Integrative Strong Body and Mind Training for Pediatric Sickle Cell Pain (I-STRONG for SCD): Multi-site, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 155
- 试验地点
- 5
- 主要终点
- Brief Pain Inventory (BPI) Pain severity
研究概览
简要总结
This research aims to answer the question: does a group training program specifically for teens with chronic sickle cell disease (SCD) pain that teaches skills to strengthen the mind and body help improve everyday functioning and reduce pain symptoms?
The program will be tailored to address challenges related to frequent or chronic sickle cell pain and may improve participants' physical and emotional health.
The program, called I-STRONG for SCD (Integrative Strong Body and Mind Training for Sickle Cell Disease), may help improve everyday functioning and pain symptoms in teens with chronic pain related to SCD. The research team aims to determine how participants (teens and parents) respond to this program.
详细描述
I-STRONG for SCD integrates evidence-based mind-body, cognitive-behavioral, and neuromuscular movement training. It will be tested using an individually randomized group treatment (IRGT) design, comparing early start to the enhanced usual care. The primary objective is to determine whether I-STRONG for SCD combined with standard care is more effective than standard care alone in improving pain intensity from baseline to the 3-month follow-up in adolescents with SCD.
Adolescent participants with sickle cell disease and their caregivers will be recruited for this study. Participants of all genders, races, and ethnicities are eligible, with a majority expected to be Black or African American females, consistent with previous studies of individuals with SCD and chronic pain. The study will last approximately 36 months, with participant involvement lasting 9 months.
I-STRONG for SCD has been adapted from the Fibromyalgia Integrative Training for Teens (FIT Teens) program based on feedback from patients and caregivers, focusing on chronic SCD pain. In addition to usual care, participants will receive the I-STRONG intervention, which consists of 16 group-based telehealth sessions (90 minutes each), held twice weekly for 8 weeks. All patients can participate in I-STRONG, with randomization determining whether they begin with Early Start (after completing the baseline assessment) or Enhanced Usual Care (approximately 8 months after the baseline assessment).
Support from and inclusion in the National Institutes of Health (NIH) Helping to End Addiction Long-term Initiative (HEAL), or NIH HEAL Initiative, is provided for this study. For more information about the initiative visit the HEAL Initiative (https://heal.nih.gov/).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form for adolescents 18 years old and caregivers' participation
- •For children <18, informed assent and parental informed consent to participate in the study
- •Willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
- •Males and females; Ages 12-18 years for adolescents; no age limitations for caregivers
- •Documented diagnosis of sickle cell disease (any genotype) for adolescents
- •Adolescent scores at least 3 on the Pediatric Pain Screening Tool
- •Adolescent reports typical pain intensity in the past week at least 4 on a 0-10 cm Visual Analog Scale
- •Adolescent on stable disease-modifying treatments, if applicable (e.g., hydroxyurea, glutamine, voxelotor, crizanlizumab) as defined by not newly initiated or significantly increased dosages (mg/kg) in the past 3 months
- •Speak and read English
排除标准
- •An adolescent has comorbid medical conditions typically associated with pain but unrelated to SCD (e.g., rheumatologic disorders or inflammatory bowel disease)
- •Adolescent has undergone genetic or hematopoietic stem cell therapy
- •Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation
- •Adolescents receiving active treatment (e.g., weekly appointments with a provider) for nonpharmacological therapies (e.g., structured behavioral pain management, physical therapy, or acupuncture program) that overlap with the active phase of the study intervention
研究组 & 干预措施
I-STRONG - Early Start
Youth and caregivers will receive the I-STRONG for SCD intervention in addition to standard care.
干预措施: I-STRONG (Behavioral)
Enhanced Usual Care (EUC)
Participants randomized to EUC will continue with standard care and optimal management of their SCD and chronic pain for approximately 8 months. After completing the 6-month follow-up assessment, participants will have the opportunity to start the I-STRONG SCD intervention.
干预措施: Enhanced Usual Care (EUC) (Other)
结局指标
主要结局
Brief Pain Inventory (BPI) Pain severity
时间窗: Baseline, immediately post-intervention, 3 months and 6 months post-intervention
Pain intensity is rated with the pain severity item of the Brief Pain Inventory (BPI). The single item is scored on a scale from 0 to 10 where no pain = 0 and severe pain = 10. This outcome applies to teens only.
次要结局
- Change in Brief Pain Inventory (BPI) Pain Interference Score(Baseline, immediately post-intervention, 3 months and 6 months post-intervention)
- Patient Health Questionnaire (PHQ-8) Score(Baseline, immediately post-intervention, 3 months and 6 months post-intervention)
- General Anxiety Disorder (GAD-2)(Baseline, immediately post-intervention, 3 months and 6 months post-intervention)
- Pain Catastrophizing Scale(Baseline, immediately post-intervention, 3 months and 6 months post-intervention)
- Pediatric Quality of Life Inventory (PedsQL) Score(Baseline, immediately post-intervention, 3 months and 6 months post-intervention)
- Adolescent Sleep-Wake Scale (ASWS) Score Short Form(Baseline, immediately post-intervention, 3 months and 6 months post-intervention)
- National Institute on Drug Abuse (NIDA)-Modified ASSIST (NM ASSIST) Tool Level 2 score(Baseline, 3 months post-intervention)
- Opioid Use(Baseline, immediately post-intervention, 3 months and 6 months post-intervention)
- Opioid morphine milligram equivalent Use(Baseline and 3 months post-intervention)
- Patient Global Impression of Change (PGIC) Score(Baseline, 3 months and 6 months post-intervention)
- Treatment Evaluation Inventory-Short Form (TEI-SF) Score(Immediately post-intervention)
- Tampa Scale of Kinesiophobia (TSK) Score(Baseline, immediately post-intervention, 3 months and 6 months post-intervention)
- PROMIS Pediatric Fatigue Short Form(Baseline, immediately post-intervention, 3 months and 6 months post-intervention)
- Chronic Pain Acceptance Questionnaire (CPAQ)(Baseline, immediately post-intervention, 3 months and 6 months post-intervention)
- Coping Self-Efficacy(Baseline, immediately post-intervention, 3 months and 6 months post-intervention)
- Therapeutic Factor Inventory - 8 (TFI-8)(Immediately post-intervention)
研究者
Soumitri Sil
Associate Professor
Emory University