified
Jul 2026
First submitted
18 Sep 2025
Last updated
14 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: After results are reported in a peer-reviewed manuscript on the trial outcomes all data (i.e. metadata, documentation, protocols, measures) will be shared and associated with the datasets.

Publications

  • Centers for Disease Control and Prevention. Disability and Health Data System (DHDS). In:2023.

  • Granjon M, Pillaud N, Popa-Roch M, Aubé B, Rohmer O. Attitudes towards invisible disabilities: Evidence from behavioral tendencies. Current Research in Behavioral Sciences. 2025;8:100164.

  • Bonuck K, Fishman A. Reducing translational science roadblocks to disability research. J Clin Transl Sci. 2025 Jun 9;9(1):e174. doi: 10.1017/cts.2025.10073. eCollection 2025.

    PubMed 40979104

  • Havercamp SM, Krahn GL, Larson SA, Fujiura G, Goode TD, Kornblau BL; National Health Surveillance for IDD Workgroup. Identifying People With Intellectual and Developmental Disabilities in National Population Surveys. Intellect Dev Disabil. 2019 Oct;57(5):376-389. doi: 10.1352/1934-9556-57.5.376.

    PubMed 31568737

  • Schieve LA, Gonzalez V, Boulet SL, Visser SN, Rice CE, Van Naarden Braun K, Boyle CA. Concurrent medical conditions and health care use and needs among children with learning and behavioral developmental disabilities, National Health Interview Survey, 2006-2010. Res Dev Disabil. 2012 Mar-Apr;33(2):467-76. doi: 10.1016/j.ridd.2011.10.008. Epub 2011 Nov 24.

    PubMed 22119694

  • Maenner MJ, Shaw KA, Bakian AV, Bilder DA, Durkin MS, Esler A, Furnier SM, Hallas L, Hall-Lande J, Hudson A, Hughes MM, Patrick M, Pierce K, Poynter JN, Salinas A, Shenouda J, Vehorn A, Warren Z, Constantino JN, DiRienzo M, Fitzgerald RT, Grzybowski A, Spivey MH, Pettygrove S, Zahorodny W, Ali A, Andrews JG, Baroud T, Gutierrez J, Hewitt A, Lee LC, Lopez M, Mancilla KC, McArthur D, Schwenk YD, Washington A, Williams S, Cogswell ME. Prevalence and Characteristics of Autism Spectrum Disorder Among Children Aged 8 Years - Autism and Developmental Disabilities Monitoring Network, 11 Sites, United States, 2018. MMWR Surveill Summ. 2021 Dec 3;70(11):1-16. doi: 10.15585/mmwr.ss7011a1.

    PubMed 34855725

  • Zablotsky B, Black LI, Maenner MJ, Schieve LA, Danielson ML, Bitsko RH, Blumberg SJ, Kogan MD, Boyle CA. Prevalence and Trends of Developmental Disabilities among Children in the United States: 2009-2017. Pediatrics. 2019 Oct;144(4):e20190811. doi: 10.1542/peds.2019-0811.

    PubMed 31558576

  • Karpur A, Vasudevan V, Shih A, Frazier T. Brief Report: Impact of COVID-19 in Individuals with Autism Spectrum Disorders: Analysis of a National Private Claims Insurance Database. J Autism Dev Disord. 2022 May;52(5):2350-2356. doi: 10.1007/s10803-021-05100-x. Epub 2021 May 26.

    PubMed 34041682

  • McDermott S, Royer J, Cope T, Lindgren S, Momany E, Lee JC, McDuffie MJ, Lauer E, Kurtz S, Armour BS. Using Medicaid Data to Characterize Persons With Intellectual and Developmental Disabilities in Five U.S. States. Am J Intellect Dev Disabil. 2018 Jul;123(4):371-381. doi: 10.1352/1944-7558-123.4.371.

    PubMed 29949427

  • Fujiura GT, Li H, Magana S. Health Services Use and Costs for Americans With Intellectual and Developmental Disabilities: A National Analysis. Intellect Dev Disabil. 2018 Apr;56(2):101-118. doi: 10.1352/1934-9556-56.2.101.

    PubMed 29584559

  • Barth S LS, Simmons T,. Medicaid Services for People with Intellectual or Developmental Disabilities - Evolution of Addressing Service Needs and Preferences 2020.

  • Centers for Disease Control and Prevention, National Center on Birth Defects and Developmental Disabilities, Disability. Disability and Health Data System (DHDS) Data . Centers for Disease Control and Prevention; 2021.

  • Rios D, Magasi S, Novak C, Harniss M. Conducting Accessible Research: Including People With Disabilities in Public Health, Epidemiological, and Outcomes Studies. Am J Public Health. 2016 Dec;106(12):2137-2144. doi: 10.2105/AJPH.2016.303448. Epub 2016 Oct 13.

    PubMed 27736212

  • National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Population Health and Public Health Practice; Committee on Community-Based Solutions to Promote Health Equity in the United States; Baciu A, Negussie Y, Geller A, Weinstein JN, editors. Communities in Action: Pathways to Health Equity. Washington (DC): National Academies Press (US); 2017 Jan 11. Available from http://www.ncbi.nlm.nih.gov/books/NBK425848/

    PubMed 28418632

  • Swenor B, Deal JA. Disability Inclusion as a Key Component of Research Study Diversity. N Engl J Med. 2022 Jan 20;386(3):205-207. doi: 10.1056/NEJMp2115475. Epub 2022 Jan 15. No abstract available.

    PubMed 35029848

Questions about this trial

What is this clinical trial studying?

A study testing eLearning module in people with Developmental Disability and Intellectual Disability, run by Albert Einstein College of Medicine at 1 site in United States.

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

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

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

What does the primary outcome measure?

Change in Attitudes Towards Disability (time frame: Pre-intervention at baseline and 3-4 weeks post intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07220837, which also lists 16 linked publications.

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

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

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.

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