NCT Number: NCT06076889
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.
Interested in participating?
Request Info12 year–18 year
All sexes
Observational
Toronto, Ontario, M5G 1X8, Canada
Location status: Recruiting
Chitra Lalloo, BHSc, PhD
CONTACT
416-813-7654 ext. 302332
Jennifer Stinson, RN, PhD
PRINCIPAL_INVESTIGATOR
Rachel Kelly, BA
CONTACT
416-813-7654 ext. 302314
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: 8 weeks
Assessed via the post-implementation qualitative interview.
Time frame: 8 weeks
Assessed using frequency counts and percentages of types/severity of problems encountered via monthly audit of technical support tickets
Time frame: 8 weeks
Assessed via characterization of the severity of encountered issues on the Power over Pain portal
Time frame: 8 weeks
Characterized by intervention use analytics.
Time frame: 8 weeks
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
Time frame: 8 weeks
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.
Time frame: 8 weeks
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.
Time frame: 8 weeks
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.
Time frame: 8 weeks
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.
Contact information is provided by the study sponsor or research team.
Chitra Lalloo, PhD
CONTACT
416-813-7654 ext. 302332
Jennifer N Stinson, RN, PhD
CONTACT
416-813-7654 ext. 304514
The Hospital for Sick Children
Other
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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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