Interventions for Children With Attention and Reading Disorders

The University of Texas Health Science Center, Houston222 enrolled

Overview

The objective of this randomized clinical trial is to address unanswered questions about the relative effectiveness of treatments for children with both Attention Deficit Hyperactivity Disorder (ADHD) and significant reading difficulties (RD). The study evaluates attentional and word reading outcomes for students with both conditions when provided with either (a) disorder-specific ADHD treatment (carefully managed medication + parent training), (b) disorder-specific RD treatment (intensive, individualized reading instruction), or (c) the combination of ADHD and RD treatment. The study aims to address the relative benefits of providing either disorder-specific ADHD or RD treatment alone and providing the combined treatment. The investigators hypothesize that the combined treatment approach will result in better outcomes in terms of both word reading/decoding and a reduction in ADHD symptoms than either of the disorder-specific treatments alone. Treatment will last for 16 weeks, with assessment prior to and following treatment and some measures collected regularly throughout the intervention periods.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

222

Conditions

Attention Deficit Hyperactivity Disorder Reading Disabilities

Interventions

MethylphenidateDRUG

Appropriate dosage to be individually determined; daily for 16 weeks

Intensive reading instructionBEHAVIORAL

Individualized phonologically-based instruction delivered 4 days per week for 45 min. per day by a highly trained tutor.

Parent TrainingBEHAVIORAL

Nine sessions on parenting a child with ADHD

Eligibility

Sex: ALLMin age: 7 YearsMax age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Meet criteria for ADHD, Combined Type or ADHD, Predominantly Inattentive Type based on the Diagnostic Interview Schedule for Children, 4.0 (DISC) parent interview, Teacher baseline Swanson Nolan and Pelham Rating Scale (SNAP) endorses additional non-overlapping Inattentive symptoms with the parent DISC, which when combined with the parent ratings result in endorsement of 6 or more symptoms required for diagnosis by the Diagnostic and Statistical Manual. 2. Have at least 4 symptoms of inattention rated "Often" or "Very Often" on the teacher version of the SNAP-IV. 3. Have a standard score of 90 or lower on either the Woodcock-Johnson III Tests of Achievement Letter-Word Identification or Word Attack Subtests, or on the Basic Reading Skills Cluster 4. Attend a participating school in Grades 2-5 5. Have at least one parent or guardian who understands English well enough to participate in the behavioral parent training intervention. 6. Have a Full Scale OR Non-Verbal Intelligence Quotient (IQ) estimate higher than 70 based on the IQ Composite and Non-Verbal IQ estimate of the Kaufman Brief Intelligence Test (KBIT-2). Exclusion Criteria: 1. Any documented or suspected bipolar disorder, severe psychosis, or other severe emotional disturbance, developmental disability, or autism. 2. Receipt of primary school reading instruction in a language other than English. 3. A history or presence of cardiovascular problems that would contraindicate stimulant treatment. 4. Chronic vocal tics. 5. Children will be excluded if they are taking a concomitant medication that has the potential to significantly affect their ADHD symptoms, that would be contraindicated to take along with the study medication, or if they have not been on a stable dose of a psychotropic medication long enough to fully assess the clinical outcome or tolerability.

Locations (2)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

University of Texas Health Science Center

Houston, Texas, United States

Outcomes

Primary Outcomes

Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Inattention

Rating Scale of ADHD symptomology completed by parents and teachers. Raters evaluate how well each DSM-IV (Diagnostic and Statistical Manual) ADHD symptom describes a child on a four-point Likert scale (0=Not at all, 1=Just a little, 2=Quite a bit, 3=Very much). The measure shows adequate internal consistency (.94) and test-retest reliability (Bussing et al., 2008; Gau et al., 2008).

Time frame: 16 weeks (end of Active Treatment phase), and follow-up

Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Hyperactivity-impulsivity

Time frame: 16 weeks (end of Active Treatment phase), and follow-up

Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Inattention

Rating Scale of ADHD symptomology completed by parents and teachers. Raters evaluate how well each DSM-IV ADHD symptom describes a child on a four-point Likert scale (0=Not at all, 1=Just a little, 2=Quite a bit, 3=Very much). The measure shows adequate internal consistency (.94) and test-retest reliability (Bussing et al., 2008; Gau et al., 2008).

Time frame: Week 16 (End of Active Treatment Phase) and Follow-Up

Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Hyperactivity-impulsivity

Time frame: Week 16 (End of Active Treatment Phase) and Follow-Up

Data from ClinicalTrials.gov

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Secondary Outcomes

Wechsler Individual Achievement Test-III (WIAT-III) Reading Comprehension Subtest

The WIAT-III is an individually-administered test of academic achievement. This subtest involves reading sentences and longer passages and then answering a set of literal and inferential comprehension questions about the text. Scores reported here are standardized scores with a mean of 100 and standard deviation of 15. Higher scores represent a better outcome.

Time frame: Week 16, End of Active Treatment Phase

Dynamic Indicators of Basic Early Literacy Skills Oral Reading Fluency Subtest (DIBELS ORF)

DIBELS ORF measures oral reading fluency in connected text. Students are presented with a passage on their grade level to read orally, and the score is the number of words of the passage read correctly in a one-minute period. Students in this study read two passages at each test administration, and the mean score for the two passages was the dependent variable analyzed. A research synthesis of studies reporting psychometric properties for DIBELS ORF determined that reliability coefficients in these studies exceeded .80 and that the measure demonstrated moderate to high concurrent and predictive validity across studies (Goffreda \& DiPerna, 2010).

Time frame: Week 16 (End of Active Treatment Phase) and Follow-Up

Test of Word Reading Efficiency (TOWRE) - Sight Word Efficiency

The TOWRE Sight Word Efficiency subtest measures fluency of reading words in lists. The raw score is the number of words or nonwords identified correctly in 45 seconds. Standard scores with a mean of 100 and standard deviaion of 15 are reported here. Higher scores represent a better outcome.

Time frame: Week 16 (End of Active Treatment Phase) and Follow-Up

Test of Word Reading Efficiency (TOWRE) - Phonemic Decoding Efficiency

The TOWRE Phonemic Decoding Efficiency measures the student's fluent decoding of nonsense words that follow the spelling rules of the English language. The raw score is the number of nonwords identified correctly in 45 seconds. Standardized scores with a mean of 100 and standard deviaion of 15 are reported here. Higher scores represent a better outcome.

Time frame: Week 16 (End of Active Treatment Phase) and Follow-Up

Test of Silent Reading Fluency and Comprehension (TOSREC)

The TOSREC measures sentence-level comprehension and silent reading fluency. It is a sentence verification task; children are presented with a list of sentences and must tell whether they are true or false. Items are based on common knowledge (e.g., All apples are blue). The raw score is the number of items answered correctly in 3 minutes. Standardized with a mean of 100 and standard deviation of 15 are reported here. Higher scores represent a better outcome.

Time frame: Week 16, End of Active Treatment Phase