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.
COMPLETED
NA
28 participants
1.5 Years
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
| 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.
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|---|---|
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Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
6
|
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.
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|---|---|
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Overall Study
Withdrawal by Subject
|
5
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Overall Study
Lost to Follow-up
|
1
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Baseline Characteristics
Feeling and Body Investigators for Pediatric Abdominal Pain
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.
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|---|---|
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Age, Continuous
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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 YearsTreatment 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
| 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.
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|---|---|
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Number of Participants Who Complete Treatment
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22 Participants
|
PRIMARY outcome
Timeframe: 1.5 YearsEnrollees 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
| 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.
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|---|---|
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Number of Participants Completing Homework Assignment
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15 Participants
|
Adverse Events
Feeling and Body Investigators (FBI) Caregiver-Child Dyads - Children
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place