Trial · NCT01133847
Interventions for Children With Attention and Reading Disorders
NCT01133847, Phase 4, Completed, The University of Texas Health Science Center, Houston; results first posted 2017-04-11
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ConductScience Library. Interventions for Children With Attention and Reading Disorders. Trials, record NCT01133847. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01133847
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Interventions for Children With Attention and Reading Disorders
- NCT number
- NCT01133847
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 222 participants, actual
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Conditions
- Attention Deficit Hyperactivity Disorder, Reading Disabilities
- Interventions
- Methylphenidate, Intensive reading instruction, Parent Training, Mixed Salt Amphetamine, Atomoxetine, Guanfacine
- First posted
- 2010-05-31
- Last updated
- 2017-04-11
- Results first posted
- 2017-04-11
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Inattention | 16 weeks (end of Active Treatment phase), and follow-up | 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). |
| Primary | Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Hyperactivity-impulsivity | 16 weeks (end of Active Treatment phase), and follow-up | 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). |
| Primary | Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Inattention | Week 16 (End of Active Treatment Phase) and Follow-Up | 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). |
| Primary | Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Hyperactivity-impulsivity | Week 16 (End of Active Treatment Phase) and Follow-Up | 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). |
| Primary | Wechsler Individual Achievement Test-III (WIAT-III) Word Reading Subtest | Week 16 (End of Active Treatment Phase) and Follow-Up | 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. |
| Primary | Wechsler Individual Achievement Test-III (WIAT-III) Pseudoword Decoding Subtest | Week 16 (End of Active Treatment Phase) and Follow-Up | 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. |
| Secondary | Wechsler Individual Achievement Test-III (WIAT-III) Reading Comprehension Subtest | Week 16, End of Active Treatment Phase | 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. |
| Secondary | Dynamic Indicators of Basic Early Literacy Skills Oral Reading Fluency Subtest (DIBELS ORF) | Week 16 (End of Active Treatment Phase) and Follow-Up | 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). |
| Secondary | Test of Word Reading Efficiency (TOWRE) - Sight Word Efficiency | Week 16 (End of Active Treatment Phase) and Follow-Up | 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. |
| Secondary | Test of Word Reading Efficiency (TOWRE) - Phonemic Decoding Efficiency | Week 16 (End of Active Treatment Phase) and Follow-Up | 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Inattention | 16 weeks (end of Active Treatment phase), and follow-up | 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. | Units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Hyperactivity-impulsivity | 16 weeks (end of Active Treatment phase), and follow-up | 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. | units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Inattention | Week 16 (End of Active Treatment Phase) and Follow-Up | 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. | Units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Hyperactivity-impulsivity | Week 16 (End of Active Treatment Phase) and Follow-Up | 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. | Units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Wechsler Individual Achievement Test-III (WIAT-III) Word Reading Subtest | Week 16 (End of Active Treatment Phase) and Follow-Up | 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. | standardized scores, M=100, SD = 15 | LEAST_SQUARES_MEAN |
| PRIMARY | Wechsler Individual Achievement Test-III (WIAT-III) Pseudoword Decoding Subtest | Week 16 (End of Active Treatment Phase) and Follow-Up | 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. | standardized scores | LEAST_SQUARES_MEAN |
| SECONDARY | Wechsler Individual Achievement Test-III (WIAT-III) Reading Comprehension Subtest | Week 16, End of Active Treatment Phase | 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. | standardized scores | LEAST_SQUARES_MEAN |
| SECONDARY | Dynamic Indicators of Basic Early Literacy Skills Oral Reading Fluency Subtest (DIBELS ORF) | Week 16 (End of Active Treatment Phase) and Follow-Up | 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. | words read correctly per minute | MEAN |
| SECONDARY | Test of Word Reading Efficiency (TOWRE) - Sight Word Efficiency | Week 16 (End of Active Treatment Phase) and Follow-Up | 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. | standardized scores | LEAST_SQUARES_MEAN |
| SECONDARY | Test of Word Reading Efficiency (TOWRE) - Phonemic Decoding Efficiency | Week 16 (End of Active Treatment Phase) and Follow-Up | 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. | standardized scores | LEAST_SQUARES_MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Inattention | ADHD Treatment | 16-Week Outcomes | 1.1 | Standard Error 0.1 | Units on a scale |
| Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Inattention | Intensive Reading Instruction | 16-Week Outcomes | 1.7 | Standard Error 0.1 | Units on a scale |
| Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Inattention | Combined ADHD Treatment and Reading Instruction | 16-Week Outcomes | 1.0 | Standard Error 0.1 | Units on a scale |
| Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Inattention | ADHD Treatment | Follow-up Outcomes | 1.3 | Standard Error 0.1 | Units on a scale |
| Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Inattention | Intensive Reading Instruction | Follow-up Outcomes | 1.6 | Standard Error 0.1 | Units on a scale |
| Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Inattention | Combined ADHD Treatment and Reading Instruction | Follow-up Outcomes | 1.0 | Standard Error 0.1 | Units on a scale |
| Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Hyperactivity-impulsivity | ADHD Treatment | 16-Week Outcomes | 0.8 | Standard Error 0.1 | units on a scale |
| Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Hyperactivity-impulsivity | Intensive Reading Instruction | 16-Week Outcomes | 1.3 | Standard Error 0.1 | units on a scale |
| Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Hyperactivity-impulsivity | Combined ADHD Treatment and Reading Instruction | 16-Week Outcomes | 0.6 | Standard Error 0.1 | units on a scale |
| Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Hyperactivity-impulsivity | ADHD Treatment | Follow-up Outcomes | 0.9 | Standard Error 0.1 | units on a scale |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Active Treatment Phase (Weeks 1-16) | STARTED | ADHD Treatment | 78 | |
| Active Treatment Phase (Weeks 1-16) | STARTED | Intensive Reading Instruction | 74 | |
| Active Treatment Phase (Weeks 1-16) | STARTED | Combined ADHD Treatment and Reading Instruction | 70 | |
| Active Treatment Phase (Weeks 1-16) | COMPLETED | ADHD Treatment | 73 | |
| Active Treatment Phase (Weeks 1-16) | COMPLETED | Intensive Reading Instruction | 73 | |
| Active Treatment Phase (Weeks 1-16) | COMPLETED | Combined ADHD Treatment and Reading Instruction | 67 | |
| Active Treatment Phase (Weeks 1-16) | NOT COMPLETED | ADHD Treatment | 5 | |
| Active Treatment Phase (Weeks 1-16) | NOT COMPLETED | Intensive Reading Instruction | 1 | |
| Active Treatment Phase (Weeks 1-16) | NOT COMPLETED | Combined ADHD Treatment and Reading Instruction | 3 | |
| Follow-Up Phase | STARTED | ADHD Treatment | 73 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events3
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Aggressive behaviors | Social circumstances | ADHD Treatment | 3 | 71 | 3 |
| other | Aggressive behaviors | Social circumstances | Intensive Reading Instruction | 1 | 74 | 1 |
| other | Aggressive behaviors | Social circumstances | Combined ADHD Treatment and Reading Instruction | 5 | 68 | 5 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ADHD Treatment | ||
| Total, all-cause mortality | Intensive Reading Instruction | ||
| Total, all-cause mortality | Combined ADHD Treatment and Reading Instruction | ||
| Total, other adverse events | ADHD Treatment | 3 | 71 |
| Total, other adverse events | Intensive Reading Instruction | 1 | 74 |
| Total, other adverse events | Combined ADHD Treatment and Reading Instruction | 5 | 68 |
| Total, serious adverse events | ADHD Treatment | 0 | 71 |
| Total, serious adverse events | Intensive Reading Instruction | 0 | 74 |
| Total, serious adverse events | Combined ADHD Treatment and Reading Instruction | 0 | 68 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33772416 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01HD060617 | Reading ICARD: Interventions for Children With Attention and Reading Disorders | DENTON, CAROLYN A | UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2010 to 2014 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Sentence Verification Task | Secondary outcome |
Source ConductCognition
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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