This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Reproductive Life Planning for Women With Mental Illness (NCT03969589), a randomized na study. The primary outcome is Reproductive Life Goal Behavioral Intentions.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03969589 |
| Phase | NA |
| Condition | Psychotic Disorders, Mood Disorders, Stress Disorders, Post-Traumatic |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 40 |
| Arms in the primary outcome | n/a |
| Lead sponsor | VA Office of Research and Development |
| Results posted | Yes |
2. Clinical Question
Population
Women Veterans with mental illness were the population of interest. The listed conditions are psychotic disorders, mood disorders, and stress disorders, post-traumatic. Detailed eligibility criteria, such as age limits or requirements concerning reproductive status, are not reported in the registry record.
Intervention
The intervention was Reproductive Life Planning-Mental Health (RLP-MH). Its described components include an in-person interactive session with a facilitator to explore pregnancy intentions and reproductive life goals, and to consider factors that may affect those goals, including mental health. Further session details are not reported in the registry record.
Comparator
The comparison condition was written materials on reproductive life planning. The registry says participants received materials on reproductive life planning, contraception, and VA resources, with study staff briefly discussing the content. It does not describe this as no care or no information.
Primary question
The study aimed to assess whether RLP-MH was feasible and acceptable to women Veterans and whether it increased engagement in behaviors addressing reproductive life goals. The listed primary measure is self-reported intention to engage in those behaviors, measured from baseline to 2-month post-intervention (~2 months). The registry record does not report arm-level scores or a single comparison for that endpoint, so the posted information does not quantify a difference between conditions.
3. Trial Design
NCT03969589, titled “Reproductive Life Planning for Women With Mental Illness,” is listed as a randomized, single-masked, parallel-group study. The registry lists enrollment of 40 and identifies the study status as completed. The sponsor is the VA Office of Research and Development. The study start date is 2019-07-01, and the primary completion date is 2021-01-31. Phase is listed as NA.
Participants were assigned to the RLP-MH intervention or written reproductive life planning materials. The first condition involved an in-person interactive session with a facilitator, focused on pregnancy intentions, reproductive life goals, and relevant factors including mental health. The comparator involved written information about reproductive life planning, contraception, and VA resources, with a brief discussion by study staff. Further details of intervention delivery, including the number or duration of sessions, are not reported in the registry record.
“Single-masked” is the registry’s masking description; which people were masked and how masking was maintained are not reported in the registry record. The method used to generate the random allocation sequence, conceal assignments, and handle departures from assigned conditions is also not reported in the registry record. Those details matter when assessing how assignment might have influenced recruitment, behavior, or outcome measurement.
The registry describes a continuous primary measure collected at baseline and at 2-month post-intervention (~2 months). Three participants in the RLP-MH condition and three in the written materials condition did not complete the post-treatment assessment. The registry notes that the number analyzed in outcome rows differs from overall enrollment for this reason. Arm-specific analyzed counts and a full description of analysis populations are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Reproductive Life Planning-Mental Health Intervention | Written Materials on Reproductive Life Planning |
|---|---|---|
| STARTED | 20 | 20 |
| COMPLETED | 17 | 17 |
| NOT COMPLETED | 3 | 3 |
Reasons for not completing this period:
| Reason | Reproductive Life Planning-Mental Health Intervention | Written Materials on Reproductive Life Planning |
|---|---|---|
| Lost to Follow-up | 3 | 2 |
| Declined Follow-Up | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: Number analyzed in the rows differ from overall because 3 participants in RLP-MH and 3 in the written materials condition did not complete the 2 month post-treatment assessment
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.
| Characteristic | Unit | Reproductive Life Planning-Mental Health Intervention | Written Materials on Reproductive Life Planning | Total |
|---|---|---|---|---|
| Participants analysed | 20 | 20 | 40 | |
| Age, Continuous | years | 35.9 (SD 3.9) | 34.1 (SD 4.7) | 35.0 (SD 4.3) |
| Sex: Female, Male: Female | Participants | 20 | 20 | 40 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 9 | 10 | 19 |
| Race (NIH/OMB): White | Participants | 8 | 6 | 14 |
| Race (NIH/OMB): More than one race | Participants | 3 | 4 | 7 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | Participants | 20 | 20 | 40 |
6. Primary Endpoint
The registry lists the primary outcome as Reproductive Life Goal Behavioral Intentions, measured over Baseline to 2-Month Post-Intervention (~2 months).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | score on scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is Reproductive Life Goal Behavioral Intentions, measured as a score on a scale. It captures participants’ self-reported intentions to engage in behavior addressing their own reproductive life goals. The registry says a total score was calculated by summing item responses and reports the average total score across participants. The stated scale range is 1 to 5, with higher scores indicating greater intentions to engage in goal-related behaviors.
This measure is relevant to the study’s stated aim of examining engagement in behaviors addressing reproductive life goals. An intention score, however, is a measure of reported intention; it is not itself a count of completed behaviors or a direct measure of pregnancy outcomes. The registry does not report the scale’s item wording, scoring details beyond the total-score description, validation information, or how incomplete item responses were handled.
The stated timeframe is baseline to 2-month post-intervention (~2 months). Although the registry identifies this endpoint and its interpretation, arm-specific means, standard deviations, changes over time, and a defined between-condition estimate are not reported in the registry record. The endpoint description therefore explains what was intended to be measured, but does not provide a numerical result with which to judge the size or precision of any difference.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes a randomized comparison of RLP-MH with written reproductive life planning materials and identifies reproductive life goal behavioral intentions as the primary measure. It also states the direction of the scale: higher scores correspond to greater self-reported intentions to engage in behaviors addressing reproductive life goals. These details clarify the outcome’s meaning, but they are not outcome estimates.
Arm-level endpoint means and standard deviations are not reported in the registry record. A change from baseline, a difference between conditions, a confidence interval, and a p-value are also not reported in the registry record. Consequently, the posted record does not quantify whether the scores changed, how the conditions compared, or how precisely a comparison was estimated. A direction or magnitude of effect should not be inferred from the study’s aim, intervention description, or completion status.
The registry notes that the primary outcome has several categories or time points and is not reduced to one comparison. This limits the extent to which a single summary estimate can be interpreted from the posted results. In particular, the record does not establish whether a reported score would represent a follow-up value, a change from baseline, or another contrast. These are different statistical quantities and answer different questions.
Three participants in each condition did not complete the 2-month post-treatment assessment, and the registry notes that analyzed numbers in outcome rows differ from overall numbers for this reason. This identifies some missing follow-up data, but does not explain whether missingness was related to participants’ scores or condition, nor how it was handled analytically. The resulting potential for bias cannot be assessed from the registry record alone.
The record lists no serious adverse events, other adverse events, or deaths in either condition during the reported risk accounting. Those figures describe what was recorded; they do not by themselves establish that an intervention has no risk. The registry’s endpoint and safety descriptions should therefore be read separately: the endpoint concerns stated intentions, while the adverse-event counts concern recorded events. Neither yields a complete account of feasibility or acceptability, and the registry’s aims are not equivalent to reported findings on those aims.
9. Statistical Methods Explained
What does the scale mean?
General: A continuous outcome is a measure that can take values along a numerical scale, rather than only naming a category. Reporting an average gives a central summary across participants, while a standard deviation describes how spread out individual scores are around that average. The registry identifies the primary measure as a mean with standard deviation and gives the scale range as 1 to 5. It does not report the observed averages or standard deviations by condition, so the spread and typical score in either condition cannot be assessed from the registry record.
The scale is a sum of item responses, as described in the registry. A higher total is defined as indicating greater intention to engage in behaviors addressing reproductive life goals. That direction supports interpretation of any reported score, but does not by itself identify an effect of the intervention. A score at follow-up, a change in score, and a difference in change between conditions are not interchangeable. The registry does not report which single contrast should stand for the primary comparison.
What would a comparison estimate?
General: In a randomized parallel-group study, an arm-level comparison can describe how outcomes differ between participants assigned to the conditions. A clearly defined estimand states which outcome, time point, population, and treatment contrast the estimate concerns. For a repeated measure, one might compare follow-up scores, changes from baseline, or differences in changes. Each approach answers a different question and can use baseline information differently. The registry record does not give a single summarized primary comparison for this endpoint, so the intended estimand and its numerical estimate are not reported in the registry record.
General: A confidence interval expresses the range of values compatible with an estimate under the statistical model and its assumptions. It conveys precision as well as direction and size; a point estimate alone would not show that uncertainty. No confidence interval or arm-level effect estimate is reported in the registry record. A p-value, if reported, would address compatibility with a specified null hypothesis under a model, not the importance or practical meaning of a difference. No p-value for this endpoint is reported in the registry record.
What does randomization contribute?
General: Random allocation is intended to reduce systematic differences between conditions at assignment, on average. It does not guarantee that groups will be alike in every characteristic, especially in a study with limited enrollment. It also cannot correct biased outcome measurement, differential missingness, or departures from the assigned intervention by itself. The record identifies randomized allocation, but details of sequence generation, concealment, adherence, and any analysis adjustment are not reported in the registry record. Thus, the label alone is not enough to evaluate how randomization was implemented or reflected in the analysis.
The registry describes masking as single-masked but does not identify who was masked. General: Masking can reduce the influence of expectations on participant reporting, staff behavior, or outcome assessment, depending on who is masked and how. In a behavioral intervention with an interactive session, whether participants and facilitators could be unaware of the condition may be especially relevant, but the record does not specify the masking arrangements. No conclusion about the success of masking can be drawn from the designation alone.
How should missing follow-up be considered?
General: Missing outcome data reduce the information available for estimating a treatment contrast. The consequences depend not only on how much data are missing but also on why they are missing and how analysis accounts for them. Complete-case analysis, imputation, and model-based approaches rely on different assumptions. No particular missing-data method is reported in the registry record. The registry does identify three participants in RLP-MH and three in the written materials condition who did not complete the 2-month post-treatment assessment. It does not state whether those participants had baseline values, whether other outcome items were missing, or whether sensitivity analyses were conducted.
What can the planning illustration tell readers?
The registry’s planning assumptions describe an illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation between conditions, and a normal approximation. The illustration is defined in terms of detecting a stated fraction of the observed effect; participant requirements are expressed per arm for non-time-to-event outcomes. However, no calculated participant requirements or observed endpoint effect are reported in the registry record. These illustrations are planning scenarios, not observed power and not evidence that the study achieved a particular precision. They also cannot substitute for a confidence interval around an observed comparison.
General: Statistical interpretation depends on seeing the estimate, its uncertainty, the analysis population, and the assumptions used. For this record, the design and outcome definition are available, but the primary numerical comparison and details of its analysis are not reported in the registry record. The appropriate conclusion is therefore limited to describing the planned measurement and the information that remains unavailable, rather than inferring a treatment effect.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists three outcome measures and notes that the primary outcome has several categories or time points, so it is not reduced to one comparison. The record does not explain how the multiple categories or time points were organized for analysis, which comparison was designated as primary, or whether any adjustment for multiple testing was planned. A multiplicity procedure and any adjusted results are not reported in the registry record.
General: When several outcomes, time points, or contrasts are examined, the chance of obtaining a nominally unusual result can increase if each is assessed separately. A prespecified primary contrast, a hierarchy of outcomes, or an adjustment can help make interpretation more disciplined. These are general statistical considerations, not claims about what investigators did. The registry record does not provide enough analysis detail to determine how multiplicity was handled.
For missing data, the registry specifically reports that three participants in the RLP-MH condition and three in the written materials condition did not complete the 2-month post-treatment assessment. It also notes that numbers analyzed in outcome rows differ from overall numbers for this reason. The method used to handle those missing endpoint observations, any assumptions about their absence, and any sensitivity analysis are not reported in the registry record.
The registry does not report arm-level outcome denominators or a full definition of the analysis population. It is therefore not possible to determine from the record whether the primary analysis included all randomized participants, only participants with observed follow-up data, or another population. No imputation approach, covariate adjustment, or analysis plan is reported in the registry record. These omissions limit assessment of how missingness and multiple comparisons may affect the interpretation of results.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Reproductive Life Planning-Mental Health Intervention | 0 | 20 | 0.0% |
| Written Materials on Reproductive Life Planning | 0 | 20 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Reproductive Life Planning-Mental Health Intervention | 0 of 20 |
| Written Materials on Reproductive Life Planning | 0 of 20 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Reproductive Life Planning-Mental Health Intervention | 0 of 20 |
| Written Materials on Reproductive Life Planning | 0 of 20 |
The registry reports zero serious adverse events and zero other adverse events in the RLP-MH condition, with 20 participants at risk for each category. It reports the same figures for the written materials condition. Deaths are recorded as zero in each condition. These are the registry’s posted safety counts; they do not provide a detailed description of surveillance procedures, event definitions, or the period during which events were collected, which are not reported in the registry record.
General: A zero count means that no events of that category were recorded in the stated risk accounting. It does not prove that an event is impossible or that the risk is exactly zero. Rare events may not occur in a study even when a risk exists, and interpretation depends on how events were solicited and followed. The registry does not list serious-event terms, and it does not provide a broader narrative explaining the absence of event reports.
The counts should be interpreted as safety reporting, not as evidence about the primary intention score or about feasibility and acceptability. They also do not establish comparative safety beyond the limited reported event categories and accounting. No medical advice or conclusion about treatment safety follows from these counts alone.
12. What the Result Does, and Does Not, Mean
The study record documents a randomized comparison of an interactive, mental health-informed reproductive life planning intervention with written reproductive life planning materials. It identifies self-reported reproductive life goal behavioral intentions as the primary measure and gives the scale’s direction and range. It also records the follow-up period and reports that some participants did not complete the post-treatment assessment.
What the registry does not provide is a numerical result for the primary endpoint by condition, a baseline-to-follow-up change, or a defined between-condition estimate with uncertainty. Accordingly, it does not allow readers to determine the size or precision of any difference in intentions. Completion of the study does not itself establish that an intervention was feasible, acceptable, or associated with changed intentions. Those are study aims; corresponding findings are not reported in the registry record.
The endpoint concerns stated intentions to act on reproductive life goals. General: Intention and behavior are related but distinct concepts. A self-reported intention score should not be interpreted as proof that a participant performed a behavior, achieved a reproductive goal, or experienced a particular health outcome. The registry’s description does not report those outcomes as the primary endpoint.
The record also lists no adverse events or deaths in the reported categories, but these counts do not establish absence of risk. Important details about event monitoring and the analysis are not reported in the registry record. The most defensible reading is therefore descriptive: the registry records the study design, intervention conditions, scale definition, follow-up timing, missing post-treatment assessments, and safety counts, while leaving the primary comparative result and its precision unreported.
13. Why This Trial Matters Statistically
This trial addresses a statistical question that is broader than whether an intervention can be assigned at random: how to define and interpret a patient-reported outcome that reflects reproductive life goals in the context of mental illness. The registry describes an individualized, interactive intervention and a written-material comparator, while the primary measure concerns reported intentions. Keeping the intervention’s aim distinct from the measured endpoint is important when evaluating what an eventual estimate would mean.
The repeated measurement at baseline and 2-month post-intervention (~2 months) also highlights a common analysis issue. A follow-up score and a change from baseline are different summaries, and the choice of comparison affects interpretation. Because the registry notes multiple categories or time points without reducing the primary outcome to one comparison, a reader cannot identify a single numerical result that captures the intended contrast. The absent arm-level estimates and uncertainty further limit interpretation.
Missing follow-up is another statistically relevant feature. The registry identifies noncompletion in both conditions and states that analyzed counts differ from overall numbers. Understanding the impact requires information about the missing-data method and assumptions, which are not reported in the registry record. This matters because results based only on observed follow-up can be sensitive to why observations are absent.
Finally, the posted safety counts illustrate the distinction between recording no events and demonstrating that no risk exists. More generally, this record is useful for examining how trial design, outcome definition, repeated measurement, missing data, and reporting completeness shape the conclusions a reader can draw. Its statistical value lies in making those limits explicit, not in supporting a quantified treatment-effect claim that the record does not report.
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 main limitation for interpreting efficacy is that the registry record does not report the primary outcome’s arm-level means or standard deviations, a change estimate, a between-condition contrast, or its uncertainty. The outcome is described, but no numerical primary result is available in the record. The note that the primary outcome has several categories or time points and is not reduced to one comparison further prevents a single estimate from being identified.
Outcome reporting is also incomplete for a reader seeking to reproduce or evaluate the analysis. The scale is described as a sum of item responses and a mean total score, but item wording, missing-item rules, and psychometric details are not reported in the registry record. The analysis population, model, covariates, and missing-data approach are not reported either. Noncompletion of the 2-month assessment is documented in both conditions, but reasons for noncompletion are not reported in the registry record.
Methodological details of randomization and masking are limited. The registry identifies randomized allocation and single masking, but sequence generation, allocation concealment, the masked parties, and implementation details are not reported in the registry record. The duration and full content of the interactive intervention are also not available in the description.
General: Limited enrollment can constrain precision, but the registry record does not provide a confidence interval or other estimate of precision for the primary endpoint. It would be inappropriate to infer precision from enrollment alone. The safety record is similarly limited to event counts without reported monitoring details or an event narrative. These limitations apply to interpretation of the registry record and do not establish that unreported procedures or analyses were not conducted.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Reproductive Life Planning for Women With Mental Illness — NCT03969589.
- Registry record last updated 2022-04-22; status last verified 2022-04.
- Results first posted 2022-04-22.
- 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.
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18. Record Summary
NCT03969589 is a completed randomized, single-masked, parallel-group study sponsored by the VA Office of Research and Development. The registry lists enrollment of 40, a start date of 2019-07-01, and a primary completion date of 2021-01-31. It compares RLP-MH, an in-person interactive reproductive life planning intervention, with written reproductive life planning materials.
The primary measure is the Reproductive Life Goal Behavioral Intentions scale, with scores ranging from 1 to 5 and higher scores indicating greater self-reported intentions. The stated assessment period is baseline to 2-month post-intervention (~2 months). Three participants in each condition did not complete the post-treatment assessment.
Arm-level primary outcome results, a single summarized comparison, and its precision are not reported in the registry record. The posted safety counts show zero serious adverse events, zero other adverse events, and zero deaths in each condition.