Feeling and Body Investigators (FBI)

August 25, 2020 updated by: Duke University

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 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27701
        • Duke University Young Child Lab at Brightleaf Square
      • Durham, North Carolina, United States, 27705
        • Duke Children's Primary Care Picket Road

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Functional Abdominal Pain (FAP)
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.
Behavioral: Feeling and Body Investigators 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.

Other Names:
  • Ten Session Therapy for Young Children with Functional Abdominal Pain
Behavioral: Treatment Strategies
  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;
  3. incorporate caregivers as role models and facilitators based on attachment research.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Complete Treatment
Time Frame: 1.5 Years
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.
1.5 Years
Percentage 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.
1.5 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Nancy Zucker, PhD, Director, Duke Center for Eating Disorders, Assistant Professor
  • Principal Investigator: Helen Egger, MD, Head, Division of Child and Adolescent Psychiatry, Associate Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2014

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

February 27, 2014

First Submitted That Met QC Criteria

February 28, 2014

First Posted (Estimate)

March 3, 2014

Study Record Updates

Last Update Posted (Actual)

August 26, 2020

Last Update Submitted That Met QC Criteria

August 25, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00043556
  • MH097959 (Other Grant/Funding Number: Federal Identifier)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Functional Abdominal Pain

Clinical Trials on Feeling and Body Investigators with Functional Abdominal Pain

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe