Study of an Online Program to Help Parents Talk With Their Tween Children About Health, Gender, Body-Image, and Relationships: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Study of an Online Program to Help Parents Talk With Their Tween Children About Health, Gender, Body-Image, and Relationships (NCT06408818), a randomized na study. The primary outcome is Change From Pretest in Child Report of Frequency of Parent-child Communication.

2. Clinical Question

3. Trial Design

The registry describes a randomized, double-masked, parallel-group study comparing Media Aware Parent -Tween with an active control resource. The study status is completed. Its registry enrollment is 390. The outcome summaries list 98 participants for the intervention and 97 for the active control; these are the group counts associated with the posted primary outcome summaries, not a description of everyone enrolled.

The intervention was an online program for parents of tweens ages 9–12. Parents in the active control group could access medically accurate information on related topics. The program was intended to support parent-child conversations about health and media, including topics such as body image and sexual development. The registry record does not explain the procedures used to generate the random allocation or identify which people were masked.

The study start date is 2024-05-06, and the primary completion date is 2025-03-24. The primary endpoint timeframe is pretest at baseline and posttest about four weeks after completion of the pretest questionnaire. The study phase is listed as NA. The record reports 13 outcome measures and 13 analyses, but does not describe the analysis plan, sample-size justification, interim analyses, or participant flow.

The primary endpoint is a continuous score derived from children’s responses about communication frequency. The study also reports a linear-regression analysis of final values and labels it an equivalence analysis. The record does not report the equivalence margin or a confidence interval for that sponsor analysis, so its equivalence claim cannot be evaluated from those details alone.

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

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.

Population: Parents and children who were eligible and completed pretest. (Intervention included 98 parent-child pairs and control included 97 parent-child pairs)

6. Primary Endpoint

The registry lists the primary outcome as Change From Pretest in Child Report of Frequency of Parent-child Communication, measured over Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion).

The primary endpoint concerns how often children say their parent has talked with them about 12 topics related to prepubescent health. Children respond on a Likert-type scale: 1 = Never, 2 = A little, and 3 = A lot. Item responses are averaged, and a higher score is defined as a more favorable outcome. The endpoint is expressed as a score on a scale.

The measure is intended to capture communication from the child’s perspective, rather than relying only on a parent’s account of what was discussed. It is relevant to the stated aim of helping parents have conversations with their children about health and media. It measures reported frequency across the specified topics; it does not directly measure conversation quality, knowledge gained, or later behavior.

The registry names the endpoint as change from pretest, with posttest about four weeks after the pretest questionnaire. However, the sponsor’s posted analysis is described as a mean difference in final values, and the arm summaries provide final scores. The registry record does not report a separate change estimate, baseline group scores, or the method used to handle incomplete item responses. Those omissions limit how fully the change endpoint can be reconstructed from the posted results.

7. Results Posted in the Registry

• Intervention Program: Media Aware Parent -Tween: mean 2.18 versus 2.20 on control; difference -0.02 (95% CI -0.15 to 0.11), standardized effect d = -0.04; z-test p = 0.755.

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is continuous: it is an average score formed from children’s responses about communication frequency. The registry reports group means and standard errors, and the sponsor reports a linear-regression mean difference in final values. The supplementary recalculation uses posted summary statistics to describe an unadjusted group contrast. It is not a replacement for the sponsor’s analysis.

What does a mean difference represent?

A mean difference expresses the average score in one group minus the average score in the comparison group. Here, the reported direction is intervention minus active control, and the difference is -0.02. A negative value means the intervention group’s posted final mean is lower on the outcome scale than the active control group’s mean. Since higher scores are defined as more favorable, the direction alone does not establish a meaningful disadvantage; the size and uncertainty of the contrast matter.

A group mean condenses responses into one summary. It does not show individual scores, the distribution of scores, or whether the intervention effect varies among participants. Nor does a final-score difference answer a change-from-baseline question unless baseline information and the relevant analysis are available. General: for a continuous outcome, a mean difference is naturally expressed in the original scale units, which can make its direction easier to interpret than a unitless effect measure.

Why report standard errors?

The arm summaries report standard errors of 0.05 and 0.04. A standard error describes the statistical uncertainty in an estimated mean, rather than the spread of individual participants’ scores. It generally becomes smaller when an estimate is more precise. It should not be read as a range containing most individual responses.

The recalculated contrast uses the posted group summaries and estimates an unadjusted difference. The registry record indicates that the standard deviations used in that recalculation are approximate, inferred from the reported standard errors and group counts. This makes the recalculated interval and test useful as a summary-statistic check, but they are not the sponsor’s regression analysis and do not account for any adjustments that may have been used in that analysis. Those adjustments are not reported in the registry record.

What does the p-value say?

The unadjusted recalculation reports p = 0.755. General: a p-value describes how compatible the observed data are with a specified null model, under the assumptions of the test. It is not the probability that the null hypothesis is true, and it does not measure the probability that the result will replicate. A value such as this does not prove equality or rule out differences that the study may not estimate precisely.

The sponsor’s reported p-value is 0.69, from a linear regression of final values. It is a separate result from the unadjusted recalculation. Since the registry record does not give the regression specification or its interval estimate, the p-values should not be treated as interchangeable. The sponsor labels its test as an equivalence analysis, but the record does not report the margin required to interpret that label.

What is the role of a confidence interval?

A confidence interval gives a range of effect estimates compatible with the data and the method used to calculate it. The recalculated interval for the mean difference extends across zero, so it includes both a small negative contrast and a small positive contrast. This indicates that the posted summaries do not pin down the direction of the underlying difference. The numerical endpoints are not repeated because the reported endpoints exceed the permitted display precision.

General: interval width conveys precision. A narrow interval indicates that the estimate is more tightly constrained under the model; a wide interval leaves a broader range of effects compatible with the data. Whether any particular range matters in practice requires a prespecified meaningful-difference threshold, which is not reported for this endpoint.

How does equivalence differ from a difference test?

General: a conventional test of difference asks whether the data are inconsistent with a zero difference. Equivalence asks whether the plausible difference is sufficiently contained within a prespecified range around zero. A result that does not reject zero difference cannot by itself establish equivalence, because the uncertainty may still include differences outside the acceptable range. The sponsor’s analysis is labeled equivalence, but the registry record does not report the margin or the interval needed to assess that conclusion independently.

The posted sample-size illustrations are based on the observed effect and specified planning assumptions, rather than the original trial design. They do not indicate how the study was originally planned. The original sample-size justification and statistical plan are not reported in the registry record.

10. Confidence Intervals and Precision

The unadjusted recalculation gives a mean difference of -0.02, with a confidence interval that crosses zero. The interval therefore does not isolate a single direction of difference: values on either side of zero remain compatible with the recalculated result. Its endpoints are not repeated because the registry-derived values have more than three decimal places.

Precision is distinct from whether a result is statistically significant or practically important. An interval describes uncertainty under the calculation method; a meaningful-difference threshold would help determine which values matter in context. The registry record does not report such a threshold for this score. It also does not give a confidence interval for the sponsor’s regression result, so the sponsor’s analysis cannot be compared with the recalculated interval on that basis.

The arm summaries report means of 2.18 and 2.2, with standard errors of 0.05 and 0.04. These standard errors describe uncertainty in the group means, not the range of children’s scores. The recalculation uses approximate standard deviations derived from those standard errors and the outcome group counts, and is unadjusted. Its interval should therefore be understood as a summary-statistic reanalysis rather than an adjusted estimate from the sponsor’s model.

The lack of a reported baseline score and change estimate also matters for precision and interpretation. The endpoint title specifies change from pretest, while the posted regression analysis is described as comparing final values. Without the baseline summaries, the size and uncertainty of the change contrast cannot be read from the posted final-value result.

11. 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 planning figures are participants per arm, not total events. They illustrate sample sizes for 80% and 90% power under the stated assumptions, using the observed effect as a reference and considering planning for 100%, 75%, and 50% of that observed effect. The assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. Time-to-event planning displays use total events, but this continuous outcome uses participants per arm.

For planning at 100% of the observed effect, the figures are 7,862 participants per arm for 80% power and 10,525 for 90% power. For planning at 75% of the observed effect, they are 13,977 and 18,711 participants per arm, respectively. For planning at 50% of the observed effect, they are 31,448 and 42,100 participants per arm, respectively.

In plain terms, the 80% power column gives the per-arm sample size associated with an 80% chance of detecting the specified effect under the calculation assumptions; the 90% column gives the corresponding size for a 90% chance. These are planning illustrations, not observed power. Smaller target effects require more participants to detect under the same assumptions, which is why the figures rise as the planning effect becomes a smaller share of the observed effect.

These calculations are based on the posted observed effect and are not the study’s original design justification. The registry record does not report the original sample-size assumptions or justification. The figures should not be read as evidence that the completed study had, or lacked, a particular power for its planned analysis.

12. 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 = -0.020; pooled standard deviation σ = 0.448.
2. n = 2 × (1.96 + 0.842)² × 0.448² / -0.020² = 7,861.9, rounded up to 7,862 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 <- -0.02                      # observed difference in means
sigma <- 0.447585346595537                     # 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(6408818)
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 = 7,862 (80% power), 10,525 (90% power)
 75% of observed effect: n per arm = 13,977 (80% power), 18,711 (90% power)
 50% of observed effect: n per arm = 31,448 (80% power), 42,100 (90% power)
power.t.test: 7862.9 
Simulated power at n = 7,862 per arm: 0.800 (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.

13. Analyses Reported by the Sponsor

The sponsor’s posted analysis is a linear regression comparing final values. It reports a mean difference of -0.02 and p = 0.69, and is classified in the registry as an equivalence analysis. The registry record does not give a confidence interval for this estimate or the equivalence margin used by the sponsor. Without those details, the equivalence conclusion cannot be checked from the posted record.

The supplementary recalculation is an unadjusted comparison derived from the group summaries. It reports the same mean difference of -0.02, with p = 0.755 and a confidence interval spanning zero. Its standard deviations are approximate, derived from the reported standard errors and group counts. It is not the sponsor’s regression model, and the two p-values need not match because the analyses differ in method and potentially in adjustment.

The registry record does not flag a discrepancy between the sponsor result and the recalculation. The sponsor’s result remains the reported analysis; the recalculation is a transparent summary-statistic comparison, not a correction or substitute. Neither the p-values nor the small point estimate alone establish equivalence. That assessment requires the sponsor’s prespecified margin and uncertainty estimate, which are not reported in the registry record.

14. Multiplicity, Missing Data and Analysis Populations

The registry record lists 13 outcome measures and 13 analyses, while the primary measure is the child-reported frequency of parent-child communication. It reports zero secondary outcomes posted. The record does not identify the other outcome measures in enough detail to assess how the primary endpoint fits within the full set of analyses.

When several outcomes or analyses are examined, the chance of at least one apparently notable result can increase. General: multiplicity procedures can control that risk, but the appropriate method depends on which outcomes were prespecified and how they are related. Whether any correction was planned or applied is not reported in the registry record. The reported unadjusted recalculation is not adjusted for multiple comparisons.

The primary endpoint title refers to change from pretest, but the sponsor analysis is described as a regression of final values. Baseline scores, a separate change estimate, and the relationship between those estimands are not reported in the registry record. The record also does not report how missing questionnaires or incomplete item responses were handled, whether all randomized participants were included, or the definitions of analysis populations.

Other details that would help evaluate the analysis are not reported in the registry record, including the regression covariates, model diagnostics, approach to departures from model assumptions, and handling of any protocol deviations. The record does not describe interim analyses or the statistical analysis plan. These omissions do not prove that such procedures were absent; they mean their use cannot be established from the registry record.

Because the endpoint aggregates responses across topics, item-level missingness and the rule for calculating an average could affect which scores are available. The registry record describes averaging item responses but does not state what happens when a child does not answer every item. The posted summary therefore supports interpretation of the reported group means, but not a full audit of the analysis population or missing-data methods.

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.

The registry reports zero serious adverse events in the intervention group, with 196 at risk, and zero in the active control group, with 194 at risk. It also reports zero other adverse events in both groups and zero deaths in both groups. These are the adverse-event figures recorded for the listed groups.

These counts should be read as registry-reported results, not as proof that no adverse experiences occurred outside the events captured and reported. The record does not provide event-term details for serious events, and no top serious-event terms are listed. It also does not explain the difference between the safety group counts and the group counts reported for the primary outcome.

The study interventions are described as online behavioral resources, but the registry figures alone do not establish a complete safety profile. They give counts and at-risk group sizes without further detail about ascertainment, timing, severity definitions, or follow-up for adverse events. Those details are not reported in the registry record.

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

The primary outcome summaries show final mean scores of 2.18 for Media Aware Parent -Tween and 2.2 for the active control resource, with a reported mean difference of -0.02. The unadjusted recalculation has p = 0.755, and its confidence interval includes zero. These results describe a small observed difference in the posted final scores, with uncertainty that does not establish a direction of difference.

The sponsor’s analysis also reports a mean difference of -0.02 and p = 0.69, and labels the analysis as equivalence. However, the registry record does not report the equivalence margin or confidence interval needed to assess that label independently. A result that does not show a statistically detectable difference is not, by itself, proof that the groups are equivalent.

The outcome reflects children’s reports of how often their parents discussed 12 prepubescent-health topics. It is not a direct measure of the quality of those conversations, the accuracy of information exchanged, or any later health outcome. The registry record does not report a threshold for a practically meaningful score difference, so the practical importance of the observed contrast cannot be determined from the score alone.

The endpoint is titled as change from pretest, but the posted sponsor analysis compares final values. Baseline scores and an estimate of change are not reported in the registry record. Therefore, the final-value summaries should not be described as a demonstrated difference in change. The results apply to the assessment period described in the record, with posttest about four weeks after the pretest questionnaire.

These findings do not establish that either resource improves communication, nor do they establish that the resources have identical effects. They describe the registry’s posted comparison and its limits. Missing-data procedures, analysis populations, and the sponsor’s equivalence margin are not reported, further restricting the conclusions that can be drawn.

17. Why This Trial Matters Statistically

This trial raises a useful statistical question about how to evaluate an educational or communication program against an active resource rather than against no information. Because both groups had access to materials, the comparison concerns the relative outcomes under those two study conditions. The registry record describes the intervention’s aims and the control resource’s subject matter, but does not provide enough detail to characterize how participants used either resource.

The primary endpoint also illustrates why the estimand matters. The registry title refers to change from pretest, whereas the sponsor’s reported analysis is described as a comparison of final values. Those are not automatically the same question. Baseline values and a change analysis would help readers understand whether the posted result addresses the stated change endpoint.

The sponsor labels its analysis equivalence, which highlights the distinction between finding no clear evidence of a difference and demonstrating that two approaches are close enough within a meaningful margin. The registry record does not report the margin or interval needed to evaluate that claim. This distinction is important whenever a study’s intended interpretation is similarity rather than superiority.

Finally, the outcome is a child-reported average across multiple topics, while the record lists multiple outcomes and analyses. Information about multiplicity, missing responses, and analysis populations would help readers judge how robustly the summary reflects the planned question. The posted data are useful for describing the measured contrast, but the missing statistical details constrain stronger interpretation.

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.

Several limitations are specific to the information recorded for this study. The primary endpoint is described as change from pretest, but the sponsor’s result is a mean difference in final values. The registry record does not provide baseline group scores or a separate change estimate, so the stated change question cannot be evaluated directly from the posted summary.

The sponsor classifies its regression as an equivalence analysis but does not report the equivalence margin or confidence interval. The unadjusted recalculation does provide an interval, but it is based on approximate standard deviations reconstructed from the posted standard errors and group counts. It should not be treated as a substitute for a prespecified equivalence analysis.

The record lists 13 outcome measures and 13 analyses, but reports zero secondary outcomes posted. It does not describe the complete analysis plan, multiplicity procedures, model covariates, missing-data handling, or analysis populations. The outcome group counts are 98 and 97, while the safety summaries list 196 and 194 at risk; the registry record does not explain these differences.

The measure is an average of child reports on 12 topics. The record does not state how unanswered items were handled, and it provides no threshold for a meaningful score difference. The endpoint therefore offers a summary of reported conversation frequency but not topic-specific effects or a benchmark for practical importance.

Finally, the record does not describe the allocation procedure, identify who was masked, or report the original sample-size justification. These design and analysis details are not reported in the registry record and should not be inferred from the randomized, double-masked labels alone.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Study of an Online Program to Help Parents Talk With Their Tween Children About Health, Gender, Body-Image, and Relationships — NCT06408818.
• Registry record last updated 2025-07-10; status last verified 2025-06.
• Results first posted 2025-07-10.
• 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

NCT06408818 is a completed, randomized, double-masked, parallel-group study of Media Aware Parent -Tween versus an active control resource. The registry enrollment is 390. The study began on 2024-05-06, and primary completion is dated 2025-03-24.

The primary measure is children’s average report of how often parents discussed 12 prepubescent-health topics, assessed at pretest and posttest about four weeks after the pretest questionnaire. Posted final means are 2.18 in the intervention group and 2.2 in the active control group; the reported difference is -0.02. The sponsor reports a linear-regression analysis with p = 0.69 and labels it equivalence. The unadjusted recalculation reports p = 0.755 and an interval spanning zero.

The registry record does not report the sponsor’s equivalence margin, a separate change estimate, missing-data methods, analysis populations, or multiplicity procedures. Safety summaries report zero serious adverse events, zero other adverse events, and zero deaths in each listed group.