Evidence-Based Interventions to Enhance Outcomes Among Struggling Readers

NCT ID: NCT04059939

Last Updated: 2024-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 542 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2024-07-31

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.

Conditions

Reading Disability; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Reading Plus Attention Control

Group Type: EXPERIMENTAL

Reading

Intervention Type: OTHER

Small group reading instruction

Attention Control (math practice)

Intervention Type: OTHER

Attention Control (math practice)

Reading Plus Anxiety

Group Type: EXPERIMENTAL

Reading

Intervention Type: OTHER

Small group reading instruction

Anxiety Management

Intervention Type: BEHAVIORAL

small group anxiety management skills instruction

BAU

Group Type: ACTIVE_COMPARATOR

Classroom Business as Usual

Intervention Type: OTHER

Classroom Business as Usual

Interventions

Reading

Small group reading instruction

Intervention Type: OTHER

Anxiety Management

small group anxiety management skills instruction

Intervention Type: BEHAVIORAL

Classroom Business as Usual

Classroom Business as Usual

Intervention Type: OTHER

Attention Control (math practice)

Attention Control (math practice)

Intervention Type: OTHER

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas at Austin

OTHER

Sponsor Role: collaborator

Boston University Charles River Campus

OTHER

Sponsor Role: lead

Responsible Party

Amie E. Grills

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amie E Grills, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Sharon Vaughn, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Austin

Locations

University of Texas at Austin

Austin, Texas, United States

Countries

United States

Other Identifiers

RHD087706A

Identifier Type: -

Identifier Source: org_study_id