Complete Cognitive Intervention for cSLE
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lupus Teen Online Problem Solving program.
- Who it may be relevant to
- Registry conditions: Lupus. Basic parameters: 13 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Promoting Health-Related Quality of Life in Pediatric Lupus Patients: Development and Implementation of a Tailored Brain Health Intervention
Overview
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.
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.
Interventions
- 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,
Primary outcome measures
- 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]
Secondary outcome measures (7)
- Depressive symptoms [Time frame: Baseline and 10 weeks]
- Anxiety symptoms [Time frame: Baseline and 10 weeks]
- Executive function [Time frame: Baseline and 10 weeks]
- Self-efficacy [Time frame: Baseline and 10 weeks]
- Social engagement [Time frame: Baseline and 10 weeks]
- Medication adherence [Time frame: Baseline and 10 weeks]
- Health-related quality of life [Time frame: Baseline and 10 weeks]
Eligibility criteria
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.)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- The Hospital for Sick Children — Toronto
Identifiers
NCT: NCT07302113 · 3413