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Transforming Care for Individuals With Childhood-onset Systemic Lupus Erythematosus

RECRUITINGN/ASponsored by Michigan State University
Actively Recruiting
PhaseN/A
SponsorMichigan State University
Started2024-09-12
Est. completion2027-04-01
Eligibility
Age12 Years – 22 Years
Healthy vol.Accepted
Locations6 sites

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.

Eligibility

Age: 12 Years – 22 YearsHealthy volunteers 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)

Conditions3

DepressionLupusSystemic Lupus Erythematosus of Childhood (Disorder)

Locations6 sites

University of Alabama Birmingham Hospital
Birmingham, Alabama, 35233
Livie Timmerman205-638-9483lhuie@uabmc.edu
Children's Hospital of New Orleans/ Tulane University
New Orleans, Louisiana, 70118
Wyvonnia Walker504-896-9685wwalker6@tulane.edu
Helen Devos Children's Hospital
Grand Rapids, Michigan, 49503
Jocelyn S Zuckerman9785051866zucker32@msu.edu
Montefiore Medical Center
The Bronx, New York, 10467
Sheza Suleman718-696-2604sheza.suleman@einsteinmed.edu
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Jainish Patel513-636-7467jainish.patel@cchmc.org

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