Comparing Traditional and Biofeedback Telepractice Treatment for Residual Speech Errors (C-RESULTS TPT)

January 26, 2023 updated by: New York University

Comparing Traditional and Biofeedback Treatment for Residual Speech Errors Via Telepractice

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

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
      • 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

No

Genders Eligible for Study

All

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 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 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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Visual-acoustic biofeedback
Visual- acoustic biofeedback treatment (behavioral) administered via telepractice
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.
EXPERIMENTAL: Motor-based treatment
Motor-based articulation treatment administered via telepractice
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Within-session Change in Percentage of "Correct" Ratings by Blinded Naive Listeners for /r/ Sounds Produced in Word Probes
Time Frame: Change in word probe accuracy was measured in each treatment session, which were administered over ten weeks.
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.

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)

September 1, 2020

Primary Completion (ACTUAL)

March 18, 2021

Study Completion (ACTUAL)

March 18, 2021

Study Registration Dates

First Submitted

September 8, 2020

First Submitted That Met QC Criteria

November 5, 2020

First Posted (ACTUAL)

November 12, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 13, 2023

Last Update Submitted That Met QC Criteria

January 26, 2023

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-RESULTS-TPT
  • 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.

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