A Phase 2 interventional study of AI-guided maintenance training with visual-acoustic biofeedback and Treatment as Usual (TAU) in Speech Sound Disorder, sponsored by New York University. Recruiting at 2 sites in United States. Open to participants aged 9 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-05-13.
Sponsored by New York University · Phase 2, Interventional, and Treatment
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).
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.
46 studies on the registry are indexed under Speech Sound Disorder; 16 are open to participants now.
This study's planned enrollment of 76 is above the median of 40 across 39 interventional studies indexed under Speech Sound Disorder.
Browse Speech Sound Disorder studies →New York University is the lead sponsor of 123 studies on the registry; 32 are open to participants now.
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Must be between 9;0 and 17;11 (years;months) old at the time of enrollment.
Exclusion Criteria:
Must not exhibit voice or fluency disorder of a severity judged likely to interfere with the ability to participate in study activities.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Behavioral: Treatment as Usual (TAU)
Regular community-based care.
Behavioral: Treatment as Usual (TAU)
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.
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.
1. Percentage of "Correct" Ratings by Blinded Untrained Listeners for /r/ Sounds Produced in Word Probes
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.
Time frame: Immediately before the initiation of GAINS participation and again after the end of GAINS participation (6 weeks later)
Plan to share: Yes
Supporting information: Study protocol, Informed consent form, Analytic code
Started Dec 2024 (actual). Primary completion is estimated for Dec 2028, 48 months after the start.
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