Evidence-Based Interventions to Enhance Outcomes Among Struggling Readers

NCT04059939 | Completed DMC

• 1 other identifier: RHD087706A
• Study Type: interventional
• Target: 542
• Locations: 1 country
• Sites: 1

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.

Conditions

Reading Disability; Anxiety

Outcome Measures

Primary Outcomes (3)

• Test of Word Reading Efficiency

  Measures "ability to pronounce printed words and phonemically regular nonwords accurately and fluently"

  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

• Multidimensional Anxiety Scale for Children

  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

  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; In cohort 2, same time frames, except it was not administered at post-intervention Y1

Secondary Outcomes (16)

• Children's Test Anxiety 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

• Reading Anxiety 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

• 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; In cohort 2, same time frames, except it was not administered at post-intervention Y1

• Test of Silent Word Reading Efficiency and Comprehension

  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

  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

Study Arms (3)

Reading Plus Attention Control

EXPERIMENTAL

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

Reading Plus Anxiety

EXPERIMENTAL

Other: Reading; Behavioral: Anxiety Management

BAU

ACTIVE COMPARATOR

Other: Classroom Business as Usual

Interventions

Reading OTHER

Small group reading instruction

Reading Plus Anxiety; Reading Plus Attention Control

Anxiety Management BEHAVIORAL

small group anxiety management skills instruction

Reading Plus Anxiety

Classroom Business as Usual OTHER

Classroom Business as Usual

BAU

Attention Control (math practice) OTHER

Attention Control (math practice)

Reading Plus Attention Control

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University Charles River Campus: lead
• University of Texas at Austin: collaborator

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Dyslexia; Anxiety Disorders

Condition Hierarchy (Ancestors)

Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Specific Learning Disorder; Learning Disabilities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Amie E Grills, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

• Sharon Vaughn, PhD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: participants and evaluators are not told which interventions individual participants have been assigned to
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: August 16, 2019
• Study Start: August 1, 2017
• Primary Completion: May 31, 2022
• Study Completion: July 31, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)