Delineation of Sensorimotor Subtypes Underlying Residual Speech Errors (C-RESULTS)

December 7, 2023 updated by: New York University

Correcting Residual Errors With Spectral, Ultrasound, and Traditional Speech Therapy: Delineation of Sensorimotor Subtypes

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. Further research is 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 individual deficit profiles will predict relative response to visual-acoustic vs ultrasound biofeedback. From the larger population of children with RSE evaluated as part of C-RESULTS-RCT (Correcting Residual Errors With Spectral, Ultrasound, Traditional Speech Therapy Randomized Controlled Trial), a subset of 8 children will be selected who show a deficit in one domain (auditory or somatosensory) and intact perception in the other. Single-case methods will be used to test the hypothesis that sensory deficit profiles differentially predict response to visual-acoustic vs ultrasound biofeedback.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Single-Case Randomization Component: At the group level, speakers with RSE show poorer auditory and oral somatosensory acuity than typically developing (TD) speakers, but individuals differ in the extent to which each sensory domain is impacted. The objective of this aim is to evaluate how distinct sensory profiles mediate relative response to different types of biofeedback, with the goal of optimizing treatment through personalized learning. This study will test the working hypothesis that visual-acoustic biofeedback will produce larger gains in children whose deficit primarily affects the specification of the auditory target, while ultrasound biofeedback will produce larger gains in children with a primary somatosensory deficit. The main approach to testing this hypothesis is to select, from the larger population of children with RSE evaluated as part of C-RESULTS-RCT, a subset of 8 children who show asymmetric sensory profiles (strong auditory and weak somatosensory acuity, or vice versa). These children will be enrolled in a single-case experimental design where individual treatment sessions are randomly assigned to feature visual-acoustic or ultrasound biofeedback. Participants will complete 20 hrs of treatment (10 days, 2 sessions per day) over a 5 week period. Acoustic measures will be used to evaluate /r/ production accuracy within each session. Randomization tests will be used to evaluate differences in accuracy between ultrasound and visual-acoustic biofeedback treatment conditions.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Bloomfield, New Jersey, United States, 07003
        • Montclair State University
    • New York
      • New York, New York, United States, 10012
        • New York University
      • Syracuse, New York, United States, 13244
        • Syracuse University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 15 years (Child)

Accepts Healthy Volunteers

Yes

Description

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 (dB) 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.
  • Must show 0-5% accuracy in production of /r/ at the syllable level, based on treating clinicians' perceptual ratings, during an initial Dynamic Assessment phase consisting of 2 hours of traditional (non-biofeedback) instruction.
  • Must fit one of two profiles: (1) primary auditory deficit (scores outside the normative predictive interval for auditory measures assessing identification and discrimination of synthetic speech stimuli, but within the normative predictive interval for measures of oral stereognosis and articulator placement awareness or (2) primary somatosensory deficit, with the reverse profile of spared/impaired sensory function.

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, 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Visual-acoustic biofeedback
Visual-acoustic biofeedback treatment targeting /r/ distortions.
Behavioral: Visual-acoustic biofeedback
In visual-acoustic biofeedback treatment, the elements of traditional articulatory treatment (i.e., 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 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. I
Experimental: Ultrasound biofeedback
Ultrasound biofeedback treatment targeting /r/ distortions.
Behavioral: Ultrasound biofeedback
In ultrasound biofeedback, the elements of traditional articulatory treatment 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Normalized F3-F2 Distance, an Acoustic Measure That Correlates With Perceptual Accuracy of /r/, Measured From /r/ Sounds Produced in Treatment Sessions.
Time Frame: Acoustic accuracy was measured in all ten sessions of each type of treatment, which were administered over five weeks.
During treatment, one trial in each block of 10 was flagged for measurement and the first three formants (F1, F2, F3) were extracted from the center of the /r/ interval. The distance between the second and third formants (F3-F2) was converted to z-scores relative to normative data from age-matched children with typical speech (Lee et al., 1999). A z-score of 0 represents the mean F3-F2 distance for typical children; a z-score of 1 indicates one standard deviation of the normative sample above the sample mean. Because F3-F2 is small in perceptually accurate /r/, larger values indicate lower accuracy; z-scores above 2 are considered clinically atypical. Summary statistics report the mean and standard deviation of normalized F3-F2 distance for each treatment condition, pooled across participants and sessions. A two-tailed paired-samples t-test (superiority criterion) was used to compare mean normalized F3-F2 distance for each treatment condition across subjects.
Acoustic accuracy was measured in all ten sessions of each type of treatment, which were administered over five weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York University

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)
Syracuse University
Montclair State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Actual)

February 1, 2022

Study Completion (Actual)

February 1, 2022

Study Registration Dates

First Submitted

November 7, 2018

First Submitted That Met QC Criteria

November 7, 2018

First Posted (Actual)

November 9, 2018

Study Record Updates

Last Update Posted (Estimated)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 7, 2023

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-RESULTS-SCED
  • R01DC017476 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Speech Sound Disorder

Clinical Trials on Visual-acoustic biofeedback

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe