Trial Outcomes & Findings for Correcting Residual Errors With Spectral, Ultrasound, Traditional Speech Therapy (NCT NCT03737318)
NCT ID: NCT03737318
Last Updated: 2026-01-05
Results Overview
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.
COMPLETED
NA
108 participants
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)
2026-01-05
Participant Flow
Participant milestones
| Measure |
Group 1: Traditional Articulation Treatment
Traditional articulation treatment
|
Group 2: Biofeedback--visual-acoustic
Biofeedback--visual-acoustic
|
Group 3: Biofeedback-Ultrasound
Biofeedback-ultrasound
|
|---|---|---|---|
|
Phase 1 (Acquisition)
STARTED
|
45
|
32
|
31
|
|
Phase 1 (Acquisition)
Primary Outcome Assessment
|
45
|
32
|
31
|
|
Phase 1 (Acquisition)
COMPLETED
|
45
|
32
|
31
|
|
Phase 1 (Acquisition)
NOT COMPLETED
|
0
|
0
|
0
|
|
Phase 2 (Generalization)
STARTED
|
45
|
32
|
31
|
|
Phase 2 (Generalization)
Secondary Outcome Assessment
|
45
|
32
|
31
|
|
Phase 2 (Generalization)
COMPLETED
|
41
|
31
|
30
|
|
Phase 2 (Generalization)
NOT COMPLETED
|
4
|
1
|
1
|
Reasons for withdrawal
| Measure |
Group 1: Traditional Articulation Treatment
Traditional articulation treatment
|
Group 2: Biofeedback--visual-acoustic
Biofeedback--visual-acoustic
|
Group 3: Biofeedback-Ultrasound
Biofeedback-ultrasound
|
|---|---|---|---|
|
Phase 2 (Generalization)
Withdrawal by Subject
|
4
|
1
|
1
|
Baseline Characteristics
Correcting Residual Errors With Spectral, Ultrasound, Traditional Speech Therapy
Baseline characteristics by cohort
| Measure |
Group 1: Traditional Articulation Treatment
n=45 Participants
Traditional articulation treatment
|
Group 2: Biofeedback--visual-acoustic
n=32 Participants
Biofeedback--visual-acoustic
|
Group 3: Biofeedback-Ultrasound
n=31 Participants
Biofeedback-ultrasound
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
10.72 years
STANDARD_DEVIATION 1.54 • n=9667 Participants
|
10.86 years
STANDARD_DEVIATION 1.87 • n=6597 Participants
|
10.71 years
STANDARD_DEVIATION 1.3 • n=16264 Participants
|
10.8 years
STANDARD_DEVIATION 1.57 • n=31 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=9667 Participants
|
16 Participants
n=6597 Participants
|
9 Participants
n=16264 Participants
|
40 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=9667 Participants
|
16 Participants
n=6597 Participants
|
22 Participants
n=16264 Participants
|
68 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9667 Participants
|
0 Participants
n=6597 Participants
|
0 Participants
n=16264 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9667 Participants
|
0 Participants
n=6597 Participants
|
1 Participants
n=16264 Participants
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9667 Participants
|
0 Participants
n=6597 Participants
|
0 Participants
n=16264 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9667 Participants
|
0 Participants
n=6597 Participants
|
1 Participants
n=16264 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=9667 Participants
|
31 Participants
n=6597 Participants
|
27 Participants
n=16264 Participants
|
94 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=9667 Participants
|
0 Participants
n=6597 Participants
|
1 Participants
n=16264 Participants
|
6 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=9667 Participants
|
1 Participants
n=6597 Participants
|
1 Participants
n=16264 Participants
|
5 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=9667 Participants
|
1 Participants
n=6597 Participants
|
3 Participants
n=16264 Participants
|
8 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=9667 Participants
|
29 Participants
n=6597 Participants
|
25 Participants
n=16264 Participants
|
94 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9667 Participants
|
2 Participants
n=6597 Participants
|
3 Participants
n=16264 Participants
|
6 Participants
n=31 Participants
|
|
Response to dynamic assessment session
High initial responders
|
21 Participants
n=9667 Participants
|
14 Participants
n=6597 Participants
|
15 Participants
n=16264 Participants
|
50 Participants
n=31 Participants
|
|
Response to dynamic assessment session
Low initial responders
|
24 Participants
n=9667 Participants
|
18 Participants
n=6597 Participants
|
16 Participants
n=16264 Participants
|
58 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 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)Population: Three participants from group 2 (visual-acoustic biofeedback) could not be acoustically analyzed due to poor audio quality.
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.
Outcome measures
| Measure |
Group 1: Traditional Articulation Treatment
n=45 Participants
Traditional articulation treatment
|
Group 2: Biofeedback--visual-acoustic
n=29 Participants
Biofeedback--visual-acoustic
|
Group 3: Biofeedback-Ultrasound
n=31 Participants
Biofeedback-ultrasound
|
|---|---|---|---|
|
Change in F3-F2 Distance (Hz) Across Sessions, Measured From /r/ Sounds Produced in Syllables or Words During Practice.
|
38.2 Hertz / session
Standard Deviation 66.0
|
66.7 Hertz / session
Standard Deviation 103.0
|
85.2 Hertz / session
Standard Deviation 152.0
|
SECONDARY outcome
Timeframe: Pre (before initiation of treatment) and Post (after the end of all treatment; ~10 weeks later).Population: 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).
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.
Outcome measures
| Measure |
Group 1: Traditional Articulation Treatment
n=41 Participants
Traditional articulation treatment
|
Group 2: Biofeedback--visual-acoustic
n=30 Participants
Biofeedback--visual-acoustic
|
Group 3: Biofeedback-Ultrasound
n=29 Participants
Biofeedback-ultrasound
|
|---|---|---|---|
|
Change From Pre to Post in Percent "Correct" Ratings by Untrained Listeners, for /r/ Sounds Produced in Word Probes.
|
44.5 Percent words rated correct
Standard Deviation 34
|
43.2 Percent words rated correct
Standard Deviation 33
|
49.6 Percent words rated correct
Standard Deviation 34
|
SECONDARY outcome
Timeframe: Pre (before initiation of treatment) and Post (after completion of all treatment; ~10 weeks later)Population: 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.
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.
Outcome measures
| Measure |
Group 1: Traditional Articulation Treatment
n=41 Participants
Traditional articulation treatment
|
Group 2: Biofeedback--visual-acoustic
n=31 Participants
Biofeedback--visual-acoustic
|
Group 3: Biofeedback-Ultrasound
n=30 Participants
Biofeedback-ultrasound
|
|---|---|---|---|
|
Impact of Speech Disorder on Social, Emotional, and Academic Well-being (Parent Survey)
|
1.9 Impact score
Standard Deviation 1.1
|
1.9 Impact score
Standard Deviation 1.1
|
2.1 Impact score
Standard Deviation 1.2
|
Adverse Events
Group 1: Traditional Articulation Treatment
Group 2: Biofeedback--visual-acoustic
Group 3: Biofeedback-Ultrasound
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Tara McAllister, Associate Professor
New York University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place