TEAM-DS - Children 6-17 with Down Syndrome

STUDY BASICS

Does your child have Down syndrome and attention deficit hyperactivity disorder (ADHD)? Your child may be eligible to participate in a research project to help learn how medications prescribed for children and adolescents with Down syndrome and ADHD influence behavior, learning and health. Compensation is provided.

STUDY PURPOSE

Children with Down Syndrome (DS) have a greater prevalence of ADHD than typically developing children. Despite this higher risk, we do not have a solid understanding of the relationship between DS and ADHD. Further, children with DS and ADHD are rarely treated with stimulant medication, even though this form of treatment is both effective and recommended for use in children with intellectual disability.  Therefore, the purpose of this research study is to test the safety and effectiveness of stimulant treatment in children with DS+ADHD.

COULD THIS STUDY BE RIGHT FOR YOUR CHILD?

• Ages 6 to 17 years old
• Diagnosed with Down syndrome
• Overactivity, paying attention or distractibility are concerns 
• Able to swallow liquid medicine

WHAT PARTICIPANTS CAN EXPECT

The study includes both telehealth visits and visits at Children’s Hospital of Pittsburgh.  The study procedures will take place over 30 weeks:

• Initial Screen - child will complete cognitive and behavioral assessments. Parent/caregiver will complete parent reports.
• Medical Screen -
  • Echocardiogram (ECHO): if record of prior normal ECHO is provided, this will not be performed
  • Electrocardiogram (ECG)
  • Collection of vital signs completed, such as height, weight, and blood pressure
  • A medical examination
  • Receive an in-home sleep study kit with detailed instructions for Obstructive Sleep Apnea (OSA) screening
• Study drug administration - Including varying doses of active study drug and placebo (inactive medication)
  • Recurrent cognitive and behavioral assessments to determine efficacy
  • Medical evaluations throughout to ensure safety
  • Collaboration between parent, teacher and physician to determine optimal dosage