NCT04858022

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

April 5, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 23, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

January 15, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2024

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

February 17, 2026

Completed
Last Updated

February 17, 2026

Status Verified

January 1, 2026

Enrollment Period

2.2 years

First QC Date

April 5, 2021

Results QC Date

May 15, 2025

Last Update Submit

January 28, 2026

Conditions

Keywords

speecharticulationauditory perception

Outcome Measures

Primary Outcomes (1)

  • Rhotic Accuracy (/r/)

    To evaluate the generalization of treatment effects to untreated words, participants will complete standardized word probes comprising 50 target words. The primary outcome measure is the proportion of words rated as "correct" across all tokens, reflecting perceptual accuracy of the participant's responses.

    BL - (Initial Assessments:1-2 weeks), MP-(Midpoint assessment -1 day following First Period (10 weeks), MN - (Maintenance Assessment -1 day following Second Period (10 weeks).

Secondary Outcomes (1)

  • Change in Social-emotional Well-being

    Survey completed at BL ( evaluation) and MN ( 1 day following Second period duration). Same for both groups.

Study Arms (2)

Visual-Acoustic Biofeedback Treatment via Telepractice Followed by No Treatment

EXPERIMENTAL

Condition1: Treatment phase followed by no-treatment Children with RSE and typical perception will be allocated to a randomized controlled trial measuring the efficacy of online visual-acoustic biofeedback treatment. Twenty children with RSE will receive 10 weeks of visual-acoustic biofeedback training via video call.

Behavioral: Visual-Acoustic Biofeedback TreatmentOther: No Treatment

No Treatment Followed by Visual-Acoustic Biofeedback Treatment via Telepractice

EXPERIMENTAL

Condition 2: No treatment followed by treatment phase Following the initial evaluation, 20 children with RSE will be allocated to a 10 week no treatment condition.

Behavioral: Visual-Acoustic Biofeedback TreatmentOther: No Treatment

Interventions

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.

No Treatment Followed by Visual-Acoustic Biofeedback Treatment via TelepracticeVisual-Acoustic Biofeedback Treatment via Telepractice Followed by No Treatment

10-week period of no treatment

No Treatment Followed by Visual-Acoustic Biofeedback Treatment via TelepracticeVisual-Acoustic Biofeedback Treatment via Telepractice Followed by No Treatment

Eligibility Criteria

Age9 Years - 15 Years
Sexall
Healthy VolunteersYes
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 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montclair State University

Upper Montclair, New Jersey, 07403, United States

Location

Related Publications (19)

  • 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.

    PMID: 32097058BACKGROUND
  • 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
  • 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
  • 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.

    PMID: 28655050BACKGROUND
  • 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.

    PMID: 27481555BACKGROUND
  • 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
  • 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.

    PMID: 32783706BACKGROUND
  • 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.

    PMID: 25088034BACKGROUND
  • 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.

    BACKGROUND
  • 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
  • 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 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.

    PMID: 32046671BACKGROUND
  • 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.

    PMID: 25216375BACKGROUND
  • 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.

    PMID: 26947142BACKGROUND
  • 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.

    PMID: 28595354BACKGROUND
  • 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.

    PMID: 30795023BACKGROUND
  • 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
  • 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.

    PMID: 28834534BACKGROUND
  • 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.

    PMID: 26513374BACKGROUND

MeSH Terms

Conditions

Speech Sound DisorderSpeech

Condition Hierarchy (Ancestors)

Communication DisordersNeurodevelopmental DisordersMental DisordersVerbal BehaviorCommunicationBehavior

Results Point of Contact

Title
Dr. Elaine R. Hitchcock
Organization
Montclair State University

Study Officials

  • Elaine R. Hitchcock, PhD

    Montclair State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: This is a randomized, two-period crossover trial. Participants will be randomly assigned to one of two sequences: (1) 10 weeks (20 sessions) of visual-acoustic biofeedback treatment via telepractice followed by 10 weeks of no treatment, or (2) 10 weeks of no treatment followed by 10 weeks (20 sessions) of biofeedback treatment. Outcomes will be assessed at baseline (before the first phase), after 10 weeks (post-Period 1), and after 20 weeks (post-Period 2). The primary outcome is production accuracy, measured using standardized probes with 50 words containing the target /r/ sound in various phonetic contexts. Randomization determines the order of treatment and control phases for each participant.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 5, 2021

First Posted

April 23, 2021

Study Start

January 15, 2022

Primary Completion

April 15, 2024

Study Completion

April 15, 2024

Last Updated

February 17, 2026

Results First Posted

February 17, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations