RECRUITING

BiOfeedback, Online for Sibilant Treatment

Conditions

Speech Sound Disorder speech intervention biofeedback articulation disorder lisp

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

The goal of this clinical trial is to evaluate the efficacy of sibilant biofeedback treatment delivered via telepractice in six children ages 8:0-17;11 who present with distortions of /s/. The main questions it aims to answer are: * Primary hypothesis: Biofeedback treatment for sibilants delivered via telepractice will produce positive gains compared to a no-treatment baseline phase. * Secondary hypothesis: Participants will experience positive changes in social-emotional well-being after receiving biofeedback treatment for sibilants as reported by the participants and their guardians. Following the initial evaluation, participants will be randomly assigned to transition from baseline to treatment at one of seven possible points, ranging from 4-10 baseline sessions in which /s/ production will be probed but not treated. All participants will then receive 20, 1-hour biofeedback treatment sessions over 10 weeks with a certified Speech-Language Pathologist via teletherapy, followed by three maintenance sessions.

Official Title

Online Assessment and Enhancement of Auditory Perception for Speech Sound Errors: BiOfeedback, Online for Sibilant Treatment

Quick Facts

Study Start:2025-07-30

Study Completion:2027-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07041723

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:8 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
* Age between 8;0 and 17;11 years at the time of enrollment * English as the dominant language (must have begun learning English by age 3, per parent report) * Passes pure-tone hearing screening at 30 dB hearing level * Passes brief examination of oral structure and function * Less than 30% accuracy, based on consensus across 2 trained listeners, on a probe list eliciting fricative /s, z/ in various phonetic contexts at the word level * No more than 3 sounds other than /s/ in error on the Goldman-Fristoe Test of Articulation-3 (GFTA-3) * Diagnosis of ADHD, learning disability, dyslexia, or neurodiversity is admissible if participant meets cutoff scores on evaluation day 1 * History of CAS is admissible if participant meets cutoff scores on evaluation day 1 * Braces and removable retainers are admissible * Access to a laptop or desktop computer and a quiet space for study sessions	* Scaled score of 7 or higher on the Recalling Sentences and Formulated Sentences subtests of the Clinical Evaluation of Language Fundamentals-5 (CELF-5) * History of permanent hearing loss (temporary hearing loss due to otitis media, including recurrent OM/tubes, is admissible) * History of developmental disorder (e.g., Down syndrome, cerebral palsy) * History of major brain injury, surgery, or stroke in the past year (mild concussion is admissible) * Active diagnosis of epilepsy or other neurological disorder (permissible if well-controlled for at least 6 months) * Current diagnosis of voice or fluency disorder * Current presence of orthodontia that crosses the palate (braces and removable retainers are admissible) * Lack of access to a laptop or desktop computer and a quiet space for study sessions

Inclusion Criteria

Exclusion Criteria

* Age between 8;0 and 17;11 years at the time of enrollment
* English as the dominant language (must have begun learning English by age 3, per parent report)
* Passes pure-tone hearing screening at 30 dB hearing level
* Passes brief examination of oral structure and function
* Less than 30% accuracy, based on consensus across 2 trained listeners, on a probe list eliciting fricative /s, z/ in various phonetic contexts at the word level
* No more than 3 sounds other than /s/ in error on the Goldman-Fristoe Test of Articulation-3 (GFTA-3)
* Diagnosis of ADHD, learning disability, dyslexia, or neurodiversity is admissible if participant meets cutoff scores on evaluation day 1
* History of CAS is admissible if participant meets cutoff scores on evaluation day 1
* Braces and removable retainers are admissible
* Access to a laptop or desktop computer and a quiet space for study sessions

* Scaled score of 7 or higher on the Recalling Sentences and Formulated Sentences subtests of the Clinical Evaluation of Language Fundamentals-5 (CELF-5)
* History of permanent hearing loss (temporary hearing loss due to otitis media, including recurrent OM/tubes, is admissible)
* History of developmental disorder (e.g., Down syndrome, cerebral palsy)
* History of major brain injury, surgery, or stroke in the past year (mild concussion is admissible)
* Active diagnosis of epilepsy or other neurological disorder (permissible if well-controlled for at least 6 months)
* Current diagnosis of voice or fluency disorder
* Current presence of orthodontia that crosses the palate (braces and removable retainers are admissible)
* Lack of access to a laptop or desktop computer and a quiet space for study sessions

Contacts and Locations

Study Contact

Elaine R. Hitchcock, PhD

CONTACT

19732293797

hitchcocke@montclair.edu

Study Locations (Sites)

Montclair State University

Bloomfield, New Jersey, 07003

United States

Collaborators and Investigators

Sponsor: Montclair State 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 Date2025-07-30

Study Completion Date2027-07

Study Record Updates

Study Start Date2025-07-30

Study Completion Date2027-07

Terms related to this study

Keywords Provided by Researchers

speech intervention
biofeedback
articulation disorder
lisp

Additional Relevant MeSH Terms

Speech Sound Disorder