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NCT Number: NCT07526727

ADAPTing CBT for Pediatric Functional Abdominal Pain in Primary Care

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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Key information

Conditions

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

Age range

9 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Recruitment

    Time frame: At enrollment

    >50% agreement to participate

  2. Retention rates

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

    >80% retention

  3. Feasibility of intervention

    Time frame: at 8 week post assessment

    responses to semi-structured qualitative post assessment interview

Secondary outcomes

  1. Change in functional disability, measured using the Functional Disability Inventory (FDI)

    Time frame: 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.

  2. Changes in pain, as measured by the Pain Visual Analog Scale (VAS)

    Time frame: 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.

  3. Change in anxiety symptoms, measured using the Screen for Child Anxiety Related Disorders (SCARED)

    Time frame: 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.

Other outcomes

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

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

    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.

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

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Natoshia R Cunningham, Ph.D.

CONTACT

[email protected]

845-662-6198

Sponsors and collaborators

Lead sponsor

Michigan State University

Other

Registry information

Official study title

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

Acronym: ADAPT-PCP

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 13, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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