NCT02075437

Feeling and Body Investigators for Pediatric Abdominal Pain

Feelings and Body Investigators (FBI): Interoceptive Exposure for Child Abdominal Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 60 Months – 107 Months
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Functional Abdominal Pain

Interventions

Type	Name	Description
BEHAVIORAL	Feeling and Body Investigators with Functional Abdominal Pain	Investigator's ten session intervention trains children to be "Feeling and Body Investigators". Half of the sessions will be done in clinic and half at home via web-camera to facilitate generalization. During the treatment child/caregiver dyads will 1) gather body clues (Learn), 2) investigate (Experience: perform interoceptive mystery missions to explore a body sensation), 3) organize body clues (Contextualize: recall other context that evoke similar sensations), and 4) go on increasingly daring missions (Challenge: decrease avoidance and safety behaviors). If successful, 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.
BEHAVIORAL	Treatment Strategies	1. identify strategies with unique patterns of neural circuit maturation associated with early visceral pain on the gut-brain axis: 2. adapt acceptance-based behavioral strategies used to address psychopathology in older children to younger children; 3. incorporate caregivers as role models and facilitators based on attachment research.

Timeline

• Start date: 2014-03-01
• Primary completion: 2020-09-01
• Completion: 2020-09-01
• First posted: 2014-03-03
• Last updated: 2025-07-04
• Results posted: 2025-07-04

Locations

2 sites across 1 country: United States