TYRO Champion Dads Project Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for TYRO Champion Dads Project Study (NCT05256992), a randomized na study. The primary outcome is Primary Outcome Measures 1: Healthy Parenting Behavior.

2. Clinical Question

3. Trial Design

The TYRO Champion Dads Project Study is a randomized, parallel-group impact evaluation in Dallas, Texas. The registry lists the allocation as randomized and masking as none. It records total enrollment of 748, a study start date of 2021-04-01, primary completion of 2025-05-01, and status as completed. The registry lists the phase as NA. These design details describe the registered study; they do not establish how assignment was generated or whether any additional allocation procedures were used.

Both groups were intended to receive standard TYRO Champion Dads services, including TYRO Dads and Core Communication curricula with support services. The enhanced group was also offered Ray of Hope curriculum hours focused on domestic violence prevention. The brief summary identifies the added programming as 10 hours. The registry’s arm descriptions specify 20 hours of TYRO Dads curricula and 6 hours of Core Communication curricula as standard services. The full enhanced arm description and some details about optional services are truncated in the registry record.

The primary outcome is healthy parenting behavior, described as change from baseline to six months after enrollment. The primary analysis summaries include 34 participants assigned to enhanced services and 26 assigned to standard services. Those counts are far below total enrollment, and the registry specifically notes a low number of participants responding to the item at baseline and follow-up. The reasons for the small response group, the timing and procedures for collecting responses, and the analysis population definition are not reported in the registry record.

The study is an evaluation of an offered program package, not a masked comparison of a single isolated component. Random assignment can support a comparison between the assigned groups, but interpretation also depends on adherence, outcome availability, and how missing responses were handled. Those details, as well as the trial’s original sample-size justification and statistical analysis plan, 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

Analysis population for the primary outcome, as defined in the registry: There was a low number of participants who responded to this item in the final analysis in both the baseline and the follow-up.

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 Primary Outcome Measures 1: Healthy Parenting Behavior, measured over change from baseline to 6-months after enrollment.

The primary endpoint is healthy parenting behavior, measured by the average of 11 survey items concerning how frequently participants have positive interactions with their youngest child. Each item uses categories on a five-point scale, ranging from 1, never, to 5, every day or almost every day. The items are combined into a construct score by adding them and dividing by 11. The registry gives the possible score range as 1.0 to 5.0 and states that higher scores are always positive.

This kind of measure turns several related reports into a single continuous score. An average score can summarize the overall reported frequency across the included behaviors, while retaining more gradation than a simple yes-or-no outcome. The endpoint is relevant to the study’s stated question because it concerns positive interactions between fathers and their youngest child. It captures reported behavior rather than an independently observed interaction; the registry record does not describe an observational measure or validation procedure.

The outcome timeframe is described as change from baseline to six months after enrollment. However, the posted summaries give an arm mean and standard deviation without clarifying whether these statistics are for change scores, six-month scores, or another endpoint representation. The exact analytic construction beyond the 11-item scale is not reported in the registry record. This distinction matters because a follow-up score and a change-from-baseline score answer related but not identical statistical questions.

7. Results Posted in the Registry

• Control-Standard Services: mean 3.67 versus 3.88 on control; difference -0.21 (95% CI -0.70 to 0.28), standardized effect d = -0.22; z-test p = 0.399.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Secondary Outcome Measure 1: Healthy Parenting Attitudes

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Control-Standard Services: mean 4.76 versus 4.72 on control; difference 0.04 (95% CI -0.22 to 0.30), standardized effect d = 0.11; z-test p = 0.766.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Control-Standard Services and the control. The interval gives the range of effects that remain compatible with the data.

The registry posts one secondary outcome, healthy parenting attitudes, out of five outcome measures. Its arm means are both close to the upper part of the scale, and its estimated difference is small relative to the uncertainty described by its confidence interval. The interval includes values on either side of zero. This pattern does not provide a clear, precise contrast between groups and does not substantially change the reading of the primary healthy parenting behavior result.

The secondary measure concerns attitudes, while the primary measure concerns reported behavior. These outcomes are related in topic but are not interchangeable: an attitude score does not establish a change in reported interactions, and a behavior score does not by itself explain participants’ attitudes. A similar absence of a precise group contrast across the posted measures may be consistent with uncertainty in both, but it does not demonstrate that the intervention has no effect on either construct.

Secondary findings generally carry less confirmatory weight when many outcomes or comparisons may have been considered. Testing multiple outcomes increases the opportunity to observe an apparently notable result even when there is no underlying effect. The secondary comparison is labeled unadjusted, and the registry does not report a multiplicity procedure, a prespecified hierarchy among endpoints, or a complete analysis plan. The number of outcome measures in the record is five, while only one secondary result is posted. Without knowing which analyses were planned and how they were to be interpreted together, the secondary result is best treated as supportive descriptive evidence rather than a standalone confirmatory finding.

The registry lists no reported analyses for the secondary outcome. The posted summary can describe the available score comparison, but it cannot establish how that comparison fits into all analyses conducted or whether it was selected from a broader set of results. It also does not resolve the primary outcome’s incomplete response issue. Overall, the secondary evidence is compatible with the cautious interpretation of the primary result: both leave substantial uncertainty, and neither supports a strong conclusion about the effect of the added curriculum.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Secondary Outcome Measure 1: Healthy Parenting Attitudes

9. Statistical Interpretation

10. Statistical Methods Explained

The primary endpoint is a continuous score, so the registry reports an arm mean and standard deviation for each group and a difference in means. A mean describes the arithmetic average of observed scores. A standard deviation describes how dispersed individual scores are around that average. The mean difference provides a contrast on the endpoint’s original scale, which ranges from 1.0 to 5.0. It is not a standardized effect and does not itself describe how many participants improved.

What does the mean difference compare?

The posted contrast is standard services minus enhanced services. This orientation follows the displayed means: 3.67 for standard services and 3.88 for enhanced services, with a reported estimate of -0.21. A negative estimate therefore indicates a lower mean for standard services under this contrast definition. The sign is a matter of which group is subtracted from which; it does not change the underlying group summaries. The registry does not report whether the comparison is adjusted for baseline scores or other covariates.

The endpoint description labels the timeframe as change from baseline to six months. Yet the arm-level results are presented as means, and the record does not specify whether those means summarize individual change, six-month scores, or a model-based contrast. This is a reporting ambiguity, not something that can be resolved from the group means alone. The statistical interpretation should remain tied to the posted contrast rather than assuming an unreported adjustment or calculation.

What does a confidence interval express?

A confidence interval gives a range of values compatible with the data and the method used to calculate it, under the assumptions of that method. The primary interval runs from -0.698 to 0.278. Because it crosses zero, the data are compatible with no mean difference as well as with differences favoring either group. The interval does not say that every value inside it is equally likely, and it is not a guarantee that the true effect lies inside it. Its width reflects uncertainty in the estimated contrast.

The registry also reports an unadjusted p-value of 0.399. A p-value assesses how unusual results at least as inconsistent with a no-difference model would be if that model and the test assumptions held. It is not the probability that the no-difference model is true, and it does not quantify the chance that the observed result arose by chance in a broad, assumption-free sense. Because it is unadjusted, it does not account for testing multiple outcomes or comparisons.

Why do group counts and response availability matter?

The primary arm summaries include 34 and 26 participants. Estimates based on small analysis groups tend to have more sampling uncertainty than estimates based on larger groups, all else equal. In this record, the small primary response group is particularly relevant because total enrollment is 748 and the registry explicitly notes low response at baseline and follow-up. The analysis counts describe participants contributing to the posted outcome summaries; they should not be confused with enrollment or assumed to be the full randomized population.

Random assignment is intended to make groups comparable at the outset, on average. If outcome response is incomplete, however, the participants whose results are observed may no longer represent the initially assigned groups. This can affect the comparison if response is related to outcome values or differs in relevant ways across groups. The registry record does not report reasons for missing responses, group-specific response rates for the primary item, or a missing-data strategy. It also does not report an intention-to-treat analysis, imputation approach, or sensitivity analysis, so none should be presumed.

Why can dispersion matter for continuous outcomes?

The standard deviations are 0.871 in the enhanced-services group and 1.017 in the standard-services group. Standard deviations give context to the means by describing variation among observed scores. If scores vary substantially, a modest difference in means may be difficult to estimate precisely, particularly with small groups. In a general statistical explanation, assumptions about the distribution of observations affect how accurately a mean-based test and its confidence interval describe the evidence. Bounded scales and scores near a scale limit can also produce distributions that are not well described by a symmetric model. The registry does not report score histograms, distributional diagnostics, or a justification of the selected analysis method.

The comparison reports a pooled standard deviation of 0.937 and a standardized effect estimate of -0.224. A pooled standard deviation combines information about spread in both groups for a standardized comparison. A standardized effect expresses the mean contrast relative to that spread, which can help compare effects across measures with different units. It does not replace the original-scale estimate: the mean difference remains easier to interpret in score units. The registry’s posted primary result should be read with the reported original-scale interval and the limited analysis counts in view.

What is not established by the analysis listing?

The registry reports zero analyses in its analysis count and lists no reported analyses for the secondary outcome. That does not mean that no statistical work was done; it means the record does not post an analysis description in those fields. The original statistical plan, model specification, handling of baseline values, covariate selection, subgroup analyses, interim analyses, and any multiplicity procedure are not reported in the registry record. No assumptions about these procedures can be drawn from the estimates alone.

General statistical concepts can clarify what the posted estimates mean, but they cannot fill those reporting gaps. The observed summaries describe the participants with available outcome data and the stated comparison. They do not establish adherence, the effects of optional services, the mechanism of any group difference, or results for participants without recorded outcomes. The registry’s reported statistics should therefore be interpreted as estimates with uncertainty, not as a complete account of every analysis conducted during the evaluation.

11. Confidence Intervals and Precision

The primary mean difference is -0.21, with a 95% confidence interval from -0.698 to 0.278. This interval is broad relative to the point estimate and includes zero. It is compatible with a lower mean in the standard-services group, little or no difference, or a higher mean in that group. The data therefore leave substantial uncertainty about the direction and size of the group contrast.

Precision depends in part on the amount of outcome information available and the variability in observed scores. The primary summaries include 34 participants in the enhanced-services group and 26 in the standard-services group, and the registry notes low response at baseline and follow-up. The reported standard deviations, 0.871 and 1.017, show variation among the observed scores. These limited response counts and the observed variation are relevant context for the interval’s uncertainty, although the registry does not report a complete account of missingness or the interval calculation method.

A confidence interval is not a range that guarantees the true effect falls within its endpoints. It is an interval generated by a statistical procedure that, under its assumptions, has a stated coverage property over repeated studies. For this one estimate, the interval communicates uncertainty rather than resolving it. Its inclusion of zero does not establish equivalence or prove the groups are identical; equivalence would require a prespecified margin and an analysis designed to evaluate that question, neither of which is reported in the registry record.

The primary outcome is bounded between 1.0 and 5.0, and the registry does not give score distributions or explain whether the means represent change or follow-up scores. Those details would help assess the scale’s behavior and the relevance of the estimated contrast. The precision of the result should therefore be considered together with the small analysis groups, incomplete outcome response, and limits of the available endpoint description.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size table and curve are planning illustrations based on the observed effect, not the trial’s original design calculation. The figures for this continuous outcome are participants per arm, not total events. The listed assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation; the effect to detect is the stated fraction of the observed effect. The trial’s own original sample-size assumptions are not reported in the registry record.

The 80% power column gives the illustrative number of participants per arm for a design with an 80% probability of detecting an effect of the selected size under those planning assumptions, if that effect were the true effect and the assumptions held. The 90% column makes the same kind of illustration for a 90% probability. These are prospective design quantities, not descriptions of what the completed study achieved. They are not observed power.

The rows consider planning for 100%, 75%, and 50% of the observed effect. The smaller the effect a future study is intended to detect, the more participants it generally needs, because a smaller contrast is harder to distinguish from sampling variation. The values should be read as scenario-dependent illustrations rather than as a recommendation or a reconstruction of the trial’s design. They inherit uncertainty from the observed effect, which itself is estimated from small outcome-analysis groups. If the true effect differs from the observed estimate, the planning figures may not correspond to the sample size needed for that true effect. The registry does not report the design assumptions used when the study was originally planned.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -0.210; pooled standard deviation σ = 0.937.
2. n = 2 × (1.96 + 0.842)² × 0.937² / -0.210² = 312.3, rounded up to 313 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -0.21                      # observed difference in means
sigma <- 0.936725569792695                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(5256992)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 313 (80% power), 419 (90% power)
 75% of observed effect: n per arm = 556 (80% power), 744 (90% power)
 50% of observed effect: n per arm = 1,250 (80% power), 1,673 (90% power)
power.t.test: 313.3 
Simulated power at n = 313 per arm: 0.799 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The registry lists five outcome measures and posts one secondary outcome in addition to the primary outcome. The secondary comparison is unadjusted, and the record does not report a family-wise error procedure, false-discovery control, endpoint hierarchy, or other multiplicity plan. Without a prespecified strategy, the chance of false-positive findings across multiple tested outcomes cannot be assessed from the posted p-values alone. The statistical analysis plan and the number of analyses actually conducted are not reported in the registry record.

The registry records zero analyses in its analysis count and gives no reported analyses for the secondary outcome. These fields do not establish that analyses were not conducted; they mean that analysis details are not posted in the record. The exact primary test, any covariate adjustment, baseline handling, subgroup comparisons, interim analyses, and whether results were selected for reporting are not reported. Accordingly, the posted unadjusted p-values should not be interpreted as if a complete confirmatory testing plan were available.

Missing outcome data are a central limitation. The registry explicitly states that there was a low number of participants responding to the primary item in the final analysis in both baseline and follow-up. The primary summaries include 34 participants in the enhanced-services group and 26 in the standard-services group, compared with total enrollment of 748. The reasons for missing responses, the number of missing values at each assessment, and whether missingness differed by assigned group are not reported in the registry record.

The missing-data method is also not reported. The record does not say whether the analysis used complete cases, imputation, a model accommodating incomplete observations, or a sensitivity analysis. Each method requires assumptions about the relationship between missingness and observed or unobserved outcomes. If response depends on participants’ outcomes or other characteristics, a comparison among respondents may not represent the randomized groups as enrolled. Randomization alone does not eliminate this concern once the analysis is restricted to those with observed responses.

The registry record does not define the primary analysis population or report a flow from enrollment and assignment to outcome response. It therefore does not establish whether the posted counts reflect a prespecified population or all participants with usable scores. These reporting gaps make it difficult to evaluate the robustness of the outcome estimates and the extent to which multiplicity and missingness were addressed.

15. 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 reports adverse-event figures for 382 participants at risk in the enhanced-services group and 366 in the standard-services group. For serious adverse events, it records zero affected participants in each group. For other, non-serious adverse events, it also records zero affected participants in each group. The death count is zero in both groups. These are the registry’s posted counts; they do not by themselves establish how adverse events were solicited, classified, or monitored.

At-risk counts are the denominators attached to these safety summaries. They are distinct from the much smaller primary outcome analysis groups, because the safety and efficacy summaries can use different populations or reporting fields. The record does not explain the relationship between the safety denominators and the primary outcome response counts, nor does it provide event terms or additional narrative describing safety surveillance.

Zero recorded events means no events are listed in these categories in the registry record. It should not be read as proof that no event of any kind occurred or that the intervention has no safety risks. The record does not report the ascertainment method, observation duration for safety events, or detail on events that may not meet the registry’s reporting criteria. The figures are therefore a concise account of posted adverse-event counts, not a complete safety assessment.

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

The posted results estimate a contrast in healthy parenting behavior between participants assigned to enhanced services and those assigned to standard services. The primary estimate is a mean difference of -0.21 under a standard-services-minus-enhanced-services contrast, with a confidence interval from -0.698 to 0.278. The interval includes zero and values in both directions, so the result does not precisely distinguish the groups on this measure.

This does not establish that the groups are equivalent or that the added curriculum has no effect. A nonsignificant result can arise when the underlying difference is small, when estimates are imprecise, or when outcome information is limited. The registry’s primary response group is small, and the record explicitly notes low response at baseline and follow-up. The uncertainty and possible effects of missing data prevent a strong conclusion from the point estimate alone.

Nor does the estimate establish that the additional curriculum improves healthy parenting behavior. The point estimate’s direction is only one aspect of the evidence; the confidence interval includes a range of plausible contrasts on either side of zero. The registry does not report a prespecified threshold for a practically important difference, so the clinical or programmatic importance of values within the interval cannot be judged from the record.

The endpoint is a survey construct based on reported frequency of positive interactions with the participant’s youngest child. It does not directly measure every aspect of parenting, domestic violence, family safety, or child outcomes. The posted result should not be generalized to unmeasured outcomes, other populations, or longer periods beyond the stated six-month timeframe. The record also does not clarify whether the posted means are change scores or follow-up scores, which limits interpretation of the specific contrast.

The study is recorded as completed, but completion does not remove uncertainty created by limited outcome response or incomplete analysis reporting. The fairest reading is that the registry offers an imprecise comparison among the participants represented in the posted summaries. It does not establish a definitive benefit, harm, or absence of effect for the added curriculum.

17. Why This Trial Matters Statistically

This trial illustrates why an outcome estimate should not be read in isolation from the population that contributed data. The registry records enrollment of 748, yet the primary outcome summaries include 34 and 26 participants. It also explicitly notes low response at baseline and follow-up. This difference between overall enrollment and outcome-analysis counts makes missing-data reporting central to judging what the estimate represents.

The primary comparison shows how a point estimate and confidence interval answer different questions. The point estimate gives the direction and magnitude of the observed contrast on the score scale, while the interval communicates uncertainty around that estimate. With an interval spanning both sides of zero, the evidence is not precise enough to establish the direction of a group difference. A p-value alone would not convey that range of plausible values.

The trial also demonstrates the limits of interpreting a registry result without its statistical plan. The record does not state the original sample-size justification, the full missing-data approach, the analysis population, or a multiplicity strategy. Those omissions matter because they affect how to interpret the posted outcome counts and the evidential weight of secondary findings. The planning illustrations based on observed effects are not substitutes for the trial’s original design rationale.

Finally, the outcome is a bounded multi-item score intended to represent healthy parenting behavior. Understanding its construction, scale, assessment time, and response availability is necessary to interpret the mean difference. The registry describes the items and score range, but does not clarify whether the posted means represent change or follow-up values, or provide score distributions. This makes the study a useful example of both the value and the limits of registry-based statistical interpretation: numerical estimates can be described carefully, while unanswered design and reporting questions must remain unanswered.

18. 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 trial-specific limitation is the low number of participants contributing to the primary outcome analysis. The posted arm counts are 34 and 26, while the registry records enrollment of 748. The registry itself notes low response to the primary item in both the baseline and follow-up final analysis. It does not report why responses were missing, how many were missing at each time point, or how missingness was handled. The resulting estimate may therefore describe a selected subset rather than all randomized participants.

The registry identifies the primary outcome timeframe as change from baseline to six months, but the posted arm summaries do not say whether the means are changes, six-month scores, or adjusted estimates. This ambiguity makes it harder to identify precisely what the numerical comparison represents. The record does not report baseline group summaries, an adjustment for baseline, or the model used to estimate the contrast.

Other important design and analysis details are not reported in the registry record. These include the original sample-size calculation, allocation implementation, full analysis population, adherence to assigned services, details of optional services, the missing-data strategy, sensitivity analyses, and the multiplicity plan. Some arm-description text is truncated, limiting the available description of the full service contrast. The registry also does not give distributions of the bounded survey score or information on its measurement properties.

The outcome is self-reported and focuses on interactions with the participant’s youngest child. The available measure does not directly capture every parenting or family outcome that could be relevant to the program. The reported six-month timeframe also does not establish persistence beyond that period. These limits do not invalidate the posted comparison, but they constrain the populations, outcomes, and time horizon to which it can be applied.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: TYRO Champion Dads Project Study — NCT05256992.
• Registry record last updated 2025-11-21; status last verified 2025-11.
• Results first posted 2025-11-21.
• 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.

22. Record Summary

The registry record describes a completed randomized, parallel-group evaluation of the TYRO Champion Dads Project in Dallas, Texas, with enrollment of 748. Both groups were assigned standard services, while the enhanced-services group was also offered the Ray of Hope curriculum. Masking is listed as none.

The primary endpoint is a score for healthy parenting behavior, described as change from baseline to six months. The posted analysis includes 34 participants in the enhanced-services group and 26 in the standard-services group. The estimated mean difference is -0.21, with a 95% confidence interval from -0.698 to 0.278 and an unadjusted p-value of 0.399. The interval includes zero and leaves uncertainty about the direction and size of the contrast.

The registry notes low response to the primary item at baseline and follow-up. It does not report the original sample-size rationale, full analysis plan, missing-data approach, or multiplicity procedure. One secondary outcome is posted, and the safety record lists zero serious adverse events, zero other adverse events, and zero deaths in both groups.