Generalization With AI Navigation Using StaRt (GAINS)

May 11, 2026 updated by: New York University

Randomized Trial of AI-Enhanced Maintenance Training With Visual-Acoustic Biofeedback

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will measure the effects of AI-guided home practice as a follow-up to participation in a study of technology-enhanced treatment for speech sound disorder affecting the American English "r" sound. Participants will sign a single consent form that covers their participation in the original VISIT study (in which they are randomized to receive biofeedback treatment in person or via telepractice) and and the follow-up GAINS study (in which participants are randomized to a follow-up period of treatment as usual [TAU] or treatment as usual plus an AI-guided maintenance program with biofeedback [TAU+AI]).We will measure production accuracy at the start and end of GAINS to test our working hypothesis that children/adolescents with speech sound disorder will show higher accuracy in /r/ production after six weeks of TAU+AI than six weeks of TAU alone. All GAINS treatment sessions will be carried out in the home setting using online tools. Pre and post treatment evaluations will be carried out in the laboratory setting.

Study Type

Interventional

Enrollment (Estimated)

76

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Tara McAllister, PhD
  • Phone Number: 212-992-9445
  • Email: tkm214@nyu.edu

Study Contact Backup

  • Name: Twylah Campbell, MA
  • Phone Number: 516-265-5389
  • Email: tjc10@nyu.edu

Study Locations

  • United States
    • New Jersey
      • Bloomfield, New Jersey, United States, 07003
        • Recruiting
        • Montclair State University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Elaine R Hitchcock, PhD
    • New York
      • Syracuse, New York, United States, 13244
        • Recruiting
        • Syracuse University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jonathan L Preston, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: 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.
Behavioral: 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.
Active Comparator: Treatment as usual [TAU]
Regular community-based care.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
To assess generalization of treatment gains to untreated words, participants will be assessed with standard probes (30 words [considered the primary target], 20 syllables, and 10 sentences containing /r/ in various phonetic contexts). Stimuli in each probe will be presented individually in randomized order with blocking by stimulus type (word, syllable, sentence). Individual words will be isolated from the audio record of each word probe and presented in randomized order for binary rating (correct/incorrect) by 9 untrained listeners who are blind to treatment condition and time point, but will see the written representation of each target word. We will use the proportion of "correct" ratings for each token as our primary measure of perceptually rated accuracy.
Immediately before the initiation of GAINS participation and again after the end of GAINS participation (6 weeks later)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York University

Collaborators

Syracuse University
Montclair State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2024

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

July 1, 2029

Study Registration Dates

First Submitted

March 13, 2025

First Submitted That Met QC Criteria

March 13, 2025

First Posted (Actual)

March 19, 2025

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRESULTS GAINS
  • 2R01DC017476 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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