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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)
Awards & highlights
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)
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 moreTrial 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.
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Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,625 Previous Clinical Trials
937,193 Total Patients Enrolled
Ann & Robert H Lurie Children's Hospital of ChicagoOTHER
264 Previous Clinical Trials
5,193,058 Total Patients Enrolled
Megan Y Roberts, PhDPrincipal InvestigatorNorthwestern University
3 Previous Clinical Trials
236 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are able to hear and understand spoken language from your parents.One of my parents has normal hearing.My child is between 12 and 18 months old.You were born with hearing loss in both ears, as confirmed by your medical records.
Research Study Groups:
This trial has the following groups:- Group 1: Parent-Implemented Communication Intervention (PICT)
- Group 2: No Intervention - Business-as-usual control
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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