Parental decision making about clinical trial enrollment: A survey of parents of children with Fragile X syndrome.

Abstract

Opportunities for patients to enroll in clinical trials for neurodevelopmental conditions are increasing. We studied what factors are associated with parents' decisional process to enroll their child in a clinical trial for a genetic neurodevelopmental condition (Fragile X syndrome). Parents (n = 354; mostly biological mothers of a child with Fragile X syndrome) were recruited through Fragile X syndrome advocacy groups. Parents reported attitudes about children in research, trust in child's doctor, threat resources (self-affirmation and dispositional optimism), and demographic and clinical characteristics in an online questionnaire. Three outcome measures assessed associations with these factors at different stages of the decision-making process. The three outcomes were (a) awareness about clinical trial opportunities, (b) enrollment decisions, and (c) decisional regret. Parents who were positive about involving children in research were more aware of clinical trial opportunities (OR = 3.27, 95% CI [2.11, 5.07]), were more likely to have enrolled their child in a clinical trial (OR = 1.69, 95% CI [1.12, 2.56]), and reported lower levels of decisional regret (β = -8.95, 95% CI [-16.38, -1.52]). Parents with higher threat resources had considered enrolling their child in a clinical trial (OR = 1.51, 95% CI [1.02, 2.23]) and reported lower levels of decisional regret (β = -8.73, 95% CI [-17.36, -0.11]). Among parents with lower levels of trust in their child's doctor, higher threat resources were associated with higher enrollment (β = 0.60, 95% CI [0.12, 1.08]). It may be possible to intervene on the factors (attitudes about children in research and threat resources) associated with clinical trial decision making to boost trial enrollment and promote informed decision making. (PsycInfo Database Record (c) 2020 APA, all rights reserved).