Feeling and Body Investigators (FBI)
Primary Purpose
Functional Abdominal Pain
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Feeling and Body Investigators with Functional Abdominal Pain
Treatment Strategies
Sponsored by
About this trial
This is an interventional treatment trial for Functional Abdominal Pain focused on measuring Functional Abdominal Pain, Children, Finding a treatment or intervention for children
Eligibility Criteria
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.
Sites / Locations
- Duke University Young Child Lab at Brightleaf Square
- Duke Children's Primary Care Picket Road
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Functional Abdominal Pain (FAP)
Arm Description
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.
Outcomes
Primary Outcome Measures
Percentage of Participants Who Complete Treatment
Treatment in this study refers to10 treatment sessions (4 via webcam or over cell phone video chat from the subject's home and 6 in the investigator's lab) using an acceptance-based behavioral treatment for children 5 through 8 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.
Percentage 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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02075437
Brief Title
Feeling and Body Investigators
Acronym
FBI
Official Title
Feelings and Body Investigators (FBI): Interoceptive Exposure for Child Abdominal Pain
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
5. Study Description
Brief 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". 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 26 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Abdominal Pain
Keywords
Functional Abdominal Pain, Children, Finding a treatment or intervention for children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
126 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Functional Abdominal Pain (FAP)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Feeling and Body Investigators with Functional Abdominal Pain
Other Intervention Name(s)
Ten Session Therapy for Young Children with Functional Abdominal Pain
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment Strategies
Intervention Description
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 Outcome Measure Information:
Title
Percentage of Participants Who Complete Treatment
Description
Treatment in this study refers to10 treatment sessions (4 via webcam or over cell phone video chat from the subject's home and 6 in the investigator's lab) using an acceptance-based behavioral treatment for children 5 through 8 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.
Time Frame
1.5 Years
Title
Percentage of Participants Completing Homework Assignment
Description
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.
Time Frame
1.5 Years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Months
Maximum Age & Unit of Time
107 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Zucker, PhD
Organizational Affiliation
Director, Duke Center for Eating Disorders, Assistant Professor
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Helen Egger, MD
Organizational Affiliation
Head, Division of Child and Adolescent Psychiatry, Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Young Child Lab at Brightleaf Square
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27701
Country
United States
Facility Name
Duke Children's Primary Care Picket Road
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28826066
Citation
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.
Results Reference
derived
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Feeling and Body Investigators
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