BiOfeedback, Online for Sibilant Treatment

NCT07041723 | Recruiting DMC

• 2 other identifiers: 20-21-2137-Study 52R15DC019775-02
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Speech Sound Disorder

Keywords

speech intervention; biofeedback; articulation disorder; lisp

Outcome Measures

Primary Outcomes (1)

• Perceptually rated accuracy of /s/ production

  To assess generalization of perceptual training to production, participants will be assessed with standard probes administered in the first three baseline sessions , at the start of each treatment session and in three post-treatment maintenance sessions. Probes will elicit 60 words \[considered the primary target\], containing /s, z/ in various phonetic contexts. Stimuli in each probe will be presented individually in randomized order. No auditory models will be provided; for children with reading difficulty, semantic cues will be provided to elicit the intended word. Individual words will be isolated from the audio record of each word probe and presented in randomized order for binary rating (correct/incorrect) by 4 trained listeners who are blind to treatment condition and time point (but will see the written representation of each target word). The proportion of "correct" ratings for each token will be used as the measure of perceptually rated accuracy.

  Standard word probes will be elicited at baseline and post treatment (after 20 weeks).

Secondary Outcomes (1)

• Survey evaluating impacts of treatment on participants' socio-emotional well-being

  The survey will be administered at baseline and post-treatment (after 20 weeks).

Study Arms (1)

Visual acoustic biofeedback

EXPERIMENTAL

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

Behavioral: Visual-acoustic biofeedback for Sibilants

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.

Visual acoustic biofeedback

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age between 8;0 and 17;11 years at the time of enrollment
• English as the dominant language (must have begun learning English by age 3, per parent report)
• Passes pure-tone hearing screening at 30 dB hearing level
• Passes brief examination of oral structure and function
• Less than 30% accuracy, based on consensus across 2 trained listeners, on a probe list eliciting fricative /s, z/ in various phonetic contexts at the word level
• No more than 3 sounds other than /s/ in error on the Goldman-Fristoe Test of Articulation-3 (GFTA-3)
• Diagnosis of ADHD, learning disability, dyslexia, or neurodiversity is admissible if participant meets cutoff scores on evaluation day 1
• History of CAS is admissible if participant meets cutoff scores on evaluation day 1
• Braces and removable retainers are admissible
• Access to a laptop or desktop computer and a quiet space for study sessions

You may not qualify if:

• Scaled score of 7 or higher on the Recalling Sentences and Formulated Sentences subtests of the Clinical Evaluation of Language Fundamentals-5 (CELF-5)
• History of permanent hearing loss (temporary hearing loss due to otitis media, including recurrent OM/tubes, is admissible)
• History of developmental disorder (e.g., Down syndrome, cerebral palsy)
• History of major brain injury, surgery, or stroke in the past year (mild concussion is admissible)
• Active diagnosis of epilepsy or other neurological disorder (permissible if well-controlled for at least 6 months)
• Current diagnosis of voice or fluency disorder
• 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

Sponsors & Collaborators

• Montclair State University: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Montclair State University

Bloomfield, New Jersey, 07003, United States

RECRUITING

Related Publications (6)

• Hitchcock ER, Ochs LC, Swartz MT, Leece MC, Preston JL, McAllister T. Tutorial: Using Visual-Acoustic Biofeedback for Speech Sound Training. Am J Speech Lang Pathol. 2023 Jan 11;32(1):18-36. doi: 10.1044/2022_AJSLP-22-00142. Epub 2023 Jan 9.

  PMID: 36623212 BACKGROUND

• Shriberg, L.D., R. Paul, and P. Flipsen, Childhood speech sound disorders: From crow to the postgenomic era. Speech sound disorders in children, 2009: p. 1-33.

  BACKGROUND

• Kraljevic JK, Matic A, Dokoza KP. Telepractice as a Reaction to the COVID-19 Crisis: Insights from Croatian SLP Settings. Int J Telerehabil. 2020 Dec 8;12(2):93-104. doi: 10.5195/ijt.2020.6325.

  PMID: 33520098 BACKGROUND

• Whitehead E, Dorfman V, Tremper G, Kramer A, Sigler A, Gosman A. Telemedicine as a means of effective speech evaluation for patients with cleft palate. Ann Plast Surg. 2012 Apr;68(4):415-7. doi: 10.1097/SAP.0b013e31823b6897.

  PMID: 22421491 BACKGROUND

• Lincoln M, Hines M, Fairweather C, Ramsden R, Martinovich J. Multiple stakeholder perspectives on teletherapy delivery of speech pathology services in rural schools: a preliminary, qualitative investigation. Int J Telerehabil. 2015 Jan 29;6(2):65-74. doi: 10.5195/IJT.2014.6155. eCollection 2014 Fall.

  PMID: 25945230 BACKGROUND

• Wales D, Skinner L, Hayman M. The Efficacy of Telehealth-Delivered Speech and Language Intervention for Primary School-Age Children: A Systematic Review. Int J Telerehabil. 2017 Jun 29;9(1):55-70. doi: 10.5195/ijt.2017.6219. eCollection 2017 Spring.

  PMID: 28814995 BACKGROUND

MeSH Terms

Conditions

Speech Sound Disorder; Articulation Disorders

Condition Hierarchy (Ancestors)

Communication Disorders; Neurodevelopmental Disorders; Mental Disorders; Speech Disorders; Language Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Elaine R. Hitchcock, PhD

CONTACT

19732293797; hitchcocke@montclair.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: For all treatment sessions, the participant and SLP will meet in a secure videoconference room. Participants will be provided with a standard headset with microphone (Plantronics Blackwire C3225) to capture their voice as input to the SonaSpeech II software running the SonaMatch real time FFT function. Information about the distribution of energy across the frequency range from the FFT spectrum has been found to reliably differentiate /s/ from other fricatives; clinically, this can be translated to differentiated perceptually accurate /s/ from misarticulated productions. 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. Other aspects of the treatment protocol will follow the current research team's published guidelines for biofeedback intervention, modified for /s/ targets.

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 27, 2025
• Study Start: July 30, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)