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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 : October 10, 2019
Sponsor:
Collaborators:
Southern Methodist University
Florida State University
Information provided by (Responsible Party):
Jeanne Wanzek, Vanderbilt University

Tracking Information
First Submitted Date  ICMJE August 7, 2017
First Posted Date  ICMJE August 25, 2017
Last Update Posted Date October 10, 2019
Actual Study Start Date  ICMJE August 18, 2017
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2017)
  • 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
  • Change in Passage Reading Comprehension [ 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.
  • Change in Word Reading [ Time Frame: baseline, within 3 weeks of intervention completion ]
    Students reads a list of real words
  • Change in Decoding [ Time Frame: baseline, within 3 weeks of intervention completion ]
    Student reads a list of nonsense words
  • 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.
  • Change in Phonological Processing Blending [ 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.
  • Change in Phonological Processing Deletion [ 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.
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2017)
  • Mindset [ Time Frame: baseline, within 3 weeks of intervention completion ]
    Ratings of how student thinks about learning and the brain
  • Change in Math Problem Solving [ Time Frame: baseline, within 3 weeks of intervention completion ]
    Students analyze and solve math problems
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Response to Intervention in Students With or at Risk of Reading Disabilities
Official Title  ICMJE Improving Response to Intervention in Students With or at Risk of Reading Disabilities
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. The investigators will use the results from Study 1 to determine the most appropriate comparison treatment. If, as hypothesized, Study 1 results indicate Reading Intervention Plus Mindset is more beneficial than Reading Intervention alone then Reading Intervention Embedded with Mindset will be compared to Reading Intervention Plus Mindset to determine if higher effects are found when mindset is specifically embedded in the content. However, if Study 1 determines that Reading Intervention Plus Mindset does not bring added benefit to student learning then Reading Intervention Embedded with Mindset will be compared to Reading Intervention only to examine the effects of intervention when mindset is directly embedded in the reading intervention. There is also a business as usual comparison condition. Students will be randomly assigned to one of the three study conditions. The investigators will examine the effects of intervention on students' mindset, general academic achievement, phonological awareness, 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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; (b) Reading Intervention or Reading Intervention Plus Mindset (dependent on Study 1 results), or (c) Business as Usual comparison.

Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Reading Problem
Intervention  ICMJE
  • 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.
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Behavioral: Reading
    • Behavioral: Mindset
  • 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.
    Interventions:
    • Behavioral: Reading
    • Behavioral: Mindset
    • Behavioral: Reading Embedded with Mindset
  • Active Comparator: Reading
    Multicomponent reading intervention providing explicit and systematic instruction in phonological awareness, phonics and word recognition, and reading fluency.
    Intervention: Behavioral: Reading
  • Active Comparator: Business as Usual
    Participation in the typical reading instruction and intervention provided within participating schools.
    Intervention: Behavioral: Business as Usual
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 6, 2018)
720
Original Estimated Enrollment  ICMJE
 (submitted: August 22, 2017)
864
Estimated Study Completion Date  ICMJE May 31, 2021
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Fourth grader Identified with reading difficulty

-

Exclusion Criteria:

Identified vision, hearing, or intellectual disability

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 9 Years to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jennifer Educational Consultant (615) 875-8389 jennifer.l.shearon@vanderbilt.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03261661
Other Study ID Numbers  ICMJE 170686
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jeanne Wanzek, Vanderbilt University
Study Sponsor  ICMJE Vanderbilt University
Collaborators  ICMJE
  • Southern Methodist University
  • Florida State University
Investigators  ICMJE Not Provided
PRS Account Vanderbilt University
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP