Understanding the experiences of living with Down syndrome v2.0
Research type
Research Study
Full title
Understanding the experiences of living with Down syndrome
IRAS ID
152215
Contact name
Elaine Brohan
Contact email
Sponsor organisation
Hoffmann-La Roche
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
What are individuals' experiences of living with Down syndrome? Are currently used questionnaires and measures appropriate for use in Down syndrome?
This study aims to understand the experience of living with Down syndrome in order to assess or develop suitable clinical outcomes assessments (COAs) for evaluating treatment experience in clinical trials. COAs are typically questionnaire-based measures and include patient-reported outcomes (PROs), observer-reported outcomes (ObsROs) and clinician-reported outcomes (ClinROs).
Open-ended, qualitative interviews will be conducted with a range of individuals including: 1) individuals with Down syndrome (n=8); 2) caregivers of individuals with Down syndrome (n=32); 3) teachers with experience of teaching individuals with Down syndrome (n=4); and 4) clinicians experienced in assessing and treating individuals with Down syndrome (n=5).
The aim of these interviews is to develop an understanding of the factors/concepts involved in the experience of Down syndrome and to develop a conceptual model to display these in a visual form. As we also wish to determine if there are existing suitable questionnaires and measures available for use in Down syndrome, we will also have a second phase of interviews where clinicians and test administrators will use several existing measures at the beginning of a series of interviews. This will include administering the Vineland Adaptive Behaviour Scales (VABS-II) to caregivers and the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) to individuals with Down syndrome. Following administration, the VABS-II will then be debriefed during an in-depth interview with the caregivers (n=16) and there will be a short 15 minute interview to explore test administrators' opinions of the measure (n=4). Following administration, the RBANS will be debriefed with test administrators (n=2), clinicians (n=2) and teachers (n=2). The Observer Memory Questionnaire-Parent Form (OMQ-PF) and Pediatric Quality of Life Inventory (PedsQL) will also be debriefed at interview with caregivers of people with Down syndrome (n=8).
REC name
Wales REC 4
REC reference
14/WA/1094
Date of REC Opinion
8 Oct 2014
REC opinion
Further Information Favourable Opinion