LupusNCT07771088
Exploring Biological Mechanisms Underlying the TEACH Intervention for Adolescents With Lupus
A study testing TEACH in people with Lupus, run by The Hospital for Sick Children.
Trial summary
This study aims to understand how the TEACH program helps improve mental health and well-being in adolescents with childhood-onset lupus. Researchers will examine changes in brain function and inflammation before and after the program and explore how these changes relate to improvements in symptoms such as anxiety… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Lupus
- What is being tested?
- TEACH
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- be diagnosed with cSLE, meeting 2012 American College of Rheumatology (ACR)/System Lupus International Collaborating Clinics (SLICC) and/or European League Against Rheumatism (EULAR)/ACR classification criteria for SLE by age 18 years
- be between the ages of 12 and 18 years
- have stable disease meeting criteria for low lupus disease activity state (LLDAS)
- in recognition of the heterogeneity of symptoms, have elevations (T scores ≥60; see Measures section) in fatigue 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)
- have English language proficiency for cognitive assessment.
Who cannot join
- other chronic medical conditions (e.g., juvenile arthritis)
- a documented developmental delay, severe cognitive impairment, or thought disorder
- an untreated major psychiatric illness (e.g., bipolar disorder, psychosis, severe depression (T score ≥90) or active suicidal ideation (SI), based on the Children's Depression Inventory (CDI-II) /Beck Depression Inventory (BDI-II) items or PHQ9 score ≥21.
- current psychotropic medication use
- concurrent psychotherapy or other psychological intervention
- conditions precluding cognitive task assessment (history of major head trauma, learning disability, alcohol/drug use within 24 hours of assessment, severe developmental problems affecting cognition, hearing loss or vision problems).
About this study
This study aims to understand how the TEACH program helps improve mental health and well-being in adolescents with childhood-onset lupus. Researchers will examine changes in brain function and inflammation before and after the program and explore how these changes relate to improvements in symptoms such as anxiety, depression, fatigue, and pain. Twenty adolescents with cSLE, aged 12-18 years, will participate by completing the TEACH program, brain imaging, blood tests, and questionnaires.
- Conditions
- Lupus
- Being tested
- TEACH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEACHBehavioural
TEACH is a form of cognitive behavioral therapy that has been carefully adapted for adolescents with lupus. It targets common and debilitating symptoms in cSLE, including depression, fatigue, anxiety, and pain. Core components include psychoeducation, activity pacing, cognitive restructuring, relaxation and mindfulness strategies, problem solving, and caregiver-supported skill development. TEACH has previously demonstrated clinical efficacy in reducing depressive symptoms and improving fatigue and anxiety in adolescents with lupus.
| Study group | Role | What they receive |
|---|---|---|
| TEACH | Experimental | Treatment and Education Approach for Childhood-Onset Lupus (TEACH) is a form of cognitive behavioral therapy that has been carefully adapted for adolescents with lupus. It is delivered remotely and teaches skills for managing mood, stress, fatigue, and pain in the context of living with a chronic illness. TEACH utilizes semi-scripted sessions to help ensure consistent content delivery. It consists of 6 weekly one-hour sessions with a trained interventionist. Receives: Behavioral: TEACH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of serum brain-injury biomarkers and inflammatory cytokines
Measurement: Serum concentrations of brain-injury-related proteins (S100, serum neurofilament light chain [sNFL], glial fibrillary acidic protein [GFAP], and Tau) and inflammatory cytokines (including IFN-γ, IL-10, IL-12p70, IL-1β, IL-22, IL-4, IL-5, IL-6, IL-8, and TNF-α), measured using laboratory-based immunoassays. Whole blood RNA expression, including the interferon (IFN) gene signature, will also be assessed using RNA sequencing (RNA-seq).
Unit of measure: Concentration (e.g., pg/mL) for serum proteins and cytokines; normalized gene expression levels for RNA-seq/IFN gene signature.
Measured: From baseline (start of TEACH) to the end of treatment at 8 weeks.
Change in brain neural function and tissue susceptibility
Will look at changes in neuroimaging-derived measures of brain activity/connectivity (fMRI and OPM-MEG) and quantitative magnetic susceptibility (QSM)
Measured: From baseline (start of TEACH) to the end of intervention at 8 weeks
Depression symptom severity using CDI/BDI questionnaire
We will use the total score on the Children's Depression Inventory 2nd Edition (CDI-2) to assess depressive symptoms for youth <13 years, and The Beck Depression Inventory-II (BDI-II) for youth >=13 years with higher scores indicating greater depression symptom severity.
Measured: Through study completion, an average of 1 year
Secondary outcomes (4)
Longitudinal changes in serum brain-injury biomarker concentrations
Longitudinal changes in serum brain-injury biomarker concentrations (S100, sNFL, GFAP, and Tau) measured using laboratory-based immunoassays
Measured: 26-week and 56-weeks from baseline
Longitudinal changes in brain function and tissue susceptibility in multimodal neuroimaging
Longitudinal changes in brain function and tissue susceptibility measured using fMRI, OPM-MEG, and quantitative susceptibility mapping (QSM)
Measured: 26-weeks and 52-weeks from baseline
Fatigue will be measured via the PROMIS Pediatric Fatigue Short Form questionnaire
PROMIS T-score, with higher scores indicating greater fatigue.
Measured: Through study completion, an average of 1 year
Anxiety symptom severity measured using the Screen for Child Anxiety Related Disorders (SCARED) questionnaire
Total SCARED score, with higher scores indicating greater anxiety symptom severity
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start1 Dec 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LupusStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Knight, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771088
- Sponsor's protocol ID
- 4327
- Status last verified
- Oct 2026
- First submitted
- 6 Aug 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Biological Mechanisms Underlying the TEACH Intervention for Adolescents With Lupus
- ClinicalTrials.gov ID
- NCT07771088
- Acronym / sponsor ID
- 4327
- Conditions
- Lupus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to understand how the TEACH program helps improve mental health and well-being in adolescents with childhood-onset lupus. Researchers will examine changes in brain function and inflammation before and after the program and explore how these changes relate to improvements in symptoms such as anxiety, depression, fatigue, and pain. Twenty adolescents with cSLE, aged 12-18 years, will participate by completing the TEACH program, brain imaging, blood tests, and questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TEACH | Experimental | Behavioral: TEACHTreatment and Education Approach for Childhood-Onset Lupus (TEACH) is a form of cognitive behavioral therapy that has been carefully adapted for adolescents with lupus. It is delivered remotely and teaches skills for managing mood, stress, fatigue, and pain in the context of living with a chronic illness. TEACH utilizes semi-scripted sessions to help ensure consistent content delivery. It consists of 6 weekly one-hour sessions with a trained interventionist. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- be diagnosed with cSLE, meeting 2012 American College of Rheumatology (ACR)/System Lupus International Collaborating Clinics (SLICC) and/or European League Against Rheumatism (EULAR)/ACR classification criteria for SLE by age 18 years
- be between the ages of 12 and 18 years
- have stable disease meeting criteria for low lupus disease activity state (LLDAS)
- in recognition of the heterogeneity of symptoms, have elevations (T scores ≥60; see Measures section) in fatigue 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)
- have English language proficiency for cognitive assessment.
Key exclusion criteria (6 listed)
- other chronic medical conditions (e.g., juvenile arthritis)
- a documented developmental delay, severe cognitive impairment, or thought disorder
- an untreated major psychiatric illness (e.g., bipolar disorder, psychosis, severe depression (T score ≥90) or active suicidal ideation (SI), based on the Children's Depression Inventory (CDI-II) /Beck Depression Inventory (BDI-II) items or PHQ9 score ≥21.
- current psychotropic medication use
- concurrent psychotherapy or other psychological intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEACHTEACH is a form of cognitive behavioral therapy that has been carefully adapted for adolescents with lupus. It targets common and debilitating symptoms in cSLE, including depression, fatigue, anxiety, and pain. Core components include psychoeducation, activity pacing, cognitive restructuring, relaxation and mindfulness strategies, problem solving, and caregiver-supported skill development. TEACH has previously demonstrated clinical efficacy in reducing depressive symptoms and improving fatigue and anxiety in adolescents with lupus. | Behavioural | TEACH |
Primary outcome
Concentration of serum brain-injury biomarkers and inflammatory cytokines
Time frame: From baseline (start of TEACH) to the end of treatment at 8 weeks.
Measurement: Serum concentrations of brain-injury-related proteins (S100, serum neurofilament light chain [sNFL], glial fibrillary acidic protein [GFAP], and Tau) and inflammatory cytokines (including IFN-γ, IL-10, IL-12p70, IL-1β, IL-22, IL-4, IL-5, IL-6, IL-8, and TNF-α), measured using laboratory-based immunoassays. Whole blood RNA expression, including the interferon (IFN) gene signature, will also be assessed using RNA sequencing (RNA-seq). Unit of measure: Concentration (e.g., pg/mL) for serum proteins and cytokines; normalized gene expression levels for RNA-seq/IFN gene signature.
Change in brain neural function and tissue susceptibility
Time frame: From baseline (start of TEACH) to the end of intervention at 8 weeks
Will look at changes in neuroimaging-derived measures of brain activity/connectivity (fMRI and OPM-MEG) and quantitative magnetic susceptibility (QSM)
Depression symptom severity using CDI/BDI questionnaire
Time frame: Through study completion, an average of 1 year
We will use the total score on the Children's Depression Inventory 2nd Edition (CDI-2) to assess depressive symptoms for youth <13 years, and The Beck Depression Inventory-II (BDI-II) for youth >=13 years with higher scores indicating greater depression symptom severity.
4 secondary outcomes
Longitudinal changes in serum brain-injury biomarker concentrations
Time frame: 26-week and 56-weeks from baseline
Longitudinal changes in brain function and tissue susceptibility in multimodal neuroimaging
Time frame: 26-weeks and 52-weeks from baseline
Fatigue will be measured via the PROMIS Pediatric Fatigue Short Form questionnaire
Time frame: Through study completion, an average of 1 year
Anxiety symptom severity measured using the Screen for Child Anxiety Related Disorders (SCARED) questionnaire
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing TEACH in people with Lupus, run by The Hospital for Sick Children.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of serum brain-injury biomarkers and inflammatory cytokines (time frame: From baseline (start of TEACH) to the end of treatment at 8 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.