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Interventions for Children With Attention and Reading Disorders

Information source: The University of Texas Health Science Center, Houston
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Attention Deficit Hyperactivity Disorder; Reading Disabilities

Intervention: Methylphenidate (Drug); Intensive reading instruction (Behavioral); Parent Training (Behavioral); Mixed Salt Amphetamine (Drug); Atomoxetine (Drug); Guanfacine (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: The University of Texas Health Science Center, Houston

Official(s) and/or principal investigator(s):
Carolyn A Denton, Ph.D., Principal Investigator, Affiliation: The University of Texas Health Science Center, Houston

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.

Clinical Details

Official title: Reading ICARD: Interventions for Children With Attention and Reading Disorders

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

Primary outcome:

Wechsler Individual Achievement Test of Word Reading and Pseudoword Decoding

Swanson, Nolan, and Pelham checklist for DSM-IV

Secondary outcome:

Stop-Signal Test

Test of Word Reading Efficiency

Wechsler Individual Achievement Test of Reading Comprehension

Dynamic Indicators of Basic Early Literacy Skills Oral Reading Fluency

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

Minimum age: 7 Years. Maximum age: 12 Years. Gender(s): Both.

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.

Locations and Contacts

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio 45206, United States

University of Texas Health Science Center, Houston, Texas 77030, United States

Additional Information

Starting date: November 2010
Last updated: May 26, 2015

Page last updated: August 23, 2015

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