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Reading DisabilityNCT04059939

Evidence-Based Interventions to Enhance Outcomes Among Struggling Readers

A study testing Reading, Anxiety Management and Classroom Business as Usual in people with Reading Disability and Anxiety, run by Boston University Charles River Campus at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 8 to 14 years
Conditions the study is for
Reading Disability, Anxiety
What is being tested?
Reading, Anxiety Management and Classroom Business as Usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
542 participants
Where
1 siteUnited States
Study dates
1 Aug 2017to 31 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Texas at Austin

    Austin, Texas, 78712

Other trials in United States

About this study

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.

Read the 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.

Being tested
Reading, Anxiety Management, Classroom Business as Usual, Attention Control (math practice)
Medical subject headings
Dyslexia, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ReadingOther

    Small group reading instruction

  • Anxiety ManagementBehavioural

    small group anxiety management skills instruction

  • Classroom Business as UsualOther

    Classroom Business as Usual

  • Attention Control (math practice)Other

    Attention Control (math practice)

Study groups in NCT04059939
Study groupRoleWhat they receive
Reading Plus Attention ControlExperimentalNot described
Receives: Other: Reading; Other: Attention Control (math practice)
Reading Plus AnxietyExperimentalNot described
Receives: Other: Reading; Behavioral: Anxiety Management
BAUActive comparatorNot described
Receives: Other: Classroom Business as Usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Test of Word Reading Efficiency

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

    Measured: 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

  2. 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.

    Measured: 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

  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.

    Measured: 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)
  1. Children's Test Anxiety Scale

    30-item scale with a 4-point Likert Scale (1-4). Scale ranges from 30-120 with higher scores indicating greater test anxiety.

    Measured: 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. Reading Anxiety Scale

    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.

    Measured: 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

  3. Attention

    child attention scale, Effortful Control-Persistence/Low Distractibility subscale, Strength and Weaknesses of Attention-Deficit/Hyperactivity Disorder, (SWAN) parent/teacher reported attention

    Measured: 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

  4. Test of Silent Word Reading Efficiency and Comprehension

    Measured: 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

    Oral Reading Fluency

    Measured: 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

  6. Beck Anxiety Inventory

    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. Administered to intervention teachers in cohorot 2.

    Measured: 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

  7. Beck Youth Inventories (BYI)

    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.

    Measured: 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

  8. Stress management skills evaluation

    Measured: 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)

    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.

    Measured: 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

  10. Reading Comprehension

    Kaufman Test of Educational Achievement-III (KTEA-3)

    Measured: 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

  11. Fluency/Comprehension

    Test of Silent Word Reading Fluency

    Measured: 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

  12. Verbal Knowledge/Matrices

    Kaufman Brief Intelligence Test

    Measured: 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

  13. Math Calculation

    Woodcock-Johnson Psycho-Educational Test Battery-III Calculation

    Measured: Change from baseline to post-intervention year 2

  14. Essential Word Knowledge

    Measured: Change from baseline to post-intervention year 2

  15. Reading Comprehension

    Gates-MacGinitie Reading Comprehension

    Measured: 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

  16. Home Literacy Questions

    A total of 7 questions (e.g., how many children's books are in your home; how many times per a week have you read with your child while schools have been closed?) examine home literacy prior to COVID19 and during COVID19.

    Measured: Cohort 2 Only- administered at post-intervention Y1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2019
  2. Study start1 Aug 2017
  3. Primary completion31 May 2022
  4. Study completion31 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
542 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04059939
Sponsor's protocol ID
RHD087706A
Status last verified
Aug 2024
First submitted
9 Feb 2017
Last updated
7 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Reading, Anxiety Management and Classroom Business as Usual in people with Reading Disability and Anxiety, run by Boston University Charles River Campus at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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; In cohort 2, same time frames, except it was not administered at post-intervention Y1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.

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