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Transforming Care for Individuals With Childhood-onset Systemic Lupus Erythematosus

Transforming Behavioral Healthcare to Improve the Quality of Life for Individuals With Childhood-onset Lupus

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years to 22 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 1 year
  • Procedures mentioned: Questionnaires, Interviews

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Aim 2: To determine longitudinal trajectories (over 1 year) of depressive symptoms, the impact of TEACH, and its association with patient characteristics, psychological/functional outcomes, and disease-related outcomes."
  • "We will identify implementation outcomes (e.g., barriers and facilitators, acceptability, fidelity, reach, sustainability) of TEACH through surveys and interviews of providers and patients to inform future adoption/sustainability."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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 ≥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)

Study sites (6)

AL

LA

MI

NY

OH

WA