Visual-acoustic Intervention With Service Delivery In-person and Via Telepractice Trial

NCT ID: NCT06517225

Last Updated: 2025-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2028-12-31

Brief Summary

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Children with speech sound disorder show diminished intelligibility in spoken communication and may thus be perceived as less capable than peers, with negative consequences for both socioemotional and socioeconomic outcomes. New technologies have the potential to transform interventions for speech sound disorder, but there is a lack of rigorous evidence to substantiate this promise. This research will meet a public health need by systematically evaluating the efficacy of visual-acoustic biofeedback intervention delivered in-person versus via telepractice.

The objective of this study is to test the hypothesis that treatment incorporating visual-acoustic biofeedback can be delivered via telepractice without a significant loss of efficacy. Participants will be randomly assigned to receive identical treatment either via online telepractice or in the laboratory setting. The same software for visual-acoustic biofeedback, staRt, will be used in both conditions. Participants' progress in treatment will be evaluated based on blinded listeners' perceptual ratings of probes produced before and after treatment. Pre and post treatment evaluations will be carried out in person for all participants.

Detailed Description

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This study aims to test the working hypothesis that biofeedback treatment delivery via telepractice will not be associated with a reduction in efficacy that exceeds a maximum acceptable value determined a priori. In a prospective randomized controlled non-inferiority trial, children will be randomly assigned to receive a standard course of visual-acoustic biofeedback intervention delivered in-person or via telepractice. Progress will be measured with blinded listeners' ratings of untreated words produced before and after treatment. A survey will also be administered before and after treatment to assess changes in participants' participation and socio-emotional well-being, as well as participants' and caregivers' satisfaction with the therapy experience.

Conditions

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Speech Sound Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

All participants will complete an initial evaluation to determine eligibility and estimate the severity of speech sound disorder. Participants will be categorized into low and high severity groups and will be randomized with stratification by severity to the in-person or telepractice treatment condition. Participants will then complete 10 weeks of visual-acoustic biofeedback treatment in their randomly assigned condition. Treatment will be delivered individually by a speech-language pathologist and will elicit structured practice of /r/ in 20 semiweekly sessions.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Telepractice delivery

Participants will receive visual-acoustic biofeedback treatment from a clinician in a private, password-protected WebRTC room.

Group Type EXPERIMENTAL

Visual-acoustic biofeedback

Intervention Type BEHAVIORAL

Behavioral: Visual-acoustic biofeedback In visual-acoustic biofeedback treatment, the elements of traditional treatment (auditory models and verbal descriptions of articulator placement) are enhanced with a dynamic display of the speech signal in the form of the real-time LPC (Linear Predictive Coding) spectrum. The web-based software staRt will be used for intervention delivery.

In-person delivery

Participants will receive visual-acoustic biofeedback treatment from a clinician in a private room in research space at one of the two clinical research sites.

Group Type ACTIVE_COMPARATOR

Visual-acoustic biofeedback

Intervention Type BEHAVIORAL

Behavioral: Visual-acoustic biofeedback In visual-acoustic biofeedback treatment, the elements of traditional treatment (auditory models and verbal descriptions of articulator placement) are enhanced with a dynamic display of the speech signal in the form of the real-time LPC (Linear Predictive Coding) spectrum. The web-based software staRt will be used for intervention delivery.

Interventions

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Visual-acoustic biofeedback

Behavioral: Visual-acoustic biofeedback In visual-acoustic biofeedback treatment, the elements of traditional treatment (auditory models and verbal descriptions of articulator placement) are enhanced with a dynamic display of the speech signal in the form of the real-time LPC (Linear Predictive Coding) spectrum. The web-based software staRt will be used for intervention delivery.

Intervention Type BEHAVIORAL

Other Intervention Names

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staRt app

Eligibility Criteria

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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 exhibit less than thirty percent accuracy, based on trained listener ratings, on a probe list eliciting /r/ in various phonetic contexts at the word level.
* 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 in the event of randomization to the telepractice condition.
* Must have home wifi sufficient to support video calls in the event of randomization to the telepractice condition.

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

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Syracuse University

OTHER

Sponsor Role collaborator

Montclair State University

OTHER

Sponsor Role collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role collaborator

New York University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Montclair State University

Bloomfield, New Jersey, United States

Site Status RECRUITING

New York University

New York, New York, United States

Site Status ACTIVE_NOT_RECRUITING

Syracuse University

Syracuse, New York, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Elaine R Hitchcock, PhD

Role: primary

973-229-3797

Laura C Ochs, MS

Role: backup

(619) 784-4979

Jonathan L Preston, PhD

Role: primary

315-443-3143

Megan Leece, MS

Role: backup

315-443-1351

References

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Ayala SA, Eads A, Kabakoff H, Swartz MT, Shiller DM, Hill J, Hitchcock ER, Preston JL, McAllister T. Auditory and Somatosensory Development for Speech in Later Childhood. J Speech Lang Hear Res. 2023 Apr 12;66(4):1252-1273. doi: 10.1044/2022_JSLHR-22-00496. Epub 2023 Mar 17.

Reference Type BACKGROUND
PMID: 36930986 (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)

Campbell H, Harel D, Hitchcock E, McAllister Byun T. Selecting an acoustic correlate for automated measurement of American English rhotic production in children. Int J Speech Lang Pathol. 2018 Nov;20(6):635-643. doi: 10.1080/17549507.2017.1359334. Epub 2017 Aug 10.

Reference Type BACKGROUND
PMID: 28795872 (View on PubMed)

Campbell H, McAllister Byun T. Deriving individualised /r/ targets from the acoustics of children's non-rhotic vowels. Clin Linguist Phon. 2018;32(1):70-87. doi: 10.1080/02699206.2017.1330898. Epub 2017 Jul 13.

Reference Type BACKGROUND
PMID: 28703653 (View on PubMed)

Harel D, Hitchcock ER, Szeredi D, Ortiz J, McAllister Byun T. Finding the experts in the crowd: Validity and reliability of crowdsourced measures of children's gradient speech contrasts. Clin Linguist Phon. 2017;31(1):104-117. doi: 10.3109/02699206.2016.1174306. Epub 2016 Jun 7.

Reference Type BACKGROUND
PMID: 27267258 (View on PubMed)

Hitchcock ER, Ochs LC, Swartz MT, Leece MC, Preston JL, McAllister T. Tutorial: Using Visual-Acoustic Biofeedback for Speech Sound Training. Am J Speech Lang Pathol. 2023 Jan 11;32(1):18-36. doi: 10.1044/2022_AJSLP-22-00142. Epub 2023 Jan 9.

Reference Type BACKGROUND
PMID: 36623212 (View on PubMed)

Hitchcock ER, Harel D, Byun TM. Social, Emotional, and Academic Impact of Residual Speech Errors in School-Aged Children: A Survey Study. Semin Speech Lang. 2015 Nov;36(4):283-94. doi: 10.1055/s-0035-1562911. Epub 2015 Oct 12.

Reference Type BACKGROUND
PMID: 26458203 (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)

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)

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, 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)

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)

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)

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)

Preston JL, McAllister T, Phillips E, Boyce S, Tiede M, Kim JS, Whalen DH. Treatment for Residual Rhotic Errors With High- and Low-Frequency Ultrasound Visual Feedback: A Single-Case Experimental Design. J Speech Lang Hear Res. 2018 Aug 8;61(8):1875-1892. doi: 10.1044/2018_JSLHR-S-17-0441.

Reference Type BACKGROUND
PMID: 30073249 (View on PubMed)

Preston JL, Holliman-Lopez G, Leece MC. Do Participants Report Any Undesired Effects in Ultrasound Speech Therapy? Am J Speech Lang Pathol. 2018 May 3;27(2):813-818. doi: 10.1044/2017_AJSLP-17-0121.

Reference Type BACKGROUND
PMID: 29546269 (View on PubMed)

Preston JL, McAllister Byun T, Boyce SE, Hamilton S, Tiede M, Phillips E, Rivera-Campos A, Whalen DH. Ultrasound Images of the Tongue: A Tutorial for Assessment and Remediation of Speech Sound Errors. J Vis Exp. 2017 Jan 3;(119):55123. doi: 10.3791/55123.

Reference Type BACKGROUND
PMID: 28117824 (View on PubMed)

McAllister T, Preston JL, Hitchcock ER, Benway NR, Hill J. Protocol for visual-acoustic intervention with service delivery in-person and via telepractice (VISIT) non-inferiority trial for residual speech sound disorder. BMC Pediatr. 2025 Jan 27;25(1):65. doi: 10.1186/s12887-024-05364-z.

Reference Type DERIVED
PMID: 39871189 (View on PubMed)

Other Identifiers

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2R01DC017476

Identifier Type: NIH

Identifier Source: secondary_id

View Link

VISIT non-inferiority

Identifier Type: -

Identifier Source: org_study_id

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