Evaluating Treatment of ADHD in Children With Down Syndrome
Status:
Recruiting
Trial end date:
2022-01-01
Target enrollment:
Participant gender:
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.
Therefore, the investigators propose a pilot clinical trial to support the first randomized
clinical trial of stimulant medication in children with DS+ADHD. The purpose of this study is
to inform sample size estimates for the larger clinical trial. 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. Further, children will
take part in the pilot methylphenidate clinical trial to inform measures retained and desired
sample size for the future clinical trial.