BiOfeedback, Online for Sibilant Treatment

Recruiting now · Not applicable

Conditions studied: Speech Sound Disorder

In brief

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.

Key facts

Study ID

NCT07041723

Run by

Montclair State University

People needed

6

Starts

2025-07-30

Expected to finish

2027-07-01

Last updated by the study team

2025-08-03

Who can join

Age: 8 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Montclair State University — Bloomfield, New Jersey, United States (enrolling)

Full record on ClinicalTrials.gov

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