Young Parents Program, Project Connect: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Young Parents Program, Project Connect (NCT01379924), a randomized na study. The primary outcome is Rapid Repeat Pregnancy.

2. Clinical Question

3. Trial Design

This was a randomized, parallel-group trial of the Young Parents Program, Project Connect. The registry identifies the allocation as randomized and the model as parallel. Masking is listed as none, so the trial was open-label in the sense that no masking was reported. The registry marks the study completed. Its start is recorded as 2007-09 and its primary completion as 2012-08. Enrollment is listed as 140.

The comparison was between Young Parents Program plus Parenting/Life Skills modules and Young Parents Program usual care. The intervention description says modules were delivered one-on-one during the first year of the child’s life, alongside standard medical and social services. The usual-care description says participants received regular standard care without modules. The registry also lists a teen-tot medical home intervention, but further detail about its relationship to the two arm descriptions is not reported in the registry record.

The posted primary outcome counts are based on 62.0 participants in the modules arm and 55.0 in usual care who had pregnancy data available at 12 months follow-up. These outcome populations do not describe the full enrollment count. The reasons that some enrolled participants do not appear in the primary outcome counts, and the approach used to retain participants in their randomized groups, are not reported in the registry record.

The registry lists phase as NA. Further information on the randomization sequence, allocation concealment, recruitment procedures, site structure, adherence to the modules, and the original sample-size justification is not reported in the registry record. Those details cannot be inferred from the randomized designation or from the posted outcome results.

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: Of 152 eligible patients who received care in the Young Parents Program who were invited to participate in the randomized trial, 12 declined to participate and were never enrolled into the study, but continued to receive care in the program.

Baseline

12-month Assessment

24-month Assessment

36-month Assessment

Analysis population for the primary outcome, as defined in the registry: Participants with pregnancy data available at 12 months 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 Rapid Repeat Pregnancy, measured over 12 months follow-up.

The primary endpoint is Rapid Repeat Pregnancy, measured as the number of participants with any repeat pregnancy by 12 months follow-up. The registry describes the measure as a number and percent at each follow-up time point and specifies that the primary analysis population consists of participants with pregnancy data available at 12 months. The posted result is a count for each arm.

A repeat-pregnancy outcome is relevant to the study’s stated aim of evaluating outcomes among adolescent parents. As a binary event, it distinguishes participants with a repeat pregnancy by the specified follow-up from those without one, among those whose pregnancy data were available. This kind of endpoint can be summarized as event counts and compared using a difference in event risks, or modeled using a regression method such as logistic regression.

The registry’s brief summary also describes an aim to evaluate repeat pregnancy at 12 and 24 months after first delivery. The primary outcome result posted for this analysis is specified at 12 months. A 24-month primary result is not reported in the registry record. The record does not give further operational detail on pregnancy ascertainment, such as the data source or how uncertain or incomplete pregnancy information was handled.

7. Results Posted in the Registry

• Young Parents Program Plus Parenting/Life Skills Modules: 12.9% (8/62) versus 29.1% (16/55) on control; risk difference -16.2 percentage points (95% CI -30.8 to -1.6), risk ratio 0.44 (0.21–0.96); unadjusted two-proportion z-test p = 0.030.

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.

Maternal Parenting Self-esteem Total 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 errors.
• Result:
  • Young Parents Program Plus Parenting/Life Skills Modules: mean 116.20 versus 112.80 on control; difference 3.40 (95% CI -1.45 to 8.25), standardized effect d = 0.26; z-test p = 0.170.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Young Parents Program Plus Parenting/Life Skills Modules and the control. The interval gives the range of effects that remain compatible with the data.

Parenting Profile - Parent-Child Role Responsibilities

• 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 errors.
• Result:
  • Young Parents Program Plus Parenting/Life Skills Modules: mean 5.90 versus 5.60 on control; difference 0.30 (95% CI -0.68 to 1.28), standardized effect d = 0.12; z-test p = 0.549.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Young Parents Program Plus Parenting/Life Skills Modules and the control. The interval gives the range of effects that remain compatible with the data.

Life Skills 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 errors.
• Result:
  • Young Parents Program Plus Parenting/Life Skills Modules: mean 83.00 versus 81.40 on control; difference 1.60 (95% CI -4.67 to 7.87), standardized effect d = 0.09; z-test p = 0.617.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Young Parents Program Plus Parenting/Life Skills Modules and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes add information about parenting-related scores, parent-child role responsibilities and life skills, rather than measuring the primary pregnancy outcome. Across the posted recalculations, the mean estimates are in the direction of higher scores in the modules arm, but the intervals for those comparisons include no difference. The sponsor-reported mixed-model p-values for the two outcomes with posted model analyses are also not small. Taken together, these results do not provide a clear, precise pattern of group separation on the secondary measures.

These outcomes are related to the intervention’s stated aims: its modules address educational attainment, budgeting, child development, safety and substance abuse, while the brief summary describes aims concerning parenting attitudes and skills, daily living and social relationships. However, the secondary scores do not substitute for the primary repeat-pregnancy result. A difference in a scale score would not directly establish a difference in pregnancy outcomes, and the primary outcome does not capture the full range of parenting or life-skill outcomes.

The registry lists 15 outcome measures, 14 analyses and 12 posted secondary results. The outcome listings include repeated names for some measures. The record does not report a multiplicity adjustment or clarify whether all these measures and analyses were planned before the data were examined. When many outcomes are tested, some may appear more notable by chance, even if there is no underlying group difference. For that reason, unadjusted secondary findings generally carry less weight than a clearly prespecified primary outcome analysis, particularly when the analysis plan and multiplicity strategy are unavailable.

The secondary results are best treated as exploratory context. Their pattern does not overturn the primary comparison, but neither do the posted data establish a broad effect across the wider set of parenting and service outcomes described in the trial aims. More information about measurement, timing, prespecification and analysis would be needed to assess the strength of evidence across those outcomes.

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

• Maternal Parenting Self-esteem Total Score
• Maternal Parenting Self-esteem Total Score
• Maternal Parenting Self-esteem Total Score
• Parenting Profile - Parent-Child Role Responsibilities
• Parenting Profile - Parent-Child Role Responsibilities
• Parenting Profile - Parent-Child Role Responsibilities
• Life Skills Score
• Life Skills Score

9. Statistical Interpretation

10. Statistical Methods Explained

The primary endpoint is binary: each participant with available pregnancy data is classified according to whether any repeat pregnancy was recorded by 12 months follow-up. For a binary outcome, event counts are interpreted alongside the number of participants contributing data in each group. The counts alone are not enough to compare groups fairly when the group sizes differ; a comparison must account for the number of participants at risk or included in the analysis.

What the unadjusted comparison means

The recalculated primary comparison uses the posted event counts and outcome-group sizes to estimate a risk difference. A risk difference is the event proportion in one group minus the event proportion in the other group. A negative value under the stated group ordering means the observed event proportion is lower in the modules group than in usual care. This is an unadjusted summary: it compares the groups without modeling other participant characteristics. The recalculation is not a replacement for a prespecified trial analysis, and it does not account for factors that were not included in the posted summary statistics.

The unadjusted p-value is 0.03. A p-value describes how compatible the observed data are with a specified null model, assuming that model and the calculation’s assumptions apply. It is not the probability that the null hypothesis is true, nor does it measure the size or practical importance of a difference. A small p-value also does not correct for missing data, selective reporting, or multiple outcome testing.

How to read the sponsor’s model

The registry reports logistic regression for the primary comparison and presents an odds ratio. Logistic regression is commonly used when the outcome is binary. The odds ratio compares the odds of the event between groups; odds and risks are related but are not the same quantity. The registry reports an odds ratio of 0.25, a 95% confidence interval from .07 to .92, and p = .037. The record does not report which covariates, if any, were included in this regression, so the model should not be described as adjusted for particular characteristics.

The sponsor-reported model and the unadjusted recalculation are not identical estimands: one reports an odds ratio from logistic regression, while the recalculation reports a difference in event risks from the group summaries. They can be considered alongside one another, while keeping their distinct scales and methods clear. The registry record does not flag a discrepancy between the sponsor analysis and the recalculation.

Continuous secondary outcomes

The posted secondary outcomes include mean scores on scales, with standard errors recorded for the arm summaries. For a continuous measure, a mean difference compares the average score between groups. Its confidence interval describes the range of differences compatible with the data under the calculation’s model and assumptions. The standard error describes the estimated uncertainty in a mean; it is not the spread of individual scores. The registry does not provide standard deviations in those arm summaries, and the posted recalculations use the reported standard errors to estimate the comparison.

Some secondary results also have sponsor-reported mixed-model analyses, described as group-by-time interaction coefficients. A mixed model can account for repeated measurements and can test whether patterns over time differ between groups. The specific model structure, included time points, covariance assumptions, and handling of incomplete repeated measurements are not reported in the registry record. The interaction coefficients and their p-values therefore should not be treated as fully interpretable without those details.

What recalculation can and cannot establish

Recalculated comparisons based on posted summary statistics are simple, unadjusted analyses. They are useful for making the observed group contrast explicit and for describing its uncertainty using the information in the registry. They do not reconstruct individual participant data, recover an analysis plan, or establish whether the sponsor’s model included additional terms. Where a sponsor analysis is reported, it remains the registry’s own analysis and should be interpreted in light of its stated method.

For the primary outcome, the available-data group counts allow a direct binary comparison. For continuous secondary outcomes, the posted means and standard errors allow approximate comparisons of group averages. In either setting, confidence intervals express statistical precision under a model; they do not address systematic errors such as differential measurement or selection into the available-data sample. Further details on model diagnostics, covariate selection and robustness checks are not reported in the registry record.

11. Confidence Intervals and Precision

Precision is conveyed by the confidence interval around an estimate. A confidence interval is a range of values compatible with the observed data under the statistical model used to construct it. It reflects sampling uncertainty, but it does not capture every source of uncertainty. In particular, it does not automatically account for bias from missing outcomes, measurement error, selective reporting or limitations in the study design.

For the primary unadjusted risk-difference comparison, the posted recalculated confidence interval excludes zero. Zero is the value corresponding to no difference in event risks under that measure. The interval therefore indicates that the data are not equally compatible with every possible difference: values near no difference are less compatible with the observed data under the calculation than values in the direction of the observed contrast. The registry’s sponsor-reported odds-ratio interval, .07 to .92, excludes 1, the null value for an odds ratio. These interval statements describe statistical compatibility, not certainty about a causal effect.

The primary outcome is based on 62.0 participants in the modules arm and 55.0 in usual care with pregnancy data available at follow-up. The confidence interval’s width should be read in the context of those analysis populations and the number of observed events. The registry does not report enough detail to assess how uncertainty would change under different assumptions about participants without available pregnancy data.

For the continuous secondary measures, the posted recalculated intervals vary in width and include the no-difference value. An interval that includes no difference does not prove the groups are equivalent; it means the data are compatible with a range of differences that includes no difference. Nor does an interval excluding no difference automatically establish importance. The measurement scale, direction, and context matter, and the registry record does not report thresholds for a meaningful difference.

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 planning figures are illustrations based on the observed effect, not a reconstruction of the original trial design. For this binary primary outcome, the figures describe participants per arm. The planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation; the target effect is the stated fraction of the observed effect. The original design assumptions and any original sample-size justification are not reported in the registry record.

The 80% power column gives the number of participants per arm that the planning calculation estimates would be needed to have an 80% chance of detecting the specified effect under the stated assumptions, if that effect were the true effect. The 90% power column gives the corresponding planning number for a higher chance of detecting that effect. These are prospective planning quantities: they describe hypothetical study designs, not the probability that the completed trial found a true effect.

The planning rows consider 100%, 75% and 50% of the observed effect. The numbers increase as the target effect becomes smaller, because a smaller difference is harder to distinguish from random variation without more information. For example, the calculation gives 99 participants per arm for 80% power when planning for 100% of the observed effect, compared with 188 participants per arm when planning for 75% of that effect and 449 participants per arm when planning for 50% of that effect. These figures should be read as illustrations tied to the observed estimate, which may itself be uncertain.

The stated sample-size assumptions are not the trial’s own documented assumptions. The calculation is not observed power. In addition, planning figures depend on the model assumptions and the selected effect size; they do not guarantee a particular result or compensate for missing outcome data, nonadherence or other design limitations. For other kinds of outcomes, the registry’s planning convention may refer to participants per arm or total events as appropriate; the primary binary comparison’s figures are participants per arm.

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, p₀ and p₁ are the control and treatment proportions, and p̄ is their average.

Worked calculation for this trial

1. Control proportion p₀ = 0.291; treatment proportion p₁ = 0.129; average p̄ = 0.210.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.5760 = 1.1289.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.5645 = 0.4751.
4. n = (1.1289 + 0.4751)² / (-0.1619)² = 98.2, rounded up to 99 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
p0 <- 0.290909090909091                          # control proportion
p1 <- 0.129032258064516                          # treatment proportion
n_per_arm <- function(power, frac = 1) {
  q1 <- p0 + (p1 - p0) * frac               # smaller effect = fraction of the observed difference
  pbar <- (p0 + q1) / 2
  z_b <- qnorm(power)
  ceiling(round((z_a * sqrt(2 * pbar * (1 - pbar)) + z_b * sqrt(p0 * (1 - p0) + q1 * (1 - q1)))^2 / (q1 - p0)^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 (unrounded n per arm)
cat("power.prop.test:", round(power.prop.test(p1 = p0, p2 = p1, power = 0.80)$n, 1), "\n")

# Simulation: how often does the z-test reject at the 80%-power sample size?
set.seed(1379924)
n    <- n_per_arm(0.80)
reps <- 20000
x0 <- rbinom(reps, n, p0); x1 <- rbinom(reps, n, p1)
ph <- (x0 + x1) / (2 * n)
z  <- ((x1 - x0) / n) / sqrt(ph * (1 - ph) * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(z) > z_a, na.rm = TRUE), reps))

Output from running the code

100% of observed effect: n per arm = 99 (80% power), 131 (90% power)
 75% of observed effect: n per arm = 188 (80% power), 251 (90% power)
 50% of observed effect: n per arm = 449 (80% power), 601 (90% power)
power.prop.test: 98.2 
Simulated power at n = 99 per arm: 0.817 (20000 replicates)

The simulation draws many pairs of event counts at the planned sample size and counts how often the two-proportion z-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 logistic regression, with an odds ratio of 0.25, a 95% confidence interval from .07 to .92, and p = .037. The registry classifies it as a superiority analysis. The unadjusted recalculation uses the posted group counts and reports a risk-difference comparison with p = 0.03. Both analyses point in the direction of fewer observed repeat-pregnancy events in the modules arm, and each reported interval excludes its respective null value.

The estimates should not be treated as interchangeable. The sponsor’s odds ratio compares odds, while the recalculation compares event risks. The regression may also depend on model specifications that are not described in the registry record. In particular, the record does not report which covariates, if any, were included. The recalculation uses only the posted summary counts and is not an adjusted replication of the sponsor’s model.

The registry does not identify a discrepancy between the sponsor analysis and the recalculation. The sponsor result is therefore best read as the reported model-based analysis, and the recalculation as a transparent, unadjusted comparison using the posted outcome summaries. Neither analysis alone establishes how missing outcome information was handled or whether the effect would persist under alternative analyses.

15. Multiplicity, Missing Data and Analysis Populations

The registry lists multiple outcomes and analyses, including the primary repeat-pregnancy outcome and secondary measures of parenting self-esteem, parent-child role responsibilities and life skills. It reports 15 outcome measures, 14 analyses and 12 posted secondary results. The repeated names among the outcome listings make it difficult to determine from the registry record alone how many distinct hypotheses were intended or how each measure relates to a particular time point or analysis.

A multiplicity plan explains how interpretation accounts for testing several outcomes or contrasts. When many statistical tests are performed, the chance of at least one apparently unusual result can increase. The registry record does not report whether the trial used a multiplicity adjustment, which outcomes were designated primary at each time point, or whether secondary analyses were prespecified. The unadjusted p-values should therefore be interpreted as results for individual tests, not as evidence that the entire family of outcomes has been considered together.

The primary outcome population is explicitly described as participants with pregnancy data available at 12 months follow-up. The posted counts are 62.0 in the modules arm and 55.0 in usual care. Reasons for unavailable outcome data, the amount and pattern of missingness, and any imputation or sensitivity analyses are not reported in the registry record. The record also does not clarify whether the analysis followed an intention-to-treat principle or how participants who did not complete modules were handled.

These omissions matter because availability of outcome data may be related to participant characteristics or outcomes. If the participants with available data differ from those without it, the observed comparison may not represent the full randomized groups. The randomized allocation is an important design feature, but it does not by itself resolve bias that can arise after randomization through missing follow-up information or exclusions. No missing-data method or analysis-population definition beyond availability of pregnancy data at 12 months should be assumed.

Further details about protocol-defined outcomes, analysis populations, handling of missing data and multiplicity would help distinguish confirmatory findings from exploratory results. Those details are not reported in the registry record.

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’s adverse-event entries report zero serious events among 12 at risk in the group labeled Non Randomized, zero among 72 at risk in the group labeled Modules, and zero among 68 at risk in the group labeled Control. It also reports zero other events in each of those at-risk groups and zero deaths in each group. No serious-event terms are listed.

These entries describe what was recorded for the registry’s adverse-event groups; they should not be confused with the primary-outcome populations or assumed to map directly onto the randomized comparison without further detail. The labels and at-risk denominators in the adverse-event record are distinct from the primary endpoint group counts. The registry does not report additional detail about the definition, collection window, severity grading or ascertainment of adverse events.

Zero recorded events does not show that no adverse events occurred outside the recorded categories or observation process. It means that the registry lists none for these categories and groups. Because the record gives limited information about safety monitoring and event collection, the figures should be read narrowly as registry-reported counts rather than as a comprehensive assessment of safety.

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

The posted primary data show fewer repeat-pregnancy events in the modules group than in usual care among participants with pregnancy data available at 12 months follow-up. The unadjusted comparison has a confidence interval that excludes no difference, and the registry’s logistic regression result also has an interval excluding the null odds ratio. These findings describe the observed comparison and its statistical uncertainty under the reported analyses.

They do not establish that the modules caused the difference. Randomized allocation supports a causal comparison in principle, but interpretation also depends on how allocation was implemented, whether participants were analyzed in their assigned groups, how missing outcomes were handled, and whether pregnancy ascertainment was comparable across groups. Those details are not reported in the registry record. Nor can the available-data outcome counts be assumed to represent all enrolled participants.

The result applies to the stated outcome and follow-up: any repeat pregnancy by 12 months among participants with pregnancy data available. It does not, on its own, answer whether outcomes differed at 24 months, whether other parenting outcomes changed, or whether effects would generalize beyond the population and service setting represented in this trial. The registry’s brief summary names a broader set of aims, but the posted primary result is limited to the 12-month endpoint.

The secondary outcomes offer additional context, but the registry does not report enough about prespecification or multiplicity to treat all secondary comparisons as equally confirmatory. The results also do not define a clinically meaningful threshold for score differences or establish the practical importance of the primary contrast. Statistical evidence, causal interpretation and practical importance are related but separate questions.

In short, the record supports a description of a lower observed event count in the modules arm in the available-data population, with statistical intervals that exclude their respective null values. It does not settle the effects of missing data, the robustness of the result under other models, or the broader consequences of the intervention.

18. Why This Trial Matters Statistically

This trial illustrates why statistical interpretation benefits from separating the outcome counts, the comparison measure and the analysis population. The primary endpoint is a binary event, so the number of events must be considered in relation to the number of participants contributing data. The two arm populations at the primary follow-up are not the full enrollment count, which makes the definition of the analyzed population central to interpretation.

It also demonstrates that different statistical methods can describe the same comparison on different scales. The sponsor reports a logistic-regression odds ratio, while the unadjusted recalculation uses a risk difference. Both can be useful, but they answer related rather than identical questions. A reader should not translate one measure directly into the other or treat a model-based result as proof that the groups were comparable in every respect.

The trial’s secondary results show another common challenge: a study may measure several outcomes that reflect different parts of its intervention aims. Those outcomes can add context, but their interpretation depends on whether hypotheses were prespecified and whether multiplicity was considered. The registry does not report those details, limiting how strongly the secondary findings can be weighed.

Finally, planning calculations based on an observed effect are not the same as the original design justification and are not observed power. They are sensitive to the effect chosen for planning. Separating such illustrations from the completed trial’s actual enrollment and analysis populations helps avoid reading a retrospective planning exercise as evidence about whether the trial was adequately designed.

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.

The registry record leaves important design and analysis details unreported. It identifies randomized allocation, a parallel model and no masking, but does not describe sequence generation, allocation concealment or procedures used to implement randomization. It also does not report the original sample-size justification or the assumptions used to design the trial. These omissions limit assessment of how the study was planned and protected against bias.

The primary result uses participants with pregnancy data available at 12 months, with group counts of 62.0 and 55.0. The record does not explain why other enrolled participants are absent from these outcome counts, whether missingness differed between groups, or what sensitivity analyses were performed. The intention-to-treat status of the primary comparison and handling of intervention nonparticipation are not reported in the registry record.

Outcome ascertainment details are also limited. The record does not describe how repeat pregnancies were identified, how event timing was verified, or how ambiguous data were handled. The primary result is specified at 12 months, while the brief summary describes an aim to evaluate repeat pregnancy at both 12 and 24 months. A 24-month primary result is not reported in the registry record.

The intervention description identifies five one-on-one modules and their intended topics, but the record does not report adherence, fidelity, or variation in delivery. Usual care is described as regular standard care without modules, but further details are unavailable. The relationship of the separately listed teen-tot medical home intervention to the comparison arms is also not clarified.

Finally, the registry does not report a multiplicity strategy for the range of outcome measures and analyses, or sufficient detail to interpret the mixed-model specifications. These limitations do not negate the posted results, but they restrict the strength and scope of conclusions that can be drawn from the registry record alone.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Young Parents Program, Project Connect — NCT01379924.
• Registry record last updated 2020-08-13; status last verified 2020-07.
• Results first posted 2020-08-13.
• 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 completed randomized, parallel-group study compared Young Parents Program plus Parenting/Life Skills modules with Young Parents Program usual care. Enrollment was 140, with no masking listed. The primary endpoint was any repeat pregnancy by 12 months follow-up among participants with pregnancy data available.

The posted primary counts were 8.0 among 62.0 participants in the modules arm and 16.0 among 55.0 in usual care. The unadjusted recalculation reports a confidence interval excluding no difference and p = 0.03. The sponsor’s logistic regression reports an odds ratio of 0.25, a 95% confidence interval from .07 to .92, and p = .037.

Secondary results cover parenting and life-skills measures. The registry does not report key details on missing-data handling, multiplicity, the original sample-size justification, or several analysis specifications. The findings therefore describe the posted outcomes and analyses, with important limits on broader interpretation.