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N/A N=108 Randomized Single-blind Treatment

Correcting Residual Errors With Spectral, Ultrasound, Traditional Speech Therapy

Speech Sound Disorder

Enrolled (actual)
108
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Change in F3-F2 Distance (Hz) Across Sessions, Measured From /r/ Sounds Produced in Syllables or Words During Practice. — 38.2; 66.7; 85.2 Hertz / session — p=< .0001

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Biofeedback-ultrasound (Behavioral); Biofeedback--visual-acoustic (Behavioral); Traditional articulation treatment (Behavioral)
Age
Pediatric · 9+ yrs
Sex
All
Sponsor
New York University
Primary completion
Aug 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in F3-F2 Distance (Hz) Across Sessions, Measured From /r/ Sounds Produced in Syllables or Words During Practice.
38.2; 66.7; 85.2 < .0001 sig
SECONDARY
Change From Pre to Post in Percent "Correct" Ratings by Untrained Listeners, for /r/ Sounds Produced in Word Probes.
44.5; 43.2; 49.6 < .001 sig
SECONDARY
Impact of Speech Disorder on Social, Emotional, and Academic Well-being (Parent Survey)
1.9; 1.9; 2.1 .80

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.

Eligibility Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03737318). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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