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Visual Acoustic Biofeedback for RSE Via Telepractice

Primary Purpose

Speech Sound Disorder

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Visual Acoustic Biofeedback

No treatment - waitlist

About this trial

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

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 20dB hearing level.
Must pass a brief examination of oral structure and function.
Must exhibit less than 30% accuracy, based on consensus across 2 trained listeners, on a probe list eliciting rhotics in various phonetic contexts at the word level.
Must exhibit no more than 3 sounds other than /r/ in error on the Goldman-Fristoe Test of Articulation-3 (GFTA-3).

Exclusion Criteria:

Must not receive a T score more than 1.3 SD below the mean on the Wechsler Abbreviated Scale of Intelligence-2 (WASI-2) Matrix Reasoning
Must not receive a scaled score of 7 or higher on the Recalling Sentences and Formulated Sentences subtests of the Clinical Evaluation of Language Fundamentals-5 (CELF-5).
Must not have an existing diagnosis of developmental disability or major neurobehavioral syndrome such as cerebral palsy, Down Syndrome, or Autism Spectrum Disorder

Sites / Locations

Montclair State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Visual Acoustic Biofeedback for RSE via Telepractice-Treatment

Visual Acoustic Biofeedback for RSE via Telepractice-Wait

Arm Description

Condition1: Treatment-first Children with RSE and typical perception will be allocated to a randomized controlled trial measuring the efficacy of online visual-acoustic biofeedback treatment. Ten children with RSE will receive 10 weeks of visual-acoustic biofeedback training via video call.

Condition 2: Waitlist-first Following the initial evaluation, 10 children with RSE will be allocated to a 10 week no treatment condition.

Outcomes

Primary Outcome Measures

Change in perceptually rated accuracy of /r/

To assess generalization of treatment gains to untreated words, participants will be assessed with standard probes (30 words [considered the primary target], 20 syllables, and 10 sentences containing /r/ in various phonetic contexts). Stimuli in each probe will be presented individually in randomized order with blocking by stimulus type (word, syllable, sentence). No auditory models will be provided; for children with reading difficulty, semantic cues will be provided to elicit the intended word. Individual words will be isolated from the audio record of each word probe and presented in randomized order for binary rating (correct/incorrect) by 9 naïve listeners who are blind to treatment condition and time point (but will see the written representation of each target word). The investigators will use the proportion of "correct" ratings for each token as our primary measure of perceptually rated accuracy.

Secondary Outcome Measures

Change in social-emotional well-being

This 11-item survey, which asks parents to report the impact of speech disorder on their child's social, emotional, and academic well-being, was validated in a published study by members of the research team. An impact score, calculated as described in our previous research, will be used as the primary measure of socio-emotional well-being.

Full Information

NCT ID

NCT04858022

First Posted

April 5, 2021

Last Updated

August 3, 2023

Sponsor

Montclair State University

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD), New York University, Syracuse University

1. Study Identification

Unique Protocol Identification Number

NCT04858022

Brief Title

Visual Acoustic Biofeedback for RSE Via Telepractice

Official Title

Online Assessment and Enhancement of Auditory Perception for Speech Sound Errors: Visual Acoustic Biofeedback for RSE Via Telepractice

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 15, 2022 (Actual)

Primary Completion Date

April 15, 2024 (Anticipated)

Study Completion Date

July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Montclair State University

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD), New York University, Syracuse University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This research will meet a public health need by evaluating the efficacy of speech intervention supplemented with real-time visual-acoustic biofeedback when delivered using remote technologies.

Detailed Description

In a crossover design, participants will be randomly assigned to receive 10 weeks/20 sessions of visual-acoustic biofeedback treatment via telepractice followed by a 10-week period of no treatment, or the same two conditions in the reverse order. Production accuracy will be assessed with standard probes (20 syllables, 30 words, and 10 sentences containing /r/ in various phonetic contexts) administered prior to the beginning of treatment (baseline), after the first 10-week phase, and again at the end of the study.

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, auditory perception

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Factorial Assignment

Model Description

Children with residual speech errors (RSE) and typical perception will assigned to a randomized controlled trial measuring the efficacy of online visual-acoustic biofeedback treatment relative to a waitlist comparison condition. Treatment will last a total of 20 weeks. The investigators will randomly assign 20 children to receive 10 weeks of biofeedback training via video call followed by 10 weeks in a no-treatment phase; 20 children will receive the same phases in reverse order. Children with RSE may vary in pre-treatment severity, and the extent to which they can approximate /r/ may be an important indicator of subsequent treatment response. Therefore, a blocked randomization procedure will be used to protect against a situation where treatment groups are unbalanced with respect to pre-treatment severity.

Masking

Outcomes Assessor

Masking Description

All perceptual ratings will be obtained from blinded, skilled clinician listeners recruited through online crowdsourcing. Following protocols refined in previous published research, binary rating responses (1=correct; 0=incorrect) will be aggregated over at least 9 unique listeners per token.

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Visual Acoustic Biofeedback for RSE via Telepractice-Treatment

Arm Type

Experimental

Arm Description

Arm Title

Visual Acoustic Biofeedback for RSE via Telepractice-Wait

Arm Type

Experimental

Arm Description

Condition 2: Waitlist-first Following the initial evaluation, 10 children with RSE will be allocated to a 10 week no treatment condition.

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 (Linear Predictive Coding) 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. They will be encouraged to attend to the visual display while adjusting the placement of their articulators and observing how those adjustments impact F3.

Intervention Type

Other

Intervention Name(s)

No treatment - waitlist

Intervention Description

10-week period of no treatment

Primary Outcome Measure Information:

Title

Change in perceptually rated accuracy of /r/

Description

Time Frame

Pre-, mid- (after 10 weeks), and 1 week post-treatment

Secondary Outcome Measure Information:

Title

Change in social-emotional well-being

Description

Time Frame

Pre- and 1 week post-treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

9 Years

Maximum Age & Unit of Time

15 Years

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 20dB hearing level. Must pass a brief examination of oral structure and function. Must exhibit less than 30% accuracy, based on consensus across 2 trained listeners, on a probe list eliciting rhotics in various phonetic contexts at the word level. Must exhibit no more than 3 sounds other than /r/ in error on the Goldman-Fristoe Test of Articulation-3 (GFTA-3). Exclusion Criteria: Must not receive a T score more than 1.3 SD below the mean on the Wechsler Abbreviated Scale of Intelligence-2 (WASI-2) Matrix Reasoning Must not receive a scaled score of 7 or higher on the Recalling Sentences and Formulated Sentences subtests of the Clinical Evaluation of Language Fundamentals-5 (CELF-5). Must not have an existing diagnosis of developmental disability or major neurobehavioral syndrome such as cerebral palsy, Down Syndrome, or Autism Spectrum Disorder

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Elaine R Hitchcock, PhD

Phone

973-229-3797

hitchcocke@montclair.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elaine R. Hitchcock, PhD

Organizational Affiliation

Montclair State University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Montclair State University

City

Upper Montclair

State/Province

New Jersey

ZIP/Postal Code

07403

Country

United States

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32097058

Citation

Preston JL, Hitchcock ER, Leece MC. Auditory Perception and Ultrasound Biofeedback Treatment Outcomes for Children With Residual /ɹ/ Distortions: A Randomized Controlled Trial. J Speech Lang Hear Res. 2020 Feb 26;63(2):444-455. doi: 10.1044/2019_JSLHR-19-00060. Epub 2020 Feb 26.

Results Reference

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PubMed Identifier

22442281

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.

Results Reference

background

PubMed Identifier

28389677

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.

Results Reference

background

PubMed Identifier

28655050

Citation

Byun TM, Campbell H, Carey H, Liang W, Park TH, Svirsky M. Enhancing Intervention for Residual Rhotic Errors Via App-Delivered Biofeedback: A Case Study. J Speech Lang Hear Res. 2017 Jun 22;60(6S):1810-1817. doi: 10.1044/2017_JSLHR-S-16-0248.

Results Reference

background

PubMed Identifier

27481555

Citation

McAllister Byun T, Harel D, Halpin PF, Szeredi D. Deriving gradient measures of child speech from crowdsourced ratings. J Commun Disord. 2016 Nov-Dec;64:91-102. doi: 10.1016/j.jcomdis.2016.07.001. Epub 2016 Jul 6.

Results Reference

background

PubMed Identifier

27267258

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.

Results Reference

background

PubMed Identifier

32783706

Citation

Preston JL, Benway NR, Leece MC, Hitchcock ER, McAllister T. Tutorial: Motor-Based Treatment Strategies for /r/ Distortions. Lang Speech Hear Serv Sch. 2020 Oct 2;51(4):966-980. doi: 10.1044/2020_LSHSS-20-00012. Epub 2020 Aug 12.

Results Reference

background

PubMed Identifier

25088034

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.

Results Reference

background

Citation

Hitchcock, ER, Cabbage, KL, T. Swartz, M, Carrell, TD. Measuring Speech Perception Using the Wide-Range Acoustic Accuracy Scale: Preliminary Findings. Perspectives of the ASHA Special Interest Groups, 5(4):1098-1112, 2020.

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

background

PubMed Identifier

28207800

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.

Results Reference

background

PubMed Identifier

32046671

Citation

McAllister T, Preston JL, Hitchcock ER, Hill J. Protocol for Correcting Residual Errors with Spectral, ULtrasound, Traditional Speech therapy Randomized Controlled Trial (C-RESULTS RCT). BMC Pediatr. 2020 Feb 11;20(1):66. doi: 10.1186/s12887-020-1941-5.

Results Reference

background

PubMed Identifier

25216375

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.

Results Reference

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PubMed Identifier

26947142

Citation

McAllister Byun T, Swartz MT, Halpin PF, Szeredi D, Maas E. Direction of attentional focus in biofeedback treatment for /r/ misarticulation. Int J Lang Commun Disord. 2016 Jul;51(4):384-401. doi: 10.1111/1460-6984.12215. Epub 2016 Mar 6.

Results Reference

background

PubMed Identifier

28595354

Citation

Byun TM, Hitchcock ER, Ferron J. Masked Visual Analysis: Minimizing Type I Error in Visually Guided Single-Case Design for Communication Disorders. J Speech Lang Hear Res. 2017 Jun 10;60(6):1455-1466. doi: 10.1044/2017_JSLHR-S-16-0344.

Results Reference

background

PubMed Identifier

30795023

Citation

Hitchcock ER, Swartz MT, Lopez M. Speech Sound Disorder and Visual Biofeedback Intervention: A Preliminary Investigation of Treatment Intensity. Semin Speech Lang. 2019 Mar;40(2):124-137. doi: 10.1055/s-0039-1677763. Epub 2019 Feb 22.

Results Reference

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PubMed Identifier

26458203

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.

Results Reference

background

PubMed Identifier

28834534

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.

Results Reference

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PubMed Identifier

26513374

Citation

Hitchcock ER, Koenig LL. Longitudinal observations of typical English voicing acquisition in a 2-year-old child: Stability of the contrast and considerations for clinical assessment. Clin Linguist Phon. 2015;29(12):955-76. doi: 10.3109/02699206.2015.1083617. Epub 2015 Oct 29.

Results Reference

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Visual Acoustic Biofeedback for RSE Via Telepractice

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