Clinical Trials Directory

Trials / Completed

CompletedNCT03737318

Correcting Residual Errors With Spectral, Ultrasound, Traditional Speech Therapy

Correcting Residual Errors With Spectral, Ultrasound, and Traditional Speech Therapy: A Randomized Controlled Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
108 (actual)
Sponsor
New York University · Academic / Other
Sex
All
Age
9 Years – 15 Years
Healthy volunteers
Accepted

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.

Detailed description

Randomized Trial Component: Previous findings suggest that biofeedback interventions can outperform traditional speech therapy for children with RSE, but the research base to date is limited to small-scale studies that do not reach the level of evidence needed to support large-scale changes in practice. The primary objective of the C-RESULTS RCT is to test the working hypothesis that a group of individuals randomly assigned to receive biofeedback-enhanced treatment will show larger and/or faster gains in /r/ production accuracy than an equivalent group receiving the same dose of non-biofeedback treatment. To test this hypothesis, n=110 children will be randomly assigned to receive a standard course of intervention with or without biofeedback. Acoustic and perceptual measures will be used to test for differences in both short-term learning of treated targets (Acquisition) and longer-term carryover of learning to untreated contexts (Generalization). In addition, a survey assessing participants' socio-emotional well-being will be collected from caregivers both pre and post treatment.

Conditions

Interventions

TypeNameDescription
BEHAVIORALBiofeedback-ultrasoundIn ultrasound biofeedback, the elements of traditional treatment (auditory models and verbal descriptions of articulator placement) are enhanced with a real-time ultrasound display of the shape and movements of the tongue. One or two target tongue shapes will be selected for each participant, and a trace of the selected target will be superimposed over the ultrasound screen. Participants will be cued to reshape the tongue to match this target during /r/ production.
BEHAVIORALBiofeedback--visual-acousticIn visual-acoustic biofeedback treatment, the elements of traditional treatment (auditory models and verbal descriptions of articulator placement) are enhanced with a dynamic display of the speech signal in the form of the real-time LPC (Linear Predictive Coding) spectrum. Because correct vs incorrect productions of /r/ contrast acoustically in the frequency of the third formant (F3), participants will be cued to make their real-time LPC spectrum match a visual target characterized by a low F3 frequency. They will be encouraged to attend to the visual display while adjusting the placement of their articulators and observing how those adjustments impact F3.
BEHAVIORALTraditional articulation treatmentTraditional articulation treatment involves providing auditory models and verbal descriptions of correct articulator placement, then cueing repetitive motor practice. Images and diagrams of the vocal tract will be used as visual aids; however, no real-time visual display of articulatory or acoustic information will be made available.

Timeline

Start date
2019-03-01
Primary completion
2024-08-31
Completion
2024-08-31
First posted
2018-11-09
Last updated
2026-01-05
Results posted
2026-01-05

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT03737318. Inclusion in this directory is not an endorsement.