Transforming Care for Individuals With Childhood-onset Systemic Lupus Erythematosus

Launched by MICHIGAN STATE UNIVERSITY · Jan 22, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a program called TEACH, which stands for Treatment and Education Approach for Childhood-onset Lupus. The goal is to see if this program can help young people aged 12 to 22 years who have been diagnosed with childhood-onset systemic lupus erythematosus (cSLE). Many of these young individuals experience symptoms like fatigue, pain, and feelings of sadness, so the TEACH program will teach them skills to better cope with these challenges as part of their regular medical care.

To participate in this study, potential participants need to have a diagnosis of cSLE and experience significant fatigue, depressive symptoms, or pain. They must also be comfortable using English or have a caregiver who speaks English or Spanish. Importantly, those under 18 will need consent from a parent or guardian. While this trial is currently recruiting, it does not accept participants with other serious medical conditions or untreated mental health issues. If eligible, participants can expect to learn useful coping strategies that may improve their quality of life while managing their lupus.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 (i.e., ≥10 on the PHQ-9), 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
• Exclusion Criteria:
• • 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 (score ≥20) or active suicidal ideation (SI), based on the Pediatric Health Questionnaire (PHQ-9) items plus clinical interview; see Measures section)