Functional Abdominal PainFBINCT02075437
Feeling and Body Investigators for Pediatric Abdominal Pain
A study testing Feeling and Body Investigators with Functional Abdominal Pain and Treatment Strategies in people with Functional Abdominal Pain, run by Duke University at 2 sites in United States.
Trial 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". Read more about this study
- Who is it for?
- Ages 60 to 107 months
- Conditions the study is for
- Functional Abdominal Pain
- What is being tested?
- Feeling and Body Investigators with Functional Abdominal Pain and Treatment Strategies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2014to Sep 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 107 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University Young Child Lab at Brightleaf Square
Durham, North Carolina, 27701
Duke Children's Primary Care Picket Road
Durham, North Carolina, 27705
About this study
Official title: Feelings and Body Investigators (FBI): Interoceptive Exposure for Child 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.
- Conditions
- Functional Abdominal Pain
- Being tested
- Feeling and Body Investigators with Functional Abdominal Pain, Treatment Strategies
- Keywords
- Functional Abdominal Pain, Children, Finding a treatment or intervention for children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feeling and Body Investigators with Functional Abdominal PainBehavioural
Also called Ten Session Therapy for Young Children 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.
Treatment StrategiesBehavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Functional Abdominal Pain (FAP) | Experimental | To access (FAP) subjects will participate in: 10 therapy sessions; and the following treatments: 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; and 3) incorporate caregivers as role models and facilitators based on attachment research. Receives: Behavioral: Feeling and Body Investigators with Functional Abdominal Pain; Behavioral: Treatment Strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Complete Treatment
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.
Measured: 1.5 Years
Number of Participants Completing Homework Assignment
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.
Measured: 1.5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionSep 2020
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Functional Abdominal PainStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nancy Zucker, PhD, Principal investigator, Director, Duke Center for Eating Disorders, ProfessorHelen Egger, MD, Principal investigator, Head, Division of Child and Adolescent Psychiatry, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02075437
- Sponsor's protocol ID
- Pro00043556
- Other IDs
- MH097959
- Acronym
- FBI
- Status last verified
- Jun 2025
- First submitted
- 27 Feb 2014
- Last updated
- 4 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Zucker NL, Pendergast J, Rivera-Cancel A, Ives L, Small B, Gagliano ME, Lewis G, Davila M, Keith Walter B, Datta N, Erwin S, Farber M, Romer A, Gil C, Pilato I, Stein K, Craske MG, van Tilburg MAL, Maslow G, Egger H. A Randomized Trial Testing a Body-Focused Exposure Treatment of Functional Abdominal Pain in Children. Am J Gastroenterol. 2026 Mar 31. doi: 10.14309/ajg.0000000000004010. Online ahead of print.
PubMed 41914616Zucker N, Mauro C, Craske M, Wagner HR, Datta N, Hopkins H, Caldwell K, Kiridly A, Marsan S, Maslow G, Mayer E, Egger H. Acceptance-based interoceptive exposure for young children with functional abdominal pain. Behav Res Ther. 2017 Oct;97:200-212. doi: 10.1016/j.brat.2017.07.009. Epub 2017 Jul 29.
PubMed 28826066
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feelings and Body Investigators (FBI): Interoceptive Exposure for Child Abdominal Pain
- ClinicalTrials.gov ID
- NCT02075437
- Acronym / sponsor ID
- FBI / Pro00043556
- Conditions
- Functional Abdominal Pain
- Keywords
- Functional Abdominal Pain, Children, Finding a treatment or intervention for children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- Sep 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 3 Mar 2014 (estimated)
- Results
- Posted 4 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Functional Abdominal Pain (FAP) | Experimental | Behavioral: Feeling and Body Investigators with Functional Abdominal Pain, Behavioral: Treatment StrategiesTo access (FAP) subjects will participate in: 10 therapy sessions; and the following treatments: 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; and 3) incorporate caregivers as role models and facilitators based on attachment research. |
Who may qualify
- Ages
- 60 to 107 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Feeling and Body Investigators with Functional Abdominal PainAlso: Ten Session Therapy for Young Children with Functional Abdominal PainInvestigator'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. | Behavioural | Functional Abdominal Pain (FAP) |
| Treatment Strategies1. 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. | Behavioural | Functional Abdominal Pain (FAP) |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41914616Zucker NL, Pendergast J, Rivera-Cancel A, Ives L, Small B, Gagliano ME, Lewis G, Davila M, Keith Walter B, Datta N, Erwin S, Farber M, Romer A, Gil C, Pilato I, Stein K, Craske MG, van Tilburg MAL, Maslow G, Egger H. A Randomized Trial Testing a Body-Focused Exposure Treatment of Functional Abdominal Pain in Children. Am J Gastroenterol. 2026 Mar 31. doi: 10.14309/ajg.0000000000004010. Online ahead of print.
- Derived from this study: PubMed 28826066Zucker N, Mauro C, Craske M, Wagner HR, Datta N, Hopkins H, Caldwell K, Kiridly A, Marsan S, Maslow G, Mayer E, Egger H. Acceptance-based interoceptive exposure for young children with functional abdominal pain. Behav Res Ther. 2017 Oct;97:200-212. doi: 10.1016/j.brat.2017.07.009. Epub 2017 Jul 29.
Related trials for Functional Abdominal Pain
Not yet recruiting
The Mechanism Underlying the Analgesic Effect of the Music of IBS Pain
Abdominal Pain/ Discomfort, Irritable Bowel Syndrome
RecruitingObservational study
Overlapping Pain Trajectory Study
Migraine, Musculoskeletal Pain
Not yet recruiting
ADAPTing CBT for Pediatric Functional Abdominal Pain in Spain
Abdominal Pain
Active, not recruiting
A Personalized Approach to Abdominal Pain in Irritable Bowel Syndrome
Irritable Bowel Syndrome, Inflammatory Bowel Diseases
Not yet recruiting
ADAPTing CBT for Pediatric Functional Abdominal Pain in Primary Care
Abdominal Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy Zucker, PhD principal investigator
Director, Duke Center for Eating Disorders, Professor
Helen Egger, MD principal investigator
Head, Division of Child and Adolescent Psychiatry, Associate Professor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feeling and Body Investigators with Functional Abdominal Pain and Treatment Strategies in people with Functional Abdominal Pain, run by Duke University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Complete Treatment (time frame: 1.5 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02075437, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.