Collaborative Perinatal Mental Health and Parenting Support in Primary Care: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Collaborative Perinatal Mental Health and Parenting Support in Primary Care (NCT02724774), a randomized na study. The primary outcome is Change in Parent Sensitivity in Teaching.

2. Clinical Question

3. Trial Design

The registry describes a randomized, single-masked, parallel-group trial with enrollment of 252. It is marked completed. The registry lists the phase as not applicable. The study was sponsored by the University of Washington and was conducted from 2015-11-24, with primary completion on 2020-04-04.

The two groups were Promoting First Relationships® (PFR) and the Parent Information Packet. PFR was a ten-week home-visiting program. The packet was mailed to families and included handouts about child development, health, and local resources. The study’s stated purpose was to evaluate adding a research-based parenting program to evidence-based mental health treatment. The registry summary describes the intended population as English- and Spanish-speaking low-income mothers who began publicly funded mental or behavioral health treatment during pregnancy at primary care community health centers.

Random allocation is intended to make treatment groups comparable on average, while a parallel design means the groups are compared over the same trial period rather than participants crossing from one group to another. The record identifies the trial as single-masked, but does not report who was masked or how masking was implemented. Details of allocation concealment, treatment adherence, follow-up procedures, and the trial’s own statistical analysis plan are not reported in the registry record.

The posted primary outcome is change in parent sensitivity in teaching from baseline to infant age 12 months. The record also lists secondary infant outcomes, including interactive quality and behavioral regulation scores. The trial’s sample-size justification and its original design assumptions 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.

Before assignment: 599 cases were screened for eligibility. 353 were determined eligible and contacted about the study 101 declined (74 not interested; 20 unreachable; 7 could not be enrolled because at that time there was no space in the program). 252 were seen in the baseline visit and randomized.

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.

Population: Mother-infant dyads were recruited and randomized in pairs.

6. Primary Endpoint

The registry lists the primary outcome as Change in Parent Sensitivity in Teaching, measured over Baseline to infant age 12 months.

The primary endpoint is change in parent sensitivity in teaching from baseline to infant age 12 months. Sensitivity was measured with the Nursing Child Assessment Teaching Scale, coded from an observation of a mother interacting with her infant during a teaching task. The score can range from 0 to 50, and higher scores indicate greater sensitivity.

Observational measures can capture aspects of interaction that may not be represented by a questionnaire or a clinical symptom measure. In this trial, the teaching task provided a defined interaction for coding, making it possible to compare group means on a common scale. The endpoint is therefore directly related to the parenting-support aim described in the registry, rather than being a measure of maternal mental health symptoms alone.

The registry labels the outcome as a change measure, but does not describe how missing baseline or follow-up observations were handled, how the change score was constructed, or whether the reported group summaries are adjusted for any baseline characteristics. Those details are not reported in the registry record. The numerical result should therefore be read as the posted group-level summary, alongside the sponsor’s reported regression analysis, rather than as a complete account of every analytic decision.

7. Results Posted in the Registry

• Parent Information Packet: mean 35.32 versus 36.73 on control; difference -1.41 (95% CI -2.56 to -0.26), standardized effect d = -0.32; z-test p = 0.017.

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.

Change in Infant Interactive Quality

• 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:
  • Parent Information Packet: mean 2.71 versus 2.23 on control; difference 0.48 (95% CI -0.10 to 1.06), standardized effect d = 0.22; z-test p = 0.102.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Parent Information Packet and the control. The interval gives the range of effects that remain compatible with the data.

Infant Behavioral Regulation: Externalizing T Score

• 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:
  • Parent Information Packet: mean 62.54 versus 59.24 on control; difference 3.30 (95% CI 0.35 to 6.25), standardized effect d = 0.28; z-test p = 0.028.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for Parent Information Packet than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Infant Behavioral Regulation: Internalizing T Score

• 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:
  • Parent Information Packet: mean 54.93 versus 53.64 on control; difference 1.29 (95% CI -1.51 to 4.09), standardized effect d = 0.12; z-test p = 0.367.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Parent Information Packet and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes present a mixed pattern rather than a single consistent direction across all infant measures. The estimated group contrasts vary in direction, and their intervals differ in whether they include zero. This means the secondary findings do not uniformly reinforce the primary sensitivity result. Nor do they, by themselves, settle whether the parenting program changed infant outcomes.

The infant interactive quality comparison is less conclusive than a simple reading of its point estimate alone would suggest: its interval includes zero, and the sponsor-reported regression p value is 0.094. For behavioral regulation, the externalizing comparison has an interval that excludes zero and a sponsor-reported p value of 0.029, whereas the internalizing comparison has an interval that includes zero and a sponsor-reported p value of .389. These outcomes are distinct measures; the registry does not give a common scale for combining them or a threshold for judging meaningful change.

Secondary outcomes generally carry less inferential weight than a prespecified primary outcome. When many outcomes are examined, some results may appear more unusual even if there is no underlying group difference. A multiplicity adjustment, a prespecified hierarchy, or other plan for interpreting the family of outcomes can help address that concern. Such a plan is not reported in the registry record, and the posted secondary p values should therefore be treated as unadjusted evidence unless otherwise stated.

The record reports 8 outcome measures and 8 analyses, while four secondary outcomes are posted in the secondary results. It does not explain how the posted secondary outcomes relate to all listed measures or whether additional analyses were planned. The pattern can be used as context for the primary endpoint, but not as a substitute for a clearly defined analysis strategy or a single primary finding.

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

• Change in Infant Interactive Quality
• Infant Behavioral Regulation: Externalizing T Score
• Infant Behavioral Regulation: Internalizing T Score
• Infant Behavioral Regulation: Dysregulation T Score

9. Statistical Interpretation

10. Statistical Methods Explained

What does a mean difference describe?

A mean is the average score in a group. For the primary outcome, the registry posts means and standard deviations for both groups. The recalculated mean difference compares the packet-group mean with the PFR-group mean. Its sign depends on that ordering: a negative estimate means the packet-group mean is lower. Since higher scores on this scale indicate greater sensitivity, the direction can be related to the meaning of the score, but the size’s practical importance cannot be judged without a meaningful-change threshold, which is not reported in the registry record.

A standard deviation describes how spread out individual scores are around a group mean. It is not the uncertainty in the estimated mean difference. The uncertainty of a group comparison depends on both the variability in scores and the amount of information available. The posted summaries make it possible to form a simple unadjusted comparison, but do not reveal all participant-level features that could affect a regression analysis.

What does the confidence interval add?

A confidence interval presents a range of estimates compatible with the observed data under a statistical procedure. It communicates precision as well as direction: a narrower interval indicates more precision than a wider interval, for the same scale and method. The primary interval ranges from -2.563 to -0.257 for packet minus PFR. Its endpoints are not a guarantee that the true difference lies within that range, nor do they measure the probability that a particular effect is true. The confidence level for the posted interval is not reported in the registry record.

The primary interval does not include zero, which is consistent with the unadjusted p value of .017 for a test of no mean difference under the same basic comparison. This correspondence is a general feature of intervals and hypothesis tests when they use compatible assumptions. It does not mean that the interval and p value convey the same information: the interval shows a range of magnitudes, whereas the p value measures how unusual the data would be under a specified null model.

How should the p values be read?

A p value is a measure of compatibility between observed data and a statistical null hypothesis, given a model and its assumptions. It is not the probability that the null hypothesis is true, and it does not tell readers the probability that the result occurred “by chance.” A smaller p value can indicate greater incompatibility with the null under the analysis assumptions, but it does not measure effect size or practical importance.

The unadjusted p value of .017 comes from a simple recalculation using the posted primary group summaries. The sponsor’s own reported primary p value is .026 from linear regression. These are different analyses, and the registry does not report enough detail about the regression model to reproduce it. The sponsor’s analysis should be read as the trial’s reported model-based result; the summary-statistic re-calculation is a transparent, unadjusted companion analysis.

Why might regression and a simple comparison differ?

Linear regression models a continuous outcome as a function of group and any other variables included in the model. If the model includes baseline values or other covariates, the group estimate can differ from a comparison of group means. Regression can also reflect the analysis population and handling of incomplete data. These are general reasons estimates or p values can vary between analyses; the registry record does not state which covariates or missing-data procedures were used in the sponsor’s model.

Randomization supports a comparison between assigned groups, but it does not eliminate every analytic choice. The interpretation of an estimate depends on how the outcome, groups, and available observations were modeled. The record labels the sponsor method as linear regression and identifies a superiority analysis, but details beyond that are not reported in the registry record.

What assumptions underlie the recalculation?

The simple recalculation treats the posted group summaries as the basis for an unadjusted comparison. It does not adjust for baseline characteristics, account for any clustering, or incorporate participant-level data. The registry record does not report whether such features are relevant to the sponsor’s analysis. General methods for continuous outcomes often use a model for the group means and uncertainty around them; the validity of that model depends on assumptions about the observations and the distribution of the outcome.

With continuous measures, unusually skewed values or unequal variability can affect how well a simple model describes the data. Over-dispersion is more commonly discussed for count outcomes, where observed variability exceeds what a particular count model expects; accounting for it can widen uncertainty. That general issue should not be assumed to apply to this continuous sensitivity score. The posted summaries do not permit a full assessment of distributional shape or model diagnostics.

The recalculated figures are deliberately limited to what can be derived from group means, standard deviations, and sample sizes posted for the outcome. They are not a reconstruction of the trial’s complete analysis plan. The registry record does not report a protocol justification for the sample size, planned interim analyses, missing-data rules, or a complete statistical analysis plan. Those omissions limit how fully the reported result can be audited.

11. Confidence Intervals and Precision

The primary unadjusted mean difference is -1.41 points for Parent Information Packet minus PFR, with an interval from -2.563 to -0.257. The interval lies below zero, matching the direction of the posted group means: 35.32 for the packet group and 36.73 for PFR. Because higher scores represent greater sensitivity, the estimated direction favors a higher mean score in the PFR group. The confidence level associated with this interval is not reported in the registry record.

The interval is useful because it conveys uncertainty around the estimated difference. Its lower and upper endpoints allow readers to see that the estimate is not perfectly precise, and that plausible values under the calculation range in magnitude. It does not establish the probability of a treatment effect, nor does it identify what size of difference would matter to families or clinicians. A meaningful-change threshold is not reported in the registry record.

The sponsor reports a linear regression p value of .026, but its estimate and confidence interval are not posted. The recalculated interval is based on unadjusted summary statistics, so it should not be read as the interval for the sponsor’s regression model. The record does not provide enough information to compare precision under the two analyses in detail.

Precision also depends on the observed variability and the number of observations contributing to each estimate. The outcome summaries list 113 participants in the PFR group and 112 in the packet group. These outcome-specific counts should not be confused with total enrollment of 252. The registry record does not explain why the outcome counts differ from enrollment or whether missing observations, exclusions, or another analysis-population definition account for the distinction.

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 planning figures are participants per arm for the primary continuous-outcome comparison, not total events. They are illustrative calculations based on the observed effect, not the trial’s original design assumptions. The calculation assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, a normal approximation, and an effect to detect set at the stated fraction of the observed effect. The trial’s own sample-size justification and original planning assumptions are not reported in the registry record.

For planning for 100% of the observed effect, the figures are 154 participants per arm for 80% power and 206 participants per arm for 90% power. For planning for 75% of the observed effect, the figures are 274 participants per arm for 80% power and 366 participants per arm for 90% power. For planning for 50% of the observed effect, the figures are 615 participants per arm for 80% power and 823 participants per arm for 90% power.

In plain terms, 80% power is the chance of detecting an effect of the specified size under the calculation’s assumptions if that effect is real; the 90% column represents a higher target chance under those same assumptions. Smaller effects are harder to distinguish from random variation, so the planning figures require more participants per arm as the target effect becomes smaller. The figures are not observed power and do not indicate the probability that this trial’s result is true.

A planning curve gives a visual way to consider how required group size changes as the assumed effect changes. It is an aid to designing a future study, not evidence that the trial enrolled the number needed to detect a particular effect under its original protocol. The registry record does not report that original design rationale.

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 = -1.410; pooled standard deviation σ = 4.411.
2. n = 2 × (1.96 + 0.842)² × 4.411² / -1.410² = 153.6, rounded up to 154 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 <- -1.41                      # observed difference in means
sigma <- 4.41087852103799                     # 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(2724774)
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 = 154 (80% power), 206 (90% power)
 75% of observed effect: n per arm = 274 (80% power), 366 (90% power)
 50% of observed effect: n per arm = 615 (80% power), 823 (90% power)
power.t.test: 154.6 
Simulated power at n = 154 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. Analyses Reported by the Sponsor

The sponsor’s primary analysis is reported as linear regression with p = .026 for the comparison between PFR and the Parent Information Packet. The registry does not post the model’s estimated group difference, confidence interval, included covariates, or other details needed to reproduce the analysis.

The recalculation from the posted group means and standard deviations is unadjusted. It estimates a packet-minus-PFR difference of -1.41 points, with an interval from -2.563 to -0.257 and unadjusted p = .017. This calculation provides a direct comparison of the displayed summaries, but it does not replace the sponsor’s regression analysis. The two p values arise from different analytic approaches and are not required to match.

The record does not flag a discrepancy between its reported analysis and the recalculation. Even so, interpretation should keep the analyses distinct: the sponsor’s regression is the trial’s own reported inferential analysis, while the recalculation is a simple, unadjusted check based on summary statistics. The absent regression estimate and interval make it impossible to compare the magnitude and precision of the sponsor’s model-based result with the recalculated estimate in full.

The p value alone does not establish the size or practical importance of the difference. That assessment would require the model estimate, an interval, and a basis for judging meaningful change; these are not reported for the sponsor’s primary analysis in the registry record.

15. Multiplicity, Missing Data and Analysis Populations

Multiplicity arises when several outcomes, time points, or analyses are tested. Even if each test uses a conventional significance threshold, examining a family of tests increases the chance that at least one result will appear noteworthy by chance. This is a general statistical concern, not a claim about what happened in this trial. The registry lists multiple outcomes and analyses, including a primary outcome and secondary infant outcomes.

The record does not report whether the investigators adjusted secondary p values for multiple comparisons, set a hierarchy among secondary outcomes, or identified a limited family of tests for formal inference. It also does not report an analysis plan establishing which outcomes or comparisons were confirmatory. Consequently, the secondary p values should not be read as if multiplicity had been addressed unless the trial’s fuller documentation establishes that it was.

Missing-data handling is also not reported in the registry record. The primary outcome summaries list 113 participants for PFR and 112 for the packet group, while the trial enrollment is 252. The record does not explain the relationship between enrollment and the outcome-specific counts, including whether they reflect unavailable measurements, exclusions, or a defined analysis population. It does not state whether missing values were imputed, whether analyses used complete cases, or whether sensitivity analyses assessed assumptions about missing outcomes.

The analysis population is not described in enough detail to determine whether results follow an intention-to-treat approach, a per-protocol approach, or another rule. The registry labels the study randomized and reports a linear regression analysis, but does not state which randomized participants were included in each model or how adherence was considered.

These omissions matter because the interpretation of a group comparison depends partly on which participants contribute data and how incomplete observations are treated. Randomization describes assignment, but it does not by itself answer questions about follow-up, missingness, or analysis populations. The record does not report planned interim analyses, a full statistical analysis plan, or the trial’s sample-size justification.

16. 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 no serious adverse events in either group: 0 among 127 participants at risk in the PFR group and 0 among 125 at risk in the Parent Information Packet group. It also reports no other adverse events in the groups at risk, and deaths are listed as 0 in each group.

These figures describe events recorded in the registry, not a guarantee that no adverse experiences occurred. The registry record does not report the safety-monitoring approach, the duration of safety observation, event definitions, or how completely events were collected. The at-risk counts in the safety listing are not the same as the outcome-specific sample sizes reported for the primary measure.

Zero events in a registry listing should be interpreted as zero events recorded under the reported categories and denominators. It does not establish that an intervention is risk-free or rule out uncommon events. The available safety figures are descriptive and do not support a broader conclusion about safety beyond what the record lists.

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

The primary posted summaries show a higher mean parent-sensitivity score in the PFR group than in the Parent Information Packet group from baseline to infant age 12 months. The unadjusted comparison is -1.41 points when expressed as packet minus PFR, and the interval from -2.563 to -0.257 excludes zero. The sponsor also reports a linear regression p value of .026. These statistics describe a group-level contrast on an observed scale; they do not indicate what happened for every mother or infant.

The score’s direction is defined: higher values indicate greater sensitivity. However, the registry does not report a threshold for clinically or practically meaningful change, so statistical evidence cannot by itself tell readers whether the magnitude matters in everyday parenting or family outcomes. The primary measure is an observed teaching interaction, not a direct measure of all parenting contexts or infant development.

The trial’s stated aim concerned adding a parenting program to mental health treatment. The available result should not be extended beyond the population and outcome described in the registry. It does not establish effects for populations with different characteristics, different service settings, or outcomes that were not measured or posted. The registry summary describes low-income English- and Spanish-speaking mothers who began publicly funded mental or behavioral health treatment during pregnancy at primary care community health centers.

The secondary outcomes offer additional but mixed information, and their interpretation is limited by the absence of a reported multiplicity plan. The record also does not provide key details about missing data, the analysis population, or the sponsor regression model. These limitations make it important to distinguish the posted statistical evidence from broader claims about effectiveness, mechanisms, long-term outcomes, or individual benefit.

In statistical terms, the primary result is evidence of a group difference under the reported analyses, with an unadjusted estimate whose direction favors PFR on the sensitivity scale. It is not proof of a particular causal pathway, a statement that every participant benefited, or a clinical recommendation.

18. Why This Trial Matters Statistically

This trial raises a useful statistical question about how to evaluate an intervention intended to affect both parenting interactions and infant outcomes. The primary endpoint is an observed behavior measure, while the secondary endpoints cover infant interactive quality and behavioral regulation. These outcomes represent related but distinct domains, so a statistical assessment needs to preserve what each measure captures rather than treating them as interchangeable.

The record also illustrates why an estimate, interval, and p value are more informative together than a p value alone. The primary unadjusted mean difference gives a direction and scale, its interval conveys uncertainty, and the sponsor’s regression p value shows the result under the reported model. Because the regression estimate and interval are absent, the two analyses cannot be compared fully. This is a practical reminder that complete reporting of model estimates and uncertainty supports interpretation beyond a significance label.

There is also a design-planning lesson. Sample-size illustrations based on observed effects can show how requirements change when a future study aims to detect smaller effects. They cannot reveal the original rationale for enrollment or establish the power of the completed trial. The registry does not report its original sample-size assumptions, which are distinct from the displayed planning illustration.

Finally, the number and variety of outcomes make multiplicity and outcome hierarchy relevant. A clear prespecified plan helps readers distinguish primary evidence from exploratory patterns. The registry record does not report such details, missing-data procedures, or the analysis population. Those reporting gaps do not erase the posted results, but they limit how confidently the full analytic process can be assessed.

19. 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 reporting gaps constrain interpretation. The registry identifies the study as single-masked but does not state who was masked or describe how masking was maintained. It does not report allocation concealment, adherence to the home-visiting program, or details of how the Parent Information Packet was used by families.

The sponsor’s primary method is identified as linear regression, but the registry does not report the model estimate, confidence interval, covariates, diagnostic checks, or missing-data procedures. The analysis population is also not specified. The primary outcome counts differ from total enrollment, but the record does not explain the difference. These gaps prevent a full assessment of how the reported regression result relates to all randomized participants.

The primary interval’s confidence level is not stated in the registry record, and no threshold for meaningful change on the parent-sensitivity scale is reported. The record describes how the score is coded and its range, but does not provide a basis for deciding whether the estimated difference is important in practice.

The registry lists multiple outcomes and analyses but does not report whether secondary comparisons were adjusted for multiplicity or arranged in a prespecified hierarchy. The timing and details of outcome assessment beyond the stated timeframe, planned interim analyses, and the full statistical analysis plan are not reported. The trial’s original sample-size justification is also unavailable in the registry record.

Finally, the safety entries are descriptive and lack details on monitoring, event collection, and observation duration. These limitations are specific to the information recorded and should not be mistaken for proof that corresponding procedures were absent from the full trial documentation.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Collaborative Perinatal Mental Health and Parenting Support in Primary Care — NCT02724774.
• Registry record last updated 2021-12-15; status last verified 2021-11.
• Results first posted 2021-12-15.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

23. Record Summary

The registry describes a completed randomized, single-masked, parallel-group trial with enrollment of 252, comparing a ten-week Promoting First Relationships® home-visiting program with a mailed Parent Information Packet. The target population was English- and Spanish-speaking low-income mothers who began publicly funded mental or behavioral health treatment during pregnancy at primary care community health centers.

The primary outcome was change in observed parent sensitivity in teaching from baseline to infant age 12 months. Posted group means were 36.73 for PFR and 35.32 for the packet group. The recalculated unadjusted mean difference for packet minus PFR was -1.41, with an interval from -2.563 to -0.257 and p = .017. The sponsor reports a linear regression p value of .026.

Secondary results show a mixed pattern, and the registry does not report a multiplicity plan. Details of the sponsor model, missing-data handling, analysis populations, and original sample-size justification are not reported in the registry record. The safety listing reports zero serious adverse events, zero other adverse events, and zero deaths in both groups.