Evaluating Assessment and Medication Treatment of ADHD in Children with Down Syndrome
Children's Hospital Medical Center, Cincinnati
Summary
Children with Down syndrome (DS) have a 3-5 time greater prevalence of Attention Deficit Hyperactivity Disorder (ADHD) than typically developing (TD) children. Despite this higher risk of ADHD, rates of stimulant medication treatment are disproportionately low in children with DS+ADHD, even though stimulants are the most efficacious ADHD treatment and are recommended by consensus guidelines for use in children with intellectual disability and ADHD. The investigators propose the first randomized clinical trial (RCT) of stimulant medication in children with DS+ADHD. This RCT may provide evidence regarding the short- and long-term safety and efficacy of stimulant use in children with DS+ADHD, both with and without CHD. All children enrolled in the study will complete a comprehensive assessment battery evaluating ADHD diagnostic criteria, as well as behavioral, cognitive, academic, and functional impairments.
Description
The purpose of this study is to conduct a clinical trial of stimulant medication treatment (i.e., methylphenidate (MPH)) in children with DS+ADHD to determine methylphenidate's efficacy in remediating behavioral, cognitive, and functional impairments in children with DS+ADHD and to assess the short- and long-term safety of stimulant treatment in children with DS+ADHD with a specific focus on cardiac safety. It has the potential to significantly improve the outcomes of approximately 45,000 children with DS+ADHD nationwide. To achieve this, 100 children with DS+ADHD, between the ages of 6.00-17…
Eligibility
- Age range
- 6–17 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Stated willingness to comply with all study procedures and availability for the duration of the study. * Male or female, between the ages of 6.00-17.99 years at the time of consent. * Able to take oral (liquid) medication. * English is primary language. * Meets criteria for ADHD (hyperactivity, inattention, or combined) on the KSADS * Meets criteria for ADHD (hyperactivity, inattention, or combined) on the Vanderbilt (historically or currently, as indicated by a teacher/professional) Exclusion Criteria: * Current use of ADHD stimulant or non-stimulant medication and un…
Interventions
- DrugQuillivant XR
Long-lasting liquid solution of Quillivant XR.
- DrugPlacebo
Liquid solution to mimic the color and taste of Quillivant XR.
Locations (4)
- University of California Davis MIND InstituteSacramento, California
- Boston Children's HospitalBoston, Massachusetts
- Cincinnati Children's Hospital Medical CenterCincinnati, Ohio
- University of Pittsburgh Medical CenterPittsburgh, Pennsylvania