Clinical trial NCT06232304: Transforming Care for Individuals With Childhood-onset Systemic Lupus Erythematosus
Official title: Transforming Behavioral Healthcare to Improve the Quality of Life for Individuals With Childhood-onset Lupus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Systemic Lupus Erythematosus of Childhood (Disorder)
Keywords: lupus
depression
depressive symptoms
fatigue
pain
SLE
rheumatic disease
rheumatology
cognitive behavioral
Childhood-onset Systemic Lupus Erythematosus
cSLE
Implementation
Coping skills
Mindfulness
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: The Hospital for Sick Children
name: Seattle Children's Hospital
name: Children's Hospital Medical Center, Cincinnati
name: Tulane University
name: University of Alabama at Birmingham
name: Helen DeVos Children's Hospital
name: Montefiore Medical Center
First posted: 2024-01-30
Enrollment: 196
Sex: ALL
Minimum age (years): 12
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization occurs at the site level. Participants enrolled will either receive TEACH, a coping skills program, or medical treatment as usual.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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 (i.e., ≥10 on the PHQ-9), 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 (score ≥20) or active suicidal ideation (SI), based on the Pediatric Health Questionnaire (PHQ-9) items plus clinical interview; see Measures section)

Primary outcomes:
measure: Depressive symptoms, as measured by the Children's Depression Inventory-2 (CDI-2) and Beck Depression Inventory-II (BDI-II) (primary)
timeFrame: T1 (baseline), T2 (8 weeks)
measure: Depressive symptoms, as measured by the Patient Health Questionnaire - 9 (PHQ-9) (primary)
timeFrame: T1 (baseline), T2 (8 weeks)
measure: Fatigue, as measured by the PROMIS Fatigue short form (secondary)
timeFrame: T1 (baseline), T2 (8 weeks)
measure: Pain, as measured by the Pain Visual Analog Scale (VAS)
timeFrame: T1 (baseline), T2 (8 weeks)
measure: Pain, as measured by PROMIS Pain Interference Short Form
timeFrame: T1 (baseline), T2 (8 weeks)
measure: Psychological stress, as measured by the PROMIS psychological stress experience measure
timeFrame: T1 (baseline), T2 (8 weeks)
measure: Cognitive functioning, as measured by the PROMIS Cognitive Function Short Form for Adults and the PROMIS Cognitive Function Short Form for Pediatrics
timeFrame: T1 (baseline), T2 (8 weeks)
measure: Quality of life, as measured by the Pediatric Quality of Life (PedsQL) Generic Core
timeFrame: T1 (baseline), T2 (8 weeks)
measure: Quality of life, as measured by the Pediatric Quality of Life (PedsQL) Rheumatology Core
timeFrame: T1 (baseline), T2 (8 weeks)
measure: Medication adherence, as measured by the Medication Adherence Self-Report Inventory (MASRI)
timeFrame: T1 (baseline), T2 (8 weeks)
measure: Disease activity, as measured by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI 2K)
timeFrame: T1 (baseline), T2 (8 weeks)
measure: Disease activity, as measured by the Systemic Lupus International Collaborating Clinics/ACR Damage Index for Systemic Lupus Erythematosus (SLICC)
timeFrame: T1 (baseline), T2 (8 weeks)
measure: Disease activity, as measured by the Lupus Low Disease Activity State (LLDAS)
timeFrame: T1 (baseline), T2 (8 weeks)
measure: Disease manifestations
timeFrame: T1 (baseline), T2 (8 weeks)
measure: Anxiety, as measured by the Screen for Child Anxiety Related Disorders (SCARED) and Screen for Adult Anxiety Related Disorders (SCAARED)
timeFrame: T1 (baseline), T2 (8 weeks)
Secondary outcomes:
measure: Depressive symptoms, as measured by the Children's Depression Inventory-2 (CDI-2) and Beck Depression Inventory-II (BDI-II)
timeFrame: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
measure: Depressive symptoms, as measured by the Patient Health Questionnaire - 9 (PHQ-9) (primary)
timeFrame: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
measure: Fatigue, as measured by the PROMIS Fatigue SF
timeFrame: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
measure: Pain, as measured by the Pain Visual Analog Scale (VAS)
timeFrame: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
measure: Pain, as measured by PROMIS Pain Interference Short Form
timeFrame: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
measure: Psychological stress, as measured by the PROMIS psychological stress experience measure
timeFrame: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
measure: Cognitive functioning, as measured by the PROMIS Cognitive Function Short Form for Adults and the PROMIS Cognitive Function Short Form for Pediatrics
timeFrame: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
measure: Quality of life, as measured by the Pediatric Quality of Life (PedsQL) Generic Core
timeFrame: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
measure: Quality of life, as measured by the Pediatric Quality of Life (PedsQL) Rheumatology Core
timeFrame: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
measure: Medication adherence, as measured by the Medication Adherence Self-Report Inventory (MASRI)
timeFrame: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
measure: Disease activity, as measured by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI 2K)
timeFrame: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
measure: Disease activity, as measured by the Systemic Lupus International Collaborating Clinics/ACR Damage Index for Systemic Lupus Erythematosus (SLICC)
timeFrame: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
measure: Disease activity, as measured by the Lupus Low Disease Activity State (LLDAS)
timeFrame: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
measure: Disease manifestations
timeFrame: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
measure: Anxiety, as measured by the Screen for Child Anxiety Related Disorders (SCARED) and Screen for Adult Anxiety Related Disorders (SCAARED)
timeFrame: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
Other outcomes:
measure: Reach
timeFrame: April, 2023 to October, 2027
measure: Adoption
timeFrame: April, 2023 to October, 2027
measure: Fidelity
timeFrame: April, 2023 to October, 2027
measure: Feasibility, acceptability, and appropriateness
timeFrame: April, 2023 to October, 2027
measure: Provider knowledge
timeFrame: April, 2023 to October, 2027
measure: Implementation success
timeFrame: April, 2023 to October, 2027
measure: Implementation success
timeFrame: April, 2023 to October, 2027
measure: Maintenance
timeFrame: April, 2023 to October, 2027
measure: Adverse Childhood Events (ACEs)
timeFrame: Through study completion, up to 56 weeks
measure: Area Deprivation Index (ADI)
timeFrame: Baseline (T1)
measure: Canadian Index of Multiple Deprivation (CIMD)
timeFrame: Baseline (T1)
measure: Pubertal Development Scale
timeFrame: Baseline (T1)
measure: COVID-19 Diagnosis
timeFrame: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
measure: Depression Anxiety and Stress Scales 21 (DASS21) (caregiver)
timeFrame: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
measure: Concomitant medications
timeFrame: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
measure: Concomitant treatment
timeFrame: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
measure: Demographic information of participants
timeFrame: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
measure: Demographic information of mental health champions
timeFrame: T1 (baseline)
measure: Adverse events
timeFrame: Throughout the duration of the study.
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham Hospital
state: Alabama
city: New Orleans
country: United States
facility: Children's Hospital of New Orleans/ Tulane University
state: Louisiana
city: Grand Rapids
country: United States
facility: Helen Devos Children's Hospital
state: Michigan
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: Michigan State University
name: Natoshia R Cunningham, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Hospital for Sick Children
name: Andrea Knight, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: