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Speech Sound DisorderPhase 2NCT04858022

Visual Acoustic Biofeedback for RSE Via Telepractice

A Phase 2 study testing Visual-Acoustic Biofeedback Treatment and No Treatment in people with Speech Sound Disorder, run by Montclair State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 9 to 15 yearsHealthy volunteers can take part
Conditions the study is for
Speech Sound Disorder
What is being tested?
Visual-Acoustic Biofeedback Treatment and No Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
15 Jan 2022to 15 Apr 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 to 15 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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).

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Montclair State University

    Upper Montclair, New Jersey, 07403

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Visual-Acoustic Biofeedback Treatment, No Treatment
Keywords
speech, articulation, auditory perception
Medical subject headings
Speech Sound Disorder, Speech

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Visual-Acoustic Biofeedback TreatmentBehavioural

    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 TreatmentOther

    10-week period of no treatment

Study groups in NCT04858022
Study groupRoleWhat they receive
Visual-Acoustic Biofeedback Treatment via Telepractice Followed by No TreatmentExperimentalCondition1: 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.
Receives: Behavioral: Visual-Acoustic Biofeedback Treatment; Other: No Treatment
No Treatment Followed by Visual-Acoustic Biofeedback Treatment via TelepracticeExperimentalCondition 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.
Receives: Behavioral: Visual-Acoustic Biofeedback Treatment; Other: No Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)
  1. Change in Social-emotional Well-being

    An 11-item survey was developed to assess parent perceptions of the impact of their child's /r/-related speech sound disorder on life participation and satisfaction. Each survey item was mapped to the most relevant chapter within the Activities and Participation domain of the World Health Organization's International Classification of Functioning, Disability and Health (ICF) framework. Most items corresponded to chapters on interpersonal interactions and relationships, and major life areas; two items were categorized under communication. Each item was rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree), with higher average scores indicating greater perceived negative impact of the speech sound disorder.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2021
  2. Study start15 Jan 2022
  3. Primary completion15 Apr 2024
  4. Study completion15 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04858022
Sponsor's protocol ID
20-21-2137-Study 2
Other IDs
R15DC019775-01
Status last verified
Jan 2026
First submitted
5 Apr 2021
Last updated
17 Feb 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32097058
  • 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.

    PubMed 22442281
  • 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.

    PubMed 28389677
  • 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.

    PubMed 28655050
  • 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.

    PubMed 27481555
  • 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.

    PubMed 27267258
  • 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.

    PubMed 32783706
  • 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.

    PubMed 25088034
  • 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.

  • 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.

    PubMed 29792525
  • 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.

    PubMed 28207800
  • 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.

    PubMed 32046671
  • 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.

    PubMed 25216375
  • 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.

    PubMed 26947142
  • 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.

    PubMed 28595354

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Visual-Acoustic Biofeedback Treatment and No Treatment in people with Speech Sound Disorder, run by Montclair State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rhotic Accuracy (/r/) (time frame: 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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04858022, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.

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