xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05962359</url>
    </required_header>
    <id_info>
      <org_study_id>R01DC019387</org_study_id>
      <nct_id>NCT05962359</nct_id>
    </id_info>
    <brief_title>Neural Prediction to Enhance Language</brief_title>
    <official_title>Neural Prediction to Enhance Language Outcomes in Children With Cochlear Implant</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ann &amp; Robert H Lurie Children's Hospital of Chicago</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Chinese University of Hong Kong</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Northwestern University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of North Carolina, Chapel Hill</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Southern California</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Miami</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The University of Texas at Dallas</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Ann &amp; Robert H Lurie Children's Hospital of Chicago</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The language outcome of children receiving cochlear implantation to address bilateral&#xD;
        sensorineural hearing loss is more variable than that of typical hearing children. The&#xD;
        research is focused upon development of neural predictive models based upon brain imaging to&#xD;
        forecast language after cochlear implantation on the individual child level. The long-term&#xD;
        goal is improving children's language by using predictive models to enable a custom &quot;predict&#xD;
        to prescribe&quot; approach to intervene with more effective behavioral therapy for children at&#xD;
        risk to develop poorer language. The investigators previously developed models for short term&#xD;
        language outcome of English-learning implanted children. The aims of this study are to 1.&#xD;
        Develop models able to predict long term outcome for English- learning and Spanish-learning&#xD;
        children; and 2. To evaluate whether English-learning children predicted to achieve lower&#xD;
        language based on the investigators' previously constructed models can demonstrate&#xD;
        significant gains from Parent Implemented Communication Treatment (PICT). PICT is an&#xD;
        intensive parent education program about strategies to improve children's communication.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Arm1: Non-treatment Model Building. Up to 700 children will be recruited from 5 cochlear&#xD;
        implant programs in the United States. Children will be enrolled and followed for up to four&#xD;
        years after implantation. Study information will be obtained from each child's medical record&#xD;
        before and after implantation including cause of hearing loss, general health, language and&#xD;
        communication history, family history, cochlear implant device and surgery. Audiological&#xD;
        information before and after implantation will be collected from routine visits that are part&#xD;
        of cochlear implant candidacy evaluation and audiology evaluations after implantation. This&#xD;
        includes audiology evaluations after activation of the cochlear implant that take place at&#xD;
        around 6, 12, 18, 24, 36 and/or 48 months. Pre-surgical MRI done at each participating site&#xD;
        as part of routine pre-operative evaluation will also be collected for analysis. If enrolled&#xD;
        into the study at Lurie Children's Hospital of Chicago before the pre-surgical MRI is done,&#xD;
        the parent or guardian will have the option to have their child undergo additional research&#xD;
        scans during the pre-surgical MRI.&#xD;
  &#xD;
        Parents will be asked to complete baseline and follow-up surveys. The surveys will ask about&#xD;
        family demographic and health information, language exposure in the home, therapy and school&#xD;
        services, and language and communication ability of the child. Parental surveys will be&#xD;
        readministered at about 12-month intervals after the child's device is turned on. In&#xD;
        addition, surveys about the child's cognition will be sent to parents after their child has&#xD;
        used their implant for one and two years. Surveys will be offered online by a secure link&#xD;
        provided during clinical visits, emailed after the visit or sent by MyChart to the&#xD;
        parent/guardian for completion at home.&#xD;
  &#xD;
        An in-person research-only speech and language evaluation will be done at about one-year&#xD;
        intervals after initial implantation during each year the child is enrolled in the study. The&#xD;
        evaluation will take less than two hours.&#xD;
  &#xD;
        Arm 2: Communication Treatment. In addition to all of the study procedures described above&#xD;
        for Arm1, at only Lurie Children's Hospital of Chicago, 10 children will be enrolled in each&#xD;
        of four years who meet additional inclusion criteria. Children enrolled in this arm will&#xD;
        receive Parent Implemented Communication Treatment (PICT). PICT involves training parents to&#xD;
        use communication skills to support development of their child's language. PICT will consist&#xD;
        of one-hour weekly sessions for about six months provided virtually by a secure video chat&#xD;
        system such as Zoom. The child and parent/caregiver will both participate in each weekly&#xD;
        session. In addition, parent and child social interactions will be evaluated by video chat&#xD;
        each month for six months and then annually for two years. The parent and child social&#xD;
        interaction evaluation will take less than 15 minutes. Children who receive PICT will&#xD;
        continue to receive all other therapies. In other words, no therapies will be discontinued&#xD;
        during the time children are receiving PICT.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 23, 2023</start_date>
    <completion_date type="Anticipated">January 23, 2028</completion_date>
    <primary_completion_date type="Anticipated">July 23, 2027</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Preschool Language Scales, Fifth Edition (PLS-5)</measure>
      <time_frame>At 12 months after cochlear implant activation</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Preschool Language Scales, Fifth Edition (PLS-5)</measure>
      <time_frame>At 24 months after cochlear implant activation</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Preschool Language Scales, Fifth Edition (PLS-5)</measure>
      <time_frame>At 36 months after cochlear implant activation</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Preschool Language Scales, Fifth Edition (PLS-5)</measure>
      <time_frame>At 48 months after cochlear implant activation</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Expressive One-Word Picture Vocabulary Test, Fourth Edition (EOWPVT-4)</measure>
      <time_frame>At 12 months after cochlear implant activation</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Expressive One-Word Picture Vocabulary Test, Fourth Edition (EOWPVT-4)</measure>
      <time_frame>At 24 months after cochlear implant activation</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Expressive One-Word Picture Vocabulary Test, Fourth Edition (EOWPVT-4)</measure>
      <time_frame>At 36 months after cochlear implant activation</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Expressive One-Word Picture Vocabulary Test, Fourth Edition (EOWPVT-4)</measure>
      <time_frame>At 48 months after cochlear implant activation</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>MacArthur-Bates Communicative Development Inventory (CDI)</measure>
      <time_frame>At 12 months after cochlear implant activation</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>MacArthur-Bates Communicative Development Inventory (CDI)</measure>
      <time_frame>At 24 months after cochlear implant activation</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>MacArthur-Bates Communicative Development Inventory (CDI)</measure>
      <time_frame>At 36 months after cochlear implant activation</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>MacArthur-Bates Communicative Development Inventory (CDI)</measure>
      <time_frame>At 48 months after cochlear implant activation</time_frame>
      <description>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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Behavior Rating Inventory of Executive Function (BRIEF)</measure>
      <time_frame>At 12 months after cochlear implant activation</time_frame>
      <description>A parent-reported executive function questionnaire that utilizes T-scores to reflect individual's level of executive functioning. Higher T-scores indicate better performance.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Behavior Rating Inventory of Executive Function (BRIEF)</measure>
      <time_frame>At 24 months after cochlear implant activation</time_frame>
      <description>A parent-reported executive function questionnaire that utilizes T-scores to reflect individual's level of executive functioning. Higher T-scores indicate better performance.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P)</measure>
      <time_frame>At 12 months after cochlear implant activation</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P)</measure>
      <time_frame>At 24 months after cochlear implant activation</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pediatric Minimum Speech Test Battery (PMSTB)</measure>
      <time_frame>At 6 months after cochlear implant activation</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pediatric Minimum Speech Test Battery (PMSTB)</measure>
      <time_frame>At 12 months after cochlear implant activation</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pediatric Minimum Speech Test Battery (PMSTB)</measure>
      <time_frame>At 18 months after cochlear implant activation</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pediatric Minimum Speech Test Battery (PMSTB)</measure>
      <time_frame>At 24 months after cochlear implant activation</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pediatric Minimum Speech Test Battery (PMSTB)</measure>
      <time_frame>At 36 months after cochlear implant activation</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pediatric Minimum Speech Test Battery (PMSTB)</measure>
      <time_frame>At 48 months after cochlear implant activation</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">700</enrollment>
    <condition>Bilateral Sensorineural Hearing Loss</condition>
    <condition>Speech and Language Development Delay Due to Hearing Loss</condition>
    <condition>Social Communication</condition>
    <arm_group>
      <arm_group_label>Non-treatment Model Building</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Communication Treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Parent-Implemented Communication Treatment</intervention_name>
      <description>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.</description>
      <arm_group_label>Communication Treatment</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria (Arm 1):&#xD;
  &#xD;
            1. Children with sensorineural hearing loss who meet clinical criteria for cochlear&#xD;
               implantation in both ears who meet the following age criteria at time cochlear implant&#xD;
               evaluation begins:&#xD;
  &#xD;
                 -  Age 5 years and under.&#xD;
  &#xD;
                 -  English or Spanish as the dominant language.&#xD;
  &#xD;
            2. Lurie site only: Age under 7 years for children with unilateral sensorineural hearing&#xD;
               loss who meet clinical criteria for cochlear implantation.&#xD;
  &#xD;
            3. English or Spanish dominant language in the home.&#xD;
  &#xD;
          Inclusion Criteria (Arm 2):&#xD;
  &#xD;
            1. Children with bilateral sensorineural hearing loss who meet clinical criterial for&#xD;
               cochlear implantation&#xD;
  &#xD;
            2. English dominant spoken language by family&#xD;
  &#xD;
            3. Age at implantation of 36 months and younger when treatment begins&#xD;
  &#xD;
            4. Parent or caregiver that is willing to participate who understands spoken English&#xD;
  &#xD;
            5. Child is exposed to spoken language by at least one parent (total communication or&#xD;
               auditory/oral) in the home&#xD;
  &#xD;
          Exclusion Criteria (Arm 1):&#xD;
  &#xD;
            1. Severe motor and /or cognitive disability that would preclude evaluation of progress&#xD;
  &#xD;
            2. Limited electrode insertion likely to significantly impact development of speech&#xD;
               perception&#xD;
  &#xD;
            3. Hearing loss due to bacterial meningitis&#xD;
  &#xD;
            4. Neither English or Spanish as the dominant family language in the home&#xD;
  &#xD;
          Exclusion Criteria (Arm 2):&#xD;
  &#xD;
            1. Severe motor and /or cognitive disability that would preclude evaluation of progress&#xD;
  &#xD;
            2. Limited electrode insertion likely to significantly impact development of speech&#xD;
               perception&#xD;
  &#xD;
            3. Hearing loss due to bacterial meningitis&#xD;
  &#xD;
            4. Dominant language other than English&#xD;
  &#xD;
            5. Diagnoses or medical conditions expected to impact language development independent of&#xD;
               hearing loss&#xD;
  &#xD;
            6. Cochlear nerve deficiency in implanted ears or severe cochlear malformation&#xD;
  &#xD;
            7. Children already having spoken language who score better than 25th percentile on the&#xD;
               Words and Sentences portion of the CDI language evaluation.&#xD;
  &#xD;
            8. Child with more than two months CI experience prior to start of treatment&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>0 Months</minimum_age>
      <maximum_age>7 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Nancy M Young, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Ann &amp; Robert H Lurie Children's Hospital of Chicago</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Nancy M Young, MD</last_name>
      <phone>312-227-6812</phone>
      <email>nyoung@luriechildrens.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Emily (Shimeng) Xu, PhD</last_name>
      <email>sxu@luriechildrens.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Ann &amp; Robert H. Lurie Children's Hospital of Chicago</name>
        <address>
          <city>Chicago</city>
          <state>Illinois</state>
          <zip>60611</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Nancy Young, MD</last_name>
        <email>nyoung@luriechildrens.org</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 6, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 21, 2023</last_update_submitted>
    <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ann &amp; Robert H Lurie Children's Hospital of Chicago</investigator_affiliation>
      <investigator_full_name>Nancy Young, MD</investigator_full_name>
      <investigator_title>Head, Section of Otology/Neurotology and Medical Director, Audiology &amp; Cochlear Implant Programs</investigator_title>
    </responsible_party>
    <keyword>Hearing Loss</keyword>
    <keyword>Children</keyword>
    <keyword>Parent-mediated intervention</keyword>
    <keyword>Language prediction</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hearing Loss</mesh_term>
      <mesh_term>Deafness</mesh_term>
      <mesh_term>Hearing Loss, Sensorineural</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Informed Consent Form: Arm 1 - Non-treatment Model Building</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>December 23, 2022</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/59/NCT05962359/ICF_000.pdf</document_url>
      </provided_document>
      <provided_document>
        <document_type>Informed Consent Form: Arm 2 - Communication Treatment</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>December 23, 2022</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/59/NCT05962359/ICF_001.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05962359
  org study id: R01DC019387
  nct id: NCT05962359
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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: Communication Treatment. In addition to all of the study procedures described above
        for Arm1, at only Lurie Children's Hospital of Chicago, 10 children will be enrolled in each
        of four years who meet additional inclusion criteria. Children enrolled in this arm will
        receive Parent Implemented Communication Treatment (PICT). PICT involves training parents to
        use communication skills to support development of their child's language. PICT will consist
        of one-hour weekly sessions for about six months provided virtually by a secure video chat
        system such as Zoom. The child and parent/caregiver will both participate in each weekly
        session. In addition, parent and child social interactions will be evaluated by video chat
        each month for six months and then annually for two years. The parent and child social
        interaction evaluation will take less than 15 minutes. Children who receive PICT will
        continue to receive all other therapies. In other words, no therapies will be discontinued
        during the time children are receiving PICT.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Preschool Language Scales, Fifth Edition (PLS-5)
  time frame: At 12 months after cochlear implant activation
  description: 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.
  measure: Preschool Language Scales, Fifth Edition (PLS-5)
  time frame: At 24 months after cochlear implant activation
  description: 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.
  measure: Preschool Language Scales, Fifth Edition (PLS-5)
  time frame: At 36 months after cochlear implant activation
  description: 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.
  measure: Preschool Language Scales, Fifth Edition (PLS-5)
  time frame: At 48 months after cochlear implant activation
  description: 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.
  measure: Expressive One-Word Picture Vocabulary Test, Fourth Edition (EOWPVT-4)
  time frame: At 12 months after cochlear implant activation
  description: 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.
  measure: Expressive One-Word Picture Vocabulary Test, Fourth Edition (EOWPVT-4)
  time frame: At 24 months after cochlear implant activation
  description: 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.
  measure: Expressive One-Word Picture Vocabulary Test, Fourth Edition (EOWPVT-4)
  time frame: At 36 months after cochlear implant activation
  description: 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.
  measure: Expressive One-Word Picture Vocabulary Test, Fourth Edition (EOWPVT-4)
  time frame: At 48 months after cochlear implant activation
  description: 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.
  measure: MacArthur-Bates Communicative Development Inventory (CDI)
  time frame: At 12 months after cochlear implant activation
  description: 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.
  measure: MacArthur-Bates Communicative Development Inventory (CDI)
  time frame: At 24 months after cochlear implant activation
  description: 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.
  measure: MacArthur-Bates Communicative Development Inventory (CDI)
  time frame: At 36 months after cochlear implant activation
  description: 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.
  measure: MacArthur-Bates Communicative Development Inventory (CDI)
  time frame: At 48 months after cochlear implant activation
  description: 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.
  measure: Behavior Rating Inventory of Executive Function (BRIEF)
  time frame: At 12 months after cochlear implant activation
  description: A parent-reported executive function questionnaire that utilizes T-scores to reflect individual's level of executive functioning. Higher T-scores indicate better performance.
  measure: Behavior Rating Inventory of Executive Function (BRIEF)
  time frame: At 24 months after cochlear implant activation
  description: A parent-reported executive function questionnaire that utilizes T-scores to reflect individual's level of executive functioning. Higher T-scores indicate better performance.
  measure: Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P)
  time frame: At 12 months after cochlear implant activation
  description: 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.
  measure: Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P)
  time frame: At 24 months after cochlear implant activation
  description: 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.
  measure: Pediatric Minimum Speech Test Battery (PMSTB)
  time frame: At 6 months after cochlear implant activation
  description: 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.
  measure: Pediatric Minimum Speech Test Battery (PMSTB)
  time frame: At 12 months after cochlear implant activation
  description: 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.
  measure: Pediatric Minimum Speech Test Battery (PMSTB)
  time frame: At 18 months after cochlear implant activation
  description: 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.
  measure: Pediatric Minimum Speech Test Battery (PMSTB)
  time frame: At 24 months after cochlear implant activation
  description: 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.
  measure: Pediatric Minimum Speech Test Battery (PMSTB)
  time frame: At 36 months after cochlear implant activation
  description: 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.
  measure: Pediatric Minimum Speech Test Battery (PMSTB)
  time frame: At 48 months after cochlear implant activation
  description: 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.
  arm group label: Non-treatment Model Building
  arm group type: No Intervention
  arm group label: Communication Treatment
  arm group type: Experimental
  intervention type: Behavioral
  intervention name: Parent-Implemented Communication Treatment
  description: 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.
  arm group label: Communication Treatment
  criteria: 
  gender: All
  minimum age: 0 Months
  maximum age: 7 Years
  healthy volunteers: No
  last name: Nancy M Young, MD
  role: Principal Investigator
  affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
  last name: Nancy M Young, MD
  phone: 312-227-6812
  email: nyoung@luriechildrens.org
  last name: Emily (Shimeng) Xu, PhD
  email: sxu@luriechildrens.org
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
  investigator full name: Nancy Young, MD
  investigator title: Head, Section of Otology/Neurotology and Medical Director, Audiology & Cochlear Implant Programs
  mesh term: Hearing Loss
  mesh term: Deafness
  mesh term: Hearing Loss, Sensorineural
  sharing ipd: No
  provided document: 
  provided document: 