Transforming Care for Individuals With Childhood-onset Systemic Lupus Erythematosus

Background/Rationale: Childhood-onset systemic lupus erythematosus (cSLE) is a chronic, multisystem, autoimmune disease that disproportionately impacts females of color. It is associated with a more severe disease presentation, and a 20-fold increased risk of mortality compared to adult-onset SLE. Depressive symptoms, anxiety, fatigue, and pain are among the most common presenting complaints which impact health-related quality of life (QOL) in individuals with cSLE. These symptoms are potentially modifiable with behavioral intervention. Our team has created an evidence-based, brief and tailored 6-session program, Treatment and Education Approach for Childhood-onset lupus \[TEACH\], which can be delivered in person or remotely using cognitive behavioral therapy (CBT) strategies to address mental health symptoms, fatigue, and pain. Our nearly completed multi-site RCT, comparing TEACH (delivered by research interventionists) to standard medical care, shows efficacy for psychological/functional outcomes and benefit for disease-related outcomes. Although TEACH is extremely promising, patients do not currently have access to this program as part of their rheumatology care. cSLE patients would likely benefit from TEACH integrated into their medical care, leveraging existing relationships with their providers. As rheumatology teams are often identified as primary providers by cSLE patients, they have a key role in facilitating mental health intervention to enhance patient QOL. They are therefore well-positioned for training in the management of these common, debilitating, yet modifiable symptoms.

Objective: The objective is to determine the effectiveness of a coping skills program, TEACH, designed to improve psychological/functional- and disease- related outcomes in youth with cSLE. We will also investigate longitudinal trajectories of depressive symptoms in recipients and explore implementation outcomes.

Specific Aims \& Hypotheses:

Aim 1: To examine the effect of TEACH on psychological/ functional outcomes and disease-related outcomes in youth with cSLE in real-world rheumatology settings versus medical TAU at post assessment (after 8 weeks). We hypothesize that both psychological/functional outcomes (depressive symptoms \[primary\], fatigue \[secondary\], anxiety, pain, cognitive function) and disease-related outcomes (health-related QOL, medication adherence, disease activity/flares) will significantly improve for the TEACH group vs medical TAU.

Aim 2: To determine longitudinal trajectories (over 1 year) of depressive symptoms, the impact of TEACH, and its association with patient characteristics, psychological/functional outcomes, and disease-related outcomes. We hypothesize that: i) distinct trajectories of depressive symptoms \[low stable, improving, worsening\] will emerge through growth mixture modeling, ii) TEACH vs TAU will be associated with decreased depressive symptoms and improved functioning over time, and iii) worsening depressive symptoms will be associated with poorer psychological/functional outcomes \& disease-related outcomes.

Aim 3: To evaluate TEACH implementation outcomes using a mixed method approach. We will identify implementation outcomes (e.g., barriers and facilitators, acceptability, fidelity, reach, sustainability) of TEACH through surveys and interviews of providers and patients to inform future adoption/sustainability. We hypothesize results will demonstrate TEACH implementation success (e.g., high acceptability, appropriateness, feasibility, fidelity, knowledge of intervention), and metrics of sustainability will be positive.

Research Strategy: We propose a multi-site stepped wedge trial utilizing an effectiveness-implementation hybrid design (type 1) to study the clinical effectiveness and implementation of TEACH administered by integrated trained mental health champions. Seven participating sites across the US and Canada will train integrated mental health champions on the rheumatology team to deliver an empirically supported coping skills program, TEACH, to youth with cSLE. Our multidisciplinary research team consists of rheumatologists, behavioral scientists, and consumer advocates representing several national lupus organizations. Impact: Integrated mental health champions will provide evidence-based strategies to improve psychologicaland disease-related outcomes in youth with cSLE. Our vision is to transform care and improve patient QOL.

• Depressive symptoms, as measured by the Children's Depression Inventory-2 (CDI-2) and Beck Depression Inventory-II (BDI-II) [Срок оценки: 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) [Срок оценки: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)]
• Fatigue, as measured by the PROMIS Fatigue SF [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)]
• Cognitive functioning, as measured by the PROMIS Cognitive Function Short Form for Adults and the PROMIS Cognitive Function Short Form for Pediatrics [Срок оценки: 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 [Срок оценки: 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) Rheumatology Core [Срок оценки: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)]
• Medication adherence, as measured by the Medication Adherence Self-Report Inventory (MASRI) [Срок оценки: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)]
• Disease activity, as measured by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI 2K) [Срок оценки: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)]
• Disease activity, as measured by the Systemic Lupus International Collaborating Clinics/ACR Damage Index for Systemic Lupus Erythematosus (SLICC) [Срок оценки: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)]