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Search / Trial NCT06884943

Generalization With AI Navigation Using StaRt

Launched by NEW YORK UNIVERSITY · Mar 13, 2025

Trial Information

Current as of May 09, 2025

Not yet recruiting

Keywords

Speech Articulation

ClinConnect Summary

This clinical trial, called GAINS (Generalization with AI Navigation using StaRt), is studying a new way to help children with Speech Sound Disorder (SSD). SSD can make it hard for kids to pronounce words correctly, which can affect their social interactions and emotions as they grow up. The trial will test whether using artificial intelligence (AI) tools for practice at home can help children use the speech skills they learn in therapy more effectively in everyday conversations. This study is important because it aims to provide a resource for families to continue therapy outside of appointments, which can be difficult to manage.

To be eligible for the trial, participants must be between 9 and 17 years old, speak English well, and have started learning English by age 3. They need to pass a hearing test and show that they can understand and express language at their age level. It's also important for them to have a computer and reliable internet for video calls during the study. Participants will have already taken part in a related study and shown some success in treating their speech issues. Throughout the trial, families can expect to engage with AI tools designed to help their child improve their speech skills at home, alongside regular check-ins. This study is not yet recruiting, but it aims to provide valuable insights into how technology can support speech therapy for children.

Gender

ALL

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.

About New York University

New York University (NYU) is a prestigious research institution renowned for its commitment to advancing medical knowledge and improving patient care through innovative clinical trials. With a robust infrastructure and a diverse team of leading experts, NYU conducts cutting-edge research across various therapeutic areas, focusing on translating scientific discoveries into effective treatments. The university fosters collaboration among multidisciplinary teams and engages with a broad patient population, ensuring that its trials adhere to the highest ethical standards and regulatory requirements. NYU's dedication to excellence in research and education positions it as a key contributor to the advancement of healthcare and clinical practice.

Locations

Syracuse, New York, United States

Bloomfield, New Jersey, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported