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Speech Sound DisorderPhase 2GAINSNCT06884943

Generalization With AI Navigation Using StaRt

A Phase 2 study testing AI-guided maintenance training with visual-acoustic biofeedback and Treatment as Usual (TAU) in people with Speech Sound Disorder, run by New York University at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 9 to 17 years
Conditions the study is for
Speech Sound Disorder
What is being tested?
AI-guided maintenance training with visual-acoustic biofeedback and Treatment as Usual (TAU)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
2 sitesUnited States
Study dates
18 Dec 2024to 1 Jul 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • • 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.
Show all 11Show fewer
  • 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.

Who cannot join

  • • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Tara McAllister, PhD contact

212-992-9445

tkm214@nyu.edu

Twylah Campbell, MA contact

516-265-5389

tjc10@nyu.edu

United States2 sites, 2 recruiting

  • Montclair State University

    Bloomfield, New Jersey, 07003

    Elaine R Hitchcock, Ph, 973-229-3797, hitchcocke@montclair.edu

    Laura Ochs, MS, 619-784-4979, ochsl@montclair.edu

    Recruiting

  • Syracuse University

    Syracuse, New York, 13244

    Jonathan L Preston, PhD, 315-443-3143, jopresto@syr.edu

    Megan C Leece, MS, 315-443-1351, mcleece@syr.edu

    Recruiting

Other trials in United States

About this study

Official title: 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).

Read the 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.

Being tested
AI-guided maintenance training with visual-acoustic biofeedback, Treatment as Usual (TAU)
Keywords
speech, articulation
Medical subject headings
Speech Sound Disorder, Speech

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AI-guided maintenance training with visual-acoustic biofeedbackBehavioural

    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)Behavioural

    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.

Study groups in NCT06884943
Study groupRoleWhat they receive
AI-guided maintenance training with visual-acoustic biofeedbackExperimentalParticipants will receive visual-acoustic biofeedback treatment from a clinician in a private, password-protected WebRTC room.
Receives: Behavioral: AI-guided maintenance training with visual-acoustic biofeedback; Behavioral: Treatment as Usual (TAU)
Treatment as usual [TAU]Active comparatorRegular community-based care.
Receives: Behavioral: Treatment as Usual (TAU)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2025
  2. Study start18 Dec 2024
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion1 Jul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
76 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06884943
Sponsor's protocol ID
CRESULTS GAINS
Other IDs
2R01DC017476
Acronym
GAINS
Status last verified
May 2026
First submitted
13 Mar 2025
Last updated
13 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 38764857

  • 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.

    PubMed 35050705

  • 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.

    PubMed 22442281

  • 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.

    PubMed 25088034

  • 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.

    PubMed 25578293

  • 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.

    PubMed 27891084

  • 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.

    PubMed 28389677

  • 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.

    PubMed 25216375

  • 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.

    PubMed 37319018

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AI-guided maintenance training with visual-acoustic biofeedback and Treatment as Usual (TAU) in people with Speech Sound Disorder, run by New York University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tara McAllister, PhD (212-992-9445, tkm214@nyu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06884943, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.

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