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Behavioral Intervention

Coping Skills Program for Lupus (cSLE Trial)

N/A
Recruiting
Led By Natoshia R Cunningham, PhD
Research Sponsored by Michigan State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up t1 (baseline), t2 (8 weeks), t3 (20 weeks), t4 (32 weeks), t5 (44 weeks), t6 (56 weeks)
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to see if a program called TEACH can help young people with lupus learn coping skills to deal with fatigue, pain, and feeling sad.

Who is the study for?
This trial is for young individuals aged 12-22 with childhood-onset Systemic Lupus Erythematosus (cSLE). They must meet specific criteria by age 18, experience fatigue, depression, or pain related to cSLE and be proficient in English. A consenting caregiver is required for participants under the legal adult age.
What is being tested?
The study tests a program called TEACH (Treatment and Education Approach for Childhood-onset Lupus), which teaches coping skills to manage symptoms like fatigue, pain, and depressive symptoms that affect adolescents and young adults with lupus.
What are the potential side effects?
Since TEACH is a cognitive behavioral coping skills program rather than a medication, it may not have typical drug side effects. However, discussing sensitive topics might cause temporary emotional discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I was diagnosed with lupus (SLE) before I turned 18.
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I am between 12 and 22 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~t1 (baseline), t2 (8 weeks), t3 (20 weeks), t4 (32 weeks), t5 (44 weeks), t6 (56 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and t1 (baseline), t2 (8 weeks), t3 (20 weeks), t4 (32 weeks), t5 (44 weeks), t6 (56 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Depressive symptoms, as measured by the Children's Depression Inventory-2 (CDI-2) and Beck Depression Inventory-II (BDI-II) (primary)
Fatigue, as measured by the PROMIS Fatigue short form (secondary)
Secondary study objectives
Anxiety, as measured by the Screen for Child Anxiety Related Disorders (SCARED) and Screen for Adult Anxiety Related Disorders (SCAARED)
Cognitive functioning, as measured by the PROMIS Cognitive Function Short Form for Adults and the PROMIS Cognitive Function Short Form for Pediatrics
Depressive symptoms, as measured by the Children's Depression Inventory-2 (CDI-2) and Beck Depression Inventory-II (BDI-II)
+12 more
Other study objectives
Adoption
Adverse Childhood Events (ACEs)
Adverse events
+15 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TEACHExperimental Treatment1 Intervention
Participants will undergo a cognitive behavioral coping skills program and continue medical treatment as usual.
Group II: ControlActive Control1 Intervention
Participants will only continue medical treatment as usual.

Find a Location

Who is running the clinical trial?

Michigan State UniversityLead Sponsor
198 Previous Clinical Trials
685,044 Total Patients Enrolled
Tulane UniversityOTHER
121 Previous Clinical Trials
238,904 Total Patients Enrolled
University of Alabama at BirminghamOTHER
1,647 Previous Clinical Trials
2,342,260 Total Patients Enrolled
~131 spots leftby Apr 2027
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