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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ before the initiation of treatment and again after the end of all treatment (10 weeks later)

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

0 / 9Eligibility criteria met