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Clinical Trials/NCT04858022
NCT04858022
Completed
Phase 2

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

Montclair State University1 site in 1 country40 target enrollmentJanuary 15, 2022

Overview

Phase
Phase 2
Intervention
Visual-Acoustic Biofeedback Treatment
Conditions
Speech Sound Disorder
Sponsor
Montclair State University
Enrollment
40
Locations
1
Primary Endpoint
Rhotic Accuracy (/r/)
Status
Completed
Last Updated
2 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 15, 2022
End Date
April 15, 2024
Last Updated
2 months ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elaine Hitchcock

Associate Professor

Montclair State University

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

Arms & Interventions

Visual-Acoustic Biofeedback Treatment via Telepractice Followed by No Treatment

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.

Intervention: Visual-Acoustic Biofeedback Treatment

Visual-Acoustic Biofeedback Treatment via Telepractice Followed by No Treatment

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.

Intervention: No Treatment

No Treatment Followed by Visual-Acoustic Biofeedback Treatment via Telepractice

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.

Intervention: Visual-Acoustic Biofeedback Treatment

No Treatment Followed by Visual-Acoustic Biofeedback Treatment via Telepractice

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.

Intervention: No Treatment

Outcomes

Primary Outcomes

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).

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.

Secondary Outcomes

  • Change in Social-emotional Well-being(Survey completed at BL ( evaluation) and MN ( 1 day following Second period duration). Same for both groups.)

Study Sites (1)

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