<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03261661</url>
  </required_header>
  <id_info>
    <org_study_id>170686</org_study_id>
    <nct_id>NCT03261661</nct_id>
  </id_info>
  <brief_title>Improving Response to Intervention in Students With or at Risk of Reading Disabilities</brief_title>
  <official_title>Improving Response to Intervention in Students With or at Risk of Reading Disabilities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Southern Methodist University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Florida State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Vanderbilt University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the proposed studies is to examine a reading intervention for fourth grade&#xD;
      students with reading difficulties that integrate work in mindset (beliefs about whether&#xD;
      abilities are innate or can be developed) with the academic component of reading.&#xD;
      Specifically, the investigators will examine the extent to which integrating mindset&#xD;
      intervention improves student response to reading intervention. The investigators will use&#xD;
      previous research in intensive reading intervention for students with reading difficulties in&#xD;
      the upper elementary grades to examine an intervention that addresses reading skill deficits,&#xD;
      while also providing mindset training along with (Study 1) or embedded in (Study 2) the&#xD;
      reading intervention. It is hypothesized that students in the reading intervention with&#xD;
      mindset conditions will improve their reading outcomes more than students in the reading&#xD;
      intervention only and business as usual groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the proposed studies is to examine a reading intervention for fourth grade&#xD;
      students with RD that integrates the psychosocial component of mindset with the academic&#xD;
      component of reading. Specifically, the investigators will examine the extent to which&#xD;
      integrating mindset intervention improves student response to reading intervention. The&#xD;
      investigators will use previous research in intensive reading intervention for students with&#xD;
      RD in the upper elementary grades to examine an intervention that addresses reading skill&#xD;
      deficits, while providing mindset training along with (Study 1) or embedded in (Study 2) the&#xD;
      reading intervention.&#xD;
&#xD;
      Specific Aim 1. To determine the effects of intensive reading intervention with mindset&#xD;
      training (Reading Intervention Plus Mindset) relative to reading intervention alone and&#xD;
      business as usual comparison on the academic outcomes of fourth grade students with or&#xD;
      at-risk for reading disabilities. The proposed study will target students with or at-risk for&#xD;
      reading disabilities in fourth grade to examine the effects of reading intervention with&#xD;
      mindset training relative to reading intervention alone and business as usual comparison on&#xD;
      students' mindset, general academic achievement, phonological awareness, word reading,&#xD;
      fluency, and reading comprehension outcomes. Students will be randomly assigned to condition&#xD;
      with students in the Reading Intervention Plus Mindset condition receiving the mindset&#xD;
      training along with their reading intervention. Students assigned to the Reading Intervention&#xD;
      will receive the same reading intervention but without the mindset training. Students in the&#xD;
      Business as Usual condition will continue to receive their typical school services which will&#xD;
      be carefully documented. It is hypothesized that students in the Reading Intervention Plus&#xD;
      Mindset condition will improve their reading outcomes more than students in the Reading&#xD;
      Intervention only and Business as Usual groups by continuing to develop a growth mindset to&#xD;
      work through the challenges in their reading development and, thus, being able to progress&#xD;
      more efficiently in the reading intervention.&#xD;
&#xD;
      Specific Aim 2. To determine the effects of embedding mindset training in an intensive&#xD;
      reading intervention on the mindset and academic outcomes of fourth grade students with or&#xD;
      at-risk for reading disabilities. The proposed study will use the results from Specific Aim 1&#xD;
      to further examine the effects of an intensive reading intervention with mindset embedded in&#xD;
      the content with a new cohort of fourth grade students with or at-risk for reading&#xD;
      disabilities. Embedding mindset practices directly in the content area of difficulty for&#xD;
      students with learning difficulties could be more powerful than separate mindset training.&#xD;
      Students will be randomly assigned to one of two conditions (Embedded or Business as Usual).&#xD;
      The investigators will examine the effects of intervention on students' mindset, word&#xD;
      reading, fluency, and reading comprehension measures. It is hypothesized that embedding&#xD;
      mindset training directly in the reading content will further improve student reading&#xD;
      outcomes by allowing students to directly apply a growth mindset to their work in the area of&#xD;
      difficulty, reading.&#xD;
&#xD;
      Specific Aim 3. To link student characteristics to response to intervention. The proposed&#xD;
      study will link students' initial reading achievement, initial mindset, vocabulary ability,&#xD;
      behavior/attention as well as race, sex, socioeconomic status, and parents' educational&#xD;
      background to student response to intervention. It is hypothesized that students with lower&#xD;
      initial reading achievement, higher initial levels of fixed mindset, higher vocabulary, lower&#xD;
      parent educational background or socioeconomic status, and/or higher levels of problem&#xD;
      behavior/attention initially will benefit more from the mindset intervention, particularly&#xD;
      the embedded mindset intervention. It is hypothesized that no differences based on gender or&#xD;
      race.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 18, 2017</start_date>
  <completion_date type="Actual">May 31, 2021</completion_date>
  <primary_completion_date type="Actual">May 31, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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.&#xD;
Study 2: (a) Reading Intervention Embedded with Mindset or (b) Business as Usual comparison.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Cloze Reading Comprehension</measure>
    <time_frame>baseline, within 3 weeks of intervention completion</time_frame>
    <description>Students are instructed to read a short passage and identify a missing key word that would make sense</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Passage Reading Comprehension Study 1 only</measure>
    <time_frame>baseline, within 3 weeks of intervention completion</time_frame>
    <description>The comprehension assessment consists of expository and narrative passages that increase in length, followed by multiple choice questions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Word Reading</measure>
    <time_frame>baseline, within 3 weeks of intervention completion</time_frame>
    <description>Students reads a list of real words</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Decoding</measure>
    <time_frame>baseline, within 3 weeks of intervention completion</time_frame>
    <description>Student reads a list of nonsense words</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Reading Fluency</measure>
    <time_frame>baseline, within 3 weeks of intervention completion</time_frame>
    <description>Students read three passages aloud for 1 min. The total number of correct words is counted.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Phonological Processing Blending Study 1 only</measure>
    <time_frame>baseline, within 3 weeks of intervention completion</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Phonological Processing Deletion Study 1 only</measure>
    <time_frame>baseline, within 3 weeks of intervention completion</time_frame>
    <description>Elision requires a student to listen to a segmented word and then pronounce the word without a segment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Word Reading Fluency</measure>
    <time_frame>baseline, within 3 weeks of intervention completion</time_frame>
    <description>Students reads a list of real words. The number of words read in 45 seconds is counted</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Decoding Fluency</measure>
    <time_frame>baseline, within 3 weeks of intervention completion</time_frame>
    <description>Student reads a list of nonsense words. The number of words read in 45 seconds is counted</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mindset</measure>
    <time_frame>baseline, within 3 weeks of intervention completion</time_frame>
    <description>Ratings of how student thinks about learning and the brain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Math Problem Solving Study 1 only</measure>
    <time_frame>baseline, within 3 weeks of intervention completion</time_frame>
    <description>Students analyze and solve math problems</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">580</enrollment>
  <condition>Reading Problem</condition>
  <arm_group>
    <arm_group_label>Reading Plus Mindset</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reading Embedded with Mindset</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reading</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Multicomponent reading intervention providing explicit and systematic instruction in phonological awareness, phonics and word recognition, and reading fluency.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Business as Usual</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participation in the typical reading instruction and intervention provided within participating schools.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Reading</intervention_name>
    <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.</description>
    <arm_group_label>Reading</arm_group_label>
    <arm_group_label>Reading Embedded with Mindset</arm_group_label>
    <arm_group_label>Reading Plus Mindset</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindset</intervention_name>
    <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.</description>
    <arm_group_label>Reading Embedded with Mindset</arm_group_label>
    <arm_group_label>Reading Plus Mindset</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Reading Embedded with Mindset</intervention_name>
    <description>Mindset training explicitly linked to the reading content through lesson openers, feedback prompts, and self-monitoring of mindset during reading work.</description>
    <arm_group_label>Reading Embedded with Mindset</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Business as Usual</intervention_name>
    <description>Reading interventions already provided to students with reading difficulties as per typical procedures at the participating school</description>
    <arm_group_label>Business as Usual</arm_group_label>
    <other_name>Typical Instruction</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Fourth grader Identified with reading difficulty&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Identified vision, hearing, or intellectual disability&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Vanderbilt University</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Methodist University</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75275</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>August 3, 2021</last_update_submitted>
  <last_update_submitted_qc>August 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University</investigator_affiliation>
    <investigator_full_name>Jeanne Wanzek</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyslexia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03261661
org study id: 170686
nct id: NCT03261661
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
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.
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Cloze Reading Comprehension
time frame: baseline, within 3 weeks of intervention completion
description: Students are instructed to read a short passage and identify a missing key word that would make sense
measure: Change in Passage Reading Comprehension Study 1 only
time frame: baseline, within 3 weeks of intervention completion
description: The comprehension assessment consists of expository and narrative passages that increase in length, followed by multiple choice questions.
measure: Change in Word Reading
time frame: baseline, within 3 weeks of intervention completion
description: Students reads a list of real words
measure: Change in Decoding
time frame: baseline, within 3 weeks of intervention completion
description: Student reads a list of nonsense words
measure: Change in Reading Fluency
time frame: baseline, within 3 weeks of intervention completion
description: Students read three passages aloud for 1 min. The total number of correct words is counted.
measure: Change in Phonological Processing Blending Study 1 only
time frame: baseline, within 3 weeks of intervention completion
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.
measure: Change in Phonological Processing Deletion Study 1 only
time frame: baseline, within 3 weeks of intervention completion
description: Elision requires a student to listen to a segmented word and then pronounce the word without a segment.
measure: Change in Word Reading Fluency
time frame: baseline, within 3 weeks of intervention completion
description: Students reads a list of real words. The number of words read in 45 seconds is counted
measure: Change in Decoding Fluency
time frame: baseline, within 3 weeks of intervention completion
description: Student reads a list of nonsense words. The number of words read in 45 seconds is counted
measure: Mindset
time frame: baseline, within 3 weeks of intervention completion
description: Ratings of how student thinks about learning and the brain
measure: Change in Math Problem Solving Study 1 only
time frame: baseline, within 3 weeks of intervention completion
description: Students analyze and solve math problems
arm group label: Reading Plus Mindset
arm group type: Experimental
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 group label: Reading Embedded with Mindset
arm group type: Experimental
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 group label: Reading
arm group type: Active Comparator
description: Multicomponent reading intervention providing explicit and systematic instruction in phonological awareness, phonics and word recognition, and reading fluency.
arm group label: Business as Usual
arm group type: Active Comparator
description: Participation in the typical reading instruction and intervention provided within participating schools.
intervention type: Behavioral
intervention name: Reading
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.
arm group label: Reading
arm group label: Reading Embedded with Mindset
arm group label: Reading Plus Mindset
intervention type: Behavioral
intervention name: Mindset
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.
arm group label: Reading Embedded with Mindset
arm group label: Reading Plus Mindset
intervention type: Behavioral
intervention name: Reading Embedded with Mindset
description: Mindset training explicitly linked to the reading content through lesson openers, feedback prompts, and self-monitoring of mindset during reading work.
arm group label: Reading Embedded with Mindset
intervention type: Behavioral
intervention name: Business as Usual
description: Reading interventions already provided to students with reading difficulties as per typical procedures at the participating school
arm group label: Business as Usual
other name: Typical Instruction
criteria: 
gender: All
minimum age: 9 Years
maximum age: 11 Years
healthy volunteers: No
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University
investigator full name: Jeanne Wanzek
investigator title: Professor
mesh term: Dyslexia