NCT06076889

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 31, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

October 11, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

July 2, 2025

Status Verified

June 1, 2025

Enrollment Period

2.9 years

First QC Date

September 13, 2023

Last Update Submit

June 27, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    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.

    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

    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

    8 weeks

  • Fidelity

    Characterized by intervention use analytics.

    8 weeks

Secondary Outcomes (5)

  • Client outcomes

    8 weeks

  • Client outcomes

    8 weeks

  • Client outcomes

    8 weeks

  • Client outcomes

    8 weeks

  • Client outcomes

    8 weeks

Interventions

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.

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Jennifer N Stinson, RN, PhD

CONTACT

Chitra Lalloo, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinician Scientist, Clinical Nurse Specialist/NP

Study Record Dates

First Submitted

September 13, 2023

First Posted

October 11, 2023

Study Start

October 31, 2022

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

July 2, 2025

Record last verified: 2025-06

Locations