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

项目总结 儿童时期接触患有慢性疼痛的父母是导致疼痛和不良心理和心理障碍的一个关键风险因素 儿童的身体健康结果。特别是，父母患有肠易激综合征(IBS)， 一种特发性慢性腹痛障碍，使儿童患上腹痛的风险增加2倍 疼痛障碍。我们自己的研究表明，特定于疼痛的社交学习在这方面具有很大的影响力 代际传播。然而，之前的研究基本上没有尝试过 与父母一起干预，预防儿童早期的患病行为，此时这些患病行为往往 涌现并建立起来。我们的团队开发并测试了社交学习和认知行为 治疗(SLCBT)干预以改变父母的行为和模式，以减少儿童疾病 行为。我们假设SLCBT可以被修改为预防IBS的父母谁谁 有4-6岁的无症状儿童，以减少危险因素(焦虑、灾难、 养育压力)和增加保护性因素(积极的情感、社会支持)，导致腹部变少 儿童出现疼痛症状，卫生保健利用率降低，与健康相关的残疾减少。因此， 目前应用的目的是测试针对父母的早期预防性干预的有效性 患有IBS，其年幼的孩子因此患疾病行为的风险更高，随后 慢性腹痛障碍的诊断。增强可伸缩性和传播的潜力，以及 为了满足家长的喜好，我们建议通过我们的方式通过互联网提供干预 该团队已经成功地将其与其他心理社会疼痛干预措施结合使用。研究设计为随机设计。 对照试验，平行1：1分配给两个学习组，1)注意教育控制，2)SLCBT 预防干预。我们的目标是招募460名患有IBS的父母，他们的孩子年龄在4-6岁之间。 参与者将在基线、6周(干预后立即)、6个月、12个月和18个月- 一个月的随访期。所有研究程序将使用数字平台和网络远程进行- 基于技术的。社交媒体广告将被用来宣传这项研究并招募参与者。初级阶段 结果是父母的关心/保护行为发生了变化。次要结果包括父母风险和 保护因素与儿童健康和症状结果。我们将确定实施 这对18个月以上的卫生保健支出和资源利用进行了预防性干预。建议数 这项研究将第一次评估早期预防性心理社会干预的潜在好处。 特别是针对有常见儿科疼痛症状风险的儿童。如果成功，这项研究具有很高的潜力 影响为广泛的儿科健康问题提供预防性干预的模式 影响儿童时期以后的功能，其中父母的反应是影响因素。

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.