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/NCT05993832</url>
    </required_header>
    <id_info>
      <org_study_id>4067E</org_study_id>
      <nct_id>NCT05993832</nct_id>
    </id_info>
    <brief_title>Word Learning in Deaf Children Using Eye-tracking and Behavioral Measures</brief_title>
    <official_title>Word Learning in Deaf Children Using Eye-tracking and Behavioral Measures</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Boston University Charles River Campus</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Boston University Charles River Campus</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>
        Mutual exclusivity is a word learning constraint in which the learner assumes that a given&#xD;
        word refers to only one category of objects. In spoken languages, mutual exclusivity has been&#xD;
        demonstrated in monolingual children as young as 17 months and cross-linguistically, while&#xD;
        multilingual learners show an attenuated mutual exclusivity bias. Mutual exclusivity has not&#xD;
        been robustly demonstrated in deaf children acquiring American Sign Language (ASL). Further,&#xD;
        it is unclear if mutual exclusivity applies to those learning both a signed and a spoken&#xD;
        language. Like unimodal bilinguals, bimodal bilingual (BiBi) children learn two words for an&#xD;
        object, but these words are separated by modality. A BiBi child could therefore assume that&#xD;
        all objects have two words (like unimodal bilinguals) or that all objects have one spoken&#xD;
        word and one sign (within-modality mutual exclusivity). The goals of the current study are to&#xD;
        demonstrate mutual exclusivity in monolingual deaf children acquiring ASL, and to determine&#xD;
        if BiBi deaf children utilize mutual exclusivity within each modality.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The investigators will investigate how deaf children prioritize input cues to word meaning&#xD;
        when linguistic cues (i.e. mutual exclusivity) and referential gaze are in conflict in a&#xD;
        structured word learning task.&#xD;
  &#xD;
        Participants: Deaf children (n=40) ages 24-60 months. Investigators will recruit 60 children&#xD;
        to allow for 33% attrition. While the inclusion criteria are the same as other studies, here&#xD;
        investigators do use spoken language exposure as a grouping variable, as follows: based on&#xD;
        responses to the language background questionnaire regarding exposure to spoken English,&#xD;
        participants will be grouped according to language use as monolingual ASL or bimodal&#xD;
        bilingual (spoken English/ASL). Participants will be identified as bimodal bilingual is 1)&#xD;
        the primary caregiver reports spoken English to communicate with their child (either alone or&#xD;
        in conjunction with ASL), and 2) the primary caregiver reports that their child's ability to&#xD;
        understand spoken English is at least a 3 on a Likert-type scale ranging from 0-5. Parents in&#xD;
        this group will complete the short-form English CDI in addition to the ASL language measures.&#xD;
  &#xD;
        Procedure: Participants will sit across a table from an experimenter who will present pairs&#xD;
        of objects--one familiar, one novel--with one pair in each of nine trials (three per&#xD;
        condition). The experimenter will prompt the participant to give them one of the toys,&#xD;
        signing &quot;I WANT YOU-GIVE-ME WHAT?&quot; Then the experimenter will provide a cue; the child's&#xD;
        selection will be recorded. In the gaze condition, the cue will be a gaze shift to the&#xD;
        familiar object. In the mutual exclusivity condition, the cue will be a novel sign. In the&#xD;
        conflict condition, both a gaze shift to the familiar object and a novel sign will be used.&#xD;
        The trial order and object pair will be pseudo-randomly assigned.&#xD;
  &#xD;
        Planned analysis: Investigators will use an omnibus mixed effects binomial model to determine&#xD;
        how well condition and language environment predict the likelihood to select the novel&#xD;
        object, with item and child as random factors.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 7, 2023</start_date>
    <completion_date type="Anticipated">January 2027</completion_date>
    <primary_completion_date type="Anticipated">May 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Selected object</measure>
      <time_frame>10 seconds following experimenter prompt</time_frame>
      <description>Children will select one of the two objects on the table in front of them. Their selection will be scored as correct or incorrect based on the target object.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Deafness</condition>
    <arm_group>
      <arm_group_label>Referential cues to object</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Each object pair that is presented to the child is accompanied by 1) gaze only (3 trials); 2) novel label only (3 trials); or 3) conflicting gaze and novel label (3 trials)</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>input cue</intervention_name>
      <description>The object is labelled with 1) gaze only; 2) novel label only; or 3) conflicting gaze and novel label</description>
      <arm_group_label>Referential cues to object</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Deaf children ages 18-60 months&#xD;
  &#xD;
            -  born severely to profoundly deaf&#xD;
  &#xD;
            -  have either deaf or hearing parents&#xD;
  &#xD;
            -  communicate using American Sign Language&#xD;
  &#xD;
            -  have normal to corrected normal vision&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Deaf children who have not been exposed to American Sign Language&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Months</minimum_age>
      <maximum_age>60 Months</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Amy Lieberman, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Boston University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Amy Lieberman, PhD</last_name>
      <phone>617-353-3377</phone>
      <email>alieber@bu.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Boston University</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02215</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Amy Lieberman</last_name>
        <email>alieber@bu.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>deafness</keyword>
    <keyword>American Sign Language</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Deafness</mesh_term>
      <mesh_term>Hearing Loss</mesh_term>
    </condition_browse>
    <!-- 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/NCT05993832
  org study id: 4067E
  nct id: NCT05993832
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Mutual exclusivity is a word learning constraint in which the learner assumes that a given
        word refers to only one category of objects. In spoken languages, mutual exclusivity has been
        demonstrated in monolingual children as young as 17 months and cross-linguistically, while
        multilingual learners show an attenuated mutual exclusivity bias. Mutual exclusivity has not
        been robustly demonstrated in deaf children acquiring American Sign Language (ASL). Further,
        it is unclear if mutual exclusivity applies to those learning both a signed and a spoken
        language. Like unimodal bilinguals, bimodal bilingual (BiBi) children learn two words for an
        object, but these words are separated by modality. A BiBi child could therefore assume that
        all objects have two words (like unimodal bilinguals) or that all objects have one spoken
        word and one sign (within-modality mutual exclusivity). The goals of the current study are to
        demonstrate mutual exclusivity in monolingual deaf children acquiring ASL, and to determine
        if BiBi deaf children utilize mutual exclusivity within each modality.
  The investigators will investigate how deaf children prioritize input cues to word meaning
        when linguistic cues (i.e. mutual exclusivity) and referential gaze are in conflict in a
        structured word learning task.
  
        Participants: Deaf children (n=40) ages 24-60 months. Investigators will recruit 60 children
        to allow for 33% attrition. While the inclusion criteria are the same as other studies, here
        investigators do use spoken language exposure as a grouping variable, as follows: based on
        responses to the language background questionnaire regarding exposure to spoken English,
        participants will be grouped according to language use as monolingual ASL or bimodal
        bilingual (spoken English/ASL). Participants will be identified as bimodal bilingual is 1)
        the primary caregiver reports spoken English to communicate with their child (either alone or
        in conjunction with ASL), and 2) the primary caregiver reports that their child's ability to
        understand spoken English is at least a 3 on a Likert-type scale ranging from 0-5. Parents in
        this group will complete the short-form English CDI in addition to the ASL language measures.
  
        Procedure: Participants will sit across a table from an experimenter who will present pairs
        of objects--one familiar, one novel--with one pair in each of nine trials (three per
        condition). The experimenter will prompt the participant to give them one of the toys,
        signing "I WANT YOU-GIVE-ME WHAT?" Then the experimenter will provide a cue; the child's
        selection will be recorded. In the gaze condition, the cue will be a gaze shift to the
        familiar object. In the mutual exclusivity condition, the cue will be a novel sign. In the
        conflict condition, both a gaze shift to the familiar object and a novel sign will be used.
        The trial order and object pair will be pseudo-randomly assigned.
  
        Planned analysis: Investigators will use an omnibus mixed effects binomial model to determine
        how well condition and language environment predict the likelihood to select the novel
        object, with item and child as random factors.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Selected object
  time frame: 10 seconds following experimenter prompt
  description: Children will select one of the two objects on the table in front of them. Their selection will be scored as correct or incorrect based on the target object.
  arm group label: Referential cues to object
  arm group type: Experimental
  description: Each object pair that is presented to the child is accompanied by 1) gaze only (3 trials); 2) novel label only (3 trials); or 3) conflicting gaze and novel label (3 trials)
  intervention type: Other
  intervention name: input cue
  description: The object is labelled with 1) gaze only; 2) novel label only; or 3) conflicting gaze and novel label
  arm group label: Referential cues to object
  criteria: 
  gender: All
  minimum age: 18 Months
  maximum age: 60 Months
  healthy volunteers: No
  last name: Amy Lieberman, PhD
  role: Principal Investigator
  affiliation: Boston University
  last name: Amy Lieberman, PhD
  phone: 617-353-3377
  email: alieber@bu.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Deafness
  mesh term: Hearing Loss