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Generalization With AI Navigation Using StaRt

Study acronym: GAINS
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv4
  2. Primary completion date: Aug 31, 2028 to Dec 31, 2028
    • Study completion date: Dec 31, 2028 to Jul 1, 2029
    • Start date: May 1, 2025 to Dec 18, 2024
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 1, 2025 to May 1, 2025
    • Site details revised at 2 of 2 sites
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06884943
Lead Sponsor New York University
Collaborators: Syracuse University, Montclair State University
Conditions
(from sponsor)		 Speech Sound Disorder
Related terms Speech, Speech Sound Disorder
Enrollment 76 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov