This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Family-Based Interoceptive Exposure for Avoidant Restrictive Food Intake Disorder (NCT06110806), a na na study. The primary outcome is MBIE-adapted Therapy Suitability and Acceptability Scale to Measure Patient MBIE Therapy Tolerability.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06110806 |
| Phase | NA |
| Condition | Avoidant Restrictive Food Intake Disorder |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 12 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Icahn School of Medicine at Mount Sinai |
| Results posted | Yes |
2. Clinical Question
Population
Youth diagnosed with avoidant restrictive food intake disorder (ARFID) and their families. The registry record does not report an age range or further eligibility details.
Intervention
Mindfulness-based interoceptive exposure (MBIE), described as outpatient therapy using mindfulness and exposures in a family-based approach for individuals with ARFID.
Comparator
No separate comparison group is listed. The study is described as single-group, with allocation recorded as NA and masking as none.
Primary question
How suitable and acceptable is MBIE from the patient's perspective, including perceived fit, responsiveness, discomfort, and interest in applying therapy experiences outside sessions?
This is a feasibility-focused question rather than a controlled estimate of treatment effect. The project description identifies recruitment, retention, data collection, intervention acceptability, and adherence as areas of interest. It also describes evaluating how many MBIE sessions are required to observe changes in foods avoided and mindfulness skills. Those aims concern whether study procedures and the intervention can be carried out and assessed, as well as what may be learned from repeated treatment sessions.
The primary outcome was an MBIE-adapted Therapy Suitability and Acceptability Scale. Its items ask about the perceived match between therapy and the problem, responsiveness to treatment challenges, unexpected discomfort, and interest in using therapy experiences beyond sessions. The registry record says the scale was intended to be measured up to 6 months. However, it also states that data were not collected because the six-month visit was not completed due to early termination. Consequently, the record does not provide an observed primary acceptability score. The registry record does not report a comparison with usual care, another intervention, or no treatment, so it cannot answer a comparative efficacy question.
3. Trial Design
This was a single-group behavioral intervention study of mindfulness-based interoceptive exposure for ARFID. The registry record names Icahn School of Medicine at Mount Sinai as sponsor, lists enrollment of 12, and identifies the intervention arm as outpatient, family-based therapy using mindfulness and exposures. Phase is recorded as NA. Allocation is also recorded as NA, and masking is listed as none. These features describe an intervention study without a listed randomized allocation or blinded assessment.
The registry record gives a start date of 2023-10-17 and a primary completion date of 2024-07-08. Its status is terminated. It does not report a reason for termination, the date on which the decision was made, or whether all enrolled participants began treatment. The primary outcome description specifically says that data were not collected because the six-month visit was not completed due to early termination. That statement limits interpretation of the primary outcome, but does not establish what happened to every participant or to every other study measure.
The project description emphasizes feasibility and acceptability, including recruitment, retention, data collection at the end of treatment, adherence, and the number of sessions associated with changes in foods avoided and mindfulness skills. The registry lists secondary outcomes concerning therapist adherence, withdrawal, participant acceptability, food tolerability, sessions required to achieve tolerability, calories consumed, and BMI percentile. The record lists 8 outcome measures and 0 analyses. No result estimates for these secondary measures are stated in the registry record.
Because there is no listed parallel control group, changes over time, if collected, would not by themselves separate intervention-related change from other explanations. The registry record does not report the planned analysis model, assessment schedule for each secondary outcome, or a sample-size justification for the trial. Planning illustrations based on two-arm assumptions should not be read as the study's design rationale or as observed power.
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.
Overall Study
| Stage | Mindfulness-based Interoceptive Exposure (MBIE) |
|---|---|
| STARTED | 12 |
| COMPLETED | 0 |
| NOT COMPLETED | 12 |
Reasons for not completing this period:
| Reason | Mindfulness-based Interoceptive Exposure (MBIE) |
|---|---|
| Adverse Event | 1 |
| NCCIH terminated study | 11 |
Analysis population for the primary outcome, as defined in the registry: Data not collected because 6 month visit not completed due to early termination of study.
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.
| Characteristic | Unit | Mindfulness-based Interoceptive Exposure (MBIE) |
|---|---|---|
| Participants analysed | 12 | |
| Age, Continuous | years | 14.9 (SD 2.7) |
| Sex: Female, Male: Female | Participants | 7 |
| Sex: Female, Male: Male | Participants | 5 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 11 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 9 |
| Race (NIH/OMB): More than one race | Participants | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 |
| Body Mass Index (BMI) | kg/m^2 | 19.6 (SD 3.8) |
| Calories consumed during single-item meal | kcal | 100 (SD 145.7) |
| Child and Adolescent Mindfulness Measure (CAMM) | units on a scale | 29.2 (SD 8.7) |
| Body Awareness Questionnaire (BAQ) | units on a scale | 56.1 (SD 19.3) |
| Stanford Feeding Questionnaire - avoidant restrictive food intake disorder (ARFID) Scale | units on a scale | 4.1 (SD 0.9) |
| Stanford Feeding Questionnaire - Parental Feeding Problems Scale | units on a scale | 1.7 (SD 0.5) |
| Parental self-efficacy scale | units on a scale | 21.8 (SD 3.5) |
6. Primary Endpoint
The registry lists the primary outcome as MBIE-adapted Therapy Suitability and Acceptability Scale to Measure Patient MBIE Therapy Tolerability, measured over up to 6 months.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is an MBIE-adapted Therapy Suitability and Acceptability Scale intended to measure the patient's view of how tolerable and suitable the therapy is. Its items address perceived fit between therapy and the problem, responsiveness when treatment challenges arise, unexpected discomfort related to treatment, and interest in drawing on therapy experiences outside the session. These domains are relevant to a feasibility study because they describe whether participants find the intervention appropriate and acceptable, rather than directly measuring a clinical benefit.
The scale is described as containing 10-20 items depending on session content. Each item uses a Likert scale from 1-7, and the total is calculated by summing item scores. The possible total-score range is 10 to 140; higher scores indicate greater perceived suitability and expectancy of success with the intervention. Since the item count can vary with session content, interpretation would depend on the scale as administered and on the scoring approach used for each participant. The registry record does not report further scoring rules or validation details.
The timeframe is up to 6 months. Crucially, the registry record states that the data were not collected because the six-month visit was not completed due to early termination. There is therefore no posted primary endpoint score to describe, compare, or use to estimate precision. The endpoint's stated purpose can be explained, but its observed acceptability result cannot be inferred from the scale description.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central interpretive fact is that the primary acceptability assessment was not collected. The registry record attributes this to the six-month visit not being completed because of early termination. As a result, there is no observed primary scale score, estimate of average acceptability, or measure of uncertainty for that endpoint in the registry record. The planned scale's score range and direction explain what an eventual score would mean, but they do not supply a result.
The record describes enrollment of 12 participants and lists the study as terminated. Enrollment alone does not show how many participants started the intervention, attended sessions, completed treatment, or contributed data to other endpoints. Those participant-level details are not reported in the registry record. Likewise, the project aims mention recruitment, retention, adherence, and treatment-session requirements, but aims are not outcome findings. The registry record lists outcome measures but reports 0 analyses; it does not state numerical results for the listed secondary outcomes.
The study has no listed control arm. A single-group design can describe experiences or changes among people who participate, if measurements are collected, but it cannot make a direct like-for-like comparison with a concurrent control group. Any observed before-and-after change would also be compatible with explanations other than the intervention. Here, the missing primary assessment further prevents an estimate of change or its precision for the main acceptability question.
The adverse-event figures describe events recorded in the intervention group, not comparative safety. One participant is listed as affected by a serious adverse event among 12 at risk, and the serious-event term listed is suicidal intention at 8.3%. One participant is also listed as affected by an other adverse event among 12 at risk. The record lists 0 deaths. These figures do not establish whether an event was caused by the intervention, and the registry record does not report enough detail to interpret event timing, duration, or clinical course.
Accordingly, the posted record supports a description of the study's design, aims, and reporting status, but not a quantitative conclusion about acceptability or changes in the listed secondary outcomes. A missing result is not evidence that an outcome was favorable or unfavorable. Nor does the absence of a posted analysis show that no analysis was ever conducted; it means that analyses are not reported in the registry record.
9. Statistical Methods Explained
Statistical interpretation depends on matching the analysis to the study question and design. This study is listed as a single-group behavioral intervention, with no randomized allocation and no masking. That design can be used to assess whether procedures are workable and to describe participant experience, but it does not create a concurrent treatment contrast. Without a control group, an outcome change cannot by itself identify what would have happened in the same population without the intervention.
What does a single-group design estimate?
A single-group study can report observed measurements, such as scores or changes over time, when those data are collected. Descriptive estimates characterize the participants who contributed data. They do not automatically generalize to all youth with ARFID, particularly when the record does not provide detailed recruitment, eligibility, or participant characteristics. For comparative causal questions, the absence of a control group leaves alternative explanations unresolved. General examples include changes in circumstances over time, measurement variation, or other experiences during follow-up; these are general design considerations, not reported events in this study.
The study description identifies feasibility and acceptability aims, so useful analysis could include how many participants were recruited or retained and whether intervention procedures were followed. The registry lists outcomes related to therapist adherence and participant withdrawal, but it does not report their results. It also lists food tolerability, sessions required to achieve tolerability, calories consumed, and BMI percentile. The registry record does not report the analysis methods or numerical results for these outcomes.
What would an estimate and confidence interval convey?
In general, an estimate is a summary of the observed data, while a confidence interval describes the range of values compatible with the data and the assumptions of the statistical method. A narrow interval indicates greater precision under those assumptions; a wide interval indicates greater uncertainty. Neither an estimate nor an interval corrects for a weak comparison design, missing measurements, or limitations in how an outcome was collected. No primary endpoint estimate or confidence interval is reported because the planned six-month scale data were not collected.
For a single-group scale outcome, an analysis might describe the distribution of total scores or summarize repeated measurements, if available. The scale allows a varying number of items depending on session content, so a clear analysis would need to describe how scores from different administrations were handled. The registry record gives the scale's summing rule and possible range, but does not report a plan for variable item counts, a specific summary statistic, or an inferential model. No additional scoring method should be assumed.
How should the planning illustrations be read?
Planning calculations are distinct from observed study results. The stated illustrations use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the target effect defined as a fraction of an observed effect. Those assumptions describe a planning exercise, not this trial's single-group design. The illustrations are not the trial's own design justification and do not represent observed power. A sample-size calculation based on a hypothetical or previously observed effect does not establish that the study had adequate power, and a planned sample size is not evidence that an effect was observed.
General sample-size calculations depend on the target effect, variability, chosen error rates, allocation, and analysis method. If those assumptions do not match the actual design or outcome, the resulting planning number may not answer the study's practical question. For this study, the registry record does not report a sample-size justification for the single-group feasibility aims. The enrollment of 12 is a registry value, not by itself a statistical demonstration of precision or power.
Why do missing observations matter?
Missing outcome data can reduce the information available for an estimate and can also affect interpretation if participants with missing data differ from those who contribute measurements. General methods for handling missing data rely on assumptions about why observations are absent. The registry record states that the six-month primary assessment was not collected because that visit was not completed following early termination. It does not report whether partial primary data existed at earlier visits, the pattern of missingness for secondary measures, or any imputation or sensitivity analysis. Without those details, no missing-data adjustment can be inferred.
Finally, statistical significance would not be the only relevant issue in a feasibility study. Recruitment, retention, adherence, and participant acceptability can be important descriptive questions even when a study is not designed to test a comparative effect. In this record, however, the primary acceptability data are absent and analyses are not reported. Thus the stated feasibility aims should not be mistaken for demonstrated feasibility findings.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists several secondary outcomes in addition to the primary acceptability measure. They address therapist adherence, withdrawal, participant acceptability, food tolerability, sessions needed to achieve tolerability, calories consumed, and BMI percentile. Looking at multiple outcomes can raise a multiplicity issue: when many hypotheses are tested, the chance of at least one apparently notable result may increase. General approaches include defining a primary outcome in advance, adjusting inference for multiple tests, or emphasizing estimation and descriptive reporting. The registry record does not report a multiplicity plan, and it lists 0 analyses.
The record describes the primary endpoint as not collected because the six-month visit was not completed due to early termination. It does not report how many observations are available for the secondary outcomes, whether any participants have partial follow-up, or whether the reason for termination affected data collection differently across participants. These details matter because an analysis of available observations may describe only those who were measured, while missingness can limit how well the findings represent everyone enrolled.
In general, methods such as imputation or sensitivity analysis require explicit assumptions and should be described alongside the analysis population. The registry record does not report an imputation method, a missing-data sensitivity analysis, or a definition of the population used for any analysis. It also does not report a plan specifying whether analyses were to include everyone enrolled, only those who began treatment, or participants with outcome data. No such analysis population should be inferred from the enrollment figure.
Because the primary endpoint is unavailable and outcome analyses are not reported, there is no basis in the registry record for judging multiplicity-adjusted findings or the effects of missing-data handling. These are reporting gaps, not evidence that a particular method was or was not used outside the record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Mindfulness-based Interoceptive Exposure (MBIE) | 1 | 12 | 8.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Mindfulness-based Interoceptive Exposure (MBIE) | 0 of 12 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Mindfulness-based Interoceptive Exposure (MBIE) | 1 of 12 |
Most frequent serious adverse event terms
| Event term | Organ system | Mindfulness-based Interoceptive Exposure (MBIE) |
|---|---|---|
| Suicidal intention | Psychiatric disorders | 1 of 12 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Mindfulness-based Interoceptive Exposure (MBIE) |
|---|---|---|
| Dehydration | Metabolism and nutrition disorders | 1 of 12 |
| Lack of weight gain | Metabolism and nutrition disorders | 1 of 12 |
Serious events with the highest arm-level rate: suicidal intention (8.3%).
The registry lists 12 participants at risk for serious adverse events and 1 affected, with 0 deaths. The listed serious-event term is suicidal intention, reported as 8.3%. For other adverse events, the record lists 12 at risk and 1 affected. These are the posted figures for the intervention group. The registry record does not report event timing, duration, outcome, or a detailed account of the events.
These counts should be read descriptively. The study has no listed comparison group, so the figures do not estimate how event occurrence differed from another treatment or from no intervention. They also do not establish that the intervention caused an event. The serious-event term and its percentage identify what the registry lists; they do not provide clinical context or explain the relationship between the event and treatment. The record does not report whether the person affected by a serious event was also the person affected by an other adverse event, so the two entries should not be assumed to represent distinct people.
A small study can provide limited information about uncommon events, and the listed at-risk group is the enrolled intervention group rather than a comparative safety sample. These safety data therefore describe what was recorded, not a comprehensive estimate of risk or a causal assessment.
12. What the Result Does, and Does Not, Mean
The registry record documents a family-based MBIE study intended to examine feasibility and acceptability for youth with ARFID. It identifies an intervention, a single-group design, enrollment of 12, and a terminated status. It also describes the planned primary acceptability measure and lists several secondary outcomes. Those details clarify the study's aims and the kinds of information it sought to collect.
The record does not report an observed primary acceptability result. It explicitly states that the six-month assessment was not completed because of early termination and that the data were not collected. As a result, the record cannot establish the participants' average rating of suitability, the precision of such a rating, or how acceptability changed over time. The scale's score direction and possible range explain how a collected score would be interpreted, but they cannot stand in for the missing score.
The project description also discusses feasibility, adherence, recruitment, retention, and possible changes in foods avoided and mindfulness skills. Those are study aims, not findings. The listed secondary outcomes indicate what the registry intended to measure, but numerical results and analysis details are not reported in the registry record. The record's enrollment figure cannot substitute for recruitment or retention results, and the status alone does not explain why the study was terminated.
Because no parallel comparator is listed, the design would not support a controlled treatment-effect estimate even if outcome measurements were available. Any within-group observations would describe participants' experiences and could not isolate the intervention's contribution from other explanations. The adverse-event entries are similarly descriptive and do not establish causation.
In short, the posted record is informative about study intent and reporting limitations, but it does not establish whether MBIE was acceptable, feasible, or associated with changes in the listed clinical measures. That distinction is important: an outcome not collected or not reported is unknown, rather than evidence of no change or of a particular direction of effect.
13. Why This Trial Matters Statistically
This study illustrates how the research question and design determine what a result can mean. A feasibility and acceptability project asks whether recruitment, retention, intervention delivery, and measurement procedures can be carried out, and how participants experience them. Such questions can be valuable even without a randomized comparison. They are not interchangeable with the question of whether an intervention causes better outcomes than an alternative.
The record also shows why outcome collection is fundamental to interpretation. The primary scale was designed to capture several aspects of perceived suitability, but the planned six-month data were not collected after early termination. Without observations, there is no estimate to interpret and no precision measure to report. A detailed endpoint description can explain what a result would represent, but it cannot replace the result.
Another statistical lesson concerns the separation of trial design from planning calculations. The stated sample-size illustrations use equal allocation between two arms, while the registered trial is single-group. Those calculations are planning illustrations, not observed power and not evidence that the study was designed around those assumptions. Distinguishing illustrative calculations from the actual design prevents a planning quantity from being mistaken for a finding.
Finally, the record lists multiple outcomes but reports no analyses. This makes it important to distinguish listed measures and objectives from completed analyses and results. For clinical researchers, transparent reporting of outcome availability, analysis populations, missing-data handling, and the reason for termination helps readers judge what can and cannot be learned. Here, those limits are central to the statistical interpretation, not a minor qualification attached to a treatment-effect estimate.
14. 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 most direct limitation is that the primary acceptability data were not collected. The registry record attributes this to the six-month visit not being completed because of early termination. Therefore, the primary question has no posted outcome estimate. The record does not report whether any earlier primary assessments were collected or whether partial observations could have been available.
The single-group design provides no listed concurrent comparator. Even if outcomes had been measured, changes during follow-up could not be separated from other time-related explanations using a controlled contrast. The record also lists no masking. It does not report whether outcome assessment was performed by someone independent of treatment delivery.
The registry lists 12 enrolled participants, but does not report participant flow, treatment initiation, completion, follow-up availability for each measure, or the number contributing to secondary outcomes. The reason for termination is not reported in the registry record. These omissions constrain interpretation of feasibility and retention, which are among the project's stated aims.
Although several secondary outcomes are named, the registry record lists 0 analyses and does not report their numerical findings, analysis methods, or missing-data procedures. The record also does not report the study's sample-size justification or a multiplicity plan. The planning illustrations use two-arm assumptions, which differ from the registered single-group design and should not be treated as trial-specific evidence of power.
Finally, the scale permits 10-20 items depending on session content. The registry record describes summing item scores but does not report how variation in item count was handled in analysis or whether scoring was validated for this use. These limitations do not establish that any particular method was inappropriate; they identify information not reported in the registry record and the boundaries this places on interpretation.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Family-Based Interoceptive Exposure for Avoidant Restrictive Food Intake Disorder — NCT06110806.
- Registry record last updated 2026-06-10; status last verified 2026-05.
- Results first posted 2026-06-10.
- 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.
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18. Record Summary
NCT06110806 is a terminated, single-group behavioral study of family-based mindfulness-based interoceptive exposure for avoidant restrictive food intake disorder. The registry lists enrollment of 12, no masking, and no randomized allocation. The sponsor is Icahn School of Medicine at Mount Sinai. The recorded study start is 2023-10-17, and the primary completion date is 2024-07-08.
The primary outcome was an MBIE-adapted Therapy Suitability and Acceptability Scale intended to assess patient views of therapy fit, responsiveness, discomfort, and use beyond sessions. The registry record states that the six-month assessment was not completed because of early termination, so primary data were not collected. Several secondary outcomes are listed, but the record lists 0 analyses and does not report their results. Safety entries list 1 participant affected by a serious adverse event, 1 affected by an other adverse event, and 0 deaths. These figures are descriptive and do not provide a controlled comparison.