Complete Cognitive Support for childhood-onset lupus
Promoting Health-Related Quality of Life in Pediatric Lupus Patients: Development and Implementation of a Tailored Brain Health Intervention
NA · The Hospital for Sick Children · NCT07302113
This program will try an online problem-solving course to help thinking and everyday functioning in teens (13–18) with childhood-onset lupus.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 13 Years to 18 Years |
| Sex | All |
| Sponsor | The Hospital for Sick Children (other) |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT07302113 on ClinicalTrials.gov |
What this trial studies
The project uses a patient-informed participatory action approach to co-design and pilot the Lupus Teen Online Problem Solving program tailored for brain health needs in adolescents with childhood-onset lupus (cSLE). Investigators will work directly with patients to adapt content to the cognitive and daily-life challenges faced by this group and then deliver the program virtually. The primary goals are to determine feasibility and acceptability by tracking engagement, usability, and participant feedback. Findings will guide refinements and the planning of larger effectiveness trials.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adolescents aged 13–18 with a confirmed diagnosis of childhood-onset SLE (ACR or SLICC criteria), who can give consent/assent and have access to a phone, tablet, or computer for virtual participation.
Not a fit: Patients with significant cognitive impairment (e.g., intellectual disability, active psychosis), uncorrected hearing or vision loss that prevents group participation, non-English speakers, or those without access to necessary technology are unlikely to benefit from this virtual program.
Why it matters
Potential benefit: If successful, the program could improve cognitive skills, daily functioning, and coping strategies for teens with cSLE.
How similar studies have performed: Online problem-solving interventions have shown feasibility and some benefit in other pediatric neurological populations, but applying this specific approach to cSLE is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.)
Where this trial is running
Toronto, Ontario
- The Hospital for Sick Children — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Busi Zapparoli, PhD — The Hospital for Sick Children
- Study coordinator: Busi Zapparoli, PhD
- Email: busi.zapparoli@sickkids.ca
- Phone: (416) 813-7654
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lupus, lupus, psychological intervention, adolescent, cognitive