Skip to content

Interventions for Children With Attention and Reading Disorders

Reading ICARD: Interventions for Children With Attention and Reading Disorders

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01133847
Acronym
ICARD
Enrollment
222
Registered
2010-05-31
Start date
2010-11-30
Completion date
2015-06-30
Last updated
2017-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Hyperactivity Disorder, Reading Disabilities

Brief summary

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) ADHD treatment alone, (b) RD treatment alone, or (c) the combination of ADHD and RD treatment.

Detailed description

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.

Interventions

DRUGMethylphenidate

Appropriate dosage to be individually determined; daily for 16 weeks

BEHAVIORALIntensive reading instruction

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

BEHAVIORALParent Training

Nine sessions on parenting a child with ADHD

DRUGMixed Salt Amphetamine

Appropriate dosage to be individually determined; daily for 16 weeks; prescribed only if child does not show a beneficial treatment response to Concerta

DRUGAtomoxetine

Appropriate dosage to be individually determined; daily for 16 weeks

DRUGGuanfacine

Appropriate dosage to be individually determined; daily for 16 weeks

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Children's Hospital Medical Center, Cincinnati
CollaboratorOTHER
The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Wechsler Individual Achievement Test-III (WIAT-III) Pseudoword Decoding SubtestWeek 16 (End of Active Treatment Phase) and Follow-UpThe WIAT-III is an individually-administered test of academic achievement. In the Pseudoword Decoding subtest students read a list of increasingly difficult nonsense words as a test of their ability to use phonics to decode unknown words. Scores reported here are standardized scores with a mean of 100 and standard deviation of 15. Higher scores represent a better outcome.
Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Inattention16 weeks (end of Active Treatment phase), and follow-upRating 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).
Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Hyperactivity-impulsivity16 weeks (end of Active Treatment phase), and follow-upRating 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).
Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of InattentionWeek 16 (End of Active Treatment Phase) and Follow-UpRating 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).
Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Hyperactivity-impulsivityWeek 16 (End of Active Treatment Phase) and Follow-UpRating 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).
Wechsler Individual Achievement Test-III (WIAT-III) Word Reading SubtestWeek 16 (End of Active Treatment Phase) and Follow-UpThe WIAT-III is an individually-administered test of academic achievement. In the Word Reading subtest students read a list of increasingly difficult words. Scores reported here are standardized scores with a mean of 100 and standard deviation of 15.

Secondary

MeasureTime frameDescription
Dynamic Indicators of Basic Early Literacy Skills Oral Reading Fluency Subtest (DIBELS ORF)Week 16 (End of Active Treatment Phase) and Follow-UpDIBELS 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).
Test of Word Reading Efficiency (TOWRE) - Sight Word EfficiencyWeek 16 (End of Active Treatment Phase) and Follow-UpThe 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.
Test of Word Reading Efficiency (TOWRE) - Phonemic Decoding EfficiencyWeek 16 (End of Active Treatment Phase) and Follow-UpThe 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.
Test of Silent Reading Fluency and Comprehension (TOSREC)Week 16, End of Active Treatment PhaseThe 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.
Wechsler Individual Achievement Test-III (WIAT-III) Reading Comprehension SubtestWeek 16, End of Active Treatment PhaseThe 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
ADHD Treatment
Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
77
Intensive Reading Instruction
Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
73
Combined ADHD Treatment and Reading Instruction
All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
66
Total216

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Active Treatment Phase (Weeks 1-16)Withdrawal by Subject513
Follow-Up PhaseLost to Follow-up137

Baseline characteristics

CharacteristicADHD TreatmentIntensive Reading InstructionCombined ADHD Treatment and Reading InstructionTotal
Age, Categorical
<=18 years
77 Participants73 Participants66 Participants216 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants0 Participants
Region of Enrollment
United States
77 participants73 participants66 participants216 participants
Sex: Female, Male
Female
25 Participants24 Participants35 Participants84 Participants
Sex: Female, Male
Male
52 Participants49 Participants31 Participants132 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
3 / 711 / 745 / 68
serious
Total, serious adverse events
0 / 710 / 740 / 68

Outcome results

Primary

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

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

Population: Six excluded from analyses (1 from ADHD Treatment , 1 from Intensive Reading Instruction , 4 from Combined ) because upon ex post-facto review of records, they did not meet inclusion criteria and had been included in error. Other reductions in numbers analyzed on this variable were due to missing data.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
ADHD TreatmentSwanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Hyperactivity-impulsivity16-Week Outcomes0.8 units on a scaleStandard Error 0.1
ADHD TreatmentSwanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Hyperactivity-impulsivityFollow-up Outcomes0.9 units on a scaleStandard Error 0.1
Intensive Reading InstructionSwanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Hyperactivity-impulsivity16-Week Outcomes1.3 units on a scaleStandard Error 0.1
Intensive Reading InstructionSwanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Hyperactivity-impulsivityFollow-up Outcomes1.4 units on a scaleStandard Error 0.1
Combined ADHD Treatment and Reading InstructionSwanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Hyperactivity-impulsivity16-Week Outcomes0.6 units on a scaleStandard Error 0.1
Combined ADHD Treatment and Reading InstructionSwanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Hyperactivity-impulsivityFollow-up Outcomes0.7 units on a scaleStandard Error 0.1
Primary

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

Population: Six excluded from analyses (1 from ADHD Treatment , 1 from Intensive Reading Instruction , 4 from Combined ) because upon ex post-facto review of records, they did not meet inclusion criteria and had been included in error. Other reductions in numbers analyzed on this variable were due to missing data.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
ADHD TreatmentSwanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Inattention16-Week Outcomes1.1 Units on a scaleStandard Error 0.1
ADHD TreatmentSwanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of InattentionFollow-up Outcomes1.3 Units on a scaleStandard Error 0.1
Intensive Reading InstructionSwanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Inattention16-Week Outcomes1.7 Units on a scaleStandard Error 0.1
Intensive Reading InstructionSwanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of InattentionFollow-up Outcomes1.6 Units on a scaleStandard Error 0.1
Combined ADHD Treatment and Reading InstructionSwanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Inattention16-Week Outcomes1.0 Units on a scaleStandard Error 0.1
Combined ADHD Treatment and Reading InstructionSwanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of InattentionFollow-up Outcomes1.0 Units on a scaleStandard Error 0.1
Primary

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

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

Population: Six excluded from analyses (1 from ADHD Treatment , 1 from Intensive Reading Instruction , 4 from Combined) because upon ex post-facto review of records, they did not meet inclusion criteria and had been included in error. Other reductions in numbers analyzed on this variable were due to missing data.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
ADHD TreatmentSwanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Hyperactivity-impulsivity16-Week Outcomes0.7 Units on a scaleStandard Error 0.1
ADHD TreatmentSwanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Hyperactivity-impulsivityFollow-up0.8 Units on a scaleStandard Error 0.1
Intensive Reading InstructionSwanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Hyperactivity-impulsivity16-Week Outcomes1.1 Units on a scaleStandard Error 0.1
Intensive Reading InstructionSwanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Hyperactivity-impulsivityFollow-up1.1 Units on a scaleStandard Error 0.1
Combined ADHD Treatment and Reading InstructionSwanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Hyperactivity-impulsivity16-Week Outcomes0.8 Units on a scaleStandard Error 0.1
Combined ADHD Treatment and Reading InstructionSwanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Hyperactivity-impulsivityFollow-up0.8 Units on a scaleStandard Error 0.1
Primary

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

Population: Six excluded from analyses (1 from ADHD Treatment , 1 from Intensive Reading Instruction , 4 from Combined ) because upon ex post-facto review of records, they did not meet inclusion criteria and had been included in error. Other reductions in numbers analyzed on this variable were due to missing data.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
ADHD TreatmentSwanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Inattention16-week Outcomes1.2 Units on a scaleStandard Error 0.1
ADHD TreatmentSwanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of InattentionFollow-Up1.5 Units on a scaleStandard Error 0.1
Intensive Reading InstructionSwanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Inattention16-week Outcomes1.7 Units on a scaleStandard Error 0.1
Intensive Reading InstructionSwanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of InattentionFollow-Up1.9 Units on a scaleStandard Error 0.1
Combined ADHD Treatment and Reading InstructionSwanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Inattention16-week Outcomes1.4 Units on a scaleStandard Error 0.1
Combined ADHD Treatment and Reading InstructionSwanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of InattentionFollow-Up1.5 Units on a scaleStandard Error 0.1
Primary

Wechsler Individual Achievement Test-III (WIAT-III) Pseudoword Decoding Subtest

The WIAT-III is an individually-administered test of academic achievement. In the Pseudoword Decoding subtest students read a list of increasingly difficult nonsense words as a test of their ability to use phonics to decode unknown words. 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) and Follow-Up

Population: Six excluded from analyses (1 from ADHD Treatment , 1 from Intensive Reading Instruction , 4 from Combined ) because upon ex post-facto review of records, they did not meet inclusion criteria and had been included in error. Other reductions in numbers analyzed on this variable were due to missing data.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
ADHD TreatmentWechsler Individual Achievement Test-III (WIAT-III) Pseudoword Decoding Subtest16-Week Outcomes78.3 standardized scoresStandard Error 1
ADHD TreatmentWechsler Individual Achievement Test-III (WIAT-III) Pseudoword Decoding SubtestFollow-Up77.1 standardized scoresStandard Error 1
Intensive Reading InstructionWechsler Individual Achievement Test-III (WIAT-III) Pseudoword Decoding Subtest16-Week Outcomes83.8 standardized scoresStandard Error 1
Intensive Reading InstructionWechsler Individual Achievement Test-III (WIAT-III) Pseudoword Decoding SubtestFollow-Up82.6 standardized scoresStandard Error 1.1
Combined ADHD Treatment and Reading InstructionWechsler Individual Achievement Test-III (WIAT-III) Pseudoword Decoding Subtest16-Week Outcomes83.0 standardized scoresStandard Error 1.1
Combined ADHD Treatment and Reading InstructionWechsler Individual Achievement Test-III (WIAT-III) Pseudoword Decoding SubtestFollow-Up81.9 standardized scoresStandard Error 1.2
Primary

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

The WIAT-III is an individually-administered test of academic achievement. In the Word Reading subtest students read a list of increasingly difficult words. Scores reported here are standardized scores with a mean of 100 and standard deviation of 15.

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

Population: Six excluded from analyses (1 from ADHD Treatment , 1 from Intensive Reading Instruction , 4 from Combined ) because upon ex post-facto review of records, they did not meet inclusion criteria and had been included in error. Other discrepancies in numbers are due to missing data.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
ADHD TreatmentWechsler Individual Achievement Test-III (WIAT-III) Word Reading Subtest16-Week Outcomes76.9 standardized scores, M=100, SD = 15Standard Error 0.7
ADHD TreatmentWechsler Individual Achievement Test-III (WIAT-III) Word Reading SubtestFollow-Up77.1 standardized scores, M=100, SD = 15Standard Error 0.8
Intensive Reading InstructionWechsler Individual Achievement Test-III (WIAT-III) Word Reading Subtest16-Week Outcomes79.0 standardized scores, M=100, SD = 15Standard Error 0.7
Intensive Reading InstructionWechsler Individual Achievement Test-III (WIAT-III) Word Reading SubtestFollow-Up78.1 standardized scores, M=100, SD = 15Standard Error 0.8
Combined ADHD Treatment and Reading InstructionWechsler Individual Achievement Test-III (WIAT-III) Word Reading Subtest16-Week Outcomes79.9 standardized scores, M=100, SD = 15Standard Error 0.7
Combined ADHD Treatment and Reading InstructionWechsler Individual Achievement Test-III (WIAT-III) Word Reading SubtestFollow-Up78.8 standardized scores, M=100, SD = 15Standard Error 0.8
Secondary

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

Population: Six excluded from analyses (1 from ADHD Treatment , 1 from Intensive Reading Instruction , 4 from Combined ) because upon ex post-facto review of records, they did not meet inclusion criteria and had been included in error. Other reductions in numbers analyzed on this variable were due to missing data.

ArmMeasureGroupValue (MEAN)Dispersion
ADHD TreatmentDynamic Indicators of Basic Early Literacy Skills Oral Reading Fluency Subtest (DIBELS ORF)16-Week Outcomes53.67 words read correctly per minuteStandard Deviation 30.3
ADHD TreatmentDynamic Indicators of Basic Early Literacy Skills Oral Reading Fluency Subtest (DIBELS ORF)Follow-Up63.06 words read correctly per minuteStandard Deviation 31.97
Intensive Reading InstructionDynamic Indicators of Basic Early Literacy Skills Oral Reading Fluency Subtest (DIBELS ORF)16-Week Outcomes50.71 words read correctly per minuteStandard Deviation 31.94
Intensive Reading InstructionDynamic Indicators of Basic Early Literacy Skills Oral Reading Fluency Subtest (DIBELS ORF)Follow-Up57.40 words read correctly per minuteStandard Deviation 31.06
Combined ADHD Treatment and Reading InstructionDynamic Indicators of Basic Early Literacy Skills Oral Reading Fluency Subtest (DIBELS ORF)16-Week Outcomes53.83 words read correctly per minuteStandard Deviation 33.5
Combined ADHD Treatment and Reading InstructionDynamic Indicators of Basic Early Literacy Skills Oral Reading Fluency Subtest (DIBELS ORF)Follow-Up59.05 words read correctly per minuteStandard Deviation 31.97
Secondary

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

Population: Six excluded from analyses (1 from ADHD Treatment , 1 from Intensive Reading Instruction , 4 from Combined ) because upon ex post-facto review of records, they did not meet inclusion criteria and had been included in error. Other reductions in numbers analyzed on this variable were due to missing data.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
ADHD TreatmentTest of Silent Reading Fluency and Comprehension (TOSREC)17.40 standardized scoresStandard Error 0.7
Intensive Reading InstructionTest of Silent Reading Fluency and Comprehension (TOSREC)17.70 standardized scoresStandard Error 0.7
Combined ADHD Treatment and Reading InstructionTest of Silent Reading Fluency and Comprehension (TOSREC)18.57 standardized scoresStandard Error 0.75
Secondary

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

Population: Six excluded from analyses (1 from ADHD Treatment , 1 from Intensive Reading Instruction , 4 from Combined ) because upon ex post-facto review of records, they did not meet inclusion criteria and had been included in error. Other reductions in numbers analyzed on this variable were due to missing data.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
ADHD TreatmentTest of Word Reading Efficiency (TOWRE) - Phonemic Decoding Efficiency16-Week Outcomes80.4 standardized scoresStandard Error 0.79
ADHD TreatmentTest of Word Reading Efficiency (TOWRE) - Phonemic Decoding EfficiencyFollow-Up81.49 standardized scoresStandard Error 0.83
Intensive Reading InstructionTest of Word Reading Efficiency (TOWRE) - Phonemic Decoding Efficiency16-Week Outcomes83.4 standardized scoresStandard Error 0.79
Intensive Reading InstructionTest of Word Reading Efficiency (TOWRE) - Phonemic Decoding EfficiencyFollow-Up84.50 standardized scoresStandard Error 0.86
Combined ADHD Treatment and Reading InstructionTest of Word Reading Efficiency (TOWRE) - Phonemic Decoding Efficiency16-Week Outcomes82.9 standardized scoresStandard Error 0.84
Combined ADHD Treatment and Reading InstructionTest of Word Reading Efficiency (TOWRE) - Phonemic Decoding EfficiencyFollow-Up84.32 standardized scoresStandard Error 0.92
Secondary

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

Population: Six excluded from analyses (1 from ADHD Treatment , 1 from Intensive Reading Instruction , 4 from Combined ) because upon ex post-facto review of records, they did not meet inclusion criteria and had been included in error. Other reductions in numbers analyzed on this variable were due to missing data.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
ADHD TreatmentTest of Word Reading Efficiency (TOWRE) - Sight Word Efficiency16-Week Outcomes80.8 standardized scoresStandard Error 0.82
ADHD TreatmentTest of Word Reading Efficiency (TOWRE) - Sight Word EfficiencyFollow-Up83.57 standardized scoresStandard Error 0.82
Intensive Reading InstructionTest of Word Reading Efficiency (TOWRE) - Sight Word Efficiency16-Week Outcomes82.7 standardized scoresStandard Error 0.82
Intensive Reading InstructionTest of Word Reading Efficiency (TOWRE) - Sight Word EfficiencyFollow-Up85.04 standardized scoresStandard Error 0.84
Combined ADHD Treatment and Reading InstructionTest of Word Reading Efficiency (TOWRE) - Sight Word Efficiency16-Week Outcomes83.5 standardized scoresStandard Error 0.87
Combined ADHD Treatment and Reading InstructionTest of Word Reading Efficiency (TOWRE) - Sight Word EfficiencyFollow-Up84.15 standardized scoresStandard Error 0.9
Secondary

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

Population: Six excluded from analyses (1 from ADHD Treatment , 1 from Intensive Reading Instruction , 4 from Combined ) because upon ex post-facto review of records, they did not meet inclusion criteria and had been included in error.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
ADHD TreatmentWechsler Individual Achievement Test-III (WIAT-III) Reading Comprehension Subtest88.27 standardized scoresStandard Error 0.9
Intensive Reading InstructionWechsler Individual Achievement Test-III (WIAT-III) Reading Comprehension Subtest84.70 standardized scoresStandard Error 0.9
Combined ADHD Treatment and Reading InstructionWechsler Individual Achievement Test-III (WIAT-III) Reading Comprehension Subtest86.35 standardized scoresStandard Error 1

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026