Empowered Relief for Caregivers

NCT07636980 | Not Yet Recruiting

• 1 other identifier: 86875
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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

• 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.

  1-2 weeks post class

Secondary Outcomes (9)

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

  Pre-class, 1 month, 2 months, and 3 months post class

• Bath Adolescent Pain Parental Impact Questionnaire

  Pre-class, 1 month, 2 months, and 3 months post class

• Child Activity Limitations Interview-9

  Pre-class, 1 month, 2 months, and 3 months post class

• Generalized Anxiety Disorder-2

  Pre-class, 1 month, 2 months, and 3 months post class

• Pain Catastrophizing Scale - Parent

  Pre-class, 1 month, 2 months, and 3 months post class

Study Arms (1)

Empowered Relief for Caregivers (ER-CY)

EXPERIMENTAL

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

Empowered Relief for Caregivers (ER-CY) BEHAVIORAL

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.

Empowered Relief for Caregivers (ER-CY)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Chronic Pain; Musculoskeletal Pain; Fibromyalgia; Neuralgia; Complex Regional Pain Syndromes; Abdominal Pain

Interventions

Caregivers

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Autonomic Nervous System Diseases; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Laura Simons, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeremy Giberson

CONTACT

650-723-5814; jgiberso@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 9, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: June 9, 2026

Record last verified: 2026-06

Locations

US (1)