NCT01133847

Interventions for Children With Attention and Reading Disorders

Reading ICARD: Interventions for Children With Attention and Reading Disorders

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 222 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 7 Years – 12 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Attention Deficit Hyperactivity Disorder
• Reading Disabilities

Interventions

Type	Name	Description
DRUG	Methylphenidate	Appropriate dosage to be individually determined; daily for 16 weeks
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
DRUG	Atomoxetine	Appropriate dosage to be individually determined; daily for 16 weeks
DRUG	Guanfacine	Appropriate dosage to be individually determined; daily for 16 weeks

Timeline

• Start date: 2010-11-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2010-05-31
• Last updated: 2017-04-11
• Results posted: 2017-04-11

Locations

2 sites across 1 country: United States