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.

项目概要 童年时期接触患有慢性疼痛的父母是导致疼痛和不良心理和不良情绪的一个关键风险因素。 特别是，父母患有肠易激综合症（IBS）， 一种特发性腹部慢性疼痛疾病，使儿童患腹部疼痛的风险增加 2 倍 我们自己的研究表明，针对疼痛的社交学习对此有很大影响。 然而，之前基本上没有研究尝试过。 与父母进行干预，以防止幼儿时期的疾病行为，因为这些疾病行为经常发生 我们的团队已经开发并测试了社交学习和行为。 治疗（SLCBT）干预措施改变父母的行为和榜样，以减少儿童的疾病 我们追求对 SLCBT 进行修改，以针对患有 IBS 的父母进行预防。 养育 4-6 岁的无症状儿童，以减少风险因素（焦虑、灾难性的、 养育压力）并增加保护因素（积极情感、社会支持），从而减少腹部疼痛 儿童疼痛症状、医疗保健利用率降低以及与健康相关的残疾减少。 当前应用程序的目的是测试针对父母的早期预防干预的有效性 患有 IBS 的幼儿因此更有可能出现疾病行为，并随后出现 诊断慢性腹痛疾病以增强可扩展性和传播的潜力，以及 满足家长的喜好，我们建议通过互联网通过我们的方法进行干预 研究小组已成功地与其他社会心理疼痛干预措施一起使用。该研究设计是随机的。 对照试验，平行 1:1 分配给两个研究组，1) 注意力教育控制，2) SLCBT 我们的目标是招募 460 名有 4-6 岁孩子的 IBS 家长。 参与者将在基线、6周（干预后立即）、6个月、12个月和18个月时接受评估 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用于宣传该研究并招募主要参与者。 结果是父母关心/保护行为的改变，次要结果包括父母的风险和。 我们将确定实施的成本节约。 这种预防性干预措施在 18 个月内对医疗保健支出和资源利用进行了干预。 研究将是第一个评估早期预防性心理社会干预的潜在益处的研究 如果成功的话，这项研究将具有很大的潜力。 影响为广泛的儿科健康问题提供预防性干预模型， 影响儿童期以后的功能，其中父母的反应是影响因素。