Pilot Testing a Cognitive Behavioral Program Addressing Pediatric Functional Abdominal Pain in Primary Care Settings
| Registry | NCT07526727, acronym ADAPT-PCP |
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 15 (Estimated) |
| Sponsor | Michigan State University (Other) |
| Conditions | Abdominal Pain |
| Interventions | Aim to Decrease Anxiety and Pain Treatment (ADAPT) (Behavioral) |
| Dates | start 2026-10-01 (estimated), primary completion 2026-12-01 (estimated), completion 2026-12-01 (estimated), first posted 2026-04-13, last updated 2026-10-06 |
Related Papers Related Patents Related Grants Related Experts
All trials for Abdominal Pain All trials of Aim to Decrease Anxiety and Pain Treatment (ADAPT)
-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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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| 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 |
- 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
+Outcome measures
Primary outcomes
- Recruitment [At enrollment]: >50% agreement to participate
- Retention rates [From baseline to post assessment (8 weeks)]: >80% retention
- Feasibility of intervention [at 8 week post assessment]: responses to semi-structured qualitative post assessment interview
Secondary outcomes
- 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.
Other outcomes
- Eating behavior, measured by the Nine Item Avoidant/Restrictive Food Intake Disorder Screen (NIAS) [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.
- Eating behavior, as measured by the Children's Eating Attitudes Test (ChEAT) [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.
+Eligibility
Sex: All, ages: 9 Years to 14 Years
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