Generalization With AI Navigation Using StaRt (GAINS)

New York University (NYU)

Status and phase: Enrolling; Phase 2

Conditions: Speech Sound Disorder

Treatments: Behavioral: Treatment as Usual (TAU); Behavioral: AI-guided maintenance training with visual-acoustic biofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT06884943

CRESULTS GAINS

2R01DC017476 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full description

This study will measure the effects of AI-guided home practice as a follow-up to participation in a study of technology-enhanced treatment for speech sound disorder affecting the American English "r" sound. Participants will sign a single consent form that covers their participation in the original VISIT study (in which they are randomized to receive biofeedback treatment in person or via telepractice) and and the follow-up GAINS study (in which participants are randomized to a follow-up period of treatment as usual [TAU] or treatment as usual plus an AI-guided maintenance program with biofeedback [TAU+AI]).We will measure production accuracy at the start and end of GAINS to test our working hypothesis that children/adolescents with speech sound disorder will show higher accuracy in /r/ production after six weeks of TAU+AI than six weeks of TAU alone. All GAINS treatment sessions will be carried out in the home setting using online tools. Pre and post treatment evaluations will be carried out in the laboratory setting.

Enrollment: 76 estimated patients

Sex: All

Ages: 9 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• • Must be between 9;0 and 17;11 (years;months) old at the time of enrollment.

  • Must speak English as the dominant or equally dominant language
  • Must have begun learning English by age 3, per parent report.
  • Must hear a rhotic dialect of English from at least one speaker in the home if the home language is English.
  • 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).
  • Must have access to a laptop or desktop computer for study sessions.
  • Must have home wifi sufficient to support video calls in the event of randomization to the telepractice condition.
  • Must have completed participation in the VISIT randomized controlled trial.
  • Must score at least 60% correct in at least one treatment session during the related previous study, VISIT.

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 currently have orthodontia that crosses the palate and cannot be removed.
  • Must not have history of permanent hearing loss.
  • Must not have an existing diagnosis of developmental disability such as cerebral palsy or Down Syndrome.
  • Must not have history of major brain injury, surgery, or stroke in the past year.
  • Must not have epilepsy with active seizure incidents with in the past 6 months.
  • Must not show clinically significant signs of apraxia of speech or dysarthria.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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76 participants in 2 patient groups

AI-guided maintenance training with visual-acoustic biofeedback

Experimental group

Description:

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

Treatment:

Behavioral: AI-guided maintenance training with visual-acoustic biofeedback

Behavioral: Treatment as Usual (TAU)

Treatment as usual [TAU]

Active Comparator group

Description:

Regular community-based care.

Treatment:

Behavioral: Treatment as Usual (TAU)