Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 31 of 61 for:    Dyslexia

Interventions for Children With Attention and Reading Disorders (ICARD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01133847
Recruitment Status : Completed
First Posted : May 31, 2010
Results First Posted : April 11, 2017
Last Update Posted : April 11, 2017
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Children's Hospital Medical Center, Cincinnati
Information provided by (Responsible Party):
Carolyn Denton, The University of Texas Health Science Center, Houston

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Attention Deficit Hyperactivity Disorder
Reading Disabilities
Interventions Drug: Methylphenidate
Behavioral: Intensive reading instruction
Behavioral: Parent Training
Drug: Mixed Salt Amphetamine
Drug: Atomoxetine
Drug: Guanfacine
Enrollment 222
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ADHD Treatment Intensive Reading Instruction Combined ADHD Treatment and Reading Instruction
Hide Arm/Group Description 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. 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 Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment. 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.
Period Title: Active Treatment Phase (Weeks 1-16)
Started 78 74 70
Completed 73 73 67
Not Completed 5 1 3
Reason Not Completed
Withdrawal by Subject             5             1             3
Period Title: Follow-Up Phase
Started 73 73 67
Completed 72 70 60
Not Completed 1 3 7
Reason Not Completed
Lost to Follow-up             1             3             7
Arm/Group Title ADHD Treatment Intensive Reading Instruction Combined ADHD Treatment and Reading Instruction Total
Hide Arm/Group Description 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. 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 77 73 66 216
Hide Baseline Analysis Population Description
Baseline characteristics are for our final analysis sample, consisting of all children randomized to each condition except for 1 in the ADHD arm, 1 in the Reading arm, and 4 in the Combined arm, who were excluded because upon ex post-facto review of records, they did not meet either ADHD, RD, or IQ inclusion criteria and had been included in error.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 73 participants 66 participants 216 participants
<=18 years
77
 100.0%
73
 100.0%
66
 100.0%
216
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 73 participants 66 participants 216 participants
Female
25
  32.5%
24
  32.9%
35
  53.0%
84
  38.9%
Male
52
  67.5%
49
  67.1%
31
  47.0%
132
  61.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 77 participants 73 participants 66 participants 216 participants
77 73 66 216
1.Primary Outcome
Title Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Inattention
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ADHD Treatment Intensive Reading Instruction Combined ADHD Treatment and Reading Instruction
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 71 72 60
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
16-Week Outcomes 1.1  (0.1) 1.7  (0.1) 1.0  (0.1)
Follow-up Outcomes 1.3  (0.1) 1.6  (0.1) 1.0  (0.1)
2.Primary Outcome
Title Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Hyperactivity-impulsivity
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ADHD Treatment Intensive Reading Instruction Combined ADHD Treatment and Reading Instruction
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 71 72 60
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
16-Week Outcomes Number Analyzed 71 participants 72 participants 60 participants
0.8  (0.1) 1.3  (0.1) 0.6  (0.1)
Follow-up Outcomes Number Analyzed 66 participants 66 participants 52 participants
0.9  (0.1) 1.4  (0.1) 0.7  (0.1)
3.Primary Outcome
Title Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Inattention
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ADHD Treatment Intensive Reading Instruction Combined ADHD Treatment and Reading Instruction
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 72 71 63
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
16-week Outcomes Number Analyzed 72 participants 71 participants 63 participants
1.2  (0.1) 1.7  (0.1) 1.4  (0.1)
Follow-Up Number Analyzed 65 participants 65 participants 51 participants
1.5  (0.1) 1.9  (0.1) 1.5  (0.1)
4.Primary Outcome
Title Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Hyperactivity-impulsivity
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ADHD Treatment Intensive Reading Instruction Combined ADHD Treatment and Reading Instruction
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 72 71 63
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
16-Week Outcomes Number Analyzed 72 participants 71 participants 63 participants
0.7  (0.1) 1.1  (0.1) 0.8  (0.1)
Follow-up Number Analyzed 65 participants 65 participants 51 participants
0.8  (0.1) 1.1  (0.1) 0.8  (0.1)
5.Primary Outcome
Title Wechsler Individual Achievement Test-III (WIAT-III) Word Reading Subtest
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ADHD Treatment Intensive Reading Instruction Combined ADHD Treatment and Reading Instruction
Hide Arm/Group Description:
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.
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.

All interventions described in Reading Instruction and ADHD treatment arms:

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.

Overall Number of Participants Analyzed 72 72 63
Least Squares Mean (Standard Error)
Unit of Measure: standardized scores, M=100, SD = 15
16-Week Outcomes Number Analyzed 72 participants 72 participants 63 participants
76.9  (0.7) 79.0  (0.7) 79.9  (0.7)
Follow-Up Number Analyzed 71 participants 68 participants 59 participants
77.1  (0.8) 78.1  (0.8) 78.8  (0.8)
6.Primary Outcome
Title Wechsler Individual Achievement Test-III (WIAT-III) Pseudoword Decoding Subtest
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ADHD Treatment Intensive Reading Instruction Combined ADHD Treatment and Reading Instruction
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 72 72 63
Least Squares Mean (Standard Error)
Unit of Measure: standardized scores
16-Week Outcomes Number Analyzed 72 participants 72 participants 63 participants
78.3  (1.0) 83.8  (1.0) 83.0  (1.1)
Follow-Up Number Analyzed 71 participants 68 participants 59 participants
77.1  (1.0) 82.6  (1.1) 81.9  (1.2)
7.Secondary Outcome
Title Wechsler Individual Achievement Test-III (WIAT-III) Reading Comprehension Subtest
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ADHD Treatment Intensive Reading Instruction Combined ADHD Treatment and Reading Instruction
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 72 72 63
Least Squares Mean (Standard Error)
Unit of Measure: standardized scores
88.27  (0.9) 84.70  (0.9) 86.35  (1.0)
8.Secondary Outcome
Title Dynamic Indicators of Basic Early Literacy Skills Oral Reading Fluency Subtest (DIBELS ORF)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ADHD Treatment Intensive Reading Instruction Combined ADHD Treatment and Reading Instruction
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 72 72 63
Mean (Standard Deviation)
Unit of Measure: words read correctly per minute
16-Week Outcomes Number Analyzed 72 participants 72 participants 63 participants
53.67  (30.3) 50.71  (31.94) 53.83  (33.5)
Follow-Up Number Analyzed 70 participants 68 participants 59 participants
63.06  (31.97) 57.40  (31.06) 59.05  (31.97)
9.Secondary Outcome
Title Test of Word Reading Efficiency (TOWRE) - Sight Word Efficiency
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ADHD Treatment Intensive Reading Instruction Combined ADHD Treatment and Reading Instruction
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 72 72 63
Least Squares Mean (Standard Error)
Unit of Measure: standardized scores
16-Week Outcomes Number Analyzed 72 participants 72 participants 59 participants
80.8  (0.82) 82.7  (0.82) 83.5  (0.87)
Follow-Up Number Analyzed 70 participants 68 participants 59 participants
83.57  (0.82) 85.04  (0.84) 84.15  (0.90)
10.Secondary Outcome
Title Test of Word Reading Efficiency (TOWRE) - Phonemic Decoding Efficiency
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ADHD Treatment Intensive Reading Instruction Combined ADHD Treatment and Reading Instruction
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 72 72 63
Least Squares Mean (Standard Error)
Unit of Measure: standardized scores
16-Week Outcomes Number Analyzed 72 participants 72 participants 63 participants
80.4  (0.79) 83.4  (0.79) 82.9  (0.84)
Follow-Up Number Analyzed 70 participants 68 participants 59 participants
81.49  (0.83) 84.50  (0.86) 84.32  (0.92)
11.Secondary Outcome
Title Test of Silent Reading Fluency and Comprehension (TOSREC)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ADHD Treatment Intensive Reading Instruction Combined ADHD Treatment and Reading Instruction
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 72 72 63
Least Squares Mean (Standard Error)
Unit of Measure: standardized scores
17.40  (0.7) 17.70  (0.7) 18.57  (0.75)
Time Frame 6 years
Adverse Event Reporting Description

Children who received ADHD treatment (ADHD, Combined arms) were systematically assessed through regular clinic visits, phone calls, and rating scales of side effects and functioning completed by parents and teachers. Children receiving Reading Instruction were observed by their tutors about 4 days/week.

Total at-risk (total monitored) = total in each arm who received some intervention. Those not receiving intervention were presumed not at-risk for treatment-related Adverse Events (AEs).

 
Arm/Group Title ADHD Treatment Intensive Reading Instruction Combined ADHD Treatment and Reading Instruction
Hide Arm/Group Description 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. 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. 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.
All-Cause Mortality
ADHD Treatment Intensive Reading Instruction Combined ADHD Treatment and Reading Instruction
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
ADHD Treatment Intensive Reading Instruction Combined ADHD Treatment and Reading Instruction
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/71 (0.00%)      0/74 (0.00%)      0/68 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ADHD Treatment Intensive Reading Instruction Combined ADHD Treatment and Reading Instruction
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/71 (4.23%)      1/74 (1.35%)      5/68 (7.35%)    
Social circumstances       
Aggressive behaviors   3/71 (4.23%)  3 1/74 (1.35%)  1 5/68 (7.35%)  5
Indicates events were collected by systematic assessment
There was some non-adherence, particularly for the ADHD treatment. Our oversampling of low income, African American children, although valuable in an understudied population, may limit generalizability.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Carolyn Denton
Organization: University of Texas Health Science Center Houston
Phone: 713-500-3891
Responsible Party: Carolyn Denton, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01133847     History of Changes
Other Study ID Numbers: HSC-MS-09-0531
R01HD060617 ( U.S. NIH Grant/Contract )
First Submitted: May 26, 2010
First Posted: May 31, 2010
Results First Submitted: October 31, 2016
Results First Posted: April 11, 2017
Last Update Posted: April 11, 2017