Phase 1
N=14
Comparing Traditional and Biofeedback Telepractice Treatment for Residual Speech Errors
Speech Sound Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04625062 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcome: Primary: Within-session Change in Percentage of "Correct" Ratings by Blinded Naive Listeners for /r/ Sounds Produced in Word Probes — 1.4; 1.9 Percent correct — p=.72
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Visual-acoustic biofeedback (Behavioral); Motor-based treatment (Behavioral)
- Age
- Pediatric · 9+ yrs
- Sex
- All
- Sponsor
- New York University
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Within-session Change in Percentage of "Correct" Ratings by Blinded Naive Listeners for /r/ Sounds Produced in Word Probes |
1.4; 1.9 | .72 |
Summary
This study aims to evaluate the relative efficacy of biofeedback and traditional treatment for residual speech errors when both are delivered via telepractice. In a single-case randomization design, up to eight children with RSE will receive both visual-acoustic biofeedback and traditional treatment via telepractice. Acoustic measures of within-session change will be compared across sessions randomly assigned to each condition. It is hypothesized that participants will exhibit a clinically significant overall treatment response and that short-term measures of change will indicate that biofeedback is associated with larger increments of progress than traditional treatment.
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 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.
Exclusion Criteria
- Must not receive a T score more than 1.3 standard deviations (SD) below the mean on the Wechsler Abbreviated Scale of Intelligence-2 (WASI-2) Matrix Reasoning.
- Must not receive a scaled score below 6 on the CELF-5 Recalling Sentences or Formulated Sentences subtests.
- Must not have history of sensorineural hearing loss or failed infant hearing screening.
- Must not have an existing diagnosis of developmental disability, major neurobehavioral syndrome such as cerebral palsy, Down Syndrome, or Autism Spectrum Disorder, or major neural disorder (e.g., epilepsy, agenesis of the corpus callosum) or insult (e.g., traumatic brain injury, stroke, or tumor resection).
- Must not show clinically significant signs of apraxia of speech or dysarthria.
- Must not have major orthodontia that could interfere with tongue-palate contact.
Data sourced from ClinicalTrials.gov (NCT04625062). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.