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Feeling and Body Investigators (FBI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT02075437
First received: February 27, 2014
Last updated: October 1, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Functional Abdominal Pain
Behavioral: Feeling and Body Investigators with Functional Abdominal Pain
Behavioral: Treatment Strategies

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feelings and Body Investigators (FBI): Interoceptive Exposure for Child Abdominal Pain

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Percentage of Participants Who Complete Treatment [ Time Frame: 1.5 Years ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Completing Homework Assignment [ Time Frame: 1.5 Years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 126
Study Start Date: March 2014
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

  Eligibility

Ages Eligible for Study:   60 Months to 107 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02075437

Contacts
Contact: Nancy Zucker, PhD 919-668-0075 nancy.zucker@dm.duke.edu
Contact: Kristen A Caldwell, BA 919-687-4686 ext 300 kristen.caldwell@dm.duke.edu

Locations
United States, North Carolina
Duke Children's Primary Care Picket Road Recruiting
Durham, North Carolina, United States, 27705
Contact: Kristen A Caldwell, BA    919-687-4686 ext 300    kristen.caldwell@dm.duke.edu   
Principal Investigator: Nancy Zucker, PhD         
Principal Investigator: Helen Egger, PhD         
Duke University Young Child Lab at Brightleaf Square Recruiting
Durham, North Carolina, United States, 27701
Contact: Kristen A Caldwell, BA    919-687-4686 ext 300    kristen.caldwell@dm.duke.edu   
Contact: Vikki F Matherly, BA    919-687-4686 ext 268    vikki.matherly@dm.duke.edu   
Principal Investigator: Nancy Zucker, PhD         
Principal Investigator: Helen Egger, MD         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02075437     History of Changes
Other Study ID Numbers: Pro00043556, MH097959
Study First Received: February 27, 2014
Last Updated: October 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Functional Abdominal Pain, Children
Finding a treatment or intervention for children

Additional relevant MeSH terms:
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on November 25, 2014