Neural Prediction to Enhance Language

NCT05962359 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2024-08-05

No results posted yet for this study

Summary

The language outcome of children receiving cochlear implantation to address bilateral sensorineural hearing loss is more variable than that of typical hearing children. The research is focused upon development of neural predictive models based upon brain imaging to forecast language after cochlear implantation on the individual child level. The long-term goal is improving children's language by using predictive models to enable a custom "predict to prescribe" approach to intervene with more effective behavioral therapy for children at risk to develop poorer language. The investigators previously developed models for short term language outcome of English-learning implanted children. The aims of this study are to 1. Develop models able to predict long term outcome for English- learning and Spanish-learning children; and 2. To evaluate whether English-learning children predicted to achieve lower language based on the investigators' previously constructed models can demonstrate significant gains from Parent Implemented Communication Treatment (PICT). PICT is an intensive parent education program about strategies to improve children's communication.

Conditions

  • Bilateral Sensorineural Hearing Loss
  • Speech and Language Development Delay Due to Hearing Loss
  • Social Communication

Interventions

BEHAVIORAL

Parent-Implemented Communication Treatment

The intervention will be taught by a qualified professional online and/or in-person for about 6 months. Parents will learn strategies to enhance their children's social communication and will receive coaching and feedback.

Sponsors & Collaborators

  • Chinese University of Hong Kong

    collaborator OTHER
  • Northwestern University

    collaborator OTHER
  • University of North Carolina, Chapel Hill

    collaborator OTHER
  • University of Southern California

    collaborator OTHER
  • University of Miami

    collaborator OTHER
  • The University of Texas at Dallas

    collaborator OTHER
  • Ann & Robert H Lurie Children's Hospital of Chicago

    lead OTHER

Principal Investigators

  • Nancy M Young, MD · Ann & Robert H Lurie Children's Hospital of Chicago

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
0 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-23
Primary Completion
2027-07-23
Completion
2028-01-23

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05962359 on ClinicalTrials.gov