Generalization With AI Navigation Using StaRt (NCT06884943) | Clinical Trial Compass
RecruitingPhase 2
Generalization With AI Navigation Using StaRt
United States76 participantsStarted 2024-12-18
Plain-language 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).
Who can participate
Age range
9 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
1. Percentage of "Correct" Ratings by Blinded Untrained Listeners for /r/ Sounds Produced in Word Probes
Timeframe: Immediately before the initiation of GAINS participation and again after the end of GAINS participation (6 weeks later)