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Behavioral Intervention

Visual Acoustic Biofeedback for Speech Sound Disorder

Phase 2

Recruiting

Led By Elaine R. Hitchcock, PhD

Research Sponsored by Montclair State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must speak a rhotic dialect of English.

Must be between 9;0 and 15;11 years of age at the time of enrollment.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-, mid- (after 10 weeks), and 1 week post-treatment

Awards & highlights

Study Summary

This trial will evaluate if a speech intervention supplemented with real-time visual and acoustic feedback can be delivered effectively using remote technologies.

Who is the study for?

This trial is for English-speaking children aged 9 to almost 16 with speech sound disorders, specifically difficulty pronouncing the 'r' sound. They must have normal hearing and oral function, speak a rhotic dialect of English as their primary language from an early age, and not have more than three other speech errors or any major developmental disabilities.Check my eligibility

What is being tested?

The study tests if giving speech therapy through remote technologies with visual-acoustic biofeedback helps improve pronunciation compared to no treatment. Biofeedback shows patients real-time visuals of their speech sounds, aiming to correct the 'r' sound.See study design

What are the potential side effects?

Since this trial involves non-invasive speech therapy techniques, there are minimal expected side effects. However, participants may experience frustration or fatigue during sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I speak a version of English where the 'r' sound is pronounced.

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I am between 9 and 15 years old.

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English is my first language, learned by age 2.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-, mid- (after 10 weeks), and 1 week post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-, mid- (after 10 weeks), and 1 week post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-, mid- (after 10 weeks), and 1 week post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in perceptually rated accuracy of /r/

Secondary outcome measures

Change in social-emotional well-being

Trial Design

2Treatment groups

Experimental Treatment

Group I: Visual Acoustic Biofeedback for RSE via Telepractice-WaitExperimental Treatment1 Intervention

Condition 2: Waitlist-first Following the initial evaluation, 10 children with RSE will be allocated to a 10 week no treatment condition.

Group II: Visual Acoustic Biofeedback for RSE via Telepractice-TreatmentExperimental Treatment1 Intervention

Condition1: Treatment-first Children with RSE and typical perception will be allocated to a randomized controlled trial measuring the efficacy of online visual-acoustic biofeedback treatment. Ten children with RSE will receive 10 weeks of visual-acoustic biofeedback training via video call.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Montclair State UniversityLead Sponsor

9 Previous Clinical Trials

821 Total Patients Enrolled

4 Trials studying Speech Sound Disorder

134 Patients Enrolled for Speech Sound Disorder

National Institute on Deafness and Other Communication Disorders (NIDCD)NIH

330 Previous Clinical Trials

178,431 Total Patients Enrolled

10 Trials studying Speech Sound Disorder

412 Patients Enrolled for Speech Sound Disorder

New York UniversityOTHER

226 Previous Clinical Trials

314,077 Total Patients Enrolled

5 Trials studying Speech Sound Disorder

149 Patients Enrolled for Speech Sound Disorder

Media Library

Visual Acoustic Biofeedback (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04858022 — Phase 2

Speech Sound Disorder Research Study Groups: Visual Acoustic Biofeedback for RSE via Telepractice-Wait, Visual Acoustic Biofeedback for RSE via Telepractice-Treatment

Speech Sound Disorder Clinical Trial 2023: Visual Acoustic Biofeedback Highlights & Side Effects. Trial Name: NCT04858022 — Phase 2

Visual Acoustic Biofeedback (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04858022 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the protocol for this research exclude those below 55 years of age?

"Participants aged between 9 and 15 years old are eligible to join this clinical trial."

Answered by AI

Who is eligible to participate in this scientific experiment?

"To be eligible for this trial, applicants must suffer from speech-related disorders and fall within the age range of 9 to 15. Approximately 40 participants are required for recruitment."

Answered by AI

What is the maximum capacity of participants for this medical trial?

"Affirmative. According to clinicaltrials.gov, this project remains open and is currently recruiting participants who meet the criteria. The trial was published on January 15th 2022 and its details were last updated June 24th 2022. A total of 40 volunteers are needed at a single site for enrollment in the study."

Answered by AI

Has the FDA authorized Visual Acoustic Biofeedback for medicinal purposes?

"Due to its Phase 2 trial status, our team put Visual Acoustic Biofeedback's safety level at a 2 based on the available data. Unfortunately, there is still no evidence that it can support efficacy in patients."

Answered by AI

Is this research endeavor searching for participants at present?

"Affirmative. According to the information housed on clinicaltrials.gov, this research project is currently recruiting participants and has been since January 15th of 2022. The most recent revision was made on June 24th 2022; 40 individuals are sought from a single site."

Answered by AI