NCT06884943 · New York University
Generalization With AI Navigation Using StaRt
(GAINS)
What this study is about
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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Bloomfield, New Jersey
- Syracuse, New York
Collaborators
Syracuse University, Montclair State University
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 13, 2026 · Source of record for eligibility and locations