NCT03261661

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
580

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2017

Completed
11 days until next milestone

Study Start

First participant enrolled

August 18, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 25, 2017

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

August 4, 2021

Status Verified

August 1, 2021

Enrollment Period

3.8 years

First QC Date

August 7, 2017

Last Update Submit

August 3, 2021

Conditions

Outcome Measures

Primary Outcomes (9)

  • Change in Cloze Reading Comprehension

    Students are instructed to read a short passage and identify a missing key word that would make sense

    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.

    baseline, within 3 weeks of intervention completion

  • Change in Word Reading

    Students reads a list of real words

    baseline, within 3 weeks of intervention completion

  • Change in Decoding

    Student reads a list of nonsense words

    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.

    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.

    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.

    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

    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

    baseline, within 3 weeks of intervention completion

Secondary Outcomes (2)

  • Mindset

    baseline, within 3 weeks of intervention completion

  • Change in Math Problem Solving Study 1 only

    baseline, within 3 weeks of intervention completion

Study Arms (4)

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.

Behavioral: ReadingBehavioral: 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.

Behavioral: ReadingBehavioral: MindsetBehavioral: 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.

Behavioral: Reading

Business as Usual

ACTIVE COMPARATOR

Participation in the typical reading instruction and intervention provided within participating schools.

Behavioral: Business as Usual

Interventions

ReadingBEHAVIORAL

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.

ReadingReading Embedded with MindsetReading Plus Mindset
MindsetBEHAVIORAL

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 MindsetReading Plus Mindset

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

Reading Embedded with Mindset

Reading interventions already provided to students with reading difficulties as per typical procedures at the participating school

Also known as: Typical Instruction
Business as Usual

Eligibility Criteria

Age9 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Fourth grader Identified with reading difficulty

You may not qualify if:

  • Identified vision, hearing, or intellectual disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Vanderbilt University

Nashville, Tennessee, 37203, United States

Location

Southern Methodist University

Dallas, Texas, 75275, United States

Location

MeSH Terms

Interventions

Stress Mindset MeasureCommerce

Intervention Hierarchy (Ancestors)

Technology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 7, 2017

First Posted

August 25, 2017

Study Start

August 18, 2017

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

August 4, 2021

Record last verified: 2021-08

Locations