BiOfeedback, Online for Sibilant Treatment

Part of paid clinical trials in Bloomfield, New Jersey.

Sponsor
Montclair State University
Study ID
NCT07041723
Status
Recruiting
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Conditions

  • Speech Sound Disorder

Eligibility Criteria

Sex
ALL
Age
8 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Visual-acoustic biofeedback for Sibilants — BEHAVIORAL
    Participants will view a real-time FFT spectrum and will be cued to match a visual target for /s/ where the spectral energy is concentrated to the right side of the display, primarily in the 5000-10,000 Hz region of the spectrum. Practice will occur in blocks of 10 consecutive trials on the same item (e.g., 10 /sa/), after which a new item will be addressed (e.g., 10 /se/). Within each block, the clinician will provide qualitative (knowledge of performance) feedback as prompted by the research team's custom open-source software, Challenge Point Program (CPP). The CPP software prompts clinician actions such as delivery of knowledge of performance (KP) feedback. Following each block of ten trials, the software automatically tallies the scores entered by the clinician and uses the summed scores to make adaptive changes in practice difficulty.

Study Details

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 present with distortions of /s/. The main questions it aims to answer are: * Primary hypothesis: Biofeedback treatment for sibilants delivered via telepractice will produce positive gains compared to a no-treatment baseline phase. * Secondary hypothesis: Participants will experience positive changes in social-emotional well-being after receiving biofeedback treatment for sibilants as reported by the participants and their guardians. Following the initial evaluation, participants will be randomly assigned to transition from baseline to treatment at one of seven possible points, ranging from 4-10 baseline sessions in which /s/ production will be probed but not treated. All participants will then receive 20, 1-hour biofeedback treatment sessions over 10 weeks with a certified Speech-Language Pathologist via teletherapy, followed by three maintenance sessions.

Key Dates

Start date
Jul 30, 2025
Status verified
Jul 2025
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
6 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Perceptually rated accuracy of /s/ production [ Time Frame: Standard word probes will be elicited at baseline and post treatment (after 20 weeks). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Montclair State UniversityBloomfieldNew Jersey07003
Elaine R. Hitchcock, PhD
[email protected]
9732293797
[email protected]
Elaine R. Hitchcock, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Montclair State University· Bloomfield, NJ

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