Recruiting
Phase 2

AI Navigation

Sponsor:

New York University

Code:

NCT06884943

Conditions

Speech Sound Disorder

Eligibility Criteria

Sex: All

Age: 9 - 17

Healthy Volunteers: Not accepted

Interventions

AI-guided maintenance training with visual-acoustic biofeedback

Treatment as Usual (TAU)

Study Details

Brief 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).

Conditions

Speech Sound Disorder

Study ID

NCT06884943

Start date

Dec 18, 2024

Status verified date

May, 2026

Completion date

Jul 1, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 9 - 17

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

76 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: AI-guided maintenance training with visual-acoustic biofeedback

Participants will receive visual-acoustic biofeedback treatment from a clinician in a private, password-protected WebRTC room.

active comparator: Treatment as usual [TAU]

Regular community-based care.

Interventions

AI-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.

Treatment 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.

Primary outcome measure

  • 1. Percentage of "Correct" Ratings by Blinded Untrained Listeners for /r/ Sounds Produced in Word Probes [ Time Frame: Immediately before the initiation of GAINS participation and again after the end of GAINS participation (6 weeks later) ]

Central Contacts and Locations

Central contacts

Tara McAllister, PhD

212-992-9445tkm214@nyu.edu

Twylah Campbell, MA

516-265-5389tjc10@nyu.edu

Locations

Montclair State University

Recruiting

Bloomfield, New Jersey, United States, 07003

Contacts

Elaine R Hitchcock, Ph

973-229-3797hitchcocke@montclair.edu

Laura Ochs, MS

619-784-4979ochsl@montclair.edu

Principal Investigator:

Elaine R Hitchcock, PhD

Syracuse University

Recruiting

Syracuse, New York, United States, 13244

Contacts

Jonathan L Preston, PhD

315-443-3143jopresto@syr.edu

Megan C Leece, MS

315-443-1351mcleece@syr.edu

Principal Investigator:

Jonathan L Preston, PhD

More Information

Sponsor

New York University

Last update posted

May 13, 2026

Last verified

May, 2026

Keywords

  • speech
  • articulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by New York University on 2026-05-13.