Interventions for Children With Attention and Reading Disorders

Attention Deficit Hyperactivity Disorder Clinical Trial

— ICARD  

Official title:

Reading ICARD: Interventions for Children With Attention and Reading Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01133847
• Other study ID #: HSC-MS-09-0531
• Secondary ID: R01HD060617
• Status: Completed
• Phase: Phase 4
• First received: May 26, 2010
• Last updated: December 8, 2015
• Start date: November 2010
• Est. completion date: June 2015

Study information

• Verified date: December 2015
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 12 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Dyslexia
• Reading Disabilities

Intervention

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.
• 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
• Atomoxetine
Appropriate dosage to be individually determined; daily for 16 weeks
• Guanfacine
Appropriate dosage to be individually determined; daily for 16 weeks

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	University of Texas Health Science Center	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Children's Hospital Medical Center, Cincinnati, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wechsler Individual Achievement Test of Word Reading and Pseudoword Decoding		Week 16	No
Primary	Swanson, Nolan, and Pelham checklist for DSM-IV	Measure of ADHD symptomology completed by parents and teachers	Week 16	No
Secondary	Stop-Signal Test		Week 16	No
Secondary	Test of Word Reading Efficiency		Week 16	No
Secondary	Wechsler Individual Achievement Test of Reading Comprehension		Week 16	No
Secondary	Dynamic Indicators of Basic Early Literacy Skills Oral Reading Fluency		Week 16	No