It's WeWomen Plus Intervention for Health, Safety and Empowerment: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for It's WeWomen Plus Intervention for Health, Safety and Empowerment (NCT04098276), a randomized na study. The primary outcome is Change in Severity of Physical and Sexual Intimate Partner Violence as Assessed by the Revised Conflict Tactics Scale.

2. Clinical Question

The trial therefore addresses whether an adaptive, technology-based approach to safety planning and follow-up is associated with changes in reported intimate partner violence scores over time. Its primary measure is a continuous score, not a count of participants who did or did not experience violence. The score is intended to represent the frequency and severity of several types of abusive acts in intimate partner relationships.

The primary question has multiple follow-up times, and the intervention itself has sequential stages. These features matter for interpretation: an overall conclusion would depend on the outcome definition, the time point or time points being compared, and how participants were assigned or analyzed across stages. The registry record identifies the measure and the scheduled assessments, but does not report a single primary contrast, effect estimate, confidence interval or p-value. Consequently, the record establishes what the study set out to assess, but not the direction, size or precision of an outcome result.

3. Trial Design

The registry record describes a randomized, single-masked, sequential study of WeWomen Plus. The study status is completed, and enrollment is reported as 1265. The start date is 2021-01-11 and the primary completion date is 2024-07-29. The listed phase is NA. Johns Hopkins University is named as sponsor. These registration details describe the study framework; they do not by themselves show what outcomes the trial observed.

The intervention is classified as behavioral and technology-based. At the first stage, the personalized online intervention group received online safety planning informed by a culturally specific danger assessment. The record contrasts this with online usual care or standard online safety information, described as usual safety-planning resources modeled on national and state domestic violence online resources. The registry description says those resources did not provide immediate visual feedback about a participant's danger level or tailored safety planning.

The sequential design also lists two second-stage intervention options: WeWomen Plus text messaging only, and WeWomen Plus text messaging and phone. The record describes these options as follow-up for a nonresponder group, with nonresponse characterized as not improving in the intervention or control arms above. Text messaging was intended to follow up on enactment of a tailored safety plan. The phone-call description refers to motivational interviewing adapted for abused women, solution-focused therapy and a strengths perspective. The available descriptions do not specify all operational details of the sequence, assignment probabilities, or the definition and timing of every decision point.

Randomization indicates that assignment involved a chance-based process, but the record does not report enough information to reconstruct the randomization procedure. “Single” is the recorded masking designation; the identity of the masked party and the procedures used to maintain masking are not reported in the registry record. The record does not report the statistical analysis plan, the model used for repeated assessments, or the specific comparisons intended to support the primary conclusion. The design labels alone do not establish that any particular analysis was conducted.

The registry lists five outcome measures and names four secondary outcomes: depressive symptoms on the PHQ-9, post-traumatic stress symptoms on the Harvard Trauma Questionnaire, overall empowerment on the Personal Progress Scale-Revised, and safety-related empowerment on the MOVERS scale. The primary outcome is change on the adapted Revised Conflict Tactics Scale. The registry record does not report outcome estimates for these measures.

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.

First Stage Randomization

Second Stage Re-Randomization

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 Change in Severity of Physical and Sexual Intimate Partner Violence as Assessed by the Revised Conflict Tactics Scale, measured over Baseline (1st month), 3 months, 6 months, 12 months.

The primary endpoint is change in severity of physical and sexual intimate partner violence, assessed with an adapted version of the Revised Conflict Tactics Scale (CTS2). The description says the instrument covers physical aggression, injury, psychological aggression and sexual coercion. Responses range from 0=never to 4=very frequently; total scores range from 0-164, with higher scores indicating greater frequency and severity of intimate partner violence experiences.

Items were scored using a severity-times-frequency weighted method described in the registry record. Change scores were calculated by comparing baseline CTS-2 total scores with follow-up scores at 3, 6 and 12 months. The record identifies baseline as the 1st month. This approach represents change on a continuous measure, rather than classifying participants into a simple event/no-event outcome. Such a measure can capture variation in reported severity and frequency across the behaviors covered by the instrument.

Using a standardized instrument can make outcome measurement more systematic and support comparisons across assessment times. The inclusion of several domains means the total score reflects more than a single type of abusive act. At the same time, interpretation depends on how the adapted instrument was administered and how change was analyzed. Details such as the handling of incomplete items, the exact aggregation rules beyond the stated weighting, and whether the analysis adjusted for baseline scores are not reported in the registry record.

The endpoint description specifies what was measured, but not the direction or magnitude of change observed. The registry record does not report group means, change estimates, uncertainty intervals or a test of the intervention comparison. Therefore, the measure's scale and scoring should not be mistaken for evidence of a treatment effect.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does the primary score represent?

The primary outcome is a continuous measure. In general, a continuous score can take a range of values rather than sorting each participant into only two categories. Here, the adapted CTS2 total is described as a weighted score for frequency and severity of abusive or violent acts. Its range is 0-164, and higher scores indicate greater frequency and severity. A change score compares a participant's score at follow-up with the baseline score. Interpreting the direction of a change requires knowing the subtraction convention and the reported values; the registry record describes change as the difference between baseline and follow-up scores but does not report the results.

The registry identifies the mean as the parameter and the standard deviation as the dispersion measure. In general, a mean describes the average score, while a standard deviation describes how dispersed individual scores are around that average. These answer different questions: the mean characterizes a group's center, and the standard deviation characterizes within-group variability. A mean difference between groups, if reported, would describe a contrast in average outcomes, but its precision would also matter. No such group-specific means or contrasts are reported in the registry record.

Why do repeated assessments matter?

Baseline, 3-month, 6-month and 12-month assessments allow researchers to examine outcomes over time. In general, measurements from the same participant are related, so they are not interchangeable with measurements from unrelated people. An analysis of repeated measurements should account for that within-person relationship or define a specific time point for comparison. The registry record does not report the model, covariance assumptions, or whether time points were analyzed separately or together. Those choices affect how an estimate should be interpreted and how its uncertainty is calculated.

There is also a distinction between comparing follow-up scores and comparing changes from baseline. An analysis can adjust for baseline scores, analyze change scores, or use another approach. These methods are not automatically equivalent in every dataset. The record states that change scores were calculated, but it does not report the inferential model or whether the primary comparison used those scores in a particular way.

What does randomization contribute?

In general, random assignment is intended to make comparison groups similar, on average, in factors measured and unmeasured before assignment. This supports causal interpretation when assignment is implemented as intended and the analysis preserves the randomized comparison. It does not guarantee that groups will be identical, ensure complete follow-up, or remove bias caused by missing data or departures from the assigned strategy.

This study is recorded as randomized and sequential. The registry description identifies a first-stage comparison and later intervention options for a nonresponder group. In a sequential study, questions may concern the initial assignment, a later assignment among eligible participants, or a whole adaptive strategy. The appropriate analysis depends on the question and assignment process. The record does not report assignment probabilities, decision rules in sufficient detail to reconstruct the process, or the analysis population for each comparison.

How should uncertainty be read?

General statistical explanation: a confidence interval describes uncertainty around an estimate under the assumptions of the statistical method. It is not a guarantee that the true effect lies in the interval, and it does not establish clinical importance. A precise estimate has a relatively narrow interval; a less precise estimate has a wider interval. The registry record does not report confidence intervals for the primary outcome, so its precision cannot be assessed from the posted information.

A p-value is a measure of how compatible the observed data are with a specified null hypothesis under a statistical model. It is not the probability that the null hypothesis is true, and it does not measure the size of an effect. A p-value also cannot resolve whether the chosen outcome, time point, model or comparison was appropriate. No primary-outcome p-value is reported in the registry record.

What are the planning illustrations?

The registry's sample-size assumptions describe planning illustrations computed from an observed effect, using a two-sided significance level of 0.05, equal allocation between two arms and a normal approximation. They describe the effect to detect as a stated fraction of the observed effect. For non-time-to-event outcomes, the stated unit is participants per arm for 80% power; time-to-event illustrations use total events. These are planning calculations, not observed power and not evidence that the trial had a particular probability of detecting an effect.

General statistical explanation: a planning calculation depends on assumptions about the target effect, variability, allocation and analysis. If an assumed target effect changes, the required sample size can change as well. A planning illustration based on an observed estimate can be especially sensitive to uncertainty in that estimate. The registry record does not provide the underlying primary-outcome estimate or the numerical planning results in the information, so no specific sample-size implication can be drawn.

Why can over-dispersion matter?

General statistical explanation: over-dispersion occurs when data vary more than a model's assumptions allow. If it is ignored, standard errors can be too small and confidence intervals can be too narrow. This concept is most relevant to models for count-like outcomes; the registered primary endpoint is described as a continuous score summarized by a mean and standard deviation. The record does not report a model or a finding of over-dispersion, so it should not be assumed to have affected this analysis.

Overall, the record makes the measurement scale and broad design legible but leaves the inferential methods largely unspecified. The statistical analysis plan, model details, covariate adjustment, handling of repeated measurements, treatment of missing outcome data and definition of the main comparison are not reported in the registry record. Without those details and the outcome estimates, readers cannot evaluate the precision or robustness of a primary effect estimate.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists five outcome measures, including the primary CTS2 outcome and four named secondary outcomes. The primary outcome is assessed at baseline and at 3, 6 and 12 months. Examining several outcomes and time points raises a multiplicity question: when many comparisons are made, some may appear notable by chance even if there is no underlying effect. In general, prespecifying a main comparison or using an appropriate adjustment can help clarify how confirmatory findings should be interpreted. The registry record does not report a multiplicity strategy, a hierarchy of outcomes, or which time point was intended to carry the main inferential claim.

The registry reports zero analyses. It does not provide results for the primary or secondary outcomes, nor does it report whether results were withheld, not entered, or analyzed elsewhere. The reason for the absence of analyses is not reported in the registry record. The lack of posted analyses means readers cannot assess effect estimates, confidence intervals, p-values or consistency across outcomes.

Missing-data methods are also not reported in the registry record. The record does not state the amount or pattern of missing outcome data at each assessment, whether participants discontinued or were lost to follow-up, how incomplete questionnaires were handled, or whether any imputation or sensitivity analysis was used. These details matter because conclusions can depend on who contributes measurements and on assumptions about why some measurements are unavailable.

Analysis populations are not reported in the registry record. It does not state whether analyses followed original randomized assignment, included only participants who received an intervention, or used another definition. The sequential design makes this particularly important because a second-stage assignment is described for nonresponders. The record does not specify the population or estimand for each stage or how participants were grouped in any analysis. These omissions limit the ability to judge the comparability of analyzed groups and the scope of any result.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry lists serious adverse events and other adverse events by group. For Personalized Online Intervention, the record lists 0 serious adverse events and 0 other adverse events, with 660 at risk in each category. For Online Usual Care or Standard Online Safety Information, it lists 0 serious adverse events and 0 other adverse events, with 605 at risk in each category. For WeWomen Plus Text Messaging Only, it lists 0 in both event categories, with 183 at risk in each. For WeWomen Plus Text Messaging and Phone, it also lists 0 in both event categories, with 183 at risk in each. Deaths are listed as 0 for all four groups.

These figures describe what is entered in the registry adverse-event record. They should be read as reported counts, not as proof that no adverse experiences of any kind occurred. The record does not report the event-collection period, definitions used for event categories, methods of ascertainment, or whether the listed at-risk denominators refer to a common observation window. The group figures are not interchangeable with the study's enrollment figure, and should not be combined or interpreted as a single exposure total.

The serious-event term list is empty. This means no serious-event terms are listed in that part of the registry record; it does not provide further detail about surveillance or adjudication. The entries are limited to the event categories and counts recorded, and do not establish comparative safety or quantify the possibility of unrecorded or unreported events.

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

The registry record establishes that the study was designed to evaluate a technology-based adaptive intervention for immigrant women with intimate partner violence experiences. It identifies a randomized, single-masked, sequential design and describes online safety planning, standard online safety information, and later text-only or text-plus-phone options. It also defines a continuous primary measure and lists secondary mental-health and empowerment outcomes.

Those details define the study question, but they do not answer it. No primary outcome results are reported in the registry record: there are no group-level scores, changes, effect estimates, uncertainty intervals or inferential tests. The record also does not report results for the named secondary outcomes. It is therefore not possible to characterize an observed effect, its direction, magnitude or precision, or whether any result was consistent across assessment times and measures.

The absence of outcome findings should not be turned into a claim that the intervention did or did not change participants' scores. Nor does a completed study status establish that the planned comparisons were reported or that the intervention was effective. The posted adverse-event counts are also limited to the entries shown and do not support a broader conclusion about safety beyond those recorded categories and counts.

Statistical evidence is strongest when a clearly defined comparison is accompanied by an effect estimate and uncertainty interval, with a transparent account of the analysis population, missing data and multiplicity. These elements are not reported in the registry record. The trial's design and outcome definitions can inform what future results would need to address, but without results the record does not support a quantitative conclusion about the intervention's effects.

The practical meaning of a score difference would also depend on how large it is and how the scale behaves in this population. A statistically detectable difference is not automatically important to participants, and a non-significant result would not by itself establish equivalence or absence of an effect. No such determination can be made from the posted information because the primary effect estimate and its precision are not reported.

13. Why This Trial Matters Statistically

This trial is statistically notable for combining random assignment with a sequential intervention structure. The first-stage comparison concerns personalized online safety planning informed by a culturally specific danger assessment versus standard online safety information. Later options involve text messaging alone or text messaging with phone calls for a group described as nonresponders. A study organized in stages can address questions about how intervention components are deployed over time, but the interpretation depends on explicit definitions of eligibility, response, assignment and the target comparison.

The primary endpoint is also measured repeatedly. Baseline and follow-up assessments at 3, 6 and 12 months could support questions about whether outcomes differ at particular times or how they evolve over time. Those questions require careful specification because repeated observations from a participant are related, and multiple time points can create multiplicity concerns. The registry record identifies the measurement schedule but does not report the model or inferential strategy.

The outcome itself is a weighted continuous score spanning several domains of violence-related experience. This provides a way to represent variation in reported frequency and severity, rather than relying only on a binary outcome. However, interpretation depends on the score's construction and the analysis of change. The registry record describes the scale and scoring approach, but not the results or the detailed statistical treatment.

The study record therefore illustrates the importance of separating design information from evidence about outcomes. Enrollment, completion status, randomization and a defined endpoint do not establish what the intervention achieved. With no analyses reported, the key statistical questions—effect size, precision, consistency across times and sensitivity to missing data or analysis choices—remain unanswered in the registry record. Those gaps are especially relevant for an adaptive design, where a clear account of each stage and the estimand is needed for readers to understand what a comparison represents.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The central limitation for interpreting this trial record is that it does not report analyses. The primary outcome is described in detail, but no group-specific values, estimated changes, treatment contrasts, confidence intervals or p-values are present. The record therefore cannot support a quantitative account of the primary finding. The secondary outcomes are named but their estimates and uncertainty are also not reported.

The registry description does not identify the exact primary contrast or the principal time point for inference. It lists follow-up assessments at 3, 6 and 12 months, but does not state whether each was a separate primary comparison, whether the outcome was combined across time, or how repeated measurements were modeled. The record also does not report covariate adjustment, the analysis population, or whether analysis followed randomized assignment.

Because the trial is sequential, important details for interpreting treatment strategies are absent. The record does not fully specify the decision rules, operational definition of nonresponse, assignment process at each stage, or which participants were eligible for each comparison. The descriptions identify intervention components, but do not establish how the statistical analyses distinguished first-stage effects from effects of later options or from the effect of an adaptive sequence.

Missing-data procedures and participant flow are not reported in the registry record. The number with outcome data at each assessment, reasons for missingness, questionnaire completion rules and any sensitivity analyses are not available. Multiplicity procedures for the several outcomes and time points are also not reported. These omissions prevent assessment of how robust a result might be to incomplete follow-up or multiple testing.

Finally, the record's listed enrollment and adverse-event entries do not fill these gaps. Enrollment does not reveal how many participants contributed to each outcome analysis, and the adverse-event counts do not specify ascertainment duration or methods. The available information is thus useful for understanding the intended design and measurement, but limited for judging efficacy, precision, missing-data bias or the completeness of safety reporting.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: It's WeWomen Plus Intervention for Health, Safety and Empowerment — NCT04098276.
• Registry record last updated 2025-06-26; status last verified 2025-06.
• Results first posted 2025-06-26.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

The registry record describes NCT04098276, “It's WeWomen Plus Intervention for Health, Safety and Empowerment,” sponsored by Johns Hopkins University. It is recorded as a completed, randomized, single-masked, sequential behavioral study, with enrollment of 1265. The start date is 2021-01-11 and the primary completion date is 2024-07-29.

The intervention involves technology-based online resources, text messaging and phone calls. The primary outcome is change in an adapted Revised Conflict Tactics Scale score, assessed from baseline to 3, 6 and 12 months. Four secondary outcomes concern depressive symptoms, post-traumatic stress symptoms, overall empowerment and safety-related empowerment.

The registry record does not report analyses or outcome estimates. It therefore does not establish the size, direction or precision of any intervention effect. Listed adverse-event counts are zero in the recorded categories for each group, with deaths listed as zero; the record does not report additional details about event ascertainment or follow-up.