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Behavioral Intervention

Visual-Acoustic Biofeedback for Speech Sound Disorder (VISIT Trial)

Phase 2
Recruiting
Research Sponsored by New York University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have access to a laptop or desktop computer for study sessions in the event of randomization to the telepractice condition
Must pass a brief examination of oral structure and function
Must not have
Must not have epilepsy with active seizure incidents within the past 6 months
Must not show clinically significant signs of apraxia of speech or dysarthria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before the initiation of treatment and again after the end of all treatment (10 weeks later)
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test if a new treatment for speech sound disorder, using visual-acoustic biofeedback, can be delivered effectively through telepractice. Children with speech sound disorder often struggle with communication and may

Who is the study for?
This trial is for children with speech sound disorder, which affects their clarity of speech. The study aims to help these children improve their spoken communication through a special treatment using visual-acoustic biofeedback.
What is being tested?
The trial is testing if visual-acoustic biofeedback therapy for speech sound disorder can be just as effective when given online (telepractice) as it is in person. Children will use the staRt software and their progress will be measured by how well they speak before and after the treatment.
What are the potential side effects?
Since this intervention involves non-invasive technology-based therapy, there are no direct physical side effects expected from the visual-acoustic biofeedback itself.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a laptop or desktop computer for study sessions.
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My mouth and its functions have been checked and are okay.
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I am between 9 years and 17 years, 11 months old.
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I speak English as my main or one of my main languages.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had an epileptic seizure in the last 6 months.
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I do not have noticeable speech difficulties.
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I do not have non-removable braces that cross my palate.
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I have not had a major brain injury, surgery, or stroke in the last year.
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I have never had permanent hearing loss.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before the initiation of treatment and again after the end of all treatment (10 weeks later)
This trial's timeline: 3 weeks for screening, Varies for treatment, and before the initiation of treatment and again after the end of all treatment (10 weeks later) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of "Correct" Ratings by Blinded Untrained Listeners for /r/ Sounds Produced in Word Probes
Secondary study objectives
1. Survey evaluating impacts of speech disorder on participants' social, emotional, and academic well-being.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Telepractice deliveryExperimental Treatment1 Intervention
Participants will receive visual-acoustic biofeedback treatment from a clinician in a private, password-protected WebRTC room.
Group II: In-person deliveryActive Control1 Intervention
Participants will receive visual-acoustic biofeedback treatment from a clinician in a private room in research space at one of the two clinical research sites.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Visual-acoustic biofeedback
2019
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

New York UniversityLead Sponsor
240 Previous Clinical Trials
315,514 Total Patients Enrolled
6 Trials studying Speech Sound Disorder
189 Patients Enrolled for Speech Sound Disorder
Montclair State UniversityOTHER
12 Previous Clinical Trials
990 Total Patients Enrolled
5 Trials studying Speech Sound Disorder
174 Patients Enrolled for Speech Sound Disorder
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
351 Previous Clinical Trials
180,963 Total Patients Enrolled
13 Trials studying Speech Sound Disorder
528 Patients Enrolled for Speech Sound Disorder
~51 spots leftby Dec 2027
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