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 A Dyadic Approach to Perinatal Depression in Primary Care: Maternal Infant and Dyadic Care (NCT04998721), a randomized na study. The primary outcome is Change From Baseline in Perinatal Depression on the PHQ-9.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04998721 |
| Phase | NA |
| Condition | Depression, Postpartum, Efficacy, Self, Anxiety |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 16 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Washington |
| Results posted | Yes |
2. Clinical Question
Population
People in the perinatal period receiving care in the study. The registry record focuses on postpartum depression but does not provide detailed eligibility criteria or participant characteristics.
Intervention
Perinatal Integrated Care together with the behavioral parenting intervention Promoting First Relationships-Brief, described as Maternal Infant Dyadic Care.
Comparator
Perinatal Integrated Care alone, described as the Control arm.
Primary question
How does change in perinatal depression, measured by the PHQ-9, compare between the two arms from baseline through the postpartum follow-up time points?
The study’s stated purpose was to assess the effectiveness of adding a parenting intervention to usual care, compared with usual care, on postpartum depression and other mental health and parenting outcomes. It also aimed to assess feasibility and acceptability of the parenting intervention. The registry record identifies change in PHQ-9 score as the primary outcome and gives assessment points at baseline, 3 Months Postpartum, and 6 Months Postpartum.
The PHQ-9 measures depression symptoms, with higher scores indicating greater symptom severity. The clinical question therefore concerns a measured change in self-reported symptoms, not a diagnosis or a broader assessment of all aspects of mental health. The record does not report comparative PHQ-9 results, so it does not establish the direction or size of any difference between arms. Nor does it report findings on feasibility or acceptability. Those questions remain distinct from the primary symptom outcome and cannot be answered from the registry entries alone.
3. Trial Design
The registry identifies MInD as a randomized, single-masked, parallel-group study. It lists enrollment of 16 and a status of Completed. The study start date is 2022-11-01, and primary completion is recorded as 2025-04-07. The phase is listed as NA. The University of Washington is named as sponsor.
Participants were assigned to Maternal Infant Dyadic Care or Control. The intervention arm combined Perinatal Integrated Care with Promoting First Relationships-Brief; the control arm received Perinatal Integrated Care alone. Both interventions are categorized as behavioral. The registry describes the comparison as parenting intervention plus usual care versus usual care, while the arm descriptions specify the components of each condition.
Random allocation is intended to make treatment groups comparable on average, including for characteristics that are not measured. In a parallel-group design, participants are assigned to an arm and the arms are compared over the study. These are general features of the design, not evidence that the groups in this trial were comparable on every characteristic. The registry does not report the allocation ratio or details of the randomization procedure. It also does not identify who was masked, what information masking covered, or whether masking was maintained.
The primary outcome is change in PHQ-9 score across baseline and postpartum follow-up. The registry lists secondary outcomes involving parental self-efficacy, dyadic interaction, disability, and maternal functioning. Enrollment of 16 makes the study small in scale; this does not by itself determine the direction of the findings, but it limits how much precision can be expected from group comparisons. The registry record does not report participant characteristics, detailed eligibility criteria, adherence, or the number completing each follow-up assessment.
Although the study is marked Completed, completion status is not the same as a report of outcome findings. The registry record lists no analyses, and the primary outcome is not reduced to a single comparison because it has multiple time points. Consequently, the design and planned measurements can be described, but a comparative estimate of the intervention effect cannot be interpreted from 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 | Intervention Group | Control |
|---|---|---|
| STARTED | 8 | 8 |
| COMPLETED | 6 | 5 |
| NOT COMPLETED | 2 | 3 |
Analysis population for the primary outcome, as defined in the registry: Difference is due to attrition
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 | Intervention | Control | Total |
|---|---|---|---|---|
| Participants analysed | 8 | 8 | 16 | |
| Age, Continuous | years | 32.19 (SD 7.42) | 30.11 (SD 5.2) | 31.15 (SD 6.28) |
| Sex: Female, Male: Female | Participants | 8 | 8 | 16 |
| 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 | 3 | 1 | 4 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 3 | 6 | 9 |
| Race (NIH/OMB): More than one race | Participants | 1 | 1 | 2 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 | 0 | 1 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 1 | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 7 | 7 | 14 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 1 | 0 | 1 |
| Patient Health Questionnaire - 9 | scores on a scale | 13.88 (SD 4.12) | 12.38 (SD 5.66) | 13.13 (SD 4.84) |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline in Perinatal Depression on the PHQ-9, measured over Baseline, 3 Months Postpartum, 6 Months Postpartum.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | scores on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change from baseline in perinatal depression measured with the PHQ-9. This is a nine-item self-report measure. Its total score ranges from 0 to 27, with higher scores indicating increased symptom severity. The registry describes the measure as validated for use in the perinatal period.
Repeated assessment is useful because symptoms can be measured at baseline and at later postpartum visits, allowing researchers to examine how scores change over time. The registry lists baseline, 3 Months Postpartum, and 6 Months Postpartum as the timeframe. A comparison between randomized arms could describe whether their observed score patterns differ, provided the analysis and the relevant outcome data are available.
The endpoint is a score-based measure of reported symptoms. It does not, by itself, describe every dimension of depression, parenting, or family functioning. The record does not report the scoring details used to define change, the analysis population, or a comparative result for any assessment point. It notes that the difference is due to attrition, but does not explain the extent or handling of that attrition. Without posted estimates and their precision, the endpoint’s observed group pattern cannot be assessed.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record contains the study design, intervention descriptions, outcome definitions, and limited safety counts, but it does not contain a primary outcome analysis. The number of analyses recorded is 0. In addition, the registry information explicitly does not reduce the primary outcome to a single comparison because it includes several time points. There is therefore no posted estimate of the between-arm difference in PHQ-9 change to interpret.
This means the record cannot establish whether the intervention arm had a larger or smaller change in depression scores than the control arm, or how large any difference might be. It also cannot show how precisely an effect was estimated. Those judgments require outcome estimates and measures of uncertainty, such as confidence intervals. No such comparative estimates are reported in the registry record. The absence of an analysis in this record is not evidence that the groups had identical outcomes, nor does it demonstrate that the intervention had no effect.
The design provides a framework for a randomized comparison: Perinatal Integrated Care plus Promoting First Relationships-Brief versus Perinatal Integrated Care alone. But the planned contrast and the actual observed result are different things. The intervention descriptions identify what was compared; they do not supply evidence about the observed PHQ-9 trajectories. Similarly, the stated aim of assessing feasibility and acceptability does not amount to a finding on either topic.
The enrollment of 16 is relevant when considering the likely precision of any group-level estimate, but it does not permit a conclusion about the result. Smaller studies generally have less information with which to distinguish an effect from random variation. This is a general statistical point, not a calculation of power or precision for this trial. The registry does not report a sample-size justification, a planned effect size, or a statistical analysis plan.
The posted adverse-event counts are descriptive and separate from the primary endpoint. They record no serious adverse events among the participants listed as at risk, and record other adverse events in both arms. These counts do not provide a causal comparison or establish overall safety. The registry does not provide event descriptions or further context to interpret those entries.
Overall, the available record supports a description of the trial question and its design, but not a conclusion about effectiveness, symptom change, or the statistical uncertainty around a treatment contrast. A complete interpretation would require the outcome data, the analysis methods, and information about missing follow-up data and the participants included in each analysis.
9. Statistical Methods Explained
What kind of outcome is being measured?
The primary outcome is continuous: it is expressed as PHQ-9 scores rather than as a category such as improved or not improved. The registry describes the summary parameter as a mean and the dispersion as a standard deviation. In general, a mean describes the center of a set of scores, while a standard deviation describes how much scores vary around that center. These summaries describe a group; they do not show the full distribution of individual experiences.
What does change from baseline mean?
In general, a change score compares a participant’s later measurement with that participant’s baseline measurement. A group-level summary can then describe the pattern of change within an arm, and a comparative analysis can assess whether the patterns differ between arms. The registry identifies baseline and postpartum assessments but does not report the score summaries or the exact analysis used to estimate change. It also does not state whether the primary comparison was based on change scores, a model of repeated measurements, or another method. Those approaches can make different assumptions and use the data in different ways, so the specific method matters.
Why do repeated measurements need careful interpretation?
The PHQ-9 timeframe includes baseline, 3 Months Postpartum, and 6 Months Postpartum. Measurements from the same participant are related rather than independent. In general, an analysis of repeated measurements should account for that within-person relationship and should make clear which time point or overall contrast answers the primary question. Considering multiple time points can also create more than one possible comparison. The registry record does not report a primary contrast among the time points or an analysis plan addressing them.
What does randomization contribute?
In general, random assignment helps balance measured and unmeasured characteristics across groups on average, making a between-arm comparison more informative about the assigned intervention than a nonrandomized comparison. It does not guarantee that groups will be identical, especially in a small study. Nor does randomization resolve missing outcome data, incomplete follow-up, or ambiguity about which contrast is primary. Details of the allocation procedure and the analysis populations are not reported in the registry record.
How should uncertainty be understood?
General explanation: an estimate is a summary of the observed data, while a confidence interval expresses the uncertainty around that estimate under the assumptions of the analysis. A narrower interval indicates greater precision; a wider interval indicates less precision. A significance test addresses a different question and does not communicate the size or practical importance of an effect by itself. The registry record does not report an effect estimate, confidence interval, or test result for the primary outcome, so none can be interpreted for this comparison.
Why can over-dispersion matter?
General explanation: over-dispersion occurs when observed variation is greater than a statistical model assumes. If a model understates variability, its uncertainty estimates can be too optimistic. This issue is especially relevant to some count outcomes, but the primary outcome in this study is a continuous score summarized by a mean and standard deviation. The registry does not report a model or diagnostics, so there is no basis for saying whether over-dispersion was assessed or relevant to any analysis.
What are the planning assumptions?
The record describes a planning illustration based on a two-sided significance level of 0.05, equal allocation between arms, a normal approximation, and an effect defined as a fraction of the observed effect. Such an illustration is not an observed result and is not proof that a study had a particular probability of detecting an effect. Sample-size planning depends on assumptions about the effect and variability, among other design choices. The registry does not report the trial’s own sample-size justification, so the planning illustration should not be treated as the original design rationale or as observed power.
What does the record establish about the analysis?
The registry identifies the primary outcome and its measurement schedule but records 0 analyses. It does not report the statistical model, the handling of repeated observations, the primary between-arm contrast, the approach to missing data, or the population included in analysis. No method should be attributed to the investigators beyond what the registry record states. Without these details and posted estimates, the available information supports explanation of general statistical concepts, not reconstruction of the trial’s actual analysis.
10. Multiplicity, Missing Data and Analysis Populations
The primary endpoint is measured at baseline, 3 Months Postpartum, and 6 Months Postpartum. Multiple follow-up points can support a richer description of change, but they also raise a question about which comparison is primary. If several time points or outcomes are tested, the chance of finding at least one apparently notable result can increase unless the analysis plan addresses multiplicity. This is a general statistical concern, not a claim that any particular adjustment was or was not used in the trial. The registry record does not report a multiplicity strategy, and the primary outcome is not reduced to a single comparison.
The record lists six outcome measures. Named secondary outcomes include change in parental self-efficacy on the Self-Efficacy in a Nurturing Role, change in dyadic interaction, change in disability on the World Health Organization Disability Assessment Schedule 2.0, and change in maternal functioning on the Barkin Index of Maternal Functioning. The registry does not report analyses for these measures or explain how secondary outcomes relate to any planned hierarchy of testing.
Missing data are important because the primary outcome is measured over time and the record notes that the difference is due to attrition. The extent of attrition, reasons for missing assessments, and distribution of missingness by arm are not reported in the registry record. Nor does the record state whether the analysis used all randomized participants, only participants with available assessments, or another analysis population. General explanation: if people with missing follow-up differ in relevant ways from those with observed scores, an analysis restricted to observed data may not represent the full randomized groups. The record does not describe an imputation method, sensitivity analysis, or other approach to missing outcomes.
These omissions prevent assessment of how multiplicity and missingness may affect the interpretation of any treatment comparison. No analysis result is posted to evaluate.
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 |
|---|---|---|---|
| Intervention | 0 | 8 | 0.0% |
| Control | 0 | 8 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Intervention | 0 of 8 |
| Control | 0 of 8 |
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 |
|---|---|
| Intervention | 2 of 8 |
| Control | 4 of 8 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Intervention | Control |
|---|---|---|---|
| Suicidal ideation | Psychiatric disorders | 2 of 8 | 4 of 8 |
The registry lists serious adverse events and other adverse events separately for the Intervention and Control groups. Among 8 participants at risk in each group, the serious adverse event count is 0 in the Intervention group and 0 in the Control group. No deaths are listed in either group. The other adverse event count is 2 in the Intervention group and 4 in the Control group.
These are descriptive counts. They do not establish that events were caused by, or unrelated to, either intervention. The registry does not report the event terms, severity details for the other events, timing, duration, or investigators’ assessment of relatedness. The list of top serious event terms is empty, consistent with the recorded serious-event counts, but does not add context about the other events.
General explanation: adverse-event counts are interpreted in light of the definitions used, the time under observation, completeness of reporting, and the number of participants followed. A zero count in a small group does not show that an event is impossible, and differences in counts alone do not establish a treatment-related difference. The registry information does not support a broad conclusion about safety.
12. What the Result Does, and Does Not, Mean
The record describes a randomized comparison of a combined perinatal care and parenting intervention with perinatal care alone. It specifies postpartum depression measured by the PHQ-9 as the primary outcome and identifies follow-up time points. It also names other mental health and parenting measures and states that feasibility and acceptability were study aims. These details explain the question the trial was designed to address.
They do not show what happened to PHQ-9 scores in either arm. The registry record contains no primary outcome analysis, no comparative estimate, and no measure of statistical uncertainty. It therefore does not support a conclusion that the intervention improved, worsened, or had no effect on depression scores. A missing result must not be mistaken for evidence of no difference.
Even when comparative results are available, a score difference is an estimate for the measured outcome under the analysis assumptions. It is not automatically equivalent to a diagnosis, a complete account of mental health, or a finding about every parenting outcome. The PHQ-9 is described as a self-report measure, and its score range and symptom direction help explain what it measures, but do not themselves indicate a trial result.
The enrollment of 16 and the record’s note about attrition are important context for interpreting precision and completeness. In general, fewer observed participants and missing follow-up measurements can make an estimate less precise or make it more dependent on assumptions about missing data. The record does not give enough information to quantify either issue. The safety entries are also limited descriptive counts and should not be generalized into a conclusion about overall safety.
Accordingly, the registry record is informative about the trial’s design and intended outcomes, but it is not an outcome report from which the intervention’s comparative effect can be judged.
13. Why This Trial Matters Statistically
This trial addresses a question that combines perinatal mental health care with a parenting intervention: whether adding Promoting First Relationships-Brief to Perinatal Integrated Care is associated with different postpartum depression and parenting outcomes than Perinatal Integrated Care alone. Its focus on maternal, infant, and dyadic outcomes means the evaluation is not limited to a single symptom measure. The record also identifies feasibility and acceptability as aims, which are distinct from estimating an effect on depression.
Statistically, the design illustrates why a clearly specified primary contrast matters. PHQ-9 scores are planned across baseline and postpartum follow-up points, while several secondary outcomes are also listed. Without a reported analysis plan or a single primary comparison, readers cannot tell how the investigators intended to prioritize time points, address multiple outcomes, or interpret any potential pattern of findings. The registry record does not report those decisions.
The enrollment of 16 also highlights the role of precision in small clinical studies. General statistical principle: a small amount of information can leave substantial uncertainty around an estimated difference, even when a point estimate is available. In this record, no primary estimate is reported at all, so precision cannot be assessed. The design details and outcome definitions remain useful, but they cannot substitute for results.
The study therefore matters as an example of how trial registration documents the intended comparison and measurements, while also showing the limits of interpreting a completed study without posted analyses. For clinical researchers and biostatisticians, the distinction between a completed trial, a measured endpoint, and a reported comparative result is essential.
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 this trial from the registry record is the absence of posted outcome analyses. Although the status is Completed and the primary outcome is specified, the record lists 0 analyses. There is no comparative PHQ-9 estimate, uncertainty interval, or test result. The available information consequently cannot establish the direction, magnitude, or precision of an outcome difference.
The primary outcome is assessed at multiple time points, and the record does not identify a single comparison among them. It also does not describe the statistical model, adjustment variables, or procedures for handling repeated measurements. These details are important to understanding how a reported estimate would be constructed, but they are not reported in the registry record.
The record notes that the difference is due to attrition, but does not describe the amount, timing, or reasons for missing observations. It does not report follow-up completion by arm, an analysis population, or a method for addressing missing data. This limits assessment of whether missingness could affect the observed groups or the interpretation of a future estimate.
Enrollment was 16, and the record does not give participant characteristics or detailed eligibility criteria. The masking entry is single, but who was masked and how masking was implemented are not reported in the registry record. The allocation procedure and allocation ratio are also not described. These omissions limit appraisal of the conduct and applicability of the study.
Finally, the adverse-event information is limited to counts, without event descriptions or context. The record does not report findings on feasibility or acceptability despite identifying them as aims. The planning assumptions do not replace a reported trial-specific sample-size justification. Together, these limitations mean that the registry record describes the study question more fully than it supports an evaluation of the study’s findings.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Dyadic Approach to Perinatal Depression in Primary Care: Maternal Infant and Dyadic Care — NCT04998721.
- Registry record last updated 2026-11-04; status last verified 2026-09.
- Results first posted 2026-11-04.
- 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
MInD is a completed, randomized, single-masked, parallel-group study sponsored by the University of Washington, with enrollment of 16. It compared Perinatal Integrated Care plus Promoting First Relationships-Brief with Perinatal Integrated Care alone. The primary outcome is change in perinatal depression measured by the PHQ-9 at baseline, 3 Months Postpartum, and 6 Months Postpartum.
The registry also lists secondary outcomes involving parental self-efficacy, dyadic interaction, disability, and maternal functioning. It records 0 analyses and does not report a primary comparative result. The primary outcome has multiple time points and is not reduced to a single comparison. The record notes attrition but does not provide details on missing observations or their handling. Adverse-event entries list 0 serious events in either group and other adverse events in both groups. These details describe the record but do not establish an intervention effect or an overall safety conclusion.