Recruiting

Transforming Care for Individuals With Childhood-onset Systemic Lupus Erythematosus

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.

ClinicalTrials.gov IDNCT06232304

PhaseNA

Enrollment175

SponsorMichigan State University

Age12 Years – 22 Years

SexALL

I'm interested View official listing

Conditions studied

Systemic Lupus Erythematosus of Childhood (Disorder)

About this study

Interventions

Behavioral: TEACH — TEACH is a cognitive behavioral coping skills program. It consists of six one-hour weekly sessions that are conducted either in-person or remotely.

Primary outcomes

Depressive symptoms, as measured by the Children's Depression Inventory-2 (CDI-2) and Beck Depression Inventory-II (BDI-II) (primary) (T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks))
Depressive symptoms, as measured by the Patient Health Questionnaire - 9 (PHQ-9) (primary) (T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks))
Fatigue, as measured by the PROMIS Fatigue short form (secondary) (T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks))
Pain, as measured by the Pain Visual Analog Scale (VAS) (T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks))
Pain, as measured by PROMIS Pain Interference Short Form (T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks))
Psychological stress, as measured by the PROMIS psychological stress experience measure (T1 (baseline), T2 (8 weeks))
Cognitive functioning, as measured by the PROMIS Cognitive Function Short Form for Adults and the PROMIS Cognitive Function Short Form for Pediatrics (T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks))
Quality of life, as measured by the Pediatric Quality of Life (PedsQL) Generic Core (T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks))

Eligibility information

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 (≥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 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 (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)

Study locations

University of Alabama Birmingham Hospital, Birmingham, Alabama 35233 United States
Children's Hospital of New Orleans/ Tulane University, New Orleans, Louisiana 70118 United States
Helen Devos Children's Hospital, Grand Rapids, Michigan 49503 United States
Montefiore Medical Center, The Bronx, New York 10467 United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio 45229 United States
Seattle Children's Hospital, Seattle, Washington 98105 United States
The Hospital for Sick Children, Toronto, Ontario ON M5G 1E8 Canada

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-07.