Systemic Lupus Erythematosus of Childhood (Disorder)cSLENCT06232304
Transforming Care for Individuals With Childhood-onset Systemic Lupus Erythematosus
A study testing TEACH in people with Systemic Lupus Erythematosus of Childhood (Disorder), run by Michigan State University at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 22 years
- Conditions the study is for
- Systemic Lupus Erythematosus of Childhood (Disorder)
- What is being tested?
- TEACH
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 12 Sep 2024to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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 (≥5 on the PHQ-9, T Score ≥ 60 on the BDI or CDI II ), 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
Who cannot join
- 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 (PHQ9 score ≥21, BDI/CDI II > 90) or active suicidal ideation (SI), based on the Pediatric Health Questionnaire (PHQ-9) items plus clinical interview; see Measures section)
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 2 countries
United States6 sites, 6 recruiting
- Recruiting
University of Alabama Birmingham Hospital
Birmingham, Alabama, 35233
Livie Timmerman, 205-638-9483, lhuie@uabmc.edu
Dr. Emily Smitherman
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Jainish Patel, 513-636-7467, jainish.patel@cchmc.org
Dr. Ekemini Ogbu
- Recruiting
Helen Devos Children's Hospital
Grand Rapids, Michigan, 49503
Jocelyn S Zuckerman, 9785051866, zucker32@msu.edu
Dr. Kessler
- Recruiting
Children's Hospital of New Orleans/ Tulane University
New Orleans, Louisiana, 70118
Wyvonnia Walker, 504-896-9685, wwalker6@tulane.edu
Dr. Anita Dhanrajani
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Alber Hsu, 2069872057, Albert.Hsu@seattlechildrens.org
Dr. Rosenwasser
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10467
Sheza Suleman, 718-696-2604, sheza.suleman@einsteinmed.edu
Dr. Tamar Rubinstein
Canada1 site, 1 recruiting
- Recruiting
The Hospital for Sick Children
Toronto, Ontario, ON M5G 1E8
Asha Asha Jeyanathan, 416-813-7654 ext. 415284, asha.jeyanathan@sickkids.ca
Dr. Andrea Knight
About this study
Official title: Transforming Behavioral Healthcare to Improve the Quality of Life for Individuals With Childhood-onset Lupus
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.
Read the 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.
- Being tested
- TEACH
- Keywords
- lupus, depression, depressive symptoms, fatigue, pain, SLE, rheumatic disease, rheumatology, cognitive behavioral, Childhood-onset Systemic Lupus Erythematosus, cSLE, Implementation, Coping skills, Mindfulness
- Medical subject headings
- Depression, Fatigue, Pain, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEACHBehavioural
Also called Treatment and Education Approach for Childhood-onset Lupus
TEACH is a cognitive behavioral coping skills program. It consists of six one-hour weekly sessions that are conducted either in-person or remotely.
| Study group | Role | What they receive |
|---|---|---|
| TEACH | Experimental | Participants will undergo a cognitive behavioral coping skills program and continue medical treatment as usual. Receives: Behavioral: TEACH |
| Control | No intervention | Participants will only continue medical treatment as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms, as measured by the Children's Depression Inventory-2 (CDI-2) and Beck Depression Inventory-II (BDI-II) (primary)
The CDI-2 measures depressive symptoms on a scale of 0-54, with 0 indicating low levels of depressive symptoms, and 54 indicating high levels of depressive symptoms. The BDI-II measures depressive symptoms on a scale of 0 to 63, with 0 indicating low levels of depressive symptoms and 63 indicating high levels of depressive symptoms.
Measured: 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)
The PHQ-9 measures depressive symptoms on a scale of 1-27, with 1 indicating low levels of depressive symptoms, and 27 indicating high levels of depressive symptoms.
Measured: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
Fatigue, as measured by the PROMIS Fatigue short form (secondary)
The adult PROMIS Fatigue SF measures fatigue one a scale of 10-40; 10 indicating no fatigue, 40 indicating high levels of fatigue. The pediatric PROMIS Fatigue SF measures on a scale of 0-40; 0 indicating no fatigue and 40 indicating high levels of fatigue.
Measured: 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)
The Pain VAS measures three items on a scale of 0-10, with 0 indicating no pain and 10 indicating the worst possible pain.
Measured: 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
Interference due to pain symptoms over the past week will be collected from youth (0-32, where 0 indicates low levels of pain interference and 32 is the maximum score for pain interference) and adults (8-40, where 8 indicates low levels of pain interference and 40 is the maximum score for pain interference).
Measured: 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
PROMIS psychological stress experience measure is validated for pediatrics and adults. Scores range from 0-95 where 0 indicates no psychological stress and 95 is the maximum score for psychological stress.
Measured: T1 (baseline), T2 (8 weeks)
Cognitive functioning, as measured by the PROMIS Cognitive Function Short Form for Adults and the PROMIS Cognitive Function Short Form for Pediatrics
PROMIS Cognitive Function Adult form scores range from 8-40, where 8 indicates never having cognitive dysfunction, and 40 indicates very often having cognitive dysfunction. PROMIS Cognitive Function Pediatric form scores range from 7-35, where 7 indicates never having cognitive dysfunction, and 35 indicates having cognitive dysfunction all of the time.
Measured: 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
The PedsQL measures quality of life in several aspects such as health, school, daily activities. Each item is reversed scored and transformed to a linear scale of 0-100, such that 100 indicates a high quality of life and 0 indicates a low quality of life.
Measured: 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
The PedsQL measures quality of life in several aspects such as pain and hurt, daily activities, treatment, worry, and communication. Each item is reversed scored and transformed to a linear scale of 0-100, such that 100 indicates a high quality of life and 0 indicates a low quality of life.
Measured: 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)
The MASRI measures medication adherence on a scale of 0%-100%, such that lower scores indicate less adherence and higher scores indicate more adherence.
Measured: 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)
The SLEDAI 2K measures disease activity in SLE, and takes into consideration descriptors of the disease such as arthritis and vasculitis. Higher scores indicate more active disease/flares, and lower scores indicated less disease activity.
Measured: 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)
The SLICC measures disease activity by assessing descriptors in SLE. Higher scores indicate greater disease activity, lower scores indicate lesser disease activity
Measured: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
Disease activity, as measured by the Lupus Low Disease Activity State (LLDAS)
The LLDAS is a score from 0-5, where 0 indicates higher disease activity state and 5 indicates lower disease activity state. The LLDAS includes 5 components, each receiving either a 1 (true) or a 0 (false): 1. SLEDAI score less than or equal to 4, 2. no new lupus disease activity, 3. a SELENA-SLEDAI less than or equal to 1, 4. a maintained low prednisolone dose, and 5. well tolerated maintenance doses or immunosuppressive drugs and approved biological agents.
Measured: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
Disease manifestations
Disease manifestation will be assessed by use of the Systemic Lupus International Collaborating Clinics/ACR Damage Index for Systemic Lupus Erythematosus (SLICC) criteria checklist.
Measured: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
Anxiety, as measured by the Screen for Child Anxiety Related Disorders (SCARED) and Screen for Adult Anxiety Related Disorders (SCAARED)
The SCARED measures anxiety in children on a scale of 0 to 82, such that lower scores indicates low levels of anxiety, and high scores indicated high levels of anxiety. The SCAARED measures anxiety in adults on a scale of 0 to 88 such that lower scores indicated lower levels of anxiety and high scores indicate higher levels of anxiety. Both scales are comprised of sub-scales to measure types of anxiety (such as separation anxiety).
Measured: T1 (baseline), T2 (8 weeks)
Secondary outcomes (15)
Depressive symptoms, as measured by the Children's Depression Inventory-2 (CDI-2) and Beck Depression Inventory-II (BDI-II)
The CDI-2 measures depressive symptoms on a scale of 0-54, with 0 indicating low levels of depressive symptoms, and 54 indicating high levels of depressive symptoms. The BDI-II measures depressive symptoms on a scale of 0 to 63, with 0 indicating low levels of depressive symptoms and 63 indicating high levels of depressive symptoms.
Measured: 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)
The PHQ-9 measures depressive symptoms on a scale of 1-27, with 1 indicating low levels of depressive symptoms, and 27 indicating high levels of depressive symptoms.
Measured: 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
The adult PROMIS Fatigue SF measures fatigue one a scale of 10-40; 10 indicating no fatigue, 40 indicating high levels of fatigue. The pediatric PROMIS Fatigue SF measures on a scale of 0-40; 0 indicating no fatigue and 40 indicating high levels of fatigue.
Measured: 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)
The Pain VAS measures three items on a scale of 0-10, with 0 indicating no pain and 10 indicating the worst possible pain.
Measured: 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
Interference due to pain symptoms over the past week will be collected from youth (0-32, where 0 indicates low levels of pain interference and 32 is the maximum score for pain interference) and adults (8-40, where 8 indicates low levels of pain interference and 40 is the maximum score for pain interference).
Measured: 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
PROMIS psychological stress experience measure is validated for pediatrics and adults. Scores range from 0-95 where 0 indicates no psychological stress and 95 is the maximum score for psychological stress.
Measured: 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
PROMIS Cognitive Function Adult form scores range from 8-40, where 8 indicates never having cognitive dysfunction, and 40 indicates very often having cognitive dysfunction. PROMIS Cognitive Function Pediatric form scores range from 7-35, where 7 indicates never having cognitive dysfunction, and 35 indicates having cognitive dysfunction all of the time.
Measured: 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
The PedsQL measures quality of life in several aspects such as health, school, daily activities. Each item is reversed scored and transformed to a linear scale of 0-100, such that 100 indicates a high quality of life and 0 indicates a low quality of life.
Measured: 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
The PedsQL measures quality of life in several aspects such as pain and hurt, daily activities, treatment, worry, and communication. Each item is reversed scored and transformed to a linear scale of 0-100, such that 100 indicates a high quality of life and 0 indicates a low quality of life.
Measured: 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)
The MASRI measures medication adherence on a scale of 0%-100%, such that lower scores indicate less adherence and higher scores indicate more adherence.
Measured: 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)
The SLEDAI 2K measures disease activity in SLE, and takes into consideration descriptors of the disease such as arthritis and vasculitis. Higher scores indicate more active disease/flares, and lower scores indicated less disease activity.
Measured: 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)
The SLICC measures disease activity by assessing descriptors in SLE. Higher scores indicate greater disease activity, lower scores indicate lesser disease activity
Measured: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
Disease activity, as measured by the Lupus Low Disease Activity State (LLDAS)
The LLDAS is a score from 0-5, where 0 indicates higher disease activity state and 5 indicates lower disease activity state. The LLDAS includes 5 components, each receiving either a 1 (true) or a 0 (false): 1. SLEDAI score less than or equal to 4, 2. no new lupus disease activity, 3. a SELENA-SLEDAI less than or equal to 1, 4. a maintained low prednisolone dose, and 5. well tolerated maintenance doses or immunosuppressive drugs and approved biological agents.
Measured: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
Disease manifestations
Disease manifestation will be assessed by use of the Systemic Lupus International Collaborating Clinics/ACR Damage Index for Systemic Lupus Erythematosus (SLICC) criteria checklist.
Measured: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
Anxiety, as measured by the Screen for Child Anxiety Related Disorders (SCARED) and Screen for Adult Anxiety Related Disorders (SCAARED)
The SCARED measures anxiety in children on a scale of 0 to 82, such that lower scores indicates low levels of anxiety, and high scores indicated high levels of anxiety. The SCAARED measures anxiety in adults on a scale of 0 to 88 such that lower scores indicated lower levels of anxiety and high scores indicate higher levels of anxiety. Both scales are comprised of sub-scales to measure types of anxiety (such as separation anxiety).
Measured: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start12 Sep 2024
- Primary completion1 Apr 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus Erythematosus of Childhood (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization occurs at the site level. Participants enrolled will either receive TEACH, a coping skills program, or medical treatment as usual.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, The Hospital for Sick Children, Seattle Children's Hospital, Children's Hospital Medical Center, Cincinnati, Tulane University, University of Alabama at Birmingham, Helen DeVos Children's Hospital, Montefiore Medical Center
- Responsible party
- Principal investigator, Natoshia Cunningham, Michigan State University
- Investigators
- Natoshia R Cunningham, PhD, Principal investigator, Michigan State UniversityAndrea Knight, MD, MSCE, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06232304
- Sponsor's protocol ID
- STUDY00009194
- Acronym
- cSLE
- Status last verified
- Oct 2025
- First submitted
- 22 Jan 2024
- Last updated
- 30 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transforming Behavioral Healthcare to Improve the Quality of Life for Individuals With Childhood-onset Lupus
- ClinicalTrials.gov ID
- NCT06232304
- Acronym / sponsor ID
- cSLE / STUDY00009194
- Keywords
- lupus, depression, depressive symptoms, fatigue, pain, SLE, rheumatic disease, rheumatology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- United States Department of Defense, The Hospital for Sick Children, Seattle Children's Hospital, Children's Hospital Medical Center, Cincinnati, Tulane University, University of Alabama at Birmingham, Helen DeVos Children's Hospital, Montefiore Medical Center
- Study start
- 12 Sep 2024 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization occurs at the site level. Participants enrolled will either receive TEACH, a coping skills program, or medical treatment as usual.
| Arm | Type | Receives |
|---|---|---|
| TEACH | Experimental | Behavioral: TEACHParticipants will undergo a cognitive behavioral coping skills program and continue medical treatment as usual. |
| Control | No intervention | –Participants will only continue medical treatment as usual. |
Who may qualify
- Ages
- 12 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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 (≥5 on the PHQ-9, T Score ≥ 60 on the BDI or CDI II ), 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
Key exclusion criteria (3 listed)
- 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 (PHQ9 score ≥21, BDI/CDI II > 90) or active suicidal ideation (SI), based on the Pediatric Health Questionnaire (PHQ-9) items plus clinical interview; see Measures section)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEACHAlso: Treatment and Education Approach for Childhood-onset LupusTEACH is a cognitive behavioral coping skills program. It consists of six one-hour weekly sessions that are conducted either in-person or remotely. | Behavioural | TEACH |
Primary outcome
Depressive symptoms, as measured by the Children's Depression Inventory-2 (CDI-2) and Beck Depression Inventory-II (BDI-II) (primary)
Time frame: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
The CDI-2 measures depressive symptoms on a scale of 0-54, with 0 indicating low levels of depressive symptoms, and 54 indicating high levels of depressive symptoms. The BDI-II measures depressive symptoms on a scale of 0 to 63, with 0 indicating low levels of depressive symptoms and 63 indicating high levels of depressive symptoms.
Depressive symptoms, as measured by the Patient Health Questionnaire - 9 (PHQ-9) (primary)
Time frame: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
The PHQ-9 measures depressive symptoms on a scale of 1-27, with 1 indicating low levels of depressive symptoms, and 27 indicating high levels of depressive symptoms.
Fatigue, as measured by the PROMIS Fatigue short form (secondary)
Time frame: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
The adult PROMIS Fatigue SF measures fatigue one a scale of 10-40; 10 indicating no fatigue, 40 indicating high levels of fatigue. The pediatric PROMIS Fatigue SF measures on a scale of 0-40; 0 indicating no fatigue and 40 indicating high levels of fatigue.
Pain, as measured by the Pain Visual Analog Scale (VAS)
Time frame: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
The Pain VAS measures three items on a scale of 0-10, with 0 indicating no pain and 10 indicating the worst possible pain.
Pain, as measured by PROMIS Pain Interference Short Form
Time frame: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
Interference due to pain symptoms over the past week will be collected from youth (0-32, where 0 indicates low levels of pain interference and 32 is the maximum score for pain interference) and adults (8-40, where 8 indicates low levels of pain interference and 40 is the maximum score for pain interference).
Psychological stress, as measured by the PROMIS psychological stress experience measure
Time frame: T1 (baseline), T2 (8 weeks)
PROMIS psychological stress experience measure is validated for pediatrics and adults. Scores range from 0-95 where 0 indicates no psychological stress and 95 is the maximum score for psychological stress.
Cognitive functioning, as measured by the PROMIS Cognitive Function Short Form for Adults and the PROMIS Cognitive Function Short Form for Pediatrics
Time frame: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
PROMIS Cognitive Function Adult form scores range from 8-40, where 8 indicates never having cognitive dysfunction, and 40 indicates very often having cognitive dysfunction. PROMIS Cognitive Function Pediatric form scores range from 7-35, where 7 indicates never having cognitive dysfunction, and 35 indicates having cognitive dysfunction all of the time.
Quality of life, as measured by the Pediatric Quality of Life (PedsQL) Generic Core
Time frame: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
The PedsQL measures quality of life in several aspects such as health, school, daily activities. Each item is reversed scored and transformed to a linear scale of 0-100, such that 100 indicates a high quality of life and 0 indicates a low quality of life.
Quality of life, as measured by the Pediatric Quality of Life (PedsQL) Rheumatology Core
Time frame: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
The PedsQL measures quality of life in several aspects such as pain and hurt, daily activities, treatment, worry, and communication. Each item is reversed scored and transformed to a linear scale of 0-100, such that 100 indicates a high quality of life and 0 indicates a low quality of life.
Medication adherence, as measured by the Medication Adherence Self-Report Inventory (MASRI)
Time frame: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
The MASRI measures medication adherence on a scale of 0%-100%, such that lower scores indicate less adherence and higher scores indicate more adherence.
Disease activity, as measured by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI 2K)
Time frame: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
The SLEDAI 2K measures disease activity in SLE, and takes into consideration descriptors of the disease such as arthritis and vasculitis. Higher scores indicate more active disease/flares, and lower scores indicated less disease activity.
Disease activity, as measured by the Systemic Lupus International Collaborating Clinics/ACR Damage Index for Systemic Lupus Erythematosus (SLICC)
Time frame: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
The SLICC measures disease activity by assessing descriptors in SLE. Higher scores indicate greater disease activity, lower scores indicate lesser disease activity
Disease activity, as measured by the Lupus Low Disease Activity State (LLDAS)
Time frame: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
The LLDAS is a score from 0-5, where 0 indicates higher disease activity state and 5 indicates lower disease activity state. The LLDAS includes 5 components, each receiving either a 1 (true) or a 0 (false): 1. SLEDAI score less than or equal to 4, 2. no new lupus disease activity, 3. a SELENA-SLEDAI less than or equal to 1, 4. a maintained low prednisolone dose, and 5. well tolerated maintenance doses or immunosuppressive drugs and approved biological agents.
Disease manifestations
Time frame: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
Disease manifestation will be assessed by use of the Systemic Lupus International Collaborating Clinics/ACR Damage Index for Systemic Lupus Erythematosus (SLICC) criteria checklist.
Anxiety, as measured by the Screen for Child Anxiety Related Disorders (SCARED) and Screen for Adult Anxiety Related Disorders (SCAARED)
Time frame: T1 (baseline), T2 (8 weeks)
The SCARED measures anxiety in children on a scale of 0 to 82, such that lower scores indicates low levels of anxiety, and high scores indicated high levels of anxiety. The SCAARED measures anxiety in adults on a scale of 0 to 88 such that lower scores indicated lower levels of anxiety and high scores indicate higher levels of anxiety. Both scales are comprised of sub-scales to measure types of anxiety (such as separation anxiety).
15 secondary outcomes
Depressive symptoms, as measured by the Children's Depression Inventory-2 (CDI-2) and Beck Depression Inventory-II (BDI-II)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
Disease activity, as measured by the Lupus Low Disease Activity State (LLDAS)
Time frame: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
Disease manifestations
Time frame: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
Anxiety, as measured by the Screen for Child Anxiety Related Disorders (SCARED) and Screen for Adult Anxiety Related Disorders (SCAARED)
Time frame: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Natoshia R Cunningham, PhD principal investigator
Michigan State University
Andrea Knight, MD, MSCE principal investigator
The Hospital for Sick Children
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEACH in people with Systemic Lupus Erythematosus of Childhood (Disorder), run by Michigan State University at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jocelyn S Zuckerman, BA (9785051866, zucker32@msu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptoms, as measured by the Children's Depression Inventory-2 (CDI-2) and Beck Depression Inventory-II (BDI-II) (primary) (time frame: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2025.