Testing TEACH for systemic lupus erythematosus of childhood (disorder)
Official title: 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
Interventions
TEACH
TEACH is a cognitive behavioral coping skills program. It consists of six one-hour weekly sessions that are conducted either in-person or remotely.
Canadian Sites (1)
The Hospital for Sick Children
Toronto, Ontario, Canada
Eligibility Criteria
See who this study is looking for8 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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
- −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)
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
What is being given or done in this study: TEACH.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
One group of people involved — usually the participants — is not told which treatment is which.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment at all, and is followed for comparison.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists an age range of 12 years to 22 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 175 people.
The study is currently expected to finish around September 2027.
The main measurement is taken over: T1 (baselineBaselineYour starting measurements, taken before treatment begins.Read more →), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Depressive symptoms, as measured by the Children's Depression Inventory-2 (CDI-2) and Beck Depression Inventory-II (BDI-II) (primary) — measured over T1 (baselineBaselineYour starting measurements, taken before treatment begins.Read more →), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks).
Depressive symptoms, as measured by the Patient Health Questionnaire - 9 (PHQ-9) (primary) — measured over T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks).
Fatigue, as measured by the PROMIS Fatigue short form (secondary) — measured over T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks).
Pain, as measured by the Pain Visual Analog Scale (VAS) — measured over T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks).
The study lists 11 further main measurements.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06232304 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About TEACHBehavioural
TEACH is a cognitive behavioral coping skills program. It consists of six one-hour weekly sessions that are conducted either in-person or remotely.
From the trial registry — its own words, unedited.
What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 12 years to 22 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment and is followed for comparison.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
One group of people involved — usually the participants — is not told which treatment is which.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 12 years to 22 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: T1 (baselineBaselineYour starting measurements, taken before treatment begins.Read more →), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks).
The study as a whole is currently expected to finish around 2027-09-30.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 175 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 4 locations, including: Toronto, Ontario, Canada; Grand Rapids, Michigan, United States; The Bronx, New York, United States; Seattle, Washington, United States.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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.
Other Sites (3)
Helen Devos Children's Hospital
Grand Rapids, Michigan, United States
Montefiore Medical Center
The Bronx, New York, United States
Seattle Children's Hospital
Seattle, Washington, United States
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.