NCT05692973

Brief Summary

This project will (a) examine the relationship between knowledge retrieval and inferencing; (b) determine the effectiveness of an intervention that improves knowledge retrieval and inferencing among struggling readers; and (c) expand research opportunities for undergraduates. The research design uses 316 struggling readers in grades 4-6 of diverse backgrounds. The effects of knowledge retrieval (accuracy and speed) on inferencing will be modeled without dichotomizing the distribution. Linear mixed effect models will be fit to determine whether reader characteristics make unique contributions to inferencing across the posttest and follow-up data collection time points. First, several structural models will be considered as students may be nested in teachers, schools, and tutors. Unconditional models will estimate the intraclass correlation for each level of the study design. If significant interclass correlations emerge, multilevel models will be fit to evaluate the effectiveness of the intervention while controlling for covariates such as pre-test performance on inference-related measures and child-attributes such as English learner status. The primary analysis plan assumes an intent-to-treat model in which the efficacy of two intact conditions will be tested. Effect sizes will be estimated to report the magnitude of difference between the two conditions. Expected outcomes include (a) the identification of a method that effectively facilitates knowledge retrieval and the application of relevant knowledge to form inferences among elementary struggling readers from diverse backgrounds; (b) the validation of an intervention that teaches struggling readers how to activate, retrieve, and interweave relevant knowledge with information in the text and accurately form inferences while reading that can be broadly implemented in general education classrooms; and (c) expansion of undergraduate research opportunities, particularly among students from diverse backgrounds who have been historically underserved.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
316

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started May 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress69%
May 2023Aug 2027

First Submitted

Initial submission to the registry

November 2, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 20, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

May 31, 2023

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

June 23, 2023

Status Verified

June 1, 2023

Enrollment Period

3.3 years

First QC Date

November 2, 2022

Last Update Submit

June 21, 2023

Conditions

Keywords

Inference-makingKnowledge retrievalReading comprehension

Outcome Measures

Primary Outcomes (8)

  • Gates-MacGinite Reading Test-4th Edition; Change is being assessed

    a standardized, group-administered, multiple-choice assessment of reading comprehension.

    pre-intervention

  • Gates-MacGinite Reading Test-4th Edition; change is being assessed

    a standardized, group-administered, multiple-choice assessment of reading comprehension

    immediately after the intervention

  • Test of Language Competence-Expanded; Change is being assessed

    Inference Task asks students to read three sentences and form an inference

    pre-intervention

  • Test of Language Competence-Expanded; change is being assessed

    Inference Task asks students to read three sentences and form an inference

    immediately after the intervention

  • Bridge-IT; change is being assessed

    asks students to read a five-sentence text, form an inference, and determine if the next sentence provided continues the story.

    pre-intervention

  • Bridge-IT; change is being assessed

    asks students to read a five-sentence text, form an inference, and determine if the next sentence provided continues the story.

    immediately after the intervention

  • Clinical Evaluation of Language Fundamentals-5; change is being assessed

    Metalinguistics, Making Inferences subtest, an individually administered assessment, measures students' ability to make gap-filling inferences on the basis of causal relationships or event chains depicted in short narratives that are presented both orally and in print form.

    pre-intervention

  • Clinical Evaluation of Language Fundamentals-5; change is being assessed

    Metalinguistics, Making Inferences subtest, an individually administered assessment, measures students' ability to make gap-filling inferences on the basis of causal relationships or event chains depicted in short narratives that are presented both orally and in print form.

    immediately after the intervention

Secondary Outcomes (22)

  • Knowledge Retrieval; change is being assessed

    pre-intervention

  • Knowledge Retrieval; change is being assessed

    Immediately after the intervention

  • Knowledge Retrieval; change is being assessed

    one-week after the intervention

  • Knowledge Retrieval; change is being assessed

    one-month after the intervention

  • Test of Word Reading Efficiency-2; change is being assessed

    pre-intervention

  • +17 more secondary outcomes

Other Outcomes (1)

  • Test of Silent Reading Efficiency and Comprehension

    baseline screening of participants; pre-intervention

Study Arms (3)

Variable Test

EXPERIMENTAL

Students will be taught a knowledge base comprised of 18 facts about Egypt. After learning the knowledge base to criterion, students will practice retrieving the knowledge base across four testing sessions spaced 24 hours apart. Students will receive different questions across testing sessions. Next, students will read 6 passages about Egypt and then answer literal and inferential questions about the passages. Immediately after reading the passages, students will get re-tested on their retention of the knowledge base and use of the knowledge base to form inferences. They will also get retested one week and one month later to examine students' long-term retention of the knowledge base and use to make inferences.

Behavioral: Role of Knowledge RetrievalBehavioral: Inference Intervention

Repeated Test

EXPERIMENTAL

Students will be taught a knowledge base comprised of 18 facts about Egypt. After learning the knowledge base to criterion, students will practice retrieving the knowledge base across four testing sessions spaced 24 hours apart. Students will receive the same questions repeated across testing sessions. Next, students will read 6 passages about Egypt and then answer literal and inferential questions about the passages. Immediately after reading the passages, students will get re-tested on their retention of the knowledge base and use of the knowledge base to form inferences. They will also get retested one week and one month later to examine students' long-term retention of the knowledge base and use to make inferences.

Behavioral: Role of Knowledge RetrievalBehavioral: Inference Intervention

Placebo

PLACEBO COMPARATOR

Students will be taught a knowledge base comprised of 18 facts about Egypt. After learning the knowledge base to criterion, students will re-read the passages. They will not receive any questions. Next, students will read 6 passages about Egypt and then answer literal and inferential questions about the passages. Immediately after reading the passages, students will get re-tested on their retention of the knowledge base and use of the knowledge base to form inferences. They will also get retested one week and one month later to examine students' long-term retention of the knowledge base and use to make inferences.

Behavioral: Role of Knowledge RetrievalBehavioral: Inference Intervention

Interventions

Students will learn a new knowledge base to perfect mastery. Following the attainment of mastery students will read passages on the topic and answer questions that prompt the literal recall of key facts and the formation of inferences.

PlaceboRepeated TestVariable Test

The intervention will pre-teach students a set of 20 essential facts about Egypt. Students will interact with expository and narrative texts. Students will practice using a text clue strategy to activate and integrate prior knowledge, will make in-text connections, connections across the 3 intervention texts, and connections between text and knowledge, and will make inferences about character motives and author intent. The tutor will ask students to justify connections and evaluate how these connections enhance understanding. Students will answer inference questions that require using text and background knowledge. A simple graphic organizer will support and scaffold inferencing. Throughout the intervention, students will practice retrieving the 20 essential facts about Egypt from memory using flash cards, completed in pairs with students providing each other feedback.

PlaceboRepeated TestVariable Test

Eligibility Criteria

Age8 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • performance below a a standard score of 93 on the Test of Silent Reading Efficiency

You may not qualify if:

  • clinical diagnosis of a significant cognitive impairment
  • clinical diagnosis of a significant behavioral disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Excelsior Springs School District

Excelsior Springs, Missouri, 64024, United States

RECRUITING

Related Publications (2)

  • Barth AE, Elleman A. Evaluating the Impact of a Multistrategy Inference Intervention for Middle-Grade Struggling Readers. Lang Speech Hear Serv Sch. 2017 Jan 1;48(1):31-41. doi: 10.1044/2016_LSHSS-16-0041.

    PMID: 27776201BACKGROUND
  • Barth AE, Daniel J, Roberts G, Vaughn S, Barnes MA, Ankrum E, Kincaid H. The Role of Knowledge Availability in Forming Inferences with Rural Middle Grade English Learners. Learn Individ Differ. 2021 May;88:102006. doi: 10.1016/j.lindif.2021.102006. Epub 2021 May 12.

    PMID: 33994756BACKGROUND

MeSH Terms

Conditions

Dyslexia

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSpecific Learning DisorderLearning DisabilitiesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Amy E Barth, Ph.D

    William Jewell College

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Stoll, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: In year 1 , Participants will be randomized to a variable test condition; repeated test condition; or a placebo condition to determine if the retrieval of knowledge through testing leads to improved inference making. In year 2, participants in the variable and repeated test conditions will receive a short intervention to determine if direct instruction in inferencing leads to improved inferencing and comprehension.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2022

First Posted

January 20, 2023

Study Start

May 31, 2023

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2027

Last Updated

June 23, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

The following steps will be enacted: (a) requester will submit an email to the PI requesting data sharing; (b) A data-sharing agreement will be forwarded to the requester by the laboratory manager; (c) once the data-Sharing agreement is returned, a file will be prepared for the requester. This file will be prepared by PI or the laboratory manager; (d) files will be shared via secure data archive. Our data archives are secure and approved for use with Category I data.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will become available at the close of the project.
Access Criteria
Data will be available upon request. A data-sharing agreement will be required prior to release of data. The agreement will include a summary of the purpose of the data, methodology and procedures used to the collected the data, timing of the data use. The agreement will also state that privacy and confidentiality standards will be maintained and that manipulation of data for the purposes of identifying subjects is prohibited.

Locations