Early Communication Intervention for Toddlers with Hearing Loss

Overseen By Laura J Sudec, MSW

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Northwestern University

Disqualifiers: Down syndrome, Cerebral palsy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

105 Participants Needed

Trial Summary

What is the purpose of this trial?

Improving spoken language outcomes for children with hearing loss has important public health implications. This is a randomized clinical trial of 96 children with hearing loss that examines the effects of a parent-implemented early communication intervention on prelinguistic and spoken language outcomes. The study is open for national recruitment. Parents participate via video call with their child and receive technology to assist with virtual visits.

Research Team

Megan Y Roberts, PhD

Principal Investigator

Northwestern University

Eligibility Criteria

This trial is for toddlers aged 12-18 months with bilateral, congenital hearing loss. They should have no other disabilities like Down syndrome or cerebral palsy, and English must be the primary language spoken at home. One parent must have normal hearing, and the child should already be exposed to some spoken language.

Inclusion Criteria

You are able to hear and understand spoken language from your parents.

Have English as the primary language spoken at home

One of my parents has normal hearing.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly, 1-hour intervention sessions for 6 months focusing on communication support strategies

24 weeks

Weekly virtual visits

Follow-up

Participants are monitored for language development outcomes after the intervention

18 months

Monthly assessments

Treatment Details

Interventions

• No Intervention - Business-as-usual control
• Parent-Implemented Communication Intervention (PICT)

Trial Overview The study tests a Parent-Implemented Communication Intervention (PICT) against a control group with no intervention. It aims to improve prelinguistic and spoken language in children with hearing loss through sessions via video call, providing technology for virtual visits.

Participant Groups

Group I: Parent-Implemented Communication Intervention (PICT) Experimental Treatment 1 Intervention

Participants assigned to the PICT condition will receive weekly hour long intervention sessions in their home for 6 months. Parents will learn four sets of communication support strategies: (a) visual (e.g., modeling language within the child's line of sight), (b) interactive (e.g., following the child's attentional focus), (c) responsive (e.g., responding to all communicative attempts), and (d) linguistically stimulating (e.g., modeling language targets, expanding child communication).

Group II: No Intervention - Business-as-usual control Placebo Group 1 Intervention

Participants assigned to the BAU control group will not receive the PICT intervention.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Ann & Robert H Lurie Children's Hospital of Chicago

Collaborator

Trials

275

Recruited

5,182,000+