Speech-Language Teletherapy for Hearing Loss

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen byDylan K Chan, MD, PhD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of California, San Francisco

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for deaf or hard-of-hearing children aged 0-27 months who primarily speak English or Spanish. They must have hearing loss confirmed by tests, be fitted with a hearing aid or cochlear implant, or have plans to do so within 3 months of joining the study. Children not pursuing spoken language, with moderate to severe developmental delays, receiving speech therapy outside this study, or with certain inner ear abnormalities are excluded.

Inclusion Criteria

Primary home language is English or Spanish, determined by electronic medical record or direct parent report

You have been diagnosed with hearing loss using specific tests.

Children who have moderate to severe hearing loss and are using a hearing aid or cochlear implant, or have been identified for fitting a hearing aid or activating a cochlear implant within 3 months of joining the study.

+1 more

Exclusion Criteria

The family does not plan to help their child learn to listen and speak, according to what the parents say.

Speech-language teletherapy received through a clinical provider outside of this study at the time of enrollment, based on parent report

You have a significant delay in your overall development, as determined by a specialist.

+3 more

Participant Groups

The trial is testing if an 18-month speech/language teletherapy program can improve speech and language in deaf/hard-of-hearing children compared to usual care alone. It involves D/HH children who are publicly insured being randomly assigned to either the teletherapy group or usual care group; privately insured children will receive only usual care.

3Treatment groups

Experimental Treatment

Active Control

Group I: Usual Care + Teletherapy (Low-Income)Experimental Treatment1 Intervention

This group includes the low-income families who satisfy the criteria to receive supplemental speech-language teletherapy and are randomized to receive the intervention. They will receive both 3x comprehensive assessments every 9 months AND access to supplemental speech-language teletherapy for the 18-month study period.

Group II: Usual Care (High-Income)Active Control1 Intervention

This group will receive comprehensive assessments every 9 months for the 18-month period of enrollment, for a total of 3 assessments. They will not be randomized to receive supplemental teletherapy (intervention) and usual care.

Group III: Usual Care (Low-Income)Active Control1 Intervention

This group includes the low-income families who satisfy the criteria to receive supplemental speech-language teletherapy but are not randomized to receive the intervention after allocation. Like the "Usual Care (High-Income) arm, they will only receive comprehensive assessments every 9 months for the 18-month period of enrollment, for a total of 3 assessments and usual care.