Interventions for Children With Attention and Reading Disorders (ICARD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by The University of Texas Health Science Center, Houston
Sponsor:
Collaborators:
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: November 20, 2013
Last verified: November 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reading ICARD: Interventions for Children With Attention and Reading Disorders

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 216
Study Start Date: November 2010
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 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
  • 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 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
  • 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

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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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 Recruiting
Cincinnati, Ohio, United States, 45206
Contact: Leanne Tamm, Ph.D.       Leanne.Tamm@cchmc.org   
Principal Investigator: Leanne Tamm, Ph.D.         
Sub-Investigator: Jeff Epstein, Ph.D.         
Sub-Investigator: Aaron Vaughn, Ph.D.         
United States, Texas
University of Texas Health Science Center Recruiting
Houston, Texas, United States, 77030
Contact: Carolyn A Denton, Ph.D.       Carolyn.A.Denton@uth.tmc.edu   
Principal Investigator: Carolyn A Denton, Ph.D.         
Sub-Investigator: Anson Koshy, M.D.         
Sub-Investigator: Linda Ewing-Cobbs, Ph.D.         
Sub-Investigator: Mary Prasad, Ph.D.         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Carolyn A Denton, Ph.D. The University of Texas Health Science Center, Houston
  More Information

No publications provided

Responsible Party: Carolyn Denton, Associate 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
Study First Received: May 26, 2010
Last Updated: November 20, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dyslexia
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Learning Disorders
Signs and Symptoms
Mental Disorders Diagnosed in Childhood
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Amphetamine
Methylphenidate
Atomoxetine
Guanfacine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents

ClinicalTrials.gov processed this record on August 20, 2014