Social Communication Clinical Trial
Official title:
Neural Prediction to Enhance Language Outcomes in Children With Cochlear Implant
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.
| Status | Recruiting |
| Enrollment | 700 |
| Est. completion date | January 23, 2028 |
| Est. primary completion date | July 23, 2027 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 0 Months to 7 Years |
| Eligibility | Inclusion Criteria (Arm 1): 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: - Age 5 years and under. - English or Spanish as the dominant language. 2. Lurie site only: Age under 7 years for children with unilateral sensorineural hearing loss who meet clinical criteria for cochlear implantation. 3. English or Spanish dominant language in the home. Inclusion Criteria (Arm 2): 1. Children with bilateral sensorineural hearing loss who meet clinical criterial for cochlear implantation 2. English dominant spoken language by family 3. Age at implantation of 36 months and younger when treatment begins 4. Parent or caregiver that is willing to participate who understands spoken English 5. Child is exposed to spoken language by at least one parent (total communication or auditory/oral) in the home Exclusion Criteria (Arm 1): 1. Severe motor and /or cognitive disability that would preclude evaluation of progress 2. Limited electrode insertion likely to significantly impact development of speech perception 3. Hearing loss due to bacterial meningitis 4. Neither English or Spanish as the dominant family language in the home Exclusion Criteria (Arm 2): 1. Severe motor and /or cognitive disability that would preclude evaluation of progress 2. Limited electrode insertion likely to significantly impact development of speech perception 3. Hearing loss due to bacterial meningitis 4. Dominant language other than English 5. Diagnoses or medical conditions expected to impact language development independent of hearing loss 6. Cochlear nerve deficiency in implanted ears or severe cochlear malformation 7. Children already having spoken language who score better than 25th percentile on the Words and Sentences portion of the CDI language evaluation. 8. Child with more than two months CI experience prior to start of treatment |
| Country | Name | City | State |
|---|---|---|---|
| United States | Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois |
| Lead Sponsor | Collaborator |
|---|---|
| Ann & Robert H Lurie Children's Hospital of Chicago | Chinese University of Hong Kong, Northwestern University, The University of Texas at Dallas, University of Miami, University of North Carolina, Chapel Hill, University of Southern California |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | At 12 months after cochlear implant activation | |
| Primary | 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. | At 24 months after cochlear implant activation | |
| Primary | 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. | At 36 months after cochlear implant activation | |
| Primary | 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. | At 48 months after cochlear implant activation | |
| Primary | 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. | At 12 months after cochlear implant activation | |
| Primary | 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. | At 24 months after cochlear implant activation | |
| Primary | 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. | At 36 months after cochlear implant activation | |
| Primary | 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. | At 48 months after cochlear implant activation | |
| Primary | 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. | At 12 months after cochlear implant activation | |
| Primary | 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. | At 24 months after cochlear implant activation | |
| Primary | 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. | At 36 months after cochlear implant activation | |
| Primary | 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. | At 48 months after cochlear implant activation | |
| Secondary | 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. | At 12 months after cochlear implant activation | |
| Secondary | 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. | At 24 months after cochlear implant activation | |
| Secondary | 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. | At 12 months after cochlear implant activation | |
| Secondary | 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. | At 24 months after cochlear implant activation | |
| Secondary | 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. | At 6 months after cochlear implant activation | |
| Secondary | 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. | At 12 months after cochlear implant activation | |
| Secondary | 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. | At 18 months after cochlear implant activation | |
| Secondary | 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. | At 24 months after cochlear implant activation | |
| Secondary | 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. | At 36 months after cochlear implant activation | |
| Secondary | 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. | At 48 months after cochlear implant activation |