None listed
Conditions
Brief summary
Few studies have investigated how to improve parents' understanding of clinical trials they are asked to join or how to reduce any possible distress. The INPUT study proposed will explore the effect of positive, negative or neutral language on parents' understanding, stress and willingness to participate in clinical trials.
Interventions
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 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.
Sponsors
Professor William Odita Tarnow-Mordi
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Exclusion criteria
People whose primary language is other than English (LOTE) Children and/or young people (ie. <18 years) People who clinicians identify as unsuitable for the study
Outcome results
None listed