Empowered Relief for Youth: Development, feasibility and early effectiveness of a single session pain relief skills class

Abstract

Empowered Relief (ER) is a single-session pain management class that teaches pain science education and self-regulatory skills and has demonstrated efficacy in adults with chronic pain. We adapted ER for youth with chronic pain (Empowered Relief for Youth [ERY]) using patient partner and clinician input and evaluated feasibility, acceptability, and preliminary effectiveness in a single-arm clinical trial (NCT05998369). Among 236 youth referred from a tertiary pain clinic, 110 youth ages 10–18 years (M=14.8, SD=2.1) enrolled and completed ERY. Primary outcomes were feasibility and acceptability; secondary outcomes included pain interference, pain catastrophizing, anxiety, pain self-efficacy, and patient global impression of change assessed at 1-, 2-, and 3-month follow-up. Over 80% of participants rated ERY as credible, acceptable, and feasible and anticipated clinically meaningful improvement. Participants reported preliminary improvements in pain interference, pain catastrophizing, and anxiety from baseline to 1 month that were observed through 3 months. Pain self-efficacy improved at 2-month follow-up. Exploratory analyses showed a significant time-by-timing interaction for pain interference, with greater improvement at 3 months among youth who attended ERY within 30 days of their pain clinic evaluation compared to later attendance. These findings support ERY as a feasible, acceptable, and potentially promising brief behavioral intervention for youth with chronic pain.

Chronic pain in youth is a significant public health concern, with prevalence estimates of 20.8% with headache and musculoskeletal pain (25.7%)¹ most often reported, resulting in $19.5 billion in healthcare costs annually in the US alone². Notwithstanding the personal suffering and persistent physical and economic consequences for families, chronic pain in adolescence can predispose the persistence of chronic pain into adulthood³, highlighting the urgent need for effective and accessible pain care as early as possible in the developmental trajectory. Gold standard treatment of chronic pain is best situated within a biopsychosocial framework that integrates biological, cognitive, behavioral, and sociocultural influences that contribute to pain and associated impairment⁴. Optimal behavioral health interventions target this complex interplay through pain science education, physiological self-regulation, and cognitive and behavioral strategies that disrupt unhelpful thought and behavioral patterns to enhance functional restoration^5,6 There is strong evidence for behavioral health interventions in ameliorating pain intensity, functional impairment, and psychiatric comorbidities in pediatric chronic pain^7,8.

Unfortunately, availability of evidence based behavioral pain care remains limited due to shortage of services outside of urban centers, significant treatment-related costs, and long provider waitlists^9,10. Empowered Relief was developed to address the lack of widely available behavioral health interventions for adults with chronic pain^11,12. ER rapidly equips individuals with pain self-management skills through a 2-hour, single-session, skills-based pain management class focusing on pain science education and self-regulatory strategies to manage pain¹². Adults with chronic low back pain who attended ER experienced clinically meaningful reductions in pain catastrophizing, pain intensity, and pain interference at 3-months¹¹ with benefits persisting at 6-months¹³. Further, these positive outcomes were observed both for in-person and telehealth delivered ER^14–16.

To address the shortage of brief and accessible evidence-based behavioral health interventions for youth with chronic pain, our team adapted ER for youth living with chronic pain (Empowered Relief for Youth [ERY]). The current study outlines the development, feasibility, acceptability, and early effectiveness of ERY for youth with chronic pain. We hypothesized that ERY would be feasible and acceptable for youth with chronic pain, as indicated by high rates of participant attendance among those who registered and high levels of treatment credibility and satisfaction. We expected that the majority of participants would report that the class content was helpful and that the self-regulation skills taught in ERY were applicable for managing their pain. We also expected that participants who attended ERY would report reductions in pain interference and pain catastrophizing, from baseline to one-, two-, and three-month follow-up, and greater than half of attendees (>50%) would report minimal or greater improvement in pain at follow-ups. We conducted to post-hoc exploratory analyses focused on timing of delivery and parent presence during class attendance to inform future intervention and trial design.

Methods

Study Design

This was a single arm pilot trial preregistered at clinicaltrials.gov (NCT05998369). The study protocol was approved by the Stanford Institutional Review board (IRB-68451). The primary outcomes were post-class treatment acceptability and feasibility. Secondary outcomes were pain interference, pain catastrophizing, and patient global impression of change at 1-, 2-, and 3-month follow-up.

Participants

Youth evaluated at the Pediatric Pain Management Clinic (PPMC) at Stanford Children’s Health (SCH) from August 2023 to December 2024 were eligible to participate in this trial. Given that this was a small trial, class size was capped to eight youth, delivered monthly at a fixed day and time, and maintained an ongoing waitlist. Treatment inclusion criteria were: 1) Ages 10–18, 2) Chronic pain diagnosis (>3 months in duration), and 3) English speaking. Exclusion criteria were: 1) Significant psychosocial complexity (e.g., severe depression/ anxiety, unable to tolerate a group setting) determined by the multidisciplinary pain treatment team.

Procedures

Patients were referred to ERY by a member of the multidisciplinary pain treatment team (physician, pain psychologist, or physical therapist) at the PPMC either at the time of their initial pain clinic evaluation or later during ongoing pain care if the clinical team believed the intervention would be beneficial. Interested families completed an eligibility screening form that was reviewed by the study team within one business day. If eligible, families were invited to enroll in the next available ERY class based on scheduling and space availability, resulting in variable time between referral and class attendance. The week of class, consent/assent procedures were completed and youth and caregivers were guided through Zoom registration and baseline REDCap surveys prior to the class. At enrollment caregivers were invited to attend ERY alongside their child but were not required to do so. Youth then attended their scheduled ERY class via Zoom (approximately 1 hour, 45-minute class duration).

Intervention

ERY was based on the empirically supported ER class for adults with chronic pain. ER is a single-session, 2-hour pain management skills class that teaches evidence-based strategies-including pain education, self-regulation skills to extinguish unhelpful cognitive, emotional and physiologic arousal patterns, reduce pain-related distress, and facilitate positive coping and calming. It can be delivered live in-person or virtually. As part of the class, individuals develop a personalized plan for pain management skills to apply in their daily lives. ERY retains all the core elements of ER while being tailored to youth with chronic pain.

ERY development.

1) Patient partner input. We first invited four local youth patient partners (3 female identifying, 1 male identifying) aged 16–19 years, each with lived experience of pediatric chronic pain for more than 2 years, to individually watch a pre-recorded virtual adult ER class. The youth patient partners were encouraged to take notes as they viewed the class, including what was clear, confusing, and relevant. Youth then completed a semi-structured interview with a member of the research team focused on ER content and relevance with potential suggestions for ERY. Patient partners were financially compensated as per best practice guidelines¹⁷. 2) Clinician adaptation. Youth patient partners’ feedback and recommendation supported the psychology clinician research team (LEH, RPB, LES) in adapting the ER slide deck, including streamlining content to reduce class time, adjusting class examples to be more relevant to youth, and modifying images to be more reflective of youth’s experiences with pain. The ERY adaptations were reviewed and approved by Dr. Beth Darnall prior to launching the feasibility trial. 3) Participant feedback-led iterations. Youth feedback from exit interviews was collated and tracked on an ongoing basis by the research staff utilizing an online Mural board (likes, dislikes, suggestions for improvement). Based on this real-time feedback, changes were made to how the class was delivered (i.e., added breakout rooms for introductions and skills practice, a mid-class break, recorded a brief 10-minute binaural recording), but no suggestions led to content changes. Adaptations are outlined using the Framework for Reporting Adaptations and Modifications-Enhanced (FRAME) in Supplemental Table 1.

Clinician training and ongoing monitoring.

ER, and thus ERY, was developed to ensure fidelity with a standardized slide deck and instructor manual, coupled with the instructor certification process. All clinicians who facilitated ERY in this study (licensed psychologists, psychology postdoctoral fellows) attended an Empowered Relief (ER) Clinician Certification Workshop and received certification through the Stanford University Center for Continuing Medical Education (empoweredrelief.stanford.edu). The 11-hour interprofessional CME certification workshop includes didactics, observation of the delivery of ER, peer role play of delivering ER content, faculty feedback and group interaction, and access to all class presentation materials (instructor and patient-facing). The primary investigator (Laura E Simons [LES]) recorded the delivery of ERY for the purpose of clinician instructor training. Clinicians who delivered ERY met with LS to review the manual content and watched a recording of the ERY class prior to delivering their first class. In addition to training prior to delivery, the ERY research team had weekly in person meetings to discuss the delivery of the class, implementation of iterations from interview feedback and new referrals.

Measures

Primary Outcomes

Feasibility.

Treatment feasibility was operationalized using descriptive metrics of enrollment following referral, class attendance, and retention across follow-up assessments. Feasibility metrics were not prospectively specified in the original trial registration. These metrics were subsequently added to the trial record on ClinicalTrials.gov to improve transparency and are reported descriptively in accordance with the study’s feasibility objectives.

Acceptability.

Treatment acceptability was measured by the Treatment Expectancy and Credibility (TEC) scale¹⁸. The TEC is comprised of 6 items assessing treatment expectations and credibility. The first three item responses range from 0=not at all to 10=very much, with a rating of 0–5 considered negative or neutral and 6–10 considered positive (somewhat to very much). The second three items refer to percentage of improvement from 0% no change to 100% complete improvement, with ratings of 30% or greater considered clinically meaningful perceptions of potential improvement. Higher scores indicate higher acceptability. The TEC has been used in prior pediatric pain clinical trials¹⁹. The Program Feedback Scale (PFS)¹² assesses participant perceptions of ERY relevance, understandability, satisfaction, and anticipated skill use comprised of 1) seven statements on a scale: 0=really disagree to 4=really agree, with ratings of 3 to 4 considered agree to strongly agree, 2) two open-ended questions: What did you like about the class? and What would you change about the class?, and 3) three statements asking about satisfaction, relevance, and likelihood to practice skills based on a scale: 0=not at all satisfied/relevant/likely to practice to 6=completely satisfied/highly relevant/highly likely to practice, with ratings of 3 to 4 considered agree to strongly agree. The PFS was specifically designed to obtain feedback on the ER class (see Supplement for a copy of the PFS). TEC and PFS were completed at the end of class.

Secondary Outcomes

Pain Catastrophizing.

The Pain Catastrophizing Scale, child (PCS-C) is a 13-item survey that assesses pain-related distress with higher scores indicating greater pain-related distress. The internal consistency, factor structure, and validity are well supported²⁰. This was assessed at baseline, 1-, 2-, and 3-month follow-up.

Pain interference.

PROMIS Pain Interference is a well-validated 8-item measure that assesses the extent to which pain hinders engagement in life activities. Scores were converted to standardized T-scores with a higher score indicating greater pain interference²¹. This was assessed at baseline, 1-, 2-, and 3-month follow-up.

Patient Impression of Change.

The Patient Global Impression of Change scale asks participants a single item “Since the start of the Empowered Relief for Youth class, my overall pain is…”. Participants provide a rating from 0=“very much improved” to 6=“very much worse”²². This was assessed at 1-, 2-, and 3-month follow-up.

Other Outcomes

Self-Efficacy.

The Child Pain Self-Efficacy Scale is a 7-item measure that assesses the participants self-efficacy with regards to normal functioning when in pain based on a ranked scale (score 1=“very sure” to 5=“very unsure”) with lower scores indicating greater pain self-efficacy²³. This was assessed at baseline, 1-, 2-, and 3-month follow-up.

Anxiety.

PROMIS Anxiety scale is an 8-item measure that assesses symptoms of anxiety 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 of anxiety²⁴. Scores were converted to standardized T-scores. This was assessed at baseline, 1-, 2-, and 3-month follow-up.

Skills use and feedback.

Participants completed a Class Skill Use survey that consisted of 4 questions assessing their use of skills introduced in ERY, including: 1) a binaural relaxation recording, 2) best friend talk to reframe a negative mindset, 3) engagement in self-soothing actions, and 4) an open-ended question that asked about experience using the Empowered Relief Skills. Items 1–3 asked participants about the past month and response options were “not at all”, “a few times in the past month”, “a few times each week”, and “daily.” This was assessed at 1-, 2-, and 3-month follow-up. During the course of the trial we recognized that skill practice would be relevant to capture for future trial planning, this was assessed beginning in April 2024, thus assessed for 9 of the 17 class cohorts.

Excluded Measures.

We administered measures of depression, sleep, and hope at baseline but inadvertently did not administer them at the follow-ups until midway through the study. As they were Other Outcomes, we did not include that partial data here but include in the OSF(https://osf.io/tqpf6/) for full transparency.

Additional measures

Exit Interview.

We conducted exit interviews with participants to inform iterative changes to ERY. The exit interview was semi-structured and comprised of questions that centered on likes, dislikes, and suggestions for changes to ERY. These responses were collated on a mural board for weekly review with the clinician research team with iterative changes made over the course of the pilot trial.

Adverse events.

Adverse events were assessed at 1-, 2-, and 3-month follow-up. Youth were asked, “Is there anything that has happened related or unrelated to your participation in Empowered Relief for Youth that you want to report?” If they responded “Yes” they were asked, “What happened?” and “Was it related or unrelated to your participation in Empowered Relief for Youth?” During the course of the trial we recognized that adverse events would be relevant to capture for future trial planning, this was assessed beginning in April 2024, thus assessed for 9 of the 17 class cohorts.

Statistical Analyses

All statistical analyses were conducted with SPSS 26.

Primary outcomes.

Descriptive statistics were calculated. Open-ended responses from the Program Feedback Scale (PFS) were qualitatively analyzed using content analysis to distill themes of what participants liked about the class and what they would change. Frequencies represent the proportion of participants endorsing each theme.

Secondary outcomes.

Linear mixed effects models with maximum likelihood were used to examine effects of ERY across all secondary outcomes. We modeled outcomes at four time points (baseline, 1-month follow-up, 2-month follow-up, 3-month follow-up) (Model 1) using a mixed effects linear model with fixed effects for time and a random effect for individual. The random effect allowed us to account for the correlation in the outcome within individual over time.

Exploratory outcomes.

To explore timing of intervention delivery and caregiver presence, we conducted an exploratory analysis with a separate interaction model for time since pain clinic evaluation (≤ 30 days and > 30 days; Model 2) and caregiver presence during delivery of the class (present/not present; Model 3).

Results

Participant characteristics.

As detailed in the consort diagram (Figure 1), 308 youth in the pain clinic were assessed for eligibility. Patients (n=91) did not meet eligibility criteria for the following reasons: referred to another intervention (n=58), ineligibility due to age (n=11), language (n=15), and psychiatric complexity (n=7). Of the 217 youth who were referred for ERY, 132 enrolled (60.8% enrollment rate) with remaining referrals either not interested (18%; n=39) or lost to follow-up (21%; n=46). After screening, recruitment, and enrollment, 110 eligible participants (10–18 years; M=14.6, SD=2.15) attended the ERY class (83.3% attendance rate). Among the 22 who consented but did not attend, reasons for not attending included: lost to follow-up (n=14), too busy (n=4), sick (n=2), felt it was no longer needed (n=1), or anxiety (n=1). As detailed in Table 1, the cohort diversity was aligned with historical data from this clinic with less than 60% identifying as White and female gender (historic clinic rates: 68% White, 75% female)²⁵. Among the cohort, 51.8% (n=57) of youth had a caregiver who attended the class with them. The most common pain locations included head, shoulder/neck, abdomen, back, or leg/foot. Most participants reported pain for greater than 1 year (74.6%) occurring on a daily basis (71.4%). Time since evaluation varied greatly (range 1–1299) with approximately half of participants attending class one month after evaluation (median=29 days).

Figure 1.

ERY Consort.

Table 1.

Participant demographics and pain characteristics (n=110).

Characteristics	Category	Frequency
Age	Mean (SD)	14.7 (2.15)
Sex at birth	Male	27.3% (30)
	Female	72.7% (80)
Race/Ethnicity	Asian or Pacific Islander	10.0% (11)
	Black or African American	0.9% (1)
	Hispanic or Latino	11.8% (13)
	Native American or Alaskan Native	0.9% (1)
	White or Caucasian	57.3% (63)
	Multiracial or Biracial	11.8% (13)
	Other	1.8% (2)
	No Response/Decline to Answer	5.5% (6)
Gender Identity	Boy or Man	26.4% (29)
	Girl or Woman	58.1% (64)
	I am not sure	1.8% (2)
	Nonbinary/genderfluid/genderqueer	9.1% (10)
	Transgender Male	3.6% (4)
	Transgender Female	0.9% (1)
Pain Duration	In the past 3 months	3.6% (4)
	Between 3–6 months	8.2% (9)
	Between 7–12 months	7.3% (8)
	More than 1 year ago	47.3% (52)
	More than 5 years ago	27.3% (30)
Frequency of pain (n=105)	Daily	71.4% (75)
	One or more days a week	26.6% (28)
	Less than once a week	2% (2)
Pain Location*	Head	56.4% (62)
*could endorse 1 or more	Face or Jaw	20.9% (23)
	Shoulder or Neck	54.5% (60)
	Chest	22.7% (25)
	Arm or Hand	41.8% (46)
	Abdomen or Stomach	50% (55)
	Back	56.4% (62)
	Leg or Foot	52.7% (58)
	Hip	36.4% (40)
	Groin	10.9% (12)
	Other	15.5% (17)
Days since evaluation	Median (range)	29 (1–1299)

Primary Outcomes

Feasibility.

ERY demonstrated feasibility within a tertiary pain care clinic setting with a 60.8% enrollment rate and 83.3% attendance rate among enrolled participants. Retention across follow-up assessments among the 110 attendees was acceptable with 95.4% (n=105) completing post-class measures, 80% (n=88) completing 1-month follow-up, 70.9% (n=78) completing 2-month follow-up, and 64.5% (n=71) completing 3-month follow-up.

Acceptability.

Most participants found ERY relevant and easy to understand, agreed with the class message, and would recommend it to their peers with chronic pain (>80%; Table 2 PFS items 1–7). Most participants reported that they anticipated that it would improve their pain by at least 30% (range: 74.9–80.8%) (Table 2 TEC).

Table 2.

Treatment Acceptability

	% (n)
Program Feedback Scale (PFS; n=105)	Agree to Strongly Agree 1
I enjoyed the class	73.3% (77)
I understood the class material	90.5% (95)
This class was easy to understand	86.7% (91)
I tried my hardest during the class	89.5% (94)
I think the class would be helpful to other teens my age	81.9% (86)
I would recommend this class to a friend with chronic pain	81.9% (86)
I agree with the class message	89.5% (94)
	Somewhat to Completely Satisfied
Rate your overall satisfaction with the class	84.8%
	Somewhat to highly relevant
How relevant was the class to you?	80.8%
	Somewhat to highly likely
How likely are you to use the skills and information that you learned?	83.8%
Treatment Acceptability and Credibility (TEC; n=104)
	Somewhat to Very Much 3
Does Empowered Relief make sense for treating your pain?	85.6%
How successful do you think Empowered Relief will be in improving your pain?	69.1%
How confident would you be in recommending Empowered Relief to a friend with the same problems?	76.0%
	≥ 30%	≥ 50%
	Improvement	Improvement
By using Empowered Relief skills, how much do you think Your pain will improve?	80.8%	57.7%
At this point, how much do you really feel that Empowered Relief skills will help to improve your pain?	74.9%	50.9%
By using Empowered Relief skills, how much do you feel your Pain will improve?	76.9%	51.9%

Note.

¹PFS agreement ratings were on a 0–4 scale with 3 to 4 considered agree to strongly agree

²PFS satisfaction, relevance, and anticipated skills practice were on a 0–6 scale with ≥ 4 considered somewhat to completely

³TEC ratings were on a 0–10 scale with ≥ 6 considered somewhat to very much.

When asked, “What did you like about the class (PFS item 8; n=101 responses)?” Participants described the ERY class as generally engaging, informative, and validating. Their sentiments fit into three themes described below.

Connection and shared experience:

This was the most frequently endorsed theme (31%, n=31). Youth emphasized that the group format, including hearing from others with similar pain experiences during the class, made them feel understood, validated, and less alone in their pain journey.

Learning helpful pain management strategies and skills:

This theme, endorsed by 19% (n=19) of participants highlighted participants reports that the skills they learned in ERY, including relaxation, coping, and mindset-based techniques, were perceived as directly applicable to daily life. About 12% (n=12) reported that the class enhanced their education and understanding of pain, particularly around how the brain and body interact in pain perception. A few youth (3%, n=3) specifically noted that they appreciated the evidence-based nature of the program.

Class Delivery:

Many youth also highlighted the structure, format, and accessibility of the class (17%, n=17), describing the online, interactive design as easy to follow and engaging. Clarity, simplicity, and effective teaching were noted by 15% (n=15), with participants commending the instructor’s communication and the organization of material. Collectively, these findings highlight that the ERY class was well-received across domains, with connection and shared experience emerging as a particularly meaningful component of the intervention.

When asked, “What would you change about the class (PFS item 9; n=97)?” Most youth suggested no changes or expressed high satisfaction with the ERY class (29%, n=28), describing it as comprehensive and effective in its current form. A small number of youth provided feedback that the class was not helpful (3%, n=3). Among those suggesting modifications, two themes were generated from youth’s reports, which are described below.

Technical and format changes:

The most common recommendations focused on technical or format tweaks (21%, n=20), such as minor adjustments to slides, visuals, or the virtual platform to improve ease of participation. An equal proportion of participants (21%, n=20) requested more opportunities for interaction and discussion, including additional time for breakout sessions or peer sharing to enhance engagement and connection. One participant (1%) suggested the intervention should be shorter.

Content changes:

Some respondents offered content-related suggestions (13%, n=13), such as expanding certain topics (e.g., brain-based research) or adding examples to deepen understanding, while others noted the potential value of tailoring the class to age or developmental level (8%, n=8).

Overall, youth reported strong satisfaction and acceptability of the ERY class, with most suggestions aimed at optimizing delivery and interactivity rather than altering core content.

Secondary and Other Outcomes

Means and standard deviations of secondary and other outcomes across all time points with sample sizes for each measure is detailed in Table 3.

Table 3.

Secondary and other outcome measure means and standard deviations across time

Measure	Baseline	1-month	2-month	3-month
Secondary Outcomes
PROMIS Pain Interference	59.8 (7.6)	56.7 (10.1)	55.3 (9.4)	55.7 (10.0)
Pain Catastrophizing Scale	24.1 (12.0)	21.6 (12.5)	20.4 (11.8)	21.2 (12.4)
Other Outcomes
Pain Self-Efficacy Scale	20.5 (6.2)	18.9 (7.0)	19.9 (7.4)	18.8 (7.6)
PROMIS Anxiety	53.9 (12.3)	51.3 (11.8)	51.1 (11.5)	51.4 (10.9)

Note. Samples sizes for baseline, 4w, 8w, 12w for each measure. PROMIS Pain Interference: N = 106, 88, 78, 70; Pain Catastrophizing Scale: N = 105, 87, 78, 69; Pain Self-Efficacy Scale: N = 106, 87, 77, 68; PROMIS Anxiety: N = 106, 88, 77, 71. For pain self-efficacy, lower scores indicates less uncertainty.

Change from baseline.

Mixed-effects models for pain interference and pain catastrophizing (secondary outcomes) and pain self-efficacy and anxiety (other outcomes) for Model 1 (baseline, 1 month, 2 months, 3 months) are detailed in Table 4. For pain interference, pain catastrophizing, and anxiety significantly decreased in comparison to baseline at 1-month, 2-month, and 3-month follow-up. Pain self-efficacy significantly improved at 1-month follow-up relative to baseline.

Table 4.

Model 1 estimates for secondary outcomes.

	Intercept (Baseline) (95% CI)	1-mon FU (95% CI)	2-mon FU (95% CI)	3-mon FU (95% CI)
Secondary
Pain Interference	59.9 (58.1–61.6)	−3.04 (−4.70– −1.38)*	−3.98 (−5.30– −2.66)*	−4.11 (−6.12– −2.10)*
Pain Catastrophizing	24.0 (21.7–26.3)	−2.90 (−5.26– −0.53)*	−3.88 (−5.77– −1.98)*	−3.32 (−6.16– −0.48)*
Other
Pain Self-Efficacy	20.5 (19.2–21.8)	−1.44 (−2.86– −0.02)*	−0.64 (−1.80–0.52)	−1.37 (−3.07–0.33)
Anxiety	53.9 (51.7–56.1)	−2.45 (−4.51– −0.39)*	−2.55 (−4.19– −0.92)*	−3.40 (−5.90– −0.90)*

Note. Intercept is the estimated baseline with values at 1-, 2-, and 3-mon FU representing a change from baseline.

^*p<0.01 using Bonferroni post-hoc pair-wise comparisons.

Patient Global Impression of Change.

Participant ratings of overall pain improvement across follow-up are shown in Figure 2. At 4 weeks, 68% of participants endorsed at least minimal improvement, including 19% who reported being much or very much improved. By 8 weeks, 64% reported some level of improvement, and by 12 weeks, 65% indicated improvement, with 32% reporting much or very much improved. Reports of worsening were infrequent at all assessments (≤10%). These data demonstrate that two-thirds of participants perceived clinically meaningful benefit following participation in ERY.

Figure 2. Pediatric Global Impression of Change (PGIC) scores across time.

More than half of participants reported minimally to very much improved after the ERY class with 68.2% at 1-month (n=60 of 88), 63.3% at 2-month (n=50 of 79) and 64.3% at 3-month (n=45 of 70).

Skills use and feedback.

Of the 60 youth who attended one of the class cohorts from April 2024 to December 2024, 86.7% (n=52) completed it at 1-month and 81.7% (n=49) completed it at 2-month and 3-month follow-ups with self-reported engagement with ERY skills presented in Table 5. Across follow-up time points, the majority of participants reported continued use of ERY strategies, though frequency varied by skill type. Regarding audio file practice, about half of participants reported use a few times in the past month at 1-month, with use declining modestly by 3-months (37%). For reframing negative mindset, roughly 60% of participants reported engaging in this strategy at least occasionally at each timepoint, with a small increase in weekly practice over time (from 17% at 1-mont to 29% at 3-month). Self-soothing actions showed the highest and most sustained engagement, with daily practice increasing from 25% at 1-month to 43% at 3-months and nearly 90% of participants reporting some level of use across all timepoints.

Table 5.

Frequency of Skill Practice by Timepoint

Frequency of Practice	1 month (N=52)	2 month (N=49)	3 month (N=49)
Audio File Practice
Daily	3.8% (2)	4.1% (2)	2.0% (1)
A few times each week	13.5% (7)	6.1% (3)	8.2% (4)
A few times in the past month	46.2% (24)	32.7% (16)	36.7% (18)
Not at all	36.5% (19)	57.1% (28)	53.1% (26)
Reframing Negative Mindset
Daily	13.5% (7)	20.4% (10)	16.3% (8)
A few times each week	17.3% (9)	18.4% (9)	28.6% (14)
A few times in the past month	38.5% (20)	42.9% (21)	28.6% (14)
Not at all	30.8% (16)	18.4% (9)	26.5% (13)
Self-Soothing Actions
Daily	25.0% (13)	32.7% (16)	42.9% (21)
A few times each week	32.7% (17)	26.5% (13)	14.3% (7)
A few times in the past month	32.7% (17)	26.5% (13)	28.6% (14)
Not at all	9.6% (5)	14.3% (7)	14.3% (7)

Exploratory: Change from baseline by time since evaluation.

We also examined a separate interaction model for time since pain clinic evaluation (≤ 30 days [early] and > 30 days [later]; Model 2; Supplementary Table 2). Given that median for time since evaluation was 29 days, we used 1 month as a potentially clinically meaningful metric for comparison. There were no baseline differences between the early and later groups across outcomes. Youth in both groups reported significant improvements in pain interference, pain catastrophizing, and anxiety over time relative to baseline. Pain self-efficacy was reported to be improved at 3-month follow-up only. A significant time × evaluation interaction emerged for pain interference, indicating that participants who attended ERY within 30 days of their evaluation exhibited greater reductions in pain interference at 3-month follow-up relative to those with a longer interval between evaluation and class attendance (Supplemental Figure 1). No significant time-by-evaluation interactions were observed for pain catastrophizing, pain self-efficacy, or anxiety.

Caregiver presence during ERY class.

We also examined a separate interaction model for caregiver presence during class delivery (present/not present; Model 3; Supplementary Table 3). Among the cohort, 51.8% (n=57) of youth had a caregiver who attended the class with them. There were no baseline differences between the caregiver present and not present groups across outcomes. Youth within the parent present group reported significant improvements in pain interference and pain catastrophizing, over time relative to baseline. Anxiety was reported to be improved at 1-month follow-up only. A significant time × caregiver present interaction emerged for pain self-efficacy indicating that participants who attended ERY without their caregiver exhibited greater improvements (decreased scores) in pain self-efficacy at 3-month follow-up relative to those who attended class with a caregiver (Supplemental Figure 2). No significant time-by-evaluation interactions were observed for pain interference, pain catastrophizing, or anxiety.

Adverse events.

Among 64 youth assessed for adverse events, no serious adverse events were reported, with 5 mild events reported. Three were considered possibly related to ERY and mild in nature (e.g., difficulty engaging with skills or discomfort with the breakout room format). Two events were deemed unrelated to the intervention.

Discussion

The current investigation evaluated the feasibility, acceptability, and preliminary signals of clinical improvement of Empowered Relief for Youth (ERY), a single-session pain management skills class adapted from Empowered Relief for adults. Overall, the findings demonstrate that ERY was feasible to deliver in a tertiary pediatric pain clinic with minimal clinician training/burden, highly acceptable to participants, and associated with significant improvements in pain interference, pain catastrophizing, and anxiety that were maintained over three months. The post-hoc exploratory analysis found that youth who participated within one month of their initial interdisciplinary pain clinic evaluation exhibited greater improvements in pain interference at 3-month follow-up relative to those who waited longer, suggestive of a potential timing effect that warrants further evaluation.

Intervention Co-Development

It is recognized that the development of impactful, relevant, and equitable interventions requires the involvement of people with lived experience^26,27. Youth patient partners contributed to the earliest stage of the adaptation of ER for youth with chronic pain by reviewing the adult ER class and offering their reflections on what was clear, confusing, and relevant to own experiences. Their input was integral and directly informed early adaptations of both the format and content of ERY, including modifications to visual material and streamlining material to reduce class time. This early partnership ensured the initial iteration of the intervention was anchored in youth’s lived experiences. Further, ongoing qualitative feedback from youth obtained through exit interviews and open-ended qualitative responses, iteratively informed refinement of ERY. For example, ERY class size was capped at 8 attendees, compared to 50 or more attendees in adult ER, enabling more interaction with individual participant introductions at the start of class and the capability to do breakout rooms for skills practice. Together, this patient partnered approach ensured ERY was shaped by the youth it was designed to support.

Feasibility and Acceptability

Feasibility was supported by enrollment and retention rates, with 83% of referred youth attending ERY and the majority completing follow-up assessments. Acceptability ratings indicated that the class was perceived as relevant, easy to understand, and useful, consistent with prior adult Empowered Relief trials^{11,14–16,28} and clinical care qualitative reports²⁹. Qualitative youth reports emphasized connection with peers, shared experience, and acquisition of practical, evidence-based coping strategies as the most valued aspects of participation. Together, these findings affirm that a single-session behavioral intervention can be successfully implemented within pediatric pain services, supporting the feasibility of implementing a brief, scalable behavioral intervention that may serve as an accessible early behavioral support or adjunct to interdisciplinary pain care.

Initial Clinical and Mechanistic Signals

Preliminary signals of improvement in pain interference, pain catastrophizing, and anxiety support ERY’s potential as a brief, transdiagnostic intervention targeting key psychological mechanisms of pain-related disability. These effects parallel findings from adult Empowered Relief trials^{11,14–16,28}, suggesting shared cognitive and affective mechanisms across developmental stages. Reductions in pain catastrophizing may reflect increased understanding of pain neuroscience, normalization of pain experiences, and acquisition of cognitive reframing skills and has been identified as an important mechanism of change in pediatric pain treatment³⁰. Improvements in anxiety are promising given the class’s brevity and suggest that targeting catastrophic thinking and self-regulation may yield broader emotional benefits. In addition, the modest improvement in pain self-efficacy with significant signal at 2-month follow-up relative to baseline suggests a promising clinical endpoint that could be further enhanced through ongoing prompts for skills practice after class attendance via text messaging.

Exploratory Examination of Intervention Delivery Timing and Parent presence

The exploratory time-by-evaluation interaction for pain interference provides hypothesis generating insight into how ERY may function within pediatric pain care pathways. Youth who attended ERY closer to their initial pain clinic evaluation demonstrated greater improvements in pain interference at 3-month follow-up relative to those who attended later during ongoing pain care. This finding may reflect multiple interacting factors beyond timing alone, including stage of treatment engagement, readiness for self-management, or alignment of ERY with the initial pain treatment planning process. In addition, exploratory analyses examining caregiver presence during class delivery suggested that youth who attended independently demonstrated greater improvements in pain self-efficacy at 3-month follow-up relative to those who attended with a caregiver. This observation may reflect differences in autonomy, engagement, or family dynamics, though caregiver attendance was not randomized and likely reflected individual family preferences and clinical considerations. Because these exploratory analyses were post-hoc and reflected pragmatic clinical care pathways, findings should be interpreted cautiously and warrant prospective study.

Skill Use and Self-Management

Youth reported continued use of ERY skills over time, with the highest and most sustained engagement observed for self-soothing actions and moderate to low engagement for cognitive reframing and relaxation audio practice. These data suggest that even a single-session intervention can promote enduring adoption of pain self-management strategies. The preference for active, sensory-based strategies may reflect developmental and contextual relevance for adolescents and underscores the importance of flexible, experiential approaches. Consistent engagement with ERY skills over 3 months suggests potential durability of learning and supports the intervention’s potential to serve as a foundational behavioral platform on which more intensive treatments can build. Observed levels of engagement also provide opportunities for enhancement efforts through potentially providing means for youth to track skills practice coupled with text message prompts that provide encouragement.

Limitations

Interpretation of findings should consider several limitations. The single-arm design precludes causal inference; observed changes may reflect natural recovery or expectancy effects. Self-reported measures are subject to response bias. Attrition at later assessments reduced statistical power for detecting small group differences, particularly for interaction effects and given the preliminary clinical signal lens, we did not control for multiple comparisons. The sample was drawn from a single tertiary pain clinic and primarily included English-speaking youth, which limits generalizability beyond specialized pain care settings. We did not systematically track concomitant treatments during the follow-up period, which limits our ability to determine the extent to which observed changes may reflect the effects of ERY versus other ongoing medical, psychological, or rehabilitative care. Given variability in timing of ERY participation relative to initial clinic evaluation, participants likely differed in their exposure to concurrent treatments during follow-up. Future studies should incorporate systematic tracking of concomitant care to better isolate intervention-specific effects. Skills practice data were available only for later cohorts, thus represent only half the sample. Less than half the sample was inadvertently not administered measures of depression, sleep, and hope at follow-ups. Given that these are constructs that have been examined in adult ER with evidence of clinical signal^11,15, it will be important to include these measures in future studies as potential mechanisms and outcomes. Although acceptability, credibility and relevance were rated highly for ERY, some did not agree with the core messages of the class and future work should include assessment of treatment preferences among these individuals. Although it is recognized that parent factors have an important impact on outcomes for youth with chronic pain^31–33, caregivers were not required to attend ERY with their child and thus their lack of explicit involvement could have limited impact. A class specifically tailored to caregivers of youth with chronic pain could significantly enhance outcomes and plans for its design and testing are underway.

Future Directions

Building on this feasibility trial, randomized controlled trials are needed to establish efficacy and identify mediators of treatment response, including reductions in pain catastrophizing and increases in acceptance or regulatory capacity. Future studies should explore scalability beyond tertiary care settings where adult ER has had considerable success¹⁵ and evaluate digital asynchronous or hybrid delivery formats to enhance accessibility. Examining dose-response effects, including whether brief booster sessions sustain or augment outcomes, may also inform optimization. Integrating ERY earlier in clinical pathways could potentially reduce delays to behavioral care and possibly accelerate functional recovery for youth with chronic pain. Moreover, devising a class for caregivers that can either be delivered in tandem or independently could enhance clinical effects.

Conclusions

Overall, ERY was found to be feasible, acceptable, and a promising single-session behavioral intervention for youth with chronic pain. The program yielded significant and sustained improvements in pain interference, catastrophizing, and anxiety, with evidence that earlier delivery may enhance early gains. These findings highlight the potential for streamlined, mechanism-targeted behavioral treatments to extend access to pain care and provide youth with self-management skills.

Highlights.

• ERY was co-developed with youth partners with lived experience of chronic pain.

• ERY was feasible to implement within a tertiary pediatric pain clinic.

• Most youth rated ERY as relevant, understandable, and acceptable.

• Youth highlighted peer connection and practical coping skills as key benefits.

• ERY showed promising preliminary improvements in pain-related outcomes.

Perspective.

This study suggests that a single-session behavioral pain intervention for youth was associated with sustained improvements in pain interference and catastrophizing, key mechanisms implicated in pain-related disability.

Data availability and statistical analysis plan.

The data that support the findings of this study and the statistical analysis plan are available on Open Science Framework at https://osf.io/tqpf6/.