NCT06517225

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: New York University · Academic / Other
• Sex: Female
• Age: 9 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Speech Sound Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-07-01
• Primary completion: 2028-06-30
• Completion: 2028-12-31
• First posted: 2024-07-24
• Last updated: 2025-06-25

Locations

3 sites across 1 country: United States