Recruiting

Observational Study

Sponsor:

Michigan State University

Code:

NCT06232304

Conditions

Systemic Lupus Erythematosus of Childhood (Disorder)

Eligibility Criteria

Sex: All

Age: 12 - 22

Healthy Volunteers: Not accepted

Interventions

TEACH

Study Details

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)

Study ID

NCT06232304

Start date

Sep 12, 2024

Status verified date

Oct, 2025

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 22

Healthy Volunteers: Not accepted

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 (≥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 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 (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)

Study Design

Enrollment

175 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TEACH

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

no intervention: Control

Participants will only continue medical treatment as usual.

Interventions

TEACH

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

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) ]
  • 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 short form (secondary) [ 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) ]
  • 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) ]

Central Contacts and Locations

Central contacts

Jocelyn S Zuckerman, BA

9785051866zucker32@msu.edu

Natoshia R Cunningham, PhD

845-662-6198natoshia@msu.edu

Locations

University of Alabama Birmingham Hospital

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Livie Timmerman

205-638-9483lhuie@uabmc.edu

Principal Investigator:

Dr. Emily Smitherman

Children's Hospital of New Orleans/ Tulane University

Recruiting

New Orleans, Louisiana, United States, 70118

Contacts

Wyvonnia Walker

504-896-9685wwalker6@tulane.edu

Principal Investigator:

Dr. Anita Dhanrajani

Helen Devos Children's Hospital

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Jocelyn S Zuckerman

9785051866zucker32@msu.edu

Principal Investigator:

Dr. Kessler

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Contacts

Sheza Suleman

718-696-2604sheza.suleman@einsteinmed.edu

Principal Investigator:

Dr. Tamar Rubinstein

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Jainish Patel

513-636-7467jainish.patel@cchmc.org

Principal Investigator:

Dr. Ekemini Ogbu

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Alber Hsu

2069872057Albert.Hsu@seattlechildrens.org

Principal Investigator:

Dr. Rosenwasser

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, ON M5G 1E8

Contacts

Asha Asha Jeyanathan

416-813-7654asha.jeyanathan@sickkids.ca

Principal Investigator:

Dr. Andrea Knight

More Information

Sponsor

Michigan State University

Last update posted

Oct 30, 2025

Last verified

Oct, 2025

Keywords

  • lupus
  • depression
  • depressive symptoms
  • fatigue
  • pain
  • SLE
  • rheumatic disease
  • rheumatology
  • cognitive behavioral
  • Childhood-onset Systemic Lupus Erythematosus
  • cSLE
  • Implementation
  • Coping skills
  • Mindfulness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Michigan State University on 2025-10-30.