Reading ProblemBVU-R15NCT03782012
Knowledge Accessibility and Availability in Forming Knowledge-to-Text Inferences Among Middle Grade Readers
A study testing Supported in people with Reading Problem, run by Buena Vista University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Reading Problem
- What is being tested?
- Supported
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2019to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Must be able to hear study directions and stimuli
Who cannot join
- Students who are enrolled in a Life Skills class focused on activities of daily living
- Students who are enrolled in English as a Second language introductory classes
- Students with severe disabilities that impact reading and listening.
Trial locations and contacts
1 site in 1 country.
United States1 site
Storm Lake Community School District
Storm Lake, Iowa, 50588
About this study
Official title: Knowledge Accessibility and Availability in Forming Knowledge to Text Inferences Among Middle Grade Readers
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.
Read the detailed description
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.
- Conditions
- Reading Problem
- Being tested
- Supported
- Keywords
- Reading Comprehension, Adolescents, Knowledge Availability and Accessibility, Inference Making
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SupportedBehavioural
Visual organization of knowledge base items plus discourse-based discussion supporting knowledge availability and accessibility
| Study group | Role | What they receive |
|---|---|---|
| Knowledge Supported | Experimental | Students will have 30 seconds to view pictures of the knowledge base items and discuss relations among items. Receives: Behavioral: Supported |
| Knowledge Not Supported | Experimental | Students will be provided 30 seconds to view pictures of the knowledge base items. Receives: Behavioral: Supported |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Knowledge Accessibility and Availability
Know-It task is an individually administered assessment of knowledge accessibility (rate of response) and availability (accuracy of response) for a taught knowledge base.
Scale title is the Know-It, the minimum value is 0 the maximum value is 14, a score of 14 is a better outcome.
Construct: Literal and Inferential Comprehension Higher score indicates better reading proficiency
Measured: 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
Secondary outcomes (13)
Direct and Indirect Effect of Reading Comprehension for Grade Level Texts on Knowledge Accessibility & Availability
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. The scale title is the Gates-MacGinitie Test 4th Edition, Reading Comprehension subtest. Higher score means a better outcome.
Standard score with a mean of 100 and standard deviation of 15. Standard score range from 55 to 145.
Data on this measure was only collected for Cohort 1 (n = 145) and not for Cohort 2 (n = 96)
Construct: Reading Comprehension Higher score indicates better reading proficiency
Measured: 180 days from training of KNOW-IT knowledge base items
Direct and Indirect Effect of Reading Strategy Use for Content Area Texts on Knowledge Availability and Accessibility
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.
Toal of 49 items on the survey. Min score 49 max score 245.
Construct: Strategic reading skills
Measured: 45 days from training of KNOW-IT knowledge base items
Direct and Indirect Effect of Word and World Knowledge and Understanding on Knowledge Accessibility and Availability
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.
Standard score with a mean of 100 and standard deviation of 15. Standard score range from 55 to 145.
Construct: Vocabulary and verbal knowledge Higher score indicates better vocabulary and verbal knowledgeproficiency
Measured: 180 days from training of KNOW-IT knowledge base items
Direct and Indirect Effect of Reading Fluency for Words on Knowledge Accessibility and Availability
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.
Standard score with a mean of 100 and standard deviation of 15. Standard score range from 55 to 145.
Construct: Word reading or Decoding skills Higher score indicates better word reading skills
Measured: 180 days from training of KNOW-IT knowledge base items
Direct and Indirect Effect of Text to Text Inference Making on Knowledge Accessibility and Availability
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.
Students were asked to respond to 20 inferential questions. Min score 0, max score 20.
Higher score indicates better outcome. Construct: Inference making
Measured: 45 days from training of KNOW-IT knowledge base items
Direct and Indirect Effect of Nonverbal Reasoning on Knowledge Accessibility and Availability
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.
Standard score with a mean of 100 and standard deviation of 15. Standard score range from 55 to 145.
Construct: Nonverbal reasoning skills Higher score indicates better Nonverbal reasoning skills
Measured: 45 days from training of KNOW-IT knowledge base items
Direct and Indirect Effect of Working Memory for Words on Knowledge Accessibility and Availability
Working Memory Test from the Woodcock Johnson. This subtest measures students' memory for numbers.
Standard score with a mean of 100 and standard deviation of 15. Standard score range from 55 to 145.
Construct: Working memory Higher score indicates better working memory capacity
Measured: 45 days from training of KNOW-IT knowledge base items
Test of Word Reading Efficiency Sight Word Reading. Construct: Word Reading
Assesses students speed of reading words by sight.
Scores reported are standard scores with a mean of 100 and standard deviation of 15 Standard score range from 55 to 145.
Construct: Word reading or decoding skills Higher score indicates better word reading skills
Measured: 45 days from training of KNOW-IT knowledge base items
Direct and Indirect Effect of Working Memory for Text on Knowledge Accessibility and Availability
Woodcock Johnson Verbal Memory task requires that the student listen to a series of words and determine if the words have been heard before.
Standard score with a mean of 100 and standard deviation of 15. Standard score range from 55 to 145.
Construct: Verbal working memory Higher score indicates better verbal working memory capacity
Measured: 45 days
Direct and Indirect Effect of Reading Fluency for Nonwords on Knowledge Accessibility and Availability
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.
Standard score with a mean of 100 and standard deviation of 15 Standard score range from 55 to 145.
Construct: Decoding or word reading skills Higher score indicates better word reading skills
Measured: 45 days from training of KNOW-IT knowledge base items
Direct and Indirect Effect of Reading Fluency for Connected Text on Knowledge Accessibility and Availability
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.
Scores represent the average number of words read correctly on the oral reading fluency assessment.
Higher score indicates better word reading fluency skills
Construct: Reading fluency
Measured: 180 days from training of KNOW-IT knowledge base items
Direct and Indirect Effect of Reading Comprehension for Grade Level Texts on Knowledge Accessibility and Availability
FastBridge Adaptive Reading (aReading) is a computer adaptive assessment of reading comprehension. Reliability coefficients exceed .80 for students in grades 5-8. The aReading test measures students' proficiency in various reading-related domains such as concepts of print, vocabulary, and comprehension of literary and informational text.
aReading Scaled Score Benchmark: Grade 5: >=523 = College pathway, <509 = some risk, <497 = High risk Grade 6: >=530 = College pathway, <516 = some risk, <502 = High risk
aReading scores are listed according to bands of 50 points each starting at minimum 350 and ending at maximum 750. Note, this is an extended scale score.
Construct: Reading skills
Measured: 180 days from training of KNOW-IT knowledge base items
Direct and Indirect Effect of Word, World, and Domain Knowledge on Knowledge Accessibility and Availability
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
Standard score with a mean of 100 and standard deviation of 15. Standard score range from 55 to 145.
Construct vocabulary knowledge Higher score indicates better vocabulary knowledge
Measured: 180 from training of KNOW-IT knowledge base items
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start14 Jan 2019
- Primary completion27 May 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Reading ProblemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Buena Vista University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AMY BARTH, Buena Vista University
- Investigators
- AMY E BARTH, PHD, Principal investigator, Buena Vista University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03782012
- Sponsor's protocol ID
- R15HD092922
- Acronym
- BVU-R15
- Status last verified
- Apr 2024
- First submitted
- 17 Dec 2018
- Last updated
- 16 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data and related materials are available upon request.
Publications
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.
PubMed 8636665
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowledge Accessibility and Availability in Forming Knowledge to Text Inferences Among Middle Grade Readers
- ClinicalTrials.gov ID
- NCT03782012
- Acronym / sponsor ID
- BVU-R15 / R15HD092922
- Conditions
- Reading Problem
- Keywords
- Reading Comprehension, Adolescents, Knowledge Availability and Accessibility, Inference Making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Buena Vista UniversityUniversity, hospital or other
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 27 May 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 20 Dec 2018 (actual)
- Results
- Posted 16 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Knowledge Supported | Experimental | Behavioral: SupportedStudents will have 30 seconds to view pictures of the knowledge base items and discuss relations among items. |
| Knowledge Not Supported | Experimental | Behavioral: SupportedStudents will be provided 30 seconds to view pictures of the knowledge base items. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Must be able to hear study directions and stimuli
Key exclusion criteria (3 listed)
- Students who are enrolled in a Life Skills class focused on activities of daily living
- Students who are enrolled in English as a Second language introductory classes
- Students with severe disabilities that impact reading and listening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SupportedVisual organization of knowledge base items plus discourse-based discussion supporting knowledge availability and accessibility | Behavioural | Knowledge Not Supported, Knowledge Supported |
Primary outcome
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
Know-It task is an individually administered assessment of knowledge accessibility (rate of response) and availability (accuracy of response) for a taught knowledge base. Scale title is the Know-It, the minimum value is 0 the maximum value is 14, a score of 14 is a better outcome. Construct: Literal and Inferential Comprehension Higher score indicates better reading proficiency
13 secondary outcomes
Direct and Indirect Effect of Reading Comprehension for Grade Level Texts on Knowledge Accessibility & Availability
Time frame: 180 days from training of KNOW-IT knowledge base items
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
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
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
Direct and Indirect Effect of Text to Text Inference Making on Knowledge Accessibility and Availability
Time frame: 45 days from training of KNOW-IT knowledge base items
Direct and Indirect Effect of Nonverbal Reasoning on Knowledge Accessibility and Availability
Time frame: 45 days from training of KNOW-IT knowledge base items
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
Test of Word Reading Efficiency Sight Word Reading. Construct: Word Reading
Time frame: 45 days from training of KNOW-IT knowledge base items
Direct and Indirect Effect of Working Memory for Text on Knowledge Accessibility and Availability
Time frame: 45 days
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
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8636665Barnes 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.
- Individual participant dataSharing planned: Yes. All data and related materials are available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AMY E BARTH, PHD principal investigator
Buena Vista University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supported in people with Reading Problem, run by Buena Vista University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03782012, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.