# A Cognitive Test Battery for Intellectual Disabilities

> **NIH NIH R01** · UNIVERSITY OF CALIFORNIA AT DAVIS · 2020 · $829,843

## Abstract

Abstract
 The basic science and preclinical studies of intellectual and developmental disabilities (IDDs) have
outpaced the development and validation of tools to measure treatment response in human clinical
trials. While an ever-increasing number of targeted treatments documented to normalize
neurobiological and behavioral phenotypes in animal models are advanced for experimental
evaluation in humans with IDDs, limitations of outcome measures and lack of consensus among
investigators have been major barriers to progress in the translational pipeline. In fact, it has been
argued that true benefits of experimental treatments have been missed in some so-called “failed
trials” due to lack of sensitivity to change in the outcome measures for the disorder of interest, and/or
susceptibility to large placebo effects that obscure these potentially real changes. For the past 5
years we have made substantial progress validating the National Institutes of Health Toolbox
Cognitive Battery (NIHTB-CB) for use as a set of outcome measures for individuals with IDDs and
have generated solid psychometric evidence of its utility for a high proportion of individuals with
mental ages at or above 5 years. Despite these important advances, our work has also highlighted
critical knowledge gaps, and potential solutions. First, some of the established NIHTB-CB tests were
not feasible or lacked acceptable psychometric properties for more severely affected or very young
individuals with IDD – subgroups that remain critical targets for intervention – and the battery does
not cover important domains which can be measured very early in development. Second, while cross-
sectional data is available from the battery’s normative sample, longitudinal trajectories of NIHTB-CB
test scores among people with IDD are not available. And third, despite evidence of sensitivity to
developmental changes, there are currently no data to demonstrate that the NIHTB-CB is sensitive to
treatment-related change. For the current project we will a) optimize the NIHTB-CB for lower
functioning individuals with moderate and severe IDD, b) complete development and validation of
new NIHTB-CB tests to fill critical gaps in cognitive constructs not currently assessed, including
Concept Formation and Numeracy, c) extend understanding of developmental changes in the NIHTB-
CB tests using expanded longitudinal observations in children and youth with IDD, and d) examine
the preliminary sensitivity of the NIHTB-CB to detect treatment-related cognitive changes utilizing a
randomized, double-blind placebo-controlled stimulant (methylphenidate extended release liquid) trial
in children and adolescents with IDD + ADHD. It is anticipated that successful fulfillment of these
knowledge gaps will result in a scalable and standardized cognitive battery suitable for widespread
use in the field and consideration for FDA registration.

## Key facts

- **NIH application ID:** 10119720
- **Project number:** 2R01HD076189-06A1
- **Recipient organization:** UNIVERSITY OF CALIFORNIA AT DAVIS
- **Principal Investigator:** DAVID R HESSL
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $829,843
- **Award type:** 2
- **Project period:** 2014-09-22 → 2025-09-29

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10119720

## Citation

> US National Institutes of Health, RePORTER application 10119720, A Cognitive Test Battery for Intellectual Disabilities (2R01HD076189-06A1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10119720. Licensed CC0.

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