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Interventions for Children With Attention and Reading Disorders

NCT01133847 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 222

Last updated 2017-04-11

Study results available
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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.

Conditions

  • Attention Deficit Hyperactivity Disorder
  • Reading Disabilities

Interventions

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

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Children's Hospital Medical Center, Cincinnati

    collaborator OTHER

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Carolyn A Denton, Ph.D. · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01133847 on ClinicalTrials.gov