Phase 2
N=188
Early Communication Intervention for Toddlers With Hearing Loss
Hearing Loss, Bilateral
Bottom Line
View on ClinicalTrials.gov: NCT03803943 ↗Enrolled (actual)
188
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Use of Communication Support Strategies - Parent — .60; .02 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Parent-Implemented Communication Intervention (PICT) (Behavioral); No Intervention - Business-as-usual control (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Use of Communication Support Strategies - Parent |
.30; .09 | — |
| PRIMARY Total Number of Communicative Acts From the Language Sample - Child |
57.8; 25.24 | — |
| PRIMARY Communication and Symbolic Behavior Scales Score - Child |
104.98; 92.24 | — |
| SECONDARY Use of Communication Support Strategies - Parent |
.30; .09 | — |
| SECONDARY Spoken Words - Child |
— | — |
| SECONDARY Expressive Communication Standard Score on the Preschool Language Scale - 5th Edition - Child |
100.44; 93.81 | — |
| SECONDARY Auditory Comprehension Standard Score on the Preschool Language Scale - 5th Edition - Child |
102.46; 92.14 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT03803943). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.