Trial Outcomes & Findings for Visual Acoustic Biofeedback for RSE Via Telepractice (NCT NCT04858022)
NCT ID: NCT04858022
Last Updated: 2026-02-17
Results Overview
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.
COMPLETED
PHASE2
40 participants
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).
2026-02-17
Participant Flow
Participant milestones
| Measure |
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).
|
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).
|
|---|---|---|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
|
Overall Study
STARTED
|
19
|
21
|
|
Overall Study
COMPLETED
|
19
|
21
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Visual Acoustic Biofeedback for RSE Via Telepractice
Baseline characteristics by cohort
| Measure |
Visual-acoustic Biofeedback Treatment Via Telepractice First, Then No Treatment
n=19 Participants
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).
|
No Treatment First, Then Visual-acoustic Biofeedback Treatment Via Telepractice
n=21 Participants
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).
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
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Age, Continuous
|
11.19 years
STANDARD_DEVIATION 1.57 • n=25 Participants
|
11.27 years
STANDARD_DEVIATION 2.18 • n=20 Participants
|
11.24 years
STANDARD_DEVIATION 1.88 • n=45 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=25 Participants
|
9 Participants
n=20 Participants
|
15 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=25 Participants
|
12 Participants
n=20 Participants
|
25 Participants
n=45 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=25 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=25 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=25 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=25 Participants
|
13 Participants
n=20 Participants
|
30 Participants
n=45 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=25 Participants
|
2 Participants
n=20 Participants
|
4 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=45 Participants
|
|
Rhotic accuracy
|
11.5 percent accuracy
STANDARD_DEVIATION 9.9 • n=25 Participants
|
12 percent accuracy
STANDARD_DEVIATION 14.4 • n=20 Participants
|
11.8 percent accuracy
STANDARD_DEVIATION 9.74 • n=45 Participants
|
PRIMARY outcome
Timeframe: 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).Population: 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.
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.
Outcome measures
| Measure |
Visual-acoustic Biofeedback Treatment Via Telepractice Followed by No Treatment
n=19 Participants
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).
|
No Treatment Followed by Visual-acoustic Biofeedback Treatment Via Telepractice
n=21 Participants
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).
|
|---|---|---|
|
Rhotic Accuracy (/r/)
No treatment
|
9.54 mean difference in percent correct
Standard Deviation 11.12
|
-.78 mean difference in percent correct
Standard Deviation 8.85
|
|
Rhotic Accuracy (/r/)
Visual-acoustic biofeedback treatment via Telepractice
|
30.55 mean difference in percent correct
Standard Deviation 29.20
|
28.60 mean difference in percent correct
Standard Deviation 30.33
|
SECONDARY outcome
Timeframe: Survey completed at BL ( evaluation) and MN ( 1 day following Second period duration). Same for both groups.Population: 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.
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.
Outcome measures
| Measure |
Visual-acoustic Biofeedback Treatment Via Telepractice Followed by No Treatment
n=19 Participants
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).
|
No Treatment Followed by Visual-acoustic Biofeedback Treatment Via Telepractice
n=21 Participants
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).
|
|---|---|---|
|
Change in Social-emotional Well-being
|
2.83 Average score
Standard Deviation 1.88
|
3.08 Average score
Standard Deviation 1.75
|
Adverse Events
Visual-Acoustic Biofeedback Treatment Via Telepractice Followed by No Treatment
No Treatment Followed by Visual-Acoustic Biofeedback Treatment Via Telepractice
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place