Feeling and Body Investigators

Functional Abdominal Pain Clinical Trial

— FBI  

Official title:

Feelings and Body Investigators (FBI): Interoceptive Exposure for Child Abdominal Pain

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02075437
• Other study ID #: Pro00043556
• Secondary ID: MH097959
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 2014
• Est. completion date: September 2020

Study information

• Verified date: August 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 126
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Months to 107 Months

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Pain
• Functional Abdominal Pain

Intervention

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.
• Treatment Strategies
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.

Locations

Country	Name	City	State
United States	Duke Children's Primary Care Picket Road	Durham	North Carolina
United States	Duke University Young Child Lab at Brightleaf Square	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1.5 Years
Primary	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.	1.5 Years