Dr. Nancy Zucker
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.
This study is CURRENTLY RECRUITING
For additional information, Contact: Kristen A Caldwell, BA
919-687-4686 ext 300
ClinicalTrials.gov Identifier: NCT02075437
Duke eIRB Protocol Identifier: Pro00043556
Sometimes you just have a feeling about something; you feel it in your gut, and you know it in your heart. In this study we want to learn how intuition and gut feelings affect the everyday
lives of adolescents. The ability to feel change in your body (i.e., the beating of your heart and/or
the churning of your stomach) is different from person to person. We want to know how these
differences in adolescents relate to the intensity of their emotions and the ability to make complex decisions. We will be using MRIs, saliva samples, questionnaires, and laboratory games to see how adolescents ages 10-17 vary in their abilities to sense different aspects of their bodies.
This study is CURRENTLY CLOSED.