AI-Guided Training for Speech Sound Disorder

(GAINS Trial)

Recruiting at 1 trial location

Overseen By Tara McAllister, PhD

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: New York University

Disqualifiers: Voice disorder, Orthodontia, Hearing loss, Developmental disability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

76 Participants Needed

Trial Summary

What is the purpose of this trial?

Speech Sound Disorder (SSD) affects a significant portion of school-aged children, leading to social and emotional challenges that can persist into adolescence and adulthood. The number of productions necessary for a remediated speech sound to generalize to connected speech is challenging to achieve in practice, leading clinicians to call for accessible, reliable resources allowing children to continue therapy outside of direct clinical interactions. Artificial intelligence (AI) tools hold promise as a means to extend direct service delivery in speech-language pathology, but research investigating the topic has been limited. This study (Generalization with AI Navigation using staRt, or GAINS) will measure the effects of a course of AI-mediated home practice intended to promote generalization of gains made through biofeedback treatment in a related study, Visual-acoustic Intervention with Service Delivery In-person and Via Telepractice Trial (VISIT; NCT06517225).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on speech therapy and does not mention medication requirements.

What data supports the effectiveness of the treatment AI-guided maintenance training with visual-acoustic biofeedback for Speech Sound Disorder?

Research shows that visual-acoustic biofeedback can be effective in improving speech sounds, especially in the early stages of treatment, by providing detailed feedback on performance. Additionally, ultrasound biofeedback therapy has shown positive outcomes for speech sound disorders, suggesting that similar biofeedback methods may help improve speech accuracy. ^{1 2 3 4 5}

Is AI-guided training with visual-acoustic biofeedback safe for humans?

The research does not report any safety concerns for visual-acoustic biofeedback in treating speech sound disorders, suggesting it is generally safe for use in humans. ^{1 3 4 6 7}

How does the AI-guided maintenance training with visual-acoustic biofeedback treatment for speech sound disorder differ from other treatments?

This treatment is unique because it uses AI to guide maintenance training with visual-acoustic biofeedback, providing real-time visual feedback on tongue movements to help correct speech sounds. Unlike traditional methods, this approach offers a more interactive and engaging way to improve speech by allowing patients to see and adjust their tongue positions during speech production. ^{1 2 3 4 7}

Eligibility Criteria

This trial is for children aged 9 to 17 with Speech Sound Disorder who have normal hearing, oral function, and language abilities. They must have completed a previous study (VISIT), have access to a computer with home wifi, speak English as a primary or joint-first language from an early age, and not exhibit severe voice/fluency disorders or developmental disabilities.

Inclusion Criteria

Must pass a pure-tone hearing screening

Must pass a brief examination of oral structure and function

Must demonstrate age-appropriate receptive and expressive language abilities on the Clinical Evaluation of Language Fundamentals-5 (CELF-5)

Exclusion Criteria

Must not exhibit voice or fluency disorder of a severity judged likely to interfere with the ability to participate in study activities

Must not have an existing diagnosis of developmental disability such as cerebral palsy or Down Syndrome

I do not have non-removable braces that cross my palate.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AI-guided maintenance training with visual-acoustic biofeedback at home

6 weeks

All sessions conducted online

Follow-up

Participants are monitored for production accuracy and generalization of treatment gains

4 weeks

Pre and post treatment evaluations in laboratory

Treatment Details

Interventions

• AI-guided maintenance training with visual-acoustic biofeedback

Trial Overview The study tests AI-guided maintenance training using visual-acoustic biofeedback against the usual treatment methods for improving speech sound generalization in children. It builds on prior research by extending therapy beyond clinical settings into the home environment.

Participant Groups

Group I: AI-guided maintenance training with visual-acoustic biofeedback Experimental Treatment 2 Interventions

Participants will receive visual-acoustic biofeedback treatment from a clinician in a private, password-protected WebRTC room.

Group II: Treatment as usual [TAU] Active Control 1 Intervention

Regular community-based care.

Who Is Running the Clinical Trial?

New York University

Lead Sponsor

Trials

249

Recruited

229,000+

Montclair State University

Collaborator

Trials

14

Recruited

1,200+

Syracuse University

Collaborator

Trials

54

Recruited

118,000+

Findings from Research

Ultrasound biofeedback therapy (UBT) shows promise in improving speech for children with residual speech sound disorder (RSSD), but it can be complex and demanding, necessitating simpler articulation targets for better understanding.

The study developed an image-analysis program, TonguePART, which successfully quantified tongue movements and distinguished accurate from misarticulated /ɑr/ sounds with up to 85% classification accuracy, highlighting the importance of tongue dorsum and blade movements for effective speech production.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Classification of accurate and misarticulated /&#593;r/ for ultrasound biofeedback using tongue part displacement trajectories. Li, SR., Dugan, S., Masterson, J., et al.[2023]

Visual-acoustic biofeedback (VAB) treatment can effectively improve speech outcomes for individuals with speech sound difficulties, particularly in correcting distortions of the /ɹ/ sound.

Successful implementation of VAB relies on key factors such as understanding acoustic representations, selecting appropriate targets and strategies, and providing effective feedback, which together enhance speech sound acquisition and generalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tutorial: Using Visual-Acoustic Biofeedback for Speech Sound Training. Hitchcock, ER., Ochs, LC., Swartz, MT., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Differential Effects of Visual-Acoustic Biofeedback Intervention for Residual Speech Errors. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Classification of accurate and misarticulated /&#593;r/ for ultrasound biofeedback using tongue part displacement trajectories. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Tutorial: Using Visual-Acoustic Biofeedback for Speech Sound Training. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Multiple phonetically trained-listener comparisons of speech before and after articulatory intervention in two children with repaired submucous cleft palate. [2017]

5. England pubmed.ncbi.nlm.nih.gov

Treatment generalization from trained /ɹ/ to untrained /l/: a case study of persisting distortion errors. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Comparing Biofeedback Types for Children With Residual /ɹ/ Errors in American English: A Single-Case Randomization Design. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Enhancing Intervention for Residual Rhotic Errors Via App-Delivered Biofeedback: A Case Study. [2019]