Parent-Mediated Intervention for Hearing Loss

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Northwestern University

Disqualifiers: Down syndrome, Cerebral palsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the long-term effects of a program where parents support the communication skills of their deaf or hard-of-hearing children. Researchers aim to determine if this early intervention improves language, reading, and social skills as children begin school. The trial compares children who received this parent-mediated intervention (PMI) with those who did not, examining whether early parent involvement leads to ongoing benefits. Families who participated when their child was between 12 and 18 months old and met specific criteria, such as bilateral hearing loss and no other major diagnoses, are eligible to continue. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering families a chance to contribute to important findings.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on a parent-mediated intervention for children with hearing loss, so it's best to consult with the trial coordinators for specific guidance.

What prior data suggests that this parent-mediated intervention is safe for children with hearing loss?

Research shows that the parent-mediated intervention (PMI) is generally safe and well-tolerated. Studies have found positive effects on communication for deaf and hard-of-hearing children. For instance, one study found that parents in the PMI group used strategies that improved their children's communication. Another study noted improvements in how parents used these strategies and in their children's communication, with no negative effects reported.

Since this trial is in Phase 2, the researchers are still assessing the safety and effectiveness of the intervention. However, the absence of negative effects in earlier studies suggests that PMI is safe for participants. This intervention involves teaching parents ways to help their child's language development, which is a non-invasive and low-risk method. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Parent-Mediated Intervention (PMI) because it empowers parents to take an active role in their child's language development, which is different from many traditional therapies that primarily involve professional-led sessions. This intervention is unique because it uses a Teach-Model-Coach-Review framework, equipping parents with seven specific communication strategies to integrate into daily routines and play. The use of Zoom for weekly sessions makes this method highly accessible and flexible, allowing parents to seamlessly incorporate the techniques into their home life. This approach not only supports the child's development but also strengthens the parent-child bond, potentially leading to more sustainable outcomes.

What evidence suggests that this parent-mediated intervention is effective for supporting communication outcomes in deaf and hard-of-hearing children?

Research has shown that Parent-Mediated Intervention (PMI), which participants in this trial may receive, can greatly improve communication in deaf and hard-of-hearing (DHH) children. In earlier studies, PMI helped parents adopt more effective communication strategies with their children, resulting in a strong impact. Specifically, parents who participated in PMI improved significantly in communicating with their children. Additionally, the children's communication skills also improved markedly, demonstrating enhanced communication after the intervention. These positive changes occurred during and immediately after the intervention, suggesting that PMI could offer lasting benefits for language development in DHH children. ^{1 3 5 6 7}

Who Is on the Research Team?

Megan Y Roberts, PhD, CCC-SLP

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for deaf or hard-of-hearing toddlers who previously participated in an early communication intervention study. It's now looking at these children as they enter elementary school to see if the benefits from the earlier intervention last.

Inclusion Criteria

Exposed to some degree of spoken language by their parents.

No additional diagnoses (e.g., Down syndrome, cerebral palsy, seizure disorder, blindness, etc.)

I have been diagnosed with hearing loss in both ears.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Parent-Mediated Intervention (PMI)

Participants receive a 6-month parent-mediated intervention with weekly, hour-long Zoom sessions focusing on communication support strategies.

6 months

Weekly virtual sessions

Follow-up

Participants are monitored for long-term language, reading, and social communication outcomes during early elementary school.

5-8 years

Remote assessments

What Are the Treatments Tested in This Trial?

Interventions

• Parent-Mediated Intervention (PMI)

Trial Overview The trial tests whether a parent-mediated intervention (PMI) has long-term positive effects on language, reading, and social communication for deaf/hard-of-hearing children. The PMI involved weekly Zoom sessions teaching parents how to support their child's language development.

How Is the Trial Designed?

Group I: Parent-Mediated Intervention (PMI) Experimental Treatment 1 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. 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.

Group II: Business-As-Usual (BAU) Control Active Control 1 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.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07205484

Long-Term Outcomes of Early Communication Intervention ... The overall goal of this randomized clinical trial is to learn about the effects of a parent-mediated intervention (PMI) designed to support ...

2. publications.aap.org publications.aap.org/pediatrics/article/155/6/e2024066847/201954/Early-Communication-Intervention-for-Deaf-Hard-of

Early Communication Intervention for Deaf/Hard of Hearing ... Outcomes were measured before, during, and immediately after intervention. Parent strategy use (Cohen's d = 1.57) and child communication ( ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11807386/

Parent Perspectives on Parent-Mediated Intervention for ... Parent-mediated intervention (PMI) is a potentially scalable approach for tailored interventions in neurogenetic conditions like Down syndrome (DS).

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1750946723001095

Meta-analysis of effectiveness of parent-mediated ... (Klein et al., 2021) stated that video feedback (VF) enhances the effectiveness of PMI for young children with various developmental delays. VF allows parents ...

5. physiciansweekly.com physiciansweekly.com/post/parent-mediated-intervention-beneficial-for-toddlers-who-are-deaf

Parent-Mediated Intervention Beneficial for Toddlers Who ... The researchers found that participants in the PMI group had greater parent strategy use (Cohen's d = 1.57) and child communication (Cohen's d = ...

6. drugs.com drugs.com/news/parent-mediated-intervention-beneficial-toddlers-deaf-125130.html

Parent-Mediated Intervention Beneficial for Toddlers Who ... A parent-mediated intervention (PMI) is beneficial for child communication outcomes in children who are deaf or hard of hearing (DHH), according to a study.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12398076/

Paediatric Autism Communication Therapy (PACT) versus ... Paediatric Autism Communication Therapy (PACT) is among the first parent-mediated developmental interventions, provided in naturalistic settings ...