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

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06517225
Acronym
VISIT
Enrollment
76
Registered
2024-07-24
Start date
2024-07-01
Completion date
2028-12-31
Last updated
2025-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Speech Sound Disorder

Keywords

speech, articulation, motor development

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.

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 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.

Sponsors

Syracuse University
CollaboratorOTHER
Montclair State University
CollaboratorOTHER
National Institute on Deafness and Other Communication Disorders (NIDCD)
CollaboratorNIH
New York University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
FEMALE
Age
9 Years to 17 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Correct Ratings by Blinded Untrained Listeners for /r/ Sounds Produced in Word ProbesBefore the initiation of treatment and again after the end of all treatment (10 weeks later)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.

Secondary

MeasureTime frameDescription
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)This survey asks participants to report the impact of speech disorder on their child's social, emotional, and academic well-being. Parents are asked to circle a number from 1 to 5. For all questions, a higher score indicates a greater degree of negative impact of speech disorder on social, emotional, or academic well-being. An impact score will be calculated as described in a previous published study (Hitchcock, Harel, & McAllister Byun, 2015).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026