Esbensen, Anna J PHD
Cincinnati Children's Hospital Medical Center
The proposed project will develop and validate a novel behavioral outcome measure, the Behavior Inventory for Down Syndrome (BIDS) for children and adolescents with Down syndrome, in both English and Spanish. Current clinical trials are plagued by the dearth of clinical outcome measures appropriate and sensitive for individuals with Down syndrome. As our field continues to develop new pharmaceutical and clinical interventions, our project will support this work and have an impact on the 400,000 individuals with Down syndrome living in the United States.
Though children with Down syndrome (DS) are at increased risk for having a comorbid diagnosis of Attention- Deficit / Hyperactivity Disorder (ADHD), ADHD is often under-recognized in children with DS due to “diagnostic overshadowing” by the primary intellectual disability. Even when ADHD is diagnosed in children with DS, ADHD is often under-treated due to a lack of data to support the efficacy and safety of stimulant medication in children with DS+ADHD, especially among the 50% of children with DS who have congenital heart defects for whom there could be increased cardiac risk. This study is the first clinical trial of stimulant medication in children with DS+ADHD and will determine the short- and long-term efficacy and safety of these medications in children with DS+ADHD and has the potential to significantly improve the functional status, behavior, and quality of life of children with DS+ADHD.