NCT07054866

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
12mo left

Started Jul 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Jul 2025Jul 2027

First Submitted

Initial submission to the registry

June 27, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 8, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

July 10, 2025

Status Verified

July 1, 2025

Enrollment Period

1.4 years

First QC Date

June 27, 2025

Last Update Submit

July 7, 2025

Conditions

Outcome Measures

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.

    from Enrollment to completion of study protocol within 3 months

Secondary Outcomes (1)

  • fNIRS brain response

    from enrollment to completion of protocol within 3 months

Study Arms (1)

Language Evaluation

EXPERIMENTAL
Behavioral: Speech-Gesture combinations

Interventions

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

Language Evaluation

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • \. Normal hearing and normal vision (or corrected to normal with glasses or contacts).
  • \. 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montana State University

Bozeman, Montana, 59717, United States

RECRUITING

Related Publications (2)

  • 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).

    BACKGROUND
  • 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

    BACKGROUND

Related Links

MeSH Terms

Conditions

Autistic DisorderLanguage Development DisordersAttention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsAttention Deficit and Disruptive Behavior Disorders

Central Study Contacts

Nadya N Modyanova, Ph.D.

CONTACT

Bernadette McCrory, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Research Professor

Study Record Dates

First Submitted

June 27, 2025

First Posted

July 8, 2025

Study Start

July 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

July 1, 2027

Last Updated

July 10, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

de-identified individual participant data, including language and cognitive evaluations, along with EEG and fNIRS.

Shared Documents
STUDY PROTOCOL, SAP, ICF, 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

Locations