Attention Deficit Hyperactivity DisorderPhase 4ICARDNCT01133847

Interventions for Children With Attention and Reading Disorders

A Phase 4 study testing Methylphenidate, Intensive reading instruction and Parent Training in people with Attention Deficit Hyperactivity Disorder and Reading Disabilities, run by The University of Texas Health Science Center, Houston at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 7 to 12 years
Conditions the study is for: Attention Deficit Hyperactivity Disorder, Reading Disabilities
What is being tested?: Methylphenidate, Intensive reading instruction and Parent Training
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 222 participants
Where: 2 sitesUnited States
Study dates: Nov 2010to Jun 2015
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 7 to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

Meet criteria for ADHD, Combined Type or ADHD, Predominantly Inattentive Type based on the Diagnostic Interview Schedule for Children, 4.0 (DISC) parent interview, Teacher baseline Swanson Nolan and Pelham Rating Scale (SNAP) endorses additional non-overlapping Inattentive symptoms with the parent DISC, which when combined with the parent ratings result in endorsement of 6 or more symptoms required for diagnosis by the Diagnostic and Statistical Manual.
Have at least 4 symptoms of inattention rated "Often" or "Very Often" on the teacher version of the SNAP-IV.
Have a standard score of 90 or lower on either the Woodcock-Johnson III Tests of Achievement Letter-Word Identification or Word Attack Subtests, or on the Basic Reading Skills Cluster
Attend a participating school in Grades 2-5
Have at least one parent or guardian who understands English well enough to participate in the behavioral parent training intervention.
Have a Full Scale OR Non-Verbal Intelligence Quotient (IQ) estimate higher than 70 based on the IQ Composite and Non-Verbal IQ estimate of the Kaufman Brief Intelligence Test (KBIT-2).

Who cannot join

Any documented or suspected bipolar disorder, severe psychosis, or other severe emotional disturbance, developmental disability, or autism.
Receipt of primary school reading instruction in a language other than English.
A history or presence of cardiovascular problems that would contraindicate stimulant treatment.
Chronic vocal tics.
Children will be excluded if they are taking a concomitant medication that has the potential to significantly affect their ADHD symptoms, that would be contraindicated to take along with the study medication, or if they have not been on a stable dose of a psychotropic medication long enough to fully assess the clinical outcome or tolerability.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45206
University of Texas Health Science Center
Houston, Texas, 77030

Other trials in United States

About this study

Official title: Reading ICARD: Interventions for Children With Attention and Reading Disorders

Read the detailed description

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

Conditions: Attention Deficit Hyperactivity Disorder, Reading Disabilities
Being tested: Methylphenidate, Intensive reading instruction, Parent Training, Mixed Salt Amphetamine, Atomoxetine
Medical subject headings: Attention Deficit Disorder with Hyperactivity, Dyslexia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MethylphenidateDrug
Also called Concerta Extended Release, Ritalin
Appropriate dosage to be individually determined; daily for 16 weeks
Intensive reading instructionBehavioural
Individualized phonologically-based instruction delivered 4 days per week for 45 min. per day by a highly trained tutor.
Parent TrainingBehavioural
Nine sessions on parenting a child with ADHD
Mixed Salt AmphetamineDrug
Also called Adderall Extended Release (XR)
Appropriate dosage to be individually determined; daily for 16 weeks; prescribed only if child does not show a beneficial treatment response to Concerta
AtomoxetineDrug
Also called Strattera
Appropriate dosage to be individually determined; daily for 16 weeks
GuanfacineDrug
Also called Intuniv
Appropriate dosage to be individually determined; daily for 16 weeks

Study groups in NCT01133847
Study group	Role	What they receive
Intensive Reading Instruction	Experimental	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 weeks. The instructional approach includes an individualized combination of published programs targeting word reading and decoding; reading fluency; and reading comprehension. Receives: Behavioral: Intensive reading instruction
ADHD Intervention	Experimental	Carefully-managed medication and behavioral parent training. Medication treatment begins with a four-week titration period, beginning with a trial of methylphenidate. If benefit is insufficient or side effects are intolerable, the physician may initiate a trial of mixed salt amphetamine, followed by either Atomoxetine or Guanfacine. When the optimum medication and dosage is determined the child returns for monthly medication maintenance visits until the end of the 16-week intervention period. Parent training consists of nine group sessions provided by a psychologist addressing ADHD and its treatment, principals of behavior modification, and evidence-supported practices for managing behavior. Receives: Drug: Methylphenidate; Behavioral: Parent Training; Drug: Mixed Salt Amphetamine; Drug: Atomoxetine; Drug: Guanfacine
Combined ADHD and Reading Instruction	Experimental	All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 weeks. Carefully-managed medication and behavioral parent training. Medication treatment begins with a trial of methylphenidate. If benefit is insufficient or side effects are intolerable, the physician may initiate a trial of mixed salt amphetamine, followed by either Atomoxetine or Guanfacine. When the optimum medication and dosage is determined the child returns for monthly medication maintenance visits until the end of the 16-week intervention period. Parent training consists of nine group sessions on parenting a child with ADHD. Receives: Drug: Methylphenidate; Behavioral: Intensive reading instruction; Behavioral: Parent Training; Drug: Mixed Salt Amphetamine; Drug: Atomoxetine; Drug: Guanfacine

What is being measured

The primary outcome is the main question the study is designed to answer.

Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Inattention
Rating Scale of ADHD symptomology completed by parents and teachers. Raters evaluate how well each DSM-IV (Diagnostic and Statistical Manual) ADHD symptom describes a child on a four-point Likert scale (0=Not at all, 1=Just a little, 2=Quite a bit, 3=Very much). The measure shows adequate internal consistency (.94) and test-retest reliability (Bussing et al., 2008; Gau et al., 2008).
Measured: 16 weeks (end of Active Treatment phase), and follow-up
Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Hyperactivity-impulsivity
Rating Scale of ADHD symptomology completed by parents and teachers. Raters evaluate how well each DSM-IV (Diagnostic and Statistical Manual) ADHD symptom describes a child on a four-point Likert scale (0=Not at all, 1=Just a little, 2=Quite a bit, 3=Very much). The measure shows adequate internal consistency (.94) and test-retest reliability (Bussing et al., 2008; Gau et al., 2008).
Measured: 16 weeks (end of Active Treatment phase), and follow-up
Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Inattention
Rating Scale of ADHD symptomology completed by parents and teachers. Raters evaluate how well each DSM-IV ADHD symptom describes a child on a four-point Likert scale (0=Not at all, 1=Just a little, 2=Quite a bit, 3=Very much). The measure shows adequate internal consistency (.94) and test-retest reliability (Bussing et al., 2008; Gau et al., 2008).
Measured: Week 16 (End of Active Treatment Phase) and Follow-Up
Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Hyperactivity-impulsivity
Rating Scale of ADHD symptomology completed by parents and teachers. Raters evaluate how well each DSM-IV ADHD symptom describes a child on a four-point Likert scale (0=Not at all, 1=Just a little, 2=Quite a bit, 3=Very much). The measure shows adequate internal consistency (.94) and test-retest reliability (Bussing et al., 2008; Gau et al., 2008).
Measured: Week 16 (End of Active Treatment Phase) and Follow-Up
Wechsler Individual Achievement Test-III (WIAT-III) Word Reading Subtest
The WIAT-III is an individually-administered test of academic achievement. In the Word Reading subtest students read a list of increasingly difficult words. Scores reported here are standardized scores with a mean of 100 and standard deviation of 15.
Measured: Week 16 (End of Active Treatment Phase) and Follow-Up
Wechsler Individual Achievement Test-III (WIAT-III) Pseudoword Decoding Subtest
The WIAT-III is an individually-administered test of academic achievement. In the Pseudoword Decoding subtest students read a list of increasingly difficult nonsense words as a test of their ability to use phonics to decode unknown words. Scores reported here are standardized scores with a mean of 100 and standard deviation of 15. Higher scores represent a better outcome.
Measured: Week 16 (End of Active Treatment Phase) and Follow-Up

Secondary outcomes (5)

Wechsler Individual Achievement Test-III (WIAT-III) Reading Comprehension Subtest
The WIAT-III is an individually-administered test of academic achievement. This subtest involves reading sentences and longer passages and then answering a set of literal and inferential comprehension questions about the text. Scores reported here are standardized scores with a mean of 100 and standard deviation of 15. Higher scores represent a better outcome.
Measured: Week 16, End of Active Treatment Phase
Dynamic Indicators of Basic Early Literacy Skills Oral Reading Fluency Subtest (DIBELS ORF)
DIBELS ORF measures oral reading fluency in connected text. Students are presented with a passage on their grade level to read orally, and the score is the number of words of the passage read correctly in a one-minute period. Students in this study read two passages at each test administration, and the mean score for the two passages was the dependent variable analyzed. A research synthesis of studies reporting psychometric properties for DIBELS ORF determined that reliability coefficients in these studies exceeded .80 and that the measure demonstrated moderate to high concurrent and predictive validity across studies (Goffreda \& DiPerna, 2010).
Measured: Week 16 (End of Active Treatment Phase) and Follow-Up
Test of Word Reading Efficiency (TOWRE) - Sight Word Efficiency
The TOWRE Sight Word Efficiency subtest measures fluency of reading words in lists. The raw score is the number of words or nonwords identified correctly in 45 seconds. Standard scores with a mean of 100 and standard deviaion of 15 are reported here. Higher scores represent a better outcome.
Measured: Week 16 (End of Active Treatment Phase) and Follow-Up
Test of Word Reading Efficiency (TOWRE) - Phonemic Decoding Efficiency
The TOWRE Phonemic Decoding Efficiency measures the student's fluent decoding of nonsense words that follow the spelling rules of the English language. The raw score is the number of nonwords identified correctly in 45 seconds. Standardized scores with a mean of 100 and standard deviaion of 15 are reported here. Higher scores represent a better outcome.
Measured: Week 16 (End of Active Treatment Phase) and Follow-Up
Test of Silent Reading Fluency and Comprehension (TOSREC)
The TOSREC measures sentence-level comprehension and silent reading fluency. It is a sentence verification task; children are presented with a list of sentences and must tell whether they are true or false. Items are based on common knowledge (e.g., All apples are blue). The raw score is the number of items answered correctly in 3 minutes. Standardized with a mean of 100 and standard deviation of 15 are reported here. Higher scores represent a better outcome.
Measured: Week 16, End of Active Treatment Phase

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2010Jun 2015

First posted31 May 2010 (estimated)
Study startNov 2010
Primary completionJun 2015
Study completionJun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 222 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01133847
Sponsor's protocol ID: HSC-MS-09-0531
Other IDs: R01HD060617
Acronym: ICARD
Status last verified: Feb 2017
First submitted: 26 May 2010
Last updated: 11 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Dvorsky M, Tamm L, Denton CA, Epstein JN, Schatschneider C. Trajectories of Response to Treatments in Children with ADHD and Word Reading Difficulties. Res Child Adolesc Psychopathol. 2021 Aug;49(8):1015-1030. doi: 10.1007/s10802-021-00815-y. Epub 2021 Mar 26.
PubMed 33772416

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Reading ICARD: Interventions for Children With Attention and Reading Disorders
ClinicalTrials.gov ID: NCT01133847
Acronym / sponsor ID: ICARD / HSC-MS-09-0531
Conditions: Attention Deficit Hyperactivity Disorder, Reading Disabilities
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 222 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Children's Hospital Medical Center, Cincinnati
Study start: Nov 2010
Primary completion: Jun 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 31 May 2010 (estimated)
Results: Posted 11 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Intensive Reading Instruction	Experimental	Behavioral: Intensive reading instructionSpecialized 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 weeks. The instructional approach includes an individualized combination of published programs targeting word reading and decoding; reading fluency; and reading comprehension.
ADHD Intervention	Experimental	Drug: Methylphenidate, Behavioral: Parent Training, Drug: Mixed Salt Amphetamine, Drug: Atomoxetine, Drug: GuanfacineCarefully-managed medication and behavioral parent training. Medication treatment begins with a four-week titration period, beginning with a trial of methylphenidate. If benefit is insufficient or side effects are intolerable, the physician may initiate a trial of mixed salt amphetamine, followed by either Atomoxetine or Guanfacine. When the optimum medication and dosage is determined the child returns for monthly medication maintenance visits until the end of the 16-week intervention period. Parent training consists of nine group sessions provided by a psychologist addressing ADHD and its treatment, principals of behavior modification, and evidence-supported practices for managing behavior.
Combined ADHD and Reading Instruction	Experimental	Drug: Methylphenidate, Behavioral: Intensive reading instruction, Behavioral: Parent Training, Drug: Mixed Salt Amphetamine, Drug: Atomoxetine, Drug: GuanfacineAll interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 weeks. Carefully-managed medication and behavioral parent training. Medication treatment begins with a trial of methylphenidate. If benefit is insufficient or side effects are intolerable, the physician may initiate a trial of mixed salt amphetamine, followed by either Atomoxetine or Guanfacine. When the optimum medication and dosage is determined the child returns for monthly medication maintenance visits until the end of the 16-week intervention period. Parent training consists of nine group sessions on parenting a child with ADHD.

Who may qualify

Ages: 7 to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

Meet criteria for ADHD, Combined Type or ADHD, Predominantly Inattentive Type based on the Diagnostic Interview Schedule for Children, 4.0 (DISC) parent interview, Teacher baseline Swanson Nolan and Pelham Rating Scale (SNAP) endorses additional non-overlapping Inattentive symptoms with the parent DISC, which when combined with the parent ratings result in endorsement of 6 or more symptoms required for diagnosis by the Diagnostic and Statistical Manual.
Have at least 4 symptoms of inattention rated "Often" or "Very Often" on the teacher version of the SNAP-IV.
Have a standard score of 90 or lower on either the Woodcock-Johnson III Tests of Achievement Letter-Word Identification or Word Attack Subtests, or on the Basic Reading Skills Cluster
Attend a participating school in Grades 2-5
Have at least one parent or guardian who understands English well enough to participate in the behavioral parent training intervention.

Key exclusion criteria (5 listed)

Any documented or suspected bipolar disorder, severe psychosis, or other severe emotional disturbance, developmental disability, or autism.
Receipt of primary school reading instruction in a language other than English.
A history or presence of cardiovascular problems that would contraindicate stimulant treatment.
Chronic vocal tics.
Children will be excluded if they are taking a concomitant medication that has the potential to significantly affect their ADHD symptoms, that would be contraindicated to take along with the study medication, or if they have not been on a stable dose of a psychotropic medication long enough to fully assess the clinical outcome or tolerability.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MethylphenidateAlso: Concerta Extended Release, RitalinAppropriate dosage to be individually determined; daily for 16 weeks	Drug	ADHD Intervention, Combined ADHD and Reading Instruction
Intensive reading instructionIndividualized phonologically-based instruction delivered 4 days per week for 45 min. per day by a highly trained tutor.	Behavioural	Combined ADHD and Reading Instruction, Intensive Reading Instruction
Parent TrainingNine sessions on parenting a child with ADHD	Behavioural	ADHD Intervention, Combined ADHD and Reading Instruction
Mixed Salt AmphetamineAlso: Adderall Extended Release (XR)Appropriate dosage to be individually determined; daily for 16 weeks; prescribed only if child does not show a beneficial treatment response to Concerta	Drug	ADHD Intervention, Combined ADHD and Reading Instruction
AtomoxetineAlso: StratteraAppropriate dosage to be individually determined; daily for 16 weeks	Drug	ADHD Intervention, Combined ADHD and Reading Instruction
GuanfacineAlso: IntunivAppropriate dosage to be individually determined; daily for 16 weeks	Drug	ADHD Intervention, Combined ADHD and Reading Instruction

Primary outcome

Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Inattention
Time frame: 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).
Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Hyperactivity-impulsivity
Time frame: 16 weeks (end of Active Treatment phase), and follow-up
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).
Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Inattention
Time frame: 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).
Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Hyperactivity-impulsivity
Time frame: Week 16 (End of Active Treatment Phase) and Follow-Up
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).
Wechsler Individual Achievement Test-III (WIAT-III) Word Reading Subtest
Time frame: 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.
Wechsler Individual Achievement Test-III (WIAT-III) Pseudoword Decoding Subtest
Time frame: 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.

5 secondary outcomes

Wechsler Individual Achievement Test-III (WIAT-III) Reading Comprehension Subtest
Time frame: Week 16, End of Active Treatment Phase
Dynamic Indicators of Basic Early Literacy Skills Oral Reading Fluency Subtest (DIBELS ORF)
Time frame: Week 16 (End of Active Treatment Phase) and Follow-Up
Test of Word Reading Efficiency (TOWRE) - Sight Word Efficiency
Time frame: Week 16 (End of Active Treatment Phase) and Follow-Up
Test of Word Reading Efficiency (TOWRE) - Phonemic Decoding Efficiency
Time frame: Week 16 (End of Active Treatment Phase) and Follow-Up
Test of Silent Reading Fluency and Comprehension (TOSREC)
Time frame: Week 16, End of Active Treatment Phase

Results and safety

Results posted to the registry on 11 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ADHD Treatment	78	73
Intensive Reading Instruction	74	73
Combined ADHD Treatment and Reading Instruction	70	67

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

Time frame: 16 weeks (end of Active Treatment phase), and follow-up. Least squares mean (Standard Error). Unit: Units on a scale

Measure	ADHD Treatment n = 71	Intensive Reading Instruction n = 72	Combined ADHD Treatment and Reading Instruction n = 60
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)

Population analysed: 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.

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

Time frame: 16 weeks (end of Active Treatment phase), and follow-up. Least squares mean (Standard Error). Unit: units on a scale

Measure	ADHD Treatment n = 71	Intensive Reading Instruction n = 72	Combined ADHD Treatment and Reading Instruction n = 60
16-Week Outcomes	0.8 (0.1)	1.3 (0.1)	0.6 (0.1)
Follow-up Outcomes	0.9 (0.1)	1.4 (0.1)	0.7 (0.1)

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

Time frame: Week 16 (End of Active Treatment Phase) and Follow-Up. Least squares mean (Standard Error). Unit: Units on a scale

Measure	ADHD Treatment n = 72	Intensive Reading Instruction n = 71	Combined ADHD Treatment and Reading Instruction n = 63
16-week Outcomes	1.2 (0.1)	1.7 (0.1)	1.4 (0.1)
Follow-Up	1.5 (0.1)	1.9 (0.1)	1.5 (0.1)

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

Time frame: Week 16 (End of Active Treatment Phase) and Follow-Up. Least squares mean (Standard Error). Unit: Units on a scale

Measure	ADHD Treatment n = 72	Intensive Reading Instruction n = 71	Combined ADHD Treatment and Reading Instruction n = 63
16-Week Outcomes	0.7 (0.1)	1.1 (0.1)	0.8 (0.1)
Follow-up	0.8 (0.1)	1.1 (0.1)	0.8 (0.1)

Population analysed: 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.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ADHD Treatment	0 of 71 (0%)	3 of 71 (4.2%)	Not reported
Intensive Reading Instruction	0 of 74 (0%)	1 of 74 (1.4%)	Not reported
Combined ADHD Treatment and Reading Instruction	0 of 68 (0%)	5 of 68 (7.4%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33772416Dvorsky M, Tamm L, Denton CA, Epstein JN, Schatschneider C. Trajectories of Response to Treatments in Children with ADHD and Word Reading Difficulties. Res Child Adolesc Psychopathol. 2021 Aug;49(8):1015-1030. doi: 10.1007/s10802-021-00815-y. Epub 2021 Mar 26.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Carolyn A Denton, Ph.D. principal investigator

The University of Texas Health Science Center, Houston

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Inattention (time frame: 16 weeks (end of Active Treatment phase), and follow-up). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01133847, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2017.