Exploring Biological Mechanisms Underlying the TEACH Intervention for Adolescents With Lupus

NCT07771088 | Not Yet Recruiting

• 1 other identifier: 4327
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Lupus

Outcome Measures

Primary Outcomes (3)

• 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.

  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)

  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.

  Through study completion, an average of 1 year

Secondary Outcomes (4)

• Longitudinal changes in serum brain-injury biomarker concentrations

  26-week and 56-weeks from baseline

• Longitudinal changes in brain function and tissue susceptibility in multimodal neuroimaging

  26-weeks and 52-weeks from baseline

• Fatigue will be measured via the PROMIS Pediatric Fatigue Short Form questionnaire

  Through study completion, an average of 1 year

• Anxiety symptom severity measured using the Screen for Child Anxiety Related Disorders (SCARED) questionnaire

  Through study completion, an average of 1 year

Study Arms (1)

TEACH

EXPERIMENTAL

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

Interventions

TEACH BEHAVIORAL

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.

TEACH

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• be diagnosed with cSLE, meeting 2012 American College of Rheumatology (ACR)/System Lupus International Collaborating Clinics (SLICC) and/or European League Against Rheumatism (EULAR)/ACR classification criteria for SLE by age 18 years
• be between the ages of 12 and 18 years
• have stable disease meeting criteria for low lupus disease activity state (LLDAS)
• in recognition of the heterogeneity of symptoms, have elevations (T scores ≥60; see Measures section) in fatigue 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)
• have English language proficiency for cognitive assessment.

You may not qualify if:

• other chronic medical conditions (e.g., juvenile arthritis)
• a documented developmental delay, severe cognitive impairment, or thought disorder
• an untreated major psychiatric illness (e.g., bipolar disorder, psychosis, severe depression (T score ≥90) or active suicidal ideation (SI), based on the Children's Depression Inventory (CDI-II) /Beck Depression Inventory (BDI-II) items or PHQ9 score ≥21.
• current psychotropic medication use
• concurrent psychotherapy or other psychological intervention
• conditions precluding cognitive task assessment (history of major head trauma, learning disability, alcohol/drug use within 24 hours of assessment, severe developmental problems affecting cognition, hearing loss or vision problems).

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Investigator

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 18, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 18, 2026

Record last verified: 2026-07