Interventions for Children With Attention and Reading Disorders (ICARD)

This study is currently recruiting participants.
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

May 26, 2010
November 20, 2013
November 2010
April 2015   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01133847 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
 
Interventions for Children With Attention and Reading Disorders
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
216
April 2015
April 2015   (final data collection date for primary outcome measure)

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.
Both
7 Years to 12 Years
No
Not Provided
United States
 
NCT01133847
HSC-MS-09-0531, R01HD060617
Yes
Carolyn Denton, The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Children's Hospital Medical Center, Cincinnati
Principal Investigator: Carolyn A Denton, Ph.D. The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP