Designing Information a Child Can Use

Part of Consent and Vulnerable Populations: Minors, Assent and Refusal.

About 5 minutes. Free, in your language, no account needed.

Why this matters

The requirement is information adapted to the child's age and mental maturity. In practice this frequently means the adult document with shorter sentences, which adapts the form rather than the information.

A child needs different content, not the same content simplified. What an adult wants to know about a trial and what a child wants to know are genuinely different, and a document that answers the adult's questions in simpler words answers the wrong questions.

What children actually want to know

Consistently, across studies of how children understand research participation:

What will happen to my body. Will it hurt, how much, how long, and will I be asleep.

Will I have to have needles, and how many, and when.

Will I have to stay in hospital, and will someone stay with me.

Will I miss school, and will I miss things I care about.

Can my parent stay with me.

Can I stop. And if I stop, will anyone be cross with me.

Notice how little of this appears in an adult consent form, and how little of an adult form addresses any of it. The adult form is about purpose, risk, randomization, alternatives, confidentiality and data. The child's form must be about experience.

Tiered documents

Most pediatric trials need three or four versions, and the tiers are a starting point rather than a rule, since a child's understanding is individual.

Youngest, roughly 6 to 9. Pictures carrying most of the meaning, very short sentences, concrete descriptions of what will happen, and one clear statement that they can say no.

Middle, roughly 10 to 13. Plain language, one page, what will happen and why, an honest statement about discomfort, and that they can stop at any time.

Older, roughly 14 to 17. Closer to an adult document in content, including purpose and randomization, in accessible language, and addressing things adolescents specifically care about: confidentiality from their parents where the framework permits it, effects on their appearance, and effects on school and sport.

Honesty about discomfort

The strongest temptation in writing for children is to soften.

"You might feel a small scratch" for a procedure that hurts is not kindness. A child who is told it will not hurt much and finds that it does has learned that the adults in this building are not reliable, and that belief will affect every subsequent visit and everything else they are told.

Accurate and calibrated is better: it will hurt for a short time, like a blood test you have had before, and you can hold someone's hand, and you can tell us to stop.

The conversation, which is the actual mechanism

The documents support a conversation. They do not replace one, and for the youngest children the conversation carries essentially all of the information.

It should be conducted by someone experienced with children, at the child's eye level, with time, and with at least part of it addressed to the child directly rather than over their head to the parent.

The teach-back applies here as much as with adults, adapted: ask the child to say what is going to happen, and listen to what they describe.

In practice

A trial requiring monthly blood samples from children aged 6 to 12 prepares an assent sheet.

The first draft is the adult form shortened. It describes the study's purpose, that some children will get the medicine and some will not, and that the information will help doctors treat children in future.

The coordinator, who has worked in pediatric research, rewrites it entirely.

The new sheet has four pictures. A picture of the clinic room. A picture of a blood test with a short sentence saying it hurts a bit and is quick. A picture of a calendar showing one visit a month. A picture of a child saying no, with a sentence saying that is allowed and nobody will be cross.

The study's purpose is covered in one sentence, because the children asked almost nothing about it.

At the first ten consent conversations, the questions children ask are: will it hurt, how many times, can mum come, will I miss football. The sheet answers all four. The original draft answered none.

What this looks like when it goes wrong

A trial's assent form for children aged 8 to 12 explains that the study is testing whether a new medicine works better than the current one, and that a computer will decide which one each child gets.

A nine year old reads it, signs it, and takes part.

At the fourth visit she asks the nurse when she will find out if she got the good one.

She has understood that there are two medicines and that a computer chose. She has not understood that nobody knows which is better, which is the entire reason the study exists, and she believes one is good and one is not.

The form was accurate. The concept it needed to convey is genuinely difficult, and a written form was never going to convey it to a nine year old. A conversation might have, and the teach-back would have found the misunderstanding in the first visit rather than the fourth.

Key takeaways