<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/NCT03803943</url>
  </required_header>
  <id_info>
    <org_study_id>1R01DC016877-01A1</org_study_id>
    <nct_id>NCT03803943</nct_id>
  </id_info>
  <brief_title>Early Communication Intervention for Toddlers With Hearing Loss</brief_title>
  <official_title>Early Communication Intervention for Toddlers With Hearing Loss</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ann &amp; Robert H Lurie Children's Hospital of Chicago</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Northwestern University</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>
      Improving spoken language outcomes for children with hearing loss has important public health&#xD;
      implications. This is a randomized clinical trial of 96 children with hearing loss that&#xD;
      examines the effects of a parent-implemented early communication intervention on&#xD;
      prelinguistic and spoken language outcomes. The study is open for national recruitment.&#xD;
      Parents participate via video call with their child and receive technology to assist with&#xD;
      virtual visits.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      While children with hearing loss (HL) are experiencing greater gains in spoken language than&#xD;
      ever before, considerable variability exists and many children with HL continue to have&#xD;
      poorer language skills than their hearing peers. Critical to reducing this variability is the&#xD;
      identification of: (a) effective early communication interventions for children with HL and&#xD;
      (b) child and parent characteristics that influence intervention outcomes (moderators and&#xD;
      mediators). However, to date, only the pilot study for this proposed study has directly&#xD;
      examined the effects of an early communication intervention for children with HL within the&#xD;
      context of a randomized clinical trial. The overarching goals of the proposed study are to:&#xD;
      (a) evaluate the effects of teaching parents to use communication support strategies on child&#xD;
      communication outcomes and (b) examine parent and child characteristics that moderate and&#xD;
      mediate intervention outcomes. The central hypothesis is that systematic parent training will&#xD;
      result in greater parental use of communication support strategies, greater child&#xD;
      pre-symbolic communicative acts, and greater child spoken language outcomes. The specific&#xD;
      aims include: (a) comparing parent use of communication support strategies and child&#xD;
      pre-symbolic communicative acts between intervention and control groups during and&#xD;
      immediately following intervention (from 12 to 18 months of age), (b) examining parent&#xD;
      (identification of child communication) and child (sensitivity to social contingency;&#xD;
      attention to speech) moderators of intervention outcomes; (c) comparing parent use of&#xD;
      communication support strategies and child spoken language outcomes between intervention and&#xD;
      control groups after intervention (from 18 and 36 months of age); and (d) examining parent&#xD;
      (use of communication support strategies) and child (pre-symbolic communicative acts)&#xD;
      mediators of intervention outcomes. The proposed study will enroll 96 children with mild to&#xD;
      profound bilateral hearing loss. Children will enroll in the study around 12 months of age&#xD;
      and will be randomly assigned to either a parent-implemented communication intervention&#xD;
      (PICT) or a control group. Children in both groups will be assessed: (a) at 12 months of age&#xD;
      (immediately before intervention), (b) at 18 months of age (immediately after intervention),&#xD;
      and (c) at 36 months of age (18 months after the end of intervention). Children in the&#xD;
      intervention group will receive weekly, 1-hour intervention sessions for 6-months that: (a)&#xD;
      are delivered during an important prelinguistic period of language development, (b)&#xD;
      incorporate visual, interactive, responsive, and linguistically stimulating communication&#xD;
      support strategies that are associated with stronger language skills in children with HL, and&#xD;
      (c) include systematic parent training found to be effective in teaching parents to use&#xD;
      communication support skills in children with language delays. The proposed research is&#xD;
      significant because effective early communication intervention is likely to reduce persistent&#xD;
      language delays in children with HL, thereby advancing the field of childhood hearing loss,&#xD;
      where there is a striking paucity of rigorous communication intervention research.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 15, 2019</start_date>
  <completion_date type="Anticipated">February 28, 2024</completion_date>
  <primary_completion_date type="Anticipated">February 28, 2024</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Children will enroll in the study around 12 months of age and will be randomly assigned to either a parent-implemented communication intervention (PICT) or a control group.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Outcome assessors and coders will be naive to experimental condition</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Caregiver Use of Communication Support Strategies</measure>
    <time_frame>Change in monthly samples between pre and post when the child is 12 to 18 months (during intervention)</time_frame>
    <description>Caregiver use of communication support strategies is measured from a 10-minute caregiver-child interaction in which the dyad plays using a standard set of toys. This interaction will be video recorded and coded for their use of communication support strategies to yield the following variables: percentage of adult communication that is within the child's line of sight, percentage of adult communication that is paired with a gesture in the child's line of sight, percentage of child communication that is followed by a contingent response, percentage of adult communication that is in response to child communication, percentage of adult communication that contains a child linguistic target, and percentage of child communication to which the adult imitates and adds a word. These variables will be combined using confirmatory factor analysis to create a single latent variable.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total number of pre-symbolic communicative acts from the Language Sample</measure>
    <time_frame>Change in monthly samples between pre and post when the child is 12 to 18 months (during intervention)</time_frame>
    <description>The child plays with four different sets of toys and looks at a wordless picture book for 20 minutes, while the assessor engages with the child but does not talk. Then a research assistant transcribes and codes all child communicative behavior.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Scaled Score on the Communication and Symbolic Behavior Scales - Developmental Profile</measure>
    <time_frame>Post (immediately after intervention when the child is 18 months)</time_frame>
    <description>The child is presented with 6 different activities (wind-up toy, balloon, bubbles, jar, books, play) designed to elicit child communication. The interaction is video recorded and then scored for 20 items across 7 communication scales (emotion and eye gaze, communication, gestures, sounds, words, understanding, and object use). An overall total scaled score is calculated based on the raw score and the child's age (min = 65; max = 135). Higher scores indicate better skills.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Caregiver Use of Communication Support Strategies</measure>
    <time_frame>Monthly, up to 18 months, between post and follow-up when the child is 18 to 36 months (after intervention)</time_frame>
    <description>Caregiver use of communication support strategies will be measured from a 10-minute caregiver-child interaction in which the caregiver plays with the child using a standard set of toys. This interaction will be coded for their use of communication support strategies to yield the following variables: percentage of intervals in which the adult is communicating within the child's line of sight, percentage of adult communication that is paired with a gesture in the child's line of sight, percentage of intervals in which the adult's play is related to the child, percentage of child non-verbal actions that are imitated, percentage of child communication that is followed by a contingent response, percentage of adult communication that is in response to child communication, percentage of adult communication that contains a child linguistic target, percentage of child communication to which the adult imitates and adds a word. These variables will be combined to create a single latent variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child Spoken Words</measure>
    <time_frame>Monthly, up to 18 months, between post and follow-up when the child is 18 to 36 months (after intervention)</time_frame>
    <description>Total number of spoken words will be collected using two measures that will be combined used confirmatory factory analysis. Total Number of Words Said from the MacArthur-Bates Communicative Development Inventory: Words and Sentences and the total number of different spoken word roots from a 20-minute language sample in which an assessor plays with the child following a standardized protocol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expressive Communication Standard Score on the Preschool Language Scale - 5th Edition</measure>
    <time_frame>Follow up (18 months after the study start when child is 36 months)</time_frame>
    <description>The child is presented with different receptive tasks, such as following simple directions and pointing to pictures, until the child provides an incorrect response to six consecutive items. A total standard score is calculated based on the raw score and the child's age (min = 50; max = 150). Higher score indicate better outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Auditory Comprehension Standard Score on the Preschool Language Scale - 5th Edition</measure>
    <time_frame>Follow up (18 months after the study start when child is 36 months)</time_frame>
    <description>The child is presented with different expressive tasks, such as labeling pictures, until the child provides an incorrect response to six consecutive items. A total standard score is calculated based on the raw score and the child's age (min = 50; max = 150). Higher Scores indicate better outcomes.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">96</enrollment>
  <condition>Hearing Loss, Bilateral</condition>
  <arm_group>
    <arm_group_label>Parent-Implemented Communication Intervention (PICT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants assigned to the PICT condition will receive weekly hour long intervention sessions in their home for 6 months. Parents will learn four sets of communication support strategies: (a) visual (e.g., modeling language within the child's line of sight), (b) interactive (e.g., following the child's attentional focus), (c) responsive (e.g., responding to all communicative attempts), and (d) linguistically stimulating (e.g., modeling language targets, expanding child communication).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Intervention - Business-as-usual control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants assigned to the BAU control group will not receive the PICT intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Parent-Implemented Communication Intervention (PICT)</intervention_name>
    <description>Weekly hour long intervention sessions for 6 months</description>
    <arm_group_label>Parent-Implemented Communication Intervention (PICT)</arm_group_label>
    <other_name>PICT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Intervention - Business-as-usual control</intervention_name>
    <description>Does not receive PICT internvention</description>
    <arm_group_label>No Intervention - Business-as-usual control</arm_group_label>
    <other_name>BAU</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  have bilateral, congenital HL as measured by a review of medical records&#xD;
&#xD;
          -  enrollment in the study between 12 and 18 months of age&#xD;
&#xD;
          -  have no known additional disabilities (e.g., Down syndrome, cerebral palsy, seizure&#xD;
             disorder, blindness, etc.) as measured by review of medical records and parent report&#xD;
&#xD;
          -  have English as the primary language spoken at home&#xD;
&#xD;
          -  have one parent with normal hearing, and (f) are exposed to some degree of spoken&#xD;
             language by their parents (total communication, auditory/oral)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Months</minimum_age>
    <maximum_age>18 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Megan Y Roberts, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Megan Y Roberts, PhD</last_name>
    <phone>8474913183</phone>
    <email>ei@northwestern.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Laura J Sudec, MSW</last_name>
    <phone>8474913183</phone>
    <email>laura.sudec@northwestern.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60208</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Megan Y Roberts, PhD</last_name>
      <phone>847-491-3183</phone>
      <email>megan.y.roberts@northwestern.edu</email>
    </contact>
    <contact_backup>
      <last_name>Laura Sudec, MSW</last_name>
      <phone>8474913183</phone>
      <email>laura.sudec@northwestern.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Megan Y Roberts, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>March 21, 2023</last_update_submitted>
  <last_update_submitted_qc>March 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Megan Roberts</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Hearing Loss</keyword>
  <keyword>Toddlers</keyword>
  <keyword>Early Intervention</keyword>
  <keyword>Parent-mediated intervention</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, Bilateral</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data and associated documentation available to users only under a data-sharing agreement that provides for a commitment: (1) to use the data only for research purposes and not to identify any individual participant; (2) to secure the data using appropriate computer technology; (3) to destroy or return the data after analyses are completed; and (4) to cite the grant and key publications describing the database and measures in any resulting presentations and publications.</ipd_description>
    <ipd_access_criteria>Transcripts from caregiver-child and examiner-child language samples will also be donated to the Child Language Data Exchange System (http://childes.psy.cmu.edu), an international repository of child language data. Access to the data will be openly available. Researchers who access the transcripts will be expected to abide by the established guidelines for use of TalkBank data http://talkbank.org/share/irb/options.html.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</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>May 20, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/43/NCT03803943/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03803943
org study id: 1R01DC016877-01A1
nct id: NCT03803943
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Improving spoken language outcomes for children with hearing loss has important public health
      implications. This is a randomized clinical trial of 96 children with hearing loss that
      examines the effects of a parent-implemented early communication intervention on
      prelinguistic and spoken language outcomes. The study is open for national recruitment.
      Parents participate via video call with their child and receive technology to assist with
      virtual visits.
While children with hearing loss (HL) are experiencing greater gains in spoken language than
      ever before, considerable variability exists and many children with HL continue to have
      poorer language skills than their hearing peers. Critical to reducing this variability is the
      identification of: (a) effective early communication interventions for children with HL and
      (b) child and parent characteristics that influence intervention outcomes (moderators and
      mediators). However, to date, only the pilot study for this proposed study has directly
      examined the effects of an early communication intervention for children with HL within the
      context of a randomized clinical trial. The overarching goals of the proposed study are to:
      (a) evaluate the effects of teaching parents to use communication support strategies on child
      communication outcomes and (b) examine parent and child characteristics that moderate and
      mediate intervention outcomes. The central hypothesis is that systematic parent training will
      result in greater parental use of communication support strategies, greater child
      pre-symbolic communicative acts, and greater child spoken language outcomes. The specific
      aims include: (a) comparing parent use of communication support strategies and child
      pre-symbolic communicative acts between intervention and control groups during and
      immediately following intervention (from 12 to 18 months of age), (b) examining parent
      (identification of child communication) and child (sensitivity to social contingency;
      attention to speech) moderators of intervention outcomes; (c) comparing parent use of
      communication support strategies and child spoken language outcomes between intervention and
      control groups after intervention (from 18 and 36 months of age); and (d) examining parent
      (use of communication support strategies) and child (pre-symbolic communicative acts)
      mediators of intervention outcomes. The proposed study will enroll 96 children with mild to
      profound bilateral hearing loss. Children will enroll in the study around 12 months of age
      and will be randomly assigned to either a parent-implemented communication intervention
      (PICT) or a control group. Children in both groups will be assessed: (a) at 12 months of age
      (immediately before intervention), (b) at 18 months of age (immediately after intervention),
      and (c) at 36 months of age (18 months after the end of intervention). Children in the
      intervention group will receive weekly, 1-hour intervention sessions for 6-months that: (a)
      are delivered during an important prelinguistic period of language development, (b)
      incorporate visual, interactive, responsive, and linguistically stimulating communication
      support strategies that are associated with stronger language skills in children with HL, and
      (c) include systematic parent training found to be effective in teaching parents to use
      communication support skills in children with language delays. The proposed research is
      significant because effective early communication intervention is likely to reduce persistent
      language delays in children with HL, thereby advancing the field of childhood hearing loss,
      where there is a striking paucity of rigorous communication intervention research.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Children will enroll in the study around 12 months of age and will be randomly assigned to either a parent-implemented communication intervention (PICT) or a control group.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Outcome assessors and coders will be naive to experimental condition
measure: Caregiver Use of Communication Support Strategies
time frame: Change in monthly samples between pre and post when the child is 12 to 18 months (during intervention)
description: Caregiver use of communication support strategies is measured from a 10-minute caregiver-child interaction in which the dyad plays using a standard set of toys. This interaction will be video recorded and coded for their use of communication support strategies to yield the following variables: percentage of adult communication that is within the child's line of sight, percentage of adult communication that is paired with a gesture in the child's line of sight, percentage of child communication that is followed by a contingent response, percentage of adult communication that is in response to child communication, percentage of adult communication that contains a child linguistic target, and percentage of child communication to which the adult imitates and adds a word. These variables will be combined using confirmatory factor analysis to create a single latent variable.
measure: Total number of pre-symbolic communicative acts from the Language Sample
time frame: Change in monthly samples between pre and post when the child is 12 to 18 months (during intervention)
description: The child plays with four different sets of toys and looks at a wordless picture book for 20 minutes, while the assessor engages with the child but does not talk. Then a research assistant transcribes and codes all child communicative behavior.
measure: Total Scaled Score on the Communication and Symbolic Behavior Scales - Developmental Profile
time frame: Post (immediately after intervention when the child is 18 months)
description: The child is presented with 6 different activities (wind-up toy, balloon, bubbles, jar, books, play) designed to elicit child communication. The interaction is video recorded and then scored for 20 items across 7 communication scales (emotion and eye gaze, communication, gestures, sounds, words, understanding, and object use). An overall total scaled score is calculated based on the raw score and the child's age (min = 65; max = 135). Higher scores indicate better skills.
measure: Caregiver Use of Communication Support Strategies
time frame: Monthly, up to 18 months, between post and follow-up when the child is 18 to 36 months (after intervention)
description: Caregiver use of communication support strategies will be measured from a 10-minute caregiver-child interaction in which the caregiver plays with the child using a standard set of toys. This interaction will be coded for their use of communication support strategies to yield the following variables: percentage of intervals in which the adult is communicating within the child's line of sight, percentage of adult communication that is paired with a gesture in the child's line of sight, percentage of intervals in which the adult's play is related to the child, percentage of child non-verbal actions that are imitated, percentage of child communication that is followed by a contingent response, percentage of adult communication that is in response to child communication, percentage of adult communication that contains a child linguistic target, percentage of child communication to which the adult imitates and adds a word. These variables will be combined to create a single latent variable.
measure: Child Spoken Words
time frame: Monthly, up to 18 months, between post and follow-up when the child is 18 to 36 months (after intervention)
description: Total number of spoken words will be collected using two measures that will be combined used confirmatory factory analysis. Total Number of Words Said from the MacArthur-Bates Communicative Development Inventory: Words and Sentences and the total number of different spoken word roots from a 20-minute language sample in which an assessor plays with the child following a standardized protocol.
measure: Expressive Communication Standard Score on the Preschool Language Scale - 5th Edition
time frame: Follow up (18 months after the study start when child is 36 months)
description: The child is presented with different receptive tasks, such as following simple directions and pointing to pictures, until the child provides an incorrect response to six consecutive items. A total standard score is calculated based on the raw score and the child's age (min = 50; max = 150). Higher score indicate better outcomes.
measure: Auditory Comprehension Standard Score on the Preschool Language Scale - 5th Edition
time frame: Follow up (18 months after the study start when child is 36 months)
description: The child is presented with different expressive tasks, such as labeling pictures, until the child provides an incorrect response to six consecutive items. A total standard score is calculated based on the raw score and the child's age (min = 50; max = 150). Higher Scores indicate better outcomes.
arm group label: Parent-Implemented Communication Intervention (PICT)
arm group type: Experimental
description: Participants assigned to the PICT condition will receive weekly hour long intervention sessions in their home for 6 months. Parents will learn four sets of communication support strategies: (a) visual (e.g., modeling language within the child's line of sight), (b) interactive (e.g., following the child's attentional focus), (c) responsive (e.g., responding to all communicative attempts), and (d) linguistically stimulating (e.g., modeling language targets, expanding child communication).
arm group label: No Intervention - Business-as-usual control
arm group type: Placebo Comparator
description: Participants assigned to the BAU control group will not receive the PICT intervention.
intervention type: Behavioral
intervention name: Parent-Implemented Communication Intervention (PICT)
description: Weekly hour long intervention sessions for 6 months
arm group label: Parent-Implemented Communication Intervention (PICT)
other name: PICT
intervention type: Other
intervention name: No Intervention - Business-as-usual control
description: Does not receive PICT internvention
arm group label: No Intervention - Business-as-usual control
other name: BAU
criteria: 
gender: All
minimum age: 12 Months
maximum age: 18 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Megan Y Roberts, PhD
role: Principal Investigator
affiliation: Northwestern University
last name: Megan Y Roberts, PhD
phone: 8474913183
email: ei@northwestern.edu
last name: Laura J Sudec, MSW
phone: 8474913183
email: laura.sudec@northwestern.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Megan Roberts
investigator title: Principal Investigator
mesh term: Hearing Loss
mesh term: Deafness
mesh term: Hearing Loss, Bilateral
sharing ipd: Yes
ipd description: Data and associated documentation available to users only under a data-sharing agreement that provides for a commitment: (1) to use the data only for research purposes and not to identify any individual participant; (2) to secure the data using appropriate computer technology; (3) to destroy or return the data after analyses are completed; and (4) to cite the grant and key publications describing the database and measures in any resulting presentations and publications.
ipd access criteria: Transcripts from caregiver-child and examiner-child language samples will also be donated to the Child Language Data Exchange System (http://childes.psy.cmu.edu), an international repository of child language data. Access to the data will be openly available. Researchers who access the transcripts will be expected to abide by the established guidelines for use of TalkBank data http://talkbank.org/share/irb/options.html.
provided document: 