Feeling and Body Investigators
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Pain, Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/22/2019 |
| Start Date: | March 2014 |
| End Date: | March 2020 |
| Contact: | Nancy Zucker, PhD |
| Email: | nancy.zucker@dm.duke.edu |
| Phone: | 919-668-0075 |
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.
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.
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.
We found this trial at
2
sites
Durham, North Carolina 27701
Principal Investigator: Nancy Zucker, PhD
Phone: 919-687-4686
Click here to add this to my saved trials
Durham, North Carolina 27705
Principal Investigator: Nancy Zucker, PhD
Phone: 919-687-4686
Click here to add this to my saved trials