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.

项目总结