Exploring Biological Mechanisms Underlying the TEACH Intervention for Adolescents With Lupus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Concentration of serum brain-injury biomarkers and inflammatory cytokines
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 ≥
- •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).
结局指标
主要结局
Concentration of serum brain-injury biomarkers and inflammatory cytokines
时间窗: From baseline (start of TEACH) to the end of treatment at 8 weeks.
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.
Change in brain neural function and tissue susceptibility
时间窗: From baseline (start of TEACH) to the end of intervention at 8 weeks
Will look at changes in neuroimaging-derived measures of brain activity/connectivity (fMRI and OPM-MEG) and quantitative magnetic susceptibility (QSM)
Depression symptom severity using CDI/BDI questionnaire
时间窗: Through study completion, an average of 1 year
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.
次要结局
- 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)
研究者
Andrea Knight
Clinical Investigator
The Hospital for Sick Children