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Early Communication Intervention for Toddlers with Hearing Loss

Phase 2

Recruiting

Led By Megan Y Roberts, PhD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up monthly, up to 18 months, between post and follow-up when the child is 18 to 36 months (after intervention)

Summary

This trial is testing whether a parent-implemented early communication intervention can improve outcomes for children with hearing loss.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves educational and communication interventions rather than medical treatments, there are no direct physical side effects expected from participating in this study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ monthly, up to 18 months, between post and follow-up when the child is 18 to 36 months (after intervention)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~monthly, up to 18 months, between post and follow-up when the child is 18 to 36 months (after intervention)

This trial's timeline: 3 weeks for screening, Varies for treatment, and monthly, up to 18 months, between post and follow-up when the child is 18 to 36 months (after intervention) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Total Scaled Score on the Communication and Symbolic Behavior Scales - Developmental Profile

Total number of pre-symbolic communicative acts from the Language Sample

Secondary study objectives

Auditory Comprehension Standard Score on the Preschool Language Scale - 5th Edition

Caregiver Use of Communication Support Strategies

Child Spoken Words

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Parent-Implemented Communication Intervention (PICT)Experimental Treatment1 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 controlPlacebo Group1 Intervention

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

Do I qualify?Apply below to find out