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

Part of paid clinical trials in Evanston, Illinois.

Sponsor
Northwestern University
Study ID
NCT07205484
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

  • Hearing Loss, Bilateral

Eligibility Criteria

Sex
ALL
Age
5 Years - 8 Years
Healthy Volunteers
Not accepted

Interventions

  • Parent-Mediated Intervention (PMI) — 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

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.

Key Dates

Start date
Aug 12, 2025
Status verified
May 2026
Primary completion
Mar 31, 2030
Completion
Mar 31, 2030

Study Design

Enrollment
88 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Parent-Mediated Intervention (PMI)
    Participants in both the parent-mediated intervention (PMI) group and the business-as-usual (BAU) control group continued to receive standard community-based early intervention services outside of the clinical trial. In addition to these services, dyads in the PMI group participated in weekly intervention sessions via Zoom for 6 months. Intervention sessions followed a Teach-Model-Coach-Review framework to support parents in using communication support strategies with their child. Parents were taught seven communication support strategies in a fixed sequence: (1) Setting the Stage, (2) Play and Engage, (3) Respond and Wait, (4) Notice and Say, (5) Show It, (6) Contrast It, and (7) Add On. These strategies focused on helping parents create opportunities for language learning during everyday routines and play, notice and respond to their child's communication, and model rich, salient language.
  • No Intervention: Business-As-Usual (BAU) Control
    Participants in both the parent-mediated intervention (PMI) group and the business-as-usual (BAU) control group continued to receive standard community-based early intervention services outside of the clinical trial. Dyads in the BAU control group did not receive the PMI.

Primary Outcome Measure

Clinical Evaluation of Language Fundamentals, Fifth Edition (CELF-5) [ Time Frame: 7 - 8 years old ]

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern UniversityEvanstonIllinois60202-

Find similar trials in Evanston, IL

By research site
Northwestern University· Evanston, IL

Related Studies