Occupations as an Outcome Measure in a Clinical Trial: Fragile X Syndrome and Sertraline

Fragile X Syndrome (FXS) is the most common form of inherited intellectual and developmental disability (IDD) and the most common known genetic cause of autism. Individuals diagnosed with FXS present with deficits in social skills, sensory processing, cognition, behavior, and language development. The purpose of this research is to examine family perspectives collected during baseline and follow-up interviews as part of a randomized, controlled, medication trial of Sertraline (Zoloft) on children two to six years old diagnosed with FXS. Interview data and qualitative analysis will be used to examine family accounts of their child’s improvements in daily life contexts over the course of the clinical trial. Differences in improvements will be compared between the treatment and placebo groups. This qualitative data analysis may prove to be a more sensitive measure in contrast to standardized measurements, which can be limited in their ability to show change over time with IDD populations