Therapist Education and Massage for Parent Infant-Outcomes: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Therapist Education and Massage for Parent Infant-Outcomes (NCT04121897), a na na study. The primary outcome is Percent of Eligible Dyads Who Would Consent to Enroll (Recruitment).

2. Clinical Question

3. Trial Design

TEMPO is registered as a completed, single-group feasibility study of a therapist-led program for parents of extremely preterm infants. The registry lists enrollment as 68 and identifies the sponsor as the University of North Carolina, Chapel Hill. The recorded start date is 2019-11-25, and the primary completion date is 2022-05-01. These registration details describe the study record; they do not establish how many participants contributed data to each outcome.

The intervention description covers a structured program in which therapists train and support parents to deliver physical therapy activities. These include massage and developmental play during hospitalization and in the home setting. The broader program description also refers to developmental support, family-centered care, and educational delivery intended to support knowledge, parent-infant bonding, and confidence in continuing activities after discharge. These are program aims, not reported findings.

The registry lists allocation as NA, masking as none, and the model as single group. It does not describe a concurrent control group or a randomized allocation process. The phase is listed as NA. As a result, the design information does not support a treatment-versus-control estimate. Any observed changes within the group would need to be interpreted without a like-for-like control comparison, and the registry record does not report such changes.

The primary endpoint is a recruitment measure: the percentage of eligible participants enrolled among those approached. The record also names secondary outcomes covering infant and parent salivary cortisol, infant development, parent anxiety and depression, parenting sense of competence, and postnatal attachment. It lists 18 outcome measures overall, but the outcome values and detailed analysis procedures 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.

Overall 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.

6. Primary Endpoint

The registry lists the primary outcome as Percent of Eligible Dyads Who Would Consent to Enroll (Recruitment), measured over Baseline.

The primary endpoint is the percent of eligible participants enrolled among those approached, with the timeframe listed as baseline. It is intended to describe recruitment: the extent to which eligible people contacted about the study consented to enroll. In a feasibility study, recruitment is useful because it indicates whether the study can reach and enroll the intended population. It is distinct from an outcome that measures infant development, parent wellbeing, or the effect of an intervention.

To interpret a recruitment percentage, the numerator and denominator need to be clear. The numerator is the eligible participants who enrolled; the denominator is the eligible participants approached. The registry description specifies this definition, but does not report either count or the resulting percentage. The listed enrollment of 68 does not by itself supply those counts: it does not identify how many eligible people were approached or how many approached people declined.

Because the endpoint is a proportion, its precision depends on the underlying counts, not just the percentage. A confidence interval would describe uncertainty around an estimated recruitment proportion, but the registry record does not report an estimate or interval. No conclusion about the observed recruitment rate, or how precisely it was measured, can therefore be drawn from the endpoint entry alone.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes the primary outcome as a percentage. In general, a percentage is a proportion expressed on a percentage scale: the numerator records the people meeting the defined event, and the denominator records the relevant group from which they came. Here, the event is enrollment, and the denominator is eligible participants who were approached. The definition is important because a percentage based on everyone enrolled in the study would not answer the same recruitment question.

What does a confidence interval add?

In general, a confidence interval gives a range of values compatible with the observed data under a stated statistical method. It communicates precision as well as the point estimate: a narrower interval indicates greater precision, while a wider interval indicates more uncertainty. For a recruitment proportion, the estimate and its interval depend on the observed numerator and denominator. The registry record does not report the recruitment counts, estimate, or interval, so no numerical precision assessment is available.

The registry labels the study as single-group, with allocation listed as NA and masking as none. This is a description of the design, not a statistical method for estimating a treatment contrast. A within-group outcome can describe observations in the group, but a comparison against a control condition is needed to estimate a between-group contrast. Without such a comparison, the record cannot separate a program-related change from other explanations for change. No randomized comparison is described.

How should the planning illustrations be read?

The sample-size assumptions describe planning illustrations, not the study's own design. They use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The assumed effect to detect is expressed as a stated fraction of the observed effect. The illustrations report participants per arm for outcomes other than time-to-event outcomes; time-to-event calculations are described in terms of total events.

These assumptions do not turn TEMPO into a two-arm trial. The registry describes a single-group feasibility study. Planning calculations under a hypothetical equal-allocation comparison answer a different question from the recruitment endpoint in the registered design. They are not observed power, do not show the study's probability of detecting an effect, and do not establish that a planned comparison took place. The record does not report a sample-size justification for the actual study or a protocol-based power calculation. It also does not report the observed effect needed to assess the stated planning basis.

Why does over-dispersion matter in general?

For outcomes involving counts or proportions, a statistical model may assume a particular amount of variability. Over-dispersion means the observed variability is greater than that assumed by a model. If not accommodated, uncertainty can be understated and statistical evidence can appear more precise than it is. This is a general consideration, not a claim that an over-dispersion model was used in TEMPO. The registry record does not report the analysis model or an assessment of over-dispersion.

More generally, an analysis should match the outcome type and the study question. A recruitment percentage is naturally described using its event definition, numerator, and denominator. Continuous developmental or questionnaire outcomes require a clear summary and a method appropriate to their scales and repeated measurements. The registry lists several longitudinal outcomes, but the analysis methods, treatment of repeated measurements, and outcome-specific estimates are not reported in the registry record. No statistical method should be inferred from outcome names alone.

Results also need to be distinguished from planning assumptions and design descriptions. A sample-size illustration describes what a hypothetical design might require under specified assumptions; it is not an observed finding. The registered enrollment is a design or recruitment record entry, not a substitute for outcome-specific estimates. Since the registry record does not report the primary recruitment estimate or the secondary outcome results, there is no posted numerical effect to interpret statistically.

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("TEMPO Parents")
n      <- c(35)
events <- c(32)
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  TEMPO Parents  35  32  91.4  76.9  98.2  77.6  97.0  77.5  96.9

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 18 outcome measures, including the recruitment endpoint and secondary measures of cortisol, infant development, parent anxiety and depression, parenting sense of competence, and postnatal attachment. When a study assesses multiple outcomes, there is a general risk that chance findings may arise if each is tested separately. Methods such as prespecifying a primary outcome or adjusting for multiple comparisons can address aspects of this issue, but the registry record does not report a multiplicity strategy. The listed outcomes alone do not establish which analyses were performed or which results, if any, were considered confirmatory.

Missing data can affect both the estimate and its precision. For a recruitment percentage, an incomplete account of who was eligible and approached would make the denominator difficult to interpret. For longitudinal measures, incomplete follow-up can alter the composition of the participants contributing data at different assessments. The registry record does not report missing-data counts, reasons for missingness, or methods for handling missing values. No assumptions about complete follow-up or the impact of missing data should be made.

The record also does not define analysis populations for the reported outcomes. It does not explain which enrolled participants were included in each outcome analysis or how exclusions were handled. The enrollment entry of 68 should not be read as the denominator for every measure. Without outcome-specific analysis populations and denominators, the completeness and comparability of the results cannot be assessed. These details are not reported in the registry record.

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.

The registry safety entry is for TEMPO infants. It lists 36 infants at risk, 0 serious adverse events, 0 other adverse events, and 3 deaths. These are counts as recorded; they should not be converted into percentages without the appropriate outcome-specific denominators and context. The serious and other adverse-event counts are distinct from the death count, and the entries should not be combined or treated as interchangeable outcomes.

No serious adverse-event terms are listed. The registry record does not report whether the deaths were related to the intervention, their causes, timing, or circumstances. A count alone cannot establish that an event was caused by the program, nor can a count of 0 establish that there was no risk. Interpretation depends on how events were defined, collected, and attributed, as well as on the participants included in monitoring. Those details are not reported in the registry record.

The counts therefore provide limited safety information. They describe recorded events in the listed group, but do not give enough detail to assess causality, event ascertainment, or comparative safety. No control group is described, so these entries do not support a comparison with another condition.

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

The registry record establishes that TEMPO was registered as a completed, single-group feasibility study and identifies recruitment as its primary endpoint. The endpoint asks what percentage of eligible people approached enrolled. That is a practical question about recruitment, not a direct measure of the program's effect on infant development, parent wellbeing, or health. The observed recruitment percentage and the counts needed to interpret it are not reported in the registry record.

The intervention is described as therapist-led and includes parent training and support for massage and developmental play during hospitalization and in the home setting. The program description also presents aims related to parent knowledge, bonding, and confidence. A description of intended content and aims is not evidence that those aims were achieved. The registry names secondary measures that could address some parent and infant outcomes, but their results are not reported in the registry record.

The design also matters to what can be concluded. A single-group study without a control comparison can describe participation and outcomes within the group, but it cannot by itself show what would have happened under a different condition. The registry does not describe random allocation or a like-for-like control group. Consequently, the record does not support a comparative estimate of the program's effect.

The safety counts likewise require restraint. The record lists 0 serious events, 0 other events, and 3 deaths among 36 TEMPO infants at risk. It does not report whether the deaths were related to the intervention. These entries should be read as recorded event counts, not as proof of benefit, harm, or absence of risk.

Overall, the registry information describes the study purpose, intervention, design, and selected safety counts. It does not report the primary recruitment result, secondary outcome estimates, or enough analysis detail to assess precision and missing data. The missing results should not be filled in by inference from the enrollment entry or from the program description.

14. Why This Trial Matters Statistically

This study is statistically notable because its primary question is about feasibility rather than a treatment contrast. Recruitment is often essential to whether a clinical study can proceed, and expressing recruitment as a proportion makes the event and its denominator explicit. Here, the registry defines the denominator as eligible participants approached. That definition is more informative than an enrollment count alone, because it distinguishes the number who joined from the number who had an opportunity to join.

The record also illustrates why design and analysis must be read together. TEMPO is listed as single-group, with allocation NA and no masking. Planning illustrations based on equal allocation between two arms do not change the registered design. They are hypothetical calculations, not a description of the participants or comparisons in the study. Keeping those ideas separate prevents a planning quantity from being mistaken for evidence about the completed study.

Another statistical issue is the gap between naming outcomes and reporting results. The registry lists 18 outcome measures, but outcome names alone do not tell readers what was observed, how precisely it was estimated, or how missing data were handled. This is especially relevant where the listed outcomes cover different types of measurements and include longitudinal measures. Clear outcome-specific estimates and analysis details are needed to understand what the data can support.

The record therefore offers useful design context while leaving the main numerical interpretation unresolved. Its recruitment definition is clear, but the recruitment result is not reported. That distinction is important when reading feasibility studies: a well-defined question does not substitute for a reported estimate and its uncertainty.

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.

A central limitation for interpreting this trial is the absence of the primary recruitment estimate in the registry record. Although the endpoint is defined, the record does not report the number of eligible participants approached, the number enrolled from that group, or the resulting percentage. Enrollment is listed as 68, but that entry cannot establish the recruitment rate or its precision.

The single-group design limits what could be learned about comparative effects. Allocation is listed as NA, and a like-for-like control comparison is not described. The registry record therefore does not support attributing a change in an infant or parent measure to TEMPO. This limitation is separate from the missing result values: even reported within-group changes would not provide a randomized comparison.

Outcome reporting is also incomplete for interpretation. The record names 18 outcome measures but does not report their estimates, uncertainty, or outcome-specific analysis populations. The primary endpoint timeframe is listed as baseline; the registry does not provide enough detail to establish measurement schedules for all outcomes. Methods for repeated measurements and missing data are not reported in the registry record.

The intervention description is broad, encompassing therapist support, massage, developmental play, education, and family-centered care. The record does not report enough implementation detail to assess how consistently the program was delivered or which components participants received. Safety interpretation is similarly limited: event counts are listed, but event definitions, causes, and relationships to the intervention are not reported. These limitations mean the registered information is useful for understanding the study's scope, but insufficient for judging its outcome estimates or comparative effects.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Therapist Education and Massage for Parent Infant-Outcomes — NCT04121897.
• Registry record last updated 2023-05-06; status last verified 2023-03.
• Results first posted 2023-05-06.
• 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 describes TEMPO as a completed, single-group feasibility study sponsored by the University of North Carolina, Chapel Hill. Enrollment is listed as 68. The recorded start date is 2019-11-25, and the primary completion date is 2022-05-01. The intervention is a therapist-led program supporting parents to provide physical therapy activities, including massage and developmental play, during hospitalization and at home.

The primary endpoint is the percentage of eligible participants enrolled among those approached, at baseline. Its result is not reported in the registry record. The record lists 18 outcome measures, but does not report their results or the analysis details needed to assess them. Safety entries list 0 serious adverse events and 0 other adverse events among 36 TEMPO infants at risk, alongside 3 deaths; the relationship of deaths to the intervention is not reported. There is no control comparison described.