Randomized Controlled Trial of a Risk Reframing Tool to Change Mothers' Parenting Associated With Children's Risky Play: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Randomized Controlled Trial of a Risk Reframing Tool to Change Mothers' Parenting Associated With Children's Risky Play (NCT03374683), a randomized na study. The primary outcome is Change in Tolerance of Risk in Play Scale (TRiPS).

2. Clinical Question

3. Trial Design

This was a randomized, parallel-group controlled trial with three behavioral conditions: the RR Digital Tool, the RR In-Person Workshop, and the Position Statement on Active Outdoor Play as the control. The registry lists the allocation as randomized and the masking as double. The brief summary instead describes the study as single-blind, specifying that researchers and outcome assessors were blinded. The record does not reconcile these descriptions, so the masking procedures should be treated as unclear.

The digital intervention was delivered by a web link, with participants asked to complete it within one week. The workshop used a facilitated, in-person format lasting 45–90 minutes and covered discussions of the tasks contained in the digital tool. Participants in the control condition received a web link to the active-play position statement. The registry record does not report further detail about allocation concealment, how random assignment was generated, or whether adherence to either intervention was assessed.

The record gives enrollment as 451, while its brief summary says that 410 mothers were recruited. It also reports 451 mothers with baseline demographic data and a smaller number with primary-outcome data at each measurement occasion. These figures are not explained in relation to one another. The study is listed as completed, with a primary completion date of 2018-09-30. The record does not report the trial’s recruitment flow or provide enough information to resolve the enrollment-count discrepancy.

The primary endpoint was a continuous standardized TRiPS score. A secondary outcome was self-reported attainment of a behavior-change goal set by participants. The registry record identifies two outcome measures but does not provide a result for either outcome or describe the statistical comparison used to estimate intervention effects.

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: Participants were randomized to a condition when they were deemed eligible. After being randomized, participants received the socio-demographic questionnaire and the intervention. A total of 451 participants who completed the socio-demographic questionnaire were included in the study.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Included was 451 mothers with baseline demographic data; and, 351 mothers with baseline outcome data (TRiPS) at baseline, 333 mothers at 1-week-post-intervention, and 312 mothers at 3-month-post-intervention.

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 Change in Tolerance of Risk in Play Scale (TRiPS), measured over Baseline, 1-week-post-intervention, 3-month-post-intervention.

The primary endpoint was change in the Tolerance for Risk in Play Scale (TRiPS), a measure of adults’ tolerance of risk during children’s play. The description identifies the instrument as a 31-item measure, with one item dropped after baseline Rasch analysis because of local dependence. The final scale therefore contained 30 items. Higher standardized scores indicate greater tolerance of risky outdoor play.

The outcome is reported as a mean on a continuous scale, with standard deviation as the stated measure of dispersion. Continuous scores retain information about variation across participants rather than reducing responses to a simple count of people meeting a threshold. A mean can describe the group’s average score, while the standard deviation describes the spread of scores around that average. These summaries alone, however, do not establish whether groups differed or whether any difference was estimated precisely.

The endpoint was assessed at baseline, 1-week-post-intervention, and 3-month-post-intervention. The description says that Rasch analysis was conducted using the mirt package in R software. The resulting baseline theta standardized scores ranged from -3.372 to 1.975, with a mean of 0.000 and SD of 0.974. These are measurement-scale details, not intervention-effect estimates. The registry record does not report group means, changes from baseline, a between-group contrast, or its uncertainty at any measurement occasion.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The following concepts are general explanations of the statistical methods relevant to this trial. The registry record names some measurement procedures but does not provide a complete statistical analysis plan or report the primary outcome comparisons.

What does a randomized comparison estimate?

In a randomized trial, the central comparison is between outcomes in groups assigned to different conditions. For a continuous endpoint such as the standardized TRiPS score, an analysis may estimate group means or a contrast between groups. A contrast expresses how far apart the groups’ estimated outcomes are under the specified analysis. Its interpretation depends on the outcome scale, the time point, and whether the comparison concerns follow-up scores, change from baseline, or a model incorporating repeated measurements.

The registry record states that the trial was randomized and parallel, but it does not report the primary contrast or the model used to estimate it. It therefore does not establish whether the reported primary analysis, if any, compared follow-up means, changes from baseline, or another quantity. The intervention-effect estimate and its uncertainty are not reported in the registry record.

What does a confidence interval communicate?

General: a confidence interval presents a range of values compatible with the observed data under a specified statistical model and repeated-sampling procedure. It helps readers judge precision as well as direction and size. A narrow interval indicates more precise estimation than a broad interval, while an interval that includes values representing no difference may leave the direction of the effect uncertain. A confidence interval does not correct for bias in measurement, missing outcomes, or deviations from the analysis assumptions.

No confidence interval for the primary comparison is reported in the registry record. Thus, the precision of any difference in TRiPS scores cannot be assessed from the posted information. The standardized baseline score summaries do not serve as a confidence interval for an intervention effect.

Why does the measurement analysis matter?

The registry describes Rasch analysis of baseline TRiPS data. General: Rasch analysis is a measurement approach used to examine how items relate to an underlying construct and how responses can be represented on a common scale. The description states that one item was removed because of local dependence, leaving a 30-item scale. Local dependence refers, in general, to item responses retaining an association beyond what is expected from the underlying construct. Such dependence can affect how a scale is interpreted and scored.

The record says that theta standardized scores were generated and that a higher standardized score indicates greater tolerance of risky outdoor play. It also gives the baseline score range and distribution. These details help explain the measurement, but the record does not report evidence about measurement properties across groups or occasions, nor does it explain how the score was used in the intervention-effect model.

Why can repeated measurements need special handling?

General: when an outcome is measured repeatedly in the same participant, observations from that participant are usually related. An analysis that treats repeated measurements as independent may not represent that dependence correctly. Statistical approaches can account for within-participant correlation and can use information across measurement occasions, but their appropriateness depends on the research question, model assumptions, and missing-data handling.

TRiPS was measured at baseline, 1-week-post-intervention, and 3-month-post-intervention. The registry record does not state whether the analysis modeled the repeated observations jointly, analyzed each follow-up separately, or adjusted follow-up comparisons for baseline scores. The results needed to assess those choices are not reported in the registry record.

What do the planning assumptions mean?

The record describes planning illustrations based on the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It states that the effect to detect is a stated fraction of the observed effect and that the non-time-to-event figures are participants per arm. These are planning assumptions, not observed trial results. The record does not report a protocol sample-size justification, and the planning illustrations should not be read as observed power or as proof that the study was adequately powered.

General: a planning calculation estimates the number of participants needed under specified assumptions about an effect, variability, allocation, and statistical procedure. Its answer depends on those assumptions. A calculation based on an effect observed in the same trial is an illustration, not independent confirmation of that effect. The registry record does not provide the numerical illustration values in the information described for this analysis, so no such values can be interpreted.

10. Multiplicity, Missing Data and Analysis Populations

The trial includes three randomized conditions, a primary outcome measured at multiple occasions, and a secondary self-reported behavior-change outcome. This creates potential choices about which comparisons and time points to emphasize. General: when multiple outcomes, time points, or pairwise comparisons are examined, the chance of a misleading finding can increase if all are interpreted as though only one analysis had been planned. Trial protocols often specify a primary comparison and procedures for handling additional analyses. The registry record does not report a multiplicity strategy, a hierarchy of comparisons, or whether any adjustment was applied.

The record describes the primary outcome at baseline, 1-week-post-intervention, and 3-month-post-intervention, but does not identify which follow-up contrast was the principal treatment-effect test. It also does not report p-values or confidence intervals for any outcome. Consequently, the statistical significance or precision of the primary and secondary comparisons cannot be evaluated.

Outcome availability varies across the reported measurement occasions: 351 mothers had baseline TRiPS data, 333 had 1-week-post-intervention data, and 312 had 3-month-post-intervention data. The registry record does not report the reasons for missing observations, the number with complete follow-up by randomized group, or the method used to address missing outcome data. General: missing-data methods rely on assumptions about why data are absent and how missingness relates to observed or unobserved outcomes. Without the analysis method and supporting information, the possible influence of missingness cannot be judged.

The record does not describe an analysis population, such as whether participants were analyzed according to randomized assignment or according to intervention completion. It also does not report exclusions from the outcome analyses or an intention-to-treat approach. These details are not reported in the registry record.

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

The registry record establishes that this trial compared two risk-reframing formats with a written active-play statement and measured maternal tolerance for risky play using TRiPS. It provides information on the scale, follow-up occasions, and the intended secondary behavior-change outcome. It does not provide outcome comparisons or estimates of effect.

Accordingly, the record does not support a claim that either intervention increased tolerance, that one delivery format performed differently from the other, or that any change persisted to 3-month-post-intervention. Those are questions the trial was designed to examine, but the corresponding results are not reported in the registry record. The absence of estimates also means that the magnitude and precision of any effect cannot be assessed.

The same distinction applies to the secondary outcome: its presence in the trial description does not show whether participants attained their self-selected behavior-change goals or whether attainment differed between groups. The outcome is described as self-reported, but the record does not provide its definition, group results, or analysis.

General: statistical significance and practical importance are different considerations. A small estimated effect can be statistically distinguishable from no effect when measured precisely, while an imprecise estimate may remain uncertain even if its point estimate appears substantial. Evaluation requires the estimate, an uncertainty measure, and a clear understanding of the scale and analysis. Those elements are not available for the trial comparisons in the registry record.

The zero adverse-event counts listed for all groups are a report about event entries, not evidence of efficacy or a complete characterization of safety. The available record is therefore useful for understanding the trial question and measurement framework, but it does not permit a substantive conclusion about intervention outcomes.

12. Why This Trial Matters Statistically

This trial is statistically notable because it places a measurement question alongside an intervention question. The outcome is not a direct count of children’s play episodes; it is a standardized score representing mothers’ tolerance for risk in play. Interpretation therefore depends both on the intervention comparison and on how the underlying construct was measured.

The record describes a measurement refinement: baseline Rasch analysis identified local dependence for one item, which was dropped, leaving a final 30-item TRiPS scale. This illustrates a general point for clinical and behavioral research: outcome construction can affect what a score represents, and changes to an instrument should be transparently described. The record also explains the direction of the score, which is necessary for interpreting a future effect estimate.

The design includes two distinct intervention delivery formats and a comparison condition, with outcomes intended at short- and longer-term follow-up. That structure raises useful statistical questions about the primary comparison, repeated measurements, and the handling of several conditions and outcomes. The registry record does not provide the analysis details or results needed to answer those questions, so the methodological description is more informative than the evidence about effect magnitude.

Finally, the recorded differences in enrollment and masking descriptions, along with the changing numbers of participants with outcome data, underscore why clear reporting matters. Readers need consistent accounting of participants, explicit analysis populations, and group-specific results with uncertainty to judge the strength of evidence. Those elements are not reported in the registry record.

13. 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 principal limitation for interpreting this trial from the registry record is the absence of comparative outcome results. Group-level TRiPS summaries, treatment-effect estimates, uncertainty intervals, and statistical tests are not reported. The secondary behavior-change results are also absent. This prevents assessment of the direction, size, and precision of the findings.

Several trial descriptions are internally inconsistent. Enrollment is listed as 451, while the brief summary describes 410 mothers recruited. The primary-outcome population is separately described as 351 at baseline, 333 at 1-week-post-intervention, and 312 at 3-month-post-intervention. These counts are not reconciled. The record also lists double masking, while the brief summary describes a single-blind study with researchers and outcome assessors blinded. The record does not clarify which masking description is accurate.

The registry record does not report the randomization procedure, allocation concealment, intervention adherence, or detailed participant flow. It does not state how missing outcomes were handled, define the analysis population, or provide a complete statistical analysis plan. It also does not specify the primary between-group contrast or how multiple outcomes and time points were addressed.

The primary outcome description gives useful information about scale construction, but the record does not report whether the measure performed comparably across groups or occasions. The secondary outcome is described as self-reported goal attainment without a detailed operational definition in the available record. These limitations constrain interpretation independently of the missing effect estimates.

14. Related Tutorials

15. Related Statistical Calculators

16. Sources

• ClinicalTrials.gov: Randomized Controlled Trial of a Risk Reframing Tool to Change Mothers' Parenting Associated With Children's Risky Play — NCT03374683.
• Registry record last updated 2021-06-28; status last verified 2021-06.
• Results first posted 2021-06-28.
• 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.

17. Record Summary

The registry describes a completed randomized parallel-group trial of two risk-reframing interventions for mothers: a digital tool and an in-person workshop. The comparator was the Position Statement on Active Outdoor Play. The primary outcome was change in standardized TRiPS score, assessed at baseline, 1-week-post-intervention, and 3-month-post-intervention; self-reported behavior-change goal attainment was secondary.

The TRiPS description reports a 30-item final scale after one item was dropped following baseline Rasch analysis. The record gives differing enrollment and masking descriptions, and reports outcome data for decreasing numbers of participants over follow-up. It does not report group-level outcome results, treatment-effect estimates, confidence intervals, p-values, or details of missing-data and multiplicity handling. Thus, it describes the study question and measurement approach but does not establish the direction or precision of intervention effects.