RecruitingOBSERVATIONAL

Exploring and Measuring the Impact of Steroids in Children and Young People

This study aims to develop a new questionnaire for children and young people aged 0-18 who have rheumatic conditions like JRA or Lupus and take steroid medications. Steroids are very helpful for these conditions, reducing pain and inflammation, but they can also have side effects like weight gain or feeling anxious. This questionnaire, called a Patient Reported Outcome Measure (PROM), will help us better understand how these side effects impact young people's quality of life. We'll talk to young people and their parents in group discussions and one-on-one interviews to gather their experiences and use this information to create effective questions for the new questionnaire.

At a glance

Status

Recruiting

Sponsor

University of the West of England

Enrolment target

Start

01 Nov 2025

Estimated completion

31 Dec 2026

Rheumatic Diseases Rheumatic Disorder Rheumatologic Conditions (JRA,Lupus)

What is this study about?

This research is all about understanding how steroid medicines affect children and young people diagnosed with rheumatic conditions, such as juvenile arthritis or lupus. Steroids are really good at calming down inflammation and pain, and they can protect organs from damage. Because of this, they are often a very important part of treatment for these conditions.

However, we know that steroids can also cause some tricky side effects. These might include things like putting on weight, changes to the skin, feeling worried or anxious, changes in when puberty starts, a higher chance of developing diabetes, or sometimes even weaker bones. When these things happen, they can affect how a child or young person feels day-to-day and how they experience their overall health and well-being.

The main goal of this study is to create a new way to measure these effects, directly from the young people and their parents. We want to develop a special questionnaire, called a Patient Reported Outcome Measure (usually shortened to PROM), that will capture what it's really like to take steroids. By listening to children, young people, and their parents, we can make sure the questionnaire asks the right questions and truly reflects their experiences. This will help doctors and researchers understand the impact of steroids better in the future.

Key takeaways

This study aims to develop a new questionnaire for children and young people on steroids.
It focuses on understanding how steroids affect daily life for those with rheumatic conditions.
Participation involves sharing experiences in group or one-on-one discussions.
Your medical treatment will not change if you take part.
Your feedback will help improve future ways of understanding children's health, directly from them.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

We are looking for children and young people up to 18 years old who have a rheumatic condition and have taken steroids (either by mouth or injection) at some point in the last two years. It's important that they can understand spoken and written English well enough to follow what's happening in the study.

We also want to hear from parents or legal guardians of these children and young people. Like the young people themselves, parents need to be able to understand English to take part. Unfortunately, we can't include anyone over 18, or children who haven't taken steroids for their rheumatic condition within the last two years. If a child or parent can't understand the information well enough, they also won't be able to join.

Only parents or legal guardians can participate; other relatives cannot. It's really important that everyone involved understands the study fully before agreeing to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is the child or young person under 18 years old?
Do they have a rheumatic condition (like arthritis or lupus)?
Have they taken steroids (by mouth or injection) for their condition in the last two years?
Can the child/young person and their parent/guardian understand spoken and written English well?
Is the person wanting to take part a parent or legal guardian of the child/young person?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the first step will be to have a chat with researchers, either in a group with other people of a similar age (called a focus group) or in a one-on-one interview. They'll ask about your experiences and thoughts on taking steroids. Children and young people, as well as their parents, will be able to give feedback on how these conversations should happen and what materials are used.

The information gathered from these initial conversations will be used to help create the new questionnaire. Later, some participants might be asked to try out the new questionnaire in a one-on-one session to check if the questions are clear and easy to understand. You won't be given any new medication or asked to change your current treatment plan as part of this study. The total time you'd spend taking part would depend on whether you attend a focus group, an interview, or both, but it's likely to be a single session or a few individual sessions, not ongoing over a long period.

Potential risks and benefits

Taking part in this study won't involve any changes to your medication or clinic visits. The main benefit is that your experiences, and those of your child, will directly help create a new tool that better understands how steroids affect young people's lives. This could lead to better care in the future. The main 'risk' is simply the time and effort you give to participating in the discussions. We will make every effort to ensure you feel comfortable and that your privacy is protected. You are free to stop participating at any time, for any reason, without it affecting your or your child's medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Bristol Royal Hospital for Children
Verified postcode
Bristol, United Kingdom· Recruiting
Royal Hospital for children Glasgow
Verified postcode
Glasgow, United Kingdom· Recruiting
Alder Hey Hospital
Verified postcode
Liverpool, United Kingdom· Recruiting

Common questions

What is a 'rheumatic condition'?

Rheumatic conditions are illnesses that affect joints, muscles, and bones, and sometimes other parts of the body. Examples include juvenile arthritis and lupus.

What are 'steroids' in this study?

In this study, 'steroids' refers to medications like glucocorticoids, which are powerful medicines used to reduce inflammation and pain in rheumatic conditions.

Will I have to take new medicine or stop my current medicine?

No, this study is about understanding your experiences with your current steroid treatment. You won't be asked to take any new medicine or change your existing treatment plan.

How long will I or my child need to be involved?

Participation usually involves one or more discussion sessions (either in a group or one-on-one). It's not an ongoing commitment over a long period.

What happens with the information I share?

Your experiences will be used to help create a new questionnaire. We will share a simple summary of the study results with you, and the findings will also help other researchers and doctors.

How to find out more

Emily Barnes

emily4.barnes@live.uwe.ac.uk +447747560680 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.