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Not yet recruitingNCT07526727ADAPT-PCPUpdated Oct 6, 2026

ADAPTing CBT for Pediatric Functional Abdominal Pain in Primary Care

An interventional study of Aim to Decrease Anxiety and Pain Treatment (ADAPT) in Abdominal Pain, sponsored by Michigan State University. Not yet recruiting. Open to participants aged 9 Years to 14 Years. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by Michigan State University · Not applicable, Interventional, and Treatment

Updated Oct 6, 2026Start date movedPrimary completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
9 Years to 14 Years
Sex
All
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Study 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.

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Conditions studied

  • Abdominal Pain

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Keywords

  • functional abdominal pain disorders
  • pediatrics
  • cognitive behavioral
  • mindfulness
  • primary care
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In context

Abdominal Pain

338 studies on the registry are indexed under Abdominal Pain; 55 are open to participants now.

This study's planned enrollment of 15 is below the median of 72 across 250 interventional studies indexed under Abdominal Pain.

Browse Abdominal Pain studies →

Lead sponsor

Michigan State University is the lead sponsor of 139 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
9 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • 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)

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

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What researchers measure

Primary outcomes

  1. Recruitment

    \>50% agreement to participate

    Time frame: At enrollment

  2. Retention rates

    \>80% retention

    Time frame: From baseline to post assessment (8 weeks)

  3. Feasibility of intervention

    responses to semi-structured qualitative post assessment interview

    Time frame: at 8 week post assessment

Secondary outcomes

  1. 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.

    Time frame: From baseline to post assessment (8 weeks)

  2. 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.

    Time frame: From baseline to post assessment (8 weeks)

  3. 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.

    Time frame: From baseline to post assessment (8 weeks)

Other outcomes

  1. 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.

    Time frame: From baseline to post-assessment (8 weeks)

  2. 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.

    Time frame: From baseline to post assessment (8 weeks)

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

1 registry update since Sep 25, 2026
Start date
Aug 2026→Oct 2026
Oct 6, 2026
Primary completion
Sep 2026→Dec 2026
Oct 6, 2026
Show all 1 update
  1. Oct 6, 2026
    Start date Aug 2026→Oct 2026
    Primary completion Sep 2026→Dec 2026

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07526727
Lead sponsor
Michigan State University
Responsible party
Natoshia Cunningham (Red Cedar Distinguished Professor, Associate Professor, Michigan State University) — Principal investigator
First posted
Apr 13, 2026
Start date
Oct 2026 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Oct 6, 2026

Study contacts

Natoshia R Cunningham, Ph.D.
Contact
natoshia@msu.edu
845-662-6198

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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