Feeling and Body Investigators for Pediatric Abdominal Pain (NCT02075437) | Clinical Trial Compass
CompletedNot Applicable
Feeling and Body Investigators for Pediatric Abdominal Pain
United States28 participantsStarted 2014-03
Plain-language 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.
Who can participate
Age range
60 Months – 107 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Who Complete Treatment
Timeframe: 1.5 Years
2
Number of Participants Completing Homework Assignment