An interventional study of Parent-Implemented Communication Treatment in Bilateral Sensorineural Hearing Loss, Speech and Language Development Delay Due to Hearing Loss and Social Communication, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago. Recruiting at 1 site in United States. Open to participants aged 0 Months to 5 Years. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago · Not applicable, Interventional, and Treatment
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.
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.
205 studies on the registry are indexed under Speech; 80 are open to participants now.
This study's planned enrollment of 700 is above the median of 52 across 141 interventional studies indexed under Speech.
Browse Speech studies →Ann & Robert H Lurie Children's Hospital of Chicago is the lead sponsor of 180 studies on the registry; 28 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria (Arm 1):
Children with sensorineural hearing loss who meet clinical criteria for cochlear implantation in both ears who meet the following age criteria at time cochlear implant evaluation begins:
Inclusion Criteria (Arm 2):
Exclusion Criteria (Arm 1):
Exclusion Criteria (Arm 2):
Terminated
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.
Preschool Language Scales, Fifth Edition (PLS-5)
A standardized measure of auditory comprehension and expressive communication in children. Standard scores are obtained which are then translated to percentiles, and age equivalents. Higher standard scores indicate better performance.
Time frame: At 12 months after cochlear implant activation
Preschool Language Scales, Fifth Edition (PLS-5)
A standardized measure of auditory comprehension and expressive communication in children. Standard scores are obtained which are then translated to percentiles, and age equivalents. Higher standard scores indicate better performance.
Time frame: At 24 months after cochlear implant activation
Preschool Language Scales, Fifth Edition (PLS-5)
A standardized measure of auditory comprehension and expressive communication in children. Standard scores are obtained which are then translated to percentiles, and age equivalents. Higher standard scores indicate better performance.
Time frame: At 36 months after cochlear implant activation
Preschool Language Scales, Fifth Edition (PLS-5)
A standardized measure of auditory comprehension and expressive communication in children. Standard scores are obtained which are then translated to percentiles, and age equivalents. Higher standard scores indicate better performance.
Time frame: At 48 months after cochlear implant activation
Expressive One-Word Picture Vocabulary Test, Fourth Edition (EOWPVT-4)
An individually administered, norm-referenced assessment of how well a person can name objects, actions, or concepts presented in full-color pictures. Raw scores are obtained which are then translated to standard scores, percentiles, and age equivalents. Both higher standard scores and raw scores indicate better performance.
Time frame: At 12 months after cochlear implant activation
Expressive One-Word Picture Vocabulary Test, Fourth Edition (EOWPVT-4)
An individually administered, norm-referenced assessment of how well a person can name objects, actions, or concepts presented in full-color pictures. Raw scores are obtained which are then translated to standard scores, percentiles, and age equivalents. Both higher standard scores and raw scores indicate better performance.
Time frame: At 24 months after cochlear implant activation
Expressive One-Word Picture Vocabulary Test, Fourth Edition (EOWPVT-4)
An individually administered, norm-referenced assessment of how well a person can name objects, actions, or concepts presented in full-color pictures. Raw scores are obtained which are then translated to standard scores, percentiles, and age equivalents. Both higher standard scores and raw scores indicate better performance.
Time frame: At 36 months after cochlear implant activation
Expressive One-Word Picture Vocabulary Test, Fourth Edition (EOWPVT-4)
An individually administered, norm-referenced assessment of how well a person can name objects, actions, or concepts presented in full-color pictures. Raw scores are obtained which are then translated to standard scores, percentiles, and age equivalents. Both higher standard scores and raw scores indicate better performance.
Time frame: At 48 months after cochlear implant activation
MacArthur-Bates Communicative Development Inventory (CDI)
A set of online parent report intruments that evaluate children's early speech and langauge development. Standard scores are based on percentiles for age and sex and range from 1 to 99th percentile. Higher standard scores indicate better performance.
Time frame: At 12 months after cochlear implant activation
MacArthur-Bates Communicative Development Inventory (CDI)
A set of online parent report intruments that evaluate children's early speech and langauge development. Standard scores are based on percentiles for age and sex and range from 1 to 99th percentile. Higher standard scores indicate better performance.
Time frame: At 24 months after cochlear implant activation
MacArthur-Bates Communicative Development Inventory (CDI)
A set of online parent report intruments that evaluate children's early speech and langauge development. Standard scores are based on percentiles for age and sex and range from 1 to 99th percentile. Higher standard scores indicate better performance.
Time frame: At 36 months after cochlear implant activation
MacArthur-Bates Communicative Development Inventory (CDI)
A set of online parent report intruments that evaluate children's early speech and langauge development. Standard scores are based on percentiles for age and sex and range from 1 to 99th percentile. Higher standard scores indicate better performance.
Time frame: At 48 months after cochlear implant activation
Behavior Rating Inventory of Executive Function (BRIEF)
A parent-reported executive function questionnaire that utilizes T-scores to reflect individual's level of executive functioning. Higher T-scores indicate better performance.
Time frame: At 12 months after cochlear implant activation
Behavior Rating Inventory of Executive Function (BRIEF)
A parent-reported executive function questionnaire that utilizes T-scores to reflect individual's level of executive functioning. Higher T-scores indicate better performance.
Time frame: At 24 months after cochlear implant activation
Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P)
A parent-reported executive function questionnaire designed for preschool-aged children that utilizes T-scores to reflect children's level of executive functioning. Higher T-scores indicate better performance.
Time frame: At 12 months after cochlear implant activation
Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P)
A parent-reported executive function questionnaire designed for preschool-aged children that utilizes T-scores to reflect children's level of executive functioning. Higher T-scores indicate better performance.
Time frame: At 24 months after cochlear implant activation
Pediatric Minimum Speech Test Battery (PMSTB)
A set of measures designed to evaluate speech discrimination for infants and word/ sentence recognition for children using hearing technology before entering school. Scores range from 0 to 700. Higher scores indicate better performance.
Time frame: At 6 months after cochlear implant activation
Pediatric Minimum Speech Test Battery (PMSTB)
A set of measures designed to evaluate speech discrimination for infants and word/ sentence recognition for children using hearing technology before entering school. Scores range from 0 to 700. Higher scores indicate better performance.
Time frame: At 12 months after cochlear implant activation
Pediatric Minimum Speech Test Battery (PMSTB)
A set of measures designed to evaluate speech discrimination for infants and word/ sentence recognition for children using hearing technology before entering school. Scores range from 0 to 700. Higher scores indicate better performance.
Time frame: At 18 months after cochlear implant activation
Pediatric Minimum Speech Test Battery (PMSTB)
A set of measures designed to evaluate speech discrimination for infants and word/ sentence recognition for children using hearing technology before entering school. Scores range from 0 to 700. Higher scores indicate better performance.
Time frame: At 24 months after cochlear implant activation
Pediatric Minimum Speech Test Battery (PMSTB)
A set of measures designed to evaluate speech discrimination for infants and word/ sentence recognition for children using hearing technology before entering school. Scores range from 0 to 700. Higher scores indicate better performance.
Time frame: At 36 months after cochlear implant activation
Pediatric Minimum Speech Test Battery (PMSTB)
A set of measures designed to evaluate speech discrimination for infants and word/ sentence recognition for children using hearing technology before entering school. Scores range from 0 to 700. Higher scores indicate better performance.
Time frame: At 48 months after cochlear implant activation
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ann & Robert H Lurie Children's Hospital of Chicago →