Improving New Parents' Understanding of a Trial. The INPUT Study.

INTERVENTION: The INPUT study proposed uses a randomised 2 x 3 x 2 factorial design to compare 12 different versions of an information leaflet describing an imaginary clinical trial in preterm infants. Parents will be randomly assigned to read one of 12 combinations of contrasting descriptions of (1) background risk, (2) the primary endpoint and (3) risks of participation, using 'negative', 'neutral' or 'positive' language. Through a face‐to‐face questionnaire performed immediately after reading the leaflet, the study will evaluate the effects of these contrasting expressions on the parents' level of understanding of a hypothetical clinical trial, their level of anxiety and their willingness to participate in the trial. CONDITION: Anxiety about clinical trials Understanding of clinical trials Willingness to participate in clinical trials PRIMARY OUTCOME: Parents' level of understanding of the hypothetical clinical trial will be measured using a previously validated questionnaire (Porteri et al, 2009) adapted for use in parents of newborn infants. SECONDARY OUTCOME: Parents' level of anxiety will be measured using the previously validated State­ Trait Anxiety Inventory State (Spielberger et al, 1977; O'Brien et al, 2013). Parents' willingness to participate in the hypothetical clinical trial will be measured on a five part Likert Scale ranging from very unlikely to participate to very likely to participate. INCLUSION CRITERIA: Eligible participants must fulfill at least one of the following criteria: (i) Pregnant women in the antenatal ward with a potential preterm pregnancy and their partners, (ii) Parents whose babies are in the NICU or Special Care Nursery receiving CPAP or less. Women aged 18 ‐ 49 years Men aged >18 years