# Leveraging E-education to Advance Assent and Decision-Making Involvement in Down Syndrome Administrative Supplement

> **NIH NIH R21** · CHILDREN'S HOSP OF PHILADELPHIA · 2024 · $186,960

## Abstract

PROJECT SUMMARY/ABSTRACT
Informed
and
in
with
consent/assent
neurocognitive
and
diversity
of
support
consent in human subject research is designe to espouse the moral principle of respect for persons
is intended to provide information regardin the study purpose, procedures, risks/benefits, and voluntariness
a comprehensible format. n youth, assent is recognized as a process that requires paren input and matures
 child development. In people with intellectual disabilities such as Down syndrome, participation n the
 process can be complicated by learning disabilities, communication differences, and
decline. Unfortunately, l imited data are available to i nform an optimized consent/assent process,
 decision-making involvement has not been considered. This Administrative Supplement will expand the
of the study team, stud sites, and participant population by extending our efforts to include University
Miami and University of Texas Health Science Center-San Antonio which serve large Hispanic populations to
 ou patient-informed study of multi-media in the assent/consent process and decision-making
d
g
I t
i
y
r
involvement. Our long-term objective is to address a methodologic gap in human subjects research, namely
consent/assent in a diverse population of people with intellectual disabilities, to advance their decision making
involvement, advocate for self-efficacy, and engage them in research. Additionally, we wish to expand the
number and diversity of investigators pursuing research in Down syndrome and increase access to clinical
research for people with Down syndrome. To this end, this administrative supplement proposes to include
families with Down syndrome recruited through University of Miami and UTHSC-SA for:
  initial feedback on the videos, interactive tool, and Spanish translation of materials
  semi-structured in-person and virtual interviews with caregivers regarding engagement in research, e-
 education materials and social story, and questionnaires regarding shared decision-making.
  testing of new materials
 Additionally, we will expand feedback from investigative teams in the practicality of using these materials.

## Key facts

- **NIH application ID:** 10986605
- **Project number:** 3R21HD112758-02S1
- **Recipient organization:** CHILDREN'S HOSP OF PHILADELPHIA
- **Principal Investigator:** ANDREA Bridget KELLY
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $186,960
- **Award type:** 3
- **Project period:** 2023-08-10 → 2026-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10986605

## Citation

> US National Institutes of Health, RePORTER application 10986605, Leveraging E-education to Advance Assent and Decision-Making Involvement in Down Syndrome Administrative Supplement (3R21HD112758-02S1). Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/grant/nih/10986605. Licensed CC0.

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