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Interventions for Children With Attention and Reading Disorders (ICARD)

This study has been completed.
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Children's Hospital Medical Center, Cincinnati
Information provided by (Responsible Party):
Carolyn Denton, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01133847
First received: May 26, 2010
Last updated: February 27, 2017
Last verified: February 2017
  Purpose
The objective of this randomized clinical trial is to address unanswered questions about the relative effectiveness of treatments for children with both Attention Deficit Hyperactivity Disorder (ADHD) and significant reading difficulties (RD). The study evaluates attentional and word reading outcomes for students with both conditions when provided with either (a) ADHD treatment alone, (b) RD treatment alone, or (c) the combination of ADHD and RD treatment.

Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
Reading Disabilities
Drug: Methylphenidate
Behavioral: Intensive reading instruction
Behavioral: Parent Training
Drug: Mixed Salt Amphetamine
Drug: Atomoxetine
Drug: Guanfacine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Treatment
Official Title: Reading ICARD: Interventions for Children With Attention and Reading Disorders

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Wechsler Individual Achievement Test-III (WIAT-III) Reading Comprehension Subtest [ Time Frame: 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.

  • 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 ]
    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).

  • Test of Word Reading Efficiency (TOWRE) - Sight Word Efficiency [ Time Frame: 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.

  • Test of Word Reading Efficiency (TOWRE) - Phonemic Decoding Efficiency [ Time Frame: 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.

  • Test of Silent Reading Fluency and Comprehension (TOSREC) [ Time Frame: Week 16, End of Active Treatment Phase ]
    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.


Enrollment: 222
Study Start Date: November 2010
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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 weeks. The instructional approach includes an individualized combination of published programs targeting word reading and decoding; reading fluency; and reading comprehension.
Behavioral: Intensive reading instruction
Individualized phonologically-based instruction delivered 4 days per week for 45 min. per day by a highly trained tutor.
Experimental: ADHD Intervention
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.
Drug: Methylphenidate
Appropriate dosage to be individually determined; daily for 16 weeks
Other Names:
  • Concerta Extended Release
  • Ritalin
Behavioral: Parent Training
Nine sessions on parenting a child with ADHD
Drug: Mixed Salt Amphetamine
Appropriate dosage to be individually determined; daily for 16 weeks; prescribed only if child does not show a beneficial treatment response to Concerta
Other Name: Adderall Extended Release (XR)
Drug: Atomoxetine
Appropriate dosage to be individually determined; daily for 16 weeks
Other Name: Strattera
Drug: Guanfacine
Appropriate dosage to be individually determined; daily for 16 weeks
Other Name: Intuniv
Experimental: Combined ADHD 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 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.

Drug: Methylphenidate
Appropriate dosage to be individually determined; daily for 16 weeks
Other Names:
  • Concerta Extended Release
  • Ritalin
Behavioral: Intensive reading instruction
Individualized phonologically-based instruction delivered 4 days per week for 45 min. per day by a highly trained tutor.
Behavioral: Parent Training
Nine sessions on parenting a child with ADHD
Drug: Mixed Salt Amphetamine
Appropriate dosage to be individually determined; daily for 16 weeks; prescribed only if child does not show a beneficial treatment response to Concerta
Other Name: Adderall Extended Release (XR)
Drug: Atomoxetine
Appropriate dosage to be individually determined; daily for 16 weeks
Other Name: Strattera
Drug: Guanfacine
Appropriate dosage to be individually determined; daily for 16 weeks
Other Name: Intuniv

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.
  Eligibility

Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Any documented or suspected bipolar disorder, severe psychosis, or other severe emotional disturbance, developmental disability, or autism.
  2. Receipt of primary school reading instruction in a language other than English.
  3. A history or presence of cardiovascular problems that would contraindicate stimulant treatment.
  4. Chronic vocal tics.
  5. Children will be excluded if they are taking a concomitant medication that has the potential to significantly affect their ADHD symptoms, that would be contraindicated to take along with the study medication, or if they have not been on a stable dose of a psychotropic medication long enough to fully assess the clinical outcome or tolerability.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01133847

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45206
United States, Texas
University of Texas Health Science Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Carolyn A Denton, Ph.D. The University of Texas Health Science Center, Houston
  More Information

Responsible Party: Carolyn Denton, Professor - Pediatrics, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01133847     History of Changes
Other Study ID Numbers: HSC-MS-09-0531
R01HD060617 ( US NIH Grant/Contract Award Number )
Study First Received: May 26, 2010
Results First Received: October 31, 2016
Last Updated: February 27, 2017

Additional relevant MeSH terms:
Disease
Attention Deficit Disorder with Hyperactivity
Dyslexia
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Learning Disorders
Signs and Symptoms
Methylphenidate
Amphetamine
Atomoxetine Hydrochloride
Guanfacine
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists

ClinicalTrials.gov processed this record on April 26, 2017