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/NCT06001866</url>
    </required_header>
    <id_info>
      <org_study_id>1603017480B</org_study_id>
      <secondary_id>R01DC014708</secondary_id>
      <nct_id>NCT06001866</nct_id>
    </id_info>
    <brief_title>Retrieval-Based Word Learning in Developmental Language Disorder: Verb Learning</brief_title>
    <official_title>Retrieval-Based Word Learning in Developmental Language Disorder: Verb Learning</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 wellbeing. Word learning is&#xD;
        one of the principal weaknesses in these children. This project focuses on the word learning&#xD;
        abilities of four- and five-year-old children with DLD. The goal of the project is to build&#xD;
        on the investigators' previous work to determine whether, as has been found thus far, special&#xD;
        benefits accrue when these children must frequently recall newly introduced words during the&#xD;
        course of learning. The focus of the current study is verb-learning. The goal of the study is&#xD;
        to increase children's absolute levels of learning while maintaining the advantage that&#xD;
        repeated retrieval holds over comparison methods of learning.&#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, in particular in novel verb&#xD;
        learning.&#xD;
  &#xD;
        In the current study, the investigators seek to improve the absolute levels of word form&#xD;
        recall for verbs by modifying the method used previously. Sixteen children with DLD will be&#xD;
        recruited for this study along with 16 children with TD matched on chronological age. Using a&#xD;
        within-subjects design, children will learn eight novel verbs, four at a time. Each set of&#xD;
        four will be learned over two consecutive days, with two words in the RSR condition and two&#xD;
        words in a repeated study condition. The referents for these novel words will be&#xD;
        video-recorded transitive actions performed by actors on objects and presented on a laptop&#xD;
        screen.&#xD;
  &#xD;
        In the RSR condition, children will initially hear the word paired with a video of a novel&#xD;
        action, immediately be asked to recall the word, and then see/hear it again. After three&#xD;
        other words are presented, they will be asked to recall the original word again; this &quot;3&quot;&#xD;
        spaced retrieval schedule will continue for the rest of the learning session. In the&#xD;
        comparison condition, children will simply hear the words paired with a video of the novel&#xD;
        action. In this study, during retrieval practice, children will be prompted to respond with a&#xD;
        full sentence containing the verb.&#xD;
  &#xD;
        Recall of the verbs will be tested after the learning session on the second day and one week&#xD;
        later. At one week, children will also complete a syntactic generalization test in which they&#xD;
        are prompted to use the novel verb in a type of sentence that is different from the one used&#xD;
        during learning. Finally, children will complete a two-alternative recognition test.&#xD;
  &#xD;
        The investigators hypothesize that novel verbs that undergo RSR during the learning period&#xD;
        will be learned and recalled better than comparable novel verbs that are assigned to the&#xD;
        repeated study condition. This RSR advantage will continue to be observed when the children&#xD;
        must use the novel verbs with new actors and objects and will be seen as well in the&#xD;
        syntactic generalization test when the children must use the novel verbs in a new sentence&#xD;
        frame. Introducing novel verbs representing actions that can be performed on varying objects&#xD;
        is expected to improve overall learning. In addition, by having the child produce the verbs&#xD;
        in the context of a full sentence, the newly learned verbs should become more integrated with&#xD;
        other sentence elements (subjects and direct objects), resulting in a richer representation&#xD;
        in memory and consequently, greater recall, recognition, and syntactic flexibility than was&#xD;
        observed in the previous novel verb study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 1, 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 recall accuracy (number of verbs correctly recalled)</measure>
      <time_frame>5 minutes after end of learning period</time_frame>
      <description>Child is asked to recall and use the verb associated with each novel action in a sentence (X is VERBing the Y).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Word form recall accuracy (number of verbs correctly recalled)</measure>
      <time_frame>1 week after end of learning period</time_frame>
      <description>Child is asked to recall and use the verb associated with each novel action in a sentence (X is VERBing the Y).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Accuracy of generalizing novel verb to a new syntactic frame (number of verbs used in a syntactic frame different from the one used in initial learning and recall).</measure>
      <time_frame>1 week after end of learning period</time_frame>
      <description>Child is asked to describe the video of a novel action using the frame &quot;X likes to VERB the Y.&quot;</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 video among 2 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>completed at start of study</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>information collected at start of study</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 verb learning</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Each child will learn 8 novel verbs referring to unfamiliar transitive actions (&quot;mape&quot;). Four verbs will be learned in a condition requiring spaced retrieval practice; four verbs will be learned in a &quot;standard&quot; study-only (no retrieval practice) condition. In the spaced retrieval condition, the number of other words intervening between hearing the target and an attempt to retrieve it will increase from 0 to 3 words. In the study-only condition, children will simply hear the verb used to describe the action.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Retrieval-based verb learning</intervention_name>
      <description>Learning sessions: Novel verbs are practiced on Day 1. In one condition, the words are learned using repeated spaced retrieval practice - retrieval trials are initially immediate, then occur after 3 intervening words. In the other condition, the words and video are presented without retrieval trials. This practice schedule is repeated the next day (Day 2).&#xD;
  Testing sessions: 5 minutes after the learning session on Day 2, the child is asked to recall each word in the context of a sentence twice with actors and objects viewed during learning and twice with new actors and objects. One week after Day 1, this recall test is completed again. At this time, the child's ability to generalize the verb to a new sentence frame will be assessed. Finally, the child will complete a recognition test: viewing pairs of video clips, the child will hear each novel verb and point to the video clip that depicts that action.</description>
      <arm_group_label>Spaced Retrieval practice during verb 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 no evidence of neurological damage or disease scores on tests of nonverbal&#xD;
          intelligence above the intellectual disability range not within Autistic range on Autism&#xD;
          screening test native English speaker (can be bilingual)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  failed hearing screening known neurological damage or disease scores on tests of&#xD;
               nonverbal intelligence below the intellectual disability range (standard score less&#xD;
               than 75) autism spectrum disorder 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</name>
        <address>
          <city>West Lafayette</city>
          <state>Indiana</state>
          <zip>47907</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Patricia L Deevy, PhD</last_name>
        <phone>765-496-1821</phone>
        <email>deevy@purdue.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>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 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 www.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 www.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/66/NCT06001866/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/NCT06001866
  org study id: 1603017480B
  secondary id: R01DC014708
  nct id: NCT06001866
  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 wellbeing. 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. The focus of the current study is verb-learning. The goal of the study is
        to increase children's absolute levels of learning while maintaining the advantage that
        repeated retrieval holds over comparison methods of learning.
  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 particular in novel verb
        learning.
  
        In the current study, the investigators seek to improve the absolute levels of word form
        recall for verbs by modifying the method used previously. 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 verbs, four at a time. Each set of
        four will be learned over two consecutive days, with two words in the RSR condition and two
        words in a repeated study condition. The referents for these novel words will be
        video-recorded transitive actions performed by actors on objects and presented on a laptop
        screen.
  
        In the RSR condition, children will initially hear the word paired with a video of a novel
        action, immediately be asked to recall the word, and then see/hear it again. After three
        other words are presented, they will be asked to recall the original word again; this "3"
        spaced retrieval schedule will continue for the rest of the learning session. In the
        comparison condition, children will simply hear the words paired with a video of the novel
        action. In this study, during retrieval practice, children will be prompted to respond with a
        full sentence containing the verb.
  
        Recall of the verbs will be tested after the learning session on the second day and one week
        later. At one week, children will also complete a syntactic generalization test in which they
        are prompted to use the novel verb in a type of sentence that is different from the one used
        during learning. Finally, children will complete a two-alternative recognition test.
  
        The investigators hypothesize that novel verbs that undergo RSR during the learning period
        will be learned and recalled better than comparable novel verbs that are assigned to the
        repeated study condition. This RSR advantage will continue to be observed when the children
        must use the novel verbs with new actors and objects and will be seen as well in the
        syntactic generalization test when the children must use the novel verbs in a new sentence
        frame. Introducing novel verbs representing actions that can be performed on varying objects
        is expected to improve overall learning. In addition, by having the child produce the verbs
        in the context of a full sentence, the newly learned verbs should become more integrated with
        other sentence elements (subjects and direct objects), resulting in a richer representation
        in memory and consequently, greater recall, recognition, and syntactic flexibility than was
        observed in the previous novel verb study.
  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 recall accuracy (number of verbs correctly recalled)
  time frame: 5 minutes after end of learning period
  description: Child is asked to recall and use the verb associated with each novel action in a sentence (X is VERBing the Y).
  measure: Word form recall accuracy (number of verbs correctly recalled)
  time frame: 1 week after end of learning period
  description: Child is asked to recall and use the verb associated with each novel action in a sentence (X is VERBing the Y).
  measure: Accuracy of generalizing novel verb to a new syntactic frame (number of verbs used in a syntactic frame different from the one used in initial learning and recall).
  time frame: 1 week after end of learning period
  description: Child is asked to describe the video of a novel action using the frame "X likes to VERB the Y."
  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 video among 2 options is referred to.
  measure: Number of correctly identified words on Peabody Picture Vocabulary Test, 5th Ed.
  time frame: completed at start of study
  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: information collected at start of study
  description: Primary care-giver provides information regarding highest academic degree attained, converted to years of education
  arm group label: Spaced Retrieval practice during verb learning
  arm group type: Experimental
  description: Each child will learn 8 novel verbs referring to unfamiliar transitive actions ("mape"). Four verbs will be learned in a condition requiring spaced retrieval practice; four verbs will be learned in a "standard" study-only (no retrieval practice) condition. In the spaced retrieval condition, the number of other words intervening between hearing the target and an attempt to retrieve it will increase from 0 to 3 words. In the study-only condition, children will simply hear the verb used to describe the action.
  intervention type: Behavioral
  intervention name: Retrieval-based verb learning
  description: Learning sessions: Novel verbs are practiced on Day 1. In one condition, the words are learned using repeated spaced retrieval practice - retrieval trials are initially immediate, then occur after 3 intervening words. In the other condition, the words and video are presented without retrieval trials. This practice schedule is repeated the next day (Day 2).
  Testing sessions: 5 minutes after the learning session on Day 2, the child is asked to recall each word in the context of a sentence twice with actors and objects viewed during learning and twice with new actors and objects. One week after Day 1, this recall test is completed again. At this time, the child's ability to generalize the verb to a new sentence frame will be assessed. Finally, the child will complete a recognition test: viewing pairs of video clips, the child will hear each novel verb and point to the video clip that depicts that action.
  arm group label: Spaced Retrieval practice during verb 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 www.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 www.clinicaltrials.gov
  provided document: 