Neural Prediction to Enhance Language
Start Date
1/23/2023
Completion Date
1/23/2028
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.
Detailed Description
Arm1: Non-treatment Model Building. Up to 700 children will be recruited from 5 cochlear implant programs in the United States. Children will be enrolled and followed for up to four years after implantation. Study information will be obtained from each child's medical record before and after implantation including cause of hearing loss, general health, language and communication history, family history, cochlear implant device and surgery. Audiological information before and after implantation will be collected from routine visits that are part of cochlear implant candidacy evaluation and audiology evaluations after implantation. This includes audiology evaluations after activation of the cochlear implant that take place at around 6, 12, 18, 24, 36 and/or 48 months. Pre-surgical MRI done at each participating site as part of routine pre-operative evaluation will also be collected for analysis. If enrolled into the study at Lurie Children's Hospital of Chicago before the pre-surgical MRI is done, the parent or guardian will have the option to have their child undergo additional research scans during the pre-surgical MRI. Parents will be asked to complete baseline and follow-up surveys. The surveys will ask about family demographic and health information, language exposure in the home, therapy and school services, and language and communication ability of the child. Parental surveys will be readministered at about 12-month intervals after the child's device is turned on. In addition, surveys about the child's cognition will be sent to parents after their child has used their implant for one and two years. Surveys will be offered online by a secure link provided during clinical visits, emailed after the visit or sent by MyChart to the parent/guardian for completion at home. An in-person research-only speech and language evaluation will be done at about one-year intervals after initial implantation during each year the child is enrolled in the study. The evaluation will take less than two hours. Arm 2: Experimental: Communication Treatment is terminated. Study#372634 (the human subjects study record) to be removed/terminated in ASSIST.
Eligibility Criteria
Age Range: No minimum to 5 years
Interventions
Parent-Implemented Communication Treatment
Conditions
Locations
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois 60611
United States