Transforming Care for Individuals With Childhood-onset Systemic Lupus Erythematosus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-22
SponsorMichigan State University
About this trial
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
Qualifiers
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)
Disqualifiers
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)
Trial design
Treatments tested in this trial
- TEACH
Treatment groups
175 Participants
are divided into 2 treatment groupsSponsors and collaborators
Michigan State University
Lead sponsor
United States Department of Defense
Collaborator
The Hospital for Sick Children
Collaborator
Seattle Children's Hospital
Collaborator
Children's Hospital Medical Center, Cincinnati
Collaborator
Tulane University
Collaborator
University of Alabama at Birmingham
Collaborator
Helen DeVos Children's Hospital
Collaborator
Montefiore Medical Center
Collaborator
Source ClinicalTrials.gov