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Speech-Language Teletherapy for Hearing Loss

N/A

Waitlist Available

Led By Dylan K Chan, MD, PhD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 month

Awards & highlights

No Placebo-Only Group

Summary

This trial will study whether speech and language teletherapy can help improve outcomes for deaf or hard-of-hearing children. 140 children who are publicly insured will be randomly assigned to either receive the therapy or usual clinical care, while 70 privately insured children will only receive usual care. Assessments will be done at the start of the study and then every 9 months to see if there are any improvements.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this intervention involves educational and therapeutic activities rather than medical treatments, traditional side effects associated with medications are not expected. However, there may be indirect effects such as frustration or fatigue during sessions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PLS-5 Auditory Comprehension (AC) Standard Score - 18 month

Secondary study objectives

Family Outcomes Survey (FOS) - 18 month

Family Outcomes Survey (FOS) - 18 month change

Family Outcomes Survey (FOS) - 9 month

+32 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Do I qualify?Apply below to find out