Clinical Trial

Generalization With AI Navigation Using StaRt

Study acronym: GAINS
Recruiting Phase 2
View on ClinicalTrials.gov →
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).
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-03-13; most recent amendment 2026-05-11.
Status change: Not Yet Recruiting → Recruiting 2025-05-20
Trial Details
NCT Number NCT06884943
Lead Sponsor New York University
Collaborators: Syracuse University, Montclair State University
Conditions Speech Sound Disorder
Enrollment 76 participants
Start Date 2024-12-18
Primary Completion 2028-12-31 (estimated)
Study Completion 2029-07-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-13