NCT04474691

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 4, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 17, 2020

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

May 3, 2023

Completed
Last Updated

May 3, 2023

Status Verified

December 1, 2021

Enrollment Period

1.4 years

First QC Date

June 15, 2020

Results QC Date

December 9, 2022

Last Update Submit

April 27, 2023

Conditions

Keywords

speecharticulationmotor development

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

Visual-acoustic biofeedback

EXPERIMENTAL
Behavioral: Visual-acoustic biofeedback

Traditional articulation treatment

ACTIVE COMPARATOR
Behavioral: Traditional articulation treatment

Interventions

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.

Traditional articulation treatment

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.

Visual-acoustic biofeedback

Eligibility Criteria

Age8 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Normal performance on a pure-tone hearing screening at 20 dB HL, a screening examination of oral-motor structure and function, and a test of receptive language.

You may not qualify if:

  • History of major behavioral, neurological, or hearing impairment, per parent and/or SLP report.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University

New York, New York, 10012, United States

Location

MeSH Terms

Conditions

Speech Sound DisorderSpeech

Condition Hierarchy (Ancestors)

Communication DisordersNeurodevelopmental DisordersMental DisordersVerbal BehaviorCommunicationBehavior

Results Point of Contact

Title
Tara McAllister
Organization
New York University

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Acoustic measures will be obtained by research assistants blinded to the treatment condition assigned for each session.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2020

First Posted

July 17, 2020

Study Start

April 4, 2018

Primary Completion

August 31, 2019

Study Completion

February 28, 2022

Last Updated

May 3, 2023

Results First Posted

May 3, 2023

Record last verified: 2021-12

Locations