All in Dads! Healthy Marriage and Responsible Fatherhood Program Evaluation: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for All in Dads! Healthy Marriage and Responsible Fatherhood Program Evaluation (NCT05194020), a na na study. The primary outcome is Healthy Parenting Behavior Measurement #1.

2. Clinical Question

The program’s stated aims also include strengthening fathers’ relationships with their children and the mothers of their children, reducing domestic violence in vulnerable families, and improving economic stability through job-driven services and case management. Those aims describe the program’s broader goals; they should not be mistaken for findings from this primary outcome. The record lists Healthy Parenting Attitudes Measurement #1 as a secondary outcome, but does not provide its results. Without a comparison group, any observed change would describe the participating group over time and could not by itself isolate the program’s effect from other explanations for change.

3. Trial Design

NCT05194020, titled “All in Dads! Healthy Marriage and Responsible Fatherhood Program Evaluation,” is listed as completed. The study start date is 2021-04-01, and primary completion is recorded as 2024-03-18. The sponsor is Midwest Evaluation & Research. The record lists the phase as NA, allocation as NA, masking as none, and the model as single group. Enrollment is 731.

The single-group structure is important for interpreting the primary question. The listed intervention is Primary Services, and there is no like-for-like control arm described. The record therefore does not define a randomized comparison between participants assigned to different services. Its primary outcome instead concerns change from baseline in a parenting-behavior measure at 12 months from enrollment. Changes over time can be described, but the design alone cannot establish what would have happened to the same participants without the program.

The intervention description combines educational curricula with ongoing employment-related support. Participants receive 16 hours of Father Factor curricula, 4 hours of The New Playbook curricula, and 4 hours of Money Smart curricula over five weeks, plus ongoing job-readiness and post-employment support. The record describes these as program services; it does not report how much of each service individual participants actually received.

Although the study is marked completed, completion status does not mean that outcome analyses or numerical results are reported. The registry lists zero analyses. Details such as the recruitment approach, eligibility criteria, participant flow, handling of departures from the program, and the protocol’s statistical plan are not reported in the registry record. It is also not reported whether any interim analyses were planned or conducted. Those omissions limit assessment of how the enrolled group was formed and how the observed outcome was intended to be analyzed.

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: 248 participants responded to at least 80% of the items in this measure.

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: The baseline is number of participants who consented to be in the study.

6. Primary Endpoint

The registry lists the primary outcome as Healthy Parenting Behavior Measurement #1, measured over Change in mean from baseline in behavior in parenting behavior (interaction with children) to mean at 12 months from enrollment..

The primary endpoint is a continuous total score intended to measure healthy parenting behavior, especially interaction with children. The outcome description says seven items assess engagement with a child using a five-point frequency scale, with response categories ranging from “Never” to “Every day or almost every day.” One additional item assesses frequency of reaching out to children, using a four-point scale with categories ranging from “Every day or almost every day” to “Never in the past month.” The eight items are combined as a construct: items are added and divided by eight. The stated score range is from 1.0 to 4.5, with higher scores described as better.

The endpoint is expressed as change in mean from baseline to the mean at 12 months from enrollment. Repeated measurement is intended to describe whether the group’s reported behavior changes over that period. A mean can summarize the group’s average score, while the standard deviation describes variation in scores among participants. The registry record identifies mean and standard deviation as the summary measures, but does not report baseline or follow-up values, the mean change, or its uncertainty.

The measure is relevant to the program’s stated focus on father-child relationships because its items concern interaction and contact. The record does not report validation information, the scoring rationale for combining the two scales, or evidence about how well the score captures changes in parenting behavior.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is described as continuous, and the planned summary is a mean with a standard deviation. A continuous measure can take values across a numeric scale rather than being limited to categories such as event versus no event. The mean represents the average score in a group. The standard deviation describes how dispersed individual scores are around that average; it is not the uncertainty of the mean itself. The registry record does not report the mean or standard deviation at either time point.

What does change from baseline mean?

For a repeated-measure outcome, change from baseline describes how a participant’s later score differs from that participant’s starting score, with the group result summarizing those within-person changes. This can account for the fact that people may start at different score levels. The registry’s timeframe specifies baseline and a mean at 12 months from enrollment. It does not report whether all participants were measured at both times, the exact analysis method, or how the analysis handled participants with only one measurement. The observed change and its uncertainty are also not reported.

How should a confidence interval be understood?

In general, a confidence interval expresses the statistical uncertainty around an estimate under the assumptions of the analysis. A narrower interval indicates greater precision, while a wider interval indicates less precision. It does not resolve potential bias from missing data, measurement limitations, or the absence of a control group. No confidence interval for the primary outcome is reported in the registry record, so the precision of an estimated change cannot be assessed.

What would a significance test establish?

In general, a significance test assesses how compatible the observed data are with a specified null hypothesis under a statistical model. A result labeled statistically significant would not by itself establish that a change is important to participants, that the program caused it, or that the estimate is precise enough for a particular decision. Conversely, a result that is not statistically significant would not prove that there was no change. The registry record does not report a primary-outcome test statistic or p-value, and lists zero analyses.

What do the planning assumptions mean?

The registry record describes a planning illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It states that the effect to detect is a specified fraction of the observed effect. For non-time-to-event outcomes, such illustrations are expressed as participants per arm. No resulting participant counts or observed effect estimate are reported in the record. Such calculations are planning illustrations, not observed power, and the equal-allocation, two-arm assumption does not describe this study’s single-group design. The record does not report that these assumptions were part of the study’s original design or sample-size justification.

Why does the single-group design matter?

In general, a control group can help distinguish changes associated with a program from changes that might have occurred without it. This study is listed as single group, with no like-for-like control comparison. A within-group change, if reported, would therefore not on its own estimate a causal effect. The record does not report an alternative design or statistical method intended to address this limitation.

What can be inferred from the scale description?

The score combines eight items by adding them and dividing by eight. The item descriptions use frequency response categories, and the record states that a higher construct score is a better outcome. Combining items into a score can provide a summary of several related behaviors, but interpretation depends on the scoring and measurement properties of the instrument. The registry record does not report reliability, validation, or an analysis of the individual items. It also does not explain how the different response scales are reconciled within the construct. These details limit independent evaluation of what a change in the total score would represent.

10. Multiplicity, Missing Data and Analysis Populations

The registry record indicates four outcome measures and identifies Healthy Parenting Attitudes Measurement #1 as a secondary outcome. The primary outcome is Healthy Parenting Behavior Measurement #1. The other outcome measures are not identified in the outcome details available for this evaluation, and results for the named secondary measure are not reported. The record lists zero analyses. It does not state whether outcomes were tested, which outcomes were designated as primary in the analysis plan, or whether any adjustment for multiple comparisons was planned or used.

In general, evaluating several outcomes can increase the chance of finding at least one apparently notable result by chance when each is tested separately. Statistical procedures can account for multiple testing, but no such procedure is reported. Since the registry record contains no outcome test results, the effect of multiplicity on any findings cannot be assessed.

The record says that 248 participants responded to at least 80% of the items in the primary measure. It does not report how missing responses within a questionnaire were handled, whether participants with fewer completed items were excluded, or how missing baseline or 12-month measurements were treated. It also does not describe imputation, sensitivity analyses, or reasons for missingness. The relationship between this measure population and the enrollment of 731 is not explained.

Analysis populations are not described. The record does not state whether the primary analysis was intended to include everyone enrolled, only participants with available measurements, or another defined group. Without those details, the population represented by a potential estimate and the effect of incomplete measurement cannot be evaluated.

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 record lists one group, Primary Services, with 720 participants at risk for serious adverse events and zero affected. It also lists 720 at risk for other adverse events and zero affected, and reports zero deaths. No serious adverse event terms are listed.

These figures are registry safety tallies; they are not a comparison between intervention and control groups. The study is single group, and the record does not provide a control-arm safety estimate or a statistical comparison. The at-risk count is not the same as the enrollment count of 731. The registry record does not explain why those denominators differ, how safety events were collected, or the time period covered by each tally.

A zero count in the recorded categories means that the registry lists no affected participants for those tallies. It should not be read as proof that no adverse experiences occurred outside the reported categories, or that the program has no safety concerns. The record does not provide further detail about event definitions, monitoring procedures, or completeness of reporting. These safety figures should therefore be interpreted narrowly as the counts recorded in the registry.

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

The registry record documents a completed evaluation of a program intended to support father-child relationships, family development, and employment-related stability. It specifies a primary measure of reported parenting behavior and a planned assessment of change from baseline to 12 months from enrollment. It also describes the service package, including curricula and ongoing job-related support. These details clarify what the evaluation was designed to address.

However, the registry record does not report analyzed primary-outcome results. It gives no mean score, mean change, confidence interval, or statistical test. The record therefore does not establish whether reported parenting behavior changed, the size of any change, or the precision of an estimate. It also does not report results for the named secondary outcome.

Even if a within-group change were reported, this design would not provide a like-for-like control comparison. Such change would not by itself show that the program caused it. The registry record does not report analyses that address alternative explanations, missing outcome data, or differences between participants with and without sufficient questionnaire responses.

The distinction between program aims and evaluated findings is important. A program can aim to improve economic stability or reduce domestic violence, but those aims are not evidence that these outcomes changed. The primary measure concerns parenting behavior; the record does not provide results demonstrating effects on the broader aims. The safety record lists zero affected participants in its adverse-event tallies, but those figures likewise should be understood only as registry-recorded counts, not as proof of absence of all harms.

13. Why This Trial Matters Statistically

This evaluation illustrates a basic statistical distinction between defining an outcome and reporting evidence about it. The registry describes a specific continuous parenting-behavior measure, its component items, score construction, and intended follow-up timeframe. Those details help readers understand what a result would represent. Yet without an analyzed estimate and a measure of uncertainty, the registry record cannot answer the stated question about change.

The record also highlights why participant counts need context. Enrollment is 731, while the primary measure population is described as 248 respondents meeting an item-response criterion. These figures refer to different reported quantities, and the record does not explain the flow between them. Knowing how outcome respondents relate to everyone enrolled is essential when judging how representative an estimate might be.

Finally, the single-group design makes the distinction between change and causal effect especially important. A before-and-after measure can describe participants’ scores over time, but a comparator is needed to distinguish the program’s contribution from other explanations with greater confidence. This is a design issue, not something that can be resolved simply by applying a more elaborate analysis to the same group. Because the registry lists zero analyses and no outcome estimates, the record is informative about the intended evaluation but does not support a statistical conclusion about its primary outcome.

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.

Several trial-specific limitations constrain interpretation. The study is listed as single group, with no like-for-like control comparison, so a pre-to-post change would not alone identify a program effect. The registry record does not report an outcome estimate in any case, leaving the direction, magnitude, and precision of change unknown.

The primary measure population is 248 participants who responded to at least 80% of items, while enrollment is 731. The record does not explain the participant flow or the reasons that respondents may differ from those without sufficient item responses. It does not report missing-data methods, analysis populations, or sensitivity analyses. This makes it difficult to assess selection and missing-data concerns.

The measure combines seven items from a five-point frequency scale with one item from a four-point scale. Although the record describes the scoring rule and states that higher scores are better, it does not report validation, reliability, or the rationale for combining these items. The registry also lists four outcome measures but does not identify all of them in the outcome details or report multiplicity handling.

The program includes several service components, but the record does not report individual exposure, attendance, or variation in service receipt. It also does not report recruitment details, eligibility criteria, a statistical analysis plan, sample-size justification, or interim analyses. These omissions limit evaluation of implementation and analysis choices. Finally, the safety tallies do not include further detail on event definitions or collection, so they should be read as the registry’s recorded counts rather than a comprehensive account of safety experience.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: All in Dads! Healthy Marriage and Responsible Fatherhood Program Evaluation — NCT05194020.
• Registry record last updated 2025-09-15; status last verified 2025-09.
• Results first posted 2025-06-26.
• 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

NCT05194020 is a completed, single-group evaluation of All in Dads! Primary Services, sponsored by Midwest Evaluation & Research. The record lists enrollment of 731, no masking, and a primary outcome of change in mean healthy parenting behavior from baseline to 12 months from enrollment.

The program description includes Father Factor, The New Playbook, and Money Smart curricula, along with ongoing job-readiness and post-employment support. The primary measure combines eight reported behavior items into a score, with higher scores described as better. A total of 248 participants responded to at least 80% of its items.

The registry record lists zero analyses and does not report primary or secondary outcome results. It lists zero affected participants in its serious and other adverse-event tallies, with 720 at risk in each category, and zero deaths. Missing-data methods, analysis populations, and a statistical plan are not reported in the registry record.