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

NIH RePORTER · NIH · R21 · $186,960 · view on reporter.nih.gov ↗

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
CHILDREN'S HOSP OF PHILADELPHIA
Principal Investigator
ANDREA Bridget KELLY
Activity code
R21
Funding institute
NIH
Fiscal year
2024
Award amount
$186,960
Award type
3
Project period
2023-08-10 → 2026-07-31