Transforming Care for Individuals With Childhood-onset Systemic Lupus Erythematosus
Recruiting · NCT06232304 · Interventional (participants receive a specific treatment) · Lead sponsor: Michigan State University
View the official record on ClinicalTrials.gov →Interventions studied
TEACH
What this trial is about
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.
Who can take part
Age range
12 Years to 22 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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)
Where it is running
7 locations listed across 6 US states.
- University of Alabama Birmingham Hospital - Birmingham, Alabama, United States
- Children's Hospital of New Orleans/ Tulane University - New Orleans, Louisiana, United States
- Helen Devos Children's Hospital - Grand Rapids, Michigan, United States
- Montefiore Medical Center - The Bronx, New York, United States
- Cincinnati Children's Hospital Medical Center - Cincinnati, Ohio, United States
- Seattle Children's Hospital - Seattle, Washington, United States
- The Hospital for Sick Children - Toronto, Ontario, Canada