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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
TEACH
BehavioralTEACH is a cognitive behavioral coping skills program. It consists of six one-hour weekly sessions that are conducted either in-person or remotely.
Treatment groups
175 Participants
are divided into 2 treatment groupsGroup A: TEACHExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Depressive symptoms, as measured by the Children's Depression Inventory-2 (CDI-2) and Beck Depression Inventory-II (BDI-II) (primary)
The CDI-2 measures depressive symptoms on a scale of 0-54, with 0 indicating low levels of depressive symptoms, and 54 indicating high levels of depressive symptoms. The BDI-II measures depressive symptoms on a scale of 0 to 63, with 0 indicating low levels of depressive symptoms and 63 indicating high levels of depressive symptoms.
Time frame
T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)2
Depressive symptoms, as measured by the Patient Health Questionnaire - 9 (PHQ-9) (primary)
The PHQ-9 measures depressive symptoms on a scale of 1-27, with 1 indicating low levels of depressive symptoms, and 27 indicating high levels of depressive symptoms.
Time frame
T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)3
Fatigue, as measured by the PROMIS Fatigue short form (secondary)
The adult PROMIS Fatigue SF measures fatigue one a scale of 10-40; 10 indicating no fatigue, 40 indicating high levels of fatigue. The pediatric PROMIS Fatigue SF measures on a scale of 0-40; 0 indicating no fatigue and 40 indicating high levels of fatigue.
Time frame
T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)4
Pain, as measured by the Pain Visual Analog Scale (VAS)
The Pain VAS measures three items on a scale of 0-10, with 0 indicating no pain and 10 indicating the worst possible pain.
Time frame
T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)Secondary outcomes
1
Depressive symptoms, as measured by the Children's Depression Inventory-2 (CDI-2) and Beck Depression Inventory-II (BDI-II)
The CDI-2 measures depressive symptoms on a scale of 0-54, with 0 indicating low levels of depressive symptoms, and 54 indicating high levels of depressive symptoms. The BDI-II measures depressive symptoms on a scale of 0 to 63, with 0 indicating low levels of depressive symptoms and 63 indicating high levels of depressive symptoms.
Time frame
T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)2
Depressive symptoms, as measured by the Patient Health Questionnaire - 9 (PHQ-9) (primary)
The PHQ-9 measures depressive symptoms on a scale of 1-27, with 1 indicating low levels of depressive symptoms, and 27 indicating high levels of depressive symptoms.
Time frame
T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)3
Fatigue, as measured by the PROMIS Fatigue SF
The adult PROMIS Fatigue SF measures fatigue one a scale of 10-40; 10 indicating no fatigue, 40 indicating high levels of fatigue. The pediatric PROMIS Fatigue SF measures on a scale of 0-40; 0 indicating no fatigue and 40 indicating high levels of fatigue.
Time frame
T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)4
Pain, as measured by the Pain Visual Analog Scale (VAS)
The Pain VAS measures three items on a scale of 0-10, with 0 indicating no pain and 10 indicating the worst possible pain.
Time frame
T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks)Other outcomes
1
Reach
Enrollment rates are the percent of patients enrolled. Reasons for not enrolling will also be collected.
Time frame
April, 2023 to October, 20272
Adoption
The number of champions using TEACH during active waves will be assessed.
Time frame
April, 2023 to October, 20273
Fidelity
Providers will be asked to create a registry of patients they see and those who are enrolled. They will be asked to keep data on how many patients complete each TEACH session (up to six). Format of session completion (in person vs. telehealth) and patient use of supplemental web support tools will also be explored.
Time frame
April, 2023 to October, 20274
Feasibility, acceptability, and appropriateness
Twelve psychometrically validated items to assess program feasibility, acceptability, and appropriateness, will be administered to champions after training. Patients and champions will rate items based on responses ranging from strongly agree (5) to strongly disagree (1) (scores ranging from 12-60, where 12 is low agreement and 60 is high agreement).
Time frame
April, 2023 to October, 2027Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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