Rheumatic DiseasesNCT07350395
Exploring and Measuring the Impact of Steroids in Children and Young People
An observational study of Rheumatic Diseases and Rheumatic Disorder, run by University of the West of England at 3 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Rheumatic Diseases, Rheumatic Disorder, Rheumatologic Conditions (JRA,Lupus)
- How many people
- 70 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 1 Nov 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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)
Who may be able to join
- 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:
- Parents (mother/ father) or legal guardians of rheumatological patients fulfilling criteria 1-4 above.
- Parents or legal guardians should have capacity to consent for themselves (+/- their child) immediately prior to the interview.
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom3 sites, 3 recruiting
- Recruiting
Bristol Royal Hospital for Children
Bristol, North Somerset, BS2 8BJ
Emily Barnes, 07747560680, emily4.barnes@live.uwe.ac.uk
- Recruiting
Royal Hospital for children Glasgow
Glasgow, North Somerset, G51 4TF
Emily Barnes, 07747560680, emily4.barnes@live.uwe.ac.uk
- Recruiting
Alder Hey Hospital
Liverpool, North Somerset, L12 2AP
Emily Barnes, 07747560680, emily4.barnes@live.uwe.ac.uk
About this study
Official title: 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).
Read more
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.
- Keywords
- rheumatic diseases, children and young people, steroids, glucocorticoids, qualitative
- Medical subject headings
- Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Focus groups for parents with children under 8 years old | Not described | |
| Focus groups with children 8-12 years old | Not described | |
| Focus groups for young people aged 13-15 years old | Not described | |
| Focus groups for young people aged 16-18 years old | Not described | |
| Cognitive interviewing for parents with children under 8 years old | Not described | |
| Cognitive interviewing for children 8-12 years old | Not described | |
| Cognitive interviewing for young people aged 16-18 years old | Not described | |
| Cognitive interviewing for young people aged 13-15 years old | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To explore the impact of glucocorticoids (steroids) on health-related quality of life (HRQoL) in CYP.
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.
Measured: Through study completion, an average of 1 year.
Secondary outcomes (1)
Secondary analysis of specific topics of greatest importance to patients and families may be performed based on anonymised qualitative dataset from objective 1
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).
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Nov 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the West of England
- Sponsor type
- University, hospital or other
- Collaborators
- Alder Hey Children's NHS Foundation Trust, Bristol Royal Hospital for Children, Royal Hospital for Sick Children
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350395
- Sponsor's protocol ID
- 352096
- Status last verified
- Jan 2026
- First submitted
- 23 Sep 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This is not a trial, it is an exploratory qualitative study, therefore outcome measures are not relevant.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of Glucocorticoids in Children and Young People With Rheumatic Conditions, to Develop a Patient Reported Outcome Measure (PROM).
- ClinicalTrials.gov ID
- NCT07350395
- Acronym / sponsor ID
- 352096
- Keywords
- rheumatic diseases, children and young people, steroids, glucocorticoids, qualitative
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of the West of EnglandUniversity, hospital or other
- Collaborators
- Alder Hey Children's NHS Foundation Trust, Bristol Royal Hospital for Children, Royal Hospital for Sick Children
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 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 | – | – |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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)
Key inclusion criteria (7 listed)
- 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 (mother/ father) or legal guardians of rheumatological patients fulfilling criteria 1-4 above.
- Parents or legal guardians should have capacity to consent for themselves (+/- their child) immediately prior to the interview.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: Undecided. This is not a trial, it is an exploratory qualitative study, therefore outcome measures are not relevant.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatic Diseases and Rheumatic Disorder, run by University of the West of England at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily Barnes (+447747560680, emily4.barnes@live.uwe.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.