Teletherapy in Children Who Are Deaf and Hard of Hearing
Key facts
- Where
- Oakland, Palo Alto, San Diego, San Francisco, and Seattle, United StatesSee the 5 sites
Where in United States
- UCSF Benioff Children's Hospital OaklandOakland, United StatesNo longer taking part
- Lucile Packard Children's Hospital - StanfordPalo Alto, United StatesNo longer taking part
- Rady Children's Hospital - San DiegoSan Diego, United StatesNo longer taking part
- The University of California San FranciscoSan Francisco, United StatesNo longer taking part
- Seattle Children's HospitalSeattle, United StatesNo longer taking part
Trial details
- Who runs it
- University of California, San Francisco
- Trial code
- NCT04928209
- Record updated
- 27 March 2026
- Original description
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.Read full original descriptionShow less
Teletherapy to Address Language Disparities in Deaf and Hard-of-hearing Children
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.
Inclusion: 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.
Exclusion: 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; 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; Family does NOT have the intention to pursue listening and spoken language for their child, based on parent report.