Feeling and Body Investigators for Pediatric Abdominal Pain

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.

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Key information

Conditions

Functional Abdominal Pain

Age range

60 month–107 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Children's Primary Care Picket Road, Durham, North Carolina, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Child is between 60 and 107 months old.
Parent/legal guardian is present at the clinic visit who speaks English
Child screens positive for recurrent abdominal pain by having: 1) 8 episodes of abdominal pain over 2 months (based on Rome III criteria), or 2) 2 or more episodes of abdominal pain which are causing an incapacity greater than or equal to 25% of the time in the past two months).
Based on pediatric medical assessment, child meets criteria for functional abdominal pain (FAP) based on absence of other organic causes of recurrent abdominal pain.
Consent given by caregiver and assent by child to participate.
Presence of internet access, including that accessed by cell phone with video capabilities.

Exclusion criteria

The index child being known to have mental retardation (IQ < 70) or other pervasive developmental disorders.
Subject has a sibling who is already enrolled in our study. ***Possible Exclusion***
Parent/ guardian who would be participating in the study is pregnant.

Treatment and study plan

Feeling and Body Investigators with Functional Abdominal Pain

Behavioral

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.

Other names: Ten Session Therapy for Young Children with Functional Abdominal Pain

Treatment Strategies

Behavioral

identify strategies with unique patterns of neural circuit maturation associated with early visceral pain on the gut-brain axis:
adapt acceptance-based behavioral strategies used to address psychopathology in older children to younger children;
incorporate caregivers as role models and facilitators based on attachment research.

Primary outcomes

Number of Participants Who Complete Treatment

Time frame: 1.5 Years

Treatment in this study refers to 10 treatment sessions (2 over cell phone video chat from the subject's home and 8 in the investigator's lab) using an acceptance-based behavioral treatment for children 5 through 9 years old with impairing functional abdominal pain. This intervention is rooted in a biopsychosocial framework incorporating advances in neurodevelopment, behavioral learning theory, and attachment theory.
Number of Participants Completing Homework Assignment

Time frame: 1.5 Years

Enrollees will engage in assigned home-based practice sessions for at least nine of the ten treatment weeks. Completion of assigned practice sessions within a given week is defined as success.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Acronym: FBI

Important dates

Study start: 2014
Primary completion: 2020
Study completion: 2020
First posted: Mar 3, 2014
Registry last updated: Jul 4, 2025

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.

Published trials that share one or more normalized conditions with this study.

Completed