Transforming Care for Individuals With Childhood-onset Systemic Lupus Erythematosus
Recruiting now · Not applicable
Conditions studied: Systemic Lupus Erythematosus of Childhood (Disorder)
In brief
This study aims to investigate the feasibility and effectiveness of a cognitive behavioral coping skills program, Treatment and Education Approach for Childhood-onset Lupus (TEACH), for youth with cSLE when integrated into medical care. This TEACH program aims to teach participants skills in order to cope with fatigue, pain, and depressive symptoms--symptoms that commonly affect adolescents and young adults with lupus.
Key facts
- Study ID
- NCT06232304
- Run by
- Michigan State University
- People needed
- 175
- Starts
- 2024-09-12
- Expected to finish
- 2027-09-30
- Last updated by the study team
- 2025-10-30
Who can join
Age: 12 and older, up to 22. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 1) be diagnosed with cSLE, meeting the revised American College of Rheumatology Classification Criteria for SLE by age 18 years
- 2) be between the ages of 12 and 22 years
- 3) in recognition of the heterogeneity of cSLE symptoms, have elevations in fatigue (i.e., T scores ≥60; or at least moderate symptoms, on the PROMIS measure) OR depressive symptoms (≥5 on the PHQ-9, T Score ≥ 60 on the BDI or CDI II ), OR pain (i.e., average pain ≥3 out of 10 on the Pain VAS)
- 4) have English language proficiency (their primary caregiver can have English or Spanish language proficiency for the child to enroll)
- 5) those under age 18 years (US), or 16 years (Canada) must have a consenting caregiver
You may not qualify if…
- 1) other chronic medical conditions (e.g., juvenile arthritis)
- 2) a documented developmental delay, severe cognitive impairment, or thought disorder
- 3) an untreated major psychiatric illness (e.g., bipolar disorder, psychosis, severe depression (PHQ9 score ≥21, BDI/CDI II > 90) or active suicidal ideation (SI), based on the Pediatric Health Questionnaire (PHQ-9) items plus clinical interview; see Measures section)
Where it is running
- University of Alabama Birmingham Hospital — Birmingham, Alabama, United States (enrolling)
- Children's Hospital of New Orleans/ Tulane University — New Orleans, Louisiana, United States (enrolling)
- Helen Devos Children's Hospital — Grand Rapids, Michigan, United States (enrolling)
- Montefiore Medical Center — The Bronx, New York, United States (enrolling)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)
- Seattle Children's Hospital — Seattle, Washington, United States (enrolling)
- The Hospital for Sick Children — Toronto, Ontario, Canada (enrolling)
Full record on ClinicalTrials.gov
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