Stepping Stones and Creating Futures Plus Pilot: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Stepping Stones and Creating Futures Plus Pilot (NCT05783336), a randomized na study. The primary outcome is Physical Intimate Partner Violence.

2. Clinical Question

The primary outcome is a binary measure: a participant is counted as having the outcome if any of five behaviorally specific items receives a positive response. For women, it concerns experience of physical intimate partner violence in the past 6 months; for men, it concerns perpetration during that period. The posted results therefore address an occurrence measure, not the frequency, severity or circumstances of events.

The registry record identifies intimate partner violence and poverty as conditions of interest. It describes this as a pilot trial focused on feasibility, acceptability and potential effect size. However, numeric results for feasibility and acceptability are not reported in the registry record. The main numerical results available for this clinical question are the sex-specific counts and the posted risk-difference comparisons.

3. Trial Design

This was a completed, randomized, parallel-group pilot trial sponsored by the University of Exeter. The registry record lists enrollment of 325 and an allocation ratio of 1:1. Masking is listed as none. The study began on 2023-05-24, reached primary completion on 2023-11-28 and has a status of completed. The phase is listed as NA.

Participants were assigned to SSCF+ or a wait-list control. The intervention is described as a small-group program addressing gender, livelihoods and mental health. Its approximately 15 sessions were each described as about 3 hours. The control is described as no intervention during the wait-list period. The registry summary identifies young people aged 18-25 years in urban informal settlements in Durban and rural communities in KwaZulu-Natal, South Africa.

Primary outcome results are presented separately for women and men. The posted arm counts are 26 of 72 for women receiving SSCF+, 41 of 89 for women in control, 25 of 81 for men receiving SSCF+, and 32 of 76 for men in control. These counts are the observed outcome values and denominators listed for the respective arms; they are not estimates of the trial's randomized enrollment total.

The registry record lists 13 outcome measures and 10 posted secondary outcomes, but the number of reported analyses is 0. The original sample-size justification, planned statistical analysis, analysis populations and any interim analyses are not reported in the registry record. The study's pilot purpose is stated, but the registry record does not provide further detail on how feasibility or acceptability was defined or assessed.

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

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 Physical Intimate Partner Violence, measured over 6 months.

The primary endpoint is physical intimate partner violence at 6 months, measured as a count of participants meeting a binary definition. For women, the definition concerns experience of physical intimate partner violence during the past 6 months; for men, it concerns perpetration during that period. The registry record says the measure uses five behaviorally specific items, with examples such as being slapped or hit. Responses are recorded as “never,” “once,” “a few times” or “many times.” Any positive response across the five items is classified as “yes.”

Using a binary outcome makes the endpoint a measure of whether any qualifying event was reported, rather than how often events occurred or how severe they were. It also gives a direct count of participants with the outcome in each arm. The measure is relevant to the trial's stated focus on intimate partner violence and allows arm-level occurrence to be described at the specified follow-up.

The endpoint has an important interpretive boundary: a participant classified as positive based on one item is counted in the same category as a participant reporting positive responses to more items or more frequent experiences. The posted endpoint does not distinguish those patterns. It also uses different sex-specific interpretations—experience for women and perpetration for men—so the two strata should not be treated as identical measures of the same participant role.

The registry record provides the outcome definition and 6-month timeframe. Further information about instrument administration, missing responses or validation in this trial is not reported in the registry record.

7. Results Posted in the Registry

• Women: SSCF+: 36.1% (26/72) versus 46.1% (41/89) on control; risk difference -10.0 percentage points (95% CI -25.1 to 5.2), risk ratio 0.78 (0.54–1.15); unadjusted two-proportion z-test p = 0.203.
• Men: SSCF+: 30.9% (25/81) versus 46.1% (41/89) on control; risk difference -15.2 percentage points (95% CI -29.6 to -0.8), risk ratio 0.67 (0.45–1.00); unadjusted two-proportion z-test p = 0.042.
• Men: Control: 42.1% (32/76) versus 46.1% (41/89) on control; risk difference -4.0 percentage points (95% CI -19.1 to 11.2), risk ratio 0.91 (0.65–1.29); unadjusted two-proportion z-test p = 0.610.

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.

Depressive Symptoms

• 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:
  • Women: SSCF+: mean 18.70 versus 24.50 on control; difference -5.80 (95% CI -9.45 to -2.15), standardized effect d = -0.49; z-test p = 0.002.
  • Men: SSCF+: mean 17.80 versus 24.50 on control; difference -6.70 (95% CI -9.95 to -3.45), standardized effect d = -0.61; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Women: SSCF+ than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Men: SSCF+ than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Post-traumatic-stress Symptoms

• 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:
  • Women: SSCF+: mean 13.80 versus 18.00 on control; difference -4.20 (95% CI -7.63 to -0.77), standardized effect d = -0.37; z-test p = 0.017.
  • Men: SSCF+: mean 13.00 versus 18.00 on control; difference -5.00 (95% CI -8.06 to -1.94), standardized effect d = -0.48; z-test p = 0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Women: SSCF+ than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Men: SSCF+ than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Emotional Dysregulation

• 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:
  • Women: SSCF+: mean 31.20 versus 35.00 on control; difference -3.80 (95% CI -7.78 to 0.18), standardized effect d = -0.29; z-test p = 0.061.
  • Men: SSCF+: mean 29.90 versus 35.00 on control; difference -5.10 (95% CI -8.85 to -1.35), standardized effect d = -0.40; z-test p = 0.008.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Women: SSCF+ and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Men: SSCF+ than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The secondary outcomes cover several domains: depressive symptoms, post-traumatic-stress symptoms, emotional dysregulation, earnings, savings, hunger, livelihood activities and work stress. The numeric summaries available for symptom outcomes show a mixture of directions across sex-specific comparisons, rather than a uniform pattern across every reported measure and group. The registry record does not provide enough detail to interpret the scales' clinical meaning or to establish whether any observed score difference is important to participants.

These outcomes complement the primary endpoint by describing other dimensions relevant to the intervention's topics, including mental health and livelihoods. They do not substitute for the primary measure of physical intimate partner violence, and they do not resolve the uncertainty in the primary comparisons. The primary and secondary outcomes measure different constructs, so a pattern in a symptom score cannot be taken as confirmation of a change in intimate partner violence.

Unadjusted secondary results carry less weight as confirmatory evidence when several outcomes and comparisons are considered. With multiple tests, some apparent differences can occur by chance even when there is no underlying effect. The registry record lists 13 outcome measures and 10 posted secondary outcomes, but zero reported analyses; it does not report a multiplicity adjustment or a prespecified hierarchy for interpreting secondary endpoints. Numeric findings should therefore be treated as exploratory signals, not as stand-alone proof.

The registry record also lists earnings, savings, hunger, livelihood activities and work stress as secondary outcomes, but numeric summaries for those measures are not reported in the registry record. Feasibility and acceptability are central to the stated pilot aims, yet numeric results for those aims are also not reported in the registry record. This limits the extent to which the secondary results can address the full range of questions motivating the pilot.

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

• Depressive Symptoms
• Post-traumatic-stress Symptoms
• Emotional Dysregulation
• Earnings
• Savings
• Hunger
• Livelihood Activities
• Work Stress

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is binary because each participant is classified as either having or not having the specified outcome during the past 6 months. The registry record defines a positive classification as any positive response across five behaviorally specific items. For a binary endpoint, arm-level counts and denominators describe the observed data, while a risk difference describes the absolute difference between two proportions. A negative risk difference means the proportion in the comparison arm is lower than the reference proportion as encoded for that estimate; the coding and reference group must be understood before assigning a clinical direction.

What does the risk difference represent?

The risk difference is expressed on the probability scale. It compares the proportion with the outcome in one group with the proportion in its reference group. Unlike a ratio measure, it describes an absolute contrast. Its confidence interval represents the range of values compatible with the estimate and its sampling uncertainty under the method used. If that interval includes zero, a zero difference is among the values compatible with the data at the interval's stated level. If it excludes zero, the data are less compatible with a zero difference under that calculation, but this alone does not resolve design, measurement or reporting concerns.

The posted primary comparisons also include risk ratios and odds ratios. These are relative measures: a risk ratio compares proportions, while an odds ratio compares odds. The measures answer different mathematical questions and should not be treated as interchangeable. For this trial, the absolute risk difference is useful for describing the size and direction of the posted comparison, while the ratios can offer a relative scale. They remain unadjusted estimates in the posted comparisons.

How should p-values be understood?

A p-value is a measure of how unusual data at least as discrepant as those observed would be under a specified null model. It is not the probability that the null hypothesis is true, nor does it measure the size or importance of an effect. The reported p-values for the primary comparisons are unadjusted. They do not account for testing multiple outcomes or comparisons unless a correction is specified; such a procedure is not reported in the registry record. A p-value should be considered alongside the estimate, its confidence interval, the study design and the quality and consistency of the reported data.

For the primary endpoint, the outcome is binary, so the arm counts and risk-difference comparisons are appropriate descriptions of occurrence. The posted results are stratified by sex, and the outcome wording differs by sex: experience among women and perpetration among men. Results across those groups therefore need to be interpreted in light of both the stratification and the endpoint definition.

What do the secondary-outcome summaries add?

Depressive symptoms, post-traumatic-stress symptoms and emotional dysregulation are reported as mean scores with standard deviations. A mean difference compares the average score in SSCF+ with the average score in the stated reference group. A negative mean difference indicates a lower mean in the intervention arm relative to that reference under the posted coding. The standard deviation describes how dispersed individual scores are around the arm mean; it is not the uncertainty in the mean difference itself. The confidence interval for the mean difference addresses uncertainty in the comparison.

Continuous measures retain more gradation than a binary endpoint, but interpreting their direction or importance depends on the scale's meaning and scoring. Scale interpretation, thresholds for meaningful change and further details about the measures are not reported in the registry record. The posted mean differences are unadjusted, and the record does not provide reported analyses for these outcomes.

Why does over-dispersion matter in general?

General statistical explanation: in count models, over-dispersion occurs when the variability in counts is greater than the model assumes. If it is ignored, standard errors may be too small and confidence intervals too narrow. This primary endpoint is reported as a binary participant count, not as a count rate with a dispersion parameter; the registry record lists no dispersion value for it. Therefore, over-dispersion is not a basis for reinterpreting these posted primary estimates.

The registry record does not report the original analysis model, covariate adjustments, handling of missing outcome data, analysis population, model diagnostics or multiplicity plan. Those details cannot be inferred from the posted descriptive counts and unadjusted comparisons. The comparison-reference values also warrant attention: the men’s SSCF+ comparison lists the 41 of 89 control reference, while the separately reported men’s control arm is 32 of 76. The reason for this is not reported in the registry record.

11. Confidence Intervals and Precision

Confidence intervals communicate statistical precision by showing a range of values compatible with the estimate under the calculation used. A narrower interval indicates greater precision than a wider interval on the same scale. An interval's position relative to zero matters for a difference: if zero is inside the interval, the data are compatible with no difference as well as with values on either side. Intervals do not account for every source of uncertainty, including possible measurement problems, missing data, analysis choices or inconsistencies in the reported comparisons.

For women, the primary risk-difference estimate is -0.100, with a 95% confidence interval from -0.251 to 0.052. The interval includes zero and spans values on both sides of it, so the estimate is not precise enough to distinguish clearly between a negative difference and no difference or a positive difference. Its unadjusted p-value is 0.203.

For the men’s SSCF+ comparison, the estimate is -0.152, with a 95% confidence interval from -0.296 to -0.008. This interval excludes zero, but its interpretation is constrained by the fact that the listed reference values are 41 of 89, whereas the separately listed Men: Control arm count is 32 of 76. The registry record does not explain the discrepancy in comparison reference values. Statistical precision cannot resolve uncertainty about which control data the estimate represents.

The secondary mean-difference intervals also vary in width. A confidence interval quantifies sampling uncertainty under the calculation; it does not establish that a difference is practically important. The registry record does not report thresholds for meaningful change on the symptom scales. Nor does a confidence interval compensate for multiple unadjusted comparisons or missing information about analysis populations and missing outcomes.

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 figures are planning illustrations based on the observed effects, not the trial's original design assumptions. For these outcomes, the entries refer to participants per arm. The registry record's calculation assumptions are a two-sided significance level of 0.05, equal allocation between two arms and a normal approximation. Each planning row considers detecting a stated fraction of the observed effect. Time-to-event calculations, if present, would instead refer to total events; that convention does not apply to these posted binary and continuous outcomes.

The 80% power column describes 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 its assumptions. The 90% power column uses a higher target chance of detection and therefore generally requires more participants per arm. These are design-planning concepts, not guarantees about what a future study will find. Smaller target effects require more participants because they are harder to distinguish from random variation.

The effect sizes used in the illustrations are based on the observed pilot estimates, including rows planning for 100%, 75% and 50% of the observed effect. Pilot estimates can be unstable, so the resulting numbers are illustrative rather than definitive design recommendations. The original trial's sample-size assumptions and justification are not reported in the registry record.

These figures are not observed power. They do not describe the probability that the completed trial detected an effect, and they do not change the interpretation of the estimates or confidence intervals. The sample-size curve should likewise be read as a planning display under the stated assumptions, not as a forecast of clinical outcomes.

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 = 0.461; treatment proportion p₁ = 0.361; average p̄ = 0.411.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.6958 = 1.3637.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.6922 = 0.5826.
4. n = (1.3637 + 0.5826)² / (-0.0996)² = 382.1, rounded up to 383 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 <- 0.460674157303371                          # control proportion
p1 <- 0.361111111111111                          # 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(5783336)
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 = 383 (80% power), 512 (90% power)
 75% of observed effect: n per arm = 687 (80% power), 918 (90% power)
 50% of observed effect: n per arm = 1,557 (80% power), 2,083 (90% power)
power.prop.test: 382.1 
Simulated power at n = 383 per arm: 0.804 (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. Multiplicity, Missing Data and Analysis Populations

Multiplicity arises when several outcomes, groups or comparisons are examined. Each unadjusted test has its own chance of a false-positive result under its null model; considering many tests without an adjustment can increase the chance that at least one result appears notable by chance. The registry record lists 13 outcome measures, 10 posted secondary outcomes and zero reported analyses. A family-wise adjustment, false-discovery procedure, prespecified outcome hierarchy or other multiplicity strategy is not reported in the registry record.

The primary comparisons are reported with unadjusted p-values. The secondary comparisons are also described without a reported adjustment. Their p-values should therefore not be interpreted as if they were the result of a single prespecified confirmatory test. In particular, an unadjusted value below a conventional threshold does not by itself establish that an outcome was the principal test or that the overall pattern is robust to multiple testing.

Missing-data methods are not reported in the registry record. It does not state how missing outcome responses were handled, whether participants with missing observations were excluded, or whether any imputation or sensitivity analysis was used. The analysis population is also not reported: the record does not specify whether results use all randomized participants, participants with available outcome data or another defined set.

The original statistical analysis plan, model specification, covariate adjustments and planned handling of interim analyses are not reported in the registry record. This does not imply that these procedures were absent; their details are simply not reported in the registry record. The registry record identifies the trial as completed and lists no reported analyses, which further limits the ability to distinguish prespecified analyses from exploratory calculations.

These omissions matter because analysis choices can influence estimates and their uncertainty. They are particularly relevant to the men’s primary comparison, for which the comparison reference values differ from the separately listed Men: Control arm count. The record does not explain how that comparison was constructed. Until the reference group and analysis details are clarified, the men’s estimate requires additional caution.

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.

Most frequent serious adverse event terms

Serious events with the highest arm-level rate: violence experienced (1.1%), threat to harm (1.1%).

The serious adverse event figures are counts reported for each group, alongside the number at risk. The registry record lists zero serious adverse events among 73 women in SSCF+, two among 89 women in control, zero among 84 men in SSCF+ and zero among 79 men in control. It separately lists one death among 79 men in control and zero deaths in the other groups. These are descriptive figures; the registry record does not provide a causal assessment attributing events to the intervention.

The listed serious-event terms include “Violence experienced” and “Threat to harm,” each shown as 1.1%. The record does not provide further details about the events, their timing, severity, relationship to study participation or how the percentages were calculated. No other-event counts are listed for the groups in the posted safety data.

These figures should be read in the context of a pilot trial and the limited detail in the registry record. The small group counts and absence of event-level descriptions do not establish comparative safety or rule out events that were not recorded. The posted adverse-event information is not a substitute for a fuller safety analysis.

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

The posted results describe outcome counts and unadjusted comparisons at 6 months in a completed pilot randomized trial. They can show how many participants in each listed arm met the binary primary-outcome definition and provide preliminary estimates of differences. The confidence intervals convey uncertainty around those estimates, while the sample-size illustrations show how planning requirements change under specified effect assumptions.

They do not establish that SSCF+ caused a change in physical intimate partner violence, nor do they establish that it did not. The women’s primary comparison has an interval that includes zero. The men’s posted comparison has an interval that excludes zero, but it uses a reference count different from the separately listed men’s control arm count, and the registry record does not explain why. This prevents an unqualified interpretation of that estimate as a direct comparison with the men’s control group.

The findings also do not establish the intervention's effect on outcomes that are not numerically reported, or whether it was feasible and acceptable. The registry record names these aims but does not report numeric results for them. Secondary symptom summaries are exploratory in the absence of reported multiplicity procedures, analysis populations and missing-data methods. A statistical difference, when present, is not by itself evidence that the difference is meaningful to participants; scale thresholds for meaningful change are not reported.

Interpretation is further bounded by the pilot setting, the sex-specific outcome definitions, and the lack of detail on the original statistical plan. The posted counts and estimates are informative as preliminary trial results, but they cannot answer every question about implementation, safety, generalizability or clinical importance. No treatment recommendation follows from these data alone.

17. Why This Trial Matters Statistically

This pilot is statistically informative because it reports participant counts and preliminary effect estimates for an intervention addressing contextual factors associated with intimate partner violence. Its stated aims include feasibility, acceptability and potential effect size, which are distinct from testing a definitive efficacy claim. A pilot can help describe outcome distributions and the uncertainty that should inform later study planning, while still leaving major questions unresolved.

The results illustrate why estimates need to be read with their confidence intervals and the structure of the comparison. A point estimate alone can appear more definitive than the data warrant. The women’s interval spans zero; the men’s comparison interval does not, but its reference count does not match the separately listed men’s control arm count. Clear reporting of the analysis population, reference groups and statistical plan is important for interpreting stratified results.

The sample-size illustrations also demonstrate a general planning principle: targeting smaller effects requires larger studies under otherwise stated assumptions. They are based on observed pilot effects and should not be mistaken for the original trial's design calculation. The registry record does not report that original justification.

Finally, the combination of multiple outcome domains and unadjusted results highlights the value of prespecifying primary and secondary analyses and explaining how multiplicity and missing data will be handled. Those details are not reported in the registry record. Addressing such reporting gaps would make future evidence easier to evaluate without overstating what preliminary findings can establish.

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.

The trial is described as a pilot, and the registry record does not report its original sample-size justification or the assumptions used to design the study. The posted planning illustrations are based on observed effects, rather than the trial's own design. Consequently, they should not be used to infer whether the completed trial was designed to provide a particular level of precision.

The primary outcome combines any positive response across five items into a binary classification. This loses information about how many items were positive and how often an event occurred. The endpoint also defines experience for women and perpetration for men, so the strata represent different roles. The record does not report details about instrument administration, item-level outcomes or missing responses.

A specific reporting limitation affects the men’s primary comparison. The posted comparison reference values are 41 of 89, while the separately listed Men: Control arm count is 32 of 76. The registry record does not explain why the comparison uses the other reference values. This makes the men’s comparison difficult to interpret as a direct intervention-versus-men’s-control estimate.

The registry record does not report analysis populations, missing-data procedures, adjusted analyses, a multiplicity plan or the original statistical analysis plan. It lists zero reported analyses, although outcome summaries and unadjusted calculations are posted. Numeric results for feasibility and acceptability, and several named secondary outcomes, are not reported in the registry record.

Finally, the setting is described as urban informal settlements in Durban and rural communities in KwaZulu-Natal, and the participants are young people aged 18-25 years. The extent to which results apply beyond those settings and age range is not reported in the registry record. The posted findings should be understood within the study's population and the limits of its reporting.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Stepping Stones and Creating Futures Plus Pilot — NCT05783336.
• Registry record last updated 2026-07-13; status last verified 2026-07.
• Results first posted 2026-07-13.
• 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.

22. Record Summary

NCT05783336 is a completed, randomized, parallel-group pilot of Stepping Stones and Creating Futures Plus (SSCF+) versus a no-intervention wait-list control. It enrolled 325 young people aged 18-25 years in urban informal settlements in Durban and rural communities in KwaZulu-Natal, South Africa. The registry record lists a 1:1 allocation and no masking.

The primary endpoint is a binary measure of physical intimate partner violence at 6 months, defined as experience among women and perpetration among men. The posted arm counts and unadjusted risk-difference estimates provide preliminary outcome summaries. Interpretation is limited by uncertainty around estimates and an unexplained difference between the men’s comparison reference values and the separately listed men’s control count.

The registry record lists 13 outcome measures, 10 posted secondary outcomes and zero reported analyses. Numeric results for feasibility, acceptability and several named outcomes are not reported in the registry record. Original design assumptions, missing-data methods, analysis populations and multiplicity procedures are also not reported in the registry record.