NCT07041723 · Montclair State University
BiOfeedback, Online for Sibilant Treatment
(BOOST)
What this study is about
The goal of this clinical trial is to evaluate the effectiveness 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.
View original scientific description
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.
Interventions
BEHAVIORAL
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 measures
Perceptually rated accuracy of /s/ production
Time frame: Standard word probes will be elicited at baseline and post treatment (after 20 weeks).
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Bloomfield, New Jersey
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 31, 2026 · Source of record for eligibility and locations