Creating materials for pediatric participants, whether in digital or printed formats, presents unique challenges. This is due to the need to communicate complex ideas in simpler terms as well as create documents that appeal to that audience. Read on for tips to engage pediatric participants when developing clinical trial materials.
We often say participants are the heroes of clinical research. Let’s single out pediatric participants for special recognition since these youngsters devote part of their precious childhoods to advancing medical science. Research is very much an arena of grownups, yet the pediatric participant jumps right in to help. A search at clinicaltrials.gov found nearly 17,000 studies currently recruiting or not yet recruiting pediatric subjects.
The basics
Compared to writing for adults, writing for pediatric clinical trial participants means we use shorter words, shorter sentences, and shorter paragraphs. This makes reading the text easier and quicker. It also helps make the text more visually appealing and therefore, more likely to be read.
My primary strategy when writing to engage pediatric participants is to simplify the language without obscuring reality. An example is the use of scientific terms. If the screening visit calls for an echocardiogram, by all means, call it an echocardiogram. Describe the test in simple terms, but always acknowledge the precise term. Reality shouldn’t be a secret language shared only by adults.
The child participating in the study likely has the indication being investigated. As a result, they may have already undergone many of the tests that will be performed during the study. Therefore, they may already be familiar with the tests you are naming and describing.
Different approaches are necessary for writing clinical trial materials depending on whether the content is intended for pre-consent or post-consent use. Let’s explore each.
Writing pre-consent materials
For all pre-consent materials, we recommend addressing the parent or guardian instead of directly addressing the pediatric subject. Your legal team is likely to second this motion. The child has not yet consented to participate, and since they are a minor, it’s better to address the parent or guardian. Plus, the parent or guardian must also feel comfortable with joining the study.
Since the parent or guardian will be very much involved throughout the study, it’s best to use phrasing that acknowledges this, like “you and your child”; for example, “You and your child will visit the study clinic 12 times.”
Writing post-consent materials
This is where we can write directly to the pediatric participant. It’s impractical to create separate materials for each age in a pediatric study, so you will likely be tasked with writing for one or more age ranges. Within those ranges lie challenges. A typical pediatric study has a participant age range that spans from small to vast.
We often find ourselves with the materials being narrowed down to two age ranges, for example, one set for ages 6 to 11 and another set for ages 12 to 17. It’s still a challenge because even within the age range, the audience is in different stages of maturity and reading comprehension.
If you are communicating through peer-age characters, for example, in a comic book, and you have a range of, let’s say 12 to 17 years old, tailor the content by placing the older participant as your speaker. It’s not unlike the family dynamic of the younger sibling wanting to hang out with his older sibling yet the older sibling isn’t often drawn to the younger.
Special materials to engage pediatric participants
Special materials designed to engage pediatric participants can include unique and fun elements. Beyond the basics, such as study websites, posters, and recruitment brochures, we often create unique materials specifically for pediatric subjects. Below are some examples.
Comic books
Comic books remain popular: the worldwide compound annual growth rate from 2022 to 2030 is expected to be 10.5 percent. When tailored to clinical trials, comic books make excellent tools to inform participants about a study after the consents and assents have been signed. It’s brochure-level information presented in a fun and appealing form. The comic book is certainly a livelier way to convey study information.
The comic book should include the following descriptions:
- Why the study is being conducted
- Study duration and number of visits
- Types of medical tests
- Administration route of the study medication (i.e., injection, tablet, etc.)
- If a placebo is being used, a description of a placebo
If your demographic is very young – let’s say new readers or younger – you might consider using animals instead of children for characters. Dinosaurs are always popular.
Trial maps
Trial maps inform participants about what to expect at each study visit. This is one of the most popular materials we create to engage pediatric participants in clinical trials. They are perfect for children when compared to standard visit guides created for adult participants.
We create the trial map so each visit has its own map that shows the child’s journey from one trial procedure to the next. We usually include “start” and “finish” markers on the map. Including drawings of peers cheering them along is an excellent way to express encouragement and engage pediatric participants. Sometimes, we also create areas in the document that can be colored in by the participant during the visit.
Participant passports
These are simple documents well-suited for the very young demographic. Each page of the passport contains the dates for each visit, sometimes several visits to a page. After each visit is completed, the study team will add a stamp or sticker that reflects completion, such as the word DONE. This helps create a sense of accomplishment during their study journey. We often include messages of encouragement in the passport, such as You’re doing great! or You’re halfway done!
Activity books
These are ideal to keep participants occupied during longer study visits. Activities can include word searches, finding items in a picture, true or false quizzes, and spotting differences in two similar pictures.
Another consideration is an activity the participant can complete with their parent/guardian, like taking turns drawing, or even a classic tic-tac-toe game.
If your study branding or study name has a theme, tailor your content throughout to reinforce it. For example, if your study name or theme is ocean-related, feature artwork of fish, and include an ocean facts trivia questionnaire.
When creating an activity book for a global study, always keep the translation step in mind. You should stay away from anything that will cause extra work for the translators. If you give your translators a word search or a crossword puzzle, it’s no longer a translation task; they will have to start over from scratch.
Choosing character names when writing to engage pediatric participants
Selecting names for characters can be an art in itself, but it doesn’t need to be difficult. This is where Google comes in handy. What is a common boy’s name in South America? Mateo shows up a lot. Sounds good! The young man in our heart study is Mateo. It can be just as effective to solicit input from study sites, as their regional expertise is invaluable.
Another approach to character names is to invent names that are tailored to the study branding. One of my favorites was a space-themed trial map we created a few years ago, featuring astronaut characters. We named one of the astronauts Susie Starcloud.
Branding considerations
Branding is the overall look of your study materials, which often includes giving the study a name. I can’t emphasize this strongly enough: pediatric studies should have names rather than just a protocol number. When communicating with young readers, it’s always best to refer to the study as, for example, the Dandelion study, as opposed to the CRA-04-02006 study. Rolls off the tongue much more nicely. A study name works best if it also has a logo. This can help solidify the name and make the participants feel they are part of a team.
If your study has a name and a logo, consider providing comfort items to your participants. One example is a blanket with your study logo to give to participants for long visits or overnight stays at the study clinic.
Final thoughts
While materials created for the pediatric participant won’t eliminate the patient’s burden of time, medical tests, and travel to and from the site, they do reveal a commitment by the study team and sponsor. They can assist with recruitment and retention, compliance, help manage expectations, and contribute to making the overall trial experience a positive one.
Every young participant plays a vital role in clinical research, and our communication should reflect their importance while making the information relevant and engaging.
Writing and designing to engage pediatric participants is not just about conveying information; it’s about inspiring young heroes who step up to help advance medical science. It’s a special honor to work on behalf of clinical research’s youngest participants and to be part of their important journey.
The Imperial Advantage
Imperial specializes in helping sponsors and CROs connect with participants, sites, and medical professionals through study writing and design in digital and print materials. Study naming, branding, writing, and translating is an art and a challenge—don’t go it alone! Call on Imperial to help make your pediatric trial a success. Contact Imperial for more information or visit our website.