Feeling and Body Investigators (FBI)

Duke University

Status: Unknown

Conditions: Functional Abdominal Pain

Treatments: Behavioral: Feeling and Body Investigators with Functional Abdominal Pain; Behavioral: Treatment Strategies

Study type: Interventional

Funder types: Other

Identifiers

NCT02075437

MH097959 (Other Grant/Funding Number)

Pro00043556

Details and patient eligibility

About

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.

Enrollment: 126 estimated patients

Sex: All

Ages: 60 to 107 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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126 participants in 1 patient group

Functional Abdominal Pain (FAP)

Experimental group

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.

Treatment:

Behavioral: Treatment Strategies

Behavioral: Feeling and Body Investigators with Functional Abdominal Pain