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 Maternal Adversity, Vulnerability and Neurodevelopment (NCT03434457), a registered phase not stated study. The primary outcome is Child's Cognitive Development Measured Using the Bayley Scales of Infant Development II..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03434457 |
| Phase | Phase not stated |
| Condition | Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), Infant Development, Infant Behavior |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 630 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Douglas Mental Health University Institute |
| Results posted | Yes |
2. Clinical Question
Population
The record describes a prospective, community-based pregnancy and birth cohort of Canadian mother-child dyads. Enrollment is 630. The listed conditions include maternal mental health issues, infant development and infant behavior.
Intervention
This is not described as a treatment intervention. The project examines prenatal and postnatal influences, including their interaction, and focuses on the quality of the postnatal environment and mother-infant interactions. The named arm is “Prenatal and 3 to 72 months.”
Comparator
A randomized control group or like-for-like comparator is not reported in the registry record. The record identifies this as not a randomized comparison, and allocation is not stated. The named arm should therefore not be read as one side of a randomized treatment contrast.
Primary question
The primary outcome concerns child cognitive development measured using the Bayley Scales of Infant Development II at 6, 12, 18 and 36 months. The broader project asks how prenatal and postnatal influences, and their interaction, relate to individual differences in child development. The registry record does not report an estimated association or outcome result.
Statistically, the central issue is the relationship between the developmental assessments and the maternal, prenatal and postnatal factors the project set out to examine. The record describes the project objective but does not give a specific primary contrast, an exposure definition, a model, or a hypothesis test. It therefore does not support a claim about the direction or size of any relationship. Nor does the cohort description establish that observed associations would represent causal effects: the record does not describe randomized allocation or a control comparison. Interpretation must remain at the level of the research question and the design information recorded.
3. Trial Design
The project, titled “Maternal Adversity, Vulnerability and Neurodevelopment,” is described as a prospective, community-based pregnancy and birth cohort of Canadian mother-child dyads. Its stated objective is to examine pre- and postnatal influences on individual differences in child development, including how those influences may interact. The summary emphasizes fetal adversity in relation to the quality of the postnatal environment, with attention to mother-infant interactions.
The record lists enrollment of 630 and identifies the status as completed. The recorded start date is 2003-10-01 and the primary completion date is 2017-12-01. The named arm is “Prenatal and 3 to 72 months”; its arm description is blank in the registry record. A randomized comparison is not reported, and allocation is not stated. The project should therefore be understood from the recorded cohort description rather than as a randomized trial with treatment and control arms.
The primary outcome timeframe lists assessments at 6, 12, 18 and 36 months. The description says child development was assessed using the cognitive, motor and mental scales of the Bayley Scales of Infant Development II. The registry lists 28 outcome measures. Secondary measures include several maternal depression symptom instruments, an anxiety instrument, assessments of parental educational style and maternal sensitivity, childhood trauma, and eating behavior.
The sponsor is Douglas Mental Health University Institute. The registry record does not report recruitment procedures, eligibility criteria, the number assessed at each visit, retention, exposure group definitions, or a detailed analysis plan. These omissions limit how fully the cohort’s operational design and the intended comparisons can be reconstructed from the 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 | Prenatal and 3 to 72 Months |
|---|---|
| STARTED | 630 |
| COMPLETED | 630 |
| NOT COMPLETED | 0 |
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 | Prenatal and 3 to 72 Months |
|---|---|---|
| Participants analysed | 630 | |
| Age, Categorical: <=18 years | Participants | 630 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | 288 |
| Sex: Female, Male: Male | Participants | 342 |
| Race and Ethnicity Not Collected | Participants | — |
| Number of Participants that Provided Feedback on the Childhood Trauma Questionnaire | Participants | 429 |
6. Primary Endpoint
The registry lists the primary outcome as Child's Cognitive Development Measured Using the Bayley Scales of Infant Development II., measured over At 6, 12, 18 and 36 months.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary outcome is titled “Child's Cognitive Development Measured Using the Bayley Scales of Infant Development II.” Its timeframe is at 6, 12, 18 and 36 months. The registry description states that child development assessment used the instrument’s cognitive, motor and mental scales. The listed unit is participants, and the registered parameter is a count of participants. The record does not clarify how those labels correspond to the scale assessments or what summary of the assessments was intended as the primary result.
In general, repeated developmental assessments can describe children’s measured functioning at specified ages and can support study of patterns over time, if the analysis plan and data are available. Using a named standardized instrument also makes the measurement approach explicit, but the registry record does not report scoring details, thresholds, clinically meaningful differences, or how scores from the listed scales would be combined or analyzed. Those details should not be inferred from the instrument name alone.
The registry record reports no primary-outcome analysis or result. It therefore does not provide an effect estimate, uncertainty interval, or statistical test for cognitive development. The endpoint description identifies what the project intended to assess; it is not itself evidence of a developmental difference or association.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record gives a research objective, outcome descriptions and enrollment information, but it does not report primary-outcome results. It lists 0 analyses. No group-specific developmental summaries, effect estimates, confidence intervals, or p-values are reported in the registry record. Consequently, the posted record cannot establish the direction, magnitude, or precision of an association between prenatal or postnatal influences and child development.
The planned assessment schedule is described as 6, 12, 18 and 36 months. The outcome description names cognitive, motor and mental scales of the Bayley Scales of Infant Development II. These details identify what was assessed and when, but they do not reveal the children’s measured scores, the number with data at each visit, or how those scores were analyzed. The record’s unit and parameter labels refer to participants and a count of participants, while its narrative describes developmental scales; the registry record does not explain the relationship between these descriptions.
The project summary frames its objective around prenatal and postnatal influences and their interaction. It also emphasizes fetal adversity, postnatal environment and mother-infant interactions. Those are stated aims, not findings. Without reported estimates and methods, no conclusion about whether any exposure is associated with development, or whether one influence modifies another, can be drawn from this record.
There is no randomized comparison reported. The registry record explicitly indicates that the comparison is not randomized and that allocation is not stated. Associations observed in a cohort, if reported elsewhere, would need interpretation in light of how participants and exposures were defined and how potential confounding was handled. The record does not report those details, so it cannot support a causal interpretation.
In general, a confidence interval communicates the range of estimates compatible with the data and the chosen statistical procedure; a narrow interval indicates greater precision than a wide interval. No interval is reported for the primary outcome, so its precision cannot be assessed. Similarly, the absence of a reported p-value is not evidence that a result was or was not statistically significant. The registry record contains no result against which such a judgment could be made.
The record does report enrollment of 630 and marks the project completed. Enrollment alone does not indicate how many participants contributed data to each assessment, whether follow-up was complete, or whether the analyzed population matched enrollment. Those figures and the handling of missing observations are not reported in the registry record. The completed status should not be mistaken for a posted analysis or a conclusive result.
9. Statistical Methods Explained
The available record supports a limited description of the intended measurement and study structure. It describes a prospective cohort and a primary developmental outcome, but reports no analyses. Statistical methods should therefore be discussed as general concepts rather than as methods known to have been used for this project.
What does the cohort design imply?
In general, a prospective cohort follows participants and records exposures or characteristics and outcomes over time. This can help establish the timing of measurements and support analysis of associations. It does not, by itself, assign exposures randomly. When exposures are not randomized, differences between people with different exposure histories may also reflect other characteristics. Analyses often need to define those characteristics and explain how they are handled. The registry record does not report an adjustment strategy, exposure definitions, or a causal analysis plan. The project’s stated interest in pre- and postnatal influences and their interaction identifies scientific aims, but it does not specify a statistical model.
What does the repeated assessment schedule tell readers?
The primary outcome timeframe lists 6, 12, 18 and 36 months. In general, repeated observations can be analyzed as separate age-specific outcomes or together as a trajectory. A joint longitudinal approach can account for the fact that repeated measurements from the same child are related, rather than treating each measurement as independent. The choice depends on the research question, measurement properties and data completeness. The registry record does not say whether results were intended to be reported at each visit, as a change over time, or through another summary. It also does not report the number assessed at each age.
How should the outcome description be read?
The registry names the Bayley Scales of Infant Development II and says assessment used cognitive, motor and mental scales. It lists participants as the unit and a count of participants as the parameter. Those labels do not specify a score, threshold, or change measure. General statistical interpretation depends on knowing the actual outcome scale and its coding. For a continuous score, a mean difference and its uncertainty might be useful; for a binary outcome, a proportion or relative measure might be considered. These are general examples, not reported analyses for this project. The record does not state how the instrument’s assessments were converted into the registered participant count.
Why do distributional assumptions matter?
General statistical methods rely on assumptions about the outcome and the data structure. A model for counts, for example, needs to account for the nonnegative and discrete nature of counts. If variability exceeds what a basic count model expects, over-dispersion can make standard errors too small unless the model accounts for it. For a continuous developmental score, the appropriate model would depend on its distribution, repeated-measure structure and other features. The record does not report a count model, a continuous-outcome model, a dispersion estimate, or checks of model assumptions. No particular model should be attributed to the project.
What information would support an estimate?
In general, a statistical estimate is most informative when accompanied by an uncertainty interval and a clear description of the population, comparison, outcome, and analysis population. A point estimate describes the estimated association or contrast; the interval communicates its precision under the analysis assumptions. A p-value addresses compatibility with a null hypothesis under a specified test, but does not measure the size or practical importance of an effect. The registry record reports none of these result elements for the primary endpoint.
The record states that 28 outcome measures are listed and names several secondary measures. When multiple outcomes or tests are examined, the chance of at least one apparently notable result can increase. In general, multiplicity procedures or a prespecified hierarchy can help clarify how multiple tests are interpreted. The registry record does not report a multiplicity strategy, an outcome hierarchy beyond the primary label, or analysis results. It also does not report interim analyses, a statistical analysis plan, or a sample-size justification. These omissions mean that neither inferential procedures nor decision thresholds can be reconstructed from the registry entry.
The sample-size assumptions associated with planning illustrations describe a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. Those assumptions are described as planning illustrations rather than the project’s own design. They do not establish that the cohort used equal allocation, that the study was powered according to those assumptions, or that any observed power was calculated. The registry record does not report the project’s own sample-size justification.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 28 outcome measures and identifies one primary outcome, with secondary outcomes covering maternal symptoms and behaviors as well as other assessments. Multiple outcomes and repeated measurement occasions can create many possible comparisons. In general, testing many hypotheses without an explicit strategy can make isolated findings difficult to interpret. A prespecified hierarchy, adjustment procedure, or clearly exploratory framing can help readers understand how results should be judged. A multiplicity plan is not reported in the registry record, and no analyses are listed.
The record does not report missing-data amounts, reasons for missed visits, or methods for handling incomplete observations. With assessments at 6, 12, 18 and 36 months, the number of observations may differ across time points, but the actual follow-up pattern is not reported in the registry record. It also does not state whether any imputation, weighting, complete-case analysis, or sensitivity analysis was used. These methods have different assumptions, so no one approach can be attributed to the project.
The registry lists enrollment of 630, but does not report the analysis population for the primary endpoint or the number contributing to each assessment. It does not specify whether analyses were planned for all enrolled participants, participants with particular measurements, or another defined population. The cohort is not described as randomized, so an intention-to-treat population should not be assumed. Without population definitions and missing-data details, the extent to which any eventual estimates would represent the enrolled cohort cannot be assessed from this record.
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 |
|---|---|---|---|
| Adverse Events | 0 | 630 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Adverse Events | 0 of 630 |
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 |
|---|---|
| Adverse Events | 0 of 630 |
The adverse-event entry lists 0 serious adverse events among 630 at risk and 0 affected, and lists 0 other adverse events among 630 at risk and 0 affected. The recorded death count is 0. No serious adverse-event terms are listed. These are registry entries, not a comparative safety analysis.
In general, a zero event count means that no events of that category were recorded in the relevant entry; it does not demonstrate that an event is impossible or rule out events that were not captured or reported. Safety interpretation also depends on event definitions, monitoring, follow-up duration and completeness. Those details are not reported in the registry record. The record does not describe a randomized comparator, and the adverse-event figures should not be read as a treatment-versus-control comparison.
The at-risk counts appear separately for serious and other adverse events. They should be read as the recorded counts for those categories, not added together or taken to represent an outcome analysis. The registry does not list event-level details, severity breakdowns beyond the serious category, or an analysis of differences in risk. The figures therefore describe what the adverse-event entry records, without establishing a broader safety conclusion.
12. What the Result Does, and Does Not, Mean
The record establishes that the project was a completed prospective, community-based pregnancy and birth cohort with enrollment of 630. It describes an objective focused on prenatal and postnatal influences on individual differences in child development, and identifies the Bayley Scales of Infant Development II as the primary developmental measure. It also specifies assessments at 6, 12, 18 and 36 months and lists additional maternal and child outcome measures.
Those design details do not establish a result. The registry record reports 0 analyses and gives no primary-outcome estimate, confidence interval, p-value, or group-specific developmental summary. It is therefore not possible to determine from the record whether the project observed a particular association, how large any association was, or how precisely it was estimated. A completed study status does not substitute for posted results.
The project’s stated scientific question concerns the relationship between prenatal and postnatal influences, including their interaction, and child development. It is not described as a randomized intervention comparison. Even if associations were reported elsewhere, the cohort design would not by itself prove that an exposure caused a developmental outcome. A causal interpretation would require a suitable design and analysis, with clear definitions and attention to potential confounding. Those analytical details are not reported in the registry record.
In general, statistical significance and practical importance are different questions. A p-value alone would not convey the size of a difference, and an estimate without an uncertainty interval would not show its precision. Here, neither is reported for the primary outcome. The registry description should therefore be read as documentation of the research question and measures, not as evidence for or against a developmental effect.
The absence of posted outcome results also does not prove that no result exists outside the registry. It means only that the registry record does not report one. Conclusions should be limited to the recorded design, objectives, outcome definitions, enrollment and adverse-event entries.
13. Why This Trial Matters Statistically
Statistically, this record illustrates why a registry description and an outcome analysis serve different purposes. The record identifies a prospective cohort, a developmental assessment instrument, an assessment schedule and a broad research objective. Those details help readers understand what the project set out to study. They do not supply the estimates needed to judge the strength, direction or precision of findings.
The project’s interest in prenatal and postnatal influences and their interaction raises important design and analysis questions. Repeated assessments at 6, 12, 18 and 36 months may require methods that account for within-child dependence if observations are analyzed together. Analyses of multiple outcomes also need a transparent approach to multiplicity. In general, reporting these decisions alongside estimates and uncertainty makes results easier to evaluate and compare. The registry record does not report such methods.
The cohort framing also matters for causal interpretation. A prospective design can organize measurements over time, but it does not create randomized exposure groups. A reader needs information about exposure definitions, potential confounding, follow-up, missing observations and analytic populations to assess associations. Those details are not reported in the registry record, and no outcome analysis is listed.
Finally, a clearly described instrument is only one component of an interpretable result. The registry names the Bayley Scales of Infant Development II and the scales used, but does not clarify scoring or how the participant-count parameter relates to the assessments. Reporting that link, together with outcome summaries and uncertainty, would help readers understand what was estimated. The record is statistically informative about the project’s aims and broad structure, while leaving its empirical findings and inferential basis unreported.
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 registry record leaves several trial-specific uncertainties. It names one arm, “Prenatal and 3 to 72 months,” but gives no arm description. A comparator and allocation procedure are not reported; the record flags that this is not a randomized comparison and that allocation is not stated. The project can therefore not be interpreted as a like-for-like treatment contrast from the recorded design information.
The primary endpoint has a title referring to cognitive development, while its description mentions cognitive, motor and mental scales. The registry labels the unit as participants and the parameter as a count of participants, but does not explain the outcome coding or how the scale assessments lead to that count. It also does not give scoring details, thresholds, or a primary analysis definition. This makes the intended estimand difficult to reconstruct.
The registry record reports 28 outcome measures, but does not describe an analysis plan, multiplicity strategy, sample-size justification, interim analyses, or analysis populations. It also does not report participant flow, data availability by assessment age, missing-data methods, or follow-up completeness. Although enrollment is listed as 630, that number does not establish how many participants contributed to each analysis.
Most importantly, the record lists 0 analyses and reports no primary-outcome result. There is consequently no estimate or uncertainty measure to assess. The completed status and detailed study objective cannot fill that evidentiary gap. These limitations concern what is recorded in the registry entry; they do not establish what analyses may exist elsewhere.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Maternal Adversity, Vulnerability and Neurodevelopment — NCT03434457.
- Registry record last updated 2020-05-27; status last verified 2020-05.
- Results first posted 2020-05-27.
- 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
“Maternal Adversity, Vulnerability and Neurodevelopment” is a completed, prospective, community-based pregnancy and birth cohort of Canadian mother-child dyads. The sponsor is Douglas Mental Health University Institute. The recorded start date is 2003-10-01, primary completion date is 2017-12-01, and enrollment is 630.
The project’s stated objective is to examine pre- and postnatal influences, and their interaction, in relation to individual differences in child development. Its primary outcome is child cognitive development measured using the Bayley Scales of Infant Development II, with assessments listed at 6, 12, 18 and 36 months. The registry record lists 28 outcome measures and 0 analyses.
The entry does not report primary-outcome estimates or an analysis plan. It identifies no randomized comparison, and allocation is not stated. The adverse-event entry records 0 serious events and 0 other events among 630 at risk for each category, with 0 deaths recorded. These details describe the registry record but do not provide an outcome analysis.