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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 24 months after cochlear implant activation

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 24 months after cochlear implant activation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 24 months after cochlear implant activation

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 24 months after cochlear implant activation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Expressive One-Word Picture Vocabulary Test, Fourth Edition (EOWPVT-4)

MacArthur-Bates Communicative Development Inventory (CDI)

Preschool Language Scales, Fifth Edition (PLS-5)

Secondary outcome measures

Behavior Rating Inventory of Executive Function (BRIEF)

Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P)

Pediatric Minimum Speech Test Battery (PMSTB)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Communication TreatmentExperimental Treatment1 Intervention

Group II: Non-treatment Model BuildingActive Control1 Intervention

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

The University of Texas at DallasOTHER

58 Previous Clinical Trials

105,535 Total Patients Enrolled

Ann & Robert H Lurie Children's Hospital of ChicagoLead Sponsor

258 Previous Clinical Trials

5,188,430 Total Patients Enrolled

Chinese University of Hong KongOTHER

1,267 Previous Clinical Trials

1,212,825 Total Patients Enrolled

Media Library

Parent-Implemented Communication Treatment (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05962359 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research project accept participants who are 75 years and older?

"This trial's parameters designate that the patient cohort should range in age from infancy to 7 years old. Moreover, there are 62 trials for minors and 145 for senior citizens."

Answered by AI

Who meets the requirements to participate in this experiment?

"To be deemed eligible for this clinical trial, applicants must have sensorineural hearing loss and an age range between the span of infancy to seven years old. 700 participants are being accepted into the study."

Answered by AI

Are there any vacancies on this trial open to the public?

"Affirmative. The details shared on clinicaltrials.gov reveal that enrollment for this trial is open and ongoing. It was initially posted in January of 2023, with the latest update occurring at the end of July 2023. 700 patients are needed from a solitary site to participate in this study."

Answered by AI

How many participants are currently engaged in this clinical investigation?

"Affirmative. According to data from clinicaltrials.gov, this medical experiment is currently enlisting participants; it was initially posted on January 23rd 2023 and recently updated on July 21st 2023. It requires 700 volunteers across a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neural Prediction to Enhance Language

Nancy Young, MD 2023. "Neural Prediction to Enhance Language". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05962359.

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