Randomized Trial of AI-Enhanced Maintenance Training With Visual-Acoustic Biofeedback
Trial ID: NCT06884943
Status: RECRUITING
Study type: INTERVENTIONAL
Phase: PHASE2
Start date: 2024-12-18
Completion date: 2029-07-01
Sponsor: New York University
Collaborators: Syracuse University; Montclair State University
Conditions: Speech Sound Disorder
Interventions: AI-guided maintenance training with visual-acoustic biofeedback; Treatment as Usual (TAU)
Locations: Montclair State University; Syracuse University
Countries: United States; United States
Enrollment: 76
Age range: 9 Years - 17 Years
Sex: ALL

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 criteria:
Inclusion Criteria:

* • 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 Criteria:

* • 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.

Outcomes:
1. Percentage of "Correct" Ratings by Blinded Untrained Listeners for /r/ Sounds Produced in Word Probes