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Not yet recruitingNCT07636980ER-CYUpdated Aug 20, 2026

Empowered Relief for Caregivers

An interventional study of Empowered Relief for Caregivers (ER-CY) in Chronic Pain, Musculoskeletal Pain and Fibromyalgia, sponsored by Stanford University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by Stanford University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 47 studies in Chronic Pain by Stanford University — 14 open to participants now, 19 under way, 1 of them phase 3. Chronic Pain · Stanford University.

Planned enrollment
19th of 37
80 · median 80
Started
2026
with 5 others
No phase
25 of 47
7 open now
Primary completion
2027-12
later than 13 of 18 live
Registered
44th of 47
by date

Among the 47 studies in Chronic Pain by Stanford University, this one is the 19th largest by planned enrollment of the 37 interventional ones, is one of 6 that started in 2026, is one of 25 with no phase, reaches primary completion later than 13 of the 18 other live ones, and was the 44th registered.

By phase

47 studies; the count open now beside each. This study's row is marked.

No phasethis study25 · 7 open
Observational10 · 3 open
Phase 16 · 2 open
Phase 43 · 1 open
Phase 32 · 1 open
Phase 21 · 0 open

By the year they started

First in 1998; this study’s year is marked. 6 started in 2026.

Size and results

Median enrollment 80 across the 37 interventional studies, 263 across the 10 observational. Of the 21 that completed or were terminated, 10 (48%) have results posted.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 47 studies in Chronic Pain by Stanford University, or all of them as a file.
02

Study summary

This study is testing a new program called Empowered Relief for Caregivers (ER-CY), designed to support caregivers of children and teens who live with chronic pain. ER-CY is a single two-hour class delivered online. It teaches skills for managing the stress of caring for a child in pain and for responding to a child's pain in helpful ways.

Up to 80 caregivers of youth with chronic pain will take part in one ER-CY class and then complete surveys and a short interview over the following three months. The researchers want to learn two things: whether caregivers are willing and able to take part and find the program helpful and satisfying, and whether the program lowers caregiver distress and improves their child's day-to-day functioning. What is learned will help guide future programs and care for youth with chronic pain and their families.

Read the detailed description

Background and Rationale: Chronic pain is common in youth and is associated with significant long-term physical and mental health consequences, yet it remains under-recognized and undertreated. Cognitive behavioral therapy (CBT) is an effective treatment, but access barriers limit its reach, leaving a gap for scalable, accessible interventions. Empowered Relief (ER) is a single-session, skills-based intervention that has produced outcomes comparable to multi-session CBT in adults; a youth adaptation (ER-Y) has shown strong feasibility, acceptability, and effectiveness. At the same time, caregiver distress, including anxiety and depressive symptoms, is associated with worse child pain outcomes, but few brief, accessible interventions exist to support caregivers themselves. To address this gap, the investigators co-designed Empowered Relief for Caregivers (ER-CY), a brief virtual intervention for caregivers of youth with chronic pain, and designed this study to evaluate its feasibility, acceptability, and preliminary effectiveness.

Objectives: The study has two aims. Aim 1 is to assess the feasibility and acceptability of ER-CY, indexed by participant attendance and ratings of credibility and satisfaction. Aim 2 is to evaluate preliminary effectiveness, indexed by caregiver distress, caregiver behavior in response to their child's pain, and parent-reported youth pain interference. The investigators hypothesize that ER-CY will demonstrate strong feasibility and acceptability and that caregivers will show reduced distress and reduced unhelpful responses to pain, along with improvements in youth pain-related functioning over time.

Design and Procedures: This is a single-group study enrolling up to 80 caregivers of youth with chronic pain, conducted at the Pediatric Pain Management Clinic at Stanford Medicine Children's Health. Caregivers identified through the clinic complete an eligibility questionnaire, a screening call, and informed consent, and then complete baseline surveys via REDCap. Participants attend one approximately two-hour ER-CY class delivered virtually via Zoom and complete post-class surveys immediately afterward. Within one to two weeks, participants complete a semi-structured qualitative interview, which is audio- and video-recorded for analysis. Outcome and monitoring assessments are repeated at 1, 2, and 3 months following the intervention. Changes over time will be examined using mixed-effects models, and no interim analysis is planned.

03

Conditions studied

  • Chronic Pain
  • Musculoskeletal Pain
  • Fibromyalgia
  • Neuropathic Pain
  • Complex Regional Pain Syndromes (CRPS)
  • Abdominal Pain (AP)
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Caregiver of a youth with a chronic pain diagnosis (>3 months in duration)
  • English speaking

Exclusion criteria

Exclusion Criteria:

  • Significant psychosocial complexity based on clinical team assessment (e.g., severe depression/anxiety, unable to tolerate a group setting)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Empowered Relief for Caregivers (ER-CY)

    Participants in this single-group study attend one approximately two-hour Empowered Relief for Caregivers class, a co-designed, skills-based intervention delivered virtually via Zoom. The class teaches caregivers of youth with chronic pain strategies to manage their own distress and to respond adaptively to their child's pain. All enrolled participants receive the ER-CY intervention; there is no comparison arm.

    Behavioral: Empowered Relief for Caregivers (ER-CY)

Interventions

  • BehavioralEmpowered Relief for Caregivers (ER-CY)

    Empowered Relief for Caregivers is a single-session, skills-based behavioral intervention delivered virtually via Zoom in one session of approximately two hours. Co-designed with caregivers, it adapts the Empowered Relief approach for caregivers of youth with chronic pain, teaching strategies to reduce caregiver distress and to respond more adaptively to a child's pain. All participants receive the same single class; there are no additional sessions or booster components.

06

What researchers measure

Primary outcomes

  1. Treatment Expectancy and Credibility: Caregiver Version

    The Treatment Expectancy and Credibility: Caregiver Version assesses 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.

    Time frame: Immediately post class

  2. 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.

    Time frame: Immediately post class

  3. Exit Interview

    Semi-structured qualitative interview conducted with caregivers following the ER-CY class to assess intervention acceptability and gather feedback on their experience. Interviews are audio/video recorded, transcribed, and analyzed thematically to characterize caregivers' perspectives on program content, delivery, perceived helpfulness, and suggestions for refinement.

    Time frame: 1-2 weeks post class

Secondary outcomes

  1. Adult Responses to Children's Symptoms (ARCS) - Protect Subscale

    Time frame: Pre-class, 1 month, 2 months, and 3 months post class

  2. Bath Adolescent Pain Parental Impact Questionnaire

    Time frame: Pre-class, 1 month, 2 months, and 3 months post class

  3. Child Activity Limitations Interview-9

    Time frame: Pre-class, 1 month, 2 months, and 3 months post class

  4. Generalized Anxiety Disorder-2

    Time frame: Pre-class, 1 month, 2 months, and 3 months post class

  5. Pain Catastrophizing Scale - Parent

    Time frame: Pre-class, 1 month, 2 months, and 3 months post class

  6. Pain Catastrophizing Scale

    Time frame: Pre-class, 1 month, 2 months, and 3 months post class

  7. Patient Health Questionnaire-2

    Time frame: Pre-class, 1 month, 2 months, and 3 months post class

  8. Parent Psychological Flexibility Questionnaire - 10

    Time frame: Pre-class, 1 month, 2 months, and 3 months post class

  9. Parent Risk and Impact Screening Measure - 12

    Time frame: Pre-class, 1 month, 2 months, and 3 months post class

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07636980
Responsible party
Laura E Simons (Professor, Stanford University) — Principal investigator
First posted
Jun 9, 2026
Start date
Oct 2026 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
Sep 2028 (estimated)
Last update
Aug 20, 2026

Study contacts

Jeremy Giberson
Contact
jgiberso@stanford.edu
650-723-5814
Sahrish Masood
Contact
sahrishm@stanford.edu
Laura Simons, PhD
principal investigator · Stanford University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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