Randomized controlled trial of an internet-based prevention intervention for young children at-risk for functional abdominal pain

针对有功能性腹痛风险的幼儿进行基于互联网的预防干预的随机对照试验

• 批准号: 10608073
• 负责人: Rona L. Levy
• 金额: $ 66.61万
• 依托单位: SEATTLE CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-11 至 2027-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10608073
• 关键词: Abdomen; Abdominal Pain; Affect; Age; Anatomy; Anxiety; Attention; Behavior; Child; Child Health; Child Rearing; Child health care; Childhood; Cognitive Therapy; Cost Savings; Development; Diagnosis; Education; Environment; Esthesia; Exposure to; Family; Family health status; Future; Genetic; Health; Health Care Costs; Health Care Visit; Health Expenditures; Inflammatory; Influentials; Internet; Intervention; Irritable Bowel Syndrome; Link; Mediating; Mental Health; Metabolism; Modeling; Mothers; Neoplastic Processes; Neurobiology; Online Systems; Outcome; Pain; Pain Disorder; Parents; Participant; Patient Recruitments; Populations at Risk; Preventive; Procedures; Quality of life; Randomized, Controlled Trials; Reaction; Recurrent pain; Reporting; Research; Research Design; Resources; Risk; Risk Factors; Risk Reduction; Schools; Severities; Sick Role; Social support; Stress; Symptoms; Technology; Testing; Therapeutic Intervention; Training; Work; attentional control; chronic abdominal pain; chronic pain; chronic painful condition; digital platform; disability; early childhood; efficacy evaluation; efficacy testing; emotional distress; experience; follow-up; gastrointestinal symptom; health care service utilization; health related quality of life; high risk; improved; interest; intergenerational; offspring; pain symptom; physical conditioning; post intervention; preference; prevent; preventive intervention; primary outcome; protective behavior; protective factors; psychologic; psychosocial; recruit; response; secondary outcome; social; social learning; social media; transmission process; treatment effect; two-arm study

PROJECT SUMMARY Exposure to a parent with chronic pain in childhood is one key risk factor for pain and adverse mental and physical health outcomes among children. In particular, having a parent with Irritable Bowel Syndrome (IBS), an idiopathic chronic abdominal pain disorder, places children at 2x greater risk for developing an abdominal pain disorder. Our own research has demonstrated that pain-specific social learning is highly influential in this intergenerational transmission. However, there is essentially no previous research that has attempted to intervene with parents to prevent illness behaviors in early childhood, when these illness behaviors often emerge and become established. Our team has developed and tested social learning and cognitive behavioral therapy (SLCBT) interventions to change parental behaviors and modeling in order to reduce children’s illness behaviors. We hypothesize that SLCBT can be modified toward a preventive focus for parents with IBS who have young asymptomatic children, ages 4-6 years, in order to reduce risk factors (anxiety, catastrophizing, parenting stress) and increase protective factors (positive affect, social support), resulting in fewer abdominal pain symptoms in children, reduced health care utilization, and less health-related disability. Therefore, the objective of the current application is to test the efficacy of an early preventive intervention targeting parents with IBS whose young children are thus at higher risk for developing illness behavior and subsequently a diagnosis of a chronic abdominal pain disorder. To enhance potential for scalability and dissemination, and meet parental preferences, we propose delivering the intervention via the internet through approaches our team has successfully used with other psychosocial pain interventions. The study design is a randomized controlled trial with parallel 1:1 assignment to two study arms, 1) attention education control, and 2) SLCBT prevention intervention. We aim to recruit 460 parents with IBS who have young children ages 4-6 years. Participants will be assessed at baseline, 6-week (immediate post-intervention), 6-month, 12-month, and 18- month follow-up periods. All study procedures will be conducted remotely using digital platforms and web- based technologies. Social media ads will be used to advertise the study and recruit participants. The primary outcome is change in parental solicitous/protective behaviors. Secondary outcomes include parent risk and protective factors and child health and symptom outcomes. We will determine cost savings of implementing this preventive intervention on health care expenditures and resource utilization over 18 months. The proposed study will be the first to evaluate the potential benefit of an early preventive psychosocial intervention specifically for children at risk for a common pediatric pain condition. If successful, this study has high potential impact to provide a model for a preventive intervention for a wide range of pediatric health problems which can impact functioning beyond childhood in which parental responses are influencing factors.

项目摘要 接触儿童慢性疼痛的父母是疼痛和心理不利的关键危险因素之一 儿童的身体健康结果。特别是，有一个父母患有肠易激综合症（IBS）， 特发性慢性腹痛障碍，使儿童患腹部的风险更大 疼痛障碍。我们自己的研究表明，特定于疼痛的社会学习在这方面具有很大的影响 代际传播。但是，基本上没有以前的研究试图 当这些疾病行为经常 出现并建立。我们的团队已经发展并测试了社会学习和认知行为 治疗（SLCBT）干预措施，以改变父母的行为和建模，以减少儿童疾病 行为。我们假设可以将SLCBT修改为IBS父母的预防性重点 为了减少危险因素（焦虑，灾难性， 育儿压力）和增加受保护因素（积极影响，社会支持），导致腹部较少 儿童的疼痛症状，减少医疗保健利用以及与健康相关的残疾较少。因此， 当前应用的目的是测试针对父母的早期预防干预的效率 因此，与年幼的孩子的IBS有关疾病行为的风险更高，随后是 诊断慢性腹痛障碍。为了提高可伸缩性和传播的潜力，并 满足父母的偏好，我们建议通过互联网通过我们的方法进行干预 团队已成功地用于其他社会心理疼痛干预措施。研究设计是随机的 并行1：1分配两个研究臂，1）注意教育控制和2）SLCBT的对照试验。 预防干预。我们的目标是招募有460名年龄在4-6岁的IBS的父母。 参与者将在基线，6周（立即干预后），6个月，12个月和18岁时进行评估。 一个月的随访期。所有研究程序都将使用数字平台和网络进行远程进行 基于技术。社交媒体广告将用于宣传研究并招募参与者。主要 结果是父母坚固/保护行为的变化。次要结果包括父母风险和 保护因素和儿童健康和症状结果。我们将确定实施的成本节省 这种预防性干预了18个月的医疗保健支出和资源利用。提议 研究将是第一个评估早期预防社会心理干预的潜在益处的研究 特别适合患有常见儿科疼痛状况的儿童。如果成功，这项研究具有很高的潜力 为提供多种儿科健康问题提供预防性干预模型的影响 在童年之外，父母反应是影响因素的影响。