NCT03782012

Brief 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 (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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
241

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 20, 2018

Completed
25 days until next milestone

Study Start

First participant enrolled

January 14, 2019

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

May 16, 2024

Completed
Last Updated

May 16, 2024

Status Verified

April 1, 2024

Enrollment Period

3.4 years

First QC Date

December 17, 2018

Results QC Date

June 16, 2023

Last Update Submit

April 18, 2024

Conditions

Keywords

Reading ComprehensionAdolescentsKnowledge Availability and AccessibilityInference Making

Outcome Measures

Primary Outcomes (1)

  • 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

    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

    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

    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

    180 days from training of KNOW-IT knowledge base items

  • Direct and Indirect Effect of Reading Fluency for Words on Knowledge Accessibility and Availability

    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

    45 days from training of KNOW-IT knowledge base items

  • +8 more secondary outcomes

Study Arms (2)

Knowledge Supported

EXPERIMENTAL

Students will have 30 seconds to view pictures of the knowledge base items and discuss relations among items.

Behavioral: Supported

Knowledge Not Supported

EXPERIMENTAL

Students will be provided 30 seconds to view pictures of the knowledge base items.

Behavioral: Supported

Interventions

SupportedBEHAVIORAL

Visual organization of knowledge base items plus discourse-based discussion supporting knowledge availability and accessibility

Knowledge Not SupportedKnowledge Supported

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • \- Must be able to hear study directions and stimuli

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Storm Lake Community School District

Storm Lake, Iowa, 50588, United States

Location

Related Publications (1)

  • 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: 8636665BACKGROUND

MeSH Terms

Interventions

Palliative Care

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Limitations and Caveats

The sample was relatively small, and results of this study are based on a sample of students from one rural school district. Data was collected from one cohort of typically developing readers and one cohort of at-risk readers across two years and combined for our primary and secondary analyses. Next, we were unable to administer or did not have access to students' scores on multiple measures due to restrictions related to COVID-19. Third, students with significant disabilities were excluded.

Results Point of Contact

Title
Dr. Amy Elizabeth Barth
Organization
William Jewell College

Study Officials

  • AMY E BARTH, PHD

    Buena Vista University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Provide information about other parties who may be masked in the clinical trial,
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 17, 2018

First Posted

December 20, 2018

Study Start

January 14, 2019

Primary Completion

May 27, 2022

Study Completion

August 31, 2022

Last Updated

May 16, 2024

Results First Posted

May 16, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

All data and related materials are available upon request.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
All data and related materials are available upon request.
Access Criteria
All data and related materials are available upon request.

Locations