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Enrolling by invitationPhase 2

Long-term language and reading results of a parent-led program for deaf toddlers

Follows deaf and hard-of-hearing children into school after a parent-led communication program.

Key facts

Who runs it
Northwestern University
Where
Evanston, United StatesSee the site
Trial code
Registry title
Long-Term Outcomes of Early Communication Intervention for Deaf/Hard of Hearing Toddlers
Status
Enrolling by invitation
Phase
Phase 2
People taking part
88 people, planned
Started
12 Aug 2025
Expected to end
Mar 2030
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Parent-Mediated Intervention (PMI)
Record updated
1 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children who are deaf or hard of hearing and who took part in the first part of this trial as toddlers. It follows them into early school years.

Age
5 Years to 8 Years now. At first enrolment, children were between 12-18 months.
Sex
All
Disease stage
Hearing loss in both ears (bilateral hearing loss).
Earlier treatment
Children must have been enrolled in the first part of this trial.

Main reasons for not taking part

  • Children not enrolled in the first part of the trial cannot join.
  • Children with other diagnoses, such as Down syndrome, cerebral palsy, seizure disorder or blindness, could not join.
  • Children without at least one parent with typical hearing could not join.
  • Children not exposed to some spoken language by their parents could not join.

The registry criteria, word for word

Show all 7 criteriaShow less

Other criteria

  • Eligibility for the follow-up period of the clinical trial is dependent on enrollment in the initial period of the clinical trial
  • Child inclusion criteria were:
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 5 and 8 years old?

Where in United States

  • Northwestern UniversityEvanston, United StatesNo longer taking part

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Parent-Mediated Intervention (PMI)Treatment being tested

    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.

  • Business-As-Usual (BAU) ControlNo study treatment, for comparison

    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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Early Communication Intervention for Deaf/Hard of Hearing Toddlers: Long-Term Language and Literacy Outcomes
Plain-language title
Long-term language and reading results of a parent-led program for deaf toddlersGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT07205484, who can take part
Record updated
1 June 2026