Interventions for Children With Attention and Reading Disorders (ICARD)

Reading ICARD: Interventions for Children With Attention and Reading Disorders

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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder; Reading Disabilities
• Intervention / Treatment: Behavioral: Intensive reading instruction; Drug: Methylphenidate; Behavioral: Parent Training; Drug: Mixed Salt Amphetamine; Drug: Atomoxetine; Drug: Guanfacine

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.

• Study Type: Interventional
• Enrollment (Actual): 222
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Ritalin; Concerta Extended Release; 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 Names: Adderall Extended Release (XR); Drug: Atomoxetine; Appropriate dosage to be individually determined; daily for 16 weeks; Other Names: Strattera; Drug: Guanfacine; Appropriate dosage to be individually determined; daily for 16 weeks; Other Names: 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.	Behavioral: Intensive reading instruction; Individualized phonologically-based instruction delivered 4 days per week for 45 min. per day by a highly trained tutor.; Drug: Methylphenidate; Appropriate dosage to be individually determined; daily for 16 weeks; Other Names: Ritalin; Concerta Extended Release; 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 Names: Adderall Extended Release (XR); Drug: Atomoxetine; Appropriate dosage to be individually determined; daily for 16 weeks; Other Names: Strattera; Drug: Guanfacine; Appropriate dosage to be individually determined; daily for 16 weeks; Other Names: Intuniv

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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).	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.	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.	Week 16 (End of Active Treatment Phase) and Follow-Up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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.	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.	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.	Week 16, End of Active Treatment Phase

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: 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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: May 26, 2010
• First Submitted That Met QC Criteria: May 28, 2010
• First Posted (Estimate): May 31, 2010

Study Record Updates

• Last Update Posted (Actual): April 11, 2017
• Last Update Submitted That Met QC Criteria: February 27, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Language Disorders; Communication Disorders; Learning Disabilities; Attention Deficit Disorder with Hyperactivity; Dyslexia; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Sympathomimetics; Adrenergic Uptake Inhibitors; Methylphenidate; Atomoxetine Hydrochloride; Amphetamine; Adderall; Guanfacine
• Other Study ID Numbers: HSC-MS-09-0531; R01HD060617 (U.S. NIH Grant/Contract)