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Speech Sound DisorderBOOSTNCT07041723

BiOfeedback, Online for Sibilant Treatment

A study testing Visual-acoustic biofeedback for Sibilants in people with Speech Sound Disorder, run by Montclair State University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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/. Read more about this study

Who is it for?
Ages 8 to 17 years
Conditions the study is for
Speech Sound Disorder
What is being tested?
Visual-acoustic biofeedback for Sibilants
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
30 Jul 2025to Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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)
Show all 10Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • Montclair State University

    Bloomfield, New Jersey, 07003

    Elaine R. Hitchcock, PhD, 9732293797 ext. 973 655-7355, hitchcocke@montclair.edu

    hitchcocke@montclair.edu

    Recruiting

Other trials in United States

About this study

Official title: Online Assessment and Enhancement of Auditory Perception for Speech Sound Errors: 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 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.

Read the detailed description

Study 2 will evaluate children with residual speech sound disorder affecting /s/ (n = 6). Both male and female children will be recruited. Participants must be between 8;0 and 17;11 years of age at the time of enrollment.

Randomization. Following the initial evaluation to determine eligibility, participants will be randomly assigned to transition from the baseline to the treatment condition at one of 7 possible points, ranging from 4 to 10 baseline sessions in which /s/ production will be probed but not treated. All participants will then receive 20 sessions of /s/ production training over 10 weeks, followed by 3 maintenance sessions.

Intervention Delivery. All treatment will be provided on an individual basis by a certified speech-language pathologist. Treatment will be delivered over Zoom videoconference calls using a unique password-protected room for each participant. In the beginning of each session a standard probe eliciting /s/ in various contexts at the sentence, word and syllable levels will be elicited. Following the /s/ probes, the session will consist of relatively unstructured, highly interactive prepractice for 10 minutes, which is designed to provide instruction on the phonetic requirements for /s/ and shaping strategies to transform the child's current productions into accurate /s/. The remainder of the session will elicit up to 150 syllables/words or 40 minutes of practice, whichever occurs first. 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, promoting increased fidelity in treatment implementation both within and across sites. It also enables systematic changes in practice difficulty based on participant performance, as follows: after the software presents a stimulus and the participant attempts to produce it, the clinician scores the response as 0 or 1 based on their clinical impression of an incorrect or correct production of /s/. Following each block of ten trials, the software automatically tallies the scores entered by the clinician and uses them to make adaptive changes in practice difficulty. When a participant demonstrates at least 80% cumulative accuracy at the session level, the participants will be advanced from syllable to word-level practice; if the cumulative session-level accuracy drops below 50%, the participants will be dropped back to the syllable level to decrease difficulty. In word-level practice, parameters are adjusted on a rotating basis so that as accuracy increases, either the frequency of feedback is reduced (80%-50%-20%-0%), clinician models are faded, or word shapes increase in complexity. Qualitative feedback (either biofeedback or verbal clinician feedback) will begin at 80% of trials and, contingent upon the participant's performance, will be systematically decreased to 0% .

Being tested
Visual-acoustic biofeedback for Sibilants
Keywords
speech intervention, biofeedback, articulation disorder, lisp
Medical subject headings
Speech Sound Disorder, Articulation Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Visual-acoustic biofeedback for SibilantsBehavioural

    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 groups in NCT07041723
Study groupRoleWhat they receive
Visual acoustic biofeedbackExperimentalVisual-acoustic biofeedback using the the SonaSpeech II software running the Sona Match module with the real-time FFT function.
Receives: Behavioral: Visual-acoustic biofeedback for Sibilants

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (1)
  1. Survey evaluating impacts of treatment on participants' socio-emotional well-being

    This 11-item survey, which asks parents to report the impact of speech disorder on the child's social, emotional, and academic well-being, was validated in a published study by members of the research team. An impact score, calculated as described in the research team's previous research, will be used as the primary measure of socio-emotional well-being.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2025
  2. Study start30 Jul 2025
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
6 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07041723
Sponsor's protocol ID
20-21-2137-Study 5
Other IDs
2R15DC019775-02
Acronym
BOOST
Status last verified
Aug 2026
First submitted
4 Jun 2025
Last updated
31 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 36623212
  • 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.

  • 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.

    PubMed 33520098
  • 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.

    PubMed 22421491
  • 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.

    PubMed 25945230
  • 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.

    PubMed 28814995

Questions about this trial

What is this clinical trial studying?

A study testing Visual-acoustic biofeedback for Sibilants in people with Speech Sound Disorder, run by Montclair State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Elaine R. Hitchcock, PhD (19732293797 ext. 973 655-7355, hitchcocke@montclair.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07041723, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.

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