Objective: The purpose of this study was to assess children's comprehension of a new assent booklet, (K(id)S(ent)), which uses pictures and written information.
Study design: A randomized, crossover study evaluated the comprehension of assent documents by children, 7 to 11 years of age at a local elementary school. The two types of documents tested were the standard assent form and the K(id)S(ent) Assent Booklet. Participants were randomized as to which test document they received first by using a cluster randomization design. Participants read the document and then took a short quiz. The process was repeated for the other document on a separate day. Study participants were assigned a percentage score and a binary perfect score for each quiz. Mixed effects logistic and linear regression models with random intercepts were applied to the continuous percent quiz scores and binary perfect quiz scores, respectively.
Results: A total of 190 participants completed the standard quiz, and 195 students completed the booklet quiz. A statistically significant difference in perfect quiz scores (p=0.004) and percent quiz scores (p≤0.001) between booklet and standard form was noted.
Conclusions: The quiz scores may indicate that the style of document is not the only factor influencing participant understanding.
Keywords: assent; clinical trial; consent document; federal regulations; pediatrics.