Biofeedback for Speech Sound Disorder

(BOOST Trial)

Overseen By Elaine R. Hitchcock, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Montclair State University

Disqualifiers: Developmental disorder, Major brain injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 27

Duration: 10 weeks

6 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new speech therapy technique called visual-acoustic biofeedback to help children with distortions in their "s" sounds. Researchers aim to determine if using this method via telepractice improves speech and boosts social-emotional well-being. The trial is open to children aged 8 to 17 who speak English, have specific speech sound disorders, and have access to a computer and a quiet space. Participants will receive biofeedback treatment sessions over 10 weeks. As an unphased trial, this study offers a unique opportunity for children to access innovative therapy that could enhance their communication skills and overall well-being.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this biofeedback method is safe for children with speech sound disorder?

Research has shown that visual-acoustic biofeedback is a safe treatment option. This non-invasive therapy does not involve surgery or entering the body. It uses visual cues to help improve speech sounds and is safe for both children and adults.

In past studies, children who used this biofeedback for speech therapy improved faster than with traditional methods. This indicates that the treatment is not only safe but also effective for speech improvement. No major side effects or harm have been reported from using this therapy.

Overall, evidence suggests that visual-acoustic biofeedback is well-tolerated, with no serious safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for Speech Sound Disorder, like traditional speech therapy, involve auditory feedback and practice with a therapist. However, visual-acoustic biofeedback is unique because it uses real-time visual cues to help patients understand and adjust their speech sounds. This method employs the SonaSpeech II software, which displays visual representations of sounds, allowing patients to see how their sibilant sounds compare to target sounds. Researchers are excited about this approach because it offers an interactive and engaging way to enhance speech therapy, potentially speeding up progress and improving outcomes for patients struggling with sibilant sounds.

What evidence suggests that visual-acoustic biofeedback is effective for speech sound disorder?

Research has shown that visual-acoustic biofeedback, which participants in this trial will receive, can help treat speech sound disorders. One study found that visual biofeedback tools, such as the SonaSpeech II software, improve speech by providing real-time visual cues. These cues help individuals understand and correct their speech patterns more easily. Another study demonstrated that delivering this treatment through telepractice (online sessions) is feasible and can be as effective as in-person sessions. Overall, evidence supports that visual-acoustic biofeedback can help children with speech sound disorders improve difficult sounds like /s/. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for children aged between 8 to 17 years with speech sound disorders, specifically distortions of the /s/ sound. They must be available for multiple sessions over a period of weeks and have not received prior treatment during the study's baseline phase.

Inclusion Criteria

Passes pure-tone hearing screening at 30 dB hearing level

I started learning English by age 3, according to my parents.

Access to a laptop or desktop computer and a quiet space for study sessions

Exclusion Criteria

Current presence of orthodontia that crosses the palate (braces and removable retainers are admissible)

Lack of access to a laptop or desktop computer and a quiet space for study sessions

Scaled score of 7 or higher on the Recalling Sentences and Formulated Sentences subtests of the Clinical Evaluation of Language Fundamentals-5 (CELF-5)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants undergo 4-10 baseline sessions where /s/ production is probed but not treated

4-10 sessions

4-10 visits (virtual)

Treatment

Participants receive 20 biofeedback treatment sessions over 10 weeks via teletherapy

10 weeks

20 visits (virtual)

Maintenance

Participants attend 3 maintenance sessions to reinforce treatment gains

3 sessions

3 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Visual-acoustic biofeedback for Sibilants

Trial Overview The trial tests if visual-acoustic biofeedback delivered through online platforms can help improve /s/ sounds in children with speech disorders. It includes an initial evaluation, random assignment to start treatment after 4-10 sessions, followed by 20 treatment sessions and three maintenance sessions.

How Is the Trial Designed?

Group I: Visual acoustic biofeedback Experimental Treatment 1 Intervention

Visual-acoustic biofeedback using the the SonaSpeech II software running the Sona Match module with the real-time FFT function.

Who Is Running the Clinical Trial?

Montclair State University

Lead Sponsor

Trials

14

Recruited

1,200+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5104733/

Differential Effects of Visual-Acoustic Biofeedback ... Recent evidence suggests that the incorporation of visual biofeedback technologies may enhance response to treatment in individuals with residual speech ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07041723

NCT07041723 | BiOfeedback, Online for Sibilant Treatment The goal of this clinical trial is to evaluate the efficacy of sibilant biofeedback treatment delivered via telepractice in six children ages 8:0-17;11 who ...

3. pubs.asha.org pubs.asha.org/doi/abs/10.1044/2023_PERSP-23-00120

Traditional and Visual–Acoustic Biofeedback Treatment via ... This study aimed to examine the feasibility of telepractice delivery of a treatment package including visual–acoustic biofeedback (VAB) and motor-based ...

4. withpower.com withpower.com/trial/phase-2-speech-sound-disorder-6-2024-e152c

Visual-Acoustic Biofeedback for Speech Sound Disorder This research will meet a public health need by systematically evaluating the efficacy of visual-acoustic biofeedback intervention delivered in-person versus ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10023147/

Tutorial: Using Visual–Acoustic Biofeedback for Speech ... This tutorial summarizes current practices using visual–acoustic biofeedback (VAB) treatment to improve speech outcomes for individuals with speech sound ...

6. steinhardt.nyu.edu steinhardt.nyu.edu/news/children-receiving-biofeedback-speech-therapy-improved-faster-traditional-methods

Children Receiving Biofeedback Speech Therapy ... “This study provides the first gold-standard evidence that biofeedback can accelerate progress in treating persistent 'r' difficulties.".

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36623212/

Using Visual-Acoustic Biofeedback for Speech Sound Training This tutorial summarizes current practices using visual-acoustic biofeedback (VAB) treatment to improve speech outcomes for individuals with speech sound ...

8. researchgate.net researchgate.net/publication/388423283_Protocol_for_visual-acoustic_intervention_with_service_delivery_in-person_and_via_telepractice_VISIT_non-inferiority_trial_for_residual_speech_sound_disorder

(PDF) Protocol for visual-acoustic intervention with service ... Protocol for visual-acoustic intervention with service delivery in-person and via telepractice (VISIT) non-inferiority trial for residual speech sound disorder.