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Behavioural Intervention

Communication Treatment for Hearing Loss

N/A
Recruiting
Led By Nancy M Young, MD
Research Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
English dominant spoken language by family
Age 5 years and under.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12 months after cochlear implant activation
Awards & highlights
No Placebo-Only Group

Summary

This trial is exploring how to predict language outcomes in children who receive cochlear implants to help hearing loss. The goal is to improve the children's language through more effective therapies.

Who is the study for?
This trial is for children under 5 with bilateral sensorineural hearing loss who are candidates for cochlear implantation, and speak English or Spanish. It's also open to kids under 7 at the Lurie site with unilateral hearing loss meeting implant criteria. Participants must be exposed to spoken language at home.
What is being tested?
The study aims to develop neural predictive models based on brain imaging to forecast language development post-cochlear implantation. It will test if a custom therapy called Parent-Implemented Communication Treatment (PICT) can improve language in those predicted to have lower outcomes.
What are the potential side effects?
Since this trial involves behavioral therapy rather than medication, traditional side effects are not expected. However, there may be indirect effects such as fatigue or frustration associated with intensive educational programs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My family primarily speaks English.
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I am 5 years old or younger.
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I was 36 months old or younger when my treatment started.
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My child has hearing loss in both ears and qualifies for a cochlear implant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 months after cochlear implant activation
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 months after cochlear implant activation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Expressive One-Word Picture Vocabulary Test, Fourth Edition (EOWPVT-4)
MacArthur-Bates Communicative Development Inventory (CDI)
Preschool Language Scales, Fifth Edition (PLS-5)
Secondary study objectives
Behavior Rating Inventory of Executive Function (BRIEF)
Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P)
Pediatric Minimum Speech Test Battery (PMSTB)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Communication TreatmentExperimental Treatment1 Intervention
Group II: Non-treatment Model BuildingActive Control1 Intervention

Find a Location

Who is running the clinical trial?

The University of Texas at DallasOTHER
64 Previous Clinical Trials
106,134 Total Patients Enrolled
Ann & Robert H Lurie Children's Hospital of ChicagoLead Sponsor
267 Previous Clinical Trials
5,181,092 Total Patients Enrolled
Chinese University of Hong KongOTHER
1,334 Previous Clinical Trials
1,358,044 Total Patients Enrolled

Media Library

Parent-Implemented Communication Treatment (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05962359 — N/A
~415 spots leftby Jul 2027
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