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Empowering children with education through clinical trials

Authors: Jumo Health and ICON’s Centre for Paediatric Clinical Development

Introduction

In support of World Children’s Day 2022, ICON and Jumo Health have teamed up to share strategies to empower children every day through education, specifically in clinical trials. 

Children are not small adults and therefore a medication dose cannot be cut in half and considered to be safe and effective for paediatric use. Although it may seem alarming, more than 70% of medications given to children have never been tested in the specific age population to determine the safety and efficacy profile. This is why we need clinical research to bring safe and effective treatment options to children worldwide. In order for a medication to be approved for use by the FDA/EMA and other regulatory authorities, it must first undergo high levels of scrutiny, in clinical research. Children are a vulnerable population; however, they deserve the same rights to medication options as adults. We can achieve this by protecting children through clinical research, not from clinical research.  

World Children’s Day

World Children’s Day is an annual day of action for children, by children. This year’s theme of “Inclusion, for every child”, it is essential to communicate to children in a way that they can understand. In healthcare this is especially important, as it can impact outcomes. Simple adjustments can make a significant difference on a child’s understanding of their diagnosis or treatment. 

Participating in a clinical trial can bring up a variety of emotions, especially in children and adolescents. It is essential that care givers and parents work together to communicate to children in clinical trials and to support them in dealing with those emotions and understanding their experiences. Clear, consistent, and, perhaps most importantly, engaging communication and education are key to this support.

Communicating to children in clinical trials

We recommend breaking down communication by age groups. Broadly speaking, the paediatric population can be segregated into three age brackets:

  • Preschool and Kindergarten
  • Primary grades of 7-11 year old
  • Teenagers

Preschool and Kindergarten (2-6)

Children at this age are beginning to understand the emotions they are feeling, although as anyone who has parented a toddler knows, they still have very little control over those emotions. Simple tools can provide guidance to help young children interpret their own feelings and emotions and complex topics can be introduced using simple, character-driven narratives and social-emotional play. Child protagonists should drive the narrative as much as possible in order to make it easy for children to relate. Play-based learning allows children to explore and learn and helps them make sense of the world around them. 

Digital exploration and play

It’s astounding to see the proficiency with which a child, sometimes even at 2 years old, can navigate his or her way around an iPad – this technology is now part of their world.  In clinical trials we can take advantage of this new reality by engaging children in this space and driving retention with different digital solutions, including games, apps, and books.

Primary grades (7-11)

Early readers begin to gobble up information on their own, becoming passionate about formats and topics they love. Fellow parents will attest, though, that even at this young age, children quickly become very discerning critics. Simply put: if they don’t like it, they won’t touch it!
 
Comic books
The strength of comics as an educational tool can be summed up with the 3 E’s: engagement, efficiency, and effectiveness.

  • Engagement: Comics impart meaning through the reader’s active engagement with written language and juxtaposed sequential images
  • Efficiency: The comic format conveys large amounts of information in a short time—vitally important when you are trying to whittle down a 200 page trial protocol into a short booklet
  • Effectiveness: Processing text and images together leads to better recall and transfer of knowledge. Neurological experiments have shown that humans process text and images in different areas of the brain; this is known as the Dual-Coding Theory. These experiments also indicated that pairing an image with text leads to increased memory retention of both. With comics, you not only learn the material faster, but you also learn it better.

​Peer-to-peer communication

Kids want to hear from other kids in their own words. Direct, clear, honest peer-to-peer communication can offer clarity, empathy, and understanding. Video is an ideal medium for utilising this method of communication with children in clinical trials.

Middle and High School (12-17)

Young people in middle and high school are all about independence—they want to own and customise information to meet their needs, habits, and interests. Self-expression becomes a priority and can serve as a buffer against the loneliness, everyday stressors, and poor self-esteem that can accompany those living with a chronic illness.

Abstract thinking is achieved around the age of 12 and is well developed by the age of 14. Reasoning also becomes more logical, and independence increases, including the autonomy of self-management over one's illness, often with the support of digital tools. For this age group especially, it is important to include solutions for clinical trial engagement that harness the power of digital technology. 

Teens also often seek a community of like-minded peers, and with the advent of social media, there has been the explosion of online communities where young people spend their time seeking support and advice. For teens living with chronic diseases or disabilities, these social networks can play a vital role in offering an understanding, empathetic community without stigmas and judgment. It is important to examine how those of us working in clinical trials can become meaningfully involved in these communities as well.

Communicating to caregivers

Parents and caregivers seek tools that help them manage their hectic lives and connect and communicate better with their children. 

Easy-to-use tools and mobile technology allow researchers to continue to put educational information and study support into the hands of families, and in doing so, greatly reduce attrition rates. The importance and relevance of this cannot be overstated, whether it’s a trial for a 17-month-old or a 17-year-old.

Trust and a close relationship between site staff, the parents, and the child are of crucial importance and have been shown to be one of the major factors in parents agreeing to a clinical study and in being retained. High utility, authoritative content builds trust and supports the trial site staff in developing this beneficial close relationship.  

Effective and customised communication is vital to mitigating risks at every trial stage. It should be adapted to the developmental, social, and psychological variabilities among paediatric patients. There are various attitudinal factors amongst both adults and children that can lead to attrition, from distrust in research to worries about the disruption of daily life for parents and from feeling like a “guinea pig” to fear of risks for young people. At each trial stage these concerns can be overcome by using simple tools to ensure effective engagement and by adhering to these simple guiding principles: educate and inform, provide ongoing engagement, and show appreciation.  

Conclusion

Children deserve medicines that are adapted to them and made for them. This can be realised by protecting children through clinical research. To engage children and theirs parents/care givers in clinical research it is paramount to obtain their trust in research. This can be achieved by an open, respectful, effective, customised, age adapted communication. Communication is fundamental and can be done by different means. Let’s use the tools available to engage children and their parents/care givers in clinical research for a better world for our little ones. 

 

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