<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/NCT04501536</url>
  </required_header>
  <id_info>
    <org_study_id>2019-09-0029</org_study_id>
    <nct_id>NCT04501536</nct_id>
  </id_info>
  <brief_title>Determining Optimal Treatment Intensity for Children With Language Impairment</brief_title>
  <official_title>Determining Optimal Treatment Intensity for Children With Language Impairment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas at Austin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Texas at Austin</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The purpose of this study is to determine the amount of speech-language intervention children&#xD;
      with language impairment need to make vocabulary gains. The investigators hope to identify&#xD;
      the optimal amount of intervention needed as well as the point at which adding more&#xD;
      intervention is no longer beneficial.&#xD;
&#xD;
      Participants will be randomly assigned (like a flip of a coin) to attend therapy either one&#xD;
      time a week for 10 weeks (2 hours a session) or 4 times a week for 10 weeks (30 min per&#xD;
      session). Each therapy session will follow a word learning intervention that is designed to&#xD;
      increase children's word learning abilities using rich, robust word learning strategies&#xD;
      within story book readings.&#xD;
&#xD;
      The optimal amount of intervention relates to duration, dose, and frequency. Duration refers&#xD;
      to how long the child is seen for (e.g., 10 weeks, 1 year). Dose represents the number of&#xD;
      exposures to each new vocabulary word within a therapy session. Frequency represents the&#xD;
      number of therapy sessions per week.&#xD;
&#xD;
      The investigators will test the hypothesis that distributed learning leads to higher gains.&#xD;
      The investigators propose that the greatest gains will be observed for children who receive&#xD;
      high-frequency/low-dose or low-frequency/high-dose treatments as compared to children who&#xD;
      receive high-frequency/high-dose or low-frequency/low-dose treatments.&#xD;
&#xD;
      The investigators will test the hypothesis that for both low-frequency and high-frequency&#xD;
      treatments, there is a point at which increases in treatment dose do not correspond to any&#xD;
      additional gains in children's vocabulary skills during treatment.&#xD;
&#xD;
      At the close of this four-year study, evidence concerning optimal treatment intensity of a&#xD;
      word learning intervention will be instrumental for immediately informing speech-language&#xD;
      pathologists in how much vocabulary treatment to prescribe as well as for designing&#xD;
      additional clinical trials by our and other research teams.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to determine the optimal treatment intensity of a word learning&#xD;
      intervention for improved measures of vocabulary immediately post intervention and at&#xD;
      6-months follow up by addressing 3 specific aims.&#xD;
&#xD;
        1. to determine whether low frequency (massed) or high frequency (distributed) conditions&#xD;
           are more effective intervention schedules with respect to children's vocabulary gains&#xD;
           during treatment. Using a causally interpretable research design with children randomly&#xD;
           assigned to both conditions, the investigators will test the hypothesis that high&#xD;
           frequency treatment will be more effective than low frequency schedules, informed from&#xD;
           our own research as well as that proposed by distributed learning theorists. The&#xD;
           investigators propose that the greatest gains will be observed immediately post&#xD;
           intervention as well as 6-months post intervention for children who receive&#xD;
           high-frequency treatment as compared to children who receive low-frequency treatment.&#xD;
&#xD;
        2. to determine the optimal number of dose exposures within each condition of frequency.&#xD;
           Using a causally interpretable research design, with planned variations in dose, the&#xD;
           investigators will test the hypothesis that increases in dose are beneficial when&#xD;
           treatment frequency is low, and similarly that low levels of dose are beneficial when&#xD;
           frequency is high. The investigators propose that the greatest gains will be observed&#xD;
           for children who receive high-frequency/low-dose or low-frequency/high-dose treatments&#xD;
           as compared to children who receive high-frequency/high-dose or low-frequency/low-dose&#xD;
           treatments.&#xD;
&#xD;
        3. to identify thresholds of cumulative intensity after which additional exposures provide&#xD;
           no additional benefit to children's vocabulary gains, corresponding to a point of&#xD;
           'diminishing returns'. The investigators will test the hypothesis that for both&#xD;
           low-frequency and high-frequency treatments, there is a point at which increases in&#xD;
           treatment dose do not correspond to any additional gains in children's vocabulary skills&#xD;
           during treatment.&#xD;
&#xD;
      The proposed study features a two-group pre/post experimental design with random assignment&#xD;
      to target words across six dose exposures. Using blocked random assignment, each child will&#xD;
      first be randomized to a low-or high-frequency treatment condition. Target words will then be&#xD;
      randomly assigned to one of six dose exposures (0, 4, 8, 12, 16, 20 with 0 serving as a&#xD;
      control). Thus, this study will measure both between child (frequency) and within child&#xD;
      (dose) variance attributed to intensity of treatment. Children who meet all eligibility&#xD;
      criteria and are enrolled in the study will be randomly assigned to one of the two&#xD;
      conditions, high-or low-frequency, as previously described.&#xD;
&#xD;
      Each child will receive one-on-one treatment sessions each week for 10 weeks according to&#xD;
      their assigned frequency (one or four sessions per week for a total of 10 or 40 sessions,&#xD;
      respectively) over the summer period. Each session will follow an efficacious word learning&#xD;
      intervention. The word learning intervention uses the 10 commercially available children's&#xD;
      books from previous studies. Each week, 2 of the 10 storybooks will be read, with 3 of the 6&#xD;
      vocabulary words targeted from each book. The book and words targeted will be consistent&#xD;
      between frequency conditions. For the high-frequency condition, each book will be read once&#xD;
      per session across 4 sessions, for a total of 4 readings per book each week. For the&#xD;
      low-frequency condition, each book will be read 4 times in 1 session for a total of 4&#xD;
      readings per book each week, thereby keeping the number of book-readings equal across&#xD;
      conditions. Over the course of the 10-week intervention, two books will be read each week and&#xD;
      all 10 books will be read twice throughout the intervention. Three of the 6 targeted words&#xD;
      will be taught the first week the book is read and the other 3 of 6 targeted words taught the&#xD;
      second week the book is read. Each child will receive a total of 120 minutes of therapy each&#xD;
      week, which equates to 14-16 hours of therapy (approximately 4 hours of therapy per day for 4&#xD;
      days).&#xD;
&#xD;
      The word learning intervention is designed to increase children's word learning abilities&#xD;
      using rich, robust word learning strategies within story book readings including provision of&#xD;
      a synonym (e.g., A furnace is like a heater), definition (e.g., Furnace means something used&#xD;
      to make heat to warm buildings), and context sentence (e.g., Today it was cold outside so mom&#xD;
      turned on the furnace) during pre-book reading, book reading, and post-book reading&#xD;
      activities. During the pre-book reading, the intern will discuss the target words that the&#xD;
      child will hear in the book, with the exception of the word assigned to the 0 exposure&#xD;
      condition. During this portion of the intervention, the speech-language intern will use zero,&#xD;
      one or two strategies, depending on the assigned dose. During the book reading portion of the&#xD;
      intervention, the intern will read the book in its entirety. The intern will either not&#xD;
      elaborate the target word (0 dose) or will offer a synonym as the word is read in the book.&#xD;
      During the post-book reading, the intern will use zero, one, or two strategies depending on&#xD;
      the assigned dose.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 10, 2020</start_date>
  <completion_date type="Anticipated">January 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2024</primary_completion_date>
  <phase>N/A</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Definition Task</measure>
    <time_frame>Within 2 weeks of the last intervention session</time_frame>
    <description>The definition task assesses children's abilities to define the 60 intervention target words. To administer the definition task, children are shown a picture representing each targeted word and asked to define it.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Generalized Change in Definition Task</measure>
    <time_frame>6 months after the last intervention session</time_frame>
    <description>The definition task assesses children's abilities to define the 60 intervention target words. To administer the definition task, children are shown a picture representing each targeted word and asked to define it.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Word Definition Task Expressive One-Word Picture Vocabulary Test -Fourth Edition (EOWPVT-4); Standardized</measure>
    <time_frame>Within 2 weeks of the last intervention session</time_frame>
    <description>The EOWPVT-4 is an individually administered, norm-referenced assessment of how well a person can name objects, actions, or concepts presented in full-color pictures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Generalized Change in Word Definition Task Expressive One-Word Picture Vocabulary Test -Fourth Edition (EOWPVT-4); Standardized</measure>
    <time_frame>6 months after the last intervention session</time_frame>
    <description>The EOWPVT-4 is an individually administered, norm-referenced assessment of how well a person can name objects, actions, or concepts presented in full-color pictures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Receptive One-Word Picture Vocabulary Test-Fourth Edition (ROWPVT-4); Standardized</measure>
    <time_frame>Within 2 weeks of the last intervention session</time_frame>
    <description>The ROWPVT-4 is an individually administered, norm-referenced assessment of how well a person can match a word that is heard to objects, actions, or concepts presented in pictures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Generalized Change in Receptive One-Word Picture Vocabulary Test-Fourth Edition (ROWPVT-4); Standardized</measure>
    <time_frame>6 months after the last intervention session</time_frame>
    <description>The ROWPVT-4 is an individually administered, norm-referenced assessment of how well a person can match a word that is heard to objects, actions, or concepts presented in pictures.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Language Impairment</condition>
  <arm_group>
    <arm_group_label>High Frequency</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive therapy 4 times a week for 10 weeks for 30 minutes per session.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low Frequency</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive therapy 1 time a week for 10 weeks for 2 hours per session.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Word Learning Intervention</intervention_name>
    <description>The word learning intervention uses the 10 commercially available children's books and 6 target vocabulary words from each book that meet common criteria for appropriate vocabulary targets. Children will receive 1-on-1 treatment sessions with a trained, speech-language research assistant. Each week, 2 of 10 storybooks chosen for the study will be read with 3 of 6 targeted vocabulary words targeted from each book. The book and words targeted will be consistent between random assignment conditions. For each book reading, speech-language interns will implement word learning strategies during pre reading, during reading, and post reading. Strategies include providing a definition, a synonym, and a contextual sentence. The number of strategies used will vary on which word is being targeted; all words will be randomly assigned to a particular dose, ranging from 0 (no strategies) to 20 (all of the strategies at each reading).</description>
    <arm_group_label>High Frequency</arm_group_label>
    <arm_group_label>Low Frequency</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Is between the ages of 5:0-6:11&#xD;
&#xD;
          -  Has a primary diagnosis of a language impairment with deficits in vocabulary&#xD;
&#xD;
          -  Primarily communicates in English&#xD;
&#xD;
          -  Scores at or below 10th percentile on at least one of these three vocabulary&#xD;
             assessments:&#xD;
&#xD;
               1. Semantics subtest of the Diagnostic Evaluation of Language Variation (DELV)&#xD;
&#xD;
               2. Vocabulary subtests of the Test of Language Development (TOLD-P:5); or&#xD;
&#xD;
               3. Comprehensive Receptive and Expressive Vocabulary (CREVT)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children with concomitant diagnoses that may underlie observed language difficulties&#xD;
             (e.g., autism, hearing loss, severe cognitive disability)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mary Beth Schmitt, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Texas at Austin</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Laura Justice, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dionne Heller, BA</last_name>
    <phone>512-232-8542</phone>
    <email>dionne.heller@austin.utexas.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>The Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Julianne Nemith, BA</last_name>
      <email>nemith.1@osu.edu</email>
    </contact>
    <investigator>
      <last_name>Laura M Justice, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Texas at Austin</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78712</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Megan Thibodeaux, BA</last_name>
      <phone>512-232-8542</phone>
      <email>megan.thibodeaux@austin.utexas.edu</email>
    </contact>
    <investigator>
      <last_name>Mary Beth Schmitt, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://utexas.box.com/s/vm59g3qdg9d85r9wbvi0gbicpmof4ax3</url>
    <description>Citations associated with the original grant/study protocol</description>
  </link>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>June 23, 2023</last_update_submitted>
  <last_update_submitted_qc>June 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Texas at Austin</investigator_affiliation>
    <investigator_full_name>Mary Beth Schmitt</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Dose</keyword>
  <keyword>Frequency</keyword>
  <keyword>Vocabulary</keyword>
  <keyword>Treatment Intensity</keyword>
  <keyword>Intensity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Language Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>We would not release protected information specific to individual participants, but will share de-identified study data and protocols with other researchers who could use the data to advance knowledge of treatment processes for children with language impairment.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data and supporting information will be available one year after the study completion (1/31/2025) for 5 years.</ipd_time_frame>
    <ipd_access_criteria>Researchers interested in our data or supporting documents should contact the PI: Dr. Mary Beth Schmitt (see contact information)</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>April 21, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/36/NCT04501536/ICF_001.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/NCT04501536
org study id: 2019-09-0029
nct id: NCT04501536
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine the amount of speech-language intervention children
      with language impairment need to make vocabulary gains. The investigators hope to identify
      the optimal amount of intervention needed as well as the point at which adding more
      intervention is no longer beneficial.

      Participants will be randomly assigned (like a flip of a coin) to attend therapy either one
      time a week for 10 weeks (2 hours a session) or 4 times a week for 10 weeks (30 min per
      session). Each therapy session will follow a word learning intervention that is designed to
      increase children's word learning abilities using rich, robust word learning strategies
      within story book readings.

      The optimal amount of intervention relates to duration, dose, and frequency. Duration refers
      to how long the child is seen for (e.g., 10 weeks, 1 year). Dose represents the number of
      exposures to each new vocabulary word within a therapy session. Frequency represents the
      number of therapy sessions per week.

      The investigators will test the hypothesis that distributed learning leads to higher gains.
      The investigators propose that the greatest gains will be observed for children who receive
      high-frequency/low-dose or low-frequency/high-dose treatments as compared to children who
      receive high-frequency/high-dose or low-frequency/low-dose treatments.

      The investigators will test the hypothesis that for both low-frequency and high-frequency
      treatments, there is a point at which increases in treatment dose do not correspond to any
      additional gains in children's vocabulary skills during treatment.

      At the close of this four-year study, evidence concerning optimal treatment intensity of a
      word learning intervention will be instrumental for immediately informing speech-language
      pathologists in how much vocabulary treatment to prescribe as well as for designing
      additional clinical trials by our and other research teams.
The purpose of this study is to determine the optimal treatment intensity of a word learning
      intervention for improved measures of vocabulary immediately post intervention and at
      6-months follow up by addressing 3 specific aims.

        1. to determine whether low frequency (massed) or high frequency (distributed) conditions
           are more effective intervention schedules with respect to children's vocabulary gains
           during treatment. Using a causally interpretable research design with children randomly
           assigned to both conditions, the investigators will test the hypothesis that high
           frequency treatment will be more effective than low frequency schedules, informed from
           our own research as well as that proposed by distributed learning theorists. The
           investigators propose that the greatest gains will be observed immediately post
           intervention as well as 6-months post intervention for children who receive
           high-frequency treatment as compared to children who receive low-frequency treatment.

        2. to determine the optimal number of dose exposures within each condition of frequency.
           Using a causally interpretable research design, with planned variations in dose, the
           investigators will test the hypothesis that increases in dose are beneficial when
           treatment frequency is low, and similarly that low levels of dose are beneficial when
           frequency is high. The investigators propose that the greatest gains will be observed
           for children who receive high-frequency/low-dose or low-frequency/high-dose treatments
           as compared to children who receive high-frequency/high-dose or low-frequency/low-dose
           treatments.

        3. to identify thresholds of cumulative intensity after which additional exposures provide
           no additional benefit to children's vocabulary gains, corresponding to a point of
           'diminishing returns'. The investigators will test the hypothesis that for both
           low-frequency and high-frequency treatments, there is a point at which increases in
           treatment dose do not correspond to any additional gains in children's vocabulary skills
           during treatment.

      The proposed study features a two-group pre/post experimental design with random assignment
      to target words across six dose exposures. Using blocked random assignment, each child will
      first be randomized to a low-or high-frequency treatment condition. Target words will then be
      randomly assigned to one of six dose exposures (0, 4, 8, 12, 16, 20 with 0 serving as a
      control). Thus, this study will measure both between child (frequency) and within child
      (dose) variance attributed to intensity of treatment. Children who meet all eligibility
      criteria and are enrolled in the study will be randomly assigned to one of the two
      conditions, high-or low-frequency, as previously described.

      Each child will receive one-on-one treatment sessions each week for 10 weeks according to
      their assigned frequency (one or four sessions per week for a total of 10 or 40 sessions,
      respectively) over the summer period. Each session will follow an efficacious word learning
      intervention. The word learning intervention uses the 10 commercially available children's
      books from previous studies. Each week, 2 of the 10 storybooks will be read, with 3 of the 6
      vocabulary words targeted from each book. The book and words targeted will be consistent
      between frequency conditions. For the high-frequency condition, each book will be read once
      per session across 4 sessions, for a total of 4 readings per book each week. For the
      low-frequency condition, each book will be read 4 times in 1 session for a total of 4
      readings per book each week, thereby keeping the number of book-readings equal across
      conditions. Over the course of the 10-week intervention, two books will be read each week and
      all 10 books will be read twice throughout the intervention. Three of the 6 targeted words
      will be taught the first week the book is read and the other 3 of 6 targeted words taught the
      second week the book is read. Each child will receive a total of 120 minutes of therapy each
      week, which equates to 14-16 hours of therapy (approximately 4 hours of therapy per day for 4
      days).

      The word learning intervention is designed to increase children's word learning abilities
      using rich, robust word learning strategies within story book readings including provision of
      a synonym (e.g., A furnace is like a heater), definition (e.g., Furnace means something used
      to make heat to warm buildings), and context sentence (e.g., Today it was cold outside so mom
      turned on the furnace) during pre-book reading, book reading, and post-book reading
      activities. During the pre-book reading, the intern will discuss the target words that the
      child will hear in the book, with the exception of the word assigned to the 0 exposure
      condition. During this portion of the intervention, the speech-language intern will use zero,
      one or two strategies, depending on the assigned dose. During the book reading portion of the
      intervention, the intern will read the book in its entirety. The intern will either not
      elaborate the target word (0 dose) or will offer a synonym as the word is read in the book.
      During the post-book reading, the intern will use zero, one, or two strategies depending on
      the assigned dose.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Change in Definition Task
time frame: Within 2 weeks of the last intervention session
description: The definition task assesses children's abilities to define the 60 intervention target words. To administer the definition task, children are shown a picture representing each targeted word and asked to define it.
measure: Generalized Change in Definition Task
time frame: 6 months after the last intervention session
description: The definition task assesses children's abilities to define the 60 intervention target words. To administer the definition task, children are shown a picture representing each targeted word and asked to define it.
measure: Change in Word Definition Task Expressive One-Word Picture Vocabulary Test -Fourth Edition (EOWPVT-4); Standardized
time frame: Within 2 weeks of the last intervention session
description: The EOWPVT-4 is an individually administered, norm-referenced assessment of how well a person can name objects, actions, or concepts presented in full-color pictures.
measure: Generalized Change in Word Definition Task Expressive One-Word Picture Vocabulary Test -Fourth Edition (EOWPVT-4); Standardized
time frame: 6 months after the last intervention session
description: The EOWPVT-4 is an individually administered, norm-referenced assessment of how well a person can name objects, actions, or concepts presented in full-color pictures.
measure: Change in Receptive One-Word Picture Vocabulary Test-Fourth Edition (ROWPVT-4); Standardized
time frame: Within 2 weeks of the last intervention session
description: The ROWPVT-4 is an individually administered, norm-referenced assessment of how well a person can match a word that is heard to objects, actions, or concepts presented in pictures.
measure: Generalized Change in Receptive One-Word Picture Vocabulary Test-Fourth Edition (ROWPVT-4); Standardized
time frame: 6 months after the last intervention session
description: The ROWPVT-4 is an individually administered, norm-referenced assessment of how well a person can match a word that is heard to objects, actions, or concepts presented in pictures.
arm group label: High Frequency
arm group type: Experimental
description: Participants will receive therapy 4 times a week for 10 weeks for 30 minutes per session.
arm group label: Low Frequency
arm group type: Experimental
description: Participants will receive therapy 1 time a week for 10 weeks for 2 hours per session.
intervention type: Behavioral
intervention name: Word Learning Intervention
description: The word learning intervention uses the 10 commercially available children's books and 6 target vocabulary words from each book that meet common criteria for appropriate vocabulary targets. Children will receive 1-on-1 treatment sessions with a trained, speech-language research assistant. Each week, 2 of 10 storybooks chosen for the study will be read with 3 of 6 targeted vocabulary words targeted from each book. The book and words targeted will be consistent between random assignment conditions. For each book reading, speech-language interns will implement word learning strategies during pre reading, during reading, and post reading. Strategies include providing a definition, a synonym, and a contextual sentence. The number of strategies used will vary on which word is being targeted; all words will be randomly assigned to a particular dose, ranging from 0 (no strategies) to 20 (all of the strategies at each reading).
arm group label: High Frequency
arm group label: Low Frequency
criteria: 
gender: All
minimum age: 5 Years
maximum age: 6 Years
healthy volunteers: No
last name: Mary Beth Schmitt, PhD
role: Principal Investigator
affiliation: The University of Texas at Austin
last name: Laura Justice, PhD
role: Principal Investigator
affiliation: Ohio State University
last name: Dionne Heller, BA
phone: 512-232-8542
email: dionne.heller@austin.utexas.edu
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
url: https://utexas.box.com/s/vm59g3qdg9d85r9wbvi0gbicpmof4ax3
description: Citations associated with the original grant/study protocol
responsible party type: Principal Investigator
investigator affiliation: University of Texas at Austin
investigator full name: Mary Beth Schmitt
investigator title: Assistant Professor
mesh term: Language Disorders
sharing ipd: Yes
ipd description: We would not release protected information specific to individual participants, but will share de-identified study data and protocols with other researchers who could use the data to advance knowledge of treatment processes for children with language impairment.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Data and supporting information will be available one year after the study completion (1/31/2025) for 5 years.
ipd access criteria: Researchers interested in our data or supporting documents should contact the PI: Dr. Mary Beth Schmitt (see contact information)
provided document: 