Recruiting

Brain Health Program

Sponsor:

Andrea Knight

Code:

NCT07302113

Conditions

Lupus

Eligibility Criteria

Sex: All

Age: 13 - 18

Healthy Volunteers: Not accepted

Interventions

Lupus Teen Online Problem Solving program

Study Details

Brief 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.

Conditions

Lupus

Study ID

NCT07302113

Start date

Jan 15, 2026

Status verified date

Dec, 2025

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 18

Healthy Volunteers: Not accepted

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.)

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TOPS

Interventions

Lupus Teen Online Problem Solving program

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.

Primary outcome measure

  • Number of participants recruited [ Time Frame: 1 year ]
  • Number of intervention sessions attended [ Time Frame: through study completion, an average of 1 year ]
  • Number of participants completing the intervention [ Time Frame: through study completion, an average of 1 year ]
  • Acceptability ratings [ Time Frame: 0-2 weeks post-intervention ]
  • Qualitative feedback on feasibility and acceptability of the intervention [ Time Frame: 0-2 weeks post-intervention ]

Central Contacts and Locations

Central contacts

Busi Zapparoli, PhD

(416) 813-7654busi.zapparoli@sickkids.ca

Locations

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G 1E8

Contacts

Busi Zapparoli

416-813-7654busi.zapparoli@sickkids.ca

More Information

Sponsor

Andrea Knight

Last update posted

May 1, 2026

Last verified

Dec, 2025

Keywords

  • lupus
  • psychological intervention
  • adolescent
  • cognitive

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Andrea Knight on 2026-05-01.