CompletedNot Applicable

Correcting Residual Errors With Spectral, Ultrasound, Traditional Speech Therapy

United States108 participantsStarted 2019-03-01

Plain-language summary

Children with speech sound disorder show diminished accuracy and intelligibility in spoken communication and may thus be perceived as less capable or intelligent than peers, with negative consequences for both socioemotional and socioeconomic outcomes. While most speech errors resolve by the late school-age years, between 2-5% of speakers exhibit residual speech errors (RSE) that persist through adolescence or even adulthood, reflecting about 6 million cases in the US. Both affected children/families and speech-language pathologists (SLPs) have highlighted the critical need for research to identify more effective forms of treatment for children with RSE. In a series of single-case experimental studies, research has found that treatment incorporating technologically enhanced sensory feedback (visual-acoustic biofeedback, ultrasound biofeedback) can improve speech in individuals with RSE who have not responded to previous intervention. A randomized controlled trial (RCT) comparing traditional vs biofeedback-enhanced intervention is the essential next step to inform evidence-based decision-making for this prevalent population. Larger-scale research is also needed to understand heterogeneity across individuals in the magnitude of response to biofeedback treatment. The overall objective of this proposal is to conduct clinical research that will guide the evidence-based management of RSE while also providing novel insights into the sensorimotor underpinnings of speech. The central hypothesis is that biofeedback will yield greater gains in speech accuracy than traditional treatment, and that individual deficit profiles will predict relative response to visual-acoustic vs ultrasound biofeedback. This study will enroll n = 118 children who misarticulate the /r/ sound, the most common type of RSE. This first component of the study will evaluate the efficacy of biofeedback relative to traditional treatment in a well-powered randomized controlled trial. Ultrasound and visual-acoustic biofeedback, which have similar evidence bases, will be represented equally.

Who can participate

Age range

9 Years – 15 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Must be between 9;0 and 15;11 years of age at the time of enrollment. * Must speak English as the dominant language (i.e., must have begun learning English by age 2, per parent report). * Must speak a rhotic dialect of English. * Must pass a pure-tone hearing screening at 20 decibels Hearing Level (HL). * Must pass a brief examination of oral structure and function. * Must exhibit less than thirty percent accuracy, based on trained listener ratings, on a probe list eliciting /r/ in various phonetic contexts at the word level. Exclusion Criteria: * Must not receive a T score more than 1.3 standard deviations (SD) below the mean on the Wechsler Abbreviated Scale of Intelligence-2 (WASI-2) Matrix Reasoning. * Must not receive a standard score below 80 on the Core Language Index of the Clinical Evaluation of Language Fundamentals-5 (CELF-5). * Must not exhibit voice or fluency disorder of a severity judged likely to interfere with the ability to participate in study activities. * Must not have an existing diagnosis of developmental disability or major neurobehavioral syndrome such as cerebral palsy, Down Syndrome, or Autism Spectrum Disorder, or major neural disorder (e.g., epilepsy, agenesis of the corpus callosum) or insult (e.g., traumatic brain injury, stroke, or tumor resection). * Must not show clinically significant signs of apraxia of speech or dysarthria.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in F3-F2 Distance (Hz) Across Sessions, Measured From /r/ Sounds Produced in Syllables or Words During Practice.

Timeframe: Phase I: three 90-min treatment sessions delivered over ~1 week; reported value is the change from Session 1 to Session 3 (slope across sessions)

Trial details

NCT IDNCT03737318

SponsorNew York University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-31

Results submitted2025-09-04

View on ClinicalTrials.gov More Speech Sound Disorder trials