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

January 13, 2026 updated by: University of the West of England

Assessing the Impact of Glucocorticoids in Children and Young People With Rheumatic Conditions, to Develop a Patient Reported Outcome Measure (PROM).

Assessing the impact of glucocorticoids in children and young people with rheumatic conditions, to develop a patient reported outcome measure (PROM).

Glucocorticoids, also known as steroids, are a very effective medication for the treatment of rheumatological conditions. They are used to reduce inflammation, pain and damage to organs. However, steroids can have some unwanted side effects, such as, increased weight, skin changes, feeling anxious, delayed puberty, diabetes and loss of bone mass. These side effects can therefore impact children and young people's health related quality of life (HRQoL).

The investigators would like to create a new questionnaire for children and young people (CYP) who take steroids due to their rheumatological condition. The questionnaire, called a Patient Reported Outcome Measure, (PROM), will measure how steroids are affecting CYP. The first step in creating the questionnaire is to talk to children, young people and their parents/guardians about their experiences of taking steroids. The investigators plan to do this in focus groups, with people around the same age. The second step will then be to take everything people said in the focus group to create the questions in the questionnaire. Cognitive interviewing will then be used in a structured one on one interview to test for relevance, clarity and understanding of the questions.

Children, young people and their parents/guardians will be involved throughout the research. Children and young people will give their thoughts and feedback on resources created for participants (consent forms/assent forms/participation information sheet/interview schedule), as well as how the focus groups and cognitive interviews should be structured.

With consent, participants will be provided with a lay summary of the results. Results will also be published within peer-reviewed journals, special interest groups, trial meetings, patient charity meetings and presented at conferences.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • North Somerset
      • Bristol, North Somerset, United Kingdom, BS2 8BJ
      • Glasgow, North Somerset, United Kingdom, G51 4TF
      • Liverpool, North Somerset, United Kingdom, L12 2AP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Three NHS sites (paediatric rheumatology clinics) will be used for recruitment of participants:

Bristol Royal Hospital for Children Alder Hey Children's Hospital (Liverpool) Royal Hospital for Children (Glasgow)

Description

Inclusion Criteria:

  • 1. Rheumatology patients aged 0 to18 years old. 2. Patients should have capacity to assent or consent immediately prior to the interview.

    3. The patient should have a good understanding of spoken and written English be able to understand the participant information sheets, assent/consent forms.

    4. Treatment with glucocorticoids with intravenous or oral glucocorticoids for an autoimmune or inflammatory condition within the previous two years (or longer duration).

Parents/guardians:

  1. Parents (mother/ father) or legal guardians of rheumatological patients fulfilling criteria 1-4 above.
  2. Parents or legal guardians should have capacity to consent for themselves (+/- their child) immediately prior to the interview.
  3. The parents or legal guardians should have a good understanding of spoken and written English be able to understand the participant information sheets, assent/consent forms.

Exclusion Criteria:

  • 1. Rheumatology patients who are more than 18 years of age. 2. Patients who do not have capacity to assent or consent immediately prior to the interview.

    3. Patient who have insufficient understanding of spoken and written English be able to understand the participant information sheets, assent/consent forms.

    4. Patients who either have never taken steroids or have not taken steroids within the last two years as part of their treatment plan for their rheumatological condition.

    5. Relative is not a parent or legal guardian. 6. Parents/guardians of rheumatology patients fulfilling any of the exclusion criteria above.

    7. Parents/guardians who do not have capacity to assent or consent immediately prior to the interview.

    8. Parents/guardians who have insufficient understanding of spoken and written English be able to understand the participant information sheets, assent/consent forms.

    9. Parents/guardians of rheumatology patients who have never taken steroids or have not taken steroids within the last two years as part of their treatment plan for their rheumatological condition.

    10. Membership of the steering committee

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Focus groups for parents with children under 8 years old
Focus groups with children 8-12 years old
Focus groups for young people aged 13-15 years old
Focus groups for young people aged 16-18 years old
Cognitive interviewing for parents with children under 8 years old
Cognitive interviewing for children 8-12 years old
Cognitive interviewing for young people aged 16-18 years old
Cognitive interviewing for young people aged 13-15 years old

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To explore the impact of glucocorticoids (steroids) on health-related quality of life (HRQoL) in CYP.
Time Frame: Through study completion, an average of 1 year.
To develop a long list of potential questionnaire items for one or more patient reported outcome measures (PRO) for children and young people, who are treated with glucocorticoids, which assesses its impact of this treatment on their symptoms and everyday life.
Through study completion, an average of 1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary analysis of specific topics of greatest importance to patients and families may be performed based on anonymised qualitative dataset from objective 1
Time Frame: Through study completion, an average of 1 year.
Secondary analyses may in future also be used to explore specific topics of importance within the qualitative data, depending on what emerges as of greatest importance (e.g. impact on appearance, sense of self).
Through study completion, an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of the West of England

Collaborators

Alder Hey Children's NHS Foundation Trust
Bristol Royal Hospital for Children
Glasgow Royal Hospital for children

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

September 23, 2025

First Submitted That Met QC Criteria

January 13, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 352096

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

This is not a trial, it is an exploratory qualitative study, therefore outcome measures are not relevant.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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