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RecruitingNCT07054866RAISEUpdated Oct 8, 2026

Rural Autistic Individuals - Supporting Expression

An interventional study of Speech-Gesture combinations in Autism Disorder, Language Development Disorders and ADHD, sponsored by Montana State University. Recruiting at 1 site in United States. Open to participants aged 2 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by Montana State University · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started Oct 2025; still recruiting 1 year 1 month later.
Updated Oct 8, 2026Start date movedPrimary completion moved+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
2 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Autism Disorder
  • Language Development Disorders
  • ADHD
  • Typical Development
  • Rural Health
  • Children
  • Neuroimaging
  • Eye Tracking
  • EEG
  • fNIRS
03

In context

Autistic Disorder

1,030 studies on the registry are indexed under Autistic Disorder; 266 are open to participants now.

This study's planned enrollment of 50 is close to the median of 49 across 811 interventional studies indexed under Autistic Disorder.

Browse Autistic Disorder studies →

Lead sponsor

Montana State University is the lead sponsor of 42 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 1. Poor hearing. 2. Inborn or acquired brain damage.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Language Evaluation

    Behavioral: Speech-Gesture combinations

Interventions

  • BehavioralSpeech-Gesture combinations

    this is a pretest, test, posttest evaluation of language comprehension with and without gestures, to see if gestures can improve language comprehension

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: from enrollment to completion of protocol within 3 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

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

Individual participant data

Plan to share: Yes — de-identified individual participant data, including language and cognitive evaluations, along with EEG and fNIRS.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code

Time frame: 6 months after peer-reviewed publications from this study are made public

Access criteria: appropriate data use agreements will need to be put in place

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2025 (actual). Primary completion is estimated for Dec 2027, 26 months after the start.

Of 354 non-industry interventional studies with no phase under Autistic Disorder, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 52. This study's planned 26 months is close to that.

Counting every sponsor, half of 366 studies reached it within 26 months; a quarter within 13 and three quarters within 52.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 8, 2026: start Jul 2025 → Oct 2025, primary completion Dec 2026 → Dec 2027 and completion Jul 2027 → Dec 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jun 27, 2025
First posted
Jul 8, 2025
StartActual
Oct 1, 2025was Jul 2025
Primary completionEst.
Dec 2027was Dec 2026
CompletionEst.
Dec 2027was Jul 2027
Last update
Oct 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Jul 2025→Oct 1, 2025 (actual)
Oct 8, 2026
Primary completion
Dec 2026→Dec 2027
Oct 8, 2026
Study completion
Jul 2027→Dec 2027
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    Start date Jul 2025→Oct 1, 2025 (now actual)
    Primary completion Dec 2026→Dec 2027
    Study completion Jul 2027→Dec 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07054866
Lead sponsor
Montana State University
Responsible party
Nadezhda Modyanova (Assistant Research Professor, Montana State University) — Principal investigator
First posted
Jul 8, 2025
Start date
Oct 1, 2025
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Oct 8, 2026

Study contacts

Nadya N Modyanova, Ph.D.
Contact
language-research@montana.edu
406-848-1535
Bernadette McCrory, Ph.D.
Contact
bernadette.mccrory@montana.edu
406-994-2801

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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