Empowered Relief for Youth

Study Overview
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Brief Summary
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The purpose of this pilot study is to examine the feasibility and preliminary efficacy of Empowered Relief for Youth with chronic pain (ER-Y). ER-Y is a single-session pain management class for youth focused on pain science education and teaching self-regulatory skills for pain management based on the evidence-based adult ER class. Feasibility and acceptability of ER-Y will be assessed post-class. Preliminary efficacy will be assessed by administering surveys at baseline, 4-weeks, 8-weeks, and 12-weeks post class.

Detailed Description
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The current proposed, single-arm, uncontrolled pilot study will determine a) feasibility of ER-Y in youth with chronic pain, b) patients' perceptions and satisfaction of the ER-Y class and c) preliminary efficacy to inform the design of a subsequent randomized controlled trial.

Official Title
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Empowered Relief for Youth: A Feasibility Study of a Pain Management Class for Youth With Pain

Conditions
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Chronic Pain, Musculoskeletal Pain, Fibromyalgia, Neuropathic Pain, Complex Regional Pain Syndromes, Abdominal Pain

Intervention / Treatment
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* Behavioral: Empowered Relief for Youth


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age at least 10 years old to 18 years Diagnosis of Chronic Pain English speaking Exclusion Criteria: Diagnosis of neurological conditions such as seizures, cerebral palsy, developmental delay Severe affective disorder (e.g., severe depression/ anxiety) from medical record review.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Empowered Relief for Youth<br>Empowered Relief for Youth is a single-session pain management class focused on pain science education and teaching self-regulatory skills for pain management based on the evidence-based adult ER class. | Behavioral: Empowered Relief for Youth<br>* The Empowered Relief for Youth is a 90-minute class that provides pain science education, as well as cognitive, emotional, and physiologic self-regulation skills for youth with chronic pain. Youth will also develop a personalized plan to use the acquired skills daily. Participants will receive an audio file (Relaxation Response) post-class. The class provides patients rapid access to actionable skills for symptom management and pain relief.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Expectancy Credibility (TEC-C) | The TEC-C assess treatment expectations and credibility with standardized sum scores from using a numeric rating scale (score 0 = not at all to 10 = very much) with a higher score indicating high expectations. | Immediately post class | 
| Program Feedback Scale | The Program Feedback Scale assesses participants agreement to seven statements indicating their perceived acceptability and feasibility based on a scale (score 0 = really disagree to 4 = really agree) with a higher score indicating positive feedback and two open ended questions. | Immediately post class | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS Pain Interference | The PROMIS Pain Interference form assesses to what level pain hinders their engagement in several activities using a ranked scale (score 0 = never to 4 = almost always) with a higher score indicating great pain interference. | Pre class, 4 weeks, 8 weeks, and 12 weeks post class | 
| Patient Global Impression of Change (PGIC) | The Pain Global Impression of Change survey asks participants to rank how their overall pain has changed since the start of study using a ranked scale (score 0 = very much improved to 6 = very much worse) with higher scores indicating greater severity to their pain. | 4 weeks, 8 weeks, and 12 weeks post class | 
| Pain Catastrophizing Scale (PCS) | The Pain Catastrophizing Scale -Child Version (PCS-C, Crombez et al., 2003) assesses negative cognitions associated with pain. The PCS-C is comprised of 13-items rated on a 5-point Likert scale (score 0= not at all true to 4 very true). A total score (0-52) is obtained by summing all items. Higher scores indicate higher levels of catastrophic thinking. | Pre class, 4 weeks, 8 weeks, and 12 weeks post class |