Generalization With AI Navigation Using StaRt

Официальное название

Randomized Trial of AI-Enhanced Maintenance Training With Visual-Acoustic Biofeedback

Обзор

Speech Sound Disorder (SSD) affects a significant portion of school-aged children, leading to social and emotional challenges that can persist into adolescence and adulthood. The number of productions necessary for a remediated speech sound to generalize to connected speech is challenging to achieve in practice, leading clinicians to call for accessible, reliable resources allowing children to continue therapy outside of direct clinical interactions. Artificial intelligence (AI) tools hold promise as a means to extend direct service delivery in speech-language pathology, but research investigating the topic has been limited. This study (Generalization with AI Navigation using staRt, or GAINS) will measure the effects of a course of AI-mediated home practice intended to promote generalization of gains made through biofeedback treatment in a related study, Visual-acoustic Intervention with Service Delivery In-person and Via Telepractice Trial (VISIT; NCT06517225).

Подробное описание

This study will measure the effects of AI-guided home practice as a follow-up to participation in a study of technology-enhanced treatment for speech sound disorder affecting the American English "r" sound. Participants will sign a single consent form that covers their participation in the original VISIT study (in which they are randomized to receive biofeedback treatment in person or via telepractice) and and the follow-up GAINS study (in which participants are randomized to a follow-up period of treatment as usual \[TAU\] or treatment as usual plus an AI-guided maintenance program with biofeedback \[TAU+AI\]).We will measure production accuracy at the start and end of GAINS to test our working hypothesis that children/adolescents with speech sound disorder will show higher accuracy in /r/ production after six weeks of TAU+AI than six weeks of TAU alone. All GAINS treatment sessions will be carried out in the home setting using online tools. Pre and post treatment evaluations will be carried out in the laboratory setting.

Вмешательства

• Поведенческое AI-guided maintenance training with visual-acoustic biofeedback
  Participants will complete AI-guided practice in the home setting in which they will interact with a web interface of the staRt web-based software for speech practice. The staRt software will present words to practice and show a real-time visual display of the acoustic signal of speech (biofeedback). On select trials, feedback will be provided by a classifier for children's "r" sounds, PERCEPT. Research assistants will join sessions to facilitate but will not provide direct clinical guidance to
• Поведенческое Treatment as Usual (TAU)
  Participants will return to their regular community-based care. This may consist of treatment in the school setting or by a private SLP; participants who were not previously receiving treatment may return to a no-treatment condition. Data will be collected from parents/guardians to determine the frequency of treatment, if any, received during this phase.

Первичные конечные точки

• 1. Percentage of "Correct" Ratings by Blinded Untrained Listeners for /r/ Sounds Produced in Word Probes [Срок оценки: Immediately before the initiation of GAINS participation and again after the end of GAINS participation (6 weeks later)]

Критерии участия

Критерии включения

• • Must be between 9;0 and 17;11 (years;months) old at the time of enrollment.

• Must speak English as the dominant or equally dominant language
• Must have begun learning English by age 3, per parent report.
• Must hear a rhotic dialect of English from at least one speaker in the home if the home language is English.
• Must pass a pure-tone hearing screening.
• Must pass a brief examination of oral structure and function.
• Must demonstrate age-appropriate receptive and expressive language abilities on the Clinical Evaluation of Language Fundamentals-5 (CELF-5).
• Must have access to a laptop or desktop computer for study sessions.
• Must have home wifi sufficient to support video calls in the event of randomization to the telepractice condition.
• Must have completed participation in the VISIT randomized controlled trial.
• Must score at least 60% correct in at least one treatment session during the related previous study, VISIT.

Критерии исключения

• • Must not exhibit voice or fluency disorder of a severity judged likely to interfere with the ability to participate in study activities.

• Must not currently have orthodontia that crosses the palate and cannot be removed.
• Must not have history of permanent hearing loss.
• Must not have an existing diagnosis of developmental disability such as cerebral palsy or Down Syndrome.
• Must not have history of major brain injury, surgery, or stroke in the past year.
• Must not have epilepsy with active seizure incidents with in the past 6 months.
• Must not show clinically significant signs of apraxia of speech or dysarthria.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Montclair State University — Bloomfield
• Syracuse University — Syracuse

Публикации

• Ochs LC, Leece MC, Preston JL, McAllister T, Hitchcock ER. Traditional and Visual-Acoustic Biofeedback Treatment via Telepractice for Residual Speech Sound Disorders Affecting /ɹ/: Pilot study. Perspect ASHA Spec Interest Groups. 2023 Dec;8(6):1533-1553. doi: 10.1044/2023_persp-23-00120. Epub 2023 Nov 8. PMID 38764857
• Peterson L, Savarese C, Campbell T, Ma Z, Simpson KO, McAllister T. Telepractice Treatment of Residual Rhotic Errors Using App-Based Biofeedback: A Pilot Study. Lang Speech Hear Serv Sch. 2022 Apr 11;53(2):256-274. doi: 10.1044/2021_LSHSS-21-00084. Epub 2022 Jan 20. PMID 35050705
• Byun TM, Hitchcock ER. Investigating the use of traditional and spectral biofeedback approaches to intervention for /r/ misarticulation. Am J Speech Lang Pathol. 2012 Aug;21(3):207-21. doi: 10.1044/1058-0360(2012/11-0083). Epub 2012 Mar 21. PMID 22442281
• Byun TM, Hitchcock ER, Swartz MT. Retroflex versus bunched in treatment for rhotic misarticulation: evidence from ultrasound biofeedback intervention. J Speech Lang Hear Res. 2014 Dec;57(6):2116-30. doi: 10.1044/2014_JSLHR-S-14-0034. PMID 25088034
• McAllister Byun T, Halpin PF, Szeredi D. Online crowdsourcing for efficient rating of speech: a validation study. J Commun Disord. 2015 Jan-Feb;53:70-83. doi: 10.1016/j.jcomdis.2014.11.003. Epub 2014 Dec 15. PMID 25578293
• McAllister Byun T, Campbell H. Differential Effects of Visual-Acoustic Biofeedback Intervention for Residual Speech Errors. Front Hum Neurosci. 2016 Nov 11;10:567. doi: 10.3389/fnhum.2016.00567. eCollection 2016. PMID 27891084
• McAllister Byun T. Efficacy of Visual-Acoustic Biofeedback Intervention for Residual Rhotic Errors: A Single-Subject Randomization Study. J Speech Lang Hear Res. 2017 May 24;60(5):1175-1193. doi: 10.1044/2016_JSLHR-S-16-0038. PMID 28389677
• Hitchcock ER, Byun TM. Enhancing generalisation in biofeedback intervention using the challenge point framework: a case study. Clin Linguist Phon. 2015 Jan;29(1):59-75. doi: 10.3109/02699206.2014.956232. Epub 2014 Sep 12. PMID 25216375

Идентификаторы

NCT: NCT06884943 · CRESULTS GAINS · 2R01DC017476

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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