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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

Tracking Information
First Submitted Date  ICMJE February 9, 2017
First Posted Date  ICMJE August 16, 2019
Last Update Posted Date September 11, 2019
Actual Study Start Date  ICMJE August 1, 2017
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2019)
  • 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 ]
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 14, 2019)
  • 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 ]
  • 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 ]
    child, parent, teacher versions
  • 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 ]
    Letter-Word Identification, Word Attack
Change History Complete list of historical versions of study NCT04059939 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2019)
  • 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.
  • 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.
  • 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
  • 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 ]
  • 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
  • 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.
  • 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.
  • 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 ]
  • 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.
  • 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)
  • 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
  • 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
  • Math Calculation [ Time Frame: Change from baseline to post-intervention year 2 ]
    Woodcock-Johnson Psycho-Educational Test Battery-III Calculation
  • Essential Word Knowledge [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2019)
  • 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 ]
  • 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 ]
  • 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
  • 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 ]
  • 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
  • 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 ]
  • Beck Inventories for Youth [ 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 ]
    Depression and selfconcept subscales
  • 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 ]
  • Home environment [ 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 ]
    Confusion, Hubbub, and Order Scale (CHAOS Survey)
  • 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)
  • 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
  • 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
  • Math Calculation [ Time Frame: Change from baseline to post-intervention year 2 ]
    Woodcock-Johnson Psycho-Educational Test Battery-III Calculation
  • Essential Word Knowledge [ Time Frame: 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evidence-Based Interventions to Enhance Outcomes Among Struggling Readers
Official Title  ICMJE Evidence-Based Interventions to Enhance Outcomes Among Struggling Readers
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Reading Disability
  • Anxiety
Intervention  ICMJE
  • Other: Reading
    Small group reading instruction
  • Behavioral: Anxiety Management
    small group anxiety management skills instruction
  • Other: Classroom Business as Usual
    Classroom Business as Usual
  • Other: Attention Control (math practice)
    Attention Control (math practice)
Study Arms  ICMJE
  • Experimental: Reading Plus Attention Control
    Interventions:
    • Other: Reading
    • Other: Attention Control (math practice)
  • Experimental: Reading Plus Anxiety
    Interventions:
    • Other: Reading
    • Behavioral: Anxiety Management
  • Active Comparator: BAU
    Intervention: Other: Classroom Business as Usual
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 14, 2019)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2022
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 14 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Amie E Grills, PhD 617-353-7107 agrills@bu.edu
Contact: Sharon Vaughn, PhD 512-232-2357 srvaughn@austin.utexas.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04059939
Other Study ID Numbers  ICMJE RHD087706A
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Amie E. Grills, Boston University Charles River Campus
Study Sponsor  ICMJE Boston University Charles River Campus
Collaborators  ICMJE University of Texas at Austin
Investigators  ICMJE
Principal Investigator: Amie E Grills, PhD Boston University
Principal Investigator: Sharon Vaughn, PhD University of Texas at Austin
PRS Account Boston University Charles River Campus
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP