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

> **NIH NIH R61** · CINCINNATI CHILDRENS HOSP MED CTR · 2020 · $675,867

## 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 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 (ID) and comorbid ADHD. 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 the ID); 2) there is not a single
clinical trial 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. We propose a pilot study to define the clinical features of DS+ADHD thereby enabling more
accurate diagnosis and a pilot clinical trial to inform sample size estimates for a larger clinical trial. We propose
to perform 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 and 70 children with DS and no ADHD
(DS-ADHD), all aged 6-12 and matched on age, gender, and IQ, will participate. All 170 children enrolled in the
study will complete a comprehensive assessment battery evaluating ADHD diagnostic criteria as well as
behavioral, cognitive, academic, and functional impairments. The 100 children in the DS+ADHD group will also
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 will focus on 1) Identifying behavioral, cognitive,
academic, and functional impairments that differentiate children with DS+ADHD from children with DS-ADHD;
2) Informing sample size of larger clinical trial; 3) Assessing the short- and long-term safety of stimulant
treatment in children with DS+ADHD with a specific focus on cardiac safety; 4) Determining the short- and
long-term efficacy of stimulant treatment at remediating cognitive, behavioral, and functional impairments in
children with DS+ADHD; and 5) Exploring moderators (e.g., IQ, ADHD subtype, executive functioning,
comorbid internalizing disorders, CHD) of stimulant response and side 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:** 10022154
- **Project number:** 5R61HD100934-02
- **Recipient organization:** CINCINNATI CHILDRENS HOSP MED CTR
- **Principal Investigator:** Anna J. Esbensen
- **Activity code:** R61 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $675,867
- **Award type:** 5
- **Project period:** 2019-09-30 → 2022-09-14

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10022154

## Citation

> US National Institutes of Health, RePORTER application 10022154, Evaluating Assessment and Medication Treatment of ADHD in Children with Down Syndrome (5R61HD100934-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10022154. Licensed CC0.

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