Clinical trial NCT06517225: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Speech Sound Disorder
Keywords: speech
articulation
motor development
Lead sponsor: New York University
Sponsor class: OTHER
Collaborators: name: Syracuse University
name: Montclair State University
name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2024-07-24
Enrollment: 76
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage of "Correct" Ratings by Blinded Untrained Listeners for /r/ Sounds Produced in Word Probes
timeFrame: Before the initiation of treatment and again after the end of all treatment (10 weeks later)
Secondary outcomes:
measure: 1. Survey evaluating impacts of speech disorder on participants' social, emotional, and academic well-being.
timeFrame: Before the initiation of treatment and again after the end of all treatment (10 weeks later)
Other outcomes:
Locations:
city: Bloomfield
country: United States
facility: Montclair State University
state: New Jersey
city: New York
country: United States
facility: New York University
state: New York
city: Syracuse
country: United States
facility: Syracuse University
state: New York
Study officials:
References:
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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: 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.
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