Generalization With AI Navigation Using StaRt

NCT06884943 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2026-05-13

No results posted yet for this study

Summary

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).

Conditions

  • Speech Sound Disorder

Interventions

BEHAVIORAL

AI-guided maintenance training with visual-acoustic biofeedback

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.

BEHAVIORAL

Treatment as Usual (TAU)

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.

Sponsors & Collaborators

  • Syracuse University

    collaborator OTHER
  • Montclair State University

    collaborator OTHER
  • New York University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-18
Primary Completion
2028-12-31
Completion
2029-07-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06884943 on ClinicalTrials.gov