ADAPTing CBT for Pediatric Functional Abdominal Pain in Primary Care (ADAPT-PCP)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Abdominal Pain
• Intervention / Treatment: Behavioral: Aim to Decrease Anxiety and Pain Treatment (ADAPT)

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Natoshia R Cunningham, Ph.D.; Phone Number: 845-662-6198; Email: natoshia@msu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in functional disability, measured using the Functional Disability Inventory (FDI)	The 15-item FDI assesses youths' difficulty performing tasks across home, school, recreational, and social settings over the "past few days" due to physical symptoms. Items are rated from 0 ("no trouble") to 4 ("impossible") and summed, yielding total scores of 0-60 with scores ≥7 suggesting greater than minimal disability. Youth will complete a self-report version, and parents will complete an additional version reporting on their child.	From baseline to post assessment (8 weeks)
Changes in pain, as measured by the Pain Visual Analog Scale (VAS)	Youth and parents will each report the youth's average pain intensity over the past week using a Visual Analog Scale (VAS). Responses range from 0 (no pain) to 10 (worst imaginable pain), with ratings ≥3 indicating moderate pain.	From baseline to post assessment (8 weeks)
Change in anxiety symptoms, measured using the Screen for Child Anxiety Related Disorders (SCARED)	The 41-item Screen for Child Anxiety Related Disorders (SCARED) assesses past 3-month anxiety symptoms. Items are scored on a 3-point Likert-style scale (0 = not true or hardly ever true, 2=very true or often true), and summed to yield total scores of 0-82 with higher scores indicating greater anxiety and scores ≥25 suggesting clinical significance. Youth will complete a self-report version, and parents will complete an additional version reporting on their child.	From baseline to post assessment (8 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eating behavior, measured by the Nine Item Avoidant/Restrictive Food Intake Disorder Screen (NIAS)	The Nine Item Avoidant/Restrictive Food Intake Disorder Screen (NIAS) is a self-report questionnaire used to assess symptoms of avoidant/restrictive eating, including picky eating, low appetite, and fear of negative consequences of eating. Items are rated on a Likert-type scale and summed to yield a total score ranging from 0 to 45, with higher scores indicating greater severity of avoidant/restrictive eating symptoms. Youth will complete this measure.	From baseline to post-assessment (8 weeks)
Eating behavior, as measured by the Children's Eating Attitudes Test (ChEAT)	The Children's Eating Attitudes Test (ChEAT) is a self-report questionnaire used to assess disordered eating attitudes and behaviors in youth, including dieting, food preoccupation, and concerns about weight. Items are rated on a Likert-type scale and summed to yield a total score ranging from 0 to 78, with higher scores indicating more problematic eating attitudes and greater eating-related concerns. Youth will complete this measure.	From baseline to post assessment (8 weeks)

Collaborators and Investigators

• Sponsor: Michigan State University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 22, 2025
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: pediatrics; primary care; mindfulness; functional abdominal pain disorders; cognitive behavioral
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Abdominal Pain; Anesthesia and Analgesia; Analgesia
• Other Study ID Numbers: STUDY202500550

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No