BiOfeedback, Online for Sibilant Treatment

ConditionSpeech Sound Disorder

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age8-17

SponsorMontclair State University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

Visual-acoustic biofeedback for Sibilants
Behavioral
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.

Treatment groups

6 Participants

are divided into 1 treatment group

Group A: Visual acoustic biofeedbackExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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

Secondary outcomes

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.

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Montclair State University

Lead sponsor

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Source ClinicalTrials.gov

Apply now