Coordinated Intervention for Learning Disabilities

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University

Disqualifiers: Non-participating school, English proficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 15 weeks

334 Participants Needed

Trial Summary

What is the purpose of this trial?

The main purpose of this clinical trials is to explore short-term effects of coordinated intervention versus the business-as-usual school program on the primary endpoints of post-intervention word-reading fluency and arithmetic fluency. The study population is students who begin 1st grade with delays in word reading and calculations. Students who meet entry criteria are randomly assigned to coordinated intervention across reading and math, reading intervention, math intervention, and a business-as-usual control group (schools' typical program). The 3 researcher-delivered interventions last 15 weeks (3 sessions per week; 30 minutes per session). Students in all 4 conditions are tested before researcher-delivered intervention begins and after it ends.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Coordinated Intervention for Learning Disabilities?

Research shows that multiple-component intervention programs for reading disabilities, similar to the Coordinated Intervention, significantly improve basic reading skills in children with reading disabilities. These programs have been effective across different IQ, socioeconomic, and racial groups, indicating their broad applicability. ^{1 2 3 4 5}

Is the Coordinated Intervention for Learning Disabilities safe for humans?

The available research does not provide specific safety data for the Coordinated Intervention for Learning Disabilities or its related programs. However, interventions focused on improving reading and math skills, as well as parent education programs, generally aim to enhance child development and parent-child relationships, which are considered safe activities. ^{6 7 8 9 10}

How is the Coordinated Intervention for Learning Disabilities treatment different from other treatments for learning disabilities?

The Coordinated Intervention for Learning Disabilities is unique because it combines math and reading interventions, addressing both areas simultaneously, which is particularly beneficial for students with comorbid learning disabilities in both subjects. This approach is distinct from treatments that focus on either reading or math alone, as it targets the specific needs of students who struggle with both, potentially representing a distinct subtype of learning disability. ^{8 11 12 13 14}

Research Team

Douglas Fuchs, Ph.D.

Principal Investigator

Vanderbilt University

Eligibility Criteria

This trial is for first-grade students in Metropolitan-Nashville Public Schools who struggle with reading and math, scoring below the 25th percentile on specific tests but above the 7th percentile on cognitive measures. They must have adequate English skills and a school schedule that allows participation.

Inclusion Criteria

Attends a participating school in the Metropolitan-Nashville Public Schools

Scores at or below the 25th percentile on the study's screening math test

You scored in the lowest 25% on the reading test used for the study's screening.

Exclusion Criteria

Does not attend a participating school in the Metropolitan-Nashville Public Schools

You scored in the lowest 7% on both of the study's cognitive tests.

Is not a member of a first-grade classroom whose teacher has agreed to let his/her students participate

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pretest Assessment

Students complete the pretest battery before intervention begins

1 week

Treatment

Researcher-delivered interventions in reading, math, or coordinated reading and math for 15 weeks

15 weeks

3 sessions per week (in-person)

Posttest Assessment

Students complete the posttest assessment battery after intervention ends

1 week

Follow-up

Participants are monitored for academic performance outcomes

4 weeks

Treatment Details

Interventions

• Coordinated Intervention
• Math Intervention
• Reading Intervention

Trial Overview The study compares coordinated intervention across reading and math against standard school programs. It involves three researcher-led sessions per week over 15 weeks, assessing improvements in word-reading fluency and arithmetic fluency post-intervention.

Participant Groups

Group I: Coordinated Reading and Math Intervention Experimental Treatment 1 Intervention

Coordinated intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction addressing similar skills as those addressed in the reading intervention arm \& similar skills as the math intervention arm.

Group II: Math Intervention Active Control 1 Intervention

Math intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction on number knowledge, counting strategies, and arithmetic skill.

Group III: Business-as-usual Control Active Control 1 Intervention

Participation in the school's typical reading and math classroom instruction and, if designated by the school, its supplemental program.

Group IV: Reading Intervention Active Control 1 Intervention

Reading intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction designed to build skill on letter-sound associations, decoding, sight words, \& contextualized reading.

Who Is Running the Clinical Trial?

Vanderbilt University

Lead Sponsor

Trials

714

Recruited

6,143,000+

Findings from Research

A systematic review of 16 studies found that group-based parent education programs can effectively improve behavior problems in children aged 3 to 10, leading to positive changes in both parental perceptions and children's behavior.

Despite the promising results, the review highlighted significant variability in the interventions and populations studied, suggesting that more controlled studies are needed before broadly applying these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavior problems and group-based parent education programs. Barlow, J., Stewart-Brown, S.[2019]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

[Phonological remediation program in students with developmental dyslexia]. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Multiple-component remediation for developmental reading disabilities: IQ, socioeconomic status, and race as factors in remedial outcome. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of outpatient treatment of dyslexia. [2017]

4. England pubmed.ncbi.nlm.nih.gov

A Systematic Review of Patient- or Proxy-Reported Validated Instruments Assessing Pediatric Dysphagia. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Optometric and sensory motor changes in an adult. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Eye-trackers, digital-libraries, and print-referencing: A single case study in CDKL5. [2021]

7. Australia pubmed.ncbi.nlm.nih.gov

Evaluation of a community intervention programme for preschool behaviour problems. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

An intervention for early mathematical success: outcomes from the hybrid version of the Building Math Readiness Parents as Partners (MRPP) project. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Behavior problems and group-based parent education programs. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Literacy promotion: an essential component of primary care pediatric practice. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Intervention effects for students with comorbid forms of learning disability: understanding the needs of nonresponders. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

At the intersection of math and reading disabilities: introduction to the special issue. [2013]

13. United States pubmed.ncbi.nlm.nih.gov

Response to intervention as a vehicle for distinguishing between children with and without reading disabilities: Evidence for the role of kindergarten and first-grade interventions. [2022]

14. France pubmed.ncbi.nlm.nih.gov

Response to Intervention. [2020]