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| ID | Type | Description | Link |
|---|---|---|---|
| R01DC017476 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Syracuse University | OTHER |
| Montclair State University | OTHER |
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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Children with speech sound disorder show diminished accuracy and intelligibility in spoken communication and may thus be perceived as less capable or intelligent than peers, with negative consequences for both socioemotional and socioeconomic outcomes. While most speech errors resolve by the late school-age years, between 2-5% of speakers exhibit residual speech errors (RSE) that persist through adolescence or even adulthood, reflecting about 6 million cases in the US. Both affected children/families and speech-language pathologists (SLPs) have highlighted the critical need for research to identify more effective forms of treatment for children with RSE. In a series of single-case experimental studies, research has found that treatment incorporating technologically enhanced sensory feedback (visual-acoustic biofeedback, ultrasound biofeedback) can improve speech in individuals with RSE who have not responded to previous intervention. A randomized controlled trial (RCT) comparing traditional vs biofeedback-enhanced intervention is the essential next step to inform evidence-based decision-making for this prevalent population. Larger-scale research is also needed to understand heterogeneity across individuals in the magnitude of response to biofeedback treatment.
The overall objective of this proposal is to conduct clinical research that will guide the evidence-based management of RSE while also providing novel insights into the sensorimotor underpinnings of speech. The central hypothesis is that biofeedback will yield greater gains in speech accuracy than traditional treatment, and that individual deficit profiles will predict relative response to visual-acoustic vs ultrasound biofeedback. This study will enroll n = 118 children who misarticulate the /r/ sound, the most common type of RSE. This first component of the study will evaluate the efficacy of biofeedback relative to traditional treatment in a well-powered randomized controlled trial. Ultrasound and visual-acoustic biofeedback, which have similar evidence bases, will be represented equally.
Randomized Trial Component: Previous findings suggest that biofeedback interventions can outperform traditional speech therapy for children with RSE, but the research base to date is limited to small-scale studies that do not reach the level of evidence needed to support large-scale changes in practice. The primary objective of the C-RESULTS RCT is to test the working hypothesis that a group of individuals randomly assigned to receive biofeedback-enhanced treatment will show larger and/or faster gains in /r/ production accuracy than an equivalent group receiving the same dose of non-biofeedback treatment. To test this hypothesis, n=110 children will be randomly assigned to receive a standard course of intervention with or without biofeedback. Acoustic and perceptual measures will be used to test for differences in both short-term learning of treated targets (Acquisition) and longer-term carryover of learning to untreated contexts (Generalization). In addition, a survey assessing participants' socio-emotional well-being will be collected from caregivers both pre and post treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Traditional articulation treatment |
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| Group 2 | Experimental | Biofeedback--visual-acoustic |
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| Group 3 | Experimental | Biofeedback-ultrasound |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biofeedback-ultrasound | Behavioral | In ultrasound biofeedback, the elements of traditional treatment (auditory models and verbal descriptions of articulator placement) are enhanced with a real-time ultrasound display of the shape and movements of the tongue. One or two target tongue shapes will be selected for each participant, and a trace of the selected target will be superimposed over the ultrasound screen. Participants will be cued to reshape the tongue to match this target during /r/ production. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in F3-F2 Distance (Hz) Across Sessions, Measured From /r/ Sounds Produced in Syllables or Words During Practice. | F3-F2 distance is a number (in Hz) that reflects how close a child's /r/ sound is to a typical adult-like /r/. Smaller numbers indicate more accurate /r/ production; larger numbers indicate a distorted /r/. In typical peers, accurate /r/ is roughly ~500 Hz, whereas distorted /r/ values are often >1000 Hz. During Phase I (3 sessions over ~1 week), children produced /r/ in syllables/words. For this Outcome, we report change across sessions: a single model-based estimate of how much F3-F2 decreased from Session 1 to Session 3 (i.e., the rate of improvement). A more negative change indicates greater improvement. | Phase I: three 90-min treatment sessions delivered over ~1 week; reported value is the change from Session 1 to Session 3 (slope across sessions) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Pre to Post in Percent "Correct" Ratings by Untrained Listeners, for /r/ Sounds Produced in Word Probes. | The outcome is the percentage of untrained listeners, blinded to time point and treatment condition, who judged each /r/ production as "correct" from word-probe recordings (0-100%; higher = better). Children completed word probes at Pre and Post. Results in the table summarize change from Pre to Post using a mixed-effects model: specifically, the treatment × time interaction, which estimates the between-group difference in improvement from Pre to Post. A positive change indicates improvement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montclair State University | Bloomfield | New Jersey | 07003 | United States | ||
| Syracuse University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30199271 | Background | Preston JL, McCabe P, Tiede M, Whalen DH. Tongue shapes for rhotics in school-age children with and without residual speech errors. Clin Linguist Phon. 2019;33(4):334-348. doi: 10.1080/02699206.2018.1517190. Epub 2018 Sep 10. | |
| 30073249 | Background | Preston JL, McAllister T, Phillips E, Boyce S, Tiede M, Kim JS, Whalen DH. Treatment for Residual Rhotic Errors With High- and Low-Frequency Ultrasound Visual Feedback: A Single-Case Experimental Design. J Speech Lang Hear Res. 2018 Aug 8;61(8):1875-1892. doi: 10.1044/2018_JSLHR-S-17-0441. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Traditional Articulation Treatment | Traditional articulation treatment |
| FG001 | Group 2: Biofeedback--visual-acoustic | Biofeedback--visual-acoustic |
| FG002 | Group 3: Biofeedback-Ultrasound | Biofeedback-ultrasound |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1 (Acquisition) |
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| Phase 2 (Generalization) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Traditional Articulation Treatment | Traditional articulation treatment |
| BG001 | Group 2: Biofeedback--visual-acoustic | Biofeedback--visual-acoustic |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Change in F3-F2 Distance (Hz) Across Sessions, Measured From /r/ Sounds Produced in Syllables or Words During Practice. | F3-F2 distance is a number (in Hz) that reflects how close a child's /r/ sound is to a typical adult-like /r/. Smaller numbers indicate more accurate /r/ production; larger numbers indicate a distorted /r/. In typical peers, accurate /r/ is roughly ~500 Hz, whereas distorted /r/ values are often >1000 Hz. During Phase I (3 sessions over ~1 week), children produced /r/ in syllables/words. For this Outcome, we report change across sessions: a single model-based estimate of how much F3-F2 decreased from Session 1 to Session 3 (i.e., the rate of improvement). A more negative change indicates greater improvement. | Three participants from group 2 (visual-acoustic biofeedback) could not be acoustically analyzed due to poor audio quality. | Posted | Mean | Standard Deviation | Hertz / session | Phase I: three 90-min treatment sessions delivered over ~1 week; reported value is the change from Session 1 to Session 3 (slope across sessions) |
|
From enrollment until end of follow-up, roughly 13 weeks"
This was a low-risk behavioral speech therapy trial. Adverse events were systematically monitored with safety checks at midpoint and end of treatment. Because all randomized participants were included in adverse event monitoring, all randomized participants were treated as at risk. Study definitions were consistent with ClinicalTrials.gov definitions.
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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 | Group 1: Traditional Articulation Treatment | Traditional articulation treatment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tara McAllister, Associate Professor | New York University | 212-992-9445 | tkm214@nyu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 8, 2025 | Dec 8, 2025 | Prot_SAP_000.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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All participants will complete a Dynamic Assessment session (Phase 0) consisting of 2 hours of traditional (non-biofeedback) instruction. Participants will be categorized into high, moderate, and low response groups based on performance in Phase 0, and the response groups will be block randomized to traditional or biofeedback speech treatment. Within the biofeedback condition, individuals will be sub-randomized in equal numbers to receive visual-acoustic or ultrasound treatment. Participants will then complete two phases of speech treatment in their randomly assigned condition. Phase 1 (Acquisition) will consist of high-intensity, highly interactive practice delivered in three 90-minute sessions over one week. Phase 2 (Generalization) will elicit structured practice of /r/ in 16 semiweekly 45-minute sessions over 8 weeks.
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All perceptual ratings will be obtained from blinded, naive listeners recruited through online crowdsourcing. Following protocols refined in previous published research, binary rating responses will be aggregated over at least 9 unique listeners per token.
|
| Biofeedback--visual-acoustic | Behavioral | 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. 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. |
|
| Traditional articulation treatment | Behavioral | Traditional articulation treatment involves providing auditory models and verbal descriptions of correct articulator placement, then cueing repetitive motor practice. Images and diagrams of the vocal tract will be used as visual aids; however, no real-time visual display of articulatory or acoustic information will be made available. |
|
| Pre (before initiation of treatment) and Post (after the end of all treatment; ~10 weeks later). |
| Impact of Speech Disorder on Social, Emotional, and Academic Well-being (Parent Survey) | Parents completed a questionnaire assessing the impact of their child's speech disorder on social, emotional, and academic well-being. Each item was rated on a 5-point scale (1 = strongly disagree, 3 = neutral, 5 = strongly agree). Scores were averaged across items to yield an overall impact score ranging from 1 to 5, with higher values indicating a greater negative impact. A decrease from Pre to Post indicates improvement. | Pre (before initiation of treatment) and Post (after completion of all treatment; ~10 weeks later) |
| Syracuse |
| New York |
| 13244 |
| United States |
| 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. |
| 29546269 | Background | Preston JL, Holliman-Lopez G, Leece MC. Do Participants Report Any Undesired Effects in Ultrasound Speech Therapy? Am J Speech Lang Pathol. 2018 May 3;27(2):813-818. doi: 10.1044/2017_AJSLP-17-0121. |
| 28117824 | Background | Preston JL, McAllister Byun T, Boyce SE, Hamilton S, Tiede M, Phillips E, Rivera-Campos A, Whalen DH. Ultrasound Images of the Tongue: A Tutorial for Assessment and Remediation of Speech Sound Errors. J Vis Exp. 2017 Jan 3;(119):55123. doi: 10.3791/55123. |
| 27296780 | Background | Preston JL, Leece MC, Maas E. Motor-based treatment with and without ultrasound feedback for residual speech-sound errors. Int J Lang Commun Disord. 2017 Jan;52(1):80-94. doi: 10.1111/1460-6984.12259. Epub 2016 Jun 14. |
| 28795872 | Background | Campbell H, Harel D, Hitchcock E, McAllister Byun T. Selecting an acoustic correlate for automated measurement of American English rhotic production in children. Int J Speech Lang Pathol. 2018 Nov;20(6):635-643. doi: 10.1080/17549507.2017.1359334. Epub 2017 Aug 10. |
| 28703653 | Background | Campbell H, McAllister Byun T. Deriving individualised /r/ targets from the acoustics of children's non-rhotic vowels. Clin Linguist Phon. 2018;32(1):70-87. doi: 10.1080/02699206.2017.1330898. Epub 2017 Jul 13. |
| 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. |
| 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. |
| 27891084 | Background | McAllister Byun T, Campbell H. Differential Effects of Visual-Acoustic Biofeedback Intervention for Residual Speech Errors. Front Hum Neurosci. 2016 Nov 11;10:567. doi: 10.3389/fnhum.2016.00567. eCollection 2016. |
| 25578293 | Background | McAllister Byun T, Halpin PF, Szeredi D. Online crowdsourcing for efficient rating of speech: a validation study. J Commun Disord. 2015 Jan-Feb;53:70-83. doi: 10.1016/j.jcomdis.2014.11.003. Epub 2014 Dec 15. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 32046671 | Derived | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| BG002 | Group 3: Biofeedback-Ultrasound | Biofeedback-ultrasound |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Response to dynamic assessment session | Prior to randomization, participants completed a dynamic assessment (DA) session to evaluate their ability to respond to treatment. Participants were categorized into two groups based on the treating clinician's perceptual ratings of their articulation. The two groups were termed high initial responders (greater than 5% accuracy during DA) or low initial responders (0%-5% accuracy during DA). Randomization was stratified by DA response group. | Count of Participants | Participants |
|
| OG000 |
| Group 1: Traditional Articulation Treatment |
Traditional articulation treatment |
| OG001 | Group 2: Biofeedback--visual-acoustic | Biofeedback--visual-acoustic |
| OG002 | Group 3: Biofeedback-Ultrasound | Biofeedback-ultrasound |
|
|
|
| Secondary | Change From Pre to Post in Percent "Correct" Ratings by Untrained Listeners, for /r/ Sounds Produced in Word Probes. | The outcome is the percentage of untrained listeners, blinded to time point and treatment condition, who judged each /r/ production as "correct" from word-probe recordings (0-100%; higher = better). Children completed word probes at Pre and Post. Results in the table summarize change from Pre to Post using a mixed-effects model: specifically, the treatment × time interaction, which estimates the between-group difference in improvement from Pre to Post. A positive change indicates improvement. | The analysis population differs from the number of participants who completed the Secondary Outcome Assessment visit (Phase 2) because two participants contributed unusable secondary-outcome data (one due to corrupted audio files, and one who completed all treatment sessions but whose number of trials completed did not pass the threshold for inclusion in the analysis). | Posted | Mean | Standard Deviation | Percent words rated correct | Pre (before initiation of treatment) and Post (after the end of all treatment; ~10 weeks later). |
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| Secondary | Impact of Speech Disorder on Social, Emotional, and Academic Well-being (Parent Survey) | Parents completed a questionnaire assessing the impact of their child's speech disorder on social, emotional, and academic well-being. Each item was rated on a 5-point scale (1 = strongly disagree, 3 = neutral, 5 = strongly agree). Scores were averaged across items to yield an overall impact score ranging from 1 to 5, with higher values indicating a greater negative impact. A decrease from Pre to Post indicates improvement. | The number of participants analyzed for secondary outcome measure #3 is the same as the number of participants who completed Phase 2. The data quality-related exclusions that impacted the secondary outcome measure #2 did not impact secondary outcome measure #3. | Posted | Mean | Standard Deviation | Impact score | Pre (before initiation of treatment) and Post (after completion of all treatment; ~10 weeks later) |
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|
|
| 0 |
| 45 |
| 0 |
| 45 |
| 0 |
| 45 |
| EG001 | Group 2: Biofeedback--visual-acoustic | Biofeedback--visual-acoustic | 0 | 32 | 0 | 32 | 0 | 32 |
| EG002 | Group 3: Biofeedback-Ultrasound | Biofeedback-ultrasound | 0 | 31 | 0 | 31 | 0 | 31 |
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| D003142 |
| Communication |
| D001519 | Behavior |
| Superiority |
| Superiority |