Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-25 @ 2:12 PM
Study NCT ID:
NCT07054866
Status:
RECRUITING
Last Update Posted:
2025-07-10
First Post:
2025-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rural Autistic Individuals - Supporting Expression
Sponsor:
Montana State University
Organization:
Study Overview
Official Title:
Rural Autistic Individuals - Supporting Expression
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RAISE
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: