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Идёт набор NCT07054866

Rural Autistic Individuals - Supporting Expression

Без фазы С лечением Autism Disorder Language Development Disorders ADHD Typical Development

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Speech-Gesture combinations.
Кому может быть актуально
Состояния в реестре: Autism Disorder, Language Development Disorders, ADHD, Typical Development. Базовые параметры: от 2 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое 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

Первичные конечные точки

  • EEG/ERP brain response [Срок оценки: from Enrollment to completion of study protocol within 3 months]
Вторичные конечные точки (1)
  • fNIRS brain response [Срок оценки: from enrollment to completion of protocol within 3 months]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • Montana State University — Bozeman

Публикации

  • 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

Идентификаторы

NCT: NCT07054866 · 2022-73

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗