Parent Acceptance and Commitment Therapy (PACT) for Parents of Children With Pediatric Feeding Disorder: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Parent Acceptance and Commitment Therapy (PACT) for Parents of Children With Pediatric Feeding Disorder (NCT06001398), a randomized na study. The primary outcome is Patient Health Questionnaire-9 (PHQ-9).

2. Clinical Question

Parents were asked to complete questionnaires at four timepoints and video-record a mealtime twice during the study. Those procedures could contribute information about change over time and delivery feasibility, but the registry record does not report the corresponding results. In particular, the primary outcome was assessed only in the active treatment group. Consequently, its recorded definition does not support a direct PACT-versus-control comparison on that outcome. The clinical question represented by the primary measure is whether individual PACT participants had reliable improvement, not whether the groups differed on PHQ-9 change.

3. Trial Design

This was a randomized, double-masked, parallel-group pilot study sponsored by Children’s Mercy Hospital Kansas City. The registry lists the study as completed, with enrollment of 30. The recorded start date is 2023-06-27, and the primary completion date is 2024-10-01. The phase is listed as not applicable.

Participants were assigned to PACT or a behavioral control intervention. PACT-F was described as a 2-session intervention based on Focused Acceptance and Commitment Therapy treatment literature. The control covered nutrition and healthy-lifestyle topics, including USDA’s MyPlate. Although the registry identifies the study as double-masked, it does not say who was masked or how masking was implemented. Randomization methods, allocation concealment, and the allocation ratio are not reported in the registry record.

The stated aims combined a preliminary assessment of parent mental health with feasibility questions about delivering PACT. Parents were asked to complete questionnaires at four timepoints and make two video recordings of mealtime. The registry summary describes comparisons involving parent stress, anxiety, and positive mealtime behaviors, while also specifying that the control group was for feasibility and acceptability evaluation. The primary PHQ-9 outcome was restricted to the active treatment group.

The registry record does not report the planned sample-size justification, operational details for intervention delivery beyond the session count, or a full statistical analysis plan. It also does not describe recruitment methods, eligibility criteria, participant flow, adherence, or the timing of the questionnaire timepoints other than the primary outcome’s post-intervention assessment. The design therefore establishes that this was a randomized pilot with parallel behavioral groups, but provides limited information for judging implementation or comparative efficacy.

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

Analysis population for the primary outcome, as defined in the registry: This outcome measure is only assessed in the active treatment group as it was pre-specified that this data is only pertinent to the active treatment group being assessed. This was a proof of concept study and the control group was only completed for feasibility/acceptability evaluation.

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.

6. Primary Endpoint

The registry lists the primary outcome as Patient Health Questionnaire-9 (PHQ-9), measured over Measured 2-week post-intervention.

The primary endpoint was the number of participants with significant within-person improvement on the Patient Health Questionnaire-9 (PHQ-9), measured 2-week post-intervention. The PHQ-9 is a 9-item self-report measure of depressive symptoms. Rather than treating any observed score change as meaningful, the registry says the study used a Reliable Change Index (RCI) to classify whether each participant’s change exceeded a threshold intended to distinguish change from measurement variability.

The RCI calculation was described as using the pre-test score, post-test score, standard deviation of the test, and test-retest reliability coefficient. A computed value exceeding +/- 1.96 was considered significant change. Participants with significant improvement were then counted and compared with those who did not meet that improvement classification. The registry does not provide the actual PHQ-9 counts, scores, or RCI values.

This kind of endpoint can describe how many people in a treatment group meet an individual-level change criterion. It does not, by itself, estimate the average treatment effect relative to a control group. The registry states that the primary measure was assessed only in the PACT group because it was considered pertinent to active treatment; the control group was intended for feasibility and acceptability evaluation. Therefore, the endpoint is a within-group proof-of-concept measure, not a direct randomized comparison of PHQ-9 outcomes.

As a general consideration, an RCI classification depends on the measurement properties used in its calculation. Those underlying standard deviation and reliability values, as well as the resulting classifications, are not reported in the registry record. The endpoint’s definition is described, but its observed result cannot be evaluated from the posted information.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The statistical description centers on an individual reliable-change classification for PHQ-9 scores in the PACT group. The registry record describes the ingredients of the classification, but does not report the numerical measurement-property inputs, participant-level changes, outcome counts, or any inferential analysis. The method can be explained, but its application and results cannot be independently assessed from the posted information.

What does the Reliable Change Index represent?

General explanation: A Reliable Change Index is designed to assess whether an individual’s observed change is large relative to the measurement error expected from an instrument. It uses information about the scale’s variability and reliability as well as a person’s scores before and after an intervention. The aim is to avoid treating every score movement as a meaningful individual change. The registry says this study used pre-test and post-test scores, the test standard deviation, and the test-retest reliability coefficient.

The study’s stated rule classified a computed within-person value exceeding +/- 1.96 as significant change. It then counted participants classified as having significant improvement and those who were not. This is a threshold-based classification rather than a reported estimate of the average PHQ-9 change. The observed counts and the values used to derive the classifications are not reported in the registry record, so readers cannot check how many participants crossed the threshold or how far scores changed.

How does an individual change rule differ from a group comparison?

General explanation: A within-person criterion asks whether an individual’s change is sufficiently large under the specified measurement rule. A randomized group comparison asks whether outcomes differ between assigned groups, accounting for the trial design and uncertainty. These questions are related but not interchangeable. A count of people meeting an individual threshold does not automatically quantify a comparative treatment effect, and it does not by itself address what would have happened in the absence of the intervention.

Here, the primary PHQ-9 outcome was assessed only in the active treatment group. The control group was described as serving feasibility and acceptability evaluation. That restriction means the specified primary endpoint cannot provide a direct PACT-versus-control PHQ-9 estimate. The registry summary mentions a broader comparison concerning parent stress and anxiety and use of positive mealtime behaviors, but does not provide the corresponding analysis results.

What would a confidence interval add?

General explanation: A confidence interval communicates the uncertainty around an estimated quantity, such as a group difference or proportion. It shows a range of values compatible with the data and the estimation method; it is not a guarantee that the true value lies within that range. The registry record does not report a confidence interval for the primary outcome or a comparative effect estimate. With no reported result and uncertainty measure, the precision of the primary finding cannot be judged.

Why does the study’s pilot status matter?

General explanation: Pilot studies can help evaluate whether procedures and interventions can be delivered and whether a larger study may be practical. Their findings may also offer preliminary outcome information, but feasibility objectives and treatment-effect estimation are distinct. This trial’s summary explicitly includes factors affecting feasibility of PACT delivery as an aim. The registry describes questionnaires at four timepoints and two mealtime video recordings, but does not report completion or feasibility findings. No sample-size justification is reported in the registry record, so the enrollment should not be interpreted as evidence that the study was sized to detect a particular clinical effect.

Statistical significance and clinical importance are also different concepts. General explanation: A statistical threshold concerns compatibility with a statistical rule, while clinical importance concerns whether a change matters in context. The study summary uses the phrase clinically meaningful for its aims, but the posted record does not report a result that can be evaluated against that aim. The RCI threshold is the stated classification rule; it should not be treated as a reported group-level estimate or a demonstrated clinical benefit.

The registry lists seven outcome measures and no analysis entries. It does not report an analysis model, handling of repeated measurements, adjustment for baseline values, covariates, or a missing-data method. General statistical principles cannot fill in those absent details. In particular, no assumptions about which participants were included in an analysis, or how incomplete questionnaires were handled, can be attributed to this trial based on the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists seven outcome measures and no analysis entries. It does not report a prespecified multiplicity strategy, such as identifying a single confirmatory hypothesis across outcomes or adjusting for multiple statistical tests. When several outcomes or timepoints are examined, the chance of at least one apparently noteworthy result can increase; this is a general statistical concern, not a finding about this trial. Because the registry does not report outcome analyses, it is not possible to assess how multiplicity was handled in practice.

The summary says parents were asked to complete questionnaires at four timepoints, but it does not describe a repeated-measures analysis or state which timepoints were intended for each secondary outcome. The primary PHQ-9 assessment is identified as 2-week post-intervention. No additional primary endpoint analysis or results are reported.

Missing-data methods are not reported in the registry record. There is no description of how incomplete questionnaires, missed visits, unavailable video recordings, or withdrawal would be handled. The registry also does not report participant flow, outcome-specific denominators, reasons for missing observations, or whether analyses used all randomized participants or a narrower group.

The primary measure was assessed only in the PACT group, while the control was described as intended for feasibility and acceptability evaluation. This is an important restriction on the population available for that endpoint and on the inference it can support. Beyond that stated restriction, the registry does not define analysis populations or explain how eligibility for the PHQ-9 assessment was determined. These reporting gaps limit interpretation of both the endpoint and the trial’s broader outcome aims.

11. 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.

The registry safety entries list the PACT group with 20 participants at risk and the control group with 10 participants at risk. For both groups, the recorded counts are zero serious adverse events, zero other adverse events, and zero deaths. These are the counts entered in the registry record; they should not be interpreted as proof that no events occurred or that safety was assessed in a particular way.

The record does not report the period over which adverse events were collected, how events were solicited or adjudicated, or whether all participants completed safety follow-up. It also does not provide descriptions of non-serious events or explain whether any events were excluded from the listed categories. Without those details, the counts cannot characterize the completeness or sensitivity of event detection.

As a general statistical point, zero recorded events do not establish zero underlying risk. The interpretation of a zero count depends on the number of people observed, duration of observation, and event-collection methods. No event-rate estimate or confidence interval is reported in the registry. The safety figures are therefore best read narrowly as the registry’s reported counts, rather than as a comparative safety analysis or a guarantee of absence of harm.

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

The record describes a randomized pilot study of PACT compared with a behavioral attention-control program for parents of children with pediatric feeding disorder. It records an enrollment of 30 and identifies a PHQ-9 reliable-change measure as the primary outcome. It also outlines questionnaire and mealtime-video procedures relevant to the study’s mental-health and feasibility aims.

What the record does not provide is essential for interpreting results: no PHQ-9 improvement count, group-level outcome estimate, confidence interval, or analysis result is reported. The primary measure was assessed in the PACT group only, so even a reported within-group count would not on its own establish a difference from control. The registry’s description of the aims is not evidence that the intended effects or feasibility objectives were achieved.

As a general distinction, a change meeting an individual reliable-change threshold is not the same as a comparative effect, and neither automatically establishes clinical importance. A treatment-effect interpretation requires outcome data for the relevant groups and an analysis that reflects the randomized design. Clinical importance also depends on contextual judgment beyond a statistical classification rule. The posted results do not provide the information needed to make those assessments for this trial.

The safety entries record zero serious adverse events, zero other adverse events, and zero deaths in both groups, but do not describe ascertainment or follow-up. Those counts cannot establish that the interventions are free of risk. Likewise, the presence of randomization and masking labels does not resolve the absence of outcome results or details about implementation.

The appropriate reading is limited: the registry records the study design, intervention descriptions, primary outcome definition, and safety counts, but does not report findings that answer whether PACT changed parent mental health relative to control. The record also does not report whether delivery was feasible or acceptable. No conclusion about treatment benefit, lack of benefit, or comparative safety can be drawn from the posted outcome information.

13. Why This Trial Matters Statistically

This trial raises several statistical questions that are especially important in pilot behavioral research. Its aims combine an individual mental-health outcome with questions about feasibility of intervention delivery. Those aims call for different kinds of evidence: a change measure addresses participant outcomes, whereas feasibility evidence concerns whether recruitment, intervention delivery, and study procedures can be carried out as intended.

The PHQ-9 endpoint uses a Reliable Change Index to classify individual change. This makes the measurement rule explicit, but the registry does not report the inputs or resulting classifications. More importantly for causal interpretation, the measure was restricted to the PACT group. A within-group change criterion cannot by itself isolate an intervention effect from other explanations for change over time. The randomized control group’s described purpose was feasibility and acceptability evaluation, not PHQ-9 comparison.

The study also illustrates why a clear distinction between a pilot objective and a confirmatory treatment-effect question matters. Pilot findings can inform the design and practicality of future research, but the record does not report feasibility outcomes, a sample-size rationale, or an analysis plan. Without those details and the outcome results, readers cannot determine what the study learned about intervention delivery or estimate the precision of the primary outcome.

Finally, registry transparency is important to statistical interpretation. The record specifies the broad design and outcome definition, yet does not provide outcome counts, effect estimates, uncertainty intervals, missing-data procedures, or multiplicity handling. These omissions restrict what can be concluded regardless of the randomized design. The record is informative about the planned question and measurement approach, but it does not report the empirical results needed to answer that question.

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 principal limitation for interpreting this trial is that the registry record does not report the primary endpoint result. There are no counts of PACT participants meeting the Reliable Change Index criterion, no PHQ-9 score summaries, and no estimate of uncertainty. This prevents assessment of the direction, size, and precision of the outcome described in the registry.

The primary PHQ-9 measure was assessed only in the active treatment group. As a result, the specified primary endpoint does not support a randomized comparison of depressive-symptom outcomes between PACT and control. The control group’s stated role was feasibility and acceptability evaluation. Although the study summary describes broader comparison aims involving stress, anxiety, and positive mealtime behaviors, their results are not reported.

Other limitations arise from missing methods information. The registry does not report the sample-size justification, randomization details, who was masked, a statistical analysis plan, multiplicity handling, missing-data methods, or analysis populations. Participant flow and outcome-specific denominators are also not reported. The four questionnaire timepoints and twice-recorded mealtimes are described as procedures, but completion and feasibility outcomes are absent.

The RCI definition names pre-test and post-test scores, test standard deviation, and test-retest reliability as inputs, but the record does not provide the values used or the participant-level results. The reliability of the classification therefore cannot be assessed from the registry. Safety entries report zero events, but the collection period and ascertainment procedures are not described. These are limitations of the available registry reporting and do not, by themselves, establish shortcomings in how the trial was conducted.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Parent Acceptance and Commitment Therapy (PACT) for Parents of Children With Pediatric Feeding Disorder — NCT06001398.
• Registry record last updated 2026-01-15; status last verified 2025-12.
• Results first posted 2026-01-15.
• 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.

18. Record Summary

NCT06001398 is a completed randomized, double-masked, parallel-group pilot study sponsored by Children’s Mercy Hospital Kansas City. The registry records enrollment of 30, a start date of 2023-06-27, and a primary completion date of 2024-10-01. It compares a 2-session PACT-F behavioral intervention with a behavioral attention-control program covering nutrition and healthy-lifestyle topics.

The primary outcome was the number of PACT participants with significant within-person PHQ-9 improvement by a Reliable Change Index, measured 2-week post-intervention. The registry says the outcome was assessed only in the active treatment group. Participants were also asked to complete questionnaires at four timepoints and record mealtimes twice.

The record does not report primary outcome counts, comparative outcome estimates, analysis methods, or feasibility findings. Safety entries list zero serious adverse events, zero other adverse events, and zero deaths in both groups. The information describes the study design and outcome approach, but does not provide results sufficient to evaluate the intended treatment or feasibility questions.