NCT06232304 Transforming Care for Individuals With Childhood-onset Systemic Lupus Erythematosus
| NCT ID | NCT06232304 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Michigan State University |
| Condition | Systemic Lupus Erythematosus of Childhood (Disorder) |
| Study Type | INTERVENTIONAL |
| Enrollment | 175 participants |
| Start Date | 2024-09-12 |
| Primary Completion | 2027-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 175 participants in total. It began in 2024-09-12 with a primary completion date of 2027-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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)
Contact & Investigator
Natoshia R Cunningham, PhD
PRINCIPAL INVESTIGATOR
Michigan State University
Frequently Asked Questions
Who can join the NCT06232304 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 22 Years, studying Systemic Lupus Erythematosus of Childhood (Disorder). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06232304 currently recruiting?
Yes, NCT06232304 is actively recruiting participants. Contact the research team at zucker32@msu.edu for enrollment information.
Where is the NCT06232304 trial being conducted?
This trial is being conducted at Birmingham, United States, New Orleans, United States, Grand Rapids, United States, The Bronx, United States and 3 additional locations.
Who is sponsoring the NCT06232304 clinical trial?
NCT06232304 is sponsored by Michigan State University. The principal investigator is Natoshia R Cunningham, PhD at Michigan State University. The trial plans to enroll 175 participants.
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