Menu
Not yet recruiting NCT07526727

ADAPTing CBT for Pediatric Functional Abdominal Pain in Primary Care

No phase Interventional Abdominal Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aim to Decrease Anxiety and Pain Treatment (ADAPT).
Who it may be relevant to
Registry conditions: Abdominal Pain. Basic parameters: 9 years — 14 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Behavioral 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

Primary outcome measures

  • Recruitment [Time frame: At enrollment]
  • Retention rates [Time frame: From baseline to post assessment (8 weeks)]
  • Feasibility of intervention [Time frame: at 8 week post assessment]
Secondary outcome measures (3)
  • Change in functional disability, measured using the Functional Disability Inventory (FDI) [Time frame: From baseline to post assessment (8 weeks)]
  • Changes in pain, as measured by the Pain Visual Analog Scale (VAS) [Time frame: From baseline to post assessment (8 weeks)]
  • Change in anxiety symptoms, measured using the Screen for Child Anxiety Related Disorders (SCARED) [Time frame: From baseline to post assessment (8 weeks)]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • <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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07526727 · STUDY202500550

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗