Actively Recruiting

Phase Not Applicable
Age: 8Years - 17Years
All Genders
NCT07041723

BiOfeedback, Online for Sibilant Treatment

Led by Montclair State University · Updated on 2025-08-03

6

Participants Needed

1

Research Sites

100 weeks

Total Duration

On this page

Sponsors

M

Montclair State University

Lead Sponsor

N

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

BiOfeedback, Online for Sibilant Treatment

Who Can Participate

Age: 8Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Montclair State University

Bloomfield, New Jersey, United States, 07003

Actively Recruiting

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Research Team

E

Elaine R. Hitchcock, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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