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

NCT07205484 | Enrolling By Invitation Phase 2

• 1 other identifier: 2R01DC016877-06A1
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hearing Loss, Bilateral

Keywords

Hearing Loss; School-Aged Outcomes; Language; Literacy; Early Intervention; Parent-Mediated Intervention

Outcome Measures

Primary Outcomes (3)

• Clinical Evaluation of Language Fundamentals, Fifth Edition (CELF-5)

  The Clinical Evaluation of Language Fundamentals, Fifth Edition (CELF-5) is a standardized assessment of language development. The Core Language Standard Score (M = 100, SD = 15) reflects the child's global language ability, with higher scores indicating better language skills.

  7 - 8 years old

• Peer-Peer Interaction, Pragmatic Observational Measure (POM)

  The Pragmatic Observational Measure (POM), a rating scale of pragmatic skills, will be scored during a naturalistic peer-peer interaction. The POM includes 27 items, capturing a range of pragmatic skills, rated on a 4-point scale (1 = rarely or never observed; 4 = almost always observed). The POM Total Raw Score (Min = 27, Max = 108) reflects the child's pragmatic skills, with higher scores indicating better pragmatic skills.

  7 - 8 years old

• Woodcock Reading Mastery Tests, Third Edition (WRMT-III)

  The Woodcock Reading Mastery Tests, Third Edition (WRMT-III) is a standardized assessment of reading development. The Total Reading Cluster Standard Score (M = 100, SD = 15) reflects the child's global reading ability, with higher scores indicating better reading skills.

  7 - 8 years old

Secondary Outcomes (5)

• Parent-Child Interaction, Keys to Interactive Parenting Scale (KIPS)

  5 - 6 years old

• Parent Empowerment and Efficacy Measure (PEEM)

  5 - 6 years old

• Parental Involvement Survey in Their Child's Elementary Studies (PISCES)

  5 - 6 years old

• The Parent Advocacy Skills and Comfort Survey

  5 - 6 years old

• Clinical Evaluation of Language Fundamentals, Fifth Edition (CELF-5)

  5 - 6 years old

Study Arms (2)

Parent-Mediated Intervention (PMI)

EXPERIMENTAL

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.

Behavioral: Parent-Mediated Intervention (PMI)

Business-As-Usual (BAU) Control

NO INTERVENTION

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.

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.

Also known as: Parent-Implemented Communication Intervention (PICT), Parent-Implemented Communication Treatment (PICT)

Parent-Mediated Intervention (PMI)

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Evanston, Illinois, 60202, United States

Location

MeSH Terms

Conditions

Hearing Loss, Bilateral; Hearing Loss; Language; Literacy

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Communication; Behavior

Study Officials

• Megan Y Roberts, PhD, CCC-SLP

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors and coders will be naive to the experimental condition
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parent-child dyads were randomly assigned to the parent-mediated intervention (PMI) or business-as-usual (BAU) control group. Randomization was stratified on hearing device and communication mode. Hearing device was dichotomized as either (1) hearing aid or (2) cochlear implant, cochlear implant candidate, or bone conduction device. Communication mode was dichotomized as using visual communication with the child (1) less than 10% of the time or (2) 10% or more of the time.

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: October 3, 2025
• Study Start: August 12, 2025
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be made available no later than the time of publication of the main study aims or the end of the project period, whichever comes first. Data will be stored and available via Dyrad in perpetuity.
• Access Criteria: Dryad datasets are indexed by the Thomas-Reuters Data Citation Index, Scopus, and Google Dataset Search. Dyrad gives each dataset a unique Digital Object Identifier, which when entered into any browser will take the user to the landing page of the dataset.

Locations

US (1)