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

Primary Purpose

Speech Sound Disorder

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Visual-acoustic biofeedback
Ultrasound biofeedback
Sponsored by
New York University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Speech Sound Disorder focused on measuring speech, articulation, motor development

Eligibility Criteria

9 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Montclair State University
  • New York University
  • Syracuse University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Visual-acoustic biofeedback

Ultrasound biofeedback

Arm Description

Visual-acoustic biofeedback treatment targeting /r/ distortions.

Ultrasound biofeedback treatment targeting /r/ distortions.

Outcomes

Primary Outcome Measures

Normalized F3-F2 Distance, an Acoustic Measure That Correlates With Perceptual Accuracy of /r/, Measured From /r/ Sounds Produced in Treatment Sessions.
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.

Secondary Outcome Measures

Full Information

First Posted
November 7, 2018
Last Updated
December 8, 2022
Sponsor
New York University
Collaborators
Syracuse University, Montclair State University, National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT03736213
Brief Title
Delineation of Sensorimotor Subtypes Underlying Residual Speech Errors
Acronym
C-RESULTS
Official Title
Correcting Residual Errors With Spectral, Ultrasound, and Traditional Speech Therapy: Delineation of Sensorimotor Subtypes
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
February 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York University
Collaborators
Syracuse University, Montclair State University, National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Speech Sound Disorder
Keywords
speech, articulation, motor development

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Model Description
In this single-case randomization design, each participant will receive an equal number of sessions of visual-acoustic and ultrasound biofeedback, with randomized allocation of treatment types to individual sessions. Treatment will last 20 hrs (10 days) over a 5 week period. Randomization will be blocked, with each day of treatment serving as a block; within each day, one hour of treatment will be randomly assigned to feature visual-acoustic and one to feature ultrasound treatment. A congruent condition and an incongruent condition will be defined for each participant based on their sensory profile, where the congruent condition is the biofeedback type that is expected to be more effective and the incongruent condition is the type expected to be less effective. Visual-acoustic biofeedback is defined as the congruent condition for individuals with a primary auditory deficit and ultrasound biofeedback is defined as congruent for individuals with a primary somatosensory deficit.
Masking
Outcomes Assessor
Masking Description
All perceptual ratings will be obtained from blinded, naive listeners recruited through online crowdsourcing. Following protocols refined in previous published research, binary rating responses will be aggregated over at least 9 unique listeners per token.
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Visual-acoustic biofeedback
Arm Type
Experimental
Arm Description
Visual-acoustic biofeedback treatment targeting /r/ distortions.
Arm Title
Ultrasound biofeedback
Arm Type
Experimental
Arm Description
Ultrasound biofeedback treatment targeting /r/ distortions.
Intervention Type
Behavioral
Intervention Name(s)
Visual-acoustic biofeedback
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Ultrasound biofeedback
Intervention Description
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.
Primary Outcome Measure Information:
Title
Normalized F3-F2 Distance, an Acoustic Measure That Correlates With Perceptual Accuracy of /r/, Measured From /r/ Sounds Produced in Treatment Sessions.
Description
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.
Time Frame
Acoustic accuracy was measured in all ten sessions of each type of treatment, which were administered over five weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 (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.
Facility Information:
Facility Name
Montclair State University
City
Bloomfield
State/Province
New Jersey
ZIP/Postal Code
07003
Country
United States
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10012
Country
United States
Facility Name
Syracuse University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13244
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30199271
Citation
Preston JL, McCabe P, Tiede M, Whalen DH. Tongue shapes for rhotics in school-age children with and without residual speech errors. Clin Linguist Phon. 2019;33(4):334-348. doi: 10.1080/02699206.2018.1517190. Epub 2018 Sep 10.
Results Reference
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Citation
Preston JL, McAllister T, Phillips E, Boyce S, Tiede M, Kim JS, Whalen DH. Treatment for Residual Rhotic Errors With High- and Low-Frequency Ultrasound Visual Feedback: A Single-Case Experimental Design. J Speech Lang Hear Res. 2018 Aug 8;61(8):1875-1892. doi: 10.1044/2018_JSLHR-S-17-0441.
Results Reference
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PubMed Identifier
29792525
Citation
Dugan SH, Silbert N, McAllister T, Preston JL, Sotto C, Boyce SE. Modelling category goodness judgments in children with residual sound errors. Clin Linguist Phon. 2019;33(4):295-315. doi: 10.1080/02699206.2018.1477834. Epub 2018 May 24.
Results Reference
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29546269
Citation
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Citation
Preston JL, McAllister Byun T, Boyce SE, Hamilton S, Tiede M, Phillips E, Rivera-Campos A, Whalen DH. Ultrasound Images of the Tongue: A Tutorial for Assessment and Remediation of Speech Sound Errors. J Vis Exp. 2017 Jan 3;(119):55123. doi: 10.3791/55123.
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Results Reference
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PubMed Identifier
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Citation
Campbell H, Harel D, Hitchcock E, McAllister Byun T. Selecting an acoustic correlate for automated measurement of American English rhotic production in children. Int J Speech Lang Pathol. 2018 Nov;20(6):635-643. doi: 10.1080/17549507.2017.1359334. Epub 2017 Aug 10.
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Citation
Campbell H, McAllister Byun T. Deriving individualised /r/ targets from the acoustics of children's non-rhotic vowels. Clin Linguist Phon. 2018;32(1):70-87. doi: 10.1080/02699206.2017.1330898. Epub 2017 Jul 13.
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Results Reference
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Delineation of Sensorimotor Subtypes Underlying Residual Speech Errors

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