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Teletherapy in Children Who Are Deaf and Hard of Hearing

NCT04928209 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2026-03-27

No results posted yet for this study

Summary

This study seeks to determine the effectiveness of speech/language teletherapy to address disparities in speech and language outcomes in children who are deaf or hard-of-hearing (D/HH). The investigators will enroll D/HH children aged 0-27 months. 140 children who are publicly insured will be randomized to receive usual clinical care or to be given access to an 18-month course of speech-language teletherapy program. 70 children who are privately insured will also be enrolled and will receive usual care. Children will undergo, at baseline and every 9 months thereafter to a study endpoint of 18 months, for a total of 3 timepoints, a battery of in-person and parent-report assessments designed to provide a comprehensive measurement of the child's auditory function, speech, verbal- and non-verbal communication, spoken language, and quality of life.

Conditions

  • Hearing Loss
  • Speech and Language Development Delay Due to Hearing Loss

Interventions

OTHER

Speech-Language Teletherapy

Access to speech-language teletherapy will be provided as a supplement to Usual Care for subjects randomized to this group. Access is provided by way of 1) direct referral by the clinical team to a teletherapist; 2) availability of a teletherapy slot. All teletherapy providers will be licensed speech-language pathologists (SLPs) and/or credentialed teachers of the deaf (TODs) with specialized training to work with children who are D/HH using an LSL approach. Fluent English and Spanish speaking providers will be matched to the child's home, native language. Teletherapy itself is within routine clinical care and is not considered a research activity. Children who randomize to the Low TT study arm will receive access to an 18-month course of weekly teletherapy, in accordance with the centers' standard of care. The exact details of the therapy course and frequency will be determined based on individual family needs.

Sponsors & Collaborators

Principal Investigators

  • Dylan K Chan, MD, PhD · The University of California - San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Months
Max Age
27 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-15
Primary Completion
2025-12-17
Completion
2025-12-17

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04928209 on ClinicalTrials.gov