Feeling and Body Investigators for Pediatric Abdominal Pain
Public ClinicalTrials.gov record NCT02075437. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Feelings and Body Investigators (FBI): Interoceptive Exposure for Child Abdominal Pain
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will provide tools to develop and pilot an intervention for Functional Abdominal Pain (FAP) using a ten session intervention with children ages 5-8. Investigators will train the subjects to be "Feeling and Body Investigators". During treatment phases the following will occur 1) gather clues (learn), 2) investigate (experience: perform interoceptive mystery missions to explore a body sensation), 3) organize body clues (contextualize: recall other contexts that evoke similar sensations), and 4) go on increasingly daring missions (challenge: decrease avoidance and safety behaviors). The FBI intervention will be developed and refined in 28 child-caregiver dyads during the current R21 phase. In the R33 phase investigators will randomize 100 subjects with FAP to FBI or an active control group in order to conduct a pilot-test of the feasibility, acceptance, and clinical significance of FBI. Young children with FAP who complete the FBI early intervention will learn to experience changes in the viscera as fun and fascinating, rather than scary, and will develop new capacities for pain management, adaptive functioning, and emotion regulation. For the R21 Phase (assessing initial feasibility) investigators hypothesize that ≥ 80% of participants enrolled in FBI will complete treatment and that ≥ 80% of participants will complete home-based practice assignments.
Study identification
- NCT ID
- NCT02075437
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 28 participants
Conditions and interventions
Conditions
Interventions
- Feeling and Body Investigators with Functional Abdominal Pain Behavioral
- Treatment Strategies Behavioral
Behavioral
Eligibility (public fields only)
- Age range
- 60 Months to 107 Months
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2014
- Primary completion
- Aug 31, 2020
- Completion
- Aug 31, 2020
- Last update posted
- Jul 3, 2025
2014 – 2020
United States locations
- U.S. sites
- 2
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Duke University Young Child Lab at Brightleaf Square | Durham | North Carolina | 27701 | — |
| Duke Children's Primary Care Picket Road | Durham | North Carolina | 27705 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02075437, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 3, 2025 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02075437 live on ClinicalTrials.gov.