Listening Visits for Emotionally Distressed Mothers of Hospitalized Newborns: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Listening Visits for Emotionally Distressed Mothers of Hospitalized Newborns (NCT03704948), a randomized na study. The primary outcome is Mean IDAS-GD Score at 4 Weeks (End of Treatment) and 8 Weeks (Follow up).

2. Clinical Question

3. Trial Design

The record describes a parallel, randomized trial comparing in-person Listening Visits delivered by NICU nurses with usual mental health care delivered by NICU social workers. Masking is listed as none. The study is marked completed, with an enrollment of 55. Its start date is 2019-02-14 and its primary completion date is 2022-06-20. The record lists the phase as NA.

A separate intervention is also listed: Listening Visits delivered by a NICU nurse via Zoom in an open trial. This should be distinguished from the randomized comparison. The record does not establish that the open trial was randomized or that its participants were included in the randomized comparison. It also does not report how enrollment was divided across the trials or how many participants contributed data to each outcome assessment.

The stated clinical context is emotional distress among mothers whose newborns are hospitalized in the NICU. The intervention is a form of nurse-delivered counseling, while the randomized comparator is usual mental health care from NICU social workers. Those descriptions identify the intended contrast, but the registry record does not report enough detail to establish how often visits occurred, how long they lasted, or how usual care varied between participants.

The primary outcome is the mean IDAS-GD score at 4 weeks and 8 weeks. The registry record does not report a statistical analysis plan, the method used to handle repeated measurements, or a treatment-effect estimate for either assessment time. It also does not report whether analyses followed the randomized assignment or another analysis population. The record’s design labels therefore describe the broad structure, not the full conduct or analysis of the trial.

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.

Before assignment: No significant events after participant enrollment.

Overall Study

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Mean IDAS-GD Score at 4 Weeks (End of Treatment) and 8 Weeks (Follow up), measured over 4 weeks and 8 weeks.

The primary endpoint is the mean score on the Inventory of Depression & Anxiety Symptoms-General Depression (sub) Scale, abbreviated IDAS-GD, at 4 weeks and 8 weeks. The record identifies 4 weeks as the end of treatment and 8 weeks as follow-up. The IDAS-GD assesses depression symptoms using 20 items. Items cover dysphoria, suicidality, lassitude, insomnia, appetite loss, and well-being. Respondents use a 5-point scale ranging from not at all to extremely to indicate how much they experienced each symptom during the past 2 weeks. The total score ranges from 1-100, with higher scores indicating more depression symptoms.

A mean is a summary of the scores in a group; the standard deviation describes how spread out those scores are around the mean. Reporting both can help readers understand the average symptom level and the variation among participants. Repeated assessment at the end of treatment and at follow-up can describe scores at each time, but interpreting change or a difference between groups requires the actual results and a defined analysis.

The registry record names this outcome and its assessment times but does not report the group means, standard deviations, or an estimated comparison. It also does not report a threshold for interpreting a score difference as clinically important. The measure indicates symptom severity as defined by the scale; it is not, by itself, a diagnosis.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary endpoint is continuous: it is a score on a scale, and the registry record identifies the summary measure as a mean with standard deviation. A mean describes the center of a set of scores. A standard deviation describes how much individual scores vary around that center. Together, they give a basic account of the distribution, although they do not show its full shape or identify every participant’s experience.

In a two-group trial, a common statistical target is the difference between group means at a defined assessment time. That contrast estimates how far apart the group averages are, under the analysis used. The estimate should be accompanied by a measure of uncertainty, often a confidence interval. In general, a confidence interval describes a range of values compatible with the data and the statistical assumptions. It is not a guarantee that the true effect lies in that range, and it does not replace attention to the size and relevance of the estimated difference.

For this trial, the registry record does not report the group means, standard deviations, a difference in means, a confidence interval, or a p-value. It therefore does not permit readers to inspect an estimated contrast or its precision. A p-value, if reported, would address how compatible the observed data are with a specified null model under stated assumptions; it would not measure the probability that the intervention works. No such value or associated test is reported in the registry record.

There are two named assessment times: 4 weeks, described as the end of treatment, and 8 weeks, described as follow-up. Analyses of repeated measurements can be organized in different ways. They might estimate a group contrast at each time, a change over time, or a group-by-time pattern. These approaches answer different questions and rely on different modeling choices. The registry record does not report which approach was used, whether the assessments were analyzed jointly, or whether any adjustment was made for baseline score.

Missing outcomes matter because the observed scores may not represent all randomized participants. If missingness is related to symptoms, treatment experience, or other factors, an analysis restricted to observed scores may be biased. Statistical approaches can use different assumptions about missingness, and sensitivity analyses can test how conclusions change under alternatives. The registry record does not report the extent of missing IDAS-GD data, the reasons for missingness, the method used to address it, or any sensitivity analyses.

The record identifies randomization, a parallel design, and no masking. Those labels do not establish how the random sequence was generated, how allocation was concealed, or how adherence and deviations were handled. Those details are not reported in the registry record. Nor is a specific test, model, covariate adjustment, or analysis population reported. These omissions prevent a detailed appraisal of the statistical analysis and its assumptions.

The sample-size assumptions describe a planning illustration rather than the trial’s own design justification. They specify a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the target effect expressed as a stated fraction of the observed effect. The record does not report the trial’s own sample-size justification. Any sample-size values derived under the illustration are planning scenarios, not observed power and not evidence about the result. A calculation based on an observed effect does not establish that a study was adequately planned before outcomes were known.

Because the outcome is a bounded scale score, statistical interpretation should also consider whether the chosen analysis matches the data distribution and the estimand of interest. General statistical practice may evaluate the shape of the score distribution and the behavior of model residuals; no such diagnostics or modeling choices are reported in the registry record. Readers should not assume a particular analysis from the fact that the outcome is a mean.

Finally, the trial includes the randomized in-person comparison and a separately listed open trial using Zoom. Combining them into one estimate would require a clearly defined analysis and suitable comparability assumptions. The registry record does not report such an analysis. The two trial components should therefore remain distinct when interpreting the record.

10. Multiplicity, Missing Data and Analysis Populations

The primary outcome is named at two assessment times: 4 weeks and 8 weeks. Considering more than one time point can raise a multiplicity question if several tests or contrasts are used to make inferential claims. In general, testing multiple hypotheses can increase the chance of at least one apparently unusual result under a null model. Statistical plans may address this through a prespecified primary time point, an adjustment procedure, or a clear distinction between primary and secondary analyses. The registry record does not report how multiplicity was handled or which time point, if either, was designated as the main inferential comparison.

The record identifies one outcome measure, but it does not provide a complete analysis plan or list any multiplicity adjustment. It is therefore not possible to determine whether the analyses included additional outcomes or contrasts beyond the named IDAS-GD assessments. The number of outcome measures recorded does not, by itself, describe the full set of analyses performed.

Missing-data methods are also not reported in the registry record. The number of participants with observed scores at each assessment, reasons for missing data, and methods for addressing missingness are not stated. Without this information, readers cannot assess whether the analyzed outcome data may differ systematically from the intended study population.

The analysis population is not reported in the registry record. In particular, the record does not say whether participants were analyzed according to randomized assignment, according to treatment received, or under another rule. It also does not report how protocol deviations or participants who did not complete treatment were handled. These details affect the meaning of an estimated treatment contrast and its relationship to the randomized comparison.

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 record reports no serious adverse events in the listed groups. For the randomized in-person Listening Visits group, 20 were at risk and 0 serious events were reported. For the usual mental health care group, 22 were at risk and 0 serious events were reported. For the Zoom open-trial group, 9 were at risk and 0 serious events were reported. The record also reports 0 other adverse events for each group and 0 deaths for each group.

These figures are counts within the listed safety groups, not estimates of comparative risk. A zero count means no event of that category was recorded in the registry results for that group; it does not prove that the risk is absent. The counts also do not establish that safety monitoring detected every event or that the groups had equivalent safety experience. The registry record does not report serious adverse event terms, and the list of top serious terms is empty.

Interpretation is limited by the absence of event descriptions, timing, severity details beyond the serious-event category, and information on how events were collected and assessed. The safety counts should be read separately from the IDAS-GD symptom outcome. They do not provide evidence about the size or precision of a depression-symptom comparison.

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

This record documents a randomized evaluation of in-person Listening Visits delivered by NICU nurses compared with usual mental health care from NICU social workers, as well as a separate open trial of visits delivered via Zoom. It identifies depression symptoms measured by the IDAS-GD as the primary outcome and names assessments at the end of treatment and follow-up. Those details describe the research question and design, not the results of the outcome comparison.

The registry record does not report the primary outcome means, standard deviations, treatment-effect estimates, confidence intervals, or p-values. Consequently, it does not allow readers to determine the observed difference between randomized groups, the precision of an estimate, or whether scores varied across assessment times. The record also does not report a threshold for clinical importance, so the clinical meaning of any possible score difference cannot be assessed from this record.

The record’s brief summary describes expected benefits and possible wider effects as the rationale for the research. A rationale is not an observed result. Similarly, completion status and a randomized design do not establish an intervention effect. The available safety counts indicate that no serious or other adverse events and no deaths were recorded in the listed groups, but zero recorded events should not be interpreted as proof of no risk or as a comparison demonstrating equal safety.

The findings cannot be generalized from this registry entry alone. Detailed participant characteristics, outcome completeness, analysis methods, and estimates of uncertainty are not reported. The separate Zoom open trial also should not be treated as an additional randomized comparison without evidence that it was designed and analyzed that way. The record supports a description of the study’s structure and measurement, but not a conclusion about benefit, lack of benefit, or comparative effectiveness.

13. Why This Trial Matters Statistically

The study addresses an outcome that can be summarized quantitatively: depression symptoms measured with a defined scale and assessed at the end of treatment and at follow-up. This offers a clear example of why an outcome name and measurement schedule are not enough to interpret a trial. Readers also need the observed group summaries, an estimate of the comparison, and information about uncertainty and missing data.

The design distinguishes a randomized comparison of in-person nurse-delivered Listening Visits with usual social-work mental health care from a separately listed open trial using Zoom. Maintaining that distinction matters statistically. Estimates from a randomized contrast and descriptions from an open trial answer different questions and depend on different assumptions. The registry record does not report an analysis that combines them.

The outcome is a self-report symptom score, so its interpretation depends on the scale’s content, scoring, and context. The record explains the score range and direction, but does not report a clinically meaningful threshold or outcome estimates. Statistical significance, if it had been reported, would not alone answer whether a difference was important to participants. Conversely, a result that is imprecise cannot be treated as evidence that groups are equivalent.

This record also illustrates the importance of reporting analysis populations, outcome completion, multiplicity decisions, and analysis methods. Without those details, readers cannot fully evaluate the credibility or precision of a comparison. The missing results do not show that the trial lacked value; they limit the claims that can be made from the registry record. Clear reporting of estimates and uncertainty is essential for translating a trial design into interpretable evidence.

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 primary limitation for interpreting the trial from this record is that the primary outcome results are not reported. There are no means or standard deviations for the IDAS-GD assessments, and no estimated group contrasts or measures of uncertainty. This prevents a quantitative account of the observed depression-symptom results.

The registry record does not report participant characteristics, baseline IDAS-GD scores, outcome completion at either assessment, or reasons for missing measurements. Although enrollment is recorded as 55, the number contributing to each analysis is not stated. It is not possible to judge from the record whether missing outcomes could affect the comparison or how representative the measured participants were.

Analysis details are also limited. The record does not report the statistical model or test, handling of repeated assessments, adjustment for baseline measurements, analysis population, missing-data approach, multiplicity procedure, or sensitivity analyses. It does not provide allocation-concealment procedures, treatment adherence, or protocol-deviation information. These details are relevant to judging bias and precision, but should not be inferred from the design labels.

The separate open trial of Zoom-delivered visits is listed alongside the randomized in-person comparison. The registry record does not report enough information to establish its relationship to the randomized trial’s outcome analyses or to support a combined estimate. The absence of masking is recorded, but its practical influence on the self-reported outcome cannot be determined from the available information.

Finally, the registry record does not report a clinical-importance threshold for the IDAS-GD score. Even if outcome estimates were available, judging their practical meaning would require context beyond a statistical comparison. These limitations apply to interpretation of the registry record and should not be mistaken for proof that the underlying study did not collect or analyze additional information.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Listening Visits for Emotionally Distressed Mothers of Hospitalized Newborns — NCT03704948.
• Registry record last updated 2023-09-29; status last verified 2023-09.
• Results first posted 2023-09-29.
• 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 NCT03704948, titled “Listening Visits for Emotionally Distressed Mothers of Hospitalized Newborns.” It lists a parallel randomized trial of in-person Listening Visits delivered by NICU nurses versus usual mental health care delivered by NICU social workers, with no masking. A separate open trial of nurse-delivered visits via Zoom is also listed. The study is marked completed, enrollment is 55, and the phase is listed as NA.

The primary outcome is mean IDAS-GD score at 4 weeks, the end of treatment, and 8 weeks, follow-up. Higher scores indicate more depression symptoms. The registry record does not report the group outcome summaries or statistical comparisons, nor does it report the analysis population or missing-data methods. It records 0 serious adverse events, 0 other adverse events, and 0 deaths in each listed safety group.