Recruiting
Phase 2

Visual-Acoustic Intervention

Sponsor:

New York University

Code:

NCT06517225

Conditions

Speech Sound Disorder

Eligibility Criteria

Sex: Female

Age: 9 - 17

Healthy Volunteers: Not accepted

Interventions

Visual-acoustic biofeedback

Study Details

Brief summary:

Children with speech sound disorder show diminished intelligibility in spoken communication and may thus be perceived as less capable than peers, with negative consequences for both socioemotional and socioeconomic outcomes. New technologies have the potential to transform interventions for speech sound disorder, but there is a lack of rigorous evidence to substantiate this promise. This research will meet a public health need by systematically evaluating the efficacy of visual-acoustic biofeedback intervention delivered in-person versus via telepractice.

The objective of this study is to test the hypothesis that treatment incorporating visual-acoustic biofeedback can be delivered via telepractice without a significant loss of efficacy. Participants will be randomly assigned to receive identical treatment either via online telepractice or in the laboratory setting. The same software for visual-acoustic biofeedback, staRt, will be used in both conditions. Participants' progress in treatment will be evaluated based on blinded listeners' perceptual ratings of probes produced before and after treatment. Pre and post treatment evaluations will be carried out in person for all participants.

Conditions

Speech Sound Disorder

Study ID

NCT06517225

Start date

Jul 1, 2024

Status verified date

Jun, 2025

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 9 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Must be between 9;0 and 17;11 (years;months) old at the time of enrollment.
  • Must speak English as the dominant or equally dominant language
  • Must have begun learning English by age 3, per parent report.
  • Must hear a rhotic dialect of English from at least one speaker in the home if the home language is English.
  • Must pass a pure-tone hearing screening.
  • 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.
  • Must demonstrate age-appropriate receptive and expressive language abilities on the Clinical Evaluation of Language Fundamentals-5 (CELF-5).
  • Must have access to a laptop or desktop computer for study sessions in the event of randomization to the telepractice condition.
  • Must have home wifi sufficient to support video calls in the event of randomization to the telepractice condition.

Exclusion Criteria:

  • Must not exhibit voice or fluency disorder of a severity judged likely to interfere with the ability to participate in study activities.
  • Must not currently have orthodontia that crosses the palate and cannot be removed.
  • Must not have history of permanent hearing loss.
  • Must not have an existing diagnosis of developmental disability such as cerebral palsy or Down Syndrome.
  • Must not have history of major brain injury, surgery, or stroke in the past year.
  • Must not have epilepsy with active seizure incidents with in the past 6 months.
  • Must not show clinically significant signs of apraxia of speech or dysarthria.

Study Design

Enrollment

76 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Telepractice delivery

Participants will receive visual-acoustic biofeedback treatment from a clinician in a private, password-protected WebRTC room.

active comparator: In-person delivery

Participants will receive visual-acoustic biofeedback treatment from a clinician in a private room in research space at one of the two clinical research sites.

Interventions

Visual-acoustic biofeedback

Behavioral: Visual-acoustic biofeedback In visual-acoustic biofeedback treatment, the elements of traditional treatment (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. The web-based software staRt will be used for intervention delivery.

Primary outcome measure

  • Percentage of "Correct" Ratings by Blinded Untrained Listeners for /r/ Sounds Produced in Word Probes [ Time Frame: Before the initiation of treatment and again after the end of all treatment (10 weeks later) ]

Central Contacts and Locations

Locations

Montclair State University

Recruiting

Bloomfield, New Jersey, United States, 07003

Contacts

Elaine R Hitchcock, PhD

973-229-3797hitchcocke@montclair.edu

Laura C Ochs, MS

(619) 784-4979ochsl@montclair.edu

Syracuse University

Recruiting

Syracuse, New York, United States, 13244

Contacts

Jonathan L Preston, PhD

315-443-3143jopresto@syr.edu

Megan Leece, MS

315-443-1351mcleece@syr.edu

More Information

Sponsor

New York University

Last update posted

Jun 25, 2025

Last verified

Jun, 2025

Keywords

  • speech
  • articulation
  • motor development

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by New York University on 2025-06-25.