Neural Prediction to Enhance Language

NCT05962359 | Recruiting

• 1 other identifier: R01DC019387
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hearing Loss; Children; Parent-mediated intervention; Language prediction

Outcome Measures

Primary Outcomes (12)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (10)

• Behavior Rating Inventory of Executive Function (BRIEF)

  At 12 months after cochlear implant activation

• Behavior Rating Inventory of Executive Function (BRIEF)

  At 24 months after cochlear implant activation

• Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P)

  At 12 months after cochlear implant activation

• Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P)

  At 24 months after cochlear implant activation

• Pediatric Minimum Speech Test Battery (PMSTB)

  At 6 months after cochlear implant activation

Study Arms (2)

Non-treatment Model Building

NO INTERVENTION

Communication Treatment

EXPERIMENTAL

Behavioral: Parent-Implemented Communication Treatment

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.

Communication Treatment

Eligibility Criteria

• Age: 0 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• English or Spanish dominant language in the home.
• Children with bilateral sensorineural hearing loss who meet clinical criterial for cochlear implantation
• English dominant spoken language by family
• Age at implantation of 36 months and younger when treatment begins
• Parent or caregiver that is willing to participate who understands spoken English
• Child is exposed to spoken language by at least one parent (total communication or auditory/oral) in the home

You may not qualify if:

• Severe motor and /or cognitive disability that would preclude evaluation of progress
• Limited electrode insertion likely to significantly impact development of speech perception
• Hearing loss due to bacterial meningitis
• Neither English or Spanish as the dominant family language in the home
• Severe motor and /or cognitive disability that would preclude evaluation of progress
• Limited electrode insertion likely to significantly impact development of speech perception
• Hearing loss due to bacterial meningitis
• Dominant language other than English
• Diagnoses or medical conditions expected to impact language development independent of hearing loss
• Cochlear nerve deficiency in implanted ears or severe cochlear malformation
• Children already having spoken language who score better than 25th percentile on the Words and Sentences portion of the CDI language evaluation.
• Child with more than two months CI experience prior to start of treatment

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead
• Chinese University of Hong Kong: collaborator
• Northwestern University: collaborator
• University of North Carolina, Chapel Hill: collaborator
• University of Southern California: collaborator
• University of Miami: collaborator
• The University of Texas at Dallas: collaborator

Study Sites (1)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Speech; Communication; Hearing Loss

Condition Hierarchy (Ancestors)

Verbal Behavior; Behavior; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nancy M Young, MD

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nancy M Young, MD

CONTACT

312-227-6812; nyoung@luriechildrens.org

Emily (Shimeng) Xu, PhD

CONTACT

sxu@luriechildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Section of Otology/Neurotology and Medical Director, Audiology & Cochlear Implant Programs

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 27, 2023
• Study Start: January 23, 2023
• Primary Completion (Estimated): July 23, 2027
• Study Completion (Estimated): January 23, 2028
• Last Updated: August 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)