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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

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Hospital for Sick Children
Coordinator of this site? Confirm its status
TorontoCanadaRecruiting
University of Alabama Birmingham Hospital
Coordinator of this site? Confirm its status
BirminghamUnited StatesRecruiting
Cincinnati Children's Hospital Medical Center
Coordinator of this site? Confirm its status
CincinnatiUnited StatesRecruiting
Helen DeVos Children's Hospital
Coordinator of this site? Confirm its status
Grand RapidsUnited StatesRecruiting
Children's Hospital of New Orleans/ Tulane University
Coordinator of this site? Confirm its status
New OrleansUnited StatesRecruiting
Seattle Children's Hospital
Coordinator of this site? Confirm its status
SeattleUnited StatesRecruiting
Montefiore Medical Center
Coordinator of this site? Confirm its status
The BronxUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.