RECRUITING

Visual-acoustic Intervention With Service Delivery In-person and Via Telepractice Trial

Conditions

Speech Sound Disorder speech articulation motor development

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

Children with speech sound disorder show diminished intelligibility in spoken communication and may thus be perceived as less capable than peers, with negative consequences for both socioemotional and socioeconomic outcomes. New technologies have the potential to transform interventions for speech sound disorder, but there is a lack of rigorous evidence to substantiate this promise. This research will meet a public health need by systematically evaluating the efficacy of visual-acoustic biofeedback intervention delivered in-person versus via telepractice. The objective of this study is to test the hypothesis that treatment incorporating visual-acoustic biofeedback can be delivered via telepractice without a significant loss of efficacy. Participants will be randomly assigned to receive identical treatment either via online telepractice or in the laboratory setting. The same software for visual-acoustic biofeedback, staRt, will be used in both conditions. Participants' progress in treatment will be evaluated based on blinded listeners' perceptual ratings of probes produced before and after treatment. Pre and post treatment evaluations will be carried out in person for all participants.

Official Title

Visual-acoustic Intervention With Service Delivery In-person and Via Telepractice (VISIT) Non-Inferiority Trial

Quick Facts

Study Start:2024-07-01

Study Completion:2028-07-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06517225

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:FEMALE

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 exhibit less than thirty percent accuracy, based on trained listener ratings, on a probe list eliciting /r/ in various phonetic contexts at the word level. * 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 in the event of randomization to the telepractice condition. * Must have home wifi sufficient to support video calls in the event of randomization to the telepractice condition.	* 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 exhibit less than thirty percent accuracy, based on trained listener ratings, on a probe list eliciting /r/ in various phonetic contexts at the word level.
* 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 in the event of randomization to the telepractice condition.
* Must have home wifi sufficient to support video calls in the event of randomization to the telepractice condition.

* 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 Locations (Sites)

Montclair State University

Bloomfield, New Jersey, 07003

United States

New York University

New York, New York, 10012

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 Date2024-07-01

Study Completion Date2028-07-31

Study Record Updates

Study Start Date2024-07-01

Study Completion Date2028-07-31

Terms related to this study

Keywords Provided by Researchers

speech
articulation
motor development

Additional Relevant MeSH Terms

Speech Sound Disorder