Complete Cognitive Intervention for cSLE

NCT07302113 | Recruiting

• 1 other identifier: 3413
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

lupus; psychological intervention; adolescent; cognitive

Outcome Measures

Primary Outcomes (5)

• Number of participants recruited

  Feasibility will be assessed by rates of participant recruitment.

  1 year

• Number of intervention sessions attended

  Feasibility will be assessed by rates of participant session attendance.

  through study completion, an average of 1 year

• Number of participants completing the intervention

  Feasibility will be assessed by rates of participant intervention completion.

  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").

  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.

  0-2 weeks post-intervention

Secondary Outcomes (7)

• Depressive symptoms

  Baseline and 10 weeks

• Anxiety symptoms

  Baseline and 10 weeks

• Executive function

  Baseline and 10 weeks

• Self-efficacy

  Baseline and 10 weeks

• Social engagement

  Baseline and 10 weeks

Study Arms (1)

TOPS

EXPERIMENTAL

Behavioral: Lupus Teen Online Problem Solving program

Interventions

Lupus Teen Online Problem Solving program BEHAVIORAL

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.

TOPS

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Andrea Knight: lead
• The Hospital for Sick Children: collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1E8, Canada

RECRUITING

Study Officials

• Busi Zapparoli, PhD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

• Andrea Knight, MD, MSCE

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Busi Zapparoli, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Investigator

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 24, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)