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

July 3, 2025 updated by: Jennifer Stinson, The Hospital for Sick Children
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
93

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
      • Calgary, Canada
        • Not yet recruiting
        • Alberta Children's Hospital
        • Principal Investigator:
          • Nicole Johnson, MD
      • Edmonton, Canada
        • Not yet recruiting
        • Stollery Children'S Hospital
        • Principal Investigator:
          • Janet Ellisworth, MD
      • Montreal, Canada
        • Not yet recruiting
        • Montreal Children's Hospital
        • Principal Investigator:
          • Sarah Campillo, MD
      • Vancouver, Canada
        • Not yet recruiting
        • BC Children's Hospital
        • Principal Investigator:
          • Lori Tucker, MD
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Not yet recruiting
        • IWK Health Center
        • Principal Investigator:
          • Adam Huber, MD
        • Contact:
          • Adam Huber, MD
        • Principal Investigator:
          • Patrick McGrath, MD
    • Ontario
      • Hamilton, Ontario, Canada, L8S 4K1
        • Recruiting
        • McMaster Children's Hospital
        • Principal Investigator:
          • Vicky Breakey, MD
      • London, Ontario, Canada, N6A 5W9
        • Not yet recruiting
        • Children's Hospital London Health Sciences
        • Contact:
      • Ottawa, Ontario, Canada
        • Not yet recruiting
        • Children's Hospital of Eastern Ontario (CHEO)
        • Contact:
          • Ciaran Duffy, MSc, FRCPC
        • Contact:
          • Karen Watanabe Duffy, MD, FRCPC
        • Sub-Investigator:
          • Paula Forgeron, MD
        • Sub-Investigator:
          • Karen Watanabe Duffy, MD, FRCPC
      • Toronto, Ontario, Canada, M5G 1X8
        • Recruiting
        • Hospital for Sick Children
        • Principal Investigator:
          • Jennifer Stinson, RN, PhD
        • Contact:
        • Contact:
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • Not yet recruiting
        • CHU Sainte-Justine
        • Principal Investigator:
          • Caroline Laverdiere, MD
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
        • Not yet recruiting
        • Jim Pattison
        • Contact:
          • Craig Eling

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention arm
Power over Pain Portal
Behavioral: Power over Pain Portal
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
16 weeks
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.
16 weeks
Appropriateness
Time Frame: 16 weeks
Perceived fit and compatibility of portal participants' needs. Assessed via the qualitative interview at T2.
16 weeks
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.
16 weeks
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.
16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
16 weeks
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.
16 weeks
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.
16 weeks
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.
16 weeks
Insomnia
Time Frame: 16 weeks
Will be assessed using a 7-item Insomnia Severity Index, higher score representing more severe insomnia.
16 weeks
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.
16 weeks
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.
16 weeks
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.
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hospital for Sick Children

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Health Network, Toronto
University of British Columbia
Centre for Addiction and Mental Health
University of Alberta
Seattle Children's Hospital
University of Calgary
Dalhousie University
London Health Sciences Centre
Children's Hospital of Eastern Ontario
University of Saskatchewan
McMaster Children's Hospital
St. Justine's Hospital
Provincial Health Services Authority
Quebec Pain Research Network
Memorial University of Newfoundland
Montreal Children's Hospital of the MUHC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 5, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 4025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings