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 在儿童时期接触患有慢性疼痛的父母是疼痛和不良精神和心理健康的一个关键风险因素。 儿童的身体健康状况。特别是，父母患有肠易激综合征（IBS）， 一种特发性慢性腹痛疾病，使儿童患上腹部疾病的风险增加2倍。 疼痛障碍我们自己的研究表明，疼痛特异性社会学习在这方面具有很大的影响力。 代际传递然而，基本上没有以前的研究试图 与父母进行干预，以防止儿童早期的疾病行为，当这些疾病行为往往 出现并建立起来。我们的团队已经开发并测试了社会学习和认知行为 治疗（SLCBT）干预，以改变父母的行为和模式，以减少儿童的疾病 行为。我们假设SLCBT可以被修改为IBS父母的预防重点， 有年幼的无症状儿童，年龄4-6岁，以减少风险因素（焦虑，灾难性， 父母的压力），并增加保护因素（积极影响，社会支持），导致更少的腹部 儿童的疼痛症状，减少卫生保健利用，减少与健康有关的残疾。因此 本申请的目的是测试针对父母的早期预防干预的有效性 患有IBS的幼儿因此有更高的风险发展疾病行为， 慢性腹痛病症的诊断。提高可扩展性和传播的潜力， 为了满足父母的喜好，我们建议通过互联网提供干预措施， 团队已成功地与其他心理社会疼痛干预措施一起使用。研究设计为随机化 对照试验，平行1：1分配至两个研究组，1）注意力教育对照，2）SLCBT 预防干预。我们的目标是招募460名患有IBS且有4-6岁幼儿的父母。 将在基线、6周（干预后即刻）、6个月、12个月和18个月时对受试者进行评估。 个月随访期。所有研究程序将使用数字平台和网络远程进行- 基于技术。社交媒体广告将用于宣传研究和招募参与者。主 结果是父母的关心/保护行为发生变化。次要结局包括母体风险和 保护因素和儿童健康及症状结果。我们将确定实施 这种预防性干预对18个月的卫生保健支出和资源利用的影响。拟议 这项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。 特别是对于有患常见儿科疼痛风险的儿童。如果成功，这项研究具有很大的潜力。 影响，为广泛的儿科健康问题提供预防性干预模式， 影响儿童期以后的功能，其中父母的反应是影响因素。