Clinical trial NCT02075437: Feeling and Body Investigators
Official title: Feelings and Body Investigators (FBI): Interoceptive Exposure for Child Abdominal Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Functional Abdominal Pain
Keywords: Functional Abdominal Pain, Children
Finding a treatment or intervention for children
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-03-03
Enrollment: 126
Sex: ALL
Minimum age (years): 60
Maximum age (years): 107
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Participants Who Complete Treatment
timeFrame: 1.5 Years
measure: Percentage of Participants Completing Homework Assignment
timeFrame: 1.5 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Young Child Lab at Brightleaf Square
state: North Carolina
city: Durham
country: United States
facility: Duke Children's Primary Care Picket Road
state: North Carolina
Study officials:
affiliation: Director, Duke Center for Eating Disorders, Assistant Professor
name: Nancy Zucker, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Head, Division of Child and Adolescent Psychiatry, Associate Professor
name: Helen Egger, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.