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

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 procedure completion, and decision-making involvement.