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NCT Number: NCT05894772

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

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Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IWK Health Center, Halifax, Nova Scotia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Power over Pain Portal

Behavioral

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.

Primary outcomes

  1. Acceptability

    Time frame: 16 weeks

    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.

  2. Adoption

    Time frame: 16 weeks

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

  3. Appropriateness

    Time frame: 16 weeks

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

  4. Portal Feasibility

    Time frame: 16 weeks

    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.

  5. Fidelity

    Time frame: 16 weeks

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

Secondary outcomes

  1. Pain Intensity

    Time frame: 16 weeks

    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.

  2. Pain Interference

    Time frame: 16 weeks

    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.

  3. Anxiety

    Time frame: 16 weeks

    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.

  4. Depression

    Time frame: 16 weeks

    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.

  5. Insomnia

    Time frame: 16 weeks

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

  6. Health Related Quality of Life

    Time frame: 16 weeks

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

  7. School Attendance

    Time frame: 16 weeks

    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.

  8. Healthcare Utilization

    Time frame: 16 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chitra Lalloo, PhD

CONTACT

[email protected]

416-813-7654 ext. 302332

Jennifer N Stinson, RN, PhD

CONTACT

[email protected]

416-813-7654 ext. 304514

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Centre for Addiction and Mental Health
  • Children's Hospital of Eastern Ontario
  • Dalhousie University
  • London Health Sciences Centre
  • McMaster Children's Hospital
  • Memorial University of Newfoundland
  • Montreal Children's Hospital of the MUHC
  • Provincial Health Services Authority British Columbia
  • Quebec Pain Research Network
  • Seattle Children's Hospital
  • St. Justine's Hospital
  • University Health Network, Toronto
  • University of Alberta
  • University of British Columbia
  • University of Calgary
  • University of Saskatchewan

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 8, 2023
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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