Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07302113

Complete Cognitive Intervention for cSLE

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Lupus

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1E8, Canada

Location status: Recruiting

Location contact

Busi Zapparoli

CONTACT

[email protected]

416-813-7654 ext. 424720

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

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.

Primary outcomes

  1. Number of participants recruited

    Time frame: 1 year

    Feasibility will be assessed by rates of participant recruitment.

  2. 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.

  3. 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.

  4. 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").

  5. 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.

Secondary outcomes

  1. Depressive symptoms

    Time frame: Baseline and 10 weeks

    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.

  2. Anxiety symptoms

    Time frame: Baseline and 10 weeks

    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.

  3. Executive function

    Time frame: Baseline and 10 weeks

    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.

  4. Self-efficacy

    Time frame: Baseline and 10 weeks

    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.

  5. Social engagement

    Time frame: Baseline and 10 weeks

    The PROMIS Social Role Participation will be used to assess participants' social engagement. Scale is 20-80. Higher score is better.

  6. Medication adherence

    Time frame: Baseline and 10 weeks

    The Medication Adherence Self-Report Inventory will be used to measure adherence to medication. 0-100% scale with higher meaning better medication adherence.

  7. Health-related quality of life

    Time frame: Baseline and 10 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Busi Zapparoli, PhD

CONTACT

[email protected]

(416) 813-7654

Sponsors and collaborators

Lead sponsor

Andrea Knight

Other

Collaborators

  • The Hospital for Sick Children

Registry information

Official study title

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

Acronym: CCIC

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 24, 2025
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.