Generalization With AI Navigation Using StaRt

NCT06884943 | Recruiting Phase 2 DMC

• 2 other identifiers: CRESULTS GAINS2R01DC017476
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

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

Keywords

speech; articulation

Outcome Measures

Primary Outcomes (1)

• 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.

  Immediately before the initiation of GAINS participation and again after the end of GAINS participation (6 weeks later)

Study Arms (2)

AI-guided maintenance training with visual-acoustic biofeedback

EXPERIMENTAL

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)

Treatment as usual [TAU]

ACTIVE COMPARATOR

Regular community-based care.

Behavioral: Treatment as Usual (TAU)

Interventions

AI-guided maintenance training with visual-acoustic biofeedback BEHAVIORAL

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.

AI-guided maintenance training with visual-acoustic biofeedback

Treatment as Usual (TAU) BEHAVIORAL

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.

AI-guided maintenance training with visual-acoustic biofeedback; Treatment as usual [TAU]

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• New York University: lead
• Syracuse University: collaborator
• Montclair State University: collaborator

Study Sites (2)

Montclair State University

Bloomfield, New Jersey, 07003, United States

RECRUITING

Syracuse University

Syracuse, New York, 13244, United States

RECRUITING

Related Publications (9)

• Ochs LC, Leece MC, Preston JL, McAllister T, Hitchcock ER. Traditional and Visual-Acoustic Biofeedback Treatment via Telepractice for Residual Speech Sound Disorders Affecting /ɹ/: Pilot study. Perspect ASHA Spec Interest Groups. 2023 Dec;8(6):1533-1553. doi: 10.1044/2023_persp-23-00120. Epub 2023 Nov 8.

  PMID: 38764857 BACKGROUND

• Peterson L, Savarese C, Campbell T, Ma Z, Simpson KO, McAllister T. Telepractice Treatment of Residual Rhotic Errors Using App-Based Biofeedback: A Pilot Study. Lang Speech Hear Serv Sch. 2022 Apr 11;53(2):256-274. doi: 10.1044/2021_LSHSS-21-00084. Epub 2022 Jan 20.

  PMID: 35050705 BACKGROUND

• Byun TM, Hitchcock ER. Investigating the use of traditional and spectral biofeedback approaches to intervention for /r/ misarticulation. Am J Speech Lang Pathol. 2012 Aug;21(3):207-21. doi: 10.1044/1058-0360(2012/11-0083). Epub 2012 Mar 21.

  PMID: 22442281 BACKGROUND

• Byun TM, Hitchcock ER, Swartz MT. Retroflex versus bunched in treatment for rhotic misarticulation: evidence from ultrasound biofeedback intervention. J Speech Lang Hear Res. 2014 Dec;57(6):2116-30. doi: 10.1044/2014_JSLHR-S-14-0034.

  PMID: 25088034 BACKGROUND

• McAllister Byun T, Halpin PF, Szeredi D. Online crowdsourcing for efficient rating of speech: a validation study. J Commun Disord. 2015 Jan-Feb;53:70-83. doi: 10.1016/j.jcomdis.2014.11.003. Epub 2014 Dec 15.

  PMID: 25578293 BACKGROUND

• McAllister Byun T, Campbell H. Differential Effects of Visual-Acoustic Biofeedback Intervention for Residual Speech Errors. Front Hum Neurosci. 2016 Nov 11;10:567. doi: 10.3389/fnhum.2016.00567. eCollection 2016.

  PMID: 27891084 BACKGROUND

• McAllister Byun T. Efficacy of Visual-Acoustic Biofeedback Intervention for Residual Rhotic Errors: A Single-Subject Randomization Study. J Speech Lang Hear Res. 2017 May 24;60(5):1175-1193. doi: 10.1044/2016_JSLHR-S-16-0038.

  PMID: 28389677 BACKGROUND

• Hitchcock ER, Byun TM. Enhancing generalisation in biofeedback intervention using the challenge point framework: a case study. Clin Linguist Phon. 2015 Jan;29(1):59-75. doi: 10.3109/02699206.2014.956232. Epub 2014 Sep 12.

  PMID: 25216375 BACKGROUND

• Benway NR, Preston JL, Hitchcock E, Rose Y, Salekin A, Liang W, McAllister T. Reproducible Speech Research With the Artificial Intelligence-Ready PERCEPT Corpora. J Speech Lang Hear Res. 2023 Jun 20;66(6):1986-2009. doi: 10.1044/2023_JSLHR-22-00343. Epub 2023 Jun 15.

  PMID: 37319018 BACKGROUND

MeSH Terms

Conditions

Speech Sound Disorder; Speech

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Communication Disorders; Neurodevelopmental Disorders; Mental Disorders; Verbal Behavior; Communication; Behavior

Central Study Contacts

Tara McAllister, PhD

CONTACT

212-992-9445; tkm214@nyu.edu

Twylah Campbell, MA

CONTACT

516-265-5389; tjc10@nyu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All perceptual ratings will be obtained from blinded, naive listeners recruited through online crowdsourcing. Following protocols refined in previous published research, binary rating responses will be aggregated over at least 9 unique listeners per token.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants who meet criteria for inclusion in the GAINS follow-up study will be categorized into low and high severity groups and will be randomized with stratification by severity to the TAU and TAU+AI conditions. Participants will then complete 6 weeks in their randomly assigned condition.

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 19, 2025
• Study Start: December 18, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: June 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE

Locations

US (2)