Clinical trial NCT06076889: Power Over Pain Portal: A Stepped-care Virtual Solution to Deliver Early Intervention to Canadian Youth With Chronic Pain
Official title: Power Over Pain Portal: A Stepped-care Virtual Solution to Deliver Early Intervention to Canadian Youth With Chronic Pain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Pain
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2023-10-11
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from a community-based sample of 100 youth with chronic pain using respondent-driven sampling (RDS), a network-based (i.e. snowball-type) method wherein a diverse group of youth with chronic pain ("seeds") provide study information to members of their social networks

As per RDS recommendations, the "seeds" will be sociodemographically diverse, live in a variety of geographical areas, and be "high energy sociometric stars" who are committed to the study goals (i.e., our diverse youth advisory group). this strategy will seek to maximize variability in age, sex, gender, ethnicity, SES and rurality.

This study focuses on youth marginalized by membership in racialized groups, SES as defined by neighbourhood, rural/urban status, sex and gender, and sexual orientation. Those belonging to a racialized group, living in a low SES neighbourhood, and/or rural location will be considered marginalized.

Brief summary: The COVID-19 pandemic is presenting one of the greatest threats to youth mental health seen in generations. Pain is one of the most common symptoms of extreme stress in youth. In 2020, the investigators created an online "stepped-care" program called the Power over Pain Portal. Stepped care is a promising way to improve access to CP care. Stepped care tailors care based on a person's symptom severity. Like a ladder, a person must start with one type of care then "step up" or "step down" to more or less intense care depending on need. The investigators also summarized all online pain management programs for youth to find the best resources to embed into the Portal. The investigators will pilot-test the Portal with youth to ensure it can be implemented effectively and will be clinically beneficial. The investigators will recruit 100 youth with CP to use the Portal for 2 months and see how they interact with the features and if it helps to improve their pain and mental health. The investigators will include a mixture of youth who represent different ages, sexes, genders, sexual orientations, races, dwellings, and school/employment status.


Eligibility criteria: Inclusion Criteria:

* Experience chronic pain
* Speak and read English
* Access to Internet / Smartphone (or will be loaned study phone with data plan)
* Intend to use the portal for 2 months

Exclusion Criteria:

* Youth self-reports:
* Receiving tertiary care or are on waitlists for tertiary care paediatric chronic pain programs
* Have moderate to severe cognitive impairment that may impact their ability to understand and use the Power over Pain Portal or complete self-reported outcomes
* Have untreated major psychiatric illness (e.g., anorexia, psychosis) and/or active suicidality at the time of screening

Primary outcomes:
measure: Acceptability
timeFrame: 8 weeks
measure: Adoption (i.e.,rate of uptake of the Power over Pain Portal)
timeFrame: 8 weeks
measure: Appropriateness (i.e., perceived fit and compatibility of the Power over Pain Portal to the needs of users)
timeFrame: 8 weeks
measure: Portal Feasibility as assessed by the extent to which the Power over Pain Portal can be used as planned
timeFrame: 8 weeks
measure: Portal Feasibility as assessed by the extent to which the Power over Pain Portal can be used as planned
timeFrame: 8 weeks
measure: Fidelity
timeFrame: 8 weeks
Secondary outcomes:
measure: Client outcomes
timeFrame: 8 weeks
measure: Client outcomes
timeFrame: 8 weeks
measure: Client outcomes
timeFrame: 8 weeks
measure: Client outcomes
timeFrame: 8 weeks
measure: Client outcomes
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
References: