Cognitive behavioral program for youth with childhood-onset lupus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the feasibility and effectiveness of the Treatment and Education Approach for Childhood-onset Lupus (TEACH) program, which integrates cognitive behavioral coping skills into medical care for youth diagnosed with childhood-onset systemic lupus erythematosus (cSLE). The TEACH program aims to help participants manage fatigue, pain, and depressive symptoms through a tailored 6-session intervention delivered either in person or remotely. The study builds on preliminary findings from a multi-site randomized controlled trial that suggests TEACH can improve psychological and functional outcomes for these patients. By incorporating this program into existing rheumatology care, the study seeks to enhance the quality of life for adolescents and young adults affected by cSLE.

Why it matters

Who can join: the full rules

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's running

• University of Alabama Birmingham Hospital
  Birmingham, Alabama, United States Recruiting
• Children's Hospital of New Orleans/ Tulane University
  New Orleans, Louisiana, United States Recruiting
• Helen Devos Children's Hospital
  Grand Rapids, Michigan, United States Recruiting
• Montefiore Medical Center
  The Bronx, New York, United States Recruiting
• Cincinnati Children's Hospital Medical Center
  Cincinnati, Ohio, United States Recruiting
• Seattle Children's Hospital
  Seattle, Washington, United States Recruiting

Study contacts

• Principal investigator: Natoshia R Cunningham, PhD — Michigan State University
• Study coordinator: Jocelyn S Zuckerman, BA
• Email: zucker32@msu.edu
• Phone: 9785051866

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.