跳至主要内容
临床试验/NCT07526727
NCT07526727尚未招募不适用

Pilot Testing a Cognitive Behavioral Program Addressing Pediatric Functional Abdominal Pain in Primary Care Settings

Michigan State University0 个研究点目标入组 15 人开始时间: 2026年8月1日最近更新:
适应症
干预措施

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

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Natoshia Cunningham

Red Cedar Distinguished Professor, Associate Professor

Michigan State University

相似试验

ADAPTing CBT for Pediatric Functional Abdominal Pain... | 临床试验