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Evidence-Based Interventions to Enhance Outcomes Among Struggling Readers

Primary Purpose

Reading Disability, Anxiety

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reading
Anxiety Management
Classroom Business as Usual
Attention Control (math practice)
Sponsored by
Boston University Charles River Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Reading Disability

Eligibility Criteria

8 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Students enrolled in the 3rd or 4th grade
  • Demonstrate difficulty with reading (which is defined as scoring at or below a standard score of 90 on the Gates MacGinite Reading Comprehension Test
  • Difficulty with reading must be confirmed by classroom teacher/school

Exclusion Criteria:

  • Students with limited English proficient (due to all assessments being administered in English only)
  • Students in life skills classes (due to task appropriateness)
  • Students who have an unrelated neurological disorder (e.g., tumor, traumatic brain injury)
  • Students who have a severe psychiatric disorder that prevents assessment (e.g., autism), or who have an uncorrected sensory disorder

Sites / Locations

  • University of Texas at AustinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Reading Plus Attention Control

Reading Plus Anxiety

BAU

Arm Description

Outcomes

Primary Outcome Measures

Test of Word Reading Efficiency
Multidimensional Anxiety Scale for Children
39-item scale of anxiety comprised of four subscales: Physical Symptoms, Harm Avoidance, Social Anxiety, and Separation/Panic. Response options range from 0-3. A total score is comprised of all subscales added together. The total score can range from 0-117. The range of the subscales are as follows: Physical Symptoms (0-36), Harm Avoidance (0-27), Social Anxiety (0-27), Separation/Panic (0-27). Higher scores indicate more anxiety. There are child, parent, teacher versions of this scale.
Woodcock-Johnson Psycho-Educational Test Battery-III
Two subtests: Letter-Word Identification and Word Attack. Scores are reported as standard scores in a range of 0-200+ or percentile ranks in a range of 0.1 to 99.9. The higher the score the greater the achievement level of the student.

Secondary Outcome Measures

Children's Test Anxiety Scale
30-item scale with a 4-point Likert Scale (1-4). Scale ranges from 30-120 with higher scores indicating greater test anxiety.
Reading Anxiety Scale
6-item scale adapted from the Wigfield and Meece (1988) Math Anxiety Scale. Designed to assess worries and stressed feelings about reading instruction and reading tests. Participants responded to each item with a 5-point Likert Scale from Never to Always. Higher scores indicate greater levels of reading anxiety.
Attention
child attention scale, Effortful Control-Persistence/Low Distractibility subscale, Strength and Weaknesses of Attention-Deficit/Hyperactivity Disorder, parent/teacher reported attention
Test of Silent Word Reading Efficiency and Comprehension
Dynamic Indicators of Basic Early Literacy Skills
Oral Reading Fluency
Beck Anxiety Inventory
Self-report measure of anxiety in the past month. 21-item scale with a 4-point Likert scale from 0-3. Items summed together. Scale range from 0-63. Score of 0-21= low anxiety. Score of 22-35 = moderate anxiety. Score of 36 and above = potentially concerning levels of anxiety. Administered to parents.
Beck Youth Inventories
Self-report measure comprised of five inventories, which measure depression, anxiety, anger, disruptive behavior, and self-concept. Each inventory has 20-items which are scored on a 4-point Likert scale (0-3). Higher scores indicate greater amounts of concept (i.e., depression, anxiety, anger, disruptive behavior, and self-concept) being measured.
Stress management skills evaluation
Confusion, Hubbub, and Order Scale (CHAOS Survey)
15-items with a 4-point Likert Scale (1-4) measuring the home environment. Completed by parent/caregiver. Total score is created by summing the responses to the items. Range is 15-60. Higher scores indicate more chaotic home environments.
Reading Comprehension
Kaufman Test of Educational Achievement-III (KTEA-3)
Fluency/Comprehension
Test of Silent Word Reading Fluency
Verbal Knowledge/Matrices
Kaufman Brief Intelligence Test
Math Calculation
Woodcock-Johnson Psycho-Educational Test Battery-III Calculation
Essential Word Knowledge
Reading Comprehension
Gates-MacGinitie Reading Comprehension

Full Information

First Posted
February 9, 2017
Last Updated
September 9, 2019
Sponsor
Boston University Charles River Campus
Collaborators
University of Texas at Austin
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1. Study Identification

Unique Protocol Identification Number
NCT04059939
Brief Title
Evidence-Based Interventions to Enhance Outcomes Among Struggling Readers
Official Title
Evidence-Based Interventions to Enhance Outcomes Among Struggling Readers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston University Charles River Campus
Collaborators
University of Texas at Austin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Despite decades of research on reading disabilities, little is known about improving reading in the middle grades (i.e., grades 3-6) and advancements have been hindered by the narrow focus on reading problems alone without acknowledgement of non-academic factors shown to affect learning (e.g., child self-regulation). This proposal employs a highly innovative approach aimed at improving intervention outcomes through the integration of evidence-based practices for addressing reading, as well as self-regulation/socioemotional skills, difficulties known to occur in a substantial percentage of struggling readers and to negatively influence academic performance. This project represents translational research that directly informs the practice community (schools, clinicians, teachers, parents), by identifying novel instructional practices that can be aggregated to more effectively influence student outcomes and reduce disparities in academic and socioemotional domains.
Detailed Description
While considerable knowledge has been accumulated on improving reading for students with reading disabilities in the primary grades, reading interventions conducted with middle-grades (i.e., grades 3-6) have been rare and have typically evidenced low impacts, even when more intensive interventions are provided for increasingly longer durations. One hindrance to extant interventions has been the narrow focus on reading problems without addressing non-academic (e.g., self-regulation, socioemotional) factors known to also affect learning. Thus, investigations of the efficacy derived from integrating additional components into standard reading skills interventions are necessary. Anxiety represents a particularly salient target for such an approach, as it is among the most commonly reported mental health issues of childhood, and significant associations have been found between anxiety and academic outcomes. Further, an overwhelming number of children who are struggling to read or who fail to respond to reading interventions report elevated anxiety. The purpose of this proposal is to evaluate an integrated program designed for middle-grade readers and comprised of evidence-based practices for the treatment of anxiety and reading difficulties. A pilot study of this program, conducted with 36 students randomized to treatment and control conditions, demonstrated its feasibility and positive effects on anxiety outcomes. The RCT will extend this work by comparing the combined reading and anxiety intervention with a reading-only condition and a control condition. Struggling readers will be included in this study and will receive two years of intervention. The study will assess efficacy of the interventions at reducing anxiety and improving reading at post-intervention and 6-month follow-up (Aim 1). This project significantly enhances extant research on interventions for struggling reading by examining mechanisms of action associated with augmented outcomes among students who receive the combined intervention (Aim 2), and by determining potential moderators of intervention effects (Aim 3). In all, 300 ethnically diverse students will be recruited. A multi-informant (student, parent, teacher), multi-method (e.g., survey, standardized test, experiential sampling) assessment will be used. Relevance of this project lies in the determination of whether the inclusion of anxiety management skills enhances existing intervention outcomes for struggling readers in the upper elementary grades (concurrently/longitudinally). Examination of contextual and mitigating factors are further relevant for understanding the complex etiology of response to intervention among struggling readers. This project represents translational research that directly informs the practice community (e.g., clinicians, teachers) by identifying novel instructional practices that can be aggregated to more effectively influence student outcomes. By providing socioemotional skills training with a reading intervention using a school-based delivery model, this work has the potential of reducing disparities in mental health outcomes by reaching students of diverse backgrounds (e.g., ethnicity, SES) who would be otherwise less likely to receive such services.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reading Disability, Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
participants and evaluators are not told which interventions individual participants have been assigned to
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Reading Plus Attention Control
Arm Type
Experimental
Arm Title
Reading Plus Anxiety
Arm Type
Experimental
Arm Title
BAU
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Reading
Intervention Description
Small group reading instruction
Intervention Type
Behavioral
Intervention Name(s)
Anxiety Management
Intervention Description
small group anxiety management skills instruction
Intervention Type
Other
Intervention Name(s)
Classroom Business as Usual
Intervention Description
Classroom Business as Usual
Intervention Type
Other
Intervention Name(s)
Attention Control (math practice)
Intervention Description
Attention Control (math practice)
Primary Outcome Measure Information:
Title
Test of Word Reading Efficiency
Time Frame
Change from baseline to post-intervention year 1, change from baseline to post-intervention year 2, change from year 1 to year 2, change from year 2 to year 3
Title
Multidimensional Anxiety Scale for Children
Description
39-item scale of anxiety comprised of four subscales: Physical Symptoms, Harm Avoidance, Social Anxiety, and Separation/Panic. Response options range from 0-3. A total score is comprised of all subscales added together. The total score can range from 0-117. The range of the subscales are as follows: Physical Symptoms (0-36), Harm Avoidance (0-27), Social Anxiety (0-27), Separation/Panic (0-27). Higher scores indicate more anxiety. There are child, parent, teacher versions of this scale.
Time Frame
Change from baseline to post-intervention year 1, change from baseline to post-intervention year 2, change from year 1 to year 2, change from year 2 to year 3
Title
Woodcock-Johnson Psycho-Educational Test Battery-III
Description
Two subtests: Letter-Word Identification and Word Attack. Scores are reported as standard scores in a range of 0-200+ or percentile ranks in a range of 0.1 to 99.9. The higher the score the greater the achievement level of the student.
Time Frame
Change from baseline to post-intervention year 1, change from baseline to post-intervention year 2, change from year 1 to year 2, change from year 2 to year 3
Secondary Outcome Measure Information:
Title
Children's Test Anxiety Scale
Description
30-item scale with a 4-point Likert Scale (1-4). Scale ranges from 30-120 with higher scores indicating greater test anxiety.
Time Frame
Change from baseline to post-intervention year 1, change from baseline to post-intervention year 2, change from year 1 to year 2, change from year 2 to year 3
Title
Reading Anxiety Scale
Description
6-item scale adapted from the Wigfield and Meece (1988) Math Anxiety Scale. Designed to assess worries and stressed feelings about reading instruction and reading tests. Participants responded to each item with a 5-point Likert Scale from Never to Always. Higher scores indicate greater levels of reading anxiety.
Time Frame
Change from baseline to post-intervention year 1, change from baseline to post-intervention year 2, change from year 1 to year 2, change from year 2 to year 3
Title
Attention
Description
child attention scale, Effortful Control-Persistence/Low Distractibility subscale, Strength and Weaknesses of Attention-Deficit/Hyperactivity Disorder, parent/teacher reported attention
Time Frame
Change from baseline to post-intervention year 1, change from baseline to post-intervention year 2, change from year 1 to year 2, change from year 2 to year 3
Title
Test of Silent Word Reading Efficiency and Comprehension
Time Frame
Change from baseline to post-intervention year 1, change from baseline to post-intervention year 2, change from year 1 to year 2, change from year 2 to year 3
Title
Dynamic Indicators of Basic Early Literacy Skills
Description
Oral Reading Fluency
Time Frame
Change from baseline to post-intervention year 1, change from baseline to post-intervention year 2, change from year 1 to year 2, change from year 2 to year 3
Title
Beck Anxiety Inventory
Description
Self-report measure of anxiety in the past month. 21-item scale with a 4-point Likert scale from 0-3. Items summed together. Scale range from 0-63. Score of 0-21= low anxiety. Score of 22-35 = moderate anxiety. Score of 36 and above = potentially concerning levels of anxiety. Administered to parents.
Time Frame
Change from baseline to post-intervention year 1, change from baseline to post-intervention year 2, change from year 1 to year 2, change from year 2 to year 3
Title
Beck Youth Inventories
Description
Self-report measure comprised of five inventories, which measure depression, anxiety, anger, disruptive behavior, and self-concept. Each inventory has 20-items which are scored on a 4-point Likert scale (0-3). Higher scores indicate greater amounts of concept (i.e., depression, anxiety, anger, disruptive behavior, and self-concept) being measured.
Time Frame
Change from baseline to post-intervention year 1, change from baseline to post-intervention year 2, change from year 1 to year 2, change from year 2 to year 3
Title
Stress management skills evaluation
Time Frame
Change from baseline to post-intervention year 1, change from baseline to post-intervention year 2, change from year 1 to year 2, change from year 2 to year 3
Title
Confusion, Hubbub, and Order Scale (CHAOS Survey)
Description
15-items with a 4-point Likert Scale (1-4) measuring the home environment. Completed by parent/caregiver. Total score is created by summing the responses to the items. Range is 15-60. Higher scores indicate more chaotic home environments.
Time Frame
Change from baseline to post-intervention year 1, change from baseline to post-intervention year 2, change from year 1 to year 2, change from year 2 to year 3
Title
Reading Comprehension
Description
Kaufman Test of Educational Achievement-III (KTEA-3)
Time Frame
Change from baseline to post-intervention year 1, change from baseline to post-intervention year 2, change from year 1 to year 2, change from year 2 to year 3
Title
Fluency/Comprehension
Description
Test of Silent Word Reading Fluency
Time Frame
Change from baseline to post-intervention year 1, change from baseline to post-intervention year 2, change from year 1 to year 2, change from year 2 to year 3
Title
Verbal Knowledge/Matrices
Description
Kaufman Brief Intelligence Test
Time Frame
Change from baseline to post-intervention year 1, change from baseline to post-intervention year 2, change from year 1 to year 2, change from year 2 to year 3
Title
Math Calculation
Description
Woodcock-Johnson Psycho-Educational Test Battery-III Calculation
Time Frame
Change from baseline to post-intervention year 2
Title
Essential Word Knowledge
Time Frame
Change from baseline to post-intervention year 2
Title
Reading Comprehension
Description
Gates-MacGinitie Reading Comprehension
Time Frame
Change from post-intervention year 1 to post-intervention year 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Students enrolled in the 3rd or 4th grade Demonstrate difficulty with reading (which is defined as scoring at or below a standard score of 90 on the Gates MacGinite Reading Comprehension Test Difficulty with reading must be confirmed by classroom teacher/school Exclusion Criteria: Students with limited English proficient (due to all assessments being administered in English only) Students in life skills classes (due to task appropriateness) Students who have an unrelated neurological disorder (e.g., tumor, traumatic brain injury) Students who have a severe psychiatric disorder that prevents assessment (e.g., autism), or who have an uncorrected sensory disorder
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amie E Grills, PhD
Phone
617-353-7107
Email
agrills@bu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sharon Vaughn, PhD
Phone
512-232-2357
Email
srvaughn@austin.utexas.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amie E Grills, PhD
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sharon Vaughn, PhD
Organizational Affiliation
University of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharon Vaughn, PhD
Phone
512-232-2357
Email
srvaughn@austin.utexas.edu
First Name & Middle Initial & Last Name & Degree
Sharon Vaughn, PhD
First Name & Middle Initial & Last Name & Degree
Gregory Roberts, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Evidence-Based Interventions to Enhance Outcomes Among Struggling Readers

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