Complete Cognitive Intervention for cSLE
ConditionLupus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-18
SponsorAndrea Knight
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.)
Trial design
Design model
Single group
Treatments tested in this trial
Lupus Teen Online Problem Solving program
BehavioralThe 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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: TOPSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants recruited
Feasibility will be assessed by rates of participant recruitment.
Time frame
1 year2
Number of intervention sessions attended
Feasibility will be assessed by rates of participant session attendance.
Time frame
through study completion, an average of 1 year3
Number of participants completing the intervention
Feasibility will be assessed by rates of participant intervention completion.
Time frame
through study completion, an average of 1 year4
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").
Time frame
0-2 weeks post-interventionSecondary outcomes
1
Depressive symptoms
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.
Time frame
Baseline and 10 weeks2
Anxiety symptoms
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.
Time frame
Baseline and 10 weeks3
Executive function
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.
Time frame
Baseline and 10 weeks4
Self-efficacy
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.
Time frame
Baseline and 10 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Andrea Knight
Lead sponsor
The Hospital for Sick Children
Sponsor institution
The Hospital for Sick Children
Collaborator
Source ClinicalTrials.gov