Cognitive behavioral program for youth with childhood-onset lupus
Transforming Behavioral Healthcare to Improve the Quality of Life for Individuals With Childhood-onset Lupus
NA · Michigan State University · NCT06232304
This study is testing a new program that teaches coping skills to help young people with childhood-onset lupus manage their pain, fatigue, and feelings of depression.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 175 (estimated) |
| Ages | 12 Years to 22 Years |
| Sex | All |
| Sponsor | Michigan State University (other) |
| Locations | 7 sites (Birmingham, Alabama and 6 other locations) |
| Trial ID | NCT06232304 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are youth aged 12 to 22 years diagnosed with cSLE who experience fatigue, depressive symptoms, or pain.
Not a fit: Patients with other chronic medical conditions, severe cognitive impairments, or untreated major psychiatric illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the mental health and overall quality of life for patients with childhood-onset lupus.
How similar studies have performed: Other studies have shown promise with similar cognitive behavioral approaches for managing chronic conditions, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Birmingham, Alabama and 6 other locations
- 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)
- The Hospital for Sick Children — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Natoshia R Cunningham, PhD — Michigan State University
- Study coordinator: Jocelyn S Zuckerman, BA
- Email: zucker32@msu.edu
- Phone: 9785051866
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Systemic Lupus Erythematosus of Childhood, lupus, depression, depressive symptoms, fatigue, pain, SLE, rheumatic disease