# Evaluating Assessment and Medication Treatment of ADHD in Children with Down Syndrome

> **NIH NIH R33** · CINCINNATI CHILDRENS HOSP MED CTR · 2024 · $379,219

## Abstract

PROJECT SUMMARY
Children with Down syndrome (DS) have a 3-5 times greater prevalence of Attention Deficit Hyperactivity
Disorder (ADHD) than typically developing children. Despite their higher risk of ADHD and consensus guideline
recommendations to treat children with intellectual disability (ID) and comorbid ADHD with stimulants (the most
efficacious ADHD treatment), children with DS+ADHD have disproportionately low rates of stimulant
medication treatment. Possible reasons for under-utilization of stimulant treatment in DS+ADHD include: 1)
diagnostic uncertainty regarding how to accurately diagnose ADHD in children with DS, making providers
prone to “diagnostic overshadowing” (i.e., attributing ADHD to their ID); 2) the absence of any prior clinical
trials examining the safety and efficacy of stimulant medication in children with DS+ADHD; and 3) concerns
about cardiac safety, given the high incidence of congenital heart disease or defects (CHD) in the DS
population. Based on R61 pilot trial findings, we propose the first randomized clinical trial of stimulant
medication in children with DS+ADHD to provide evidence regarding the short and long-term safety and
efficacy of stimulant use in children with DS+ADHD, both with and without CHD. One hundred (100) children
with DS+ADHD aged 6-17 years will participate. Children with DS+ADHD will complete a multi-phased
randomized, double-blind clinical trial with crossover to placebo and long-term follow-up to assess the short-
and long-term efficacy and safety of stimulant medications for treating ADHD symptoms and impairment in
children with DS. Study aims of the R33 will focus on 1) Assessing the short- and long-term safety of stimulant
treatment in children with DS+ADHD with a specific focus on cardiac safety; 2) Determining the short- and
long-term efficacy of stimulant treatment at remediating cognitive, behavioral, and functional impairments in
children with DS+ADHD; and 3) Exploring moderators (e.g., IQ, ADHD subtype/presentation, executive
functioning levels, comorbid internalizing disorders, CHD) of stimulant response and adverse effects. Results
from this study will provide much needed diagnostic and treatment data that will directly impact the outcomes
of the approximately 45,000 children with DS+ADHD nationwide.

## Key facts

- **NIH application ID:** 11004780
- **Project number:** 3R33HD100934-04S1
- **Recipient organization:** CINCINNATI CHILDRENS HOSP MED CTR
- **Principal Investigator:** Anna J. Esbensen
- **Activity code:** R33 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $379,219
- **Award type:** 3
- **Project period:** 2024-05-01 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11004780

## Citation

> US National Institutes of Health, RePORTER application 11004780, Evaluating Assessment and Medication Treatment of ADHD in Children with Down Syndrome (3R33HD100934-04S1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/11004780. Licensed CC0.

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