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/NCT05988190</url>
    </required_header>
    <id_info>
      <org_study_id>BinghamtonU</org_study_id>
      <nct_id>NCT05988190</nct_id>
    </id_info>
    <brief_title>Contextual Word Learning in Children With Developmental Language Disorder</brief_title>
    <official_title>Contextual Word Learning in Children With Developmental Language Disorder</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Binghamton University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of South Carolina</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Binghamton 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>
        Many children have developmental language disorder, which makes it difficulty to learn&#xD;
        language, including vocabulary, and results in ongoing academic and social difficulties.&#xD;
        Despite the fact that most words are learned in context without direct teaching, we know very&#xD;
        little about how children with developmental language disorder learn words in context. This&#xD;
        project will combine, for the first time, two strategies which improve contextual word&#xD;
        learning in children with typical development, and test their effect in both typically&#xD;
        developing children, and those with developmental language disorder. The results will provide&#xD;
        timely information that will contribute to evidence based practice for contextual word&#xD;
        learning in children with developmental language disorder.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Vocabulary achievement impacts important life outcomes such as academic success, vocational&#xD;
        options, and earning potential. Developmental language disorder is a common disorder which&#xD;
        impacts word learning, both when words are directly taught and when words are learned&#xD;
        implicitly after multiple contextual encounters. Contextual word learning is the most common&#xD;
        situation in which words are learned, and this typically occurs while reading. As such,&#xD;
        interventions which increase the effectiveness of contextual word learning have the potential&#xD;
        to meaningfully alter the trajectory of vocabulary growth.&#xD;
  &#xD;
        The long term objective of this research program is to develop effective interventions for&#xD;
        children with developmental language disorder, which target contextual word learning while&#xD;
        reading. The overall aim of this study is to test the effectiveness of an intervention which&#xD;
        combines two approaches known to be effective in typical development: metalinguistic training&#xD;
        about semantic inferencing, and use of multiple texts with high semantic diversity. Semantic&#xD;
        diversity refers to the range of semantic content in texts which contain the novel words. In&#xD;
        Aim 1, we test the effectiveness of this novel intervention in children with typical&#xD;
        development (n=50), and in Aim 2, we evaluate its effect in children with developmental&#xD;
        language disorder (n=50). Participants will complete a three session metalinguistic&#xD;
        intervention involving repeated meaning generation, explanation about proposed meanings, and&#xD;
        feedback about accuracy. The quality of semantic inferencing about novel words which are&#xD;
        untreated (not involved in the intervention) will be measured pre- and post-intervention as a&#xD;
        measure of the effect of intervention on the skill of semantic inferencing. Measures of&#xD;
        retention of the semantics of words used in intervention will be taken one week after each&#xD;
        session, and are expected to increase with more exposure to the metalinguistic intervention.&#xD;
        Within sessions, words will be presented in three different semantic diversity contexts: no&#xD;
        diversity (repeated stories), medium diversity (unique stories with the same global context),&#xD;
        and high diversity (unique stories with different global contexts). Based on prior research&#xD;
        about the effect of semantic diversity on word learning in children and adults, we predict&#xD;
        that measures of retention of the semantics of words used in intervention are expected to be&#xD;
        highest in the high semantic diversity condition.&#xD;
  &#xD;
        Results from this study will be used to support an application for a fully powered randomized&#xD;
        controlled trial of a contextual word learning intervention for children with DLD, and will&#xD;
        inform best practices for children with typical development. The project is innovative&#xD;
        because we will examine contextual word learning in developmental language disorders, we will&#xD;
        combine two treatment approaches in a novel way, and because we focus not only on the effect&#xD;
        on treated words, but also on generalization of the skill of semantic inferencing.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 2023</start_date>
    <completion_date type="Anticipated">August 2026</completion_date>
    <primary_completion_date type="Anticipated">December 2025</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>Measure of Semantic Knowledge (MSK)</measure>
      <time_frame>Aim 1a, 1b, 2a, 2b: Administered one week after exposure to novel words Aim 1c, 2c: Administered with untreated words prior to intervention and one week post intervention</time_frame>
      <description>Definitions, scored on a 5 point scale, per Duff, 2019 5 Context test questions (yes/no)</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Developmental Language Disorder</condition>
    <arm_group>
      <arm_group_label>Contextual Word Learning Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Intervention will consist of a metalinguistic intervention with novel words (n=9), based on Cain (2007), administered across three sessions, and spaced one week apart. Semantic diversity will vary across items.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Contextual Word Learning Intervention</intervention_name>
      <description>Metalinguistic intervention consisting of meaning generation, explanation and feedback, with semantic diversity varying (no, medium, high).</description>
      <arm_group_label>Contextual Word Learning Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Aim 1: Standard Score &gt; 90 on Clinical Evaluation of Language Fundamentals - Core Test&#xD;
               Language Battery administered in 2nd grade&#xD;
  &#xD;
            -  Aim 2: Standard Score &lt;= 85 on Clinical Evaluation of Language Fundamentals - Core&#xD;
               Test Language Battery administered in 2nd grade&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  hearing impairment&#xD;
  &#xD;
            -  uncorrected visual impairment&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>7 Years</minimum_age>
      <maximum_age>10 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Dawna M Duff</last_name>
      <role>Principal Investigator</role>
      <affiliation>Binghamton University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Dawna M Duff, PhD</last_name>
      <phone>6077774676</phone>
      <email>dduff@binghamton.edu</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Binghamton University</investigator_affiliation>
      <investigator_full_name>Dawna Duff</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>Developmental Language Disorder</keyword>
    <keyword>Vocabulary</keyword>
    <keyword>Semantic Diversity</keyword>
    <keyword>Word Learning</keyword>
    <keyword>Metalinguistics</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Language Disorders</mesh_term>
      <mesh_term>Language Development Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Deidentified data will be made available on Open Science Foundation.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>Data will be made available upon completion of data collection and coding, or six months after the funding period is complete, whichever comes first. Data will not be removed from public access.</ipd_time_frame>
      <ipd_access_criteria>Open Science Framework is a public access site.</ipd_access_criteria>
    </patient_data>
    <!-- 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/NCT05988190
  org study id: BinghamtonU
  nct id: NCT05988190
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Many children have developmental language disorder, which makes it difficulty to learn
        language, including vocabulary, and results in ongoing academic and social difficulties.
        Despite the fact that most words are learned in context without direct teaching, we know very
        little about how children with developmental language disorder learn words in context. This
        project will combine, for the first time, two strategies which improve contextual word
        learning in children with typical development, and test their effect in both typically
        developing children, and those with developmental language disorder. The results will provide
        timely information that will contribute to evidence based practice for contextual word
        learning in children with developmental language disorder.
  Vocabulary achievement impacts important life outcomes such as academic success, vocational
        options, and earning potential. Developmental language disorder is a common disorder which
        impacts word learning, both when words are directly taught and when words are learned
        implicitly after multiple contextual encounters. Contextual word learning is the most common
        situation in which words are learned, and this typically occurs while reading. As such,
        interventions which increase the effectiveness of contextual word learning have the potential
        to meaningfully alter the trajectory of vocabulary growth.
  
        The long term objective of this research program is to develop effective interventions for
        children with developmental language disorder, which target contextual word learning while
        reading. The overall aim of this study is to test the effectiveness of an intervention which
        combines two approaches known to be effective in typical development: metalinguistic training
        about semantic inferencing, and use of multiple texts with high semantic diversity. Semantic
        diversity refers to the range of semantic content in texts which contain the novel words. In
        Aim 1, we test the effectiveness of this novel intervention in children with typical
        development (n=50), and in Aim 2, we evaluate its effect in children with developmental
        language disorder (n=50). Participants will complete a three session metalinguistic
        intervention involving repeated meaning generation, explanation about proposed meanings, and
        feedback about accuracy. The quality of semantic inferencing about novel words which are
        untreated (not involved in the intervention) will be measured pre- and post-intervention as a
        measure of the effect of intervention on the skill of semantic inferencing. Measures of
        retention of the semantics of words used in intervention will be taken one week after each
        session, and are expected to increase with more exposure to the metalinguistic intervention.
        Within sessions, words will be presented in three different semantic diversity contexts: no
        diversity (repeated stories), medium diversity (unique stories with the same global context),
        and high diversity (unique stories with different global contexts). Based on prior research
        about the effect of semantic diversity on word learning in children and adults, we predict
        that measures of retention of the semantics of words used in intervention are expected to be
        highest in the high semantic diversity condition.
  
        Results from this study will be used to support an application for a fully powered randomized
        controlled trial of a contextual word learning intervention for children with DLD, and will
        inform best practices for children with typical development. The project is innovative
        because we will examine contextual word learning in developmental language disorders, we will
        combine two treatment approaches in a novel way, and because we focus not only on the effect
        on treated words, but also on generalization of the skill of semantic inferencing.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Measure of Semantic Knowledge (MSK)
  time frame: Aim 1a, 1b, 2a, 2b: Administered one week after exposure to novel words Aim 1c, 2c: Administered with untreated words prior to intervention and one week post intervention
  description: Definitions, scored on a 5 point scale, per Duff, 2019 5 Context test questions (yes/no)
  arm group label: Contextual Word Learning Intervention
  arm group type: Experimental
  description: Intervention will consist of a metalinguistic intervention with novel words (n=9), based on Cain (2007), administered across three sessions, and spaced one week apart. Semantic diversity will vary across items.
  intervention type: Behavioral
  intervention name: Contextual Word Learning Intervention
  description: Metalinguistic intervention consisting of meaning generation, explanation and feedback, with semantic diversity varying (no, medium, high).
  arm group label: Contextual Word Learning Intervention
  criteria: 
  gender: All
  minimum age: 7 Years
  maximum age: 10 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Dawna M Duff
  role: Principal Investigator
  affiliation: Binghamton University
  last name: Dawna M Duff, PhD
  phone: 6077774676
  email: dduff@binghamton.edu
  responsible party type: Principal Investigator
  investigator affiliation: Binghamton University
  investigator full name: Dawna Duff
  investigator title: Associate Professor
  mesh term: Language Disorders
  mesh term: Language Development Disorders
  sharing ipd: Yes
  ipd description: Deidentified data will be made available on Open Science Foundation.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Analytic Code
  ipd time frame: Data will be made available upon completion of data collection and coding, or six months after the funding period is complete, whichever comes first. Data will not be removed from public access.
  ipd access criteria: Open Science Framework is a public access site.