SLENCT06581029
Evaluating Mental Health Challenges in Juvenile Lupus Erythematosus and Their Caregivers
An observational study of SLE, run by Assiut University.
Trial summary
assessment of psychiatric problems in pediatric SLE and their caregivers. evaluate the possible risk factors of psychiatric problems such as peer victimization, academic performance, fatigue, self-esteem and quality of life. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- SLE
- What is being tested?
- The multidimensional peer victimization scale (PVS)
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 30 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 11 to 18 years
- All sexes
- Child, Adult
Study population: : this study will include patients who already diagnosed with SLE and following in allergy\&immunology and rheumatology unit assiut university children hospital
Who may be able to join
- Age from 11 to 18 years
- Both sex
- diagnosed with SLE for at least 6 months to allow for an adjustment period following diagnosis.
- Met the New ACR and EULAR criteria for classification of SLE .
- Inclusion criteria of the control healthy group : 1- no history of psychiatric and medical disease 2-Intelligence quotation more than 70.
Who cannot join
- No history of psychiatric illness prior to the diagnosis of lupus.
- Intelligence quotation more than 70.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
assessment of psychiatric problems in pediatric SLE and their caregivers. evaluate the possible risk factors of psychiatric problems such as peer victimization, academic performance, fatigue, self-esteem and quality of life.
Read the detailed description
Juvenile-onset systemic lupus erythematosus (jSLE) is a rare but severe multisystem autoimmune disease which may cause significant damage, disability, and death . Juvenile SLE patients constitute 15-20% of all SLE cases . Compared to the adult SLE, jSLE patients have higher morbidity and mortality rates. Renal, cardiovascular, and neuropsychiatric (NP) involvements are the most important reasons for morbidity and mortality .
Therefore, knowledge of common mental illnesses such as major depressive disorder (MDD) and anxiety disorders in cSLE may be limited. Establishing the prevalence of MDD and anxiety in cSLE is important , as comorbidity rates of these disorders may be increased in cSLE for several reasons. First, the diagnosis of a serious physical health condition confers psychological vulnerability to feelings of sadness, helplessness, stress, and worry about the future.9 For some individuals, such symptoms warrant further evaluation and may persist beyond the initial adjustment period and reach clinical significance, requiring therapeutic intervention. SLE carries a patient-treatment burden similar to other chronic diseases. Such treatment burden places susceptible individuals at risk of psychiatric disorder. Second, although depressed mood may present in the absence of active CNS disease, it may also occur as a symptom of neuropsychiatric c SLE (NPSLE), yielding clinically significant treatment implications. Third, treatment of SLE with known depressogenic medications like steroid may lead to depressive symptom elevation or exacerbate a co-morbid primary MDD. Moreover, among patients with depressed mood as a manifestation of NPSLE, the initiation of steroid treatment may worsen depressive symptoms. It is unclear whether such risks are observed in the cSLE population.
- Conditions
- SLE
- Being tested
- The multidimensional peer victimization scale (PVS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The multidimensional peer victimization scale (PVS)Other
The multidimensional peer victimization scale (PVS), a self-report scale for children and adolescents, was used to assess the victimization
| Study group | Role | What they receive |
|---|---|---|
| control healthy group | is 1) no history of psychiatric and medical disease 2) Intelligence quotation more than 70. | |
| SLE group | I. Age from 11 to 18 years II. Both sex III. diagnosed with SLE for at least 6 months to allow for an adjustment period following diagnosis.
use of The multidimensional peer victimization scale (PVS), a self-report scale for children and adolescents, was used to assess the victimization Receives: Other: The multidimensional peer victimization scale (PVS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating mental health challenges in juvenile SLE and their caregivers
The aim of the present study is to evaluate and assess psychiatric problems in juvenile systemic lupus erythematosus patients and their caregivers. Also, to evaluate the possible risk factors of psychiatric problems such as peer victimization, academic performance, fatigue, self-esteem and quality of life.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start1 Jun 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SLEStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sahar Samir Farghly Badran, Assiut University
- Investigators
- Nagwa Ali, Professor of pediatric, Study director, Assiut UniversityGellan Karamallah Ramadan Ahmed, lecturer of psychiatry, Study director, Assiut UniversityNaglaa Samy, Associate proff, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06581029
- Sponsor's protocol ID
- J.SLE and psychiatry
- Status last verified
- Aug 2024
- First submitted
- 29 Aug 2024
- Last updated
- 4 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sarwar S, Mohamed AS, Rogers S, Sarmast ST, Kataria S, Mohamed KH, Khalid MZ, Saeeduddin MO, Shiza ST, Ahmad S, Awais A, Singh R. Neuropsychiatric Systemic Lupus Erythematosus: A 2021 Update on Diagnosis, Management, and Current Challenges. Cureus. 2021 Sep 14;13(9):e17969. doi: 10.7759/cureus.17969. eCollection 2021 Sep.
PubMed 34667659The American College of Rheumatology nomenclature and case definitions for neuropsychiatric lupus syndromes. Arthritis Rheum. 1999 Apr;42(4):599-608. doi: 10.1002/1529-0131(199904)42:43.0.CO;2-F.
PubMed 10211873Ho RC, Mak A. The interface between medicine and psychiatry: neuropsychiatric aspects of systemic lupus erythematosus (SLE). Ann Acad Med Singap. 2014 Aug;43(8):388-90. No abstract available.
PubMed 25244986
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Mental Health Challenges in Juvenile Lupus Erythematosus and Their Caregivers
- ClinicalTrials.gov ID
- NCT06581029
- Acronym / sponsor ID
- J.SLE and psychiatry
- Conditions
- SLE
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 30 Aug 2024 (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.
assessment of psychiatric problems in pediatric SLE and their caregivers. evaluate the possible risk factors of psychiatric problems such as peer victimization, academic performance, fatigue, self-esteem and quality of life.
Detailed description
Juvenile-onset systemic lupus erythematosus (jSLE) is a rare but severe multisystem autoimmune disease which may cause significant damage, disability, and death . Juvenile SLE patients constitute 15-20% of all SLE cases . Compared to the adult SLE, jSLE patients have higher morbidity and mortality rates. Renal, cardiovascular, and neuropsychiatric (NP) involvements are the most important reasons for morbidity and mortality .
Therefore, knowledge of common mental illnesses such as major depressive disorder (MDD) and anxiety disorders in cSLE may be limited. Establishing the prevalence of MDD and anxiety in cSLE is important , as comorbidity rates of these disorders may be increased in cSLE for several reasons. First, the diagnosis of a serious physical health condition confers psychological vulnerability to feelings of sadness, helplessness, stress, and worry about the future.9 For some individuals, such symptoms warrant further evaluation and may persist beyond the initial adjustment period and reach clinical significance, requiring therapeutic intervention. SLE carries a patient-treatment burden similar to other chronic diseases. Such treatment burden places susceptible individuals at risk of psychiatric disorder. Second, although depressed mood may present in the absence of active CNS disease, it may also occur as a symptom of neuropsychiatric c SLE (NPSLE), yielding clinically significant treatment implications. Third, treatment of SLE with known depressogenic medications like steroid may lead to depressive symptom elevation or exacerbate a co-morbid primary MDD. Moreover, among patients with depressed mood as a manifestation of NPSLE, the initiation of steroid treatment may worsen depressive symptoms. It is unclear whether such risks are observed in the cSLE population.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control healthy group | – | –is 1) no history of psychiatric and medical disease 2) Intelligence quotation more than 70. |
| SLE group | – | Other: The multidimensional peer victimization scale (PVS)I. Age from 11 to 18 years II. Both sex III. diagnosed with SLE for at least 6 months to allow for an adjustment period following diagnosis. use of The multidimensional peer victimization scale (PVS), a self-report scale for children and adolescents, was used to assess the victimization |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- : this study will include patients who already diagnosed with SLE and following in allergy\&immunology and rheumatology unit assiut university children hospital
Key inclusion criteria (5 listed)
- Age from 11 to 18 years
- Both sex
- diagnosed with SLE for at least 6 months to allow for an adjustment period following diagnosis.
- Met the New ACR and EULAR criteria for classification of SLE .
- Inclusion criteria of the control healthy group : 1- no history of psychiatric and medical disease 2-Intelligence quotation more than 70.
Key exclusion criteria (2 listed)
- No history of psychiatric illness prior to the diagnosis of lupus.
- Intelligence quotation more than 70.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The multidimensional peer victimization scale (PVS)The multidimensional peer victimization scale (PVS), a self-report scale for children and adolescents, was used to assess the victimization | Other | SLE group |
Primary outcome
Evaluating mental health challenges in juvenile SLE and their caregivers
Time frame: baseline
The aim of the present study is to evaluate and assess psychiatric problems in juvenile systemic lupus erythematosus patients and their caregivers. Also, to evaluate the possible risk factors of psychiatric problems such as peer victimization, academic performance, fatigue, self-esteem and quality of life.
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 4 Feb 2025.
- Background: PubMed 34667659Sarwar S, Mohamed AS, Rogers S, Sarmast ST, Kataria S, Mohamed KH, Khalid MZ, Saeeduddin MO, Shiza ST, Ahmad S, Awais A, Singh R. Neuropsychiatric Systemic Lupus Erythematosus: A 2021 Update on Diagnosis, Management, and Current Challenges. Cureus. 2021 Sep 14;13(9):e17969. doi: 10.7759/cureus.17969. eCollection 2021 Sep.
- Background: PubMed 10211873The American College of Rheumatology nomenclature and case definitions for neuropsychiatric lupus syndromes. Arthritis Rheum. 1999 Apr;42(4):599-608. doi: 10.1002/1529-0131(199904)42:43.0.CO;2-F.
- Background: PubMed 25244986Ho RC, Mak A. The interface between medicine and psychiatry: neuropsychiatric aspects of systemic lupus erythematosus (SLE). Ann Acad Med Singap. 2014 Aug;43(8):388-90. No abstract available.
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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.
Nagwa Ali, Professor of pediatric study director
Assiut University
Gellan Karamallah Ramadan Ahmed, lecturer of psychiatry study director
Assiut University
Naglaa Samy, Associate proff study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of SLE, run by Assiut University.
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 5 inclusion and 2 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: opening soon, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Sahar Samir, resident (01067046915, samirsamar936@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluating mental health challenges in juvenile SLE and their caregivers (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06581029, which also lists 3 linked publications.
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 4 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.