NCT06884943 Generalization With AI Navigation Using StaRt
| NCT ID | NCT06884943 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | New York University |
| Condition | Speech Sound Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 76 participants |
| Start Date | 2024-12-18 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 76 participants in total. It began in 2024-12-18 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06884943 clinical trial?
This trial is open to participants of all sexes, aged 9 Years or older, up to 17 Years, studying Speech Sound Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06884943 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06884943 currently recruiting?
Yes, NCT06884943 is actively recruiting participants. Contact the research team at tkm214@nyu.edu for enrollment information.
Where is the NCT06884943 trial being conducted?
This trial is being conducted at Bloomfield, United States, Syracuse, United States.
Who is sponsoring the NCT06884943 clinical trial?
NCT06884943 is sponsored by New York University. The trial plans to enroll 76 participants.