Fathers and Late Preterm Babies Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Fathers and Late Preterm Babies Study (NCT01056653), a randomized na study. The primary outcome is Parent Child Interaction Teaching Scale (PCITS).

2. Clinical Question

The study asks whether educational home visits for first-time fathers of late preterm infants are associated with differences in observed parent–infant interaction skills. The infants were born between 34 and 36 weeks gestation. The primary outcome was the Parent Child Interaction Teaching Scale (PCITS), assessed when the infant was 8 months old, adjusting for prematurity.

The planned contrast is therefore about an observed interaction measure following differing home-visit programs, not a direct measure of later development or of every aspect of parenting. The PCITS description says that higher total and subscale scores reflect more optimal parent–infant interactions. Without the numerical results, the registry record does not establish the direction, size, or precision of any difference between groups.

3. Trial Design

The registry classifies the study as randomized, double-masked, and parallel. Enrollment is listed as 113. The sponsor is the University of Calgary, and the condition listed is premature birth. The study status is completed; the recorded start is 2008-12 and primary completion is 2012-02. The phase is listed as NA.

The parallel design assigns participants to a group whose intervention is followed over time, rather than describing each participant as receiving each intervention in sequence. The record names Group A Teal as Standard Dose, Group B Purple as High Dose, and Group C Yellow as the Comparison Group. These labels refer to different visit schedules: the Standard Dose group had home visits at 4 and 6 months of age; the High Dose group had visits at 4, 5, 6, and 7 months; and the comparison group had an information-only home visit at 4 months.

Random allocation can, in general, reduce systematic differences between groups at the time of assignment, although it does not guarantee that every characteristic is balanced. Double masking indicates that the registry classifies the study that way, but who was masked and how masking was implemented are not reported in the registry record. The record also does not describe the randomization procedure, allocation concealment, or whether the analysis followed the assigned groups.

The primary outcome was scheduled when infants were 8 months old, with adjustment for prematurity. The registry lists two secondary outcomes: parenting stress measured with the Parenting Stress Index - Third Edition (PSI-3), and perceptions of parenting an infant measured with the What Being the Parent of a Baby Is Like (WPL-R) Scale. Details of the assessment schedule for those secondary outcomes are not reported in the registry record.

The enrollment figure is not a group-specific analysis count. Primary-outcome denominators, withdrawals, and the number with observed scores in each group are not reported in the registry record. The record lists 3 outcome measures and 16 analyses, but it does not explain how those analyses map to particular outcomes, time points, or comparisons.

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: Potential participants were screened and enlisted at the time of the infant's birth. When the infant was 2.5 months old, additional screening was done and verbal consent secured.

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: Sociodemographic and health data were collected with the first home visit.

6. Primary Endpoint

The registry lists the primary outcome as Parent Child Interaction Teaching Scale (PCITS), measured over When the infant was 8 months old, adjusting for prematurity.

The primary endpoint is the Parent Child Interaction Teaching Scale (PCITS), recorded as a mean with standard deviation and described in scores on a scale. The measure assesses parent–infant interaction skills through observation of behaviours. Its stated age range is from birth to 3 years of age. The primary assessment time was when the infant was 8 months old, adjusting for prematurity.

The PCITS Parent Total is the sum of four subscales: Sensitivity to Cues, Response to Distress, Social-Emotional Growth Fostering, and Cognitive Growth Fostering. The stated ranges are 0 to 50 for Parent Total; 0 to 11 for Sensitivity to Cues; 0 to 11 for Response to Distress; 0 to 11 for Social-Emotional Growth Fostering; and 0 to 17 for Cognitive Growth Fostering. Higher scores on each subscale and the total reflect more optimal parent–infant interactions, according to the registry description.

Using an observational measure makes the endpoint relevant to the study’s focus on interaction behaviours rather than relying only on a report of perceptions or stress. In general, a mean describes the average score in a group, while a standard deviation describes how spread out individual scores are around that average. Those summaries can help characterize group outcomes, but they do not by themselves show whether a difference is precise, clinically meaningful, or attributable to the intervention.

The registry identifies the measure and its timing but does not report the numerical mean and standard deviation for each group. It also does not report a single primary comparison reduced across the outcome’s categories or time points. Consequently, the endpoint’s intended interpretation can be described, but a between-group result cannot be quantified from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a randomized, double-masked, parallel study and identifies a continuous primary measure summarized by mean and standard deviation. It does not report a detailed statistical analysis plan or the numerical primary outcome findings. The following explanations describe general statistical concepts; they do not claim that a particular method was used in this study unless the registry says so.

What does random allocation contribute?

In general, random allocation uses a chance-based procedure to assign participants to study groups. Its purpose is to reduce the risk that assignment is systematically related to participants’ characteristics. Randomization does not ensure that groups will have identical characteristics, especially in a finite study, and it does not prevent differences in follow-up or outcome availability after assignment. The registry says the allocation was randomized, but the sequence generation and allocation concealment procedures are not reported in the registry record.

A parallel design means the assigned groups are compared over the study rather than each participant serving as their own comparison after receiving all assigned conditions in turn. Here, the registry lists Standard Dose, High Dose, and Comparison Group schedules. The details of how the groups were compared in the analysis are not reported in the registry record.

What does double masking tell the reader?

In general, masking is intended to limit the influence of knowledge about group assignment on study conduct or assessment. The registry classifies the study as double-masked, but it does not identify which roles were masked, what information was concealed, or how masking was maintained. Because the intervention involves home visits with different schedules, the record alone does not clarify how masking applied to the families or intervention staff.

How should a continuous outcome be summarized?

The PCITS is reported as scores on a scale, with a mean and standard deviation specified as the summary statistics. In general, the mean is the arithmetic average of observed scores, and the standard deviation describes the spread of those scores around the mean. Together they give information about the group’s score distribution in a compact form, though they do not reveal every feature of that distribution. The registry gives possible ranges for the Parent Total and its subscales, but does not provide the observed summaries for any study group.

A group contrast on a continuous scale could be expressed as a difference in means or through a model-based estimate. The exact estimand—the quantity the analysis seeks to estimate—and the specific comparison are not reported in the registry record. The record also does not state whether the analysis used raw scores, adjusted means, or another model-based summary.

What does adjustment for prematurity mean?

The stated primary outcome timeframe says that the assessment at the infant’s age of 8 months was adjusted for prematurity. In general, an adjusted analysis includes a covariate in a statistical model to account for its relationship with the outcome. The interpretation depends on the covariate definition, model form, and other variables included. The registry does not report those details, so it is not possible to describe the adjustment procedure or determine whether additional covariates were used.

How would uncertainty be assessed?

In general, a confidence interval presents a range of values compatible with the observed data under a specified statistical method. A narrow interval indicates greater precision than a wide interval, all else being equal. An interval is not a guarantee that the true effect lies within its limits, and its interpretation depends on the analysis assumptions. No confidence interval for the primary endpoint is reported in the registry record.

A p-value is a measure of how unusual the observed data, or more extreme data, would be under a stated null model. It is not the probability that the null hypothesis is true, and it does not quantify practical importance. No primary-outcome p-value is reported in the registry record. Neither a p-value nor a confidence interval can be inferred from the study design or enrollment figure alone.

What do the sample-size illustrations represent?

The sample-size assumptions described for the page are planning illustrations based on an observed effect, not the trial’s original design justification. They use a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. For time-to-event outcomes, the stated convention is total events, while other outcomes use participants per arm. These are planning assumptions, not evidence about the study’s observed power. The numerical illustration values are not reported in the registry record, and the underlying primary effect estimates are also not reported there.

In general, a planning calculation estimates the sample size needed to detect a specified effect under stated assumptions. A calculation based on an observed effect can be sensitive to the size and uncertainty of that estimate. Such a calculation should not be interpreted as the probability that the completed study detected an effect. The trial’s own sample-size justification and any prospective power calculation are not reported in the registry record.

What can be concluded from the analysis counts?

The registry lists 3 outcome measures and 16 analyses. These counts indicate that the record contains multiple outcome analyses, but they do not identify the statistical methods, analysis populations, or relationships among tests. The primary outcome was not reduced to a single comparison because it has several categories or time points. Without estimates and analysis details, those counts cannot establish which findings were most important or how uncertainty was handled.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 3 outcome measures and 16 analyses, including the PCITS primary outcome and two secondary outcomes: parenting stress measured with the Parenting Stress Index - Third Edition (PSI-3), and perceptions of parenting an infant measured with the What Being the Parent of a Baby Is Like (WPL-R) Scale. The primary outcome also has several categories or time points and is not reduced to a single comparison in the registry record.

When an analysis involves multiple outcomes, subscales, groups, or time points, there may be multiple opportunities to observe a result that appears notable by chance. In general, multiplicity procedures can alter how evidence is interpreted across a family of tests. The registry record does not report whether multiplicity was addressed, which comparisons were designated primary, or whether any hierarchy or adjustment procedure was planned. The 16 analyses cannot by themselves answer those questions.

Missing-data handling is also not reported in the registry record. The record does not give group-specific primary-outcome denominators, the extent or reasons for missing scores, or the method used to handle missing outcomes. In general, missingness can affect interpretation if the people with observed outcomes differ systematically from those without observed outcomes. Without details about the amount, pattern, and treatment of missing data, the potential effect on the estimates cannot be assessed.

The analysis populations are not reported in the registry record. It is therefore not possible to determine whether participants were analyzed according to randomized assignment, according to the intervention received, or under another inclusion rule. The record also does not describe protocol deviations, exclusions, or sensitivity analyses. These omissions limit assessment of how robust an eventual group comparison would be to choices about analysis population, missing data, and multiple testing.

11. Safety Results

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

Other (non-serious) adverse events

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

The adverse-event record lists serious and other adverse events as zero for the at-risk groups shown. For Group A Teal, 46 were at risk and 0 were reported as affected in each of the serious and other adverse-event fields. For Group B Purple, 23 were at risk and 0 were reported as affected in each field. For Group C Yellow, 42 were at risk and 0 were reported as affected in each field. The deaths fields are not reported in the registry record.

These are registry counts, not comparative risk estimates. In general, a count of affected participants does not describe the timing, severity, duration, or relationship of an event to an intervention. The record lists no serious adverse-event terms. It does not give further details about how events were defined, collected, assessed, or monitored, and it does not describe the follow-up period for safety reporting.

Zero reported events in these fields should be read as the record’s reported counts, not as proof that no events occurred under any definition or outside the recorded reporting process. The differing at-risk counts do not establish that safety risks were equal across groups. No statistical comparison of adverse events is reported in the registry record, and the event counts alone do not support a broader safety conclusion.

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

The registry record documents a randomized study of educational home visits for first-time fathers of infants born between 34 and 36 weeks gestation. The intervention schedules differed by group, and the primary outcome was an observational measure of parent–infant interaction at the infant’s age of 8 months, adjusted for prematurity. The measure’s description states that higher PCITS scores reflect more optimal interactions.

That information defines what the study set out to assess, but it does not report the numerical primary outcome results. A reader cannot determine from the registry record whether PCITS scores were higher or lower in any group, the size of any contrast, or the precision of an estimate. The record says the primary outcome has several categories or time points and was not reduced to one comparison. Accordingly, no single comparative result can be stated from the recorded information.

Even if numerical differences were available, a score difference would describe the measured outcome and would need interpretation in light of the scale, analysis, uncertainty, and study conduct. The registry does not report a threshold for a meaningful score difference, and no such threshold should be inferred. The study’s intervention description also does not establish what fathers did outside the scheduled visits or how consistently the intervention was delivered.

The enrollment listing and adverse-event counts do not substitute for outcome findings. Nor do the listed 3 outcome measures and 16 analyses reveal which comparisons were statistically persuasive. The missing analysis details—such as the analysis population, missing-data handling, and multiplicity approach—also prevent a full appraisal of how any eventual findings were obtained.

The most defensible interpretation is therefore limited: the registry describes the randomized comparison and its intended observational endpoint, but it does not report enough numerical outcome information to assess the result. This is not evidence that the groups were the same, nor evidence that any intervention altered interaction scores. It is a statement about what the registry record does and does not report.

13. Why This Trial Matters Statistically

This study raises a statistical question about how differing schedules of an educational home-visit intervention can be compared using an observational continuous outcome. The groups had distinct visit schedules, and the comparison group received an information-only visit. The design therefore gives readers a clear contrast in planned intervention exposure, while the outcome definition focuses on recorded parent–infant interaction behaviours.

The PCITS includes a total score and several subscales, each with stated score ranges and an interpretation in which higher scores reflect more optimal interactions. That structure makes the choice of analysis important: a total score and component scores may answer related but not identical questions. The registry notes multiple categories or time points and does not reduce the primary outcome to one comparison. This makes clarity about the primary estimand, selected time point, and multiplicity especially relevant. Those details are not reported in the registry record.

The listed 3 outcome measures and 16 analyses make transparent statistical reporting important. Readers need to know which comparisons were planned, how uncertainty was quantified, how missing outcomes were addressed, and whether multiple testing was considered. Without those details and the outcome estimates, the number of analyses is context rather than evidence about the study’s findings.

The record also illustrates the difference between planning calculations and observed evidence. The described sample-size illustrations use an observed effect and specified assumptions; such calculations are planning aids, not observed power. They cannot replace a reported effect estimate with uncertainty. The trial’s design justification and primary outcome results are not reported in the registry record.

These features matter because a trial’s interpretation depends on more than its intervention labels or allocation method. The endpoint definition, analysis choices, completeness of follow-up, and uncertainty all shape what a result can support. Here, the design and measurement question are described, while the numerical evidence needed to judge a group contrast is not reported.

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.

A key limitation for interpreting this registry record is the absence of numerical primary-outcome results. Group means, standard deviations, effect estimates, confidence intervals, and p-values are not reported in the registry record. The primary outcome also has several categories or time points and is not reduced to a single comparison, which prevents a straightforward summary of a primary between-group contrast.

Details needed to assess the PCITS result are limited. The measure and its score ranges are described, but the record does not report group-specific numbers assessed, the amount of missing outcome data, or how missing observations were handled. The analysis population and the statistical model are not reported. The stated adjustment for prematurity is not accompanied by a description of the adjustment method.

The registry identifies the study as randomized and double-masked but does not report the randomization procedure, allocation concealment, or who was masked. It does not describe fidelity to the planned home-visit schedules, participant adherence, or departures from the assigned interventions. These details would help assess the contrast actually achieved and potential sources of bias.

The listed 3 outcome measures and 16 analyses raise questions about selection and multiplicity, but the record does not report the analysis hierarchy, multiplicity procedures, or a prespecified statistical analysis plan. It also does not explain which time points or PCITS categories were emphasized. The secondary-outcome assessment timing is not reported in the registry record.

The adverse-event fields show zero reported serious and other events among the listed at-risk groups, but the record does not define event collection procedures or report the deaths fields. These omissions limit what can be inferred from the safety data. The design and intervention descriptions are useful, but the absent outcome, follow-up, and analysis details constrain interpretation of both efficacy-related measures and safety reporting.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Fathers and Late Preterm Babies Study — NCT01056653.
• Registry record last updated 2017-03-29; status last verified 2017-02.
• Results first posted 2017-02-23.
• 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

The Fathers and Late Preterm Babies Study (NCT01056653) is listed as a completed, randomized, double-masked, parallel study sponsored by the University of Calgary. Enrollment is listed as 113. The recorded start is 2008-12 and primary completion is 2012-02.

The study examined educational home visits for first-time fathers of infants born between 34 and 36 weeks gestation. Group A Teal received visits at 4 and 6 months of age; Group B Purple received visits at 4, 5, 6, and 7 months; and Group C Yellow received an information-only visit at 4 months. The primary outcome was PCITS interaction scores when infants were 8 months old, adjusted for prematurity.

The registry also lists parenting stress and perceptions of parenting an infant as secondary outcomes. It records 3 outcome measures and 16 analyses. Numerical primary outcome estimates and their uncertainty are not reported in the registry record, and the primary outcome is not reduced to a single comparison. Thus, the record describes the design and measurement question but does not support a quantitative conclusion about group differences.