Ignite Creation Date:
2024-10-25 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06517225
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Visual-acoustic Intervention With Service Delivery In-person and Via Telepractice Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Visual-acoustic Intervention With Service Delivery In-person and Via Telepractice VISIT Non-Inferiority Trial
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VISIT
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None