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ADAPTing CBT for Pediatric Functional Abdominal Pain in Primary Care

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07526727
Acronym
ADAPT-PCP
Enrollment
15
Registered
2026-04-13
Start date
2026-08-01
Completion date
2026-12-01
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Pain

Keywords

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

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.

Interventions

BEHAVIORALAim 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

Sponsors

Michigan State University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
9 Years to 14 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
RecruitmentAt enrollment\>50% agreement to participate
Retention ratesFrom baseline to post assessment (8 weeks)\>80% retention
Feasibility of interventionat 8 week post assessmentresponses to semi-structured qualitative post assessment interview

Secondary

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

Contacts

CONTACTNatoshia R Cunningham, Ph.D.
natoshia@msu.edu845-662-6198

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 30, 2026