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| Name | Class |
|---|---|
| The Hospital for Sick Children | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TOPS | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants recruited | Feasibility will be assessed by rates of participant recruitment. | 1 year |
| Number of intervention sessions attended | Feasibility will be assessed by rates of participant session attendance. | through study completion, an average of 1 year |
| Number of participants completing the intervention | Feasibility will be assessed by rates of participant intervention completion. | through study completion, an average of 1 year |
| 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"). | 0-2 weeks post-intervention |
| Qualitative feedback on feasibility and acceptability of the intervention | Semi- structured interviews administered to participants post-intervention will also assess intervention feasibility and acceptability. | 0-2 weeks post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 10 weeks |
| Anxiety symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Busi Zapparoli, PhD | Contact | (416) 813-7654 | busi.zapparoli@sickkids.ca |
| Name | Affiliation | Role |
|---|---|---|
| Busi Zapparoli, PhD | The Hospital for Sick Children | Principal Investigator |
| Andrea Knight, MD, MSCE | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Recruiting | Toronto | Ontario | M5G 1E8 | Canada |
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.
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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 | 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 | 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 | 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 | 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 | 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 |