Clinical Trial

Long-Term Outcomes of Early Communication Intervention for Deaf/Hard of Hearing Toddlers

Enrolling by Invitation Phase 2
View on ClinicalTrials.gov →
Summary
The overall goal of this randomized clinical trial is to learn about the effects of a parent-mediated intervention (PMI) designed to support communication outcomes for deaf and hard-of-hearing (DHH) children. Previously, the investigators enrolled 96 DHH children between 12 and 18 months of age and their parents. Families were randomly assigned to receive either the PMI or a business-as-usual control group. The PMI was a 6-month intervention that included weekly, hour-long Zoom sessions. During the intervention sessions, parents were taught communication support strategies to support their child's language development throughout daily routines and play. This current period of the trial follows the same children into early elementary school to determine whether the effects of the PMI are long-lasting. The main questions it aims to answer are: * Does the PMI improve language, reading, and social communication outcomes in the early school years? * Does parent involvement during early intervention support continued engagement in their child's education? The investigators will compare parents and children who received the PMI to those in the business-as-usual control group to determine whether the intervention has lasting effects on these outcomes. Participants will complete standardized assessments, parent-report surveys, and video-recorded naturalistic interactions. All assessments will be completed remotely.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-09-25.
Trial Details
NCT Number NCT07205484
Lead Sponsor Northwestern University
Conditions Hearing Loss, Bilateral
Enrollment 88 participants
Start Date 2025-08-12
Primary Completion 2030-03 (estimated)
Study Completion 2030-03 (estimated)
Updated on ClinicalTrials.gov 2026-06-01