Introducing youth to clinical research: Development and pilot implementation of a children's activity book.

Introduction: Children continue to be an underrepresented population in research and clinical trials due to difficulties encountered in recruitment, assenting, and retention processes. "Sofia Learns About Research" is a children's activity book that introduces youth to clinical research and basic elements of clinical trials.

Methods: Development of the activity book began in 2016, with publication of the first paper version in 2017 and an online version adapted for computer and tablet users in 2019. In 2019, we developed internal review board-approved pre/post surveys with five statements (written at ≤ 3^rd-grade level) reflecting key concepts covered in the book. Participants were asked to indicate whether they agreed, disagreed, or were not sure about each of the statements and if they would ever want to be part of a research study. Preliminary analyses included descriptive statistics and cross-tabulations with chi squares.

Results: Despite delays in dissemination and outreach due to the COVID-19 pandemic, we obtained feedback from over 170 diverse persons across a spectrum of communities and community partners. After book exposure, more participants knew that both children and parents have to assent/consent and that participants can withdraw from a study at any time.

Conclusions: The book is an important advocacy tool with a long-term aim of increasing children's knowledge and awareness about clinical research, ultimately leading to enhanced participation in clinical research and trials.