# Cognitive Outcome Measures in School Age Children with Down Syndrome (ECODS)

> **NIH NIH R01** · CINCINNATI CHILDRENS HOSP MED CTR · 2024 · $1,000,212

## Abstract

PROJECT SUMMARY
There is a fundamental gap in the availability of cognitive outcome measures that are reliable and sensitive to
detecting change among children with Down syndrome (DS). Lack of such outcome measures represents an
important problem to interpreting clinical trials aimed at improving the lives of individuals with DS. Without
evidence-based cognitive outcome measures, future treatment trials in this population will remain suboptimal
due to poor study measures. Despite some promising findings in currently recommended assessment
batteries, the evidence base for cognitive outcome measures in DS is limited. Multi-site studies evaluating the
reliability and validity of outcome measures are the needed next step towards supporting the evaluation of new
pharmaceutical and clinical interventions for children with DS. Working groups convened by NICHD of leading
experts in DS led to recommendations of promising measures for use in this population. The prior R01
HD093754 began evaluating the psychometric properties of recommended promising measures and expanded
upon those recommendations by evaluating individual variability and accounting for the method of assessment
(verbal, nonverbal, computer, parent-report) to support our understanding of performance within a cognitive
domain. The proposed renewal continues evaluating the psychometric properties of measures that fill the gaps
in cognitive domains (Study 1), extends the natural history of change in performance on measures with annual
follow-up visits (Study 2), and refines the measurement of individual variability to include co-occurring medical
and mental health conditions across both Studies. The overall objective of this application is to establish the
psychometric properties of individual clinical outcome measures in children with DS across the cognitive
domains of episodic memory, executive functioning (set-shifting, inhibitory control, working memory), learning
and memory, and processing speed. Our rationale for working with this population is that DS is associated with
a distinct pattern of cognitive strengths and weaknesses related to their neuroanatomy. Thus, the selection of
outcome measures to be evaluated needs to take into account the DS behavioral phenotype. We propose
three specific aims: 1) To examine the psychometric properties of selected cognitive outcome measures with
children with DS. 2) To evaluate differences in the psychometric properties of the measures as a function of
variations in demographics and co-occurring medical and mental health conditions. 3) To characterize the
developmental trajectories of cognition and executive functioning. To achieve these aims, 200 children in Study
1 ages 6-17 years with DS will participate in repeated neuropsychological assessments with follow-up
evaluations at 2 weeks, 6 months, and 1 year. We will continue to follow at minimum 120 children from R01
HD093754 annually in Study 2. We anticipate that this measurement study will provide...

## Key facts

- **NIH application ID:** 10996780
- **Project number:** 2R01HD093754-06A1
- **Recipient organization:** CINCINNATI CHILDRENS HOSP MED CTR
- **Principal Investigator:** Anna J. Esbensen
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,000,212
- **Award type:** 2
- **Project period:** 2018-07-20 → 2029-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10996780

## Citation

> US National Institutes of Health, RePORTER application 10996780, Cognitive Outcome Measures in School Age Children with Down Syndrome (ECODS) (2R01HD093754-06A1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10996780. Licensed CC0.

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