Leveraging E-education to Advance Assent and Decision-Making Involvement in Down Syndrome Administrative Supplement
Project Number3R21HD112758-02S1
Former Number1R21HD112758-01
Contact PI/Project LeaderKELLY, ANDREA BRIDGET Other PIs
Awardee OrganizationCHILDREN'S HOSP OF PHILADELPHIA
Description
Abstract Text
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.
Public Health Relevance Statement
PROJECT NARRATIVE
Consent, assent, and decision-making are regularly encountered in the clinical and research settings but can be
stymied in youth and adults with Down syndrome (DS). This supplement will add 1) two sites (Miami and San
Antonio) and 2) an investigator new to research in people with DS and from a background considered under-
represented in research in its efforts to conduct a national patient-centered study of a diverse group of people
with DS and caregivers on the use of multi-media materials to promote understanding/appreciation of study
purpose, procedures, risks/benefits and decision-making involvement.
Eunice Kennedy Shriver National Institute of Child Health and Human Development
CFDA Code
865
DUNS Number
073757627
UEI
G7MQPLSUX1L4
Project Start Date
10-August-2023
Project End Date
31-July-2025
Budget Start Date
13-September-2024
Budget End Date
31-July-2025
Project Funding Information for 2024
Total Funding
$186,960
Direct Costs
$120,327
Indirect Costs
$66,633
Year
Funding IC
FY Total Cost by IC
2024
NIH Office of the Director
$186,960
Year
Funding IC
FY Total Cost by IC
Sub Projects
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