Abdominal PainADAPT-PCPNCT07526727
ADAPTing CBT for Pediatric Functional Abdominal Pain in Primary Care
A study testing Aim to Decrease Anxiety and Pain Treatment (ADAPT) in people with Abdominal Pain, run by Michigan State University.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 14 years
- Conditions the study is for
- Abdominal Pain
- What is being tested?
- Aim to Decrease Anxiety and Pain Treatment (ADAPT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- FAPD diagnosis
- Ages 9-14 years
- Functional disability score of 7 or greater
Who cannot join
- <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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Abdominal Pain
- Being tested
- Aim to Decrease Anxiety and Pain Treatment (ADAPT)
- Keywords
- functional abdominal pain disorders, pediatrics, cognitive behavioral, mindfulness, primary care
- Medical subject headings
- Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aim to Decrease Anxiety and Pain Treatment (ADAPT)Behavioural
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Aim to Decrease Anxiety and Pain Treatment (ADAPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
>50% agreement to participate
Measured: At enrollment
Retention rates
>80% retention
Measured: From baseline to post assessment (8 weeks)
Feasibility of intervention
responses to semi-structured qualitative post assessment interview
Measured: at 8 week post assessment
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: From baseline to post assessment (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natoshia Cunningham, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07526727
- Sponsor's protocol ID
- STUDY202500550
- Acronym
- ADAPT-PCP
- Status last verified
- Jun 2026
- First submitted
- 22 Dec 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Testing a Cognitive Behavioral Program Addressing Pediatric Functional Abdominal Pain in Primary Care Settings
- ClinicalTrials.gov ID
- NCT07526727
- Acronym / sponsor ID
- ADAPT-PCP / STUDY202500550
- Conditions
- Abdominal Pain
- Keywords
- functional abdominal pain disorders, pediatrics, cognitive behavioral, mindfulness, primary care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| ADAPT, cognitive behavioral program for pediatric functional abdominal pain | Experimental | 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 |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- FAPD diagnosis
- Ages 9-14 years
- Functional disability score of 7 or greater
Key exclusion criteria (5 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | ADAPT, cognitive behavioral program for pediatric functional abdominal pain |
Primary outcome
Recruitment
Time frame: At enrollment
>50% agreement to participate
Retention rates
Time frame: From baseline to post assessment (8 weeks)
>80% retention
Feasibility of intervention
Time frame: at 8 week post assessment
responses to semi-structured qualitative post assessment interview
3 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Aim to Decrease Anxiety and Pain Treatment (ADAPT) in people with Abdominal Pain, run by Michigan State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natoshia R Cunningham, Ph.D. (845-662-6198, natoshia@msu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: At enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.