What this study is
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.
What's being tested
- Parent-Mediated Intervention (PMI)
Intervention · BEHAVIORAL
The PMI consisted of weekly, 1-hour intervention sessions via Zoom for 6 months. In total, the intervention consisted of 26 intervention sessions.
Study details
- Official title
- Early Communication Intervention for Deaf/Hard of Hearing Toddlers: Long-Term Language and Literacy Outcomes
- Sponsor
- Northwestern University
- Conditions
- Hearing Loss, Bilateral
- Enrolling
- 88 people
- Starts
- 2025-08-12
- Est. completion
- 2030-03
- Design
- Single-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 5 Years – 8 YearsSex ALLHealthy volunteers Not acceptedAll participants
You may qualify if
- Eligibility for the follow-up period of the clinical trial is dependent on enrollment in the initial period of the clinical trial.
Child were
You may qualify if
- Between 12-18 months
- Diagnosed with bilateral hearing loss
- No additional diagnoses (e.g., Down syndrome, cerebral palsy, seizure disorder, blindness, etc.)
- One parent with typical hearing
- Exposed to some degree of spoken language by their parents.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openNorthwestern University
Evanston, Illinois, United States
Study team
Sponsor
Northwestern University
Study ID 2R01DC016877-06A1
Principal investigator
Megan Y Roberts, PhD, CCC-SLP
Northwestern University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.