Complete Cognitive Intervention for cSLE (CCIC)

April 27, 2026 updated by: Andrea Knight

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1E8
        • Recruiting
        • The Hospital for Sick Children
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TOPS
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants recruited
Time Frame: 1 year
Feasibility will be assessed by rates of participant recruitment.
1 year
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.
through study completion, an average of 1 year
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.
through study completion, an average of 1 year
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").
0-2 weeks post-intervention
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.
0-2 weeks post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 10 weeks
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.
Baseline and 10 weeks
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.
Baseline and 10 weeks
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.
Baseline and 10 weeks
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.
Baseline and 10 weeks
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.
Baseline and 10 weeks
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.
Baseline and 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andrea Knight

Collaborators

The Hospital for Sick Children

Investigators

  • Principal Investigator: Andrea Knight, MD, MSCE, The Hospital for Sick Children
  • Principal Investigator: Busi Zapparoli, PhD, The Hospital for Sick Children

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

December 23, 2025

First Posted (Actual)

December 24, 2025

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 3413

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will shared upon request and approval of the study plan by the PI, and when the appropriate data use agreement and ethical protocols are in place.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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