RecruitingPhase 2NCT06884943

Generalization With AI Navigation Using StaRt

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

Sponsor

New York University

Enrollment

76 participants

Start Date

Dec 18, 2024

Study Type

INTERVENTIONAL

Conditions

Speech Sound Disorder

Summary

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).

Eligibility

Min Age: 9 YearsMax Age: 17 Years

Inclusion Criteria11

• 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.

Exclusion Criteria7

• 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.

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Interventions

BEHAVIORALAI-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 participants.

BEHAVIORALTreatment 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.