Pilot Testing a Cognitive Behavioral Program Addressing Pediatric Functional Abdominal Pain in Primary Care Settings
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15
- 主要终点
- Recruitment
研究概览
简要总结
Many youth experience ongoing stomach pain that does not have a clear medical cause. These conditions, called functional abdominal pain disorders, are common and can last for years. They often interfere with school attendance, daily activities, and social life, and are frequently linked with anxiety. Families may go through many medical tests and appointments without finding relief. The investigator's research shows that teaching these children coping skills, like relaxation, problem solving, and managing anxious thoughts, can reduce pain and improve functioning. The Aim to Decrease Anxiety and Pain Treatment (ADAPT) is a brief program, using cognitive behavioral strategies and mindfulness, the investigators developed that helps children. ADAPT has been shown to work well in specialty clinics, but most children with stomach pain are first seen in primary care, where this type of support is not usually available. The purpose of this project is to test ADAPT in pediatric primary care and test whether it can be delivered successfully. The goal is to improve access to care, reduce symptoms, and better support children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 14 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •FAPD diagnosis
- •Ages 9-14 years
- •Functional disability score of 7 or greater
排除标准
- •<9 years or >14 years
- •Known developmental disability, sensory, or cognitive impairments that limit youths' ability to engage with behavioral programming
- •Unmanaged psychiatric illness (e.g., psychosis, active suicidal ideation, severe depression as indicated in electronic medical records)
- •Symptoms directly attributable to a physical health concern (e.g., cancer, cystic fibrosis, inflammatory bowel disease).
- •Lack of English proficiency
研究组 & 干预措施
ADAPT, cognitive behavioral program for pediatric functional abdominal pain
Cognitive behavioral intervention for management of pediatric functional abdominal pain, stratified to 4- or 6- sessions depending on presence of anxiety symptoms
干预措施: Aim to Decrease Anxiety and Pain Treatment (ADAPT) (Behavioral)
结局指标
主要结局
Recruitment
时间窗: At enrollment
\>50% agreement to participate
Retention rates
时间窗: From baseline to post assessment (8 weeks)
\>80% retention
Feasibility of intervention
时间窗: at 8 week post assessment
responses to semi-structured qualitative post assessment interview
次要结局
- Change in functional disability, measured using the Functional Disability Inventory (FDI)(From baseline to post assessment (8 weeks))
- Changes in pain, as measured by the Pain Visual Analog Scale (VAS)(From baseline to post assessment (8 weeks))
- Change in anxiety symptoms, measured using the Screen for Child Anxiety Related Disorders (SCARED)(From baseline to post assessment (8 weeks))
研究者
Natoshia Cunningham
Red Cedar Distinguished Professor, Associate Professor
Michigan State University
