Neural Prediction to Enhance Language

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-5
SponsorAnn & Robert H Lurie Children's Hospital of Chicago

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

700 Participants
are divided into 2 treatment groups
Group A: Non-treatment Model BuildingNo intervention 0 interventions
Group B: Communication TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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Ann & Robert H Lurie Children's Hospital of Chicago

Lead sponsor

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