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

Official title

Visual-acoustic Intervention With Service Delivery In-person and Via Telepractice (VISIT) Non-Inferiority Trial

Overview

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

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.

Interventions

• Behavioral 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.

Primary outcome measures

• Percentage of "Correct" Ratings by Blinded Untrained Listeners for /r/ Sounds Produced in Word Probes [Time frame: Before the initiation of treatment and again after the end of all treatment (10 weeks later)]

Secondary outcome measures (1)

• 1. Survey evaluating impacts of speech disorder on participants' social, emotional, and academic well-being. [Time frame: Before the initiation of treatment and again after the end of all treatment (10 weeks later)]

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 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 3 centers

• Montclair State University — Bloomfield
• New York University — New York
• Syracuse University — Syracuse

Publications

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT06517225 · VISIT non-inferiority · 2R01DC017476

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗