Bringing Education Through Technology, Empathic Listening, and Research: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Bringing Education Through Technology, Empathic Listening, and Research (NCT05214118), a randomized na study. The primary outcome is Feasibility of the Intervention.

2. Clinical Question

The randomized comparison can describe how the posted feasibility scores differed between the technology-based program and brochure groups. It cannot, by itself, establish whether the program changes health outcomes or whether the findings apply to people outside the study population. The registry record does not report detailed eligibility criteria or a broader clinical effectiveness question.

3. Trial Design

Project BETTER was a randomized, parallel-group feasibility trial. The registry lists an enrollment of 29 and describes two groups: a brochure group and a technology-based program group. Masking is listed as none, so the study was not masked according to the registry. The record lists the phase as NA and the status as completed.

The study began on 2022-02-02, and its primary completion date was 2024-01-22. Its stated purpose was to test a technology-based educational program and brochure as supplements to prenatal education from providers. The educational content addresses challenges that pregnant and parenting women receiving medication for OUD may face, including the transition to postpartum, possible NAS or NOWS, and child-welfare interactions.

The primary outcome was a summed feasibility score, assessed within 2 weeks of intervention completion. The primary outcome results list 11 participants in the brochure group and 13 in the technology-based program group. These outcome-specific counts do not account for every participant in the listed enrollment. The reason for the difference is not reported in the registry record.

The record also names Change in Perceived Competence and Change in Parental Competence as secondary outcomes. The posted parental competence results use different group counts from the primary outcome. The registry lists four outcome measures, but the outcome results available for interpretation include the primary feasibility measure and two secondary measures. The record does not describe all measurement procedures or explain the relation between the number of listed measures and the number with posted results.

Details of the randomization procedure, the original sample-size justification, the intended analysis population, and any interim analyses are not reported in the registry record. The small enrollment and feasibility focus are important context for interpreting the estimates: the study reports preliminary outcome summaries, while the precision of the group comparisons remains limited.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Participants will complete a survey about the feasibility of the intervention consisting of 4 items rated on a 0 to 6 scale. Scores will be summed to yield a final feasibility score ranging from 0 to 24. Higher scores indicate higher feasibility.

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 Feasibility of the Intervention, measured over Within 2 weeks of completing the intervention.

The primary endpoint was the feasibility of the intervention, measured using a survey completed within 2 weeks of intervention completion. The survey contained four items rated on a 0 to 6 scale. The item scores were summed, giving a final score from 0 to 24, with higher scores representing higher feasibility. The registry reports the group mean and standard deviation for this continuous measure.

A feasibility measure is useful when a study is testing whether an intervention can be delivered and assessed in its intended setting. It can provide information about participants’ ratings of the intervention and help identify whether further evaluation is warranted. It is distinct from an outcome that measures health status, infant outcomes, or the effectiveness of treatment. A high score on this survey would indicate a higher feasibility rating under the measure’s stated scoring rule; it would not establish that the program improves clinical outcomes.

The registry does not report a threshold defining an acceptable feasibility score or a threshold for a meaningful difference between groups. Without such a threshold, the mean scores and their uncertainty can be described, but they cannot be classified against a prespecified standard of feasibility based on the record.

7. Results Posted in the Registry

• Technology-based Program: mean 21.20 versus 21.50 on control; difference -0.30 (95% CI -2.38 to 1.78), standardized effect d = -0.11; z-test p = 0.778.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Change in Parental Competence

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Technology-based Program: mean -1.50 versus 3.30 on control; difference -4.80 (95% CI -13.56 to 3.96), standardized effect d = -0.47; z-test p = 0.283.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Technology-based Program and the control. The interval gives the range of effects that remain compatible with the data.

The registry names Change in Perceived Competence and Change in Parental Competence as secondary outcomes. It posts results for Change in Parental Competence, with the comparison expressed as a change from baseline to within 2 weeks of intervention completion, up to 5 weeks. The posted results for this outcome are a distinct measure from the primary feasibility score; their scale and timing should not be conflated with the primary endpoint.

Across the posted comparisons, the recalculated technology-based-program-minus-brochure point estimates are below zero. This shared direction is only a description of the estimates: the outcomes measure different constructs, and their units and interpretations are not interchangeable. In particular, a feasibility rating and a change in parental competence answer different questions. The secondary result does not confirm or directly explain the primary result.

The secondary comparison has a confidence interval that includes zero and an unadjusted p-value of 0.283. Its estimate is therefore uncertain, as is the primary estimate. The registry lists no reported analyses, and does not report a multiplicity strategy. When several outcomes are examined, unadjusted results do not account for the increased opportunity to find a nominally unusual result by chance. Secondary findings therefore generally carry less confirmatory weight than a prespecified primary analysis, especially when their analysis plan and relationship to other outcomes are not described.

The registry lists four outcome measures, but the named secondary outcomes and posted results do not account for every measure in a way the record explains. The reason is not reported. Nor does the registry give enough detail to establish whether the secondary outcomes were prespecified in the same form as posted, whether all intended analyses were completed, or how missing observations were handled. These limitations favor treating the secondary results as descriptive and hypothesis-generating rather than as independent evidence of an effect.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Change in Perceived Competence
• Change in Parental Competence

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous: each participant’s summed survey score can take values from 0 to 24. The registry reports a mean and standard deviation for each group. A mean describes the group’s average score. A standard deviation describes the spread of individual scores around that mean; it is not the uncertainty in the mean itself. The primary outcome summaries are 21.5 with a standard deviation of 2.3 for the brochure group, and 21.2 with a standard deviation of 2.9 for the technology-based program group.

What does the mean difference represent?

The recalculated mean difference is technology-based program minus brochure. Its estimate of -0.3 means that the posted average score was lower in the technology-based program group by that amount on the feasibility scale. The sign depends on the stated subtraction order: a negative estimate points toward a lower mean in the technology-based program group, while a positive estimate would point toward a higher mean in that group. This arithmetic description does not establish a meaningful or causal effect.

What does a confidence interval add?

A confidence interval communicates the uncertainty around an estimate under the assumptions of the calculation. The 95% confidence interval for the primary mean difference runs from -2.381 to 1.781. Because it includes zero, the posted summaries do not distinguish clearly between a difference favoring either group and little or no difference. The interval also shows that the estimate is not precise enough to support a narrow range of plausible group contrasts. General interpretation of a confidence interval is conditional on the method and assumptions used; the registry record does not describe a full statistical analysis plan.

What does the p-value say?

The unadjusted p-value is 0.778. A p-value describes how compatible the data are with a null hypothesis under a specified statistical model; it is not the probability that the null hypothesis is true, and it does not measure the size or importance of an effect. This value does not establish that the groups are equivalent. It should be considered alongside the estimate and confidence interval, especially because the comparison is based on limited outcome counts.

Why distinguish posted results from recalculation?

The registry provides group summary statistics, while the mean difference, confidence interval, and p-value discussed for this comparison are simple unadjusted recalculations from those summaries. Such a comparison does not adjust for baseline characteristics or other covariates. The record lists no reported analyses, and does not state the statistical test or model used in any sponsor analysis. No discrepancy is flagged between the posted values and the recalculation. When a discrepancy is flagged, the sponsor’s own analysis takes precedence; that situation is not indicated for this comparison.

Why does spread matter?

Variation among individual scores affects how precisely a group mean and the contrast between groups can be estimated. Standard deviations describe that variation. In general, greater variability makes it harder to estimate a group contrast precisely when other design features are held constant. The primary group standard deviations are 2.3 and 2.9. The recalculated pooled standard deviation is 2.644; pooling provides a common spread estimate for a standardized comparison under the calculation’s assumptions. The record does not report a clinical interpretation or meaningful-difference threshold for the feasibility scale.

What should be inferred from the design?

Random allocation is intended to support a fair comparison of assigned groups, but the registry’s design label alone does not establish how allocation was generated or concealed. Masking is listed as none, and the outcome is a participant-rated survey. General statistical reasoning recognizes that awareness of group assignment can affect subjective ratings, but the record does not show whether or how this occurred. The parallel model means the groups are described as separate arms rather than as repeated periods of treatment. Further details about implementation and analysis are not reported in the registry record.

11. Confidence Intervals and Precision

Precision is about how tightly the data locate an estimate, rather than whether the estimated difference is important. For the primary outcome, the recalculated mean difference is -0.3, and the 95% confidence interval ranges from -2.381 to 1.781. That interval includes zero and includes differences in either direction. It therefore leaves uncertainty about the direction and size of the group contrast.

The width of a confidence interval reflects the amount of information in the data together with the variability and calculation assumptions. The primary outcome results list 11 participants in the brochure group and 13 in the technology-based program group, with standard deviations of 2.3 and 2.9. These summaries are consistent with an estimate that should not be treated as exact. The confidence interval is more informative about uncertainty than the point estimate alone, but it does not account for unreported features such as missing-data handling or a prespecified analysis plan.

The interval is not a range containing 95% of individual participant scores. It is an interval for the group mean difference under the calculation’s assumptions. Nor does inclusion of zero prove that the true difference is zero. To make a claim of equivalence or non-inferiority, a study would need an appropriate design and a margin defined before interpreting results; such a margin is not reported in the registry record.

The comparison is a recalculation from summary statistics, not a reported adjusted analysis. The registry lists no reported analyses, and no discrepancy is flagged. The precision shown should therefore be understood as the uncertainty from the simple unadjusted comparison, not as a complete account of all possible sources of uncertainty in the trial.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size figures are planning illustrations based on the observed effect, not the trial’s original design assumptions. The planning assumptions listed are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is the stated fraction of the observed effect. These figures are participants per arm, not total events; the event-count convention applies to time-to-event outcomes, which are not the outcome type in this trial.

The 80% power column gives the estimated participants per arm for a future study to have an 80% chance of detecting the specified effect under the listed assumptions, if that effect and the model assumptions are correct. The 90% power column gives the corresponding planning count for a 90% chance. Power is a design concept, not a measure of how likely the observed result is to be true.

The planning rows use 100%, 75%, and 50% of the observed effect. For 100% of the observed effect, the illustration gives 1,220 participants per arm for 80% power and 1,633 for 90% power. For 75% of the observed effect, it gives 2,169 participants per arm for 80% power and 2,903 for 90% power. For 50% of the observed effect, it gives 4,879 participants per arm for 80% power and 6,531 for 90% power. The figures increase as the target effect becomes smaller because smaller differences are harder to distinguish from sampling variation.

These are not observed power calculations and should not be read as a retrospective judgment of whether the completed trial was adequately powered. They are illustrations derived from the observed effect, which itself is uncertain. The original trial’s sample-size justification and design assumptions are not reported in the registry record.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -0.300; pooled standard deviation σ = 2.644.
2. n = 2 × (1.96 + 0.842)² × 2.644² / -0.300² = 1,219.5, rounded up to 1,220 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -0.300000000000001                      # observed difference in means
sigma <- 2.64420464068464                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(5214118)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 1,220 (80% power), 1,633 (90% power)
 75% of observed effect: n per arm = 2,169 (80% power), 2,903 (90% power)
 50% of observed effect: n per arm = 4,879 (80% power), 6,531 (90% power)
power.t.test: 1220.5 
Simulated power at n = 1,220 per arm: 0.797 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The registry identifies a primary feasibility outcome and names secondary outcomes, but it does not report how multiplicity was handled. Multiplicity arises when a study examines several outcomes, time points, or comparisons: each additional analysis creates another opportunity for a chance finding. General statistical methods address this in different ways, but none should be attributed to this trial without documentation. The posted secondary p-value is unadjusted, and the record lists no reported analyses or multiplicity procedure.

The registry lists four outcome measures and names Change in Perceived Competence and Change in Parental Competence as secondary outcomes. The result details available for interpretation do not provide a complete account of all outcome measures. Whether other outcomes were collected, omitted from the posted results, or treated differently is not reported in the registry record. This limits any assessment of selective reporting or of the complete set of comparisons performed.

Missing-data handling is also not reported. The primary result counts are 11 in the brochure group and 13 in the technology-based program group; the parental competence result counts are 12 and 10, respectively. The record does not explain why the outcome counts differ or whether missing observations occurred. It does not say whether the analyses used all randomized participants, only participants with observed outcomes, or another analysis population. The reason for the outcome-specific counts should not be guessed.

The record does not report whether imputation, sensitivity analyses, or other methods were used to address missing outcomes. In general, missingness can affect estimates if participants without outcome data differ systematically from those with data. Without details about missingness and analysis populations, the posted summaries cannot establish whether missing data may have influenced the comparisons.

The original statistical analysis plan, any interim analyses, and the trial’s sample-size justification are not reported in the registry record. These omissions do not invalidate the posted descriptive values, but they restrict evaluation of how closely the results follow a prespecified analysis strategy and how comprehensively the trial’s outcomes are represented.

15. 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.

Most frequent serious adverse event terms

Serious events with the highest arm-level rate: cardiac disorders (7.7%).

The registry lists serious adverse event counts for 13 participants at risk in the brochure group and 16 in the technology-based program group. One serious adverse event is listed for the brochure group and none for the technology-based program group. The record lists zero other adverse events in each group and zero deaths in each group. These figures are counts as recorded, not estimates of comparative risk.

The registry also lists Cardiac disorders with a percentage of 7.7% among the top serious terms. The record excerpt does not identify the arm for that term, so it should not be assigned to one group based on the listed summary alone. The serious-event counts and the term listing are not a basis for inferring a treatment effect on safety.

These are small group counts in a feasibility trial. A lack of listed events in a group does not establish that no risk exists, and a listed event does not establish that the intervention caused it. The registry record does not report further details needed to assess event timing, severity, relatedness, or how events were collected. The outcome-specific counts for safety should be kept distinct from the counts reported for the feasibility and secondary outcome measures.

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

The central result is a small estimated difference in mean feasibility score between the technology-based program and brochure groups, with a confidence interval that spans zero and values in either direction. The posted summaries therefore leave uncertainty about the direction and size of the group difference. They do not demonstrate that the groups are equivalent, nor do they establish a clinically important advantage for either educational format.

The outcome is a participant survey about feasibility, not a measure of whether the program improves health or other clinical outcomes. The record’s description explains why the educational topics may matter to pregnant and parenting women receiving medication for OUD, but the posted feasibility result cannot answer whether the technology-based program affects pregnancy, postpartum, infant, or child-welfare outcomes. Those effects were not established by this primary measure.

Randomization provides a design for comparing assigned groups, but details of the allocation procedure and analysis population are not reported. The study was not masked according to the registry. Because the primary outcome is a participant-rated survey, the absence of masking is relevant context; the registry does not indicate whether awareness of group assignment changed responses. The result should be understood as a comparison of the posted outcomes under the study conditions rather than a definitive estimate for all settings or populations.

The secondary outcome findings are also uncertain and do not replace the primary feasibility result. The registry does not report a multiplicity strategy, missing-data approach, or complete analysis plan. These omissions, along with the limited outcome counts, mean that the posted results are best read as preliminary descriptive evidence from a feasibility study. They can inform questions for further evaluation, but they do not settle whether the program is effective or how it compares with other educational approaches.

The safety entries list a serious event in the brochure group and none in the technology-based program group, with no other adverse events or deaths listed in either group. Given the small counts and limited event detail, these figures do not establish comparative safety. The registry record also does not report enough information to attribute events to either educational approach.

17. Why This Trial Matters Statistically

This trial is statistically informative in part because it separates a feasibility question from a clinical effectiveness question. The primary measure assesses participants’ ratings of an educational intervention. That outcome can help characterize how an intervention is received, but it should not be mistaken for evidence about health outcomes. Keeping those questions distinct prevents a feasibility score from being interpreted as proof of clinical benefit.

The comparison also illustrates why an estimate should be read together with its uncertainty. The primary mean difference is close to zero, but the confidence interval spans values in both directions. The point estimate alone could sound more definitive than the data warrant. The interval makes clear that the available results do not narrowly locate the group contrast.

The planning illustrations provide another statistical lesson: a sample-size calculation depends on the effect a future study aims to detect. Smaller target effects require more participants under the listed assumptions. Because the observed effect is uncertain, planning from it is an illustration rather than a firm forecast. The original design assumptions are not reported, so the illustration should not be treated as the trial’s own justification.

Finally, the record shows why completeness of reporting matters. The registry lists several outcome measures, while detailed analysis plans, missing-data handling, multiplicity procedures, and analysis populations are not reported. Those details affect how confidently readers can assess selective reporting and the robustness of comparisons. For biostatisticians and clinical researchers, the trial is a useful example of reading randomized feasibility results with attention to estimand, precision, and reporting limits, without stretching descriptive findings into claims the data do not answer.

18. 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 comparison is based on outcome counts of 11 in the brochure group and 13 in the technology-based program group, despite the listed enrollment of 29. The registry does not explain the difference between enrollment and the primary outcome counts. The parental competence outcome has a different set of group counts, and the reason is also not reported. It is not possible to determine from the record whether these differences reflect missing observations, exclusions, or another process.

The registry does not report detailed eligibility criteria, the randomization procedure, allocation concealment, or the intended analysis population. Masking is listed as none. These design and implementation details would help readers judge how assignment and outcome measurement were handled. The record also does not describe the program’s delivery schedule, the brochure’s content, or the degree to which the study groups’ other prenatal education differed.

The primary endpoint is a feasibility survey, and the record provides no threshold for an acceptable score or a meaningful between-group difference. Consequently, the scale supports description of scores but does not supply a decision rule for judging the result. The posted confidence interval is based on a simple unadjusted recalculation rather than a reported adjusted analysis.

There is no reported multiplicity approach, missing-data method, interim-analysis plan, or original sample-size justification. The registry lists four outcome measures but does not fully explain the relationship between all measures and the posted result details. The safety record offers limited event detail and does not report relatedness or timing. Together, these gaps constrain interpretation of the results and their generalizability; they do not justify assumptions about unreported trial procedures.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Bringing Education Through Technology, Empathic Listening, and Research — NCT05214118.
• Registry record last updated 2025-07-18; status last verified 2025-06.
• Results first posted 2025-07-18.
• 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.

22. Record Summary

NCT05214118, Project BETTER, is a completed randomized parallel-group feasibility trial sponsored by Virginia Commonwealth University. The registry lists an enrollment of 29, no masking, and a brochure comparator. The technology-based educational program was intended to supplement prenatal education and address challenges related to pregnancy-to-postpartum transition, possible NAS or NOWS, and child-welfare interactions.

The primary outcome was a four-item feasibility survey scored from 0 to 24, completed within 2 weeks of intervention completion. The posted group means were 21.5 for brochure and 21.2 for the technology-based program. The recalculated unadjusted mean difference was -0.3, with a 95% confidence interval from -2.381 to 1.781 and an unadjusted p-value of 0.778.

The record names secondary competence outcomes and lists limited serious adverse event counts. The original sample-size justification, analysis populations, missing-data handling, multiplicity strategy, and detailed analysis plan are not reported in the registry record. The results are preliminary feasibility evidence and do not establish clinical effectiveness.