Generalization With AI Navigation Using StaRt

NCT ID: NCT06884943

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-18
• Study Completion Date: 2029-07-01

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).

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.

Conditions

Speech Sound Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

AI-guided maintenance training with visual-acoustic biofeedback

Intervention Type: 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.

Treatment as Usual (TAU)

Intervention Type: 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.

Treatment as usual [TAU]

Regular community-based care.

Group Type: ACTIVE_COMPARATOR

Treatment as Usual (TAU)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York University

OTHER

Sponsor Role: lead

Syracuse University

OTHER

Sponsor Role: collaborator

Montclair State University

OTHER

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Locations

Montclair State University

Bloomfield, New Jersey, United States

Site Status: RECRUITING

Syracuse University

Syracuse, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Tara McAllister, PhD

Role: CONTACT

tkm214@nyu.edu

212-992-9445

Twylah Campbell, MA

Role: CONTACT

tjc10@nyu.edu

516-265-5389

Facility Contacts

Elaine R Hitchcock, Ph

Role: primary

hitchcocke@montclair.edu

973-229-3797

Laura Ochs, MS

Role: backup

ochsl@montclair.edu

619-784-4979

Jonathan L Preston, PhD

Role: primary

jopresto@syr.edu

315-443-3143

Megan C Leece, MS

Role: backup

mcleece@syr.edu

315-443-1351

References

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.

Reference Type: BACKGROUND

PMID: 38764857 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35050705 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22442281 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25088034 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25578293 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27891084 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28389677 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25216375 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37319018 (View on PubMed)

Other Identifiers

2R01DC017476

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CRESULTS GAINS

Identifier Type: -

Identifier Source: org_study_id