Lupus
Conditions
Keywords
lupus, psychological intervention, adolescent, cognitive
Brief summary
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
BEHAVIORALLupus 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.
Sponsors
Andrea Knight
The Hospital for Sick Children
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 18 Years
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants recruited | 1 year | Feasibility will be assessed by rates of participant recruitment. |
| Number of intervention sessions attended | through study completion, an average of 1 year | Feasibility will be assessed by rates of participant session attendance. |
| Number of participants completing the intervention | through study completion, an average of 1 year | Feasibility will be assessed by rates of participant intervention completion. |
| Acceptability ratings | 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"). |
| Qualitative feedback on feasibility and acceptability of the intervention | 0-2 weeks post-intervention | Semi- structured interviews administered to participants post-intervention will also assess intervention feasibility and acceptability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depressive symptoms | 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. |
| Anxiety symptoms | 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. |
| Executive function | 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. |
| Self-efficacy | 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. |
| Social engagement | 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. |
| Medication adherence | 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. |
| Health-related quality of life | 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. |
Countries
Canada
Contacts
CONTACTBusi Zapparoli, PhD
PRINCIPAL_INVESTIGATORBusi Zapparoli, PhD
The Hospital for Sick Children
PRINCIPAL_INVESTIGATORAndrea Knight, MD, MSCE
The Hospital for Sick Children
Outcome results
None listed