No “Kidding”: Using Health Literacy to Communicate Clearly About Pediatric Trials

Written by: Holly Arthur

In a recent post, CISCRP’s Health Literacy team discussed why it’s important to make information about clinical trials clear for everyone. We consider a lot of things when creating materials — like brochures or videos — depending on the audience. For example, we’ve been developing brochures for people from different racial and ethnic groups about the importance of diversity and representation in clinical trials. With these projects, we’ve looked at how language, culture, personal values, and history shape people’s decisions about participation. A main goal of these projects is to connect with people who don’t always have access to information about clinical trials that is both relatable and easy to understand.

But what if your “audience” includes almost a quarter of the population of the United States, yet doesn’t include anyone legally allowed to make all their own medical decisions? Recently, the Health Literacy Team has been expanding a key part of CISCRP’s mission — “education before participation” — to a new generation. We have been working on projects to help kids, families, and their healthcare providers navigate decisions about clinical trial participation together. We’re excited to tell you about some of these projects today, and to share a few of the challenges — and accomplishments (!) — we’ve encountered so far.

Not just short adults

It may seem funny to think of children as an underrepresented group, but among clinical trial participants, they are. Just like there isn’t enough gender, racial, or ethnic diversity among trial participants, the number of registered pediatric clinical trials doesn’t reflect the number of children who depend on trials for new, safer treatments.

As the saying goes, kids aren’t just small adults. Children’s bodies may respond differently to treatments than adults’, even if it’s the same treatment for the same condition. And too often, treatments prescribed to children have only been tested in adults. Pediatric trials help us make sure that treatments children receive are safe and effective for them.

 Of course, the differences between kids and adults aren’t just physical! As they get older, people go through changes in how they think, learn, and relate to others. Even an infant and a toddler only a year apart, for example, have different abilities, interests, and needs. So do a 10- and a 16-year-old. Creating materials for pediatric participants means thinking about all kinds of age-related differences that have a big impact on health literacy.

Children also don’t have the right to sign legal documents, in most cases. This includes documents agreeing to participate in clinical trials, also called “informed consent forms.”  A parent or guardian must give permission, called “consent,” for their child to participate. Children old enough to understand what being in a trial involves are asked to give their “assent,” or agreement. This is not a substitute for a parent or guardian’s consent, but a child can refuse to give assent after learning about a trial, so it’s important to share information in a way that is age-appropriate.

What is the Health Literacy Team Doing?

Pediatric Video Project

Earlier this year, we launched our 4-part Pediatric Education Video Series, created specifically for children and their caregivers. The live-action videos were developed with help from various community members — most importantly, kids — to provide an age-appropriate overview of clinical trials. As health literacy experts, explaining ideas like “informed consent” or “placebo” so the average person can understand them is our bread and butter. Still, explaining these things to kids at all different ages and stages really forced us to up our game! The actors in the videos do a great job of making new information feel safe and not (too) scary for viewers. Check out the videos on our website or YouTube page.

Updated Brochure for Parents and Guardians

We are wrapping up a complete rewrite and redesign of our brochure on pediatric trial participation, “Should My Child Participate in a Clinical Trial?” This is one of many brochures on clinical trial participation you’ll find in CISCRP’s online education center. Like all our educational materials, the creation process was guided by insights from the CISCRP community. We listened to parents, guardians, professionals, and other experts to understand what matters most to them. What do real parents of past pediatric clinical trial participants, or potential clinical trial participants, think is most important for others to know? What information do professionals who work with pediatric participants and their families wish those families had more access to?

We heard your feedback that caring for a child with a medical condition is stressful for the whole family. Parents need empathy and support when making difficult decisions about their child’s health. We also heard your feedback that it’s important to discuss clinical trial participation with children, even though it can be a tricky subject. We used these insights to shape the content of the new brochure. Our health literacy experts worked closely with our in-house Medical Writing team to make sure this important subject hit all the right notes. The new brochure will be available soon on CISCRP’s website and for purchase in our online store. (Want more information? Contact Lucas Goren at lgoren@ciscrp.org.)

Pediatric Plain Language Summary

One of CISCRP’s signature programs is our communicating Trial Results Summaries service. All participants have the right to receive results of the study they helped make possible, written in language that makes sense to them. However, information written for and by researchers is not always clear or friendly for non-scientists. This is why CISCRP works with study sponsors to create hundreds of plain language summaries of trial results every year.

But what about pediatric trials? As it turns out, creating kid-friendly, age-appropriate plain language summaries of pediatric trial results isn’t the norm. This is partly due to lack of regulation, or unclear regulations, about sharing pediatric trial results. Because this is new territory compared to creating adult trial summaries, experts (like CISCRP) are still developing and testing best practices.

We can’t wait to share details from our first-ever pediatric plain language clinical trial results summary. It’s not ready to “go live” just yet, but we can tell you a little about what it includes. For starters, we focused on using a narrative, or story, to talk about the process of being in a pediatric clinical trial from start to finish. The summary tells the story of a character who participated in a pediatric trial as she learns about the results and reflects on being a participant. We hope this “picture-book” style helps make complicated information approachable and engaging for kids, and we’re excited to get some feedback from real-life pediatric trial participants down the road.

Consent and Assent Forms

Informed consent forms (ICFs) and assent forms can be hard to understand. But it’s very important that potential participants, and parents of participants, understand what these forms say. Knowing what a trial involves, and what the risks and benefits are, is critical for making an informed decision.

CISCRP recently worked with a sponsor company, parents, advocates, and other experts to create clear, engaging informed consent and assent forms that support health literacy. These will be shared with potential participants in a pediatric study starting soon. This project came with some challenges and some creative solutions. For example, we decided the materials should feature an animal character. But consent and assent forms need to be balanced, not biased, about possible risks and benefits of joining a study. How do you make sure a cartoon animal looks thoughtful, but not scared? Or proud, but not boastful? How do you write about risk honestly and in a way children will understand, without causing unnecessary fear because risk is a hard thing to explain, even to adults?

The balance between information and neutrality is tricky, so we had a lot to think about! But in the end, we are thrilled with how the project came out. We hope to work on more projects like this — and other new projects for pediatric participants — soon.