Can a comic help children and their parents make an informed decision about participating in clinical research? An embedded randomised controlled trial.

We investigated whether a comic-enhanced participant information sheet could help parents and children make an informed decision about participating in a clinical trial. A comic was designed to summarise key information. Parents of children aged 5 to 15 years were randomised to receive either comic-enhanced or standard participant information materials, then their comprehension of key trial details was assessed using modified versions of the Quality of Informed Consent score (parents) and Deaconess Informed Consent Comprehension Test (children). Study progression, duration of the consent process, and preferences for information materials were recorded. 104 parents and 104 children participated. There was no significant difference in comprehension of key trial details between groups receiving the comic-enhanced and standard information resource, evidencing comparable understanding. The majority of children (77%) and over half of parents (56%) preferred the comic-enhanced resource. Most parents (74-100%) felt the comic-enhanced resource helped them explain the CARE study to their child(ren). There was no significant difference in study progression or consent duration between groups. This research supports the use of comics in medical information materials for parents and children, which facilitated comparable understanding, but were preferred by children aged 5-15 years, and helped most parents discuss study participation with their child.