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TEACH Program for Childhood-onset Systemic Lupus Erythematosus

This study is exploring a program called TEACH (Treatment and Education Approach for Childhood-onset Lupus) for young people aged 12 to 22 with childhood-onset systemic lupus erythematosus (cSLE), a chronic autoimmune disease. TEACH is a six-session program that teaches coping skills to help with common symptoms like fatigue, pain, and depressive symptoms. Researchers want to see if TEACH can effectively reduce depressive symptoms and fatigue when offered as part of regular medical care. The study aims to enroll 175 participants, but its current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 175 participants. It is not specified if it is randomized or blinded.
What's involved
Participants will take part in six one-hour weekly sessions of the TEACH program, which can be in-person or remote. They will also complete questionnaires at baseline, 8 weeks, 20 weeks, 32 weeks, 44 weeks, and 56 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 56 weeks after the start of the study, with assessments at various time points.

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NCT06232304

Transforming Care for Individuals With Childhood-onset Systemic Lupus Erythematosus

Recruiting
NAAges 12–22InterventionalTreatment
Michigan State University
~175 participants
Updated 2025-10-30 on ClinicalTrials.gov
What's tested:TEACH

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Depressive symptoms, as measured by the Children's Depression Inventory-2 (CDI-2) and Beck Depression Inventory-II (BDI-II) (primary)
Measured over T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)
+14 more outcomes measured

Conditions

Systemic Lupus Erythematosus of Childhood (Disorder)

Explore related trials

Systemic Lupus Erythematosus

Where it's being run

7 sites across 7 states
Alabama1
Louisiana1
Michigan1
New York1
Ohio1
Washington1
Ontario1

Study leadership

  • Natoshia R Cunningham, PhD · PRINCIPAL_INVESTIGATOR · Michigan State University
  • Andrea Knight, MD, MSCE · PRINCIPAL_INVESTIGATOR · The Hospital for Sick Children

Who to contact

Jocelyn S Zuckerman, BA
[email protected]
9785051866
Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

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)

What this trial measures

  • Depressive symptoms, as measured by the Children's Depression Inventory-2 (CDI-2) and Beck Depression Inventory-II (BDI-II) (primary)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)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)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)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 FormT1 (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 measureT1 (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 PediatricsT1 (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 CoreT1 (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 CoreT1 (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)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)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)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)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 manifestationsT1 (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)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).