Chronic PainNCT06076889
Power Over Pain Portal: A Stepped-care Virtual Solution to Deliver Early Intervention to Canadian Youth With Chronic Pain
An observational study of Chronic Pain, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Power over Pain Portal
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 31 Oct 2022to 30 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Rachel Kelly, BA, 416-813-7654 ext. 302314, rachelr.kelly@sickkids.ca
Chitra Lalloo, BHSc, PhD, 416-813-7654 ext. 302332, chitra.lalloo@sickkids.ca
About this study
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.
- Conditions
- Chronic Pain
- Being tested
- Power over Pain Portal
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Power over Pain PortalBehavioural
Youth from different ages, sexes, gender, sexual orientations, races, dwelling and school/employment status will receive access to the portal for 2 months. The portal consists of self-assessment tools (bi-weekly check-ins to provide users with feedback on their mood, anxiety, pain, and sleep and guide decision making on choice of interventions), evidence-based virtual educational (pain neuroscience) and cognitive behavioural therapy (CBT) pain interventions that are delivered in a stepped care manner based on participant needs/preference.
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
This will be assessed using the Acceptability e-Scale administered at T2 and assessed during the post-implementation qualitative interview. The minimum value is 1 and the maximum value is 5. Higher scores on the Acceptability e-Scale indicate a better outcome.
Measured: 8 weeks
Adoption (i.e.,rate of uptake of the Power over Pain Portal)
Characterized via the user-level analytics of interactions with each feature. The benchmark will be 75% of users completing 3/4 portal assessment and accessing ≥ portal intervention.
Measured: 8 weeks
Appropriateness (i.e., perceived fit and compatibility of the Power over Pain Portal to the needs of users)
Assessed via the post-implementation qualitative interview.
Measured: 8 weeks
Portal Feasibility as assessed by the extent to which the Power over Pain Portal can be used as planned
Assessed using frequency counts and percentages of types/severity of problems encountered via monthly audit of technical support tickets
Measured: 8 weeks
Portal Feasibility as assessed by the extent to which the Power over Pain Portal can be used as planned
Assessed via characterization of the severity of encountered issues on the Power over Pain portal
Measured: 8 weeks
Fidelity
Characterized by intervention use analytics.
Measured: 8 weeks
Secondary outcomes (5)
Client outcomes
Pain intensity as assessed by the 1-item PROMIS pediatric numeric rating scale v1.0 - Pain Intensity. This maximum score on the scale is 10 and the minimum score is 0, with higher scores indicating higher levels of pain experienced by the participant. This will be administered at T1 and T2
Measured: 8 weeks
Client outcomes
Pain interference as assessed by the the PROMIS pediatric short form v2.0 - Pain Interference 8a. The maximum score on the scale is 5 and the lowest score is 1, with higher scores indicating higher pain interference in the participant's life. This will be administered at T1 and T2.
Measured: 8 weeks
Client outcomes
Anxiety as assessed by the the PROMIS pediatric short form v2.0 - Anxiety 8a. The maximum score on the scale is 5 and the lowest score is 1, with higher scores indicating higher levels of anxiety in the participant's life. This will be administered at T1 and T2.
Measured: 8 weeks
Client outcomes
Depressive symptoms as assessed by the the PROMIS pediatric short form v2.0 - Depressive Symptoms 8a. The maximum score on the scale is 5 and the lowest score is 1, with higher scores indicating higher levels of depression in the participant's life. This will be administered at T1 and T2.
Measured: 8 weeks
Client outcomes
Insomnia as assessed by the the 7-item Insomnia Severity Index. The maximum score on the scale is 4 and the lowest score is 0, with higher scores indicating more severe levels of insomnia experienced by the patient. This will be administered at T1 and T2.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start31 Oct 2022
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Jennifer Stinson, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06076889
- Sponsor's protocol ID
- REB#
- Status last verified
- Jun 2025
- First submitted
- 13 Sep 2023
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Power Over Pain Portal: A Stepped-care Virtual Solution to Deliver Early Intervention to Canadian Youth With Chronic Pain
- ClinicalTrials.gov ID
- NCT06076889
- Acronym / sponsor ID
- REB#
- Conditions
- Chronic Pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 11 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Power over Pain PortalYouth from different ages, sexes, gender, sexual orientations, races, dwelling and school/employment status will receive access to the portal for 2 months. The portal consists of self-assessment tools (bi-weekly check-ins to provide users with feedback on their mood, anxiety, pain, and sleep and guide decision making on choice of interventions), evidence-based virtual educational (pain neuroscience) and cognitive behavioural therapy (CBT) pain interventions that are delivered in a stepped care manner based on participant needs/preference. | Behavioural | – |
Primary outcome
Acceptability
Time frame: 8 weeks
This will be assessed using the Acceptability e-Scale administered at T2 and assessed during the post-implementation qualitative interview. The minimum value is 1 and the maximum value is 5. Higher scores on the Acceptability e-Scale indicate a better outcome.
Adoption (i.e.,rate of uptake of the Power over Pain Portal)
Time frame: 8 weeks
Characterized via the user-level analytics of interactions with each feature. The benchmark will be 75% of users completing 3/4 portal assessment and accessing ≥ portal intervention.
Appropriateness (i.e., perceived fit and compatibility of the Power over Pain Portal to the needs of users)
Time frame: 8 weeks
Assessed via the post-implementation qualitative interview.
Portal Feasibility as assessed by the extent to which the Power over Pain Portal can be used as planned
Time frame: 8 weeks
Assessed using frequency counts and percentages of types/severity of problems encountered via monthly audit of technical support tickets
Portal Feasibility as assessed by the extent to which the Power over Pain Portal can be used as planned
Time frame: 8 weeks
Assessed via characterization of the severity of encountered issues on the Power over Pain portal
Fidelity
Time frame: 8 weeks
Characterized by intervention use analytics.
5 secondary outcomes
Client outcomes
Time frame: 8 weeks
Client outcomes
Time frame: 8 weeks
Client outcomes
Time frame: 8 weeks
Client outcomes
Time frame: 8 weeks
Client outcomes
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer N Stinson, RN, PhD (416-813-7654 ext. 304514, jennifer.stinson@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.