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Chronic PainNCT05894772

Evaluating a Virtual Stepped Care Portal in Youth Awaiting Tertiary Chronic Pain Care: An Implementation-Effectiveness Hybrid Type III Study

A study testing Power over Pain Portal in people with Chronic Pain, run by The Hospital for Sick Children at 11 sites in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Pain is one of the most common symptoms of extreme stress in youth. Without treatment, short-term pain can last for months to years (called 'chronic pain'; CP), a problem already affecting 1 in 5 Canadian youth. The COVID-19 pandemic is one of the greatest threats to youth mental health seen in generations. 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
Could I receive a placebo?
No, everyone receives an active treatment
How many people
93 participants
Where
11 sitesCanada
Study dates
5 Aug 2023to 1 Sep 2025
Phase
Interventional
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

Who may be able to join

  • Experience chronic pain
  • Speak and read English or French
  • Have access to internet / smartphone (or are willing to be loaned a study phone with a data plan)
  • Are on the waitlist of a tertiary care CP clinic in Canada
  • Intend to use the PoP Portal for at least 4 months
  • Have the capacity to consent

Who cannot join

  • Have moderate to severe cognitive impairments that may impact their ability to understand and use the PoP Portal or complete self-reported clinical outcome measures
  • Have untreated major psychiatric illness (e.g., anorexia, psychosis) and/or active suicidality as assessed by the PoP Portal screening. Youth who have co-occurring clinically significant anxiety or depression that is currently being treated will be eligible if they meet other inclusion criteria.

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jennifer N Stinson, RN, PhD contact

416-813-7654 ext. 304514

jennifer.stinson@sickkids.ca

Chitra Lalloo, PhD contact

416-813-7654 ext. 302332

chitra.lalloo@sickkids.ca

11 sites in 1 country

Canada11 sites, 11 recruiting

  • Alberta Children's Hospital

    Calgary

    Nicole Johnson, MD

    Not yet recruiting

  • Stollery Children's Hospital

    Edmonton

    Janet Ellisworth, MD

    Not yet recruiting

  • IWK Health Center

    Halifax, Nova Scotia

    Adam Huber, MD

    Patrick McGrath, MD

    Not yet recruiting

  • McMaster Children's Hospital

    Hamilton, Ontario, L8S 4K1

    Vicky Breakey, MD

    Recruiting

  • Children's Hospital London Health Sciences

    London, Ontario, N6A 5W9

    Serina Patel, MD, 519.685.8500 ext. 52678, Serina.Patel@lhsc.on.ca

    Not yet recruiting

  • CHU Sainte-Justine

    Montreal, Quebec, H3T 1C5

    Caroline Laverdiere, MD

    Not yet recruiting

  • Montreal Children's Hospital

    Montreal

    Sarah Campillo, MD

    Not yet recruiting

  • Children's Hospital of Eastern Ontario (CHEO)

    Ottawa, Ontario

    Ciaran Duffy, MSc, FRCPC

    Karen Watanabe Duffy, MD, FRCPC

    Not yet recruiting

  • Jim Pattison

    Saskatoon, Saskatchewan

    Craig Eling

    Not yet recruiting

  • 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

    Recruiting

  • BC Children's Hospital

    Vancouver

    Lori Tucker, MD

    Not yet recruiting

Other trials in Canada

About this study

Pain is one of the most common symptoms of extreme stress in youth. Without treatment, short-term pain can last for months to years (called 'chronic pain'; CP), a problem already affecting 1 in 5 Canadian youth. The COVID-19 pandemic is one of the greatest threats to youth mental health seen in generations. CP in childhood can trigger a wave of mental health issues that last well into adulthood. In 2019, we learned that "access to pain care" is poor and a priority for youth with CP and their families. Unfortunately, COVID-19 has only made access more difficult. In 2020, we created an online "stepped care" program called the Power over Pain Portal for youth with CP. Stepped care is a promising way to improve access to CP care by tailoring care based on the symptoms each youth is experiencing. Like a ladder, youth start with one type of care and then "step up" or "step down" to more or less intense care depending on what they need. Over the past year, funded by CIHR, we worked with hundreds of youth and healthcare professionals across Canada to understand how the pandemic has affected pain and mental health. We also summarized all online pain self-management programs including peer support for youth to find the best resources to include in the Portal and will translate the portal content into French. Together with a diverse group of youth with CP, we have now co-designed the online Portal. The next step (focus of this grant) is to test the Portal with youth to ensure it can be implemented and is helpful. We will recruit 93 youth with CP waiting for specialist care at 11 CP clinics across Canada to use the Portal for 4 months. We will see how they use the Portal and if it helps to improve their pain and mental health. This study is important because it will allow us to understand how the Portal works in the real world before wide public release (English and French) to support all youth in Canada with CP with accessible, evidence-based pain care.

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 Power over Pain Portal for 4 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. The overall objective is to determine the implementation (guided by Proctor's implementation conceptual framework) and clinical effectiveness of the PoP Portal in a sample of youth (12-18 years of age) who are on the waitlist for tertiary care consultation at any pediatric CP clinic in Canada.

Study groups in NCT05894772
Study groupRoleWhat they receive
Intervention armExperimentalPower over Pain Portal
Receives: Behavioral: Power over Pain Portal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acceptability

    Will be assessed using the Acceptability e-Scale administered at T2 and during the qualitative interview. Participants rate features of the portal on a scale from 1-5 with higher scores indicating higher acceptability.

    Measured: 16 weeks

  2. Adoption

    Characterized via participant-level analytics of interactions with each feature. The benchmark will be >60% of participants completing ≥ 1 portal intervention.

    Measured: 16 weeks

  3. Appropriateness

    Perceived fit and compatibility of portal participants' needs. Assessed via the qualitative interview at T2.

    Measured: 16 weeks

  4. Portal Feasibility

    Degree to which to PoP Portal could be used as intended. Will be assessed via monthly audit of support tickets and characterization of the severity of encountered issues.

    Measured: 16 weeks

  5. Fidelity

    Degree to which the PoP Portal and each intervention independently (WEBMap, iCanCope, iPeer2Peer) was used as intended. Will be characterized by intervention use analytics.

    Measured: 16 weeks

Secondary outcomes (8)

  1. Pain Intensity

    Will be measured using the PROMIS Pain Intensity Scale which assesses pain the past 7 days using an 11-point numerical rating scale (NRS) with verbal anchors "no pain" at 0 and "worst pain you can think of" at 10. This tool demonstrates relevance, feasibility, and understandability for youth with chronic pain.

    Measured: 16 weeks

  2. Pain Interference

    Will be assessed using the PROMIS Pain Interference Short-form Scale and 8-item tool that uses a 5-point Likert scale, ranging from never to almost always, with higher scores representing greater interference with function.

    Measured: 16 weeks

  3. Anxiety

    Will be assessed using a PROMIS Paediatric Anxiety Short-form Scale, an 8-item tool that uses a 5-point Likert scale, ranging from never to almost always, with higher scores representing more anxiety symptoms.

    Measured: 16 weeks

  4. Depression

    Will be assessed using PROMIS Paediatric Depression Short-form Scale, an 8-item tool that used a 5-point Likert scale, ranging from never to almost always, with higher scores representing more depressive symptoms.

    Measured: 16 weeks

  5. Insomnia

    Will be assessed using a 7-item Insomnia Severity Index, higher score representing more severe insomnia.

    Measured: 16 weeks

  6. Health Related Quality of Life

    Will be assessed using a 7-item PROMIS Paediatric Global Health Short-form Scales with higher scores representing overall better health.

    Measured: 16 weeks

  7. School Attendance

    Will be assessed using a single item modified by investigators to capture school absenteeism as a continuous variable ranging from 0 to 240 days. Self-report of school attendance among a CP population is comparable to school administrative data.

    Measured: 16 weeks

  8. Healthcare Utilization

    Will capture family physician and emergency visits, psychological or physical therapies and changes in medication, using a CP modified version of Ambulatory and Home Care Record at T1 and T2.

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2023
  2. Study start5 Aug 2023
  3. Primary completion1 Sep 2025 (estimated)
  4. Study completion1 Sep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Implementation-effectiveness quasi-experimental design
Masking
None (open label)
Enrolment
93 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05894772
Sponsor's protocol ID
4025
Status last verified
Jul 2025
First submitted
30 May 2023
Last updated
4 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Power over Pain Portal in people with Chronic Pain, run by The Hospital for Sick Children at 11 sites 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 6 inclusion and 2 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 4 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 11 sites 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: 16 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05894772.

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 4 Jul 2025.

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