Teletherapy in Children Who Are Deaf and Hard of Hearing
Completed · Not applicable
Conditions studied: Hearing Loss, Speech and Language Development Delay Due to Hearing Loss
In brief
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.
Key facts
- Study ID
- NCT04928209
- Run by
- University of California, San Francisco
- People needed
- 210
- Starts
- 2021-07-15
- Expected to finish
- 2025-12-17
- Last updated by the study team
- 2026-03-27
Who can join
Age: any, up to 2. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 0-27 months;
- Hearing loss, as determined by auditory brainstem response (ABR) or behavioral audiometry (average of pure-tone air-conduction hearing thresholds (0.5-4 kHz; PTA) calculated from at least 2 frequencies from ABR (dB eHL) or behavioral audiometry (dB HL)):
- bilateral sensorineural, mixed, or permanent conductive hearing loss with better-ear PTA > 20 dB.
- single-sided deafness (unilateral SNHL with PTA > 70 dB);
- unilateral complete aural atresia; or
- bilateral auditory-neuropathy spectrum disorder, as determined by ABR.
- Primary home language is English or Spanish, determined by electronic medical record or direct parent report.
- For children with PTA > 20 dB, either:
- Currently fit with hearing aid or using a cochlear implant; OR
- Date identified for hearing-aid fitting or cochlear-implant activation within 3 months of enrollment.
You may not qualify if…
- Family does NOT have the intention to pursue listening and spoken language for their child, based on parent report;
- Moderate to severe global developmental delay, as determined by managing audiologist and/or otolaryngologist, based on:
- ICD-10 diagnosis code or chart review of medical progress notes indicating global developmental delay;
- presence of syndrome known to be associated with this delay (such as Trisomy 21, 22q11 syndrome, or CHARGE syndrome); OR
- parent report.
- Speech-language teletherapy received through a clinical provider outside of this study at the time of enrollment, based on parent report.
- No prognosis for access to sound as determined by managing audiologist and/or otolaryngologist. All children with bilateral severe-to-profound SNHL must have imaging to confirm this criterion prior to enrollment in the study. Children will be excluded if they have bilateral severe-to-profound sensorineural hearing loss and either:
- Contraindication to cochlear implantation, OR
- Temporal bone abnormalities that lead to great concern for poor cochlear-implant outcomes, including common cavity and/or cochlear nerve deficiency on imaging.
Where it is running
- UCSF Benioff Children's Hospital - Oakland — Oakland, California, United States
- Lucile Packard Children's Hospital Stanford — Palo Alto, California, United States
- Rady Children's Hospital - San Diego — San Diego, California, United States
- The University of California - San Francisco — San Francisco, California, United States
- Seattle Children's Hospital — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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