Trial Outcomes & Findings for Feeling and Body Investigators for Pediatric Abdominal Pain (NCT NCT02075437)

NCT ID: NCT02075437

Last Updated: 2025-07-04

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

28 participants

Primary outcome timeframe

1.5 Years

Results posted on

2025-07-04

Participant Flow

Caregiver-child dyads were enrolled to examine the acceptability and feasibility of a new treatment for child abdominal pain. Caregiver-child dyads were enrolled in the study protocol and both involved in treatment sessions.

Participant milestones

Participant milestones
Measure
Feeling and Body Investigators (FBI) Caregiver-Child Dyads
Feeling and Body Investigators (FBI) is a 10-session intervention to treat children with functional abdominal pain. The treatment contains the following components: 1) We aim to reduce fearful perceptions of somatic and visceral sensations by linking sensations to playful characters. In sessions organized by theme (e.g., the Eats), children build curious reactions to things they notice in their bodies using funny cartoon characters used to teach them the meaning of different sensations (e.g. Betty Butterfly for gut butterflies of anxiety). 2) Children perform interoceptive exposure activities designed to demonstrate how smart and tough the body is in responding to different demands (e.g., seeing how fast a child can run even if they feel uncomfortable). 3) Children learn to link body sensations to meanings and actions. Using a Body Clues Worksheet, children figure out what they were feeling, what their feeling was telling them, and try out different ways to respond to the messages of their body to see what happens. 4) Families design investigations to help them face challenging situations (e.g. devising a plan to run around at recess to try to get all their gas out and see what happens to their abdominal pain after recess). If successful, kids with FAP who complete treatment will learn to experience body sensations as fun and fascinating, rather than scary, and develop new capacities for pain management, increase adaptive functioning, and enhance interoceptive responsivity.
Overall Study
STARTED
28
Overall Study
COMPLETED
22
Overall Study
NOT COMPLETED
6

Reasons for withdrawal

Reasons for withdrawal
Measure
Feeling and Body Investigators (FBI) Caregiver-Child Dyads
Feeling and Body Investigators (FBI) is a 10-session intervention to treat children with functional abdominal pain. The treatment contains the following components: 1) We aim to reduce fearful perceptions of somatic and visceral sensations by linking sensations to playful characters. In sessions organized by theme (e.g., the Eats), children build curious reactions to things they notice in their bodies using funny cartoon characters used to teach them the meaning of different sensations (e.g. Betty Butterfly for gut butterflies of anxiety). 2) Children perform interoceptive exposure activities designed to demonstrate how smart and tough the body is in responding to different demands (e.g., seeing how fast a child can run even if they feel uncomfortable). 3) Children learn to link body sensations to meanings and actions. Using a Body Clues Worksheet, children figure out what they were feeling, what their feeling was telling them, and try out different ways to respond to the messages of their body to see what happens. 4) Families design investigations to help them face challenging situations (e.g. devising a plan to run around at recess to try to get all their gas out and see what happens to their abdominal pain after recess). If successful, kids with FAP who complete treatment will learn to experience body sensations as fun and fascinating, rather than scary, and develop new capacities for pain management, increase adaptive functioning, and enhance interoceptive responsivity.
Overall Study
Withdrawal by Subject
5
Overall Study
Lost to Follow-up
1

Baseline Characteristics

Feeling and Body Investigators for Pediatric Abdominal Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Feeling and Body Investigators (FBI) Caregiver-Child Dyads - Children
n=28 Participants
Feeling and Body Investigators (FBI) is a 10-session intervention to treat children with functional abdominal pain. The treatment contains the following components: 1) We aim to reduce fearful perceptions of somatic and visceral sensations by linking sensations to playful characters. In sessions organized by theme (e.g., the Eats), children build curious reactions to things they notice in their bodies using funny cartoon characters used to teach them the meaning of different sensations (e.g. Betty Butterfly for gut butterflies of anxiety). 2) Children perform interoceptive exposure activities designed to demonstrate how smart and tough the body is in responding to different demands (e.g., seeing how fast a child can run even if they feel uncomfortable). 3) Children learn to link body sensations to meanings and actions. Using a Body Clues Worksheet, children figure out what they were feeling, what their feeling was telling them, and try out different ways to respond to the messages of their body to see what happens. 4) Families design investigations to help them face challenging situations (e.g. devising a plan to run around at recess to try to get all their gas out and see what happens to their abdominal pain after recess). If successful, kids with FAP who complete treatment will learn to experience body sensations as fun and fascinating, rather than scary, and develop new capacities for pain management, increase adaptive functioning, and enhance interoceptive responsivity.
Age, Continuous
7.04 years
n=99 Participants
Sex: Female, Male
Female
20 Participants
n=99 Participants
Sex: Female, Male
Male
8 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
26 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
Race (NIH/OMB)
Black or African American
5 Participants
n=99 Participants
Race (NIH/OMB)
White
21 Participants
n=99 Participants
Race (NIH/OMB)
More than one race
2 Participants
n=99 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
Region of Enrollment
United States
28 Participants
n=99 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Feeling and Body Investigators (FBI) Caregiver-Child Dyads
n=28 Participants
Feeling and Body Investigators (FBI) is a 10-session intervention to treat children with functional abdominal pain. The treatment contains the following components: 1) We aim to reduce fearful perceptions of somatic and visceral sensations by linking sensations to playful characters. In sessions organized by theme (e.g., the Eats), children build curious reactions to things they notice in their bodies using funny cartoon characters used to teach them the meaning of different sensations (e.g. Betty Butterfly for gut butterflies of anxiety). 2) Children perform interoceptive exposure activities designed to demonstrate how smart and tough the body is in responding to different demands (e.g., seeing how fast a child can run even if they feel uncomfortable). 3) Children learn to link body sensations to meanings and actions. Using a Body Clues Worksheet, children figure out what they were feeling, what their feeling was telling them, and try out different ways to respond to the messages of their body to see what happens. 4) Families design investigations to help them face challenging situations (e.g. devising a plan to run around at recess to try to get all their gas out and see what happens to their abdominal pain after recess). If successful, kids with FAP who complete treatment will learn to experience body sensations as fun and fascinating, rather than scary, and develop new capacities for pain management, increase adaptive functioning, and enhance interoceptive responsivity.
Number of Participants Who Complete Treatment
22 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Feeling and Body Investigators (FBI) Caregiver-Child Dyads
n=28 Participants
Feeling and Body Investigators (FBI) is a 10-session intervention to treat children with functional abdominal pain. The treatment contains the following components: 1) We aim to reduce fearful perceptions of somatic and visceral sensations by linking sensations to playful characters. In sessions organized by theme (e.g., the Eats), children build curious reactions to things they notice in their bodies using funny cartoon characters used to teach them the meaning of different sensations (e.g. Betty Butterfly for gut butterflies of anxiety). 2) Children perform interoceptive exposure activities designed to demonstrate how smart and tough the body is in responding to different demands (e.g., seeing how fast a child can run even if they feel uncomfortable). 3) Children learn to link body sensations to meanings and actions. Using a Body Clues Worksheet, children figure out what they were feeling, what their feeling was telling them, and try out different ways to respond to the messages of their body to see what happens. 4) Families design investigations to help them face challenging situations (e.g. devising a plan to run around at recess to try to get all their gas out and see what happens to their abdominal pain after recess). If successful, kids with FAP who complete treatment will learn to experience body sensations as fun and fascinating, rather than scary, and develop new capacities for pain management, increase adaptive functioning, and enhance interoceptive responsivity.
Number of Participants Completing Homework Assignment
15 Participants

Adverse Events

Feeling and Body Investigators (FBI) Caregiver-Child Dyads - Children

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Nancy Zucker

Duke University

Phone: 919-668-0075

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place