NCT06232304Recruiting
Transforming Care for Individuals With Childhood-onset Systemic Lupus Erythematosus
Transforming Behavioral Healthcare to Improve the Quality of Life for Individuals With Childhood-onset Lupus
Source: ClinicalTrials.gov · Last updated 30 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 175 (estimated)
- First submitted
- 22 Jan 2024
- Start date
- 12 Sept 2024
- Primary completion date
- 1 Apr 2027
- Lead sponsor
- Michigan State University
- Diseases
- Lupus (SLE)
- NCT number
- NCT06232304
What you commit to
- Study type: Interventional
- Planned participants: 175
- From 12 Sept 2024 to the primary completion date, 1 Apr 2027
- 7 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Who the study is looking for
- 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
Age in the registry: 12 years to 22 years · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Hospital for Sick Children Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| University of Alabama Birmingham Hospital Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| Helen DeVos Children's Hospital Coordinator of this site? Confirm its status | Grand Rapids | United States | Recruiting |
| Children's Hospital of New Orleans/ Tulane University Coordinator of this site? Confirm its status | New Orleans | United States | Recruiting |
| Seattle Children's Hospital Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| Montefiore Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.