CompletedPhase 2

Early Communication Intervention for Toddlers With Hearing Loss

United States105 participantsStarted 2019-06-15

Plain-language summary

Improving spoken language outcomes for children with hearing loss has important public health implications. This is a randomized clinical trial of 96 children with hearing loss that examines the effects of a parent-implemented early communication intervention on prelinguistic and spoken language outcomes. The study is open for national recruitment. Parents participate via video call with their child and receive technology to assist with virtual visits.

Who can participate

Age range12 Months – 18 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * have bilateral, congenital HL as measured by a review of medical records * enrollment in the study between 12 and 18 months of age * have no known additional disabilities (e.g., Down syndrome, cerebral palsy, seizure disorder, blindness, etc.) as measured by review of medical records and parent report * have English as the primary language spoken at home * have one parent with normal hearing, and (f) are exposed to some degree of spoken language by their parents (total communication, auditory/oral)

What they're measuring

Use of Communication Support Strategies - Parent

Timeframe: Change from Baseline to Month 7

Total Number of Communicative Acts From the Language Sample - Child

Timeframe: Change from Baseline to Month 7

Communication and Symbolic Behavior Scales Score - Child

Timeframe: Month 7

Trial details

NCT IDNCT03803943

SponsorNorthwestern University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-16

Results submitted2025-05-14

View on ClinicalTrials.gov More Hearing Loss, Bilateral trials