Trial Outcomes & Findings for Interventions for Children With Attention and Reading Disorders (NCT NCT01133847)
NCT ID: NCT01133847
Last Updated: 2017-04-11
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
222 participants
Primary outcome timeframe
16 weeks (end of Active Treatment phase), and follow-up
Results posted on
2017-04-11
Participant Flow
Participant milestones
| Measure |
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.
|
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 Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
|
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.
|
|---|---|---|---|
|
Active Treatment Phase (Weeks 1-16)
STARTED
|
78
|
74
|
70
|
|
Active Treatment Phase (Weeks 1-16)
COMPLETED
|
73
|
73
|
67
|
|
Active Treatment Phase (Weeks 1-16)
NOT COMPLETED
|
5
|
1
|
3
|
|
Follow-Up Phase
STARTED
|
73
|
73
|
67
|
|
Follow-Up Phase
COMPLETED
|
72
|
70
|
60
|
|
Follow-Up Phase
NOT COMPLETED
|
1
|
3
|
7
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Active Treatment Phase (Weeks 1-16)
Withdrawal by Subject
|
5
|
1
|
3
|
|
Follow-Up Phase
Lost to Follow-up
|
1
|
3
|
7
|
Baseline Characteristics
Interventions for Children With Attention and Reading Disorders
Baseline characteristics by cohort
| Measure |
ADHD Treatment
n=77 Participants
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.
|
Intensive Reading Instruction
n=73 Participants
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.
|
Combined ADHD Treatment and Reading Instruction
n=66 Participants
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
n=216 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
77 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
216 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
132 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
77 participants
n=5 Participants
|
73 participants
n=7 Participants
|
66 participants
n=5 Participants
|
216 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 16 weeks (end of Active Treatment phase), and follow-upPopulation: 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.
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).
Outcome measures
| Measure |
ADHD Treatment
n=71 Participants
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.
|
Intensive Reading Instruction
n=72 Participants
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.
|
Combined ADHD Treatment and Reading Instruction
n=60 Participants
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.
|
|---|---|---|---|
|
Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Inattention
16-Week Outcomes
|
1.1 Units on a scale
Standard Error 0.1
|
1.7 Units on a scale
Standard Error 0.1
|
1.0 Units on a scale
Standard Error 0.1
|
|
Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Inattention
Follow-up Outcomes
|
1.3 Units on a scale
Standard Error 0.1
|
1.6 Units on a scale
Standard Error 0.1
|
1.0 Units on a scale
Standard Error 0.1
|
PRIMARY outcome
Timeframe: 16 weeks (end of Active Treatment phase), and follow-upPopulation: 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.
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).
Outcome measures
| Measure |
ADHD Treatment
n=71 Participants
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.
|
Intensive Reading Instruction
n=72 Participants
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.
|
Combined ADHD Treatment and Reading Instruction
n=60 Participants
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.
|
|---|---|---|---|
|
Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Hyperactivity-impulsivity
16-Week Outcomes
|
0.8 units on a scale
Standard Error 0.1
|
1.3 units on a scale
Standard Error 0.1
|
0.6 units on a scale
Standard Error 0.1
|
|
Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Hyperactivity-impulsivity
Follow-up Outcomes
|
0.9 units on a scale
Standard Error 0.1
|
1.4 units on a scale
Standard Error 0.1
|
0.7 units on a scale
Standard Error 0.1
|
PRIMARY outcome
Timeframe: Week 16 (End of Active Treatment Phase) and Follow-UpPopulation: 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.
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).
Outcome measures
| Measure |
ADHD Treatment
n=72 Participants
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.
|
Intensive Reading Instruction
n=71 Participants
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.
|
Combined ADHD Treatment and Reading Instruction
n=63 Participants
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.
|
|---|---|---|---|
|
Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Inattention
16-week Outcomes
|
1.2 Units on a scale
Standard Error 0.1
|
1.7 Units on a scale
Standard Error 0.1
|
1.4 Units on a scale
Standard Error 0.1
|
|
Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Inattention
Follow-Up
|
1.5 Units on a scale
Standard Error 0.1
|
1.9 Units on a scale
Standard Error 0.1
|
1.5 Units on a scale
Standard Error 0.1
|
PRIMARY outcome
Timeframe: Week 16 (End of Active Treatment Phase) and Follow-UpPopulation: 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.
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).
Outcome measures
| Measure |
ADHD Treatment
n=72 Participants
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.
|
Intensive Reading Instruction
n=71 Participants
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.
|
Combined ADHD Treatment and Reading Instruction
n=63 Participants
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.
|
|---|---|---|---|
|
Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Hyperactivity-impulsivity
16-Week Outcomes
|
0.7 Units on a scale
Standard Error 0.1
|
1.1 Units on a scale
Standard Error 0.1
|
0.8 Units on a scale
Standard Error 0.1
|
|
Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Hyperactivity-impulsivity
Follow-up
|
0.8 Units on a scale
Standard Error 0.1
|
1.1 Units on a scale
Standard Error 0.1
|
0.8 Units on a scale
Standard Error 0.1
|
PRIMARY outcome
Timeframe: Week 16 (End of Active Treatment Phase) and Follow-UpPopulation: 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.
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.
Outcome measures
| Measure |
ADHD Treatment
n=72 Participants
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.
|
Intensive Reading Instruction
n=72 Participants
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.
|
Combined ADHD Treatment and Reading Instruction
n=63 Participants
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.
|
|---|---|---|---|
|
Wechsler Individual Achievement Test-III (WIAT-III) Word Reading Subtest
16-Week Outcomes
|
76.9 standardized scores, M=100, SD = 15
Standard Error 0.7
|
79.0 standardized scores, M=100, SD = 15
Standard Error 0.7
|
79.9 standardized scores, M=100, SD = 15
Standard Error 0.7
|
|
Wechsler Individual Achievement Test-III (WIAT-III) Word Reading Subtest
Follow-Up
|
77.1 standardized scores, M=100, SD = 15
Standard Error 0.8
|
78.1 standardized scores, M=100, SD = 15
Standard Error 0.8
|
78.8 standardized scores, M=100, SD = 15
Standard Error 0.8
|
PRIMARY outcome
Timeframe: Week 16 (End of Active Treatment Phase) and Follow-UpPopulation: 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.
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.
Outcome measures
| Measure |
ADHD Treatment
n=72 Participants
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.
|
Intensive Reading Instruction
n=72 Participants
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.
|
Combined ADHD Treatment and Reading Instruction
n=63 Participants
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.
|
|---|---|---|---|
|
Wechsler Individual Achievement Test-III (WIAT-III) Pseudoword Decoding Subtest
16-Week Outcomes
|
78.3 standardized scores
Standard Error 1.0
|
83.8 standardized scores
Standard Error 1.0
|
83.0 standardized scores
Standard Error 1.1
|
|
Wechsler Individual Achievement Test-III (WIAT-III) Pseudoword Decoding Subtest
Follow-Up
|
77.1 standardized scores
Standard Error 1.0
|
82.6 standardized scores
Standard Error 1.1
|
81.9 standardized scores
Standard Error 1.2
|
SECONDARY outcome
Timeframe: Week 16, End of Active Treatment PhasePopulation: 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.
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.
Outcome measures
| Measure |
ADHD Treatment
n=72 Participants
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.
|
Intensive Reading Instruction
n=72 Participants
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.
|
Combined ADHD Treatment and Reading Instruction
n=63 Participants
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.
|
|---|---|---|---|
|
Wechsler Individual Achievement Test-III (WIAT-III) Reading Comprehension Subtest
|
88.27 standardized scores
Standard Error 0.9
|
84.70 standardized scores
Standard Error 0.9
|
86.35 standardized scores
Standard Error 1.0
|
SECONDARY outcome
Timeframe: Week 16 (End of Active Treatment Phase) and Follow-UpPopulation: 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.
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).
Outcome measures
| Measure |
ADHD Treatment
n=72 Participants
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.
|
Intensive Reading Instruction
n=72 Participants
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.
|
Combined ADHD Treatment and Reading Instruction
n=63 Participants
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.
|
|---|---|---|---|
|
Dynamic Indicators of Basic Early Literacy Skills Oral Reading Fluency Subtest (DIBELS ORF)
16-Week Outcomes
|
53.67 words read correctly per minute
Standard Deviation 30.3
|
50.71 words read correctly per minute
Standard Deviation 31.94
|
53.83 words read correctly per minute
Standard Deviation 33.5
|
|
Dynamic Indicators of Basic Early Literacy Skills Oral Reading Fluency Subtest (DIBELS ORF)
Follow-Up
|
63.06 words read correctly per minute
Standard Deviation 31.97
|
57.40 words read correctly per minute
Standard Deviation 31.06
|
59.05 words read correctly per minute
Standard Deviation 31.97
|
SECONDARY outcome
Timeframe: Week 16 (End of Active Treatment Phase) and Follow-UpPopulation: 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.
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.
Outcome measures
| Measure |
ADHD Treatment
n=72 Participants
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.
|
Intensive Reading Instruction
n=72 Participants
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.
|
Combined ADHD Treatment and Reading Instruction
n=63 Participants
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.
|
|---|---|---|---|
|
Test of Word Reading Efficiency (TOWRE) - Sight Word Efficiency
16-Week Outcomes
|
80.8 standardized scores
Standard Error 0.82
|
82.7 standardized scores
Standard Error 0.82
|
83.5 standardized scores
Standard Error 0.87
|
|
Test of Word Reading Efficiency (TOWRE) - Sight Word Efficiency
Follow-Up
|
83.57 standardized scores
Standard Error 0.82
|
85.04 standardized scores
Standard Error 0.84
|
84.15 standardized scores
Standard Error 0.90
|
SECONDARY outcome
Timeframe: Week 16 (End of Active Treatment Phase) and Follow-UpPopulation: 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.
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.
Outcome measures
| Measure |
ADHD Treatment
n=72 Participants
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.
|
Intensive Reading Instruction
n=72 Participants
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.
|
Combined ADHD Treatment and Reading Instruction
n=63 Participants
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.
|
|---|---|---|---|
|
Test of Word Reading Efficiency (TOWRE) - Phonemic Decoding Efficiency
16-Week Outcomes
|
80.4 standardized scores
Standard Error 0.79
|
83.4 standardized scores
Standard Error 0.79
|
82.9 standardized scores
Standard Error 0.84
|
|
Test of Word Reading Efficiency (TOWRE) - Phonemic Decoding Efficiency
Follow-Up
|
81.49 standardized scores
Standard Error 0.83
|
84.50 standardized scores
Standard Error 0.86
|
84.32 standardized scores
Standard Error 0.92
|
SECONDARY outcome
Timeframe: Week 16, End of Active Treatment PhasePopulation: 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.
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.
Outcome measures
| Measure |
ADHD Treatment
n=72 Participants
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.
|
Intensive Reading Instruction
n=72 Participants
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.
|
Combined ADHD Treatment and Reading Instruction
n=63 Participants
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.
|
|---|---|---|---|
|
Test of Silent Reading Fluency and Comprehension (TOSREC)
|
17.40 standardized scores
Standard Error 0.7
|
17.70 standardized scores
Standard Error 0.7
|
18.57 standardized scores
Standard Error 0.75
|
Adverse Events
ADHD Treatment
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Intensive Reading Instruction
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Combined ADHD Treatment and Reading Instruction
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ADHD Treatment
n=71 participants at risk
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.
|
Intensive Reading Instruction
n=74 participants at risk
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.
|
Combined ADHD Treatment and Reading Instruction
n=68 participants at risk
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.
|
|---|---|---|---|
|
Social circumstances
Aggressive behaviors
|
4.2%
3/71 • Number of events 3 • 6 years
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).
|
1.4%
1/74 • Number of events 1 • 6 years
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).
|
7.4%
5/68 • Number of events 5 • 6 years
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).
|
Additional Information
Dr. Carolyn Denton
University of Texas Health Science Center Houston
Phone: 713-500-3891
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place