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Improving Response to Intervention in Students With or at Risk of Reading Disabilities

Primary Purpose

Reading Problem

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reading
Mindset
Reading Embedded with Mindset
Business as Usual
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Reading Problem

Eligibility Criteria

9 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Fourth grader Identified with reading difficulty

-

Exclusion Criteria:

Identified vision, hearing, or intellectual disability

-

Sites / Locations

  • Vanderbilt University
  • Southern Methodist University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

Reading Plus Mindset

Reading Embedded with Mindset

Reading

Business as Usual

Arm Description

Multicomponent reading intervention providing explicit and systematic instruction in phonological awareness, phonics and word recognition, and reading fluency. Participants also complete mindset training and activities.

Multicomponent reading intervention (providing explicit and systematic instruction in phonological awareness, phonics and word recognition, and reading fluency) with mindset instruction specific to reading progress embedded in the intervention Participants also complete mindset training and activities.

Multicomponent reading intervention providing explicit and systematic instruction in phonological awareness, phonics and word recognition, and reading fluency.

Participation in the typical reading instruction and intervention provided within participating schools.

Outcomes

Primary Outcome Measures

Change in Cloze Reading Comprehension
Students are instructed to read a short passage and identify a missing key word that would make sense
Change in Passage Reading Comprehension Study 1 only
The comprehension assessment consists of expository and narrative passages that increase in length, followed by multiple choice questions.
Change in Word Reading
Students reads a list of real words
Change in Decoding
Student reads a list of nonsense words
Change in Reading Fluency
Students read three passages aloud for 1 min. The total number of correct words is counted.
Change in Phonological Processing Blending Study 1 only
Blending requires the students to listen to a series of real words spoken in segments and earn a point for each word they blend correctly.
Change in Phonological Processing Deletion Study 1 only
Elision requires a student to listen to a segmented word and then pronounce the word without a segment.
Change in Word Reading Fluency
Students reads a list of real words. The number of words read in 45 seconds is counted
Change in Decoding Fluency
Student reads a list of nonsense words. The number of words read in 45 seconds is counted

Secondary Outcome Measures

Mindset
Ratings of how student thinks about learning and the brain
Change in Math Problem Solving Study 1 only
Students analyze and solve math problems

Full Information

First Posted
August 7, 2017
Last Updated
August 3, 2021
Sponsor
Vanderbilt University
Collaborators
Southern Methodist University, Florida State University
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1. Study Identification

Unique Protocol Identification Number
NCT03261661
Brief Title
Improving Response to Intervention in Students With or at Risk of Reading Disabilities
Official Title
Improving Response to Intervention in Students With or at Risk of Reading Disabilities
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
August 18, 2017 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
Collaborators
Southern Methodist University, Florida State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the proposed studies is to examine a reading intervention for fourth grade students with reading difficulties that integrate work in mindset (beliefs about whether abilities are innate or can be developed) with the academic component of reading. Specifically, the investigators will examine the extent to which integrating mindset intervention improves student response to reading intervention. The investigators will use previous research in intensive reading intervention for students with reading difficulties in the upper elementary grades to examine an intervention that addresses reading skill deficits, while also providing mindset training along with (Study 1) or embedded in (Study 2) the reading intervention. It is hypothesized that students in the reading intervention with mindset conditions will improve their reading outcomes more than students in the reading intervention only and business as usual groups.
Detailed Description
The purpose of the proposed studies is to examine a reading intervention for fourth grade students with RD that integrates the psychosocial component of mindset with the academic component of reading. Specifically, the investigators will examine the extent to which integrating mindset intervention improves student response to reading intervention. The investigators will use previous research in intensive reading intervention for students with RD in the upper elementary grades to examine an intervention that addresses reading skill deficits, while providing mindset training along with (Study 1) or embedded in (Study 2) the reading intervention. Specific Aim 1. To determine the effects of intensive reading intervention with mindset training (Reading Intervention Plus Mindset) relative to reading intervention alone and business as usual comparison on the academic outcomes of fourth grade students with or at-risk for reading disabilities. The proposed study will target students with or at-risk for reading disabilities in fourth grade to examine the effects of reading intervention with mindset training relative to reading intervention alone and business as usual comparison on students' mindset, general academic achievement, phonological awareness, word reading, fluency, and reading comprehension outcomes. Students will be randomly assigned to condition with students in the Reading Intervention Plus Mindset condition receiving the mindset training along with their reading intervention. Students assigned to the Reading Intervention will receive the same reading intervention but without the mindset training. Students in the Business as Usual condition will continue to receive their typical school services which will be carefully documented. It is hypothesized that students in the Reading Intervention Plus Mindset condition will improve their reading outcomes more than students in the Reading Intervention only and Business as Usual groups by continuing to develop a growth mindset to work through the challenges in their reading development and, thus, being able to progress more efficiently in the reading intervention. Specific Aim 2. To determine the effects of embedding mindset training in an intensive reading intervention on the mindset and academic outcomes of fourth grade students with or at-risk for reading disabilities. The proposed study will use the results from Specific Aim 1 to further examine the effects of an intensive reading intervention with mindset embedded in the content with a new cohort of fourth grade students with or at-risk for reading disabilities. Embedding mindset practices directly in the content area of difficulty for students with learning difficulties could be more powerful than separate mindset training. Students will be randomly assigned to one of two conditions (Embedded or Business as Usual). The investigators will examine the effects of intervention on students' mindset, word reading, fluency, and reading comprehension measures. It is hypothesized that embedding mindset training directly in the reading content will further improve student reading outcomes by allowing students to directly apply a growth mindset to their work in the area of difficulty, reading. Specific Aim 3. To link student characteristics to response to intervention. The proposed study will link students' initial reading achievement, initial mindset, vocabulary ability, behavior/attention as well as race, sex, socioeconomic status, and parents' educational background to student response to intervention. It is hypothesized that students with lower initial reading achievement, higher initial levels of fixed mindset, higher vocabulary, lower parent educational background or socioeconomic status, and/or higher levels of problem behavior/attention initially will benefit more from the mindset intervention, particularly the embedded mindset intervention. It is hypothesized that no differences based on gender or race.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reading Problem

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Random assignment through stratification on the screening score to one of three groups: Study 1: (a) Reading Intervention Plus Mindset, (b) Reading Intervention, or (c) Business as Usual comparison. Study 2: (a) Reading Intervention Embedded with Mindset or (b) Business as Usual comparison.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
580 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reading Plus Mindset
Arm Type
Experimental
Arm Description
Multicomponent reading intervention providing explicit and systematic instruction in phonological awareness, phonics and word recognition, and reading fluency. Participants also complete mindset training and activities.
Arm Title
Reading Embedded with Mindset
Arm Type
Experimental
Arm Description
Multicomponent reading intervention (providing explicit and systematic instruction in phonological awareness, phonics and word recognition, and reading fluency) with mindset instruction specific to reading progress embedded in the intervention Participants also complete mindset training and activities.
Arm Title
Reading
Arm Type
Active Comparator
Arm Description
Multicomponent reading intervention providing explicit and systematic instruction in phonological awareness, phonics and word recognition, and reading fluency.
Arm Title
Business as Usual
Arm Type
Active Comparator
Arm Description
Participation in the typical reading instruction and intervention provided within participating schools.
Intervention Type
Behavioral
Intervention Name(s)
Reading
Intervention Description
Students are taught the processes involved in hearing, seeing, and feeling sounds as well as differences between sounds in words. New knowledge is built on previous knowledge in a step-by-step manner. Sounds build to letter-sound relationships to reading of words and syllables. Students learn the connection between reading of words (decoding) and writing/spelling words (encoding) building from simple words to multisyllabic words to text reading with fluency and understanding.
Intervention Type
Behavioral
Intervention Name(s)
Mindset
Intervention Description
Blended learning program with online and teacher-directed activities related to how the brain functions, learns, and remembers, and how it changes in a physical way when we exercise it. Instruction in how students are in control of their brain and its development, and how to apply this to their schoolwork with practical strategies for tackling academic challenges.
Intervention Type
Behavioral
Intervention Name(s)
Reading Embedded with Mindset
Intervention Description
Mindset training explicitly linked to the reading content through lesson openers, feedback prompts, and self-monitoring of mindset during reading work.
Intervention Type
Behavioral
Intervention Name(s)
Business as Usual
Other Intervention Name(s)
Typical Instruction
Intervention Description
Reading interventions already provided to students with reading difficulties as per typical procedures at the participating school
Primary Outcome Measure Information:
Title
Change in Cloze Reading Comprehension
Description
Students are instructed to read a short passage and identify a missing key word that would make sense
Time Frame
baseline, within 3 weeks of intervention completion
Title
Change in Passage Reading Comprehension Study 1 only
Description
The comprehension assessment consists of expository and narrative passages that increase in length, followed by multiple choice questions.
Time Frame
baseline, within 3 weeks of intervention completion
Title
Change in Word Reading
Description
Students reads a list of real words
Time Frame
baseline, within 3 weeks of intervention completion
Title
Change in Decoding
Description
Student reads a list of nonsense words
Time Frame
baseline, within 3 weeks of intervention completion
Title
Change in Reading Fluency
Description
Students read three passages aloud for 1 min. The total number of correct words is counted.
Time Frame
baseline, within 3 weeks of intervention completion
Title
Change in Phonological Processing Blending Study 1 only
Description
Blending requires the students to listen to a series of real words spoken in segments and earn a point for each word they blend correctly.
Time Frame
baseline, within 3 weeks of intervention completion
Title
Change in Phonological Processing Deletion Study 1 only
Description
Elision requires a student to listen to a segmented word and then pronounce the word without a segment.
Time Frame
baseline, within 3 weeks of intervention completion
Title
Change in Word Reading Fluency
Description
Students reads a list of real words. The number of words read in 45 seconds is counted
Time Frame
baseline, within 3 weeks of intervention completion
Title
Change in Decoding Fluency
Description
Student reads a list of nonsense words. The number of words read in 45 seconds is counted
Time Frame
baseline, within 3 weeks of intervention completion
Secondary Outcome Measure Information:
Title
Mindset
Description
Ratings of how student thinks about learning and the brain
Time Frame
baseline, within 3 weeks of intervention completion
Title
Change in Math Problem Solving Study 1 only
Description
Students analyze and solve math problems
Time Frame
baseline, within 3 weeks of intervention completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Fourth grader Identified with reading difficulty - Exclusion Criteria: Identified vision, hearing, or intellectual disability -
Facility Information:
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Southern Methodist University
City
Dallas
State/Province
Texas
ZIP/Postal Code
75275
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Improving Response to Intervention in Students With or at Risk of Reading Disabilities

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