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Completed

NCT Number: NCT05834725

Resilience Coaching for Adolescents With Chronic Musculoskeletal Pain

The goal of this clinical trial is to learn about resilience coaching in adolescents with chronic musculoskeletal pain. The main questions it aims to answer are to 1) determine how helpful resilience coaching is for teens with chronic musculoskeletal pain, 2) which participants are best suited for resilience coaching, and 3) barriers and facilitators to implementing resilience coaching as part of routine clinical care. Participants will complete survey measures and participate in the resilience coaching intervention called Promoting Resilience in Stress Management (PRISM). Researchers will compare youth in PRISM to those receiving usual care to determine whether PRISM leads to greater improvements in functional disability, psychological distress, and pain intensity than usual care alone.

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Key information

Conditions

Pain, Chronic Chronic Pain Mental Disorders Neurologic Manifestations Pain Pain Syndrome Pathological Conditions, Signs and Symptoms Psychological Signs and Symptoms Somatoform Disorders

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

The purpose of this study is to find out if a resilience coaching program called Promoting Resilience in Stress Management (PRISM) can help youth with chronic musculoskeletal pain better cope with their chronic illness.Researchers will recruit a total of 130 youth with chronic musculoskeletal pain and one of their caregivers (total number of participants = 260). Teens will be randomly assigned to either a control group (usual care) or a treatment group (PRISM + usual care). PRISM consists of 4 study visits with a resilience coach, and one optional coming together session in which caregivers are invited to join. PRISM will occur over approximately 12 weeks. All participants will complete survey measures at baseline, 3-months and 9 months. Selected participants in PRISM will be invited to participate in interviews to provide feedback on the intervention. We will also interview 10 pediatric rheumatologists at other centers to obtain their feedback on the intervention and whether it would be valuable and feasible in their clinical setting. At the end of the study, researchers will assess whether participants in PRISM had improved functional disability, psychological distress and pain intensity as compared to the usual care arm.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patient participants aged 12-17 years,
  • newly diagnosed with chronic musculoskeletal pain, defined as bone, joint, muscle, or related soft tissue pain lasting ≥ 3 months
  • willing to provide informed consent/assent
  • one caregiver willing to consent and participate in dyad
  • dyad identifies English as primary language
  • mild or greater impairment due to pain (defined as Patient Reported Outcomes Measurement Information System Pain Interference T-score ≥ 60 at time of last clinic visit and/or self- or parent- reported impairment of activities of daily living due to pain at time of screening)

Exclusion criteria

  • unable to provide assent and/or without a legal guardian able to provide consent for the study subject or themselves
  • isolated/localized head pain or abdominal pain
  • complex regional pain syndrome (CRPS)
  • Receiving cognitive behavioral therapy at time of screening

Treatment and study plan

Promoting Resilience in Stress Management

Behavioral

Resilience coaching program.

Usual Care

Other

Combination of physical therapy, occupational therapy, and psychological counseling as recommended by the treating provider.

Primary outcomes

  1. Functional Disability

    Time frame: Measured at 3 months post-randomization.

    Functional disability at 3 months will be measured via the Functional Disability Inventory (FDI) score (ranging from 0-60 with higher scores indicating greater self-perceived functional disability).

Secondary outcomes

  1. Psychological distress

    Time frame: Measured at 3 months post-randomization.

    Psychological distress at 3 months will be measured via the Kessler Psychological Distress Scale (K6) score. Responses are scored on 5-point Likert scale (total score ranging from 0-24). Previous studies have shown that scores ≥ 7 are consistent with "high" distress and those ≥ 13 meet criteria for serious, or debilitating psychological distress.

  2. Pain intensity

    Time frame: Measured at 3 months post-randomization.

    Pain intensity at 3 months will be measured via the PROMIS (Patient Reported Outcome Measure Information System) Pediatric Numeric Rating Scale v1.0- Pain Intensity score (ranging from 0-10 with higher scores indicating greater pain intensity).

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Official study title

A Pilot Randomized Controlled Trial of Resilience Coaching for Adolescents With Chronic Musculoskeletal Pain

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Apr 28, 2023
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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