- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04059939
Evidence-Based Interventions to Enhance Outcomes Among Struggling Readers
September 9, 2019 updated by: Amie E. Grills, Boston University Charles River Campus
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.
Study Overview
Status
Unknown
Conditions
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.
Study Type
Interventional
Enrollment (Anticipated)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Amie E Grills, PhD
- Phone Number: 617-353-7107
- Email: agrills@bu.edu
Study Contact Backup
- Name: Sharon Vaughn, PhD
- Phone Number: 512-232-2357
- Email: srvaughn@austin.utexas.edu
Study Locations
-
-
Texas
-
Austin, Texas, United States, 78712
- Recruiting
- University of Texas at Austin
-
Contact:
- Sharon Vaughn, PhD
- Phone Number: 512-232-2357
- Email: srvaughn@austin.utexas.edu
-
Principal Investigator:
- Sharon Vaughn, PhD
-
Sub-Investigator:
- Gregory Roberts, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 14 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Reading Plus Attention Control
|
Small group reading instruction
Attention Control (math practice)
|
Experimental: Reading Plus Anxiety
|
Small group reading instruction
small group anxiety management skills instruction
|
Active Comparator: BAU
|
Classroom Business as Usual
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
|
Multidimensional Anxiety Scale for Children
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
|
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.
|
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
|
Woodcock-Johnson Psycho-Educational Test Battery-III
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
|
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.
|
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 Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Children's Test Anxiety 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
|
30-item scale with a 4-point Likert Scale (1-4).
Scale ranges from 30-120 with higher scores indicating greater test anxiety.
|
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
|
Reading Anxiety 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
|
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.
|
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
|
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
|
child attention scale, Effortful Control-Persistence/Low Distractibility subscale, Strength and Weaknesses of Attention-Deficit/Hyperactivity Disorder, parent/teacher reported attention
|
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
|
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
|
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
|
|
Dynamic Indicators of Basic Early Literacy Skills
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
|
Oral Reading Fluency
|
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
|
Beck Anxiety Inventory
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
|
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.
|
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
|
Beck Youth Inventories
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
|
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.
|
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
|
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
|
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
|
|
Confusion, Hubbub, and Order Scale (CHAOS Survey)
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
|
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.
|
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
|
Reading 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
|
Kaufman Test of Educational Achievement-III (KTEA-3)
|
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
|
Fluency/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
|
Test of Silent Word Reading Fluency
|
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
|
Verbal Knowledge/Matrices
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
|
Kaufman Brief Intelligence Test
|
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
|
Math Calculation
Time Frame: Change from baseline to post-intervention year 2
|
Woodcock-Johnson Psycho-Educational Test Battery-III Calculation
|
Change from baseline to post-intervention year 2
|
Essential Word Knowledge
Time Frame: Change from baseline to post-intervention year 2
|
Change from baseline to post-intervention year 2
|
|
Reading Comprehension
Time Frame: Change from post-intervention year 1 to post-intervention year 2
|
Gates-MacGinitie Reading Comprehension
|
Change from post-intervention year 1 to post-intervention year 2
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Amie E Grills, PhD, Boston University
- Principal Investigator: Sharon Vaughn, PhD, University of Texas at Austin
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2017
Primary Completion (Anticipated)
January 1, 2022
Study Completion (Anticipated)
January 1, 2022
Study Registration Dates
First Submitted
February 9, 2017
First Submitted That Met QC Criteria
August 14, 2019
First Posted (Actual)
August 16, 2019
Study Record Updates
Last Update Posted (Actual)
September 11, 2019
Last Update Submitted That Met QC Criteria
September 9, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RHD087706A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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