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

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ClinicalTrials.gov Identifier: NCT03261661
Recruitment Status : Recruiting
First Posted : August 25, 2017
Last Update Posted : November 30, 2020
Sponsor:
Collaborators:
Southern Methodist University
Florida State University
Information provided by (Responsible Party):
Jeanne Wanzek, Vanderbilt University

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.

Condition or disease Intervention/treatment Phase
Reading Problem Behavioral: Reading Behavioral: Mindset Behavioral: Reading Embedded with Mindset Behavioral: Business as Usual Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 720 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Improving Response to Intervention in Students With or at Risk of Reading Disabilities
Actual Study Start Date : August 18, 2017
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021

Arm Intervention/treatment
Experimental: Reading Plus Mindset
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.
Behavioral: Reading
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.

Behavioral: Mindset
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.

Experimental: Reading Embedded with Mindset
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.
Behavioral: Reading
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.

Behavioral: Mindset
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.

Behavioral: Reading Embedded with Mindset
Mindset training explicitly linked to the reading content through lesson openers, feedback prompts, and self-monitoring of mindset during reading work.

Active Comparator: Reading
Multicomponent reading intervention providing explicit and systematic instruction in phonological awareness, phonics and word recognition, and reading fluency.
Behavioral: Reading
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.

Active Comparator: Business as Usual
Participation in the typical reading instruction and intervention provided within participating schools.
Behavioral: Business as Usual
Reading interventions already provided to students with reading difficulties as per typical procedures at the participating school
Other Name: Typical Instruction




Primary Outcome Measures :
  1. Change in Cloze Reading Comprehension [ Time Frame: baseline, within 3 weeks of intervention completion ]
    Students are instructed to read a short passage and identify a missing key word that would make sense

  2. Change in Passage Reading Comprehension Study 1 only [ Time Frame: baseline, within 3 weeks of intervention completion ]
    The comprehension assessment consists of expository and narrative passages that increase in length, followed by multiple choice questions.

  3. Change in Word Reading [ Time Frame: baseline, within 3 weeks of intervention completion ]
    Students reads a list of real words

  4. Change in Decoding [ Time Frame: baseline, within 3 weeks of intervention completion ]
    Student reads a list of nonsense words

  5. Change in Reading Fluency [ Time Frame: baseline, within 3 weeks of intervention completion ]
    Students read three passages aloud for 1 min. The total number of correct words is counted.

  6. Change in Phonological Processing Blending Study 1 only [ Time Frame: baseline, within 3 weeks of intervention completion ]
    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.

  7. Change in Phonological Processing Deletion Study 1 only [ Time Frame: baseline, within 3 weeks of intervention completion ]
    Elision requires a student to listen to a segmented word and then pronounce the word without a segment.

  8. Change in Word Reading Fluency [ Time Frame: baseline, within 3 weeks of intervention completion ]
    Students reads a list of real words. The number of words read in 45 seconds is counted

  9. Change in Decoding Fluency [ Time Frame: baseline, within 3 weeks of intervention completion ]
    Student reads a list of nonsense words. The number of words read in 45 seconds is counted


Secondary Outcome Measures :
  1. Mindset [ Time Frame: baseline, within 3 weeks of intervention completion ]
    Ratings of how student thinks about learning and the brain

  2. Change in Math Problem Solving Study 1 only [ Time Frame: baseline, within 3 weeks of intervention completion ]
    Students analyze and solve math problems



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   9 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Fourth grader Identified with reading difficulty

-

Exclusion Criteria:

Identified vision, hearing, or intellectual disability

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03261661


Contacts
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Contact: Jennifer Educational Consultant (615) 875-8389 jennifer.l.shearon@vanderbilt.edu

Locations
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United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37203
Contact: Jennifer Educational Consultant    615-875-8389      
United States, Texas
Southern Methodist University Recruiting
Dallas, Texas, United States, 75275
Contact: Brenna Research Assistant Professor    214-768-3720      
Sponsors and Collaborators
Vanderbilt University
Southern Methodist University
Florida State University
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Responsible Party: Jeanne Wanzek, Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT03261661    
Other Study ID Numbers: 170686
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: November 30, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dyslexia
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Learning Disorders
Neurodevelopmental Disorders
Mental Disorders