Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MH097959 | Other Grant/Funding Number | Federal Identifier |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 1.5 Years |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nancy Zucker, PhD | Director, Duke Center for Eating Disorders, Professor | Principal Investigator |
| Helen Egger, MD | Head, Division of Child and Adolescent Psychiatry, Associate Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Young Child Lab at Brightleaf Square | Durham | North Carolina | 27701 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41914616 | Derived | 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. | |
| 28826066 |
Not provided
Not provided
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.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline Characteristics were not collected from caregivers.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Feeling and Body Investigators (FBI) Caregiver-Child Dyads - Children | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 1.5 Years |
|
1.5 years
Only children were monitored for adverse events. Caregivers and children provided any info related to adverse events throughout the duration of their involvement in this clinical trial.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Feeling and Body Investigators (FBI) Caregiver-Child Dyads - Children | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nancy Zucker | Duke University | 919-668-0075 | nancy.zucker@duke.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 28, 2019 | Nov 20, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 28, 2019 | Nov 20, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 28, 2019 | Nov 20, 2024 | ICF_002.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Treatment Strategies | Behavioral |
|
|
| Duke Children's Primary Care Picket Road |
| Durham |
| North Carolina |
| 27705 |
| United States |
| Derived |
| Zucker 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. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | 1.5 Years |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
Not provided
Not provided