ADAPTing CBT for Pediatric Functional Abdominal Pain in Primary Care

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое Aim to Decrease Anxiety and Pain Treatment (ADAPT)
  Cognitive behavioral intervention for management of pediatric functional abdominal pain, stratified to 4- or 6- sessions depending on presence of anxiety symptoms, offered through primary care

Первичные конечные точки

• Recruitment [Срок оценки: At enrollment]
• Retention rates [Срок оценки: From baseline to post assessment (8 weeks)]
• Feasibility of intervention [Срок оценки: at 8 week post assessment]

Вторичные конечные точки (3)

• Change in functional disability, measured using the Functional Disability Inventory (FDI) [Срок оценки: From baseline to post assessment (8 weeks)]
• Changes in pain, as measured by the Pain Visual Analog Scale (VAS) [Срок оценки: From baseline to post assessment (8 weeks)]
• Change in anxiety symptoms, measured using the Screen for Child Anxiety Related Disorders (SCARED) [Срок оценки: From baseline to post assessment (8 weeks)]

Критерии участия

Критерии включения

• FAPD diagnosis
• Ages 9-14 years
• Functional disability score of 7 or greater

Критерии исключения

• <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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07526727 · STUDY202500550

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗