Interventions for Children With Attention and Reading Disorders (ICARD)

• Wechsler Individual Achievement Test of Word Reading and Pseudoword Decoding [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
• Swanson, Nolan, and Pelham checklist for DSM-IV [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  Measure of ADHD symptomology completed by parents and teachers

• Stop-Signal Test [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
• Test of Word Reading Efficiency [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
• Wechsler Individual Achievement Test of Reading Comprehension [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
• Dynamic Indicators of Basic Early Literacy Skills Oral Reading Fluency [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

• Stop-Signal Test [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
• Test of Word Reading Efficiency [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
• Wechsler Individual Achievement Test of Reading Comprehension [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
• Wechsler Individual Achievement Test of Spelling [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
• Dynamic Indicators of Basic Early Literacy Skills Oral Reading Fluency [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

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.

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.

• Attention Deficit Hyperactivity Disorder
• Reading Disabilities

• Drug: Methylphenidate
  Appropriate dosage to be individually determined; daily for 16 weeks
  Other Names:

  • Concerta
  • 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 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: 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.
  Intervention: Behavioral: Intensive reading instruction
• 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.
  Interventions:

  • Drug: Methylphenidate
  • Behavioral: Parent Training
  • Drug: Mixed Salt Amphetamine
  • Drug: Atomoxetine
  • Drug: Guanfacine
• 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.

  Interventions:

  • Drug: Methylphenidate
  • Behavioral: Intensive reading instruction
  • Behavioral: Parent Training
  • Drug: Mixed Salt Amphetamine
  • Drug: Atomoxetine
  • Drug: Guanfacine

Inclusion Criteria:

1. Meet criteria for ADHD, Combined Type or ADHD, Predominantly Inattentive Type based on the DISC-IV parent interview, Teacher baseline 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 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.

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Children's Hospital Medical Center, Cincinnati