Recruiting

Biofeedback Treatment

Sponsor:

Montclair State University

Code:

NCT07041723

Conditions

Speech Sound Disorder

Eligibility Criteria

Sex: All

Age: 8 - 17

Healthy Volunteers: Not accepted

Interventions

Visual-acoustic biofeedback for Sibilants

Study Details

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

Study ID

NCT07041723

Start date

Jul 30, 2025

Status verified date

Aug, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

6 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Visual-acoustic biofeedback for Sibilants

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.

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 and Locations

Central contacts

Elaine R. Hitchcock, PhD

19732293797hitchcocke@montclair.edu

Locations

Montclair State University

Recruiting

Bloomfield, New Jersey, United States, 07003

Contacts

Elaine R. Hitchcock, PhD

9732293797hitchcocke@montclair.edu

hitchcocke@montclair.edu

Principal Investigator:

Elaine R. Hitchcock, PhD

More Information

Sponsor

Montclair State University

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Keywords

  • speech intervention
  • biofeedback
  • articulation disorder
  • lisp

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montclair State University on 2026-08-31.