Clinical trial NCT06884943: Generalization With AI Navigation Using StaRt
Official title: Randomized Trial of AI-Enhanced Maintenance Training With Visual-Acoustic Biofeedback
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Speech Sound Disorder
Keywords: speech
articulation
Lead sponsor: New York University
Sponsor class: OTHER
Collaborators: name: Syracuse University
name: Montclair State University
First posted: 2025-03-19
Enrollment: 76
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 1. Percentage of "Correct" Ratings by Blinded Untrained Listeners for /r/ Sounds Produced in Word Probes
timeFrame: Immediately before the initiation of GAINS participation and again after the end of GAINS participation (6 weeks later)
Secondary outcomes:
Other outcomes:
Locations:
city: Bloomfield
country: United States
facility: Montclair State University
state: New Jersey
city: Syracuse
country: United States
facility: Syracuse University
state: New York
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.