Neural Prediction to Enhance Language

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Study ID
NCT05962359
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
0 Months - 5 Years
Healthy Volunteers
Not accepted

Interventions

  • Parent-Implemented Communication Treatment — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jan 23, 2023
Status verified
Aug 2024
Primary completion
Jul 23, 2027
Completion
Jan 23, 2028

Study Design

Enrollment
700 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Non-treatment Model Building
  • Experimental: Communication Treatment

Primary Outcome Measure

Preschool Language Scales, Fifth Edition (PLS-5) [ Time Frame: At 12 months after cochlear implant activation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ann & Robert H. Lurie Children's Hospital of ChicagoChicagoIllinois60611
Nancy Young, MD
[email protected]

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By research site
Ann & Robert H. Lurie Children's Hospital of Chicago· Chicago, IL

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