Empowered Relief for Youth (ER-Y)

August 24, 2023 updated by: Laura E Simons, Stanford University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • 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 Backup

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford University
        • Principal Investigator:
          • Laura Simons, PhD
        • Sub-Investigator:
          • Lauren Harrison, PhD
        • Sub-Investigator:
          • Rashmi Bhandari, PhD

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

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

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
Intervention / Treatment
Experimental: Empowered Relief for Youth
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Expectancy Credibility (TEC-C)
Time Frame: Immediately post class
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
Time Frame: Immediately post class
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
Time Frame: Pre class, 4 weeks, 8 weeks, and 12 weeks post class
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)
Time Frame: 4 weeks, 8 weeks, and 12 weeks post class
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)
Time Frame: Pre class, 4 weeks, 8 weeks, and 12 weeks post class
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child Pain Self-Efficacy Scale (PSES-C)
Time Frame: Pre class, 4 weeks, 8 weeks, and 12 weeks post class
The Child Pain Self- Efficacy Scale assesses the participants self-efficacy with regard to normal functioning when in pain based on a ranked scale (score 1 = "very sure" to 5 = "very unsure") with higher scores indicating enhanced uncertainty.
Pre class, 4 weeks, 8 weeks, and 12 weeks post class
PROMIS Anxiety
Time Frame: Pre class, 4 weeks, 8 weeks, and 12 weeks post class
The PROMIS anxiety study assesses fear, fear, misery, hyperarousal, and somatic symptoms related to arousal within the past seven days. Each item is scored on a 1-5 rating scale (score 1 = "never" to 5 = "almost always") with higher scores indicating greater experience to anxiety.
Pre class, 4 weeks, 8 weeks, and 12 weeks post class
PROMIS Depression
Time Frame: Pre class, 4 weeks, 8 weeks, and 12 weeks post class
The PROMIS depression study assesses symptoms related to depression within the past seven days. Each item is scored on a 1-5 rating scale (score 1 = "never" to 5 = "almost always") with higher scores indicating greater depressive symptoms.
Pre class, 4 weeks, 8 weeks, and 12 weeks post class
Hope Scale
Time Frame: Pre class, 4 weeks, 8 weeks, and 12 weeks post class
The Hope Scale assess the participant's hope level based on a ranked scale (score 1 = "definitely false" to 8 = "definitely true") with a higher score indicating highly hopeful.
Pre class, 4 weeks, 8 weeks, and 12 weeks post class

Collaborators and Investigators

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

Sponsor

Stanford University

Investigators

  • Principal Investigator: Laura Simons, PhD, Stanford University

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)

August 9, 2023

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

August 9, 2023

First Submitted That Met QC Criteria

August 9, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

August 25, 2023

Last Update Submitted That Met QC Criteria

August 24, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 68451

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.

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