ADAPTing CBT for Pediatric Functional Abdominal Pain in Primary Care

NCT07526727 | Not Yet Recruiting

• 1 other identifier: STUDY202500550
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Abdominal Pain

Keywords

functional abdominal pain disorders; pediatrics; cognitive behavioral; mindfulness; primary care

Outcome Measures

Primary Outcomes (3)

• Recruitment

  \>50% agreement to participate

  At enrollment

• Retention rates

  \>80% retention

  From baseline to post assessment (8 weeks)

• Feasibility of intervention

  responses to semi-structured qualitative post assessment interview

  at 8 week post assessment

Secondary Outcomes (3)

• 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)

Other Outcomes (2)

• Eating behavior, measured by the Nine Item Avoidant/Restrictive Food Intake Disorder Screen (NIAS)

  From baseline to post-assessment (8 weeks)

• Eating behavior, as measured by the Children's Eating Attitudes Test (ChEAT)

  From baseline to post assessment (8 weeks)

Study Arms (1)

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

Behavioral: Aim to Decrease Anxiety and Pain Treatment (ADAPT)

Interventions

Aim to Decrease Anxiety and Pain Treatment (ADAPT) BEHAVIORAL

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

ADAPT, cognitive behavioral program for pediatric functional abdominal pain

Eligibility Criteria

• Age: 9 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• \<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

Sponsors & Collaborators

• Michigan State University: lead

MeSH Terms

Conditions

Abdominal Pain

Interventions

Analgesia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Central Study Contacts

Natoshia R Cunningham, Ph.D.

CONTACT

845-662-6198; natoshia@msu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Red Cedar Distinguished Professor, Associate Professor

Model Details: 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

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: April 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share