No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
12 – 22
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
175 (estimated)
Sponsor
Michigan State University · Other
Who this trial is looking for
This trial is looking for young people with childhood-onset lupus to join a program that helps them learn to cope with fatigue, pain, and depression. Participants will receive this support alongside their regular medical care.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with childhood-onset systemic lupus erythematosus.
I am between 12 and 22 years old.
I have high levels of fatigue, pain, or depressive symptoms.
I can speak English, or my caregiver can speak English or Spanish.
If I am under 18 years old in the US or under 16 years old in Canada, I have a caregiver who agrees to my participation.
You may not be able to join if
I have another chronic medical condition.
I have a documented developmental delay or severe cognitive impairment.
I have a major untreated psychiatric illness.
I have active suicidal thoughts.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 yo…
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.
Trial Locations
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Eligibility 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 …
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)
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