Autism DisorderRAISENCT07054866
Rural Autistic Individuals - Supporting Expression
A study testing Speech-Gesture combinations in people with Autism Disorder and Language Development Disorders, run by Montana State University at 1 site in United States.
Trial summary
This research study investigates how hand gestures can support language comprehension and communication skills of hearing speaking, non-speaking, and/or minimally verbal individuals with Autism Spectrum Disorders (ASD), who are especially disadvantaged by the lack of accessible services in their rural communities. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autism Disorder, Language Development Disorders, ADHD
- What is being tested?
- Speech-Gesture combinations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to Dec 2027
- Phase
- Interventional
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 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 1.1 Confirmed (preferably) or suspected diagnosis of ASD (autism spectrum disorder), or a receptive language impairment (i.e., difficulties with comprehension, Developmental Language Disorder), or both. Additional diagnoses, including ADHD (Attention Deficit and Hyperactivity Disorder), are acceptable. Siblings and cousins of these individuals are also welcome.
- OR 1.2 No diagnoses of ASD or DLD for unrelated control typically-developing participants.
- 2. Normal hearing and normal vision (or corrected to normal with glasses or contacts).
- 3. Ages 2+. 4. English as the dominant language of caregivers. 5. Caregivers who self-identify as living in a rural area. 6. The ability to verbally or physically respond is optional.
Who cannot join
- 1. Poor hearing. 2. Inborn or acquired brain damage.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Montana State University
Bozeman, Montana, 59717
Nadya Modyanova, Ph.D., 406-848-1535, language-research@montana.edu
About this study
This research study investigates how hand gestures can support language comprehension and communication skills of hearing speaking, non-speaking, and/or minimally verbal individuals with Autism Spectrum Disorders (ASD), who are especially disadvantaged by the lack of accessible services in their rural communities. Individuals with other cognitive profiles, including Developmental Language Disorder (DLD), ADHD, Dyslexia, and others are welcome too. The study uses methods of eye tracking and recording of brain activity to understand how hand gestures adapted from signs from American Sign Language, such as [cry], can promote successful understanding of words like "cry". The overarching goal is to help families effectively utilize gestures to support communication with their children.
Read the detailed description
The investigators are researching how hand gestures and signs from American Sign Language influence language comprehension, and whether gestures/signs can support communication in children and adults with social and language impairments.
The investigators use non-invasive brain imaging methods (skin-contact only). One is EEG - electroencephalography - which records electrical brain activity on scale of milliseconds. Another is fNIRS (functional near infrared spectroscopy) which shines infrared light through scalp and measures blood flow to the brain areas which are more active during a task. The researchers employ a protocol that uses both neuroimaging methods at the same time. This involves wearing a cloth helmet, and having a lot of wires attached to the surface of the helmet. The EEG wires need gel to be put into hair to pick up the brain signal.
For psychological measurements, there are three rounds of tasks. One set of tasks about language and gestures happens as passive viewing of a computer screen with pictures of common objects and videos of a person gesturing and speaking. For example, see a picture for a dog, and hear "dog", and see gesture for "dog". There's no response required here.
Another set of tasks is in picture books to evaluate language comprehension and IQ for solving puzzles, if the participant has capacity to engage with the picture books, if not - that's optional.
Third task is 3-5 questionnaires for adults/caregivers about demographics, diagnoses (if any), experience with services, and autism, ADHD, and communication.
All together the study takes at least 2-3 hours of research time per participant, plus breaks. Both children and adults are welcome participate.
- Conditions
- Autism Disorder, Language Development Disorders, ADHD, Typical Development, Rural Health, Children
- Being tested
- Speech-Gesture combinations
- Medical subject headings
- Autistic Disorder, Language Development Disorders, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speech-Gesture combinationsBehavioural
this is a pretest, test, posttest evaluation of language comprehension with and without gestures, to see if gestures can improve language comprehension
| Study group | Role | What they receive |
|---|---|---|
| Language Evaluation | Experimental | Not described Receives: Behavioral: Speech-Gesture combinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG/ERP brain response
In a pretest-test-postest set up, the researchers measure participants' EEG/ERP (electroencephalography/event related potentials) signals in microvolts first prior to exposure to gestures, just with visual animations and auditory words; then the investigators expose participants to visual gestures with auditory words; and finally participants are exposed to animations and auditory words again, to see if gestures contributed to any changes in EEG/ERP.
Measured: from Enrollment to completion of study protocol within 3 months
Secondary outcomes (1)
fNIRS brain response
In a pretest-test-postest set up, the researchers measure participants' brain activation via blood flow response using fNIRS (functional near infrared spectroscopy). The investigators identify whether language or non-language brain areas are activated during animation, speech, or gestures.
Measured: from enrollment to completion of protocol within 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start1 Oct 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autism DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montana State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadezhda Modyanova, Montana State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054866
- Sponsor's protocol ID
- 2022-73
- Acronym
- RAISE
- Status last verified
- Oct 2026
- First submitted
- 27 Jun 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: de-identified individual participant data, including language and cognitive evaluations, along with EEG and fNIRS.
Publications
Poplin, M., Ma, J., Aviles Zuniga, T., Modyanova, N., Johnson, E., McCrory, B. (March 2025). Using Electroencephalography to Understand Learning Engagement with User-Centered Human-Computer Interaction in a Multimodal Online Learning Environment. Annual Conference of the Institute of Industrial and Systems Engineers (IISE).
Modyanova, N.N., Bolton, A. P., Storrusten, C., & McCrory, B. (2024). Improving Language Comprehension via Hand Gestures in Children with Autism Spectrum Disorders and/or Language Impairment in Rural Montana. Proceedings of the International Symposium on Human Factors and Ergonomics in Health Care, 13(1), 191-196. https://doi.org/10.1177/2327857924131012