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/NCT06026124</url>
    </required_header>
    <id_info>
      <org_study_id>1603017480C</org_study_id>
      <secondary_id>R01DC014708</secondary_id>
      <nct_id>NCT06026124</nct_id>
    </id_info>
    <brief_title>Retrieval-Based Word Learning in Developmental Language Disorder During Book Reading</brief_title>
    <official_title>Retrieval-Based Word Learning in Developmental Language Disorder During Book Reading</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Purdue University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute on Deafness and Other Communication Disorders (NIDCD)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Purdue 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>
        Children with developmental language disorder (DLD; also referred to as specific language&#xD;
        impairment) experience a significant deficit in language ability that is longstanding and&#xD;
        harmful to the children's academic, social, and eventual economic well-being. Word learning&#xD;
        is one of the principal weaknesses in these children. This project focuses on the word&#xD;
        learning abilities of four- and five-year-old children with DLD. The goal of the project is&#xD;
        to build on the investigators' previous work to determine whether, as has been found thus&#xD;
        far, special benefits accrue when these children must frequently recall newly introduced&#xD;
        words during the course of learning. In this study, the investigators seek to replicate the&#xD;
        advantage that repeated retrieval holds over simple exposure to the words and to demonstrate&#xD;
        an increase in children's absolute levels of learning by implementing retrieval practice in&#xD;
        the context of a story book.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Developmental Language Disorder (DLD) affects language learning in an estimated 7% of&#xD;
        children. Although much of the research literature has emphasized difficulties learning&#xD;
        grammar, children with DLD also have major deficits in vocabulary. In recent work, the&#xD;
        investigators have been examining the benefit of retrieval practice to enhance word learning&#xD;
        and retention in preschoolers with DLD. The rationale behind this work is grounded in the&#xD;
        growing literature in the field of cognitive psychology which shows that repeated practice in&#xD;
        retrieving information results in greater long-term retention than continuous study of that&#xD;
        information without opportunities for retrieval. In addition, retrieval practice that occurs&#xD;
        after a delay-or &quot;spacing&quot; between study of a word and subsequent recall attempts-can lead to&#xD;
        stronger effects.&#xD;
  &#xD;
        The investigators have explored the benefits of retrieval practice for preschoolers with DLD&#xD;
        and with typical language development (TD), showing that recall and retention for novel words&#xD;
        (nouns, adjectives, verbs) were greater when learned using repeated spaced retrieval (RSR)&#xD;
        than when learned using repeated study only. Despite benefitting from RSR, children with DLD&#xD;
        still showed lower levels of recall than children with TD.&#xD;
  &#xD;
        In the current study, the investigators aim to increase accuracy levels by embedding the same&#xD;
        words and retrieval schedules used in earlier studies into story contexts. Artist-illustrated&#xD;
        stories incorporate illustrations of the unfamiliar plants and animals that served as&#xD;
        referents of novel nouns in an earlier study. Sixteen children with DLD will be recruited for&#xD;
        this study along with 16 children with TD matched on chronological age. Using a&#xD;
        within-subjects design, children will learn eight novel nouns, four embedded in each story.&#xD;
        Along with each word form, children will learn a &quot;meaning&quot;, that is, an additional piece of&#xD;
        semantic information about the referent.&#xD;
  &#xD;
        For words in the RSR condition, each novel word and meaning, paired with its referent, will&#xD;
        be presented as part of the story. Immediately after hearing it, children will be asked to&#xD;
        recall both form and meaning, and then will hear those repeated. All subsequent retrieval&#xD;
        trials will occur after three other words have intervened since the last time the word&#xD;
        appeared in a study trial. Novel words assigned to the comparison condition will simply be&#xD;
        heard paired with their referent during the story at the same frequency as words in the RSR&#xD;
        condition. Children will not be asked to recall the words in the comparison condition during&#xD;
        the learning period. Stories will be presented twice on each of the learning days. As&#xD;
        written, the stories are a reasonable length and pace, but by repeating the story, children&#xD;
        will hear the words the same number of times overall as in the investigator's previous&#xD;
        studies, allowing evaluation of the benefits of the story format. Recall of the word forms&#xD;
        and meanings will be tested after the story book reading on the second day and one week&#xD;
        later. One week later, the recall test will be re-administered and children will complete a&#xD;
        three-alternative recognition test.&#xD;
  &#xD;
        The investigators hypothesize that children will show greater recall for word forms in the&#xD;
        RSR condition than those in the repeated study condition; past studies have not consistently&#xD;
        shown an advantage for recall of &quot;meaning&quot; or for recognition. It is also expected that&#xD;
        children with TD will remember more words overall than children with DLD. To the degree that&#xD;
        the story format is more engaging for children, overall recall will be enhanced for both&#xD;
        groups. Assuming that the results are replicated, it is hoped that the children's book&#xD;
        reading format will prove amenable for use by teachers and speech-language pathologists who&#xD;
        work with children with DLD.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 21, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">July 31, 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>
      <intervention_model_description>Within-participant design in which each child learns words under two conditions</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Word Form accuracy (number of words correctly recalled)</measure>
      <time_frame>5 minutes after end of learning period</time_frame>
      <description>Child is asked to recall and say the word associated with each novel referent.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Word Form accuracy (number of words correctly recalled)</measure>
      <time_frame>1 week after end of learning period</time_frame>
      <description>Child is asked to recall and say the word associated with each novel referent.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Word meaning recall accuracy (number of semantic associations correctly recalled)</measure>
      <time_frame>5 minutes after end of learning period</time_frame>
      <description>Child is asked to recall and say semantic information associated with the novel referent.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Word meaning recall accuracy (number of semantic associations correctly recalled)</measure>
      <time_frame>1 week after end of learning period</time_frame>
      <description>Child is asked to recall and say semantic information associated with the novel referent.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Word recognition (number of words accurately identified)</measure>
      <time_frame>1 week after end of learning period</time_frame>
      <description>Upon hearing a novel word, the child is asked to indicate (by pointing) which picture among 4 options is referred to.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of correctly identified words on Peabody Picture Vocabulary Test, 5th Ed.</measure>
      <time_frame>Enrollment</time_frame>
      <description>Upon hearing a word, the child is asked to indicate (by pointing) which picture among 4 options is referred to.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Years of maternal education</measure>
      <time_frame>Enrollment</time_frame>
      <description>Primary care-giver provides information regarding highest academic degree attained, converted to years of education</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">32</enrollment>
    <condition>Developmental Language Disorder</condition>
    <condition>Specific Language Impairment</condition>
    <condition>Language Development</condition>
    <arm_group>
      <arm_group_label>Spaced retrieval practice during word learning</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Each child will learn 8 novel nouns referring to unfamiliar plants and animals (&quot;nepp&quot;) and a related &quot;meaning&quot; (&quot;a nepp likes rain&quot;). Four nouns will be learned in a &quot;spaced retrieval&quot; practice condition; four will be learned in a &quot;study only&quot; practice condition. In the spaced retrieval condition, children will hear the information (word form and meaning) and be asked to immediately retrieve it. Thereafter, they will be asked to retrieve it after hearing 3 intervening word form/meanings. Each retrieval bid will be followed by feedback in the form of hearing the information again. In the &quot;study only&quot; practice condition, children will simply hear the information (word form and meaning).</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Retrieval-based word learning</intervention_name>
      <description>Learning sessions: Children will practice novel nouns in the context of a story book on Day 1. They will learn 4 words in each of the two conditions. &quot;Study only&quot; condition: they will simply hear the information (word &amp; meaning) as part of the story. &quot;Spaced retrieval&quot; condition: they will initially hear the information and be asked to retrieve it. Thereafter, they will be asked to retrieve it after hearing 3 intervening words. After each retrieval attempt, they will hear the target information again. In the &quot;study only&quot; practice condition, children will simply continue to hear the information. This practice schedule is repeated the next day (Day 2) using the same story book.&#xD;
  Testing sessions: 5 minutes after the learning session on Day 2, the child is asked to recall each word and meaning twice. One week after Day 1, this recall test is completed again. The child will also complete a recognition test: the child will hear a novel noun and point to its referent in an array of 3.</description>
      <arm_group_label>Spaced retrieval practice during word learning</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  a significant deficit in language ability (language test score below cutoff for best&#xD;
               sensitivity/specificity) or documented age-appropriate language ability.&#xD;
  &#xD;
            -  normal hearing&#xD;
  &#xD;
            -  no evidence of neurological damage or disease&#xD;
  &#xD;
            -  scores on tests of nonverbal intelligence above the intellectual disability range&#xD;
  &#xD;
            -  not within Autistic range on Autism screening test&#xD;
  &#xD;
            -  native English speaker (can be bilingual)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  failed hearing screening&#xD;
  &#xD;
            -  known neurological damage or disease&#xD;
  &#xD;
            -  scores on tests of nonverbal intelligence below the intellectual disability range&#xD;
               (standard score less than 75)&#xD;
  &#xD;
            -  autism spectrum disorder&#xD;
  &#xD;
            -  non-native English speaker&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>48 Months</minimum_age>
      <maximum_age>71 Months</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Laurence B. Leonard, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Purdue Universtiy</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Patricia L. Deevy, PhD</last_name>
      <phone>765-496-1821</phone>
      <email>deevy@purdue.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Laurence B. Leonard, PhD</last_name>
      <phone>765-496-2253</phone>
      <email>xdxl@purdue.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Purdue University's SLHS laboratories (8445 Keystone Crossing)</name>
        <address>
          <city>Indianapolis</city>
          <state>Indiana</state>
          <zip>46240</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sofia L Souto, PhD</last_name>
        <phone>317-940-9493</phone>
        <email>ssouto@butler.edu</email>
      </contact>
      <contact_backup>
        <last_name>Laurence B Leonard, PhD</last_name>
        <phone>765-496-2253</phone>
        <email>xdxl@purdue.edu</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Purdue University</investigator_affiliation>
      <investigator_full_name>Laurence Leonard</investigator_full_name>
      <investigator_title>Professor of Speech, Language, &amp; Hearing Sciences</investigator_title>
    </responsible_party>
    <keyword>word learning</keyword>
    <keyword>word retrieval</keyword>
    <keyword>preschool-aged children</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>
      <mesh_term>Specific Language Disorder</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Data that contribute to our final published results will be made available at clinicaltrials.gov.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>Data will become available after the results are published or within 12 months from the primary completion date (i.e., the date of final data collection for the primary outcome measure).</ipd_time_frame>
      <ipd_access_criteria>De-identified data will be made publicly available at clinicaltrials.gov</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>June 7, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/24/NCT06026124/ICF_000.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/NCT06026124
  org study id: 1603017480C
  secondary id: R01DC014708
  nct id: NCT06026124
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Children with developmental language disorder (DLD; also referred to as specific language
        impairment) experience a significant deficit in language ability that is longstanding and
        harmful to the children's academic, social, and eventual economic well-being. Word learning
        is one of the principal weaknesses in these children. This project focuses on the word
        learning abilities of four- and five-year-old children with DLD. The goal of the project is
        to build on the investigators' previous work to determine whether, as has been found thus
        far, special benefits accrue when these children must frequently recall newly introduced
        words during the course of learning. In this study, the investigators seek to replicate the
        advantage that repeated retrieval holds over simple exposure to the words and to demonstrate
        an increase in children's absolute levels of learning by implementing retrieval practice in
        the context of a story book.
  Developmental Language Disorder (DLD) affects language learning in an estimated 7% of
        children. Although much of the research literature has emphasized difficulties learning
        grammar, children with DLD also have major deficits in vocabulary. In recent work, the
        investigators have been examining the benefit of retrieval practice to enhance word learning
        and retention in preschoolers with DLD. The rationale behind this work is grounded in the
        growing literature in the field of cognitive psychology which shows that repeated practice in
        retrieving information results in greater long-term retention than continuous study of that
        information without opportunities for retrieval. In addition, retrieval practice that occurs
        after a delay-or "spacing" between study of a word and subsequent recall attempts-can lead to
        stronger effects.
  
        The investigators have explored the benefits of retrieval practice for preschoolers with DLD
        and with typical language development (TD), showing that recall and retention for novel words
        (nouns, adjectives, verbs) were greater when learned using repeated spaced retrieval (RSR)
        than when learned using repeated study only. Despite benefitting from RSR, children with DLD
        still showed lower levels of recall than children with TD.
  
        In the current study, the investigators aim to increase accuracy levels by embedding the same
        words and retrieval schedules used in earlier studies into story contexts. Artist-illustrated
        stories incorporate illustrations of the unfamiliar plants and animals that served as
        referents of novel nouns in an earlier study. Sixteen children with DLD will be recruited for
        this study along with 16 children with TD matched on chronological age. Using a
        within-subjects design, children will learn eight novel nouns, four embedded in each story.
        Along with each word form, children will learn a "meaning", that is, an additional piece of
        semantic information about the referent.
  
        For words in the RSR condition, each novel word and meaning, paired with its referent, will
        be presented as part of the story. Immediately after hearing it, children will be asked to
        recall both form and meaning, and then will hear those repeated. All subsequent retrieval
        trials will occur after three other words have intervened since the last time the word
        appeared in a study trial. Novel words assigned to the comparison condition will simply be
        heard paired with their referent during the story at the same frequency as words in the RSR
        condition. Children will not be asked to recall the words in the comparison condition during
        the learning period. Stories will be presented twice on each of the learning days. As
        written, the stories are a reasonable length and pace, but by repeating the story, children
        will hear the words the same number of times overall as in the investigator's previous
        studies, allowing evaluation of the benefits of the story format. Recall of the word forms
        and meanings will be tested after the story book reading on the second day and one week
        later. One week later, the recall test will be re-administered and children will complete a
        three-alternative recognition test.
  
        The investigators hypothesize that children will show greater recall for word forms in the
        RSR condition than those in the repeated study condition; past studies have not consistently
        shown an advantage for recall of "meaning" or for recognition. It is also expected that
        children with TD will remember more words overall than children with DLD. To the degree that
        the story format is more engaging for children, overall recall will be enhanced for both
        groups. Assuming that the results are replicated, it is hoped that the children's book
        reading format will prove amenable for use by teachers and speech-language pathologists who
        work with children with DLD.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Within-participant design in which each child learns words under two conditions
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Word Form accuracy (number of words correctly recalled)
  time frame: 5 minutes after end of learning period
  description: Child is asked to recall and say the word associated with each novel referent.
  measure: Word Form accuracy (number of words correctly recalled)
  time frame: 1 week after end of learning period
  description: Child is asked to recall and say the word associated with each novel referent.
  measure: Word meaning recall accuracy (number of semantic associations correctly recalled)
  time frame: 5 minutes after end of learning period
  description: Child is asked to recall and say semantic information associated with the novel referent.
  measure: Word meaning recall accuracy (number of semantic associations correctly recalled)
  time frame: 1 week after end of learning period
  description: Child is asked to recall and say semantic information associated with the novel referent.
  measure: Word recognition (number of words accurately identified)
  time frame: 1 week after end of learning period
  description: Upon hearing a novel word, the child is asked to indicate (by pointing) which picture among 4 options is referred to.
  measure: Number of correctly identified words on Peabody Picture Vocabulary Test, 5th Ed.
  time frame: Enrollment
  description: Upon hearing a word, the child is asked to indicate (by pointing) which picture among 4 options is referred to.
  measure: Years of maternal education
  time frame: Enrollment
  description: Primary care-giver provides information regarding highest academic degree attained, converted to years of education
  arm group label: Spaced retrieval practice during word learning
  arm group type: Experimental
  description: Each child will learn 8 novel nouns referring to unfamiliar plants and animals ("nepp") and a related "meaning" ("a nepp likes rain"). Four nouns will be learned in a "spaced retrieval" practice condition; four will be learned in a "study only" practice condition. In the spaced retrieval condition, children will hear the information (word form and meaning) and be asked to immediately retrieve it. Thereafter, they will be asked to retrieve it after hearing 3 intervening word form/meanings. Each retrieval bid will be followed by feedback in the form of hearing the information again. In the "study only" practice condition, children will simply hear the information (word form and meaning).
  intervention type: Behavioral
  intervention name: Retrieval-based word learning
  description: Learning sessions: Children will practice novel nouns in the context of a story book on Day 1. They will learn 4 words in each of the two conditions. "Study only" condition: they will simply hear the information (word & meaning) as part of the story. "Spaced retrieval" condition: they will initially hear the information and be asked to retrieve it. Thereafter, they will be asked to retrieve it after hearing 3 intervening words. After each retrieval attempt, they will hear the target information again. In the "study only" practice condition, children will simply continue to hear the information. This practice schedule is repeated the next day (Day 2) using the same story book.
  Testing sessions: 5 minutes after the learning session on Day 2, the child is asked to recall each word and meaning twice. One week after Day 1, this recall test is completed again. The child will also complete a recognition test: the child will hear a novel noun and point to its referent in an array of 3.
  arm group label: Spaced retrieval practice during word learning
  criteria: 
  gender: All
  minimum age: 48 Months
  maximum age: 71 Months
  healthy volunteers: Accepts Healthy Volunteers
  last name: Laurence B. Leonard, PhD
  role: Principal Investigator
  affiliation: Purdue Universtiy
  last name: Patricia L. Deevy, PhD
  phone: 765-496-1821
  email: deevy@purdue.edu
  last name: Laurence B. Leonard, PhD
  phone: 765-496-2253
  email: xdxl@purdue.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Purdue University
  investigator full name: Laurence Leonard
  investigator title: Professor of Speech, Language, & Hearing Sciences
  mesh term: Language Disorders
  mesh term: Language Development Disorders
  mesh term: Specific Language Disorder
  sharing ipd: Yes
  ipd description: Data that contribute to our final published results will be made available at clinicaltrials.gov.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: Data will become available after the results are published or within 12 months from the primary completion date (i.e., the date of final data collection for the primary outcome measure).
  ipd access criteria: De-identified data will be made publicly available at clinicaltrials.gov
  provided document: 