NCT06581029

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
7mo left

Started Jun 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress62%
Jun 2025Dec 2026

First Submitted

Initial submission to the registry

August 29, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2024

Completed
9 months until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

February 4, 2025

Status Verified

August 1, 2024

Enrollment Period

1 year

First QC Date

August 29, 2024

Last Update Submit

January 31, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline

Study Arms (2)

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

Other: The multidimensional peer victimization scale (PVS)

Interventions

The multidimensional peer victimization scale (PVS), a self-report scale for children and adolescents, was used to assess the victimization

SLE group

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

: this study will include patients who already diagnosed with SLE and following in allergy\&immunology and rheumatology unit assiut university children hospital

You may qualify if:

  • 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 .

You may not qualify if:

  • No history of psychiatric illness prior to the diagnosis of lupus.
  • Intelligence quotation more than 70.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 34667659BACKGROUND
  • The 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.

    PMID: 10211873BACKGROUND
  • Ho 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.

    PMID: 25244986BACKGROUND

Study Officials

  • Nagwa Ali, Professor of pediatric

    Assiut University

    STUDY DIRECTOR
  • Gellan Karamallah Ramadan Ahmed, lecturer of psychiatry

    Assiut University

    STUDY DIRECTOR
  • Naglaa Samy, Associate proff

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Sahar Samir, resident

CONTACT

Naglaa Samy, Associate proff

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
pediatric resident

Study Record Dates

First Submitted

August 29, 2024

First Posted

August 30, 2024

Study Start

June 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

February 4, 2025

Record last verified: 2024-08