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Transforming Care for Individuals With Childhood-onset Systemic Lupus Erythematosus

Recruiting

Transforming Behavioral Healthcare to Improve the Quality of Life for Individuals With Childhood-onset Lupus

Who can join

Ages 12 to 22 · All sexes

Full 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 (≥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)

About the study

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.

What is being tested

Sponsor: Michigan State University · Participants: 175 · Started: Sep 12, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06232304

Locations in the U.S.

AlabamaUniversity of Alabama Birmingham Hospital, Birmingham
LouisianaChildren's Hospital of New Orleans/ Tulane University, New Orleans
MichiganHelen Devos Children's Hospital, Grand Rapids
New YorkMontefiore Medical Center, The Bronx
OhioCincinnati Children's Hospital Medical Center, Cincinnati
WashingtonSeattle Children's Hospital, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.