RECRUITING

Generalization With AI Navigation Using StaRt

Conditions

Speech Sound Disorder speech articulation

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Randomized Trial of AI-Enhanced Maintenance Training With Visual-Acoustic Biofeedback

Quick Facts

Study Start:2025-05-01

Study Completion:2028-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06884943

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:9 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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.	* • 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.

Inclusion Criteria

Exclusion 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.

* • 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.

Contacts and Locations

Study Contact

Tara McAllister, PhD

CONTACT

212-992-9445

tkm214@nyu.edu

Twylah Campbell, MA

CONTACT

516-265-5389

tjc10@nyu.edu

Study Locations (Sites)

Montclair State University

Bloomfield, New Jersey, 07003

United States

Syracuse University

Syracuse, New York, 13244

United States

Collaborators and Investigators

Sponsor: New York University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-01

Study Completion Date2028-12-31

Study Record Updates

Study Start Date2025-05-01

Study Completion Date2028-12-31

Terms related to this study

Keywords Provided by Researchers

speech
articulation

Additional Relevant MeSH Terms

Speech Sound Disorder