Feeling and Body Investigators for Pediatric Abdominal Pain: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Feeling and Body Investigators for Pediatric Abdominal Pain (NCT02075437), a na na study. The primary outcome is Number of Participants Who Complete Treatment.

2. Clinical Question

The study is framed as intervention development and an initial feasibility assessment, rather than as a randomized test of comparative effectiveness. Its summary describes an early phase in which the intervention would be developed and refined in child-caregiver dyads. The stated feasibility hypotheses concern treatment completion and completion of home-based practice assignments. Those hypotheses describe what investigators intended to assess; they do not establish that either target was met.

The summary also describes a later phase in which investigators planned to randomize 100 subjects to the intervention or an active control group to pilot-test feasibility, acceptance, and clinical significance. That description is a plan in the study summary, not evidence that the randomized phase took place. Whether it was conducted, and any results from it, are not reported in the registry record. The question answerable from the listed design is therefore limited to whether participants completed treatment in the single-group study; the recorded primary outcome has no reported result.

3. Trial Design

The registry lists this study as completed, with a single-group model, no applicable allocation, and no masking. Enrollment is listed as 28. The record identifies functional abdominal pain as the condition and Duke University as the sponsor. The listed start is 2014-03 and primary completion is 2020-09. The phase is listed as not applicable.

The intervention is behavioral. Its description centers on a 10-session acceptance-based treatment for children with impairing functional abdominal pain. The primary outcome description says that two sessions took place over cell phone video chat from the participant’s home and eight in the investigator’s lab. The summary describes activities that include learning about sensations, exploring them through missions, recalling contexts in which similar sensations occur, and gradually challenging avoidance and safety behaviors. These are descriptions of the intervention, not evidence of its effects.

The record lists two behavioral interventions, but it does not describe a randomized, like-for-like comparison in this study. The listed design and allocation indicate a single-group record. Accordingly, the primary outcome should be read as a count of participants completing treatment, not as a difference between treatment groups. The registry summary’s description of a planned later randomized phase does not change the design recorded for this study.

The summary describes the early phase as involving 28 child-caregiver dyads and says that investigators planned a later phase involving randomization of 100 subjects. The record does not report whether that later phase was undertaken. The registered outcome set includes two measures, while no analyses are listed. Statistical analysis details beyond the limited design information are not reported in the registry record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: Caregiver-child dyads were enrolled to examine the acceptability and feasibility of a new treatment for child abdominal pain. Caregiver-child dyads were enrolled in the study protocol and both involved in treatment sessions.

Overall Study

Reasons for not completing this period:

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

Population: Baseline Characteristics were not collected from caregivers.

6. Primary Endpoint

The registry lists the primary outcome as Number of Participants Who Complete Treatment, measured over 1.5 Years.

The primary endpoint is the number of participants who complete treatment. It is a count outcome: it records how many participants meet the completion definition, rather than measuring a change in symptom intensity or comparing outcomes between groups. The registry defines treatment completion as completing 10 sessions. It describes those sessions as two over cell phone video chat from the participant’s home and eight in the investigator’s lab.

A treatment-completion count is relevant to a feasibility assessment because it describes whether participants stayed engaged through the planned course. The study summary also states a hypothesis about the proportion of enrolled participants who would complete treatment. That intention does not supply the observed number or proportion. The outcome is listed with a timeframe of 1.5 Years, but the registry record does not report the result for that timeframe.

The endpoint does not, by itself, measure pain improvement, functioning, emotional regulation, acceptability, or the intervention’s clinical significance. The study summary discusses these as intended areas of interest, but no corresponding result should be inferred from the completion outcome. The number completing treatment and the number enrolled would be needed to describe completion directly; the primary outcome result is not reported in the registry record. No inferential estimate or uncertainty interval for this endpoint is reported either.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registered design is single group, with allocation listed as not applicable and masking listed as none. This matters because the study does not provide a randomized contrast between the intervention and a concurrent control group. Its primary outcome is a count of participants completing treatment, not a between-group effect estimate. The record lists no analyses, so it does not report an inferential procedure used to evaluate that endpoint.

General statistical explanation: a count outcome records the number of people meeting a defined event criterion. Here, the event is treatment completion, defined as completing 10 sessions. A count is useful for describing what occurred, but interpretation often also depends on the number of participants eligible for or assessed on the outcome. Enrollment is listed as 28, but the completion count and its result are not reported in the registry record. No completion proportion should therefore be inferred from the enrollment figure.

For a binary outcome such as completion versus non-completion, an analysis might describe the event count and estimate the proportion with the event. If a confidence interval were reported, it would express the uncertainty associated with that estimated proportion under the chosen statistical method. General statistical explanation: a confidence interval is a range of values compatible with the data and method at a specified confidence level; it is not a guarantee that the true value lies in that range. No estimate or interval for treatment completion is reported in the registry record, so this framework explains what such statistics would mean rather than interpreting a study estimate.

The record’s single-group structure also affects how an estimate could be interpreted. A completion proportion could characterize this study’s participants and setting, but without a concurrent comparison it would not estimate a difference attributable to the intervention. General statistical explanation: random allocation can, under appropriate conditions, help balance factors between comparison groups. That logic does not apply to the registered single-group design. The summary’s mention of a future randomized phase is not evidence that this record contains randomized data.

Two outcome measures are listed, but no analyses are listed. The record does not identify which statistical tests, models, estimation methods, or adjustment procedures were used. It does not report whether outcomes were analyzed as counts, proportions, or another summary beyond the primary endpoint’s stated unit and parameter. Nor does it report a prespecified statistical analysis plan. These details are not reported in the registry record and should not be reconstructed from the study aims.

The registry’s sample-size assumptions describe planning illustrations based on an observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The described effect to detect is a stated fraction of the observed effect. For time-to-event illustrations, the total number of events is described as the quantity; for other illustrations, the quantity is participants per arm. These assumptions do not describe the registered single-group design, and the registry record does not report a numerical observed effect or numerical planning results in the information available for interpretation. Such illustrations are planning aids, not observed power and not evidence that the study had a particular probability of finding an effect.

General statistical explanation: planning calculations depend on assumptions about the effect to detect, variability or event frequency, allocation, and the analysis. Changing those assumptions can change the planning estimate. When planning illustrations are based on a fraction of an observed effect, that fraction is a hypothetical target for planning; it is not an observed result in a new study. A planning calculation also cannot compensate for a missing outcome report or create a comparison group that the registered design does not contain.

The information recorded does not specify an interim analysis, a stopping rule, a model for repeated observations, or handling of departures from distributional assumptions. These matters are not reported in the registry record. General statistical explanation: over-dispersion occurs when count variation exceeds what a chosen count model expects. If a model assumes less variation than the data have, standard errors can be too small and uncertainty can appear understated. No count model or dispersion estimate is reported for this endpoint, so over-dispersion cannot be assessed for the study.

Similarly, there is no reported precision estimate for the primary endpoint. General statistical explanation: statistical significance, when tested, concerns how compatible observed data are with a specified null model under the assumptions of the test; it is not a measure of clinical importance. An effect estimate and its uncertainty are generally needed to assess magnitude and precision. Since the registry record reports neither an analysis nor a primary outcome result, no significance or precision judgment is available.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Feeling and Body Investigators (FBI) Caregiver-Chi")
n      <- c(28)
events <- c(22)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Feeling and Body Investigators (FBI) Caregiver-Chi  28  22  78.6  59.0  91.7  60.5  89.8  60.3  89.7

11. Multiplicity, Missing Data and Analysis Populations

The registry lists two outcome measures but no analyses. It does not report which outcomes were treated as primary in the analysis, whether additional outcomes were exploratory, or whether any adjustment for multiple comparisons was planned or used. A multiplicity procedure and its rationale are not reported in the registry record. Because no analysis results are listed, there are no reported p-values or intervals to interpret in relation to multiple testing.

The primary outcome is defined as treatment completion, but the record does not report how missing completion status was handled. It does not state whether all enrolled participants were assessed, how withdrawals or incomplete records were classified, or whether any imputation or sensitivity analysis was used. Those procedures are not reported in the registry record. Enrollment alone cannot establish the denominator used in an outcome analysis.

The record does not identify an intention-to-treat population, a per-protocol population, or another analysis population. It also does not report exclusions from analysis or reasons for exclusion. These details are not reported in the registry record, so readers cannot determine whether the analyzed population, if one was analyzed, matched the enrolled group.

General statistical explanation: missing data can affect an estimate when the likelihood of an outcome being unobserved is related to participant characteristics or outcomes. Different assumptions about missingness can lead to different conclusions, which is why transparent reporting of denominators, missingness, and sensitivity checks is useful. No such assessment is reported for this study. With the outcome result and analysis population absent, the extent and impact of missing data cannot be evaluated.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

For the listed child group, the registry reports 28 participants at risk for serious adverse events and zero affected. It also reports 28 at risk for other adverse events and zero affected. Deaths are listed as zero. No serious adverse-event terms are listed.

These figures are event counts in the registry record, not a comparison of risks between groups. The study is recorded as single group, so there is no concurrent control estimate against which to compare the listed counts. The counts also do not establish that no adverse events could occur; they describe only what is recorded for the categories and group in this entry.

The registry record does not explain the method or observation period used to collect safety information beyond the outcome and study descriptions. It does not report a safety analysis or uncertainty estimates. The absence of listed serious-event terms is not evidence about unlisted symptoms or events, and the zero counts should not be interpreted as a general guarantee of safety.

13. What the Result Does, and Does Not, Mean

The record supports a limited description of the study: it was registered as a completed, single-group behavioral intervention study for functional abdominal pain, with enrollment listed as 28 and a primary outcome defined as treatment completion. It also records the treatment structure and reports safety counts for the listed child group. These are features of the registered study, not evidence of clinical benefit.

The primary completion result is not reported in the registry record. As a result, readers cannot determine from this entry how many participants completed treatment or whether the study’s stated feasibility target was reached. The record also does not give an outcome estimate, uncertainty interval, or analysis. It does not establish whether the intervention changed pain, functioning, emotional regulation, acceptance, or other clinical outcomes described as aims in the summary.

Because there is no reported control group in this single-group record, even a completion result would not show whether the intervention caused greater completion than another approach. The summary’s description of a planned randomized phase with an active control cannot be treated as evidence that the randomized comparison occurred or produced results. Whether that later phase took place is not reported in the registry record.

General statistical explanation: feasibility, engagement, safety, and clinical effectiveness are different questions. A completion count addresses participation in the treatment course; it does not directly quantify symptom change or comparative benefit. Evidence for one question should not be substituted for evidence about another. The reported safety counts are also descriptive and do not demonstrate comparative safety.

The appropriate reading is therefore cautious and specific: the registry record documents a completed intervention-development study, but does not report the primary outcome result or statistical analyses needed to evaluate its stated completion hypothesis. The absence of reported results is not a positive or negative finding. It leaves the central endpoint unanswered in this record.

14. Why This Trial Matters Statistically

This study illustrates the distinction between an intervention-development or feasibility question and a comparative treatment question. A count of participants completing a defined course can be relevant to whether a study intervention was deliverable and whether participants remained engaged. It does not, on its own, answer whether the intervention improves symptoms or performs better than an alternative.

Design and reporting must align with the claim being considered. A single-group study can describe what happened among its participants, but it cannot produce a randomized between-group comparison. The study summary describes a later randomized phase as a plan; separating that plan from the design recorded for this study prevents planned evidence from being mistaken for observed evidence.

The record also demonstrates why a clearly defined endpoint is not enough without a posted result. Treatment completion has a stated definition, and the registry gives a timeframe, yet the observed count is not reported. Without that result and its analysis population, readers cannot assess whether the stated feasibility expectation was met or how precisely completion was estimated.

Finally, the record distinguishes safety counts from a complete safety assessment. The listed zero counts are interpretable as reported observations for the specified group and categories, but they do not provide a randomized safety comparison or establish absence of risk. Transparent outcome reporting, denominators, missing-data handling, and analytic methods would be needed for a fuller statistical assessment. These considerations make the boundaries of the available evidence as important as the intervention’s stated goals.

15. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The primary limitation for interpretation is that the registry record does not report the primary treatment-completion result. It lists enrollment and defines the endpoint, but does not state the observed completion count. No statistical analyses are listed, and no effect estimate or uncertainty interval is reported. The stated feasibility hypothesis therefore cannot be assessed from this record.

The single-group design does not provide a reported concurrent control comparison. The allocation field is not applicable, and masking is listed as none. These design features preclude interpreting a completion count as evidence of a comparative treatment effect. The randomized active-control phase described in the study summary is a plan; its conduct and results are not reported in the registry record.

The age descriptions are not fully consistent: the study summary refers to children ages 5–8, while the primary outcome description refers to children 5 through 9 years old. The registry record does not explain the difference. It also does not report the analysis population, the number with observed completion status, or handling of missing outcome data. Whether the listed enrollment and the endpoint denominator coincide cannot be determined.

Statistical methods, multiplicity handling, and an analysis plan are not reported in the registry record. The record does not state whether interim analyses or sensitivity analyses were conducted. The limited safety counts do not provide a comparator, detailed event descriptions, or uncertainty estimates. These gaps constrain conclusions about feasibility and safety, while the absent clinical outcome results leave the intended clinical aims unassessed in this record.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Feeling and Body Investigators for Pediatric Abdominal Pain — NCT02075437.
• Registry record last updated 2025-07-04; status last verified 2025-06.
• Results first posted 2025-07-04.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

19. Record Summary

The registry record describes Feeling and Body Investigators, a behavioral intervention for children with functional abdominal pain. It is listed as completed, single group, with no applicable allocation and no masking. Enrollment is 28, the sponsor is Duke University, and the listed dates are 2014-03 for study start and 2020-09 for primary completion.

The primary endpoint is the number of participants who complete the 10-session treatment, with a listed timeframe of 1.5 Years. The endpoint result is not reported in the registry record, and no analyses are listed. The record reports zero serious adverse events, zero other adverse events, and zero deaths in the listed child group; it does not provide a comparative safety assessment.

The study summary describes a planned later randomized phase, but whether it occurred is not reported in the registry record. The available information supports a description of the study design and stated aims, not a conclusion about treatment completion, clinical effects, or comparative effectiveness.