Actively Recruiting

Phase Not Applicable
Age: 13Years - 18Years
All Genders
ID07302113

Promoting Health-Related Quality of Life in Pediatric Lupus Patients: Development and Implementation of a Tailored Brain Health Intervention

Led by Andrea Knight · Updated on 2026-05-01

60

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

A

Andrea Knight

Lead Sponsor

T

The Hospital for Sick Children

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are developing and testing a new program to support brain health in children and youth aged 13 to 18 with childhood-onset lupus (cSLE). The project uses a patient-informed approach to design an intervention tailored to the specific brain health needs of these young patients, focusing on improving quality of life and cognitive function. The intervention being studied is the Lupus Teen Online Problem Solving program, a 10-session telehealth program delivered one-on-one with a therapist. This program offers training in problem-solving, emotion regulation, and communication skills, adapted from a similar program originally created for families affected by traumatic brain injury. The study will assess how practical and acceptable this program is for participants. Participants will be involved for about one year, during which researchers will track recruitment, session attendance, and intervention completion. They will also collect ratings and feedback on the program's acceptability and feasibility shortly after the intervention. Additional assessments will measure depressive and anxiety symptoms, executive function, self-efficacy, social engagement, medication adherence, and health-related quality of life at the start and after 10 weeks of the intervention.

CONDITIONS

Brief Title

Complete Cognitive Intervention for cSLE

Who Can Participate

Age: 13Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provide informed consent
  • Have a current diagnosis of childhood-onset lupus (cSLE) meeting 1997 ACR or SLICC criteria
  • Be between 13 and 18 years old
Not Eligible

You will not qualify if you...

  • Have conditions that significantly affect cognition (such as intellectual disability or active psychosis)
  • Have hearing loss or vision problems that prevent participation
  • Do not speak English
  • Lack access to technology needed for virtual participation (phone, tablet, or computer)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or virtual) for consent and eligibility assessment

Outpatient Treatment

Duration - Approximately 10 weeks

Participants complete a 10-session telehealth brain health intervention focusing on problem-solving, emotion regulation, and communication skills with a therapist.

10 weekly telehealth sessions with a therapist

Follow-up

Duration - Up to 2 weeks post-intervention

Participants provide feedback and acceptability ratings and are assessed on depressive symptoms, anxiety, executive function, self-efficacy, social engagement, medication adherence, and quality of life.

1 follow-up visit (virtual or in-person)

Trial Site Locations

Total: 1 location

1

The Hospital for Sick Children

Toronto, Ontario, Canada, M5G 1E8

Actively Recruiting

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Research Team

B

Busi Zapparoli, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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