Clinical trial NCT04059939: Evidence-Based Interventions to Enhance Outcomes Among Struggling Readers
Official title: Evidence-Based Interventions to Enhance Outcomes Among Struggling Readers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reading Disability
Anxiety
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
Collaborators: name: University of Texas at Austin
First posted: 2019-08-16
Enrollment: 542
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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, between 300 and 350 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.

NOTE: The Covid-19 pandemic emerged mid-project and altered several of our plans for this project, as well as led to a mid-project extension. Specifically, this was designed as a 2-cohort, multi-year intervention study. While Cohort 1 completed all planned milestones and activities, for Cohort 2 the intervention was ongoing when the pandemic closed all schools. A third Cohort was then added when schools reopened, but students in Cohort 3 only received 1 year of the intended 2-year intervention.

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

Primary outcomes:
measure: Test of Word Reading Efficiency
timeFrame: 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; In cohort 2, same time frames, except it was not administered at post-intervention Y1
measure: Multidimensional Anxiety Scale for Children
timeFrame: 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
measure: Woodcock-Johnson Psycho-Educational Test Battery-III
timeFrame: 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; In cohort 2, same time frames, except it was not administered at post-intervention Y1
Secondary outcomes:
measure: Children's Test Anxiety Scale
timeFrame: 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
measure: Reading Anxiety Scale
timeFrame: 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
measure: Attention
timeFrame: 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; In cohort 2, same time frames, except it was not administered at post-intervention Y1
measure: Test of Silent Word Reading Efficiency and Comprehension
timeFrame: 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
measure: Dynamic Indicators of Basic Early Literacy Skills
timeFrame: 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; In cohort 2, same time frames, except it was not administered at post-intervention Y1
measure: Beck Anxiety Inventory
timeFrame: 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
measure: Beck Youth Inventories (BYI)
timeFrame: 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; In cohort 2, BYI depression subscale was not administered at post-intervention Y1
measure: Stress management skills evaluation
timeFrame: 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
measure: Confusion, Hubbub, and Order Scale (CHAOS Survey)
timeFrame: 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
measure: Reading Comprehension
timeFrame: 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; In cohort 2, same time frames, except it was not administered at post-intervention Y1
measure: Fluency/Comprehension
timeFrame: 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; In cohort 2, same time frames, except it was not administered at post-intervention Y1
measure: Verbal Knowledge/Matrices
timeFrame: 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; In cohort 2, same time frames, except it was not administered at post-intervention Y1
measure: Math Calculation
timeFrame: Change from baseline to post-intervention year 2
measure: Essential Word Knowledge
timeFrame: Change from baseline to post-intervention year 2
measure: Reading Comprehension
timeFrame: Change from post-intervention year 1 to post-intervention year 2; In cohort 2, same time frames, except it was not administered at post-intervention Y1
measure: Home Literacy Questions
timeFrame: Cohort 2 Only- administered at post-intervention Y1
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
Study officials:
affiliation: Boston University
name: Amie E Grills, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas at Austin
name: Sharon Vaughn, PhD
role: PRINCIPAL_INVESTIGATOR
References: