Transforming Care for Individuals With Childhood-onset Systemic Lupus Erythematosus

NCT06232304 | Recruiting

• 1 other identifier: STUDY00009194
• Study Type: interventional
• Target: 175
• Locations: 2 countries
• Sites: 7

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.

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

Outcome Measures

Primary Outcomes (15)

• 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.

  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.

  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.

  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.

  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).

  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.

  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.

  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.

  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.

  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.

  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.

  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

  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.

  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.

  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).

  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)

  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)

  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

  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)

  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

  T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)

Other Outcomes (19)

• Reach

  April, 2023 to October, 2027

• Adoption

  April, 2023 to October, 2027

• Fidelity

  April, 2023 to October, 2027

Study Arms (2)

TEACH

EXPERIMENTAL

Participants will undergo a cognitive behavioral coping skills program and continue medical treatment as usual.

Behavioral: TEACH

Control

NO INTERVENTION

Participants will only continue medical treatment as usual.

Interventions

TEACH BEHAVIORAL

TEACH is a cognitive behavioral coping skills program. It consists of six one-hour weekly sessions that are conducted either in-person or remotely.

Also known as: Treatment and Education Approach for Childhood-onset Lupus

TEACH

Eligibility Criteria

• Age: 12 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \) be diagnosed with cSLE, meeting the revised American College of Rheumatology Classification Criteria for SLE by age 18 years
• \) be between the ages of 12 and 22 years
• \) 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)
• \) have English language proficiency (their primary caregiver can have English or Spanish language proficiency for the child to enroll)
• \) those under age 18 years (US), or 16 years (Canada) must have a consenting caregiver

You may not qualify if:

• \) 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 (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)

Sponsors & Collaborators

• Michigan State University: lead
• United States Department of Defense: collaborator
• The Hospital for Sick Children: collaborator
• Seattle Children's Hospital: collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator
• Tulane University: collaborator
• University of Alabama at Birmingham: collaborator
• Helen DeVos Children's Hospital: collaborator
• Montefiore Medical Center: collaborator

Study Sites (7)

University of Alabama Birmingham Hospital

Birmingham, Alabama, 35233, United States

RECRUITING

Children's Hospital of New Orleans/ Tulane University

New Orleans, Louisiana, 70118, United States

RECRUITING

Helen Devos Children's Hospital

Grand Rapids, Michigan, 49503, United States

RECRUITING

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

Seattle Children's Hospital

Seattle, Washington, 98105, United States

RECRUITING

The Hospital for Sick Children

Toronto, Ontario, ON M5G 1E8, Canada

RECRUITING

MeSH Terms

Conditions

Depression; Fatigue; Pain; Rheumatic Diseases

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Natoshia R Cunningham, PhD

  Michigan State University

  PRINCIPAL INVESTIGATOR

• Andrea Knight, MD, MSCE

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jocelyn S Zuckerman, BA

CONTACT

9785051866; zucker32@msu.edu

Natoshia R Cunningham, PhD

CONTACT

845-662-6198; natoshia@msu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be masked to who received TEACH and who did not.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomization occurs at the site level. Participants enrolled will either receive TEACH, a coping skills program, or medical treatment as usual.

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: January 30, 2024
• Study Start: September 12, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: October 30, 2025

Record last verified: 2025-10

Locations

US (6); CA (1)