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

> **NIH NIH R21** · CHILDREN'S HOSP OF PHILADELPHIA · 2024 · $222,500

## Abstract

PROJECT SUMMARY/ABSTRACT
Informed
and
benefits,
parent
(DS),
differences,
consent/assent
will
consent in human subject research is designed to espouse the moral principles of individual autonomy
 respect for persons and s intended to provide information regarding study purpose, procedures, risks/
and voluntariness in a comprehensible format. In youth assent is recognized as a process that requires
input and matures with child development. In people with intellectual disabilities such as Down syndrome
 participation in the consent/assent process can be complicated by earning disabilities, communication
 and neurocognitive decline. Unfortunately, limited data are available t inform an optimized
process, an decision-making involvement has not bee considered. This patient-informed study
leverage 1) educational materials and multi-media platforms in use in our current studies of
i
,
l
o
d n
sleep apnea in
children and adults with DS and 2) our team expertise in decision-making involvement and communication
abilities in a diverse, national cohort. Our long-term objective is to address a methodologic gap in human subjects
research, namely consent/assent in people with intellectual disabilities, to advance their decision-making
involvement, advocate for self-efficacy, and engage them in research. To this end, this study proposes to :
 partner with families with DS, Spanish translators, and our Creative Services Design team to revise existing
 multi-media materials and develop an initial interactive mobile-friendly web application for the study team to
 assess comprehension of essential study elements and translate videos and questionnaires into Spanish.
 conduct semi-structured in-person and virtual interviews with caregivers and (when possible) their adolescent
 and young adult adults with DS from a diverse, national cohort to obtain feedback regarding research
 engagement, e-education materials and social story, and decision-making involvement questions.
 use initial feedback from interviews to “optimize material”.
 pilot the interactive mobile-friendly web application
 obtain feedback from investigative teams from across the country on the feasibility and acceptability of
 incorporating multi-media materials in real-world assent/consent implementation.
To accomplish these aims, the infrastructure for semi-structured interviews will be established in Aim 1. Then
“caregiver-child with DS (age 14-30y) dyads” from targeted regions across the country, from both rural and urban
environments, with well-represented race/ethnicity and subset with limited English proficiency will participate in
semi-structured interviews to discuss research engagement and review video, interactive digital applications,
and questionnaires. Upon study completion, the next steps will be to evaluate the applications in established
research protocols or in a trial comparing their impact vs standard approach upon patient reported outcomes,
understanding, enrollment, study proced...

## Key facts

- **NIH application ID:** 10901945
- **Project number:** 5R21HD112758-02
- **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:** $222,500
- **Award type:** 5
- **Project period:** 2023-08-10 → 2026-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10901945

## Citation

> US National Institutes of Health, RePORTER application 10901945, Leveraging E-education to Advance Assent and Decision-Making Involvement in Down Syndrome (5R21HD112758-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10901945. Licensed CC0.

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