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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 : September 7, 2018
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

  Show Detailed Description

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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; (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
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 [ 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 [ 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 [ 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 [ Time Frame: baseline, within 3 weeks of intervention completion ]
    Students analyze and solve math problems



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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, Associate Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT03261661     History of Changes
Other Study ID Numbers: 170686
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018

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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
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders