A Pilot Randomized Controlled Trial of Resilience Coaching for Adolescents With Chronic Musculoskeletal Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 260
- 试验地点
- 2
- 主要终点
- Functional Disability
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Resilience Coaching plus Usual Care
Promoting Resilience in Stress Management (PRISM) is a 1:1, remotely delivered, resilience coaching program for adolescents with chronic illness, consisting of skill-building sessions in stress management, goal setting, cognitive re-framing, and benefit-finding. Sessions are held every 1-2 weeks for a total of 4 required and one optional session and each session lasts about 30-45 minutes.
干预措施: Promoting Resilience in Stress Management (Behavioral)
Usual Care
Usual care consists of an individualized treatment combining physical therapy, occupational therapy and psychological counseling. This is determined by the treating provider.
干预措施: Usual Care (Other)
结局指标
主要结局
Functional Disability
时间窗: 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).
次要结局
- Psychological distress(Measured at 3 months post-randomization.)
- Pain intensity(Measured at 3 months post-randomization.)