Generalization With AI Navigation Using StaRt

Part of paid clinical trials in Bloomfield, New Jersey.

Sponsor
New York University
Study ID
NCT06884943
Phase
PHASE2
Status
Recruiting
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Conditions

  • Speech Sound Disorder

Eligibility Criteria

Sex
ALL
Age
9 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • AI-guided maintenance training with visual-acoustic biofeedback — BEHAVIORAL
    Participants will complete AI-guided practice in the home setting in which they will interact with a web interface of the staRt web-based software for speech practice. The staRt software will present words to practice and show a real-time visual display of the acoustic signal of speech (biofeedback). On select trials, feedback will be provided by a classifier for children's "r" sounds, PERCEPT. Research assistants will join sessions to facilitate but will not provide direct clinical guidance to participants.
  • Treatment as Usual (TAU) — BEHAVIORAL
    Participants will return to their regular community-based care. This may consist of treatment in the school setting or by a private SLP; participants who were not previously receiving treatment may return to a no-treatment condition. Data will be collected from parents/guardians to determine the frequency of treatment, if any, received during this phase.

Study Details

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).

Key Dates

Start date
Dec 18, 2024
Status verified
May 2026
Primary completion
Dec 31, 2028
Completion
Jul 1, 2029

Study Design

Enrollment
76 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AI-guided maintenance training with visual-acoustic biofeedback
    Participants will receive visual-acoustic biofeedback treatment from a clinician in a private, password-protected WebRTC room.
  • Active Comparator: Treatment as usual [TAU]
    Regular community-based care.

Primary Outcome Measure

1. Percentage of "Correct" Ratings by Blinded Untrained Listeners for /r/ Sounds Produced in Word Probes [ Time Frame: Immediately before the initiation of GAINS participation and again after the end of GAINS participation (6 weeks later) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Montclair State UniversityBloomfieldNew Jersey07003
Elaine R Hitchcock, Ph
[email protected]
973-229-3797
Laura Ochs, MS
[email protected]
619-784-4979
Elaine R Hitchcock, PhD (PRINCIPAL_INVESTIGATOR)
Syracuse UniversitySyracuseNew York13244
Jonathan L Preston, PhD
[email protected]
315-443-3143
Megan C Leece, MS
[email protected]
315-443-1351
Jonathan L Preston, PhD (PRINCIPAL_INVESTIGATOR)

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