Interventions for Children With Attention and Reading Disorders
Condition: Attention Deficit Hyperactivity Disorder; Reading Disabilities
MeSH terms: Dyslexia; Attention Deficit Disorder with Hyperactivity
Intervention: Methylphenidate; Intensive reading instruction; Parent Training; Mixed Salt Amphetamine; Atomoxetine; Guanfacine
Intervention description: Appropriate dosage to be individually determined; daily for 16 weeks; Individualized phonologically-based instruction delivered 4 days per week for 45 min. per day by a highly trained tutor.; Nine sessions on parenting a child with ADHD; Appropriate dosage to be individually determined; daily for 16 weeks; prescribed only if child does not show a beneficial treatment response to Concerta; Appropriate dosage to be individually determined; daily for 16 weeks; Appropriate dosage to be individually determined; daily for 16 weeks
Intervention MeSH terms: Guanfacine; Methylphenidate; Amphetamine; Adderall; Atomoxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 222.0
Sex: All
Minimum age: 7 Years
Maximum age: 12 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility 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.