NCT04625062

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2020

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 12, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2021

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

February 13, 2023

Completed
Last Updated

February 13, 2023

Status Verified

November 1, 2020

Enrollment Period

7 months

First QC Date

September 8, 2020

Results QC Date

May 3, 2022

Last Update Submit

January 26, 2023

Conditions

Keywords

speecharticulationmotor development

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

Visual-acoustic biofeedback

EXPERIMENTAL

Visual- acoustic biofeedback treatment (behavioral) administered via telepractice

Behavioral: Visual-acoustic biofeedback

Motor-based treatment

EXPERIMENTAL

Motor-based articulation treatment administered via telepractice

Behavioral: Motor-based treatment

Interventions

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.

Visual-acoustic biofeedback

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.

Motor-based treatment

Eligibility Criteria

Age9 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Montclair State University

Bloomfield, New Jersey, 07003, United States

Location

Syracuse University

Syracuse, New York, 13244, United States

Location

Related Publications (10)

  • 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.

    PMID: 29792525BACKGROUND
  • 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.

    PMID: 28795872BACKGROUND
  • 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.

    PMID: 28703653BACKGROUND
  • 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.

    PMID: 28389677BACKGROUND
  • 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.

    PMID: 28207800BACKGROUND
  • 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.

    PMID: 27891084BACKGROUND
  • 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.

    PMID: 25578293BACKGROUND
  • 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.

    PMID: 27267258BACKGROUND
  • 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.

    PMID: 26458203BACKGROUND
  • 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.

    PMID: 22442281BACKGROUND

MeSH Terms

Conditions

Speech Sound DisorderSpeech

Condition Hierarchy (Ancestors)

Communication DisordersNeurodevelopmental DisordersMental DisordersVerbal BehaviorCommunicationBehavior

Limitations and Caveats

Single-case randomization designs are limited in that gains from one treatment condition may carry over to the next.

Results Point of Contact

Title
Dr. Tara McAllister
Organization
New York University

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: In this within-subjects single-case randomization design, each participant will receive an equal number of sessions of visual-acoustic biofeedback and traditional treatment (n = 10 each), with randomized allocation of treatment types to individual sessions. Randomization will be blocked, with each week of treatment serving as a block; within each week/block, one session will be randomly assigned to feature visual-acoustic and one to feature traditional treatment.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2020

First Posted

November 12, 2020

Study Start

September 1, 2020

Primary Completion

March 18, 2021

Study Completion

March 18, 2021

Last Updated

February 13, 2023

Results First Posted

February 13, 2023

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations