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Evidence-Based Interventions to Enhance Outcomes Among Struggling Readers

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ClinicalTrials.gov Identifier: NCT04059939
Recruitment Status : Recruiting
First Posted : August 16, 2019
Last Update Posted : September 11, 2019
Sponsor:
Collaborator:
University of Texas at Austin
Information provided by (Responsible Party):
Amie E. Grills, Boston University Charles River Campus

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.

Condition or disease Intervention/treatment Phase
Reading Disability Anxiety Other: Reading Behavioral: Anxiety Management Other: Classroom Business as Usual Other: Attention Control (math practice) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: participants and evaluators are not told which interventions individual participants have been assigned to
Primary Purpose: Treatment
Official Title: Evidence-Based Interventions to Enhance Outcomes Among Struggling Readers
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Reading Plus Attention Control Other: Reading
Small group reading instruction

Other: Attention Control (math practice)
Attention Control (math practice)

Experimental: Reading Plus Anxiety Other: Reading
Small group reading instruction

Behavioral: Anxiety Management
small group anxiety management skills instruction

Active Comparator: BAU Other: Classroom Business as Usual
Classroom Business as Usual




Primary Outcome Measures :
  1. 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 ]
  2. 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.

  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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  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

  4. 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 ]
  5. 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

  6. 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.

  7. 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.

  8. 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 ]
  9. 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.

  10. 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)

  11. 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

  12. 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

  13. Math Calculation [ Time Frame: Change from baseline to post-intervention year 2 ]
    Woodcock-Johnson Psycho-Educational Test Battery-III Calculation

  14. Essential Word Knowledge [ Time Frame: Change from baseline to post-intervention year 2 ]
  15. Reading Comprehension [ Time Frame: Change from post-intervention year 1 to post-intervention year 2 ]
    Gates-MacGinitie Reading Comprehension



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04059939


Contacts
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Contact: Amie E Grills, PhD 617-353-7107 agrills@bu.edu
Contact: Sharon Vaughn, PhD 512-232-2357 srvaughn@austin.utexas.edu

Locations
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United States, Texas
University of Texas at Austin Recruiting
Austin, Texas, United States, 78712
Contact: Sharon Vaughn, PhD    512-232-2357    srvaughn@austin.utexas.edu   
Principal Investigator: Sharon Vaughn, PhD         
Sub-Investigator: Gregory Roberts, PhD         
Sponsors and Collaborators
Boston University Charles River Campus
University of Texas at Austin
Investigators
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Principal Investigator: Amie E Grills, PhD Boston University
Principal Investigator: Sharon Vaughn, PhD University of Texas at Austin

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Responsible Party: Amie E. Grills, Associate Professor, Boston University Charles River Campus
ClinicalTrials.gov Identifier: NCT04059939     History of Changes
Other Study ID Numbers: RHD087706A
First Posted: August 16, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dyslexia
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Learning Disorders
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders