Visual Acoustic Biofeedback for RSE Via Telepractice
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| ClinicalTrials.gov Identifier: NCT04858022 |
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Recruitment Status :
Recruiting
First Posted : April 23, 2021
Last Update Posted : January 11, 2022
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Sponsor:
Montclair State University
Collaborators:
National Institute on Deafness and Other Communication Disorders (NIDCD)
New York University
Syracuse University
Information provided by (Responsible Party):
Elaine Hitchcock, Montclair State University
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Speech Sound Disorder | Behavioral: Visual Acoustic Biofeedback Other: No treatment - waitlist | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 40 participants |
| Allocation: | Randomized |
| Intervention Model: | Factorial Assignment |
| Intervention Model Description: | Children with residual speech errors (RSE) and typical perception will assigned to a randomized controlled trial measuring the efficacy of online visual-acoustic biofeedback treatment relative to a waitlist comparison condition. Treatment will last a total of 20 weeks. The investigators will randomly assign 20 children to receive 10 weeks of biofeedback training via video call followed by 10 weeks in a no-treatment phase; 20 children will receive the same phases in reverse order. Children with RSE may vary in pre-treatment severity, and the extent to which they can approximate /r/ may be an important indicator of subsequent treatment response. Therefore, a blocked randomization procedure will be used to protect against a situation where treatment groups are unbalanced with respect to pre-treatment severity. |
| Masking: | Single (Outcomes Assessor) |
| Masking Description: | 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. |
| Primary Purpose: | Treatment |
| Official Title: | Online Assessment and Enhancement of Auditory Perception for Speech Sound Errors: Visual Acoustic Biofeedback for RSE Via Telepractice |
| Estimated Study Start Date : | January 15, 2022 |
| Estimated Primary Completion Date : | August 30, 2023 |
| Estimated Study Completion Date : | August 30, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Visual Acoustic Biofeedback for RSE via Telepractice-Treatment
Condition1: Treatment-first Children with RSE and typical perception will be allocated to a randomized controlled trial measuring the efficacy of online visual-acoustic biofeedback treatment. Ten children with RSE will receive 10 weeks of visual-acoustic biofeedback training via video call. |
Behavioral: Visual Acoustic Biofeedback
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. |
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Experimental: Visual Acoustic Biofeedback for RSE via Telepractice-Wait
Condition 2: Waitlist-first Following the initial evaluation, 10 children with RSE will be allocated to a 10 week no treatment condition. |
Other: No treatment - waitlist
10-week period of no treatment |
Primary Outcome Measures :
- Change in perceptually rated accuracy of /r/ [ Time Frame: Pre-, mid- (after 10 weeks), and 1 week post-treatment ]To assess generalization of treatment gains to untreated words, participants will be assessed with standard probes (30 words [considered the primary target], 20 syllables, and 10 sentences containing /r/ in various phonetic contexts). Stimuli in each probe will be presented individually in randomized order with blocking by stimulus type (word, syllable, sentence). No auditory models will be provided; for children with reading difficulty, semantic cues will be provided to elicit the intended word. Individual words will be isolated from the audio record of each word probe and presented in randomized order for binary rating (correct/incorrect) by 9 naïve listeners who are blind to treatment condition and time point (but will see the written representation of each target word). The investigators will use the proportion of "correct" ratings for each token as our primary measure of perceptually rated accuracy.
Secondary Outcome Measures :
- Change in social-emotional well-being [ Time Frame: Pre- and 1 week post-treatment ]This 11-item survey, which asks parents to report the impact of speech disorder on their child's social, emotional, and academic well-being, was validated in a published study by members of the research team. An impact score, calculated as described in our previous research, will be used as the primary measure of socio-emotional well-being.
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| Ages Eligible for Study: | 9 Years to 15 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04858022
Contacts
| Contact: Elaine R Hitchcock, PhD | 973-229-3797 | hitchcocke@montclair.edu |
Locations
| United States, New Jersey | |
| Montclair State University | Recruiting |
| Upper Montclair, New Jersey, United States, 07403 | |
Sponsors and Collaborators
Montclair State University
National Institute on Deafness and Other Communication Disorders (NIDCD)
New York University
Syracuse University
Publications:
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.
| Responsible Party: | Elaine Hitchcock, Associate Professor, Montclair State University |
| ClinicalTrials.gov Identifier: | NCT04858022 |
| Other Study ID Numbers: |
20-21-2137-Study 2 |
| First Posted: | April 23, 2021 Key Record Dates |
| Last Update Posted: | January 11, 2022 |
| Last Verified: | December 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Elaine Hitchcock, Montclair State University:
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speech articulation auditory perception |
Additional relevant MeSH terms:
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Speech Sound Disorder Communication Disorders Neurodevelopmental Disorders Mental Disorders |