<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/NCT03782012</url>
  </required_header>
  <id_info>
    <org_study_id>R15HD092922</org_study_id>
    <nct_id>NCT03782012</nct_id>
  </id_info>
  <brief_title>Knowledge Accessibility and Availability in Forming Knowledge-to-Text Inferences Among Middle Grade Readers</brief_title>
  <acronym>BVU-R15</acronym>
  <official_title>Knowledge Accessibility and Availability in Forming Knowledge to Text Inferences Among Middle Grade Readers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Buena Vista University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Buena Vista University</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>
      Recent adolescent-based research shows that inference making improves across grades 6-12,&#xD;
      uniquely accounts for variance in sentence- and passage-level comprehension, and that&#xD;
      individual differences in inference making relate in a principled way to variations in&#xD;
      reading comprehension for readers of all abilities (Barth et al., 2015; Barnes et al., 2015).&#xD;
      These findings suggest that comprehension requires inference making and that comprehension&#xD;
      fails when readers do not possess relevant knowledge (i.e., availability) or slowly retrieve&#xD;
      (i.e., accessibility) and integrate knowledge from text or semantic memory during reading&#xD;
      (Kendeou, 2015). To date, only one study has examined the effects of knowledge availability&#xD;
      and accessibility on inference making among adolescents. To extend this limited body of&#xD;
      research, this project will conduct two experimental studies designed to examine (a) the&#xD;
      extent to which knowledge-base availability and accessibility relates to the accuracy and&#xD;
      rate of constructing inferences using that knowledge (Aim 1) and (b) the extent to which&#xD;
      retrieval practice (i.e., spaced practice testing) increases knowledge availability and&#xD;
      accessibility and improves the accuracy and rate of forming inferences using that&#xD;
      knowledge-base among middle grade readers (Aim 2). In addition, this project will integrate&#xD;
      investigative research into an undergraduate Honors Research Program by developing an&#xD;
      investigative laboratory component that engages undergraduates in conducting applied research&#xD;
      (Aim 3). The research design uses 558 students in grades 5-8. To address Aim 1, mixed effects&#xD;
      explanatory item response models will fit to the trial-by-trial reading accuracy and speed&#xD;
      data. Repeated measures analysis of variance models will address Aim 2 with analysis of&#xD;
      variance models used for Aim 3. The expected outcomes of the proposed research include (a)&#xD;
      understanding how knowledge availability and accessibility relate to inference making among&#xD;
      adolescent readers; (b) understanding the sources of inference making difficulty; and (c)&#xD;
      methods for improving knowledge availability and accessibility and inference making to&#xD;
      broadly implement in secondary grade classrooms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This project conducts experimental studies with three objectives: (1) To determine the extent&#xD;
      to which variations in knowledge availability and accessibility influence the rate and&#xD;
      accuracy of forming inferences. (2) To investigate whether individual difference factors are&#xD;
      potential sources of variability in explaining inference making and reading comprehension.&#xD;
      (3)To determine whether systematic retrieval practice improves both knowledge availability&#xD;
      and accessibility as well as the accuracy and rate of forming inferences using the&#xD;
      knowledge-base. Study 1 Overview. Procedures modify those used by Barnes et al. (1996). In&#xD;
      Phase 1, students learn a knowledge-base of 14 facts about Gan. In Phase 2, students will&#xD;
      read and listen to an informational text that consists of six sections. A computer asks&#xD;
      students comprehension questions that tap information from that text section and the taught&#xD;
      knowledge base. Phase 3 retests retention of the knowledge-base. One week later, Phase 4&#xD;
      retests the knowledge-base and students take a larger test battery. All students will&#xD;
      complete Phases 1-4 individually. Study participants (n = 300) will come from Storm Lake&#xD;
      Community School District students in grades 5-8 (n = 657) with both males and females&#xD;
      recruited for participation. The school district will provide demographic data, reading&#xD;
      scores from the Iowa Assessment for Reading, and Gates MacGinities Reading Test for all&#xD;
      participants from which the investigator will randomly select students for the treatment or&#xD;
      control group. The investigator will replace students who exit the sample with students from&#xD;
      the same grade who consented but not randomly selected for participation. Participation will&#xD;
      exclude students with significant cognitive impairments who participate in the Life Skills&#xD;
      Class (e.g., severe autism, behavior, cognitive disability) due to task demands. Additional&#xD;
      Assessments measure the constructs of reading comprehension, inference making, word reading&#xD;
      efficiency, metacognition, working memory, and background knowledge. Multiple measures of&#xD;
      each construct allow the study to identify (a) relations among latent abilities; (b) role of&#xD;
      these latent abilities in establishing reading comprehension, independent of measure-specific&#xD;
      factors or measurement error; and (c) individual differences that lead to variation in&#xD;
      performance. Data Analysis. The investigator will screen for missing data and outliers and&#xD;
      evaluate the distributional properties of observed variables, making transformations as&#xD;
      necessary and appropriate. If possible, the investigator will correlate non-plausible values&#xD;
      or list them as missing if not possible, and label extreme data points. Power. General&#xD;
      recommendations on sample sizes in structural equation modeling (SEM) suggest minimum samples&#xD;
      of 300 (i.e., 75 participants per grades 5-8). This sample size will allow the research team&#xD;
      to detect correlations among constructs greater than 0.05 and regression coefficients in&#xD;
      latent variable regressions of 0.05 with over 80% power. Consideration of Biological&#xD;
      Variables. To sufficiently power the study and generalize findings, this study recruits males&#xD;
      and females for participation and collects gender, race, disability status, and socioeconomic&#xD;
      status to determine if these child-attributes moderate knowledge accessibility and&#xD;
      availability. Analytic Approach. The investigator will model the effects of knowledge&#xD;
      availability and accessibility on inference making without dichotomizing the distribution of&#xD;
      comprehension. To determine whether reader characteristics (i.e., knowledge availability and&#xD;
      accessibility, metacognition, reading comprehension, word reading efficiency, background&#xD;
      knowledge, working memory, and grade) make unique contributions to inference making, the&#xD;
      investigator will fit mixed effects explanatory item response models to the trial-by-trial&#xD;
      inference making accuracy and speed data with item-level accuracy and reading speeds&#xD;
      cross-classified between persons and items. The investigator will also nest people within&#xD;
      grade, treating grouping variables for people such as grade and items (i.e., literal,&#xD;
      word-to-text, and knowledge-to-text inferences) as fixed factors. If limited variability&#xD;
      exists in accuracy data, the investigator will only model response time data. The&#xD;
      investigator will also evaluate how organization of knowledge relates to knowledge&#xD;
      accessibility and inference making. Structural equation modeling will evaluate relations&#xD;
      among the constructs (i.e., comprehension, word efficiency, inference making, knowledge&#xD;
      accessibility and availability, metacognition, and working memory) to determine the role of&#xD;
      knowledge accessibility and availability in reading comprehension and factors influencing&#xD;
      knowledge accessibility and availability. Using Cain et al. (2001) framework, the&#xD;
      investigator will classify each inference failure as (1) incorrect text-premise recall (i.e.,&#xD;
      the participant fails to retrieve the relevant premise from the text); (2) incorrect&#xD;
      knowledge-based recall (i.e., the participant fails to retrieve the relevant premise from the&#xD;
      knowledge-base); and (3) integration failure (i.e., the participant fails to integrate text&#xD;
      content with knowledge). A traditional two-way ANOVA (skill group X inference type) on the&#xD;
      incorrect inference response will occur with skilled readers defined as achieving proficiency&#xD;
      on the Iowa Assessment for Reading and performance above a standard score of 90 on the Gates&#xD;
      MacGinitie Reading Test. The investigator will only compare the means for skilled versus less&#xD;
      skilled readers. The investigators hypothesize that: (1) less skilled middle grade readers&#xD;
      will make more errors than skilled readers; (2) less skilled readers will not always&#xD;
      recognize the need to form inferences during reading relative to skilled readers; and (3) no&#xD;
      significant differences will exist across the middle grades (Ahmed et al., 2016; Barth et&#xD;
      al., 2015; Barnes et al., 2015). Results of Aim 1 will tell us if less skilled readers need&#xD;
      the duration of retrieval practice increased to achieve similar benefits as more skilled&#xD;
      readers and if less skilled readers need help organizing the taught knowledge-base so that it&#xD;
      is more available and accessible when reading informational texts, which will inform Aim 2 -&#xD;
      To examine the extent to which retrieval practice (i.e., spaced practice testing) increases&#xD;
      knowledge availability and accessibility and improves the accuracy and rate of forming&#xD;
      inferences using that knowledge-base among middle grade readers. Study 2 uses procedures&#xD;
      modified from those used by Butler (2010). In Phase 1, students learn a knowledge-base of 14&#xD;
      facts about Gan. In Phase 2, students read and study the six-section informational texts with&#xD;
      reassessment of the student's retention of the knowledge base immediately after studying&#xD;
      these 6 texts. In Phase 3, students restudy two of the text sections (restudy passages),&#xD;
      repeatedly take the same test on another two text sections (same test), and repeatedly take&#xD;
      different tests on the other two text sections (variable test). Immediately after interacting&#xD;
      with all six text sections, the project reassesses the retention of the knowledge base. Phase&#xD;
      4 occurs one week later and again reassesses the students' retention of the knowledge-base&#xD;
      and administers the same additional test battery as in Aim 1. Study participants (n = 180)&#xD;
      will come from Storm Lake Community School District students in grade 5-8. The investigators&#xD;
      anticipate that students will come from diverse socio-economic and ethnic backgrounds.&#xD;
      Student Selection and Exclusions. In the fall of 2019, laboratory assistants will recruit&#xD;
      students and screen them with the Gates-MacGinitie Reading Test. Students selected for&#xD;
      participation: (1) perform below a standard score of 90 on the Gates-MacGinitie Reading Test;&#xD;
      (2) did not participate in Aim 1; and (3) are not enrolled in life skills classes (i.e.,&#xD;
      severe Autism, behavior, cognitive impairments) due to task appropriateness. The investigator&#xD;
      will document any additional services that students receive (i.e., Title, special education,&#xD;
      and reading support) and included them as contextual variables in later analyses. Power and&#xD;
      Design. The investigators estimate the sample associated with an effect size of 0.25, alpha&#xD;
      0.05, and with over 80% power at 136 participants for between group differences, 36 for&#xD;
      within group differences, and 180 for the interaction. Randomization will occur within grade,&#xD;
      with all qualified students in grade 5 available for randomization because these students did&#xD;
      not participate in Aim 1. The investigators estimate attrition to be 20% or 36 participants&#xD;
      total and will replace participants who exit the pool of consented students not randomly&#xD;
      selected for participation. Consideration of Biological Variables. To sufficiently power the&#xD;
      study and generalize findings, the study recruits males and females for participation and&#xD;
      collects gender, race, disability status, and socioeconomic status to determine if these&#xD;
      child-attributes moderate knowledge accessibility and availability. Data Analysis. As in Aim&#xD;
      1, the investigators will screen for missing data and outliers and evaluate the&#xD;
      distributional properties of observed variables, making transformations as necessary and&#xD;
      appropriate. When possible, investigators will correct non-plausible values or listed them as&#xD;
      missing if investigators cannot correct them and label extreme data points. Analytic&#xD;
      Approach. Data analysis will use repeated measures analysis of variance models to examine the&#xD;
      effect of the experimental condition on knowledge retention. Separate ANOVAs will analyze&#xD;
      scores obtained on the question types (i.e., explicit text-, word-to-text- and&#xD;
      inference-questions) and the different error types by condition. Results of Aim 2 (and Aim 1)&#xD;
      and additional analyses will inform the independent research projects conducted by&#xD;
      undergraduate laboratory assistants (Aim 3). Aim 3. To integrate investigative research into&#xD;
      an undergraduate Honors Research Program. This proposal will support the development of a&#xD;
      laboratory component for the Honors Proposal Seminar. This sophomore-level seminar focuses on&#xD;
      the organizational structure of their research proposal (i.e., introduction, hypotheses, and&#xD;
      method section). The laboratory component will provide students hands-on experiences in the&#xD;
      practices of conducting applied research in the schools. Students will also have access to&#xD;
      extant data to examine interesting questions related to the reading and reading-related&#xD;
      skills of adolescents which should heighten student interest and enthusiasm for conducting&#xD;
      research among adolescents. Laboratory Outline. This project will create a two-semester&#xD;
      laboratory course (e.g., 32 sessions) that meets weekly for two hours. Lab sessions will&#xD;
      address Institutional Review Board applications; appropriate engagement with school&#xD;
      personnel; subject recruitment; parent/guardian consent; child assent; formation of research&#xD;
      questions and hypotheses; fidelity of implementation; experimental design; inputting and&#xD;
      verifying data; analyzing data; and discussing, reporting, and publishing findings (i.e.,&#xD;
      manuscripts, presentations, and spoken posters). Throughout the year, students will also&#xD;
      engage in the primary literature, culminating with the eventual submission of a primary&#xD;
      journal article that includes appropriate introduction, method, results, and discussion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 14, 2019</start_date>
  <completion_date type="Anticipated">September 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2021</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>
    <intervention_model_description>This study will randomly select 300 from Storm Lake students in grades 5-8 (i.e., 75 students per grade) (see Table 1). Because of the short duration of the experiment (3 sessions), we estimate 20% attrition (n = 60 students). We will replace all students who exit from the sample within grade to ensure sufficiently power. Students will randomly be assigned within grade to one of two conditions: support versus no support.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Provide information about other parties who may be masked in the clinical trial,</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Knowledge Accessibility and Availability</measure>
    <time_frame>immediately after training KNOW-IT knowledge base items; one week after training KNOW-IT knowledge base items; and 1 month after training KNOW-IT knowledge base items</time_frame>
    <description>Know-It task is an individually administered assessment of knowledge accessibility (rate of response) and availability (accuracy of response) for a taught knowledge base.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Direct and indirect effect of Reading Comprehension for Grade Level texts on Knowledge Accessibility and Availability</measure>
    <time_frame>180 days from training of KNOW-IT knowledge base items</time_frame>
    <description>Gates-MacGinite Reading Test-4th Edition, a standardized, group-administered, multiple-choice assessment of reading comprehension with internal consistency for students in grades 5-8 that exceeds 0.80.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Direct and Indirect effect of Reading Strategy Use for Content Area Texts on Knowledge Availability and Accessibility</measure>
    <time_frame>45 days from training of KNOW-IT knowledge base items</time_frame>
    <description>Contextualized Reading Survey, students to report study strategies used when reading. The scale measures the types of reading strategies readers use in different types of reading situations. For each question, the reader indicates their use on a scale of 1 to 5. 1 means I almost never do this. 2 means that I rarely do this. 3 means that I sometimes to this. 4 means that I usually do this. 5 means that I almost always do this. Items load onto 4 factors: evaluation and knowledge integration; pragmatic strategies; self regulation; help seeking. Higher values indicate a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Direct and Indirect effect of Word and World Knowledge and Understanding on Knowledge Accessibility and Availability</measure>
    <time_frame>180 days from training of KNOW-IT knowledge base items</time_frame>
    <description>Kauffman Brief Intelligence Test-2, Verbal Knowledge subtest is a norm-referenced, individually administered assessment of expressive word and world knowledge. Internal consistency ranges from 0.89-0.94 for students in grades 5-8.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Direct and Indirect Effect of Reading Fluency for Words on Knowledge Accessibility and Availability</measure>
    <time_frame>180 days from training of KNOW-IT knowledge base items</time_frame>
    <description>Test of Word Reading Efficiency-2 Sight Word Efficiency, a 45-second assessment of students' word reading accuracy and speed. Reliability coefficients exceed .80 for students in grade 5-8.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Direct and Indirect Effect of Text to Text Inference making on Knowledge Accessibility and Availablility</measure>
    <time_frame>45 days from training of KNOW-IT knowledge base items</time_frame>
    <description>Bridge-IT, a computerized task, asks students to read a five-sentence text, form an inference, and determine if the next provided sentence continues the story. Internal consistency for students in the middle grades ranges from 0.83-0.87.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Direct and Indirect Effect of Nonverbal Reasoning on Knowledge Accessibility and Availability</measure>
    <time_frame>45 days from training of KNOW-IT knowledge base items</time_frame>
    <description>Kauffman Brief Intelligence Test-2 Matrices subtest assess students nonverbal reasoning and ability to identify patterns and problem solve. Reliability coefficients exceed .80 for students in grades 5-8.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Direct and Indirect Effect of Working Memory for Words on Knowledge Accessibility and Availability</measure>
    <time_frame>45 days from training of KNOW-IT knowledge base items</time_frame>
    <description>Working Memory Test Battery for Children. Word List Recall asks the student to repeat a list of monosyllabic words. Reliability coefficients exceed .80 for students in grades 5-8.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Direct and Indirect Effect of Reading Comprehension for Multi-paragraph Texts on Knowledge Accessibility and Availability</measure>
    <time_frame>180 days from training of KNOW-IT knowledge base items</time_frame>
    <description>Iowa Assessment for Reading, a group administered standardized measure of reading comprehension with internal consistency for students in grades 5-8 above 0.80.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Direct and Indirect Effect of Motivation to Read on Knowledge Accessibility and Availability</measure>
    <time_frame>45 days from training of KNOW-IT knowledge base items</time_frame>
    <description>Motivation to Read survey assesses students motivations and attitudes towards reading different types of text and reading in different contexts. After each statement, students indicate whether or not it best describes their beliefs and attitudes. 1 means not at all true of me. 2 means not very true of me. 3 means somewhat true of me. 4 means mostly true of me. 5 means very much true of me. Items load on various factors: expectancy beliefs; value; achievement goals, social goals. For most items, higher values indicate better outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Direct and Indirect Effect of Working Memory for Text on Knowledge Accessibility and Availability</measure>
    <time_frame>45 days</time_frame>
    <description>Goldman Friscoe Resonance task requires that the student listen to a series of words and determine if the words have been heard before.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Direct and Indirect Effect of Working Memory for Numbers on Knowledge Accessibility and Availability</measure>
    <time_frame>45 days from training of KNOW-IT knowledge base items</time_frame>
    <description>Woodcock Johnson III Numbers Reversed. Student listen to a series of numbers are are prompted to recall the numbers in reversed order. Reliability coefficients exceed .80 for students in grade 5-8.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Direct and Indirect Effect of Reading Fluency for Nonwords on Knowledge Accessibility and Availability</measure>
    <time_frame>45 days from training of KNOW-IT knowledge base items</time_frame>
    <description>Test of Word Reading Efficiency-2, Phonemic Decoding Efficiency, a 45-second assessment of students' non-word reading accuracy and speed. Alternate form reliability exceeds 0.90 for students in grades 5-8.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Direct and Indirect Effect of Reading Fluency for Connected Text on Knowledge Accessibility and Availability</measure>
    <time_frame>180 days from training of KNOW-IT knowledge base items</time_frame>
    <description>Curriculum Based Measure of Oral Reading Fluency, is an assessment of students ability to read connected text quickly and accurately. Reliability coefficients exceed .80 for students in grades 5-8.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Direct and Indirect Effect of Reading Comprehension for Information and Narrative Texts on Knowledge Accessibility and Availability</measure>
    <time_frame>180 days from training of KNOW-IT knowledge base items</time_frame>
    <description>A-Reading is a computer adaptive assessment of reading comprehension. Reliability coefficients exceed .80 for students in grades 5-8.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Direct and Indirect Effect of Text to Text and Knowledge-based Inference Making on Knowledge Accessibility and Availability</measure>
    <time_frame>45 days from training of KNOW-IT knowledge base items</time_frame>
    <description>Connect-IT is a group based assessment of inference making. Students read paragraphs of various lengths and form inferences. Reliability coefficients exceed .80 for students in grades 5-8.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Direct and Indirect Effect of Word, World, and Domain Knowledge on Knowledge Accessibility and Availability</measure>
    <time_frame>180 from training of KNOW-IT knowledge base items</time_frame>
    <description>Gates MacGinitie Reading Test Vocabulary subtest measures students understanding of word, world, and domain knowledge using multiple choice questions. Reliability coefficients exceed .80 for students in grades 5-8</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Reading Problem</condition>
  <arm_group>
    <arm_group_label>Knowledge Supported</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Students will have 30 seconds to view pictures of the knowledge base items and discuss relations among items.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Knowledge Not Supported</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Students will be provided 30 seconds to view pictures of the knowledge base items.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Supported</intervention_name>
    <description>Visual organization of knowledge base items plus discourse-based discussion supporting knowledge availability and accessibility</description>
    <arm_group_label>Knowledge Not Supported</arm_group_label>
    <arm_group_label>Knowledge Supported</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Must be able to hear study directions and stimuli&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Students who are enrolled in a Life Skills class focused on activities of daily living&#xD;
&#xD;
          -  Students who are enrolled in English as a Second language introductory classes&#xD;
&#xD;
          -  Students with severe disabilities that impact reading and listening.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>AMY E BARTH, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Buena Vista University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>AMY BARTH, PHD</last_name>
    <phone>17127492188</phone>
    <email>barth@bvu.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>COURTNEY BERG</last_name>
    <phone>712-749-2057</phone>
    <email>BERGC@BVU.EDU</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Storm Lake Community School District</name>
      <address>
        <city>Storm Lake</city>
        <state>Iowa</state>
        <zip>50588</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jay Slight</last_name>
      <phone>712-732-8080</phone>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Barnes MA, Dennis M, Haefele-Kalvaitis J. The effects of knowledge availability and knowledge accessibility on coherence and elaborative inferencing in children from six to fifteen years of age. J Exp Child Psychol. 1996 Apr;61(3):216-41. doi: 10.1006/jecp.1996.0015.</citation>
    <PMID>8636665</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>January 23, 2019</last_update_submitted>
  <last_update_submitted_qc>January 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Buena Vista University</investigator_affiliation>
    <investigator_full_name>AMY BARTH</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Reading Comprehension</keyword>
  <keyword>Adolescents</keyword>
  <keyword>Knowledge Availability and Accessibility</keyword>
  <keyword>Inference Making</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>All data and related materials are available upon request.</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>June 16, 2023</submitted>
    <returned>July 10, 2023</returned>
    <submitted>September 10, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03782012
org study id: R15HD092922
nct id: NCT03782012
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Recent adolescent-based research shows that inference making improves across grades 6-12,
      uniquely accounts for variance in sentence- and passage-level comprehension, and that
      individual differences in inference making relate in a principled way to variations in
      reading comprehension for readers of all abilities (Barth et al., 2015; Barnes et al., 2015).
      These findings suggest that comprehension requires inference making and that comprehension
      fails when readers do not possess relevant knowledge (i.e., availability) or slowly retrieve
      (i.e., accessibility) and integrate knowledge from text or semantic memory during reading
      (Kendeou, 2015). To date, only one study has examined the effects of knowledge availability
      and accessibility on inference making among adolescents. To extend this limited body of
      research, this project will conduct two experimental studies designed to examine (a) the
      extent to which knowledge-base availability and accessibility relates to the accuracy and
      rate of constructing inferences using that knowledge (Aim 1) and (b) the extent to which
      retrieval practice (i.e., spaced practice testing) increases knowledge availability and
      accessibility and improves the accuracy and rate of forming inferences using that
      knowledge-base among middle grade readers (Aim 2). In addition, this project will integrate
      investigative research into an undergraduate Honors Research Program by developing an
      investigative laboratory component that engages undergraduates in conducting applied research
      (Aim 3). The research design uses 558 students in grades 5-8. To address Aim 1, mixed effects
      explanatory item response models will fit to the trial-by-trial reading accuracy and speed
      data. Repeated measures analysis of variance models will address Aim 2 with analysis of
      variance models used for Aim 3. The expected outcomes of the proposed research include (a)
      understanding how knowledge availability and accessibility relate to inference making among
      adolescent readers; (b) understanding the sources of inference making difficulty; and (c)
      methods for improving knowledge availability and accessibility and inference making to
      broadly implement in secondary grade classrooms.
This project conducts experimental studies with three objectives: (1) To determine the extent
      to which variations in knowledge availability and accessibility influence the rate and
      accuracy of forming inferences. (2) To investigate whether individual difference factors are
      potential sources of variability in explaining inference making and reading comprehension.
      (3)To determine whether systematic retrieval practice improves both knowledge availability
      and accessibility as well as the accuracy and rate of forming inferences using the
      knowledge-base. Study 1 Overview. Procedures modify those used by Barnes et al. (1996). In
      Phase 1, students learn a knowledge-base of 14 facts about Gan. In Phase 2, students will
      read and listen to an informational text that consists of six sections. A computer asks
      students comprehension questions that tap information from that text section and the taught
      knowledge base. Phase 3 retests retention of the knowledge-base. One week later, Phase 4
      retests the knowledge-base and students take a larger test battery. All students will
      complete Phases 1-4 individually. Study participants (n = 300) will come from Storm Lake
      Community School District students in grades 5-8 (n = 657) with both males and females
      recruited for participation. The school district will provide demographic data, reading
      scores from the Iowa Assessment for Reading, and Gates MacGinities Reading Test for all
      participants from which the investigator will randomly select students for the treatment or
      control group. The investigator will replace students who exit the sample with students from
      the same grade who consented but not randomly selected for participation. Participation will
      exclude students with significant cognitive impairments who participate in the Life Skills
      Class (e.g., severe autism, behavior, cognitive disability) due to task demands. Additional
      Assessments measure the constructs of reading comprehension, inference making, word reading
      efficiency, metacognition, working memory, and background knowledge. Multiple measures of
      each construct allow the study to identify (a) relations among latent abilities; (b) role of
      these latent abilities in establishing reading comprehension, independent of measure-specific
      factors or measurement error; and (c) individual differences that lead to variation in
      performance. Data Analysis. The investigator will screen for missing data and outliers and
      evaluate the distributional properties of observed variables, making transformations as
      necessary and appropriate. If possible, the investigator will correlate non-plausible values
      or list them as missing if not possible, and label extreme data points. Power. General
      recommendations on sample sizes in structural equation modeling (SEM) suggest minimum samples
      of 300 (i.e., 75 participants per grades 5-8). This sample size will allow the research team
      to detect correlations among constructs greater than 0.05 and regression coefficients in
      latent variable regressions of 0.05 with over 80% power. Consideration of Biological
      Variables. To sufficiently power the study and generalize findings, this study recruits males
      and females for participation and collects gender, race, disability status, and socioeconomic
      status to determine if these child-attributes moderate knowledge accessibility and
      availability. Analytic Approach. The investigator will model the effects of knowledge
      availability and accessibility on inference making without dichotomizing the distribution of
      comprehension. To determine whether reader characteristics (i.e., knowledge availability and
      accessibility, metacognition, reading comprehension, word reading efficiency, background
      knowledge, working memory, and grade) make unique contributions to inference making, the
      investigator will fit mixed effects explanatory item response models to the trial-by-trial
      inference making accuracy and speed data with item-level accuracy and reading speeds
      cross-classified between persons and items. The investigator will also nest people within
      grade, treating grouping variables for people such as grade and items (i.e., literal,
      word-to-text, and knowledge-to-text inferences) as fixed factors. If limited variability
      exists in accuracy data, the investigator will only model response time data. The
      investigator will also evaluate how organization of knowledge relates to knowledge
      accessibility and inference making. Structural equation modeling will evaluate relations
      among the constructs (i.e., comprehension, word efficiency, inference making, knowledge
      accessibility and availability, metacognition, and working memory) to determine the role of
      knowledge accessibility and availability in reading comprehension and factors influencing
      knowledge accessibility and availability. Using Cain et al. (2001) framework, the
      investigator will classify each inference failure as (1) incorrect text-premise recall (i.e.,
      the participant fails to retrieve the relevant premise from the text); (2) incorrect
      knowledge-based recall (i.e., the participant fails to retrieve the relevant premise from the
      knowledge-base); and (3) integration failure (i.e., the participant fails to integrate text
      content with knowledge). A traditional two-way ANOVA (skill group X inference type) on the
      incorrect inference response will occur with skilled readers defined as achieving proficiency
      on the Iowa Assessment for Reading and performance above a standard score of 90 on the Gates
      MacGinitie Reading Test. The investigator will only compare the means for skilled versus less
      skilled readers. The investigators hypothesize that: (1) less skilled middle grade readers
      will make more errors than skilled readers; (2) less skilled readers will not always
      recognize the need to form inferences during reading relative to skilled readers; and (3) no
      significant differences will exist across the middle grades (Ahmed et al., 2016; Barth et
      al., 2015; Barnes et al., 2015). Results of Aim 1 will tell us if less skilled readers need
      the duration of retrieval practice increased to achieve similar benefits as more skilled
      readers and if less skilled readers need help organizing the taught knowledge-base so that it
      is more available and accessible when reading informational texts, which will inform Aim 2 -
      To examine the extent to which retrieval practice (i.e., spaced practice testing) increases
      knowledge availability and accessibility and improves the accuracy and rate of forming
      inferences using that knowledge-base among middle grade readers. Study 2 uses procedures
      modified from those used by Butler (2010). In Phase 1, students learn a knowledge-base of 14
      facts about Gan. In Phase 2, students read and study the six-section informational texts with
      reassessment of the student's retention of the knowledge base immediately after studying
      these 6 texts. In Phase 3, students restudy two of the text sections (restudy passages),
      repeatedly take the same test on another two text sections (same test), and repeatedly take
      different tests on the other two text sections (variable test). Immediately after interacting
      with all six text sections, the project reassesses the retention of the knowledge base. Phase
      4 occurs one week later and again reassesses the students' retention of the knowledge-base
      and administers the same additional test battery as in Aim 1. Study participants (n = 180)
      will come from Storm Lake Community School District students in grade 5-8. The investigators
      anticipate that students will come from diverse socio-economic and ethnic backgrounds.
      Student Selection and Exclusions. In the fall of 2019, laboratory assistants will recruit
      students and screen them with the Gates-MacGinitie Reading Test. Students selected for
      participation: (1) perform below a standard score of 90 on the Gates-MacGinitie Reading Test;
      (2) did not participate in Aim 1; and (3) are not enrolled in life skills classes (i.e.,
      severe Autism, behavior, cognitive impairments) due to task appropriateness. The investigator
      will document any additional services that students receive (i.e., Title, special education,
      and reading support) and included them as contextual variables in later analyses. Power and
      Design. The investigators estimate the sample associated with an effect size of 0.25, alpha
      0.05, and with over 80% power at 136 participants for between group differences, 36 for
      within group differences, and 180 for the interaction. Randomization will occur within grade,
      with all qualified students in grade 5 available for randomization because these students did
      not participate in Aim 1. The investigators estimate attrition to be 20% or 36 participants
      total and will replace participants who exit the pool of consented students not randomly
      selected for participation. Consideration of Biological Variables. To sufficiently power the
      study and generalize findings, the study recruits males and females for participation and
      collects gender, race, disability status, and socioeconomic status to determine if these
      child-attributes moderate knowledge accessibility and availability. Data Analysis. As in Aim
      1, the investigators will screen for missing data and outliers and evaluate the
      distributional properties of observed variables, making transformations as necessary and
      appropriate. When possible, investigators will correct non-plausible values or listed them as
      missing if investigators cannot correct them and label extreme data points. Analytic
      Approach. Data analysis will use repeated measures analysis of variance models to examine the
      effect of the experimental condition on knowledge retention. Separate ANOVAs will analyze
      scores obtained on the question types (i.e., explicit text-, word-to-text- and
      inference-questions) and the different error types by condition. Results of Aim 2 (and Aim 1)
      and additional analyses will inform the independent research projects conducted by
      undergraduate laboratory assistants (Aim 3). Aim 3. To integrate investigative research into
      an undergraduate Honors Research Program. This proposal will support the development of a
      laboratory component for the Honors Proposal Seminar. This sophomore-level seminar focuses on
      the organizational structure of their research proposal (i.e., introduction, hypotheses, and
      method section). The laboratory component will provide students hands-on experiences in the
      practices of conducting applied research in the schools. Students will also have access to
      extant data to examine interesting questions related to the reading and reading-related
      skills of adolescents which should heighten student interest and enthusiasm for conducting
      research among adolescents. Laboratory Outline. This project will create a two-semester
      laboratory course (e.g., 32 sessions) that meets weekly for two hours. Lab sessions will
      address Institutional Review Board applications; appropriate engagement with school
      personnel; subject recruitment; parent/guardian consent; child assent; formation of research
      questions and hypotheses; fidelity of implementation; experimental design; inputting and
      verifying data; analyzing data; and discussing, reporting, and publishing findings (i.e.,
      manuscripts, presentations, and spoken posters). Throughout the year, students will also
      engage in the primary literature, culminating with the eventual submission of a primary
      journal article that includes appropriate introduction, method, results, and discussion.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This study will randomly select 300 from Storm Lake students in grades 5-8 (i.e., 75 students per grade) (see Table 1). Because of the short duration of the experiment (3 sessions), we estimate 20% attrition (n = 60 students). We will replace all students who exit from the sample within grade to ensure sufficiently power. Students will randomly be assigned within grade to one of two conditions: support versus no support.
primary purpose: Diagnostic
masking: Double (Participant, Outcomes Assessor)
masking description: Provide information about other parties who may be masked in the clinical trial,
measure: Change in Knowledge Accessibility and Availability
time frame: immediately after training KNOW-IT knowledge base items; one week after training KNOW-IT knowledge base items; and 1 month after training KNOW-IT knowledge base items
description: Know-It task is an individually administered assessment of knowledge accessibility (rate of response) and availability (accuracy of response) for a taught knowledge base.
measure: Direct and indirect effect of Reading Comprehension for Grade Level texts on Knowledge Accessibility and Availability
time frame: 180 days from training of KNOW-IT knowledge base items
description: Gates-MacGinite Reading Test-4th Edition, a standardized, group-administered, multiple-choice assessment of reading comprehension with internal consistency for students in grades 5-8 that exceeds 0.80.
measure: Direct and Indirect effect of Reading Strategy Use for Content Area Texts on Knowledge Availability and Accessibility
time frame: 45 days from training of KNOW-IT knowledge base items
description: Contextualized Reading Survey, students to report study strategies used when reading. The scale measures the types of reading strategies readers use in different types of reading situations. For each question, the reader indicates their use on a scale of 1 to 5. 1 means I almost never do this. 2 means that I rarely do this. 3 means that I sometimes to this. 4 means that I usually do this. 5 means that I almost always do this. Items load onto 4 factors: evaluation and knowledge integration; pragmatic strategies; self regulation; help seeking. Higher values indicate a better outcome.
measure: Direct and Indirect effect of Word and World Knowledge and Understanding on Knowledge Accessibility and Availability
time frame: 180 days from training of KNOW-IT knowledge base items
description: Kauffman Brief Intelligence Test-2, Verbal Knowledge subtest is a norm-referenced, individually administered assessment of expressive word and world knowledge. Internal consistency ranges from 0.89-0.94 for students in grades 5-8.
measure: Direct and Indirect Effect of Reading Fluency for Words on Knowledge Accessibility and Availability
time frame: 180 days from training of KNOW-IT knowledge base items
description: Test of Word Reading Efficiency-2 Sight Word Efficiency, a 45-second assessment of students' word reading accuracy and speed. Reliability coefficients exceed .80 for students in grade 5-8.
measure: Direct and Indirect Effect of Text to Text Inference making on Knowledge Accessibility and Availablility
time frame: 45 days from training of KNOW-IT knowledge base items
description: Bridge-IT, a computerized task, asks students to read a five-sentence text, form an inference, and determine if the next provided sentence continues the story. Internal consistency for students in the middle grades ranges from 0.83-0.87.
measure: Direct and Indirect Effect of Nonverbal Reasoning on Knowledge Accessibility and Availability
time frame: 45 days from training of KNOW-IT knowledge base items
description: Kauffman Brief Intelligence Test-2 Matrices subtest assess students nonverbal reasoning and ability to identify patterns and problem solve. Reliability coefficients exceed .80 for students in grades 5-8.
measure: Direct and Indirect Effect of Working Memory for Words on Knowledge Accessibility and Availability
time frame: 45 days from training of KNOW-IT knowledge base items
description: Working Memory Test Battery for Children. Word List Recall asks the student to repeat a list of monosyllabic words. Reliability coefficients exceed .80 for students in grades 5-8.
measure: Direct and Indirect Effect of Reading Comprehension for Multi-paragraph Texts on Knowledge Accessibility and Availability
time frame: 180 days from training of KNOW-IT knowledge base items
description: Iowa Assessment for Reading, a group administered standardized measure of reading comprehension with internal consistency for students in grades 5-8 above 0.80.
measure: Direct and Indirect Effect of Motivation to Read on Knowledge Accessibility and Availability
time frame: 45 days from training of KNOW-IT knowledge base items
description: Motivation to Read survey assesses students motivations and attitudes towards reading different types of text and reading in different contexts. After each statement, students indicate whether or not it best describes their beliefs and attitudes. 1 means not at all true of me. 2 means not very true of me. 3 means somewhat true of me. 4 means mostly true of me. 5 means very much true of me. Items load on various factors: expectancy beliefs; value; achievement goals, social goals. For most items, higher values indicate better outcomes.
measure: Direct and Indirect Effect of Working Memory for Text on Knowledge Accessibility and Availability
time frame: 45 days
description: Goldman Friscoe Resonance task requires that the student listen to a series of words and determine if the words have been heard before.
measure: Direct and Indirect Effect of Working Memory for Numbers on Knowledge Accessibility and Availability
time frame: 45 days from training of KNOW-IT knowledge base items
description: Woodcock Johnson III Numbers Reversed. Student listen to a series of numbers are are prompted to recall the numbers in reversed order. Reliability coefficients exceed .80 for students in grade 5-8.
measure: Direct and Indirect Effect of Reading Fluency for Nonwords on Knowledge Accessibility and Availability
time frame: 45 days from training of KNOW-IT knowledge base items
description: Test of Word Reading Efficiency-2, Phonemic Decoding Efficiency, a 45-second assessment of students' non-word reading accuracy and speed. Alternate form reliability exceeds 0.90 for students in grades 5-8.
measure: Direct and Indirect Effect of Reading Fluency for Connected Text on Knowledge Accessibility and Availability
time frame: 180 days from training of KNOW-IT knowledge base items
description: Curriculum Based Measure of Oral Reading Fluency, is an assessment of students ability to read connected text quickly and accurately. Reliability coefficients exceed .80 for students in grades 5-8.
measure: Direct and Indirect Effect of Reading Comprehension for Information and Narrative Texts on Knowledge Accessibility and Availability
time frame: 180 days from training of KNOW-IT knowledge base items
description: A-Reading is a computer adaptive assessment of reading comprehension. Reliability coefficients exceed .80 for students in grades 5-8.
measure: Direct and Indirect Effect of Text to Text and Knowledge-based Inference Making on Knowledge Accessibility and Availability
time frame: 45 days from training of KNOW-IT knowledge base items
description: Connect-IT is a group based assessment of inference making. Students read paragraphs of various lengths and form inferences. Reliability coefficients exceed .80 for students in grades 5-8.
measure: Direct and Indirect Effect of Word, World, and Domain Knowledge on Knowledge Accessibility and Availability
time frame: 180 from training of KNOW-IT knowledge base items
description: Gates MacGinitie Reading Test Vocabulary subtest measures students understanding of word, world, and domain knowledge using multiple choice questions. Reliability coefficients exceed .80 for students in grades 5-8
arm group label: Knowledge Supported
arm group type: Experimental
description: Students will have 30 seconds to view pictures of the knowledge base items and discuss relations among items.
arm group label: Knowledge Not Supported
arm group type: Experimental
description: Students will be provided 30 seconds to view pictures of the knowledge base items.
intervention type: Behavioral
intervention name: Supported
description: Visual organization of knowledge base items plus discourse-based discussion supporting knowledge availability and accessibility
arm group label: Knowledge Not Supported
arm group label: Knowledge Supported
criteria: 
gender: All
minimum age: 10 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
last name: AMY E BARTH, PHD
role: Principal Investigator
affiliation: Buena Vista University
last name: AMY BARTH, PHD
phone: 17127492188
email: barth@bvu.edu
last name: COURTNEY BERG
phone: 712-749-2057
email: BERGC@BVU.EDU
facility: 
status: Recruiting
contact: 
country: United States
citation: Barnes MA, Dennis M, Haefele-Kalvaitis J. The effects of knowledge availability and knowledge accessibility on coherence and elaborative inferencing in children from six to fifteen years of age. J Exp Child Psychol. 1996 Apr;61(3):216-41. doi: 10.1006/jecp.1996.0015.
PMID: 8636665
responsible party type: Principal Investigator
investigator affiliation: Buena Vista University
investigator full name: AMY BARTH
investigator title: Assistant Professor
sharing ipd: Undecided
ipd description: All data and related materials are available upon request.
submitted: June 16, 2023
returned: July 10, 2023
submitted: September 10, 2023