Room to Grow Evaluation for Children: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Room to Grow Evaluation for Children (NCT04226053), a randomized na study. The primary outcome is Mean Score of Depressive Symptoms Using the CES-D Scale.

2. Clinical Question

3. Trial Design

Room to Grow Evaluation for Children (NCT04226053) is listed as a randomized, parallel-group trial with no masking. The registry lists Columbia University as the sponsor, the condition categories Parenting and Child Development, and the intervention name Parenting, Child Development. The study is marked completed. Its listed start date is 2017-03-31 and its primary completion date is 2023-10-04.

The registry reports enrollment of 322. The primary-outcome description separately refers to 320 participants enrolled and gives baseline survey counts: 158 of 161 in the intervention group and 158 of 159 in the control group were included in the baseline analysis. It says one control participant refused questions and was omitted. The reason that the overall enrollment figure differs from the count in the outcome description is not reported in the registry record.

The intervention was intended to provide mothers and babies with Room to Grow services, while controls did not receive those services. The brief study description characterizes the program as support over the child’s first three years, combining individualized sessions and ongoing communication with material assistance and referrals. The detailed intervention-group description is cut off in the registry record, so further implementation details are not available there.

The listed phase is NA. The record does not report the randomization sequence method, allocation concealment, a sample-size justification, or a detailed statistical analysis plan. These details should not be inferred from the randomized label or from the planning illustration described in 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.

Before assignment: 320 participants were enrolled and randomized to treatment. Children born during the study were not considered enrolled, however, they did contribute to assessments in the final study period.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Of the 320 participants enrolled, 158 out of 161 in the Intervention Group went on to baseline survey and were included in the analysis. 159 out of 159 in the Control Group went on to baseline survey but 1 participant in this group refused questions and was omitted, so 158 out of 159 were included in the analysis. Due to attrition, not all participants participated in the subsequent study periods; the number of participants analyzed at each survey wave are listed below under Number Analyzed.

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 Score of Depressive Symptoms Using the CES-D Scale, measured over At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child.

The primary endpoint is the mean score for depressive symptoms measured with the Center for Epidemiological Studies-Depression scale, or CES-D. The registry describes the scale as asking caregivers how often during the past week they experienced symptoms associated with depression, with examples including restless sleep, poor appetite, and feeling lonely. For the full 20-item measure, the record gives a score range of 0 to 60 and states that higher scores indicate greater depressive symptoms.

The assessment schedule includes baseline, at weeks 28-34 of pregnancy, and follow-up at 10.5 months and 25 months after the child’s birth. The record says the baseline and 25-month surveys included 12 items, while the 10.5-month survey included 7 items. It gives subscale score ranges of 0 to 21 and 0 to 36, respectively, and says higher scores indicate greater depressive symptoms. The registry description does not clarify how those two ranges correspond to the assessment points.

In general, a symptom scale provides a structured way to quantify reported experiences, allowing group averages to be compared. A mean describes the average score in a group, while the standard deviation describes variation among participants. The registry identifies the mean as the outcome measure and standard deviation as its dispersion measure. It does not report the outcome values needed to interpret the observed group averages.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a randomized, parallel-group design with no masking. Randomization is a method intended to assign participants to groups by chance, helping make baseline differences less systematic on average. A parallel-group design assigns participants to one group for comparison with another. These general properties do not establish how the sequence was generated, whether allocation was concealed, or how analyses were conducted; those details are not reported in the registry record.

What does a mean and standard deviation describe?

The primary outcome is a mean score, with standard deviation named as the measure of dispersion. In general, the mean summarizes the average observed score in a group. The standard deviation describes how spread out individual scores are around that average. A mean alone does not show the range of individual experiences, and a standard deviation is not the uncertainty of the mean or the uncertainty of a treatment contrast.

For a comparison between randomized groups, an analysis might estimate a difference in mean scores. Its interpretation depends on the time point, the participants included, and the analysis method. The registry record does not report such estimates for the CES-D outcome, so no contrast can be interpreted from the posted outcome information.

Why do assessment times matter?

The registry names baseline, 10.5 months after birth, and 25 months after birth as assessment points. These are separate occasions, not interchangeable measurements. In general, repeated measurements on the same participant may be statistically related. An analysis that uses multiple occasions may need to account for that relationship, but the particular model, covariance assumptions, and handling of time are not reported in the registry record. The record also does not report whether the main comparison was specified at one time point or across several.

The questionnaire content differs across assessment occasions: the baseline and 25-month surveys used 12 items, and the 10.5-month survey used 7 items. The registry gives two subscale ranges but does not clarify their mapping to those occasions. This limits the extent to which a reader can assess comparability of scores across time from the description alone. The record does not describe any additional scoring or standardization procedures.

What can a confidence interval and p-value tell a reader?

In general, a confidence interval expresses uncertainty around an estimated quantity under the assumptions of a statistical method. For a group contrast, it can communicate both the range of plausible values and how precisely the contrast was estimated. A p-value describes the compatibility of the data with a stated null hypothesis and model assumptions. Neither is a substitute for the estimate itself, and a p-value alone does not convey the size or importance of a difference. No confidence intervals or p-values for this primary endpoint are reported in the registry record.

How should the planning illustration be understood?

The record describes a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. The illustration is explicitly not the trial’s own design, and it is not a report of trial power. Sample-size figures for a hypothetical design are planning illustrations, not observed power and not evidence that the study was adequately or inadequately powered. The numerical planning outputs are not reported in the registry record.

The assumptions matter because planning results depend on the effect chosen for detection, variability, allocation, and the statistical method. If a planning illustration is based on an observed effect, it is a retrospective scenario rather than evidence about what investigators used when designing the trial. The record does not report a protocol-based sample-size justification, the assumed primary contrast, or the source of the effect used in that illustration.

What does the analysis count establish?

The record lists zero analyses. This means analysis results are not reported in the registry record; it does not establish that investigators performed no analyses. The record lists 14 outcome measures, but does not provide a comprehensive account of models, covariate adjustment, missing-data methods, or analysis populations. Those methodological details cannot be reconstructed from the design label or endpoint description.

10. Multiplicity, Missing Data and Analysis Populations

The primary endpoint is reported at three assessment points. The registry record says the outcome has several categories or time points and was not reduced to one comparison. No multiplicity adjustment, hierarchy of hypotheses, or prespecified primary contrast is reported in the registry record. Because several time points can lead to multiple statistical comparisons, readers would need the analysis plan and results to understand how any multiplicity was handled. Neither is available in the registry record.

The record lists 14 outcome measures and zero analyses. It does not specify which outcomes were included in formal analyses, whether any were secondary or exploratory, or how multiple outcomes were considered. The absence of reported analyses should not be read as proof that no analysis took place.

For the primary outcome at baseline, the record reports 158 of 161 intervention participants included and 158 of 159 control participants included. It states that one control participant refused questions and was omitted. Follow-up sample sizes, reasons for any other missing measurements, and missing-data methods are not reported in the registry record. The record also does not state whether analyses followed the randomized assignment regardless of service receipt, used observed cases, or applied another approach.

In general, missing data can affect both precision and the interpretation of estimates, depending on why measurements are absent and how the analysis handles them. The baseline counts alone do not establish the extent or handling of missing data at later assessments. The analysis populations and any sensitivity analyses are not reported in the registry record.

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 reports zero serious adverse events and zero deaths in each group. For the intervention group, 158 participants are listed as at risk for serious events and 158 as at risk for other adverse events. For the control group, the corresponding figures are 159 and 159. The registry lists zero participants affected in each of those categories.

These figures describe what is posted in the registry record for the listed groups and categories. They do not establish that every possible safety event was assessed or that none occurred outside the recorded categories. The record does not provide serious adverse event terms, event narratives, severity details, or information about how events were collected. No serious-event terms are listed.

In general, a zero count in a registry entry means that no events were recorded in that entry; it should not be treated as proof of zero risk. Safety interpretation also depends on the number of participants monitored, the observation period, event definitions, and completeness of reporting. The figures do not allow a broader safety conclusion about the program.

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

The registry record identifies a randomized comparison of Room to Grow services with a control group that did not receive those services. It specifies mean depressive-symptom score as the primary outcome, measured at baseline and at two follow-up times. It also describes the CES-D scoring approach and gives baseline inclusion counts for the outcome analysis.

What the record does not provide is the outcome information needed to estimate a group difference: there are no reported group means, standard deviations, contrasts, confidence intervals, or p-values for the primary endpoint. Therefore, the record does not establish whether scores differed between groups, in which direction any difference went, how large it was, or how precisely it was estimated. It also does not support a conclusion about the effect of Room to Grow on depressive symptoms.

In general, randomized allocation can support a causal comparison when the trial is implemented and analyzed appropriately, but the design label alone does not supply the result or verify the analysis. Interpretation of repeated outcomes also requires knowing which comparisons were prespecified and how missing measurements and multiple time points were handled. Those details are not reported in the registry record.

The zero adverse-event counts are limited to the categories and groups recorded. They do not establish the absence of all possible harms or provide enough information for a broad safety assessment. Likewise, the planning illustration is not evidence about the observed treatment effect or the trial’s original sample-size rationale.

The most defensible reading is descriptive: the registry records a randomized parallel-group study, a CES-D primary outcome at three times, baseline analysis counts, and no posted primary-outcome analysis. Any stronger claim about an outcome difference, its importance, or its reliability would go beyond what is reported.

13. Why This Trial Matters Statistically

This trial is statistically notable because its registered primary outcome is measured at multiple points and the registry record does not reduce those measurements to a single comparison. That makes the definition of the target contrast important: a baseline comparison, a follow-up comparison, and a comparison of change over time are different statistical questions. The registry does not report which one was intended as the principal estimate.

The endpoint description also notes that different numbers of CES-D items were used across assessments. The record gives subscale ranges but does not clarify how they map to the assessment times. That reporting detail matters when readers consider whether scores can be compared directly across occasions.

Randomized allocation is a useful design feature for comparing groups, but it does not resolve questions about outcome reporting, missing measurements, multiple comparisons, or the analysis population. Here, the registry identifies an outcome and gives baseline inclusion information but reports no analyses. The result is a clear distinction between having a registered statistical question and having enough posted numerical results to answer it.

Finally, a planning illustration based on an observed effect should not be confused with a prospective design justification or with observed power. This distinction is important for readers assessing what sample-size scenarios mean. The registry record does not report the original sample-size rationale or the outcome estimates needed to evaluate the observed statistical precision.

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 this trial from its registry record is the absence of reported primary-outcome results. No group means, standard deviations, treatment contrasts, confidence intervals, or p-values are listed for the CES-D endpoint. The record therefore does not permit assessment of the observed difference or its precision.

The registry identifies three assessment points but does not report a single primary comparison or explain how repeated measurements were analyzed. It also does not describe multiplicity handling, missing-data methods, analysis populations, covariate adjustment, or sensitivity analyses. The baseline outcome description gives group inclusion counts and notes one control participant’s refusal, but follow-up counts and reasons for missing measurements are not reported in the registry record.

The record reports overall enrollment of 322, while its primary-outcome description refers to 320 participants and gives group counts totaling that outcome population. The reason for this difference is not reported. The intervention-group description is incomplete, and the subscale ranges are not clearly mapped to the survey occasions. These reporting gaps constrain interpretation of enrollment, intervention delivery, and score comparability.

Although adverse-event counts are listed, details about event collection and definitions are not reported. The registry’s planning illustration is described as separate from the trial’s own design, and the trial’s sample-size justification is not reported in the registry record. These limitations concern the information available in the registry and should not be taken as proof about analyses or procedures that may have occurred but are not recorded there.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Room to Grow Evaluation for Children — NCT04226053.
• Registry record last updated 2026-05-22; status last verified 2026-05.
• Results first posted 2026-05-22.
• 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.

18. Record Summary

NCT04226053, Room to Grow Evaluation for Children, is listed as a completed randomized parallel-group trial sponsored by Columbia University, with no masking. The registry reports enrollment of 322 and identifies Parenting and Child Development as conditions. The intervention involved Room to Grow services; the control group did not receive those services.

The primary outcome is mean CES-D depressive-symptom score at baseline, 10.5 months after birth, and 25 months after birth. The record reports baseline inclusion counts by group, but does not report primary-outcome results or analyses. It lists 14 outcome measures and zero analyses. Serious adverse events, other adverse events, and deaths are recorded as zero in both groups.

The registry does not report a single primary comparison, a detailed analysis plan, or the trial’s sample-size justification. The available record therefore describes the study design and endpoint but does not provide enough outcome results to estimate the intervention-control difference in depressive-symptom scores.