Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R41DC016778 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
Not provided
Not provided
Not provided
Not provided
Previous research suggests that biofeedback can outperform traditional interventions for RSE, but no controlled studies have tested this hypothesis in the context of app-delivered biofeedback. The objective of this aim is to use the staRt app to test our working hypothesis that speakers will make larger gains in /r/ accuracy when app-based treatment incorporates biofeedback, compared to a non-biofeedback condition. With a network of cooperating SLPs, this project will recruit 15 children with /r/ misarticulation to receive 8 weeks of intervention using staRt. Individual sessions will be randomly assigned to include or exclude the visual biofeedback display. Randomization tests will be used to evaluate, for each individual, whether larger increments of change are associated with biofeedback and non-biofeedback sessions.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Visual-acoustic biofeedback | Experimental |
| |
| Traditional articulation treatment | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 can be used as visual aids; however, no real-time visual display of articulatory or acoustic information will be made available. Knowledge of performance feedback could describe either the desired articulator placement or the auditory quality of the target sound. |
| Measure | Description | Time Frame |
|---|---|---|
| F3-F2 Distance, an Acoustic Measure That Correlates With Perceptual Accuracy of /r/, Measured From /r/ Sounds Produced in Treatment Sessions. | From recordings of words containing /r/ produced during treatment sessions, the sound /r/ was flagged for measurement and the first three formants (F1, F2, F3) were extracted from the center of the /r/ interval. The distance between the second and third formants (F3-F2) was used as the index of rhoticity. F3-F2 is small in perceptually accurate /r/, larger values indicate lower accuracy. Summary statistics report the mean and standard deviation of normalized F3-F2 distance for each treatment condition, pooled across participants and sessions. A two-tailed paired-samples t-test (superiority criterion) was used to compare mean F3-F2 distance for each treatment condition across subjects. | F3-F2 distance was measured in all 16 treatment sessions (eight of each type), which were administered over eight weeks. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University | New York | New York | 10012 | United States |
This study used a within-subjects design. Each participant received both treatment conditions, with sessions randomly assigned to feature one condition or the other.
Social media and mailing lists were used to identify certified speech-language pathologists interested in providing the study treatment to consenting participants on their caseload. Clinical partners completed CITI human subjects training (both basic social/behavioral and Good Clinical Practice). They were also required to complete an Individual Investigator Agreement (if not already covered by an existing IRB) or secure a reliance agreement (if covered by an existing IRB) with the IRB at NYU.
| ID | Title | Description |
|---|---|---|
| FG000 | Visual-acoustic Biofeedback and Traditional Articulation Treatment | Visual-acoustic biofeedback: 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 generated by the staRt app. 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. Knowledge of performance feedback will typically involve reference to the location of the third peak or 'bump' on the visual display. Traditional articulation treatment: 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 can be used as visual aids; however, no real-time visual display of articulatory or acoustic information will be made available. Knowledge of performance feedback could describe either the desired articulator placement or the auditory quality of the target sound. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Visual-acoustic Biofeedback and Traditional Articulation Treatment | This study used a within-subjects design. Each participant received two treatment conditions (visual-acoustic biofeedback and ultrasound biofeedback), with sessions randomly assigned to feature one condition or the other. In traditional articulation treatment, the clinician provides auditory models and verbal descriptions of correct articulator placement, then cueing repetitive motor practice. Images and diagrams of the vocal tract can be used as visual aids; however, no real-time visual display of articulatory or acoustic information is made available. Knowledge of performance feedback could describe either the desired articulator placement or the auditory quality of the target sound. 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 spectrum. Because correct vs incorrect productions of /r/ contrast acoustically in the frequency of the third formant (F3), participants are cued to make their real-time LPC spectrum match a visual target characterized by a low F3 frequency. |
| 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 | F3-F2 Distance, an Acoustic Measure That Correlates With Perceptual Accuracy of /r/, Measured From /r/ Sounds Produced in Treatment Sessions. | From recordings of words containing /r/ produced during treatment sessions, the sound /r/ was flagged for measurement and the first three formants (F1, F2, F3) were extracted from the center of the /r/ interval. The distance between the second and third formants (F3-F2) was used as the index of rhoticity. F3-F2 is small in perceptually accurate /r/, larger values indicate lower accuracy. Summary statistics report the mean and standard deviation of normalized F3-F2 distance for each treatment condition, pooled across participants and sessions. A two-tailed paired-samples t-test (superiority criterion) was used to compare mean F3-F2 distance for each treatment condition across subjects. | Note that this study used a within-subjects design. Each participant received both treatment conditions, with individual sessions randomly assigned to feature one condition or the other. | Posted | Mean | Standard Deviation | Hz | F3-F2 distance was measured in all 16 treatment sessions (eight of each type), which were administered over eight weeks. |
8 weeks
The definition of adverse event and serious adverse event used to collect adverse event information does not differ from that of clinicaltrials.gov.
Not provided
| 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 | Visual-acoustic biofeedback: 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 generated by the staRt app. 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. Knowledge of performance feedback will typically involve reference to the location of the third peak or 'bump' on the visual display. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tara McAllister | New York University | 212-992-9445 | tkm214@nyu.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 10, 2020 | Dec 8, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 10, 2020 | Dec 8, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D066229 | Speech Sound Disorder |
| D013060 | Speech |
| ID | Term |
|---|---|
| D003147 | Communication Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D014705 | Verbal Behavior |
Not provided
Not provided
Children with /r/ misarticulation will receive 16 sessions/8 weeks of intervention using staRt. Individual sessions will be randomly assigned to include the visual biofeedback display (visual-acoustic biofeedback treatment) or exclude it (traditional treatment). Participants will receive an equal number of sessions (8) of each type.
Not provided
Not provided
Acoustic measures will be obtained by research assistants blinded to the treatment condition assigned for each session.
|
| Visual-acoustic biofeedback | 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 generated by the staRt app. 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. Knowledge of performance feedback will typically involve reference to the location of the third peak or 'bump' on the visual display. |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Traditional Articulation Treatment | In traditional articulation treatment, the clinician provides auditory models and verbal descriptions of correct articulator placement, then cueing repetitive motor practice. Images and diagrams of the vocal tract can be used as visual aids; however, no real-time visual display of articulatory or acoustic information is made available. Knowledge of performance feedback could describe either the desired articulator placement or the auditory quality of the target sound. |
| OG001 | 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 spectrum. Because correct vs incorrect productions of /r/ contrast acoustically in the frequency of the third formant (F3), participants are cued to make their real-time LPC spectrum match a visual target characterized by a low F3 frequency. |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Traditional Articulation Treatment | Traditional articulation treatment: 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 can be used as visual aids; however, no real-time visual display of articulatory or acoustic information will be made available. Knowledge of performance feedback could describe either the desired articulator placement or the auditory quality of the target sound. | 0 | 15 | 0 | 15 | 0 | 15 |
Not provided
Not provided
| D003142 |
| Communication |
| D001519 | Behavior |