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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04625062
Other study ID # C-RESULTS-TPT
Secondary ID R01DC017476
Status Completed
Phase Phase 1
First received
Last updated
Start date September 1, 2020
Est. completion date March 18, 2021

Study information

Verified date November 2020
Source New York University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to evaluate the relative efficacy of biofeedback and traditional treatment for residual speech errors when both are delivered via telepractice. In a single-case randomization design, up to eight children with RSE will receive both visual-acoustic biofeedback and traditional treatment via telepractice. Acoustic measures of within-session change will be compared across sessions randomly assigned to each condition. It is hypothesized that participants will exhibit a clinically significant overall treatment response and that short-term measures of change will indicate that biofeedback is associated with larger increments of progress than traditional treatment.


Description:

The COVID-19 crisis has forced speech-language pathologists to migrate from in-person delivery of speech treatment services to remote delivery via telepractice. This study will compare the efficacy of visual-acoustic biofeedback treatment versus non-biofeedback treatment in this setting. Specifically, participants will receive both visual-acoustic biofeedback treatment and non-biofeedback treatment via telepractice (Zoom call with screen-sharing) in a single-case randomization design. The hypothesis of interest is that sessions featuring visual-acoustic biofeedback will be associated with larger short-term gains than sessions featuring non-biofeedback treatment. To test this hypothesis, the study team will recruit up to 8 participants who will receive an initial treatment orientation followed by an equal dose of both types of treatment (10 sessions of visual-acoustic biofeedback and 10 sessions of non-biofeedback treatment). Participants will complete approximately two sessions per week via telepractice; each week will feature one session of each type, randomly ordered. They will also complete 4 pre-treatment baseline sessions and 3 post-treatment maintenance sessions to evaluate the overall magnitude of change over the course of treatment.


Recruitment information / eligibility

Status Completed
Enrollment 7
Est. completion date March 18, 2021
Est. primary completion date March 18, 2021
Accepts healthy volunteers No
Gender All
Age group 9 Years to 15 Years
Eligibility 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 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 scaled score below 6 on the CELF-5 Recalling Sentences or Formulated Sentences subtests. - Must not have history of sensorineural hearing loss or failed infant hearing screening. - 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. - Must not have major orthodontia that could interfere with tongue-palate contact.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Visual-acoustic biofeedback
In visual-acoustic biofeedback treatment, participants view a dynamic display of the speech signal in the form of a 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 were cued to make their real-time LPC spectrum match a visual target characterized by a low F3 frequency.
Motor-based treatment
Motor-based 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 were used as visual aids; however, no real-time visual display of articulatory or acoustic information will be made available.

Locations

Country Name City State
United States Montclair State University Bloomfield New Jersey
United States Syracuse University Syracuse New York

Sponsors (4)

Lead Sponsor Collaborator
New York University Montclair State University, National Institute on Deafness and Other Communication Disorders (NIDCD), Syracuse University

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Within-session Change in Percentage of "Correct" Ratings by Blinded Naive Listeners for /r/ Sounds Produced in Word Probes To assess /r/ production accuracy, participants read probe lists eliciting 25 utterances of /r/ in various phonetic contexts at the start and end of each treatment session. Recorded probe words are presented in randomized order for binary rating (correct/incorrect) by naive listeners who are blind to treatment condition and time point; the accuracy of each token is quantified as the percentage of "correct" ratings across 9 blinded listeners. We then compute the mean percent correct ratings for each probe; the change in this value from pre to post session ("within-session change") is our outcome measure of interest. Summary statistics report the mean and standard deviation of within-session change for each treatment condition, pooled across participants and sessions. This Outcome Measure is assessed using a two-tailed paired-samples t-test comparing mean change in percent correct for each treatment condition across subjects. Outcomes are evaluated relative to a superiority criterion. Change in word probe accuracy was measured in each treatment session, which were administered over ten weeks.
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