LupusCCICNCT07302113
Complete Cognitive Intervention for cSLE
A study testing Lupus Teen Online Problem Solving program in people with Lupus, run by Andrea Knight at 1 site in Canada.
Trial summary
This project will work closely with patients to design and test a new program that supports brain health in children and youth with childhood-onset lupus (cSLE). The investigators will see how practical and helpful the program is for patients. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Lupus
- What is being tested?
- Lupus Teen Online Problem Solving program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jan 2026to Jan 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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Receive subject-informed consent;
- Have a current diagnosis of cSLE that meets the 1997 American College of Rheumatology (ACR) or System Lupus International Collaborating Clinics (SLICC) classification criteria
- Aged 13-18 years old
Who cannot join
- Conditions that significantly affect cognition (e.g., intellectual disability diagnosis, active psychosis), hearing loss or vision problems precluding participation in group
- Non-English speaking
- Lack of access to technology that would allow them to participate in the virtual intervention (e.g., phone, tablet, computer, etc.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
The Hospital for Sick Children
Toronto, Ontario, M5G 1E8
Busi Zapparoli, 416-813-7654 ext. 424720, busi.zapparoli@sickkids.ca
About this study
Official title: Promoting Health-Related Quality of Life in Pediatric Lupus Patients: Development and Implementation of a Tailored Brain Health Intervention
This project will work closely with patients to design and test a new program that supports brain health in children and youth with childhood-onset lupus (cSLE). The investigators will see how practical and helpful the program is for patients.
Read the detailed description
The proposed project will use a patient-informed participatory action approach to develop and assess preliminary feasibility and acceptability of an intervention tailored to address the specific brain health needs of cSLE patients.
- Conditions
- Lupus
- Being tested
- Lupus Teen Online Problem Solving program
- Keywords
- lupus, psychological intervention, adolescent, cognitive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lupus Teen Online Problem Solving programBehavioural
The Lupus Teen Online Problem Solving program is a brain health intervention developed to meet the needs of youth with childhood-onset lupus. The original Teen Online Problem Solving Program (TOPS) was developed for use with families impacted by traumatic brain injury. The Lupus Teen Online Problem Solving program is based on TOPS, with modifications to maximize relevance and accessibility. The intervention is a 10 session, evidence-based telehealth program providing training in problem-solving, emotion regulation, and communication skills in a one-to-one therapist-mediated design.
| Study group | Role | What they receive |
|---|---|---|
| TOPS | Experimental | Not described Receives: Behavioral: Lupus Teen Online Problem Solving program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants recruited
Feasibility will be assessed by rates of participant recruitment.
Measured: 1 year
Number of intervention sessions attended
Feasibility will be assessed by rates of participant session attendance.
Measured: through study completion, an average of 1 year
Number of participants completing the intervention
Feasibility will be assessed by rates of participant intervention completion.
Measured: through study completion, an average of 1 year
Acceptability ratings
Participant acceptability will be determined ratings of their satisfaction with aspects of the program on a brief survey using 5-point Likert scales (ranging from "dissatisfied" to "extremely satisfied").
Measured: 0-2 weeks post-intervention
Qualitative feedback on feasibility and acceptability of the intervention
Semi- structured interviews administered to participants post-intervention will also assess intervention feasibility and acceptability.
Measured: 0-2 weeks post-intervention
Secondary outcomes (7)
Depressive symptoms
The 21-item Beck Depression Inventory-II will be used to assess depressive symptoms. Minimum possible total score of 0 and a maximum possible total score of 63. Higher scores means worse.
Measured: Baseline and 10 weeks
Anxiety symptoms
The 41-item Screen for Child Anxiety Related Disorders self-report form will be used to assess anxiety symptoms. Minimum total score 0 and the maximum total score 82. Higher means worse.
Measured: Baseline and 10 weeks
Executive function
The self-report Behavior Rating Inventory of Executive Function, Second Edition will be used to assess executive functioning skills, defined as a set of higher-level cognitive skills that enable problem-solving and goal-directed behaviour.
Measured: Baseline and 10 weeks
Self-efficacy
The Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Chronic Conditions scale will be used to measure self-efficacy, defined as an individual's belief in their capacity to act in the ways necessary to reach specific goals. Scores range 4-20 with higher scores meaning better efiicacy.
Measured: Baseline and 10 weeks
Social engagement
The PROMIS Social Role Participation will be used to assess participants' social engagement. Scale is 20-80. Higher score is better.
Measured: Baseline and 10 weeks
Medication adherence
The Medication Adherence Self-Report Inventory will be used to measure adherence to medication. 0-100% scale with higher meaning better medication adherence.
Measured: Baseline and 10 weeks
Health-related quality of life
The Pediatric Quality of Life Inventory (PedsQL) will be used to assess participants' health-related quality of life, including aspects of physical functioning, emotional functioning, social functioning, and school functioning. 0-100 range with higher being better.
Measured: Baseline and 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start15 Jan 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 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.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andrea Knight
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospital for Sick Children
- Responsible party
- Sponsor-investigator, Andrea Knight, The Hospital for Sick Children
- Investigators
- Busi Zapparoli, PhD, Principal investigator, The Hospital for Sick ChildrenAndrea Knight, MD, MSCE, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07302113
- Sponsor's protocol ID
- 3413
- Acronym
- CCIC
- Status last verified
- Dec 2025
- First submitted
- 18 Nov 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will shared upon request and approval of the study plan by the PI, and when the appropriate data use agreement and ethical protocols are in place.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Health-Related Quality of Life in Pediatric Lupus Patients: Development and Implementation of a Tailored Brain Health Intervention
- ClinicalTrials.gov ID
- NCT07302113
- Acronym / sponsor ID
- CCIC / 3413
- Conditions
- Lupus
- Keywords
- lupus, psychological intervention, adolescent, cognitive
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Andrea KnightUniversity, hospital or other
- Collaborators
- The Hospital for Sick Children
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 24 Dec 2025 (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 project will work closely with patients to design and test a new program that supports brain health in children and youth with childhood-onset lupus (cSLE). The investigators will see how practical and helpful the program is for patients.
Detailed description
The proposed project will use a patient-informed participatory action approach to develop and assess preliminary feasibility and acceptability of an intervention tailored to address the specific brain health needs of cSLE patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TOPS | Experimental | Behavioral: Lupus Teen Online Problem Solving program |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Receive subject-informed consent;
- Have a current diagnosis of cSLE that meets the 1997 American College of Rheumatology (ACR) or System Lupus International Collaborating Clinics (SLICC) classification criteria
- Aged 13-18 years old
Key exclusion criteria (3 listed)
- Conditions that significantly affect cognition (e.g., intellectual disability diagnosis, active psychosis), hearing loss or vision problems precluding participation in group
- Non-English speaking
- Lack of access to technology that would allow them to participate in the virtual intervention (e.g., phone, tablet, computer, etc.)
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 |
|---|---|---|
| Lupus Teen Online Problem Solving programThe Lupus Teen Online Problem Solving program is a brain health intervention developed to meet the needs of youth with childhood-onset lupus. The original Teen Online Problem Solving Program (TOPS) was developed for use with families impacted by traumatic brain injury. The Lupus Teen Online Problem Solving program is based on TOPS, with modifications to maximize relevance and accessibility. The intervention is a 10 session, evidence-based telehealth program providing training in problem-solving, emotion regulation, and communication skills in a one-to-one therapist-mediated design. | Behavioural | TOPS |
Primary outcome
Number of participants recruited
Time frame: 1 year
Feasibility will be assessed by rates of participant recruitment.
Number of intervention sessions attended
Time frame: through study completion, an average of 1 year
Feasibility will be assessed by rates of participant session attendance.
Number of participants completing the intervention
Time frame: through study completion, an average of 1 year
Feasibility will be assessed by rates of participant intervention completion.
Acceptability ratings
Time frame: 0-2 weeks post-intervention
Participant acceptability will be determined ratings of their satisfaction with aspects of the program on a brief survey using 5-point Likert scales (ranging from "dissatisfied" to "extremely satisfied").
Qualitative feedback on feasibility and acceptability of the intervention
Time frame: 0-2 weeks post-intervention
Semi- structured interviews administered to participants post-intervention will also assess intervention feasibility and acceptability.
7 secondary outcomes
Depressive symptoms
Time frame: Baseline and 10 weeks
Anxiety symptoms
Time frame: Baseline and 10 weeks
Executive function
Time frame: Baseline and 10 weeks
Self-efficacy
Time frame: Baseline and 10 weeks
Social engagement
Time frame: Baseline and 10 weeks
Medication adherence
Time frame: Baseline and 10 weeks
Health-related quality of life
Time frame: Baseline and 10 weeks
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 1 May 2026.
- Individual participant dataSharing planned: Yes. Data will shared upon request and approval of the study plan by the PI, and when the appropriate data use agreement and ethical protocols are in place.
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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.
Busi Zapparoli, PhD principal investigator
The Hospital for Sick Children
Andrea Knight, MD, MSCE principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lupus Teen Online Problem Solving program in people with Lupus, run by Andrea Knight at 1 site in Canada.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Busi Zapparoli, PhD ((416) 813-7654, busi.zapparoli@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants recruited (time frame: 1 year). The study lists 5 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 1 May 2026.