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NCT02075437 · ClinicalTrials.gov registry record · NA
Feeling and Body Investigators for Pediatric Abdominal Pain
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 28
- Enrollment target
NCT02075437: Completed NA study, sponsored by Duke University.
NCT02075437 is a NA study that has completed, run by Duke University. The registered enrollment target is 28 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02075437, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 28 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- BEHAVIORAL Feeling and Body Investigators with Functional Abdominal Pain
- BEHAVIORAL Treatment Strategies
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2014-03 |
| Est. Completion | 2020-09 |
| Phase | NA |
What the finished NCT02075437 record still lists
NCT02075437 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Feeling and Body Investigators with Functional Abdominal Pain is the first listed.
NCT02075437 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02075437 about?
NCT02075437 is a clinical study titled "Feeling and Body Investigators for Pediatric 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 clu...
What is the current status of trial NCT02075437?
This trial is currently completed. It is a NA study. The enrollment target is 28 participants. The study started on 2014-03. Estimated completion is 2020-09.
What interventions are being tested in trial NCT02075437?
The interventions under investigation include: Feeling and Body Investigators with Functional Abdominal Pain (BEHAVIORAL), Treatment Strategies (BEHAVIORAL).
Who is sponsoring clinical trial NCT02075437?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02075437's enrollment target sits among peer trials
28 1704th of 2000 higher than 293 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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