Clinical trial NCT03736213: Delineation of Sensorimotor Subtypes Underlying Residual Speech Errors
Official title: Correcting Residual Errors With Spectral, Ultrasound, and Traditional Speech Therapy: Delineation of Sensorimotor Subtypes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Speech Sound Disorder
Keywords: speech
articulation
motor development
Lead sponsor: New York University
Sponsor class: OTHER
Collaborators: name: Syracuse University
name: Montclair State University
name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2018-11-09
Enrollment: 7
Sex: ALL
Minimum age (years): 9
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Normalized F3-F2 Distance, an Acoustic Measure That Correlates With Perceptual Accuracy of /r/, Measured From /r/ Sounds Produced in Treatment Sessions.
timeFrame: Acoustic accuracy was measured in all ten sessions of each type of treatment, which were administered over five weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Bloomfield
country: United States
facility: Montclair State University
state: New Jersey
city: New York
country: United States
facility: New York University
state: New York
city: Syracuse
country: United States
facility: Syracuse University
state: New York
Study officials:
References:
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.
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.
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.
citation: Preston JL, Holliman-Lopez G, Leece MC. Do Participants Report Any Undesired Effects in Ultrasound Speech Therapy? Am J Speech Lang Pathol. 2018 May 3;27(2):813-818. doi: 10.1044/2017_AJSLP-17-0121.
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.
citation: Preston JL, Leece MC, Maas E. Motor-based treatment with and without ultrasound feedback for residual speech-sound errors. Int J Lang Commun Disord. 2017 Jan;52(1):80-94. doi: 10.1111/1460-6984.12259. Epub 2016 Jun 14.
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.
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.
citation: McAllister Byun T. Efficacy of Visual-Acoustic Biofeedback Intervention for Residual Rhotic Errors: A Single-Subject Randomization Study. J Speech Lang Hear Res. 2017 May 24;60(5):1175-1193. doi: 10.1044/2016_JSLHR-S-16-0038.
citation: McAllister Byun T, Tiede M. Perception-production relations in later development of American English rhotics. PLoS One. 2017 Feb 16;12(2):e0172022. doi: 10.1371/journal.pone.0172022. eCollection 2017.
citation: McAllister Byun T, Campbell H. Differential Effects of Visual-Acoustic Biofeedback Intervention for Residual Speech Errors. Front Hum Neurosci. 2016 Nov 11;10:567. doi: 10.3389/fnhum.2016.00567. eCollection 2016.
citation: McAllister Byun T, Halpin PF, Szeredi D. Online crowdsourcing for efficient rating of speech: a validation study. J Commun Disord. 2015 Jan-Feb;53:70-83. doi: 10.1016/j.jcomdis.2014.11.003. Epub 2014 Dec 15.
citation: Hitchcock ER, Byun TM, Swartz M, Lazarus R. Efficacy of Electropalatography for Treating Misarticulation of /r/. Am J Speech Lang Pathol. 2017 Nov 8;26(4):1141-1158. doi: 10.1044/2017_AJSLP-16-0122.
citation: Harel D, Hitchcock ER, Szeredi D, Ortiz J, McAllister Byun T. Finding the experts in the crowd: Validity and reliability of crowdsourced measures of children's gradient speech contrasts. Clin Linguist Phon. 2017;31(1):104-117. doi: 10.3109/02699206.2016.1174306. Epub 2016 Jun 7.
citation: Hitchcock ER, Harel D, Byun TM. Social, Emotional, and Academic Impact of Residual Speech Errors in School-Aged Children: A Survey Study. Semin Speech Lang. 2015 Nov;36(4):283-94. doi: 10.1055/s-0035-1562911. Epub 2015 Oct 12.
citation: Hitchcock ER, Byun TM. Enhancing generalisation in biofeedback intervention using the challenge point framework: a case study. Clin Linguist Phon. 2015 Jan;29(1):59-75. doi: 10.3109/02699206.2014.956232. Epub 2014 Sep 12.
citation: Byun TM, Hitchcock ER, Swartz MT. Retroflex versus bunched in treatment for rhotic misarticulation: evidence from ultrasound biofeedback intervention. J Speech Lang Hear Res. 2014 Dec;57(6):2116-30. doi: 10.1044/2014_JSLHR-S-14-0034.
citation: Byun TM, Hitchcock ER. Investigating the use of traditional and spectral biofeedback approaches to intervention for /r/ misarticulation. Am J Speech Lang Pathol. 2012 Aug;21(3):207-21. doi: 10.1044/1058-0360(2012/11-0083). Epub 2012 Mar 21.
citation: Lee S, Potamianos A, Narayanan S. Acoustics of children's speech: developmental changes of temporal and spectral parameters. J Acoust Soc Am. 1999 Mar;105(3):1455-68. doi: 10.1121/1.426686.
citation: Benway NR, Hitchcock ER, McAllister T, Feeny GT, Hill J, Preston JL. Comparing Biofeedback Types for Children With Residual /ɹ/ Errors in American English: A Single-Case Randomization Design. Am J Speech Lang Pathol. 2021 Jul 14;30(4):1819-1845. doi: 10.1044/2021_AJSLP-20-00216. Epub 2021 Jul 7.