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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
View on ClinicalTrials.gov →
NCT06232304
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
Children's Hospital of New Orleans/ Tulane University
New Orleans, Louisiana, 70118
Helen Devos Children's Hospital
Grand Rapids, Michigan, 49503
Montefiore Medical Center
The Bronx, New York, 10467
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
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Actively Recruiting
PhaseN/A
SponsorMichigan State University
Started2024-09-12
Est. completion2027-04-01
Eligibility
Age12 Years – 22 Years
Healthy vol.Accepted
Locations6 sites
View on ClinicalTrials.gov →
NCT06232304