Menu
Recruiting NCT07054866

Rural Autistic Individuals - Supporting Expression

No phase Interventional Autism Disorder Language Development Disorders ADHD Typical Development

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Speech-Gesture combinations.
Who it may be relevant to
Registry conditions: Autism Disorder, Language Development Disorders, ADHD, Typical Development. Basic parameters: from 2 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

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.

Interventions

  • Behavioral Speech-Gesture combinations
    this is a pretest, test, posttest evaluation of language comprehension with and without gestures, to see if gestures can improve language comprehension

Primary outcome measures

  • EEG/ERP brain response [Time frame: from Enrollment to completion of study protocol within 3 months]
Secondary outcome measures (1)
  • fNIRS brain response [Time frame: from enrollment to completion of protocol within 3 months]

Eligibility criteria

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Montana State University — Bozeman

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

Identifiers

NCT: NCT07054866 · 2022-73

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗