Reading ProblemNCT03261661
Improving Response to Intervention in Students With or at Risk of Reading Disabilities
A study testing Reading, Mindset and Reading Embedded with Mindset in people with Reading Problem, run by Vanderbilt University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 11 years
- Conditions the study is for
- Reading Problem
- What is being tested?
- Reading, Mindset and Reading Embedded with Mindset
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 580 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Aug 2017to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Fourth grader Identified with reading difficulty
- -
Who cannot join
- Identified vision, hearing, or intellectual disability
- -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Southern Methodist University
Dallas, Texas, 75275
Vanderbilt University
Nashville, Tennessee, 37203
About this study
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.
Read the 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.
- Conditions
- Reading Problem
- Being tested
- Reading, Mindset, Reading Embedded with Mindset, Business as Usual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReadingBehavioural
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.
MindsetBehavioural
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.
Reading Embedded with MindsetBehavioural
Mindset training explicitly linked to the reading content through lesson openers, feedback prompts, and self-monitoring of mindset during reading work.
Business as UsualBehavioural
Also called Typical Instruction
Reading interventions already provided to students with reading difficulties as per typical procedures at the participating school
| Study group | Role | What they receive |
|---|---|---|
| Reading Plus Mindset | Experimental | 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. Receives: Behavioral: Reading; Behavioral: Mindset |
| Reading Embedded with Mindset | Experimental | 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. Receives: Behavioral: Reading; Behavioral: Mindset; Behavioral: Reading Embedded with Mindset |
| Reading | Active comparator | Multicomponent reading intervention providing explicit and systematic instruction in phonological awareness, phonics and word recognition, and reading fluency. Receives: Behavioral: Reading |
| Business as Usual | Active comparator | Participation in the typical reading instruction and intervention provided within participating schools. Receives: Behavioral: Business as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cloze Reading Comprehension
Students are instructed to read a short passage and identify a missing key word that would make sense
Measured: baseline, within 3 weeks of intervention completion
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.
Measured: baseline, within 3 weeks of intervention completion
Change in Word Reading
Students reads a list of real words
Measured: baseline, within 3 weeks of intervention completion
Change in Decoding
Student reads a list of nonsense words
Measured: baseline, within 3 weeks of intervention completion
Change in Reading Fluency
Students read three passages aloud for 1 min. The total number of correct words is counted.
Measured: baseline, within 3 weeks of intervention completion
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.
Measured: baseline, within 3 weeks of intervention completion
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.
Measured: baseline, within 3 weeks of intervention completion
Change in Word Reading Fluency
Students reads a list of real words. The number of words read in 45 seconds is counted
Measured: baseline, within 3 weeks of intervention completion
Change in Decoding Fluency
Student reads a list of nonsense words. The number of words read in 45 seconds is counted
Measured: baseline, within 3 weeks of intervention completion
Secondary outcomes (2)
Mindset
Ratings of how student thinks about learning and the brain
Measured: baseline, within 3 weeks of intervention completion
Change in Math Problem Solving Study 1 only
Students analyze and solve math problems
Measured: baseline, within 3 weeks of intervention completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start18 Aug 2017
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reading ProblemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 580 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- Southern Methodist University, Florida State University
- Responsible party
- Principal investigator, Jeanne Wanzek, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261661
- Sponsor's protocol ID
- 170686
- Status last verified
- Aug 2021
- First submitted
- 7 Aug 2017
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Response to Intervention in Students With or at Risk of Reading Disabilities
- ClinicalTrials.gov ID
- NCT03261661
- Acronym / sponsor ID
- 170686
- Conditions
- Reading Problem
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 580 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- Southern Methodist University, Florida State University
- Study start
- 18 Aug 2017 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 25 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Reading Plus Mindset | Experimental | Behavioral: Reading, Behavioral: MindsetMulticomponent reading intervention providing explicit and systematic instruction in phonological awareness, phonics and word recognition, and reading fluency. Participants also complete mindset training and activities. |
| Reading Embedded with Mindset | Experimental | Behavioral: Reading, Behavioral: Mindset, Behavioral: Reading Embedded with MindsetMulticomponent 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. |
| Reading | Active comparator | Behavioral: ReadingMulticomponent reading intervention providing explicit and systematic instruction in phonological awareness, phonics and word recognition, and reading fluency. |
| Business as Usual | Active comparator | Behavioral: Business as UsualParticipation in the typical reading instruction and intervention provided within participating schools. |
Who may qualify
- Ages
- 9 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Fourth grader Identified with reading difficulty
- -
Key exclusion criteria (2 listed)
- Identified vision, hearing, or intellectual disability
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReadingStudents 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. | Behavioural | Reading, Reading Embedded with Mindset, Reading Plus Mindset |
| MindsetBlended 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. | Behavioural | Reading Embedded with Mindset, Reading Plus Mindset |
| Reading Embedded with MindsetMindset training explicitly linked to the reading content through lesson openers, feedback prompts, and self-monitoring of mindset during reading work. | Behavioural | Reading Embedded with Mindset |
| Business as UsualAlso: Typical InstructionReading interventions already provided to students with reading difficulties as per typical procedures at the participating school | Behavioural | Business as Usual |
Primary outcome
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 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.
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 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.
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.
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
2 secondary outcomes
Mindset
Time frame: baseline, within 3 weeks of intervention completion
Change in Math Problem Solving Study 1 only
Time frame: baseline, within 3 weeks of intervention completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reading, Mindset and Reading Embedded with Mindset in people with Reading Problem, run by Vanderbilt University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cloze Reading Comprehension (time frame: baseline, within 3 weeks of intervention completion). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2021.