Feeling and Body Investigators for Pediatric Abdominal Pain

NCT02075437 | Completed Results

• 2 other identifiers: Pro00043556MH097959
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

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 28 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.

Conditions

Functional Abdominal Pain

Keywords

Functional Abdominal Pain, Children; Finding a treatment or intervention for children

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Complete Treatment

  Treatment in this study refers to 10 treatment sessions (2 over cell phone video chat from the subject's home and 8 in the investigator's lab) using an acceptance-based behavioral treatment for children 5 through 9 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

• Number 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

Study Arms (1)

Functional Abdominal Pain (FAP)

EXPERIMENTAL

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; Behavioral: Treatment Strategies

Interventions

Feeling and Body Investigators with Functional Abdominal Pain BEHAVIORAL

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.

Also known as: Ten Session Therapy for Young Children with Functional Abdominal Pain

Functional Abdominal Pain (FAP)

Treatment Strategies BEHAVIORAL

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.

Functional Abdominal Pain (FAP)

Eligibility Criteria

• Age: 60 Months - 107 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• The index child being known to have mental retardation (IQ \< 70) or other pervasive developmental disorders.
• Parent/ guardian who would be participating in the study is pregnant.

Sponsors & Collaborators

• Duke University: lead

Study Sites (2)

Duke University Young Child Lab at Brightleaf Square

Durham, North Carolina, 27701, United States

Location

Duke Children's Primary Care Picket Road

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

• 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.

  PMID: 28826066 DERIVED

Results Point of Contact

• Title: Dr. Nancy Zucker
• Organization: Duke University

nancy.zucker@duke.edu

919-668-0075

Study Officials

• Nancy Zucker, PhD

  Director, Duke Center for Eating Disorders, Professor

  PRINCIPAL INVESTIGATOR

• Helen Egger, MD

  Head, Division of Child and Adolescent Psychiatry, Associate Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2014
• First Posted: March 3, 2014
• Study Start: March 1, 2014
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: July 4, 2025
• Results First Posted: July 4, 2025

Record last verified: 2025-06

Locations

US (2)