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

NCT06517225 | Recruiting Phase 2 DMC

• 2 other identifiers: VISIT non-inferiority2R01DC017476
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Speech Sound Disorder

Keywords

speech; articulation; motor development

Outcome Measures

Primary Outcomes (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. The proportion of "correct" ratings for each token will be used as the primary measure of perceptually rated accuracy.

  Before the initiation of treatment and again after the end of all treatment (10 weeks later)

Secondary Outcomes (1)

• 1. Survey evaluating impacts of speech disorder on participants' social, emotional, and academic well-being.

  Before the initiation of treatment and again after the end of all treatment (10 weeks later)

Study Arms (2)

Telepractice delivery

EXPERIMENTAL

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

Behavioral: Visual-acoustic biofeedback

In-person delivery

ACTIVE COMPARATOR

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.

Behavioral: Visual-acoustic biofeedback

Interventions

Visual-acoustic biofeedback 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.

Also known as: staRt app

In-person delivery; Telepractice delivery

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: female
• 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 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.

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
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (3)

Montclair State University

Bloomfield, New Jersey, 07003, United States

RECRUITING

New York University

New York, New York, 10012, United States

ACTIVE NOT RECRUITING

Syracuse University

Syracuse, New York, 13244, United States

RECRUITING

Related Publications (18)

• 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.

  PMID: 36930986 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

• 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.

  PMID: 28795872 BACKGROUND

• 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.

  PMID: 28703653 BACKGROUND

• 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.

  PMID: 27267258 BACKGROUND

• 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.

  PMID: 36623212 BACKGROUND

• 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.

  PMID: 26458203 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

• 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

• 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, 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

• 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

• 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

• 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

• 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.

  PMID: 30073249 BACKGROUND

• 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.

  PMID: 29546269 BACKGROUND

• 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.

  PMID: 28117824 BACKGROUND

• 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.

  PMID: 39871189 DERIVED

MeSH Terms

Conditions

Speech Sound Disorder; Speech

Condition Hierarchy (Ancestors)

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

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: 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.

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 24, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Data will be shared within 6 months of the study end date (7/31/28) and will be made available indefinitely.
• Access Criteria: Publicly accessible

Locations

US (3)