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Attention Deficit Hyperactivity Disorder | Interventions for Children With Attention and Reading Disorders

Attention Deficit Hyperactivity Disorder research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Attention Deficit Hyperactivity Disorder

Reading Disabilities

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:MethylphenidateAppropriate dosage to be individually determined; daily for 16 weeks

Behavioral:Intensive reading instructionIndividualized phonologically-based instruction delivered 4 days per week for 45 min. per day by a highly trained tutor.

Behavioral:Parent TrainingNine sessions on parenting a child with ADHD

Drug:Mixed Salt AmphetamineAppropriate dosage to be individually determined; daily for 16 weeks; prescribed only if child does not show a beneficial treatment response to Concerta

Drug:AtomoxetineAppropriate dosage to be individually determined; daily for 16 weeks

Drug:GuanfacineAppropriate dosage to be individually determined; daily for 16 weeks

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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 InterventionCarefully-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 InstructionAll 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.

Study Status

Completed

Start Date: November 2010

Completed Date: June 2015

Phase: Phase 4

Type: Interventional

Design:

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

Secondary Outcome: Wechsler Individual Achievement Test-III (WIAT-III) Reading Comprehension Subtest

Study sponsors, principal investigator, and references

Principal Investigator: Carolyn A Denton, Ph.D.

Lead Sponsor: The University of Texas Health Science Center, Houston

Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

More information:https://clinicaltrials.gov/show/NCT01133847

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