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| ID | Type | Description | Link |
|---|---|---|---|
| R15DC019775-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
| New York University | OTHER |
| Syracuse University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Visual-Acoustic Biofeedback Treatment via Telepractice Followed by No Treatment | Experimental | 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. |
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| No Treatment Followed by Visual-Acoustic Biofeedback Treatment via Telepractice | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visual-Acoustic Biofeedback Treatment | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elaine R. Hitchcock, PhD | Montclair State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montclair State University | Upper Montclair | New Jersey | 07403 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32097058 | Background | 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. | |
| 22442281 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Visual-acoustic Biofeedback Treatment Via Telepractice First, Then No Treatment | Condition1: Visual-acoustic biofeedback treatment via Telepractice first, then No Treatment The children with RSE assigned to the Visual-acoustic biofeedback treatment via Telepractice first then No Treatment group will enter a 10 week visual acoustic biofeedback treatment period followed by a 10 week no-treatment period. Initial Assessments: (2 days), First Period-Visual Acoustic biofeedback treatment (10 weeks), Midpoint assessment (1 day), and Second Period- No Treatment (10 weeks), Maintenance Assessment (1 day). |
| FG001 | No Treatment First, Then Visual-acoustic Biofeedback Treatment Via Telepractice | Condition 2: No Treatment first, then Visual-acoustic biofeedback treatment via Telepractice The children with RSE assigned to the No Treatment first, then Visual-acoustic biofeedback treatment via Telepractice group will enter a a 10 week no-treatment period followed by a 10 week visual-acoustic biofeedback treatment period. Initial Assessments: (1-2 weeks), First Period-No treatment (10 weeks), Midpoint assessment (1 day), and Second Period- Visual Acoustic biofeedback treatment (10 weeks), Maintenance Assessment (1 day). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All participants were required to demonstrate <30% rhotic accuracy. Average rhotic accuracy for participants at baseline was 3.41% with a standard deviation of 7.61.
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| ID | Title | Description |
|---|---|---|
| BG000 | Visual-acoustic Biofeedback Treatment Via Telepractice First, Then No Treatment | Condition 1: Visual-acoustic biofeedback treatment via Telepractice first, then No Treatment The children with RSE assigned to the Visual-acoustic biofeedback treatment via Telepractice first then No Treatment group will enter a 10 week visual acoustic biofeedback treatment period followed by a 10 week no-treatment period. Initial Assessments: (2 days), First Period-Visual Acoustic biofeedback treatment (10 weeks), Midpoint assessment (1 day), and Second Period- No Treatment (10 weeks), Maintenance Assessment (1 day). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | In this crossover design, all participants receive both visual-acoustic biofeedback via telepractice and a no-treatment period, but in different orders. This means both arms experience both interventions. Describing both conditions in each arm is necessary: the only difference is the sequence-one arm receives treatment first, the other receives it second. Thus, reporting is combined because every participant has exposure to both study phases. | Posted | Mean | Standard Deviation | mean difference in percent correct | 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). |
|
23 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Visual-Acoustic Biofeedback Treatment Via Telepractice Followed by No Treatment | Condition 1: Visual-acoustic biofeedback treatment via Telepractice followed by No Treatment The children with RSE assigned to the Visual-acoustic biofeedback treatment via Telepractice first then No Treatment group will enter a 10 week visual acoustic biofeedback treatment period followed by a 10 week no-treatment period. Initial Assessments: (2 days), First Period-Visual Acoustic biofeedback treatment (10 weeks), Midpoint assessment (1 day), and Second Period- No Treatment (10 weeks), Maintenance Assessment (1 day). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elaine R. Hitchcock | Montclair State University | 9732293797 | hitchcocke@montclair.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 9, 2022 | Jul 18, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 21, 2020 | Jul 18, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 9, 2022 | Jul 18, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D066229 | Speech Sound Disorder |
| D013060 | Speech |
| ID | Term |
|---|---|
| D003147 | Communication Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D014705 | Verbal Behavior |
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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.
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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.
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| No Treatment | Other | 10-week period of no treatment |
|
| Survey completed at BL ( evaluation) and MN ( 1 day following Second period duration). Same for both groups. |
| 28389677 | Background | 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. |
| 28655050 | Background | 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. |
| 27481555 | Background | 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. |
| 27267258 | Background | 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. |
| 32783706 | Background | 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. |
| 25088034 | Background | 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. |
| Background | 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. |
| 29792525 | Background | 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. |
| 28207800 | Background | 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. |
| 32046671 | Background | 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. |
| 25216375 | Background | 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. |
| 26947142 | Background | 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. |
| 28595354 | Background | 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. |
| 30795023 | Background | Hitchcock ER, Swartz MT, Lopez M. Speech Sound Disorder and Visual Biofeedback Intervention: A Preliminary Investigation of Treatment Intensity. Semin Speech Lang. 2019 Mar;40(2):124-137. doi: 10.1055/s-0039-1677763. Epub 2019 Feb 22. |
| 26458203 | Background | Hitchcock ER, Harel D, Byun TM. Social, Emotional, and Academic Impact of Residual Speech Errors in School-Aged Children: A Survey Study. Semin Speech Lang. 2015 Nov;36(4):283-94. doi: 10.1055/s-0035-1562911. Epub 2015 Oct 12. |
| 28834534 | Background | Hitchcock ER, Byun TM, Swartz M, Lazarus R. Efficacy of Electropalatography for Treating Misarticulation of /r/. Am J Speech Lang Pathol. 2017 Nov 8;26(4):1141-1158. doi: 10.1044/2017_AJSLP-16-0122. |
| 26513374 | Background | Hitchcock ER, Koenig LL. Longitudinal observations of typical English voicing acquisition in a 2-year-old child: Stability of the contrast and considerations for clinical assessment. Clin Linguist Phon. 2015;29(12):955-76. doi: 10.3109/02699206.2015.1083617. Epub 2015 Oct 29. |
| BG001 | No Treatment First, Then Visual-acoustic Biofeedback Treatment Via Telepractice | Condition 2: No Treatment first, then Visual-acoustic biofeedback treatment via Telepractice The children with RSE assigned to the No Treatment first, then Visual-acoustic biofeedback treatment via Telepractice group will enter a a 10 week no-treatment period followed by a 10 week visual-acoustic biofeedback treatment period. Initial Assessments: (1-2 weeks), First Period-No treatment (10 weeks), Midpoint assessment (1 day), and Second Period- Visual Acoustic biofeedback treatment (10 weeks), Maintenance Assessment (1 day). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Rhotic accuracy | Rhotic accuracy at baseline | Mean | Standard Deviation | percent accuracy |
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| Visual-acoustic Biofeedback Treatment Via Telepractice Followed by No Treatment |
Condition1: Visual-acoustic biofeedback treatment via Telepractice followed by then No Treatment The children with RSE assigned to the Visual-acoustic biofeedback treatment via Telepractice first then No Treatment group will enter a 10 week visual acoustic biofeedback treatment period followed by a 10 week no-treatment period. Initial Assessments: (2 days), First Period-Visual Acoustic biofeedback treatment (10 weeks), Midpoint assessment (1 day), and Second Period- No Treatment (10 weeks), Maintenance Assessment (1 day). |
| OG001 | No Treatment Followed by Visual-acoustic Biofeedback Treatment Via Telepractice | Condition 2: No Treatment followed by Visual-acoustic biofeedback treatment via Telepractice The children with RSE assigned to the No Treatment first, then Visual-acoustic biofeedback treatment via Telepractice group will enter a a 10 week no-treatment period followed by a 10 week visual-acoustic biofeedback treatment period. Initial Assessments: (1-2 days), First Period-No treatment (10 weeks), Midpoint assessment (1 day), and Second Period- Visual Acoustic biofeedback treatment (10 weeks), Maintenance Assessment (1 day). |
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| Secondary | 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. | In this crossover design, all participants received the social-emotional survey during BL ( evaluation) and MN (1 day following Second period of study) assessments. Thus, reporting is combined because every participant receives the survey at the same time. | Posted | Mean | Standard Deviation | Average score | Survey completed at BL ( evaluation) and MN ( 1 day following Second period duration). Same for both groups. |
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| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | No Treatment Followed by Visual-Acoustic Biofeedback Treatment Via Telepractice | Condition 2: No Treatment followed by Visual-acoustic biofeedback treatment via Telepractice The children with RSE assigned to the No Treatment first, then Visual-acoustic biofeedback treatment via Telepractice group will enter a a 10 week no-treatment period followed by a 10 week visual-acoustic biofeedback treatment period. Initial Assessments: (1-2 weeks), First Period-No treatment (10 weeks), Midpoint assessment (1 day), and Second Period- Visual Acoustic biofeedback treatment (10 weeks), Maintenance Assessment (1 day). | 0 | 21 | 0 | 21 | 0 | 21 |
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| D003142 |
| Communication |
| D001519 | Behavior |