An interventional study of TEACH in Lupus, sponsored by The Hospital for Sick Children. Not yet recruiting. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by The Hospital for Sick Children · Not applicable, Interventional, and Treatment
This study aims to understand how the TEACH program helps improve mental health and well-being in adolescents with childhood-onset lupus. Researchers will examine changes in brain function and inflammation before and after the program and explore how these changes relate to improvements in symptoms such as anxiety, depression, fatigue, and pain. Twenty adolescents with cSLE, aged 12-18 years, will participate by completing the TEACH program, brain imaging, blood tests, and questionnaires.
Exclusion Criteria:
Treatment and Education Approach for Childhood-Onset Lupus (TEACH) is a form of cognitive behavioral therapy that has been carefully adapted for adolescents with lupus. It is delivered remotely and teaches skills for managing mood, stress, fatigue, and pain in the context of living with a chronic illness. TEACH utilizes semi-scripted sessions to help ensure consistent content delivery. It consists of 6 weekly one-hour sessions with a trained interventionist.
Behavioral: TEACH
TEACH is a form of cognitive behavioral therapy that has been carefully adapted for adolescents with lupus. It targets common and debilitating symptoms in cSLE, including depression, fatigue, anxiety, and pain. Core components include psychoeducation, activity pacing, cognitive restructuring, relaxation and mindfulness strategies, problem solving, and caregiver-supported skill development. TEACH has previously demonstrated clinical efficacy in reducing depressive symptoms and improving fatigue and anxiety in adolescents with lupus.
Concentration of serum brain-injury biomarkers and inflammatory cytokines
Measurement: Serum concentrations of brain-injury-related proteins (S100, serum neurofilament light chain \[sNFL\], glial fibrillary acidic protein \[GFAP\], and Tau) and inflammatory cytokines (including IFN-γ, IL-10, IL-12p70, IL-1β, IL-22, IL-4, IL-5, IL-6, IL-8, and TNF-α), measured using laboratory-based immunoassays. Whole blood RNA expression, including the interferon (IFN) gene signature, will also be assessed using RNA sequencing (RNA-seq). Unit of measure: Concentration (e.g., pg/mL) for serum proteins and cytokines; normalized gene expression levels for RNA-seq/IFN gene signature.
Time frame: From baseline (start of TEACH) to the end of treatment at 8 weeks.
Change in brain neural function and tissue susceptibility
Will look at changes in neuroimaging-derived measures of brain activity/connectivity (fMRI and OPM-MEG) and quantitative magnetic susceptibility (QSM)
Time frame: From baseline (start of TEACH) to the end of intervention at 8 weeks
Depression symptom severity using CDI/BDI questionnaire
We will use the total score on the Children's Depression Inventory 2nd Edition (CDI-2) to assess depressive symptoms for youth \<13 years, and The Beck Depression Inventory-II (BDI-II) for youth \>=13 years with higher scores indicating greater depression symptom severity.
Time frame: Through study completion, an average of 1 year
Longitudinal changes in serum brain-injury biomarker concentrations
Longitudinal changes in serum brain-injury biomarker concentrations (S100, sNFL, GFAP, and Tau) measured using laboratory-based immunoassays
Time frame: 26-week and 56-weeks from baseline
Longitudinal changes in brain function and tissue susceptibility in multimodal neuroimaging
Longitudinal changes in brain function and tissue susceptibility measured using fMRI, OPM-MEG, and quantitative susceptibility mapping (QSM)
Time frame: 26-weeks and 52-weeks from baseline
Fatigue will be measured via the PROMIS Pediatric Fatigue Short Form questionnaire
PROMIS T-score, with higher scores indicating greater fatigue.
Time frame: Through study completion, an average of 1 year
Anxiety symptom severity measured using the Screen for Child Anxiety Related Disorders (SCARED) questionnaire
Total SCARED score, with higher scores indicating greater anxiety symptom severity
Time frame: Through study completion, an average of 1 year
No study locations are listed for this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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The Hospital for Sick Children