Reducing Adolescent Pregnancy in the Emergency Department: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Reducing Adolescent Pregnancy in the Emergency Department (NCT04744155), a randomized na study. The primary outcome is Adolescent Feasibility of Intervention.

2. Clinical Question

3. Trial Design

This was a completed, randomized, parallel-group feasibility trial, registered as NCT04744155. The record describes it as multi-site and lists an enrollment of 37. The study started on 2021-05-12 and had a primary completion date of 2022-10-31. The registry lists the phase as not applicable.

Participants were assigned to the multi-level intervention or enhanced standard of care. Both groups received motivational interviewing-enhanced counseling and a clinic referral. The intervention group was also offered immediate emergency-department-based contraception and a warm referral. In the comparison group, contraception could be obtained only at the referral. The record does not report whether participants took up the contraception offer, which methods they selected, or whether referrals led to follow-up care.

The allocation is listed as randomized, masking as single, and the model as parallel. The record does not identify who was masked, explain how randomization was generated or concealed, or describe procedures for maintaining masking. It also does not report the number or characteristics of participating sites, the recruitment process, or detailed eligibility criteria. Those details are not reported in the registry record.

The stated focus is feasibility rather than a reported estimate of pregnancy prevention. The registry lists one outcome measure and no posted analyses. The outcome data include arm-specific ratings, but no formal between-group analysis is listed. Consequently, the trial record supports a description of the design and reported feasibility scores, but it does not give a registry-reported test of differences between groups.

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.

6. Primary Endpoint

The registry lists the primary outcome as Adolescent Feasibility of Intervention, measured over 1 visit on day 1.

The primary endpoint is adolescent feasibility of the intervention, assessed with an investigator-created Feasibility Assessment during a visit on day 1. Its purpose is to capture participants’ ratings of how feasible the intervention seems, rather than to measure pregnancy outcomes. Responses range from 1 through 5; higher scores indicate greater feasibility.

The registry defines the intervention as feasible if the median score across all items is at least 3. That threshold provides a criterion for interpreting the assessment, but the record does not report the item-level responses or the overall median across all items. The posted arm results list values of 4.5 for the multi-level intervention and 4.7 for enhanced standard of care, with bounds of 4.2 to 4.8 and 4.6 to 5.0, respectively. The outcome is identified as a mean, while the criterion is expressed as a median across items. The record does not explain whether the posted arm values are means of participant scores, how the item scores were combined, or how the bounds were calculated.

Feasibility outcomes are useful in studies designed to assess whether an intervention can be delivered and evaluated in a clinical setting. They can inform interpretation of implementation and participant experience, but they do not by themselves establish an effect on pregnancy or other health outcomes. The registry record does not report a pregnancy outcome as an endpoint.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The record identifies the primary outcome as a mean score on a scale and lists the inter-quartile range as the dispersion measure. It separately defines feasibility using the median score across all items. These are different summaries: a mean describes an arithmetic average, while a median identifies the middle of an ordered set of values. They can convey different aspects of a distribution, especially when ratings are concentrated near one end of a scale or when responses are unevenly distributed. The registry does not explain how the assessment items were combined or how the arm-level outcome was derived.

What does an arm-level score describe?

An arm-level summary condenses participant responses into a value for each randomized group. The posted values are 4.5 for the multi-level intervention and 4.7 for enhanced standard of care. The scale runs from 1 through 5, and higher scores indicate greater feasibility. A summary value alone does not show how individual responses were distributed. For instance, readers cannot tell from a mean whether responses were tightly clustered or varied substantially. The record does not post the item-level values or identify the distribution of participant scores.

The record names the inter-quartile range as the dispersion measure, which generally describes the spread of the middle portion of ordered observations. However, the posted spread values are absent, and bounds are listed separately. Without an explanation, those bounds cannot be assumed to be an inter-quartile range, confidence interval, or another particular statistic. A confidence interval, in general, expresses uncertainty around an estimated quantity under a specified statistical procedure. Its interpretation depends on the method used and on what quantity it estimates. The registry record does not identify the posted bounds as confidence intervals or state how they were calculated.

Why distinguish the criterion from the summary?

The registry’s feasibility rule uses the median score across all items, with a threshold of at least 3. A mean and a median are not interchangeable. The mean can be affected by the magnitude of each response, whereas the median is based on the ordered position of responses. In addition, “across all items” does not clarify whether scores were first combined within each participant or pooled in another way. The record does not report the overall median or an explicit assessment against the criterion. The listed arm means therefore should not be substituted for the median-based rule.

General statistical interpretation also distinguishes an estimate from its precision. An estimate gives a central summary; a measure of uncertainty or spread gives information about how variable the data or estimate may be. The record reports arm values and bounds, but does not explain the bounds or provide a test of the difference between arms. No conclusion about statistical significance or comparative precision can be drawn from the record.

What does randomization contribute?

Randomization is a design method intended to make assigned groups comparable on average with respect to factors measured and unmeasured at baseline. This is a general property of randomized designs, not proof that groups in a particular trial were balanced. The registry lists the study as randomized, but does not describe sequence generation, allocation concealment, or baseline characteristics. The posted information therefore does not allow evaluation of the randomization process or of group comparability.

The study is described as parallel, meaning the groups are followed as separate assigned arms rather than in a crossover arrangement. The record also lists single masking, but does not say who was masked. Because the intervention includes an offer of immediate contraception and warm referral, the record would need to identify masked parties and procedures for readers to evaluate the practical meaning of that designation. These details are not reported in the registry record.

What can planning illustrations tell readers?

Any sample-size illustrations associated with the posted effect are planning scenarios, not an estimate of power achieved in this trial. The record describes their assumptions as a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation, with the effect to detect set as a stated fraction of the observed effect. Such calculations can illustrate the sample size that might be needed under those assumptions. They do not show that the trial was designed with those assumptions, and they are not observed power. The registry does not report the trial’s own sample-size justification or statistical design plan.

The record states that no analyses are posted. It gives no inferential procedure for the primary outcome and no adjusted or unadjusted comparison. General methods cannot be attributed to this trial unless the registry documents them. The posted data can be read descriptively, while formal claims about hypothesis testing, precision, or treatment effects remain unsupported by the analysis information in the record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists one outcome measure and no posted secondary outcomes. This limits the extent to which multiplicity across several listed endpoints can be assessed, but the record does not report a statistical analysis plan, a hierarchy of outcomes, or any adjustment for multiple testing. It also does not report whether additional outcomes were collected but not posted. The approach to multiplicity is therefore not reported in the registry record.

No analyses are listed. In particular, the record does not report whether the primary outcome was analyzed according to randomized assignment, whether any covariates were used, or whether the comparison was adjusted. It does not provide an analysis population definition, such as an intention-to-treat or per-protocol population. The record also does not describe interim analyses or stopping rules; those details are not reported in the registry record.

The feasibility outcome results list 16 in the multi-level intervention arm and 9 in enhanced standard of care. The registry’s enrollment value is 37, while the safety reporting lists at-risk counts of 25 and 12. The record does not reconcile these different counts, state why the outcome counts differ, or describe whether participants had missing scores or were excluded from a particular analysis. It does not report imputation, complete-case analysis, or another method for handling missing data. No reason for any difference in the reported counts should be inferred from the record.

For a feasibility assessment, missing responses could affect both the arm summaries and whether the median-based threshold is met. In general, readers need to know the amount and pattern of missingness and the method used to address it to judge the robustness of a result. That information is not reported in the registry record. The absence of these details limits appraisal of the posted summaries and their relation to all randomized participants.

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 lists no serious adverse events in either group: the serious-event counts are 0 for enhanced standard of care and 0 for the multi-level intervention. The at-risk counts shown for serious events are 12 and 25, respectively. The record also lists 0 other adverse events in each group and 0 deaths in each group; the at-risk counts for other adverse events are the same as the listed serious-event counts.

These figures describe the events recorded in the registry, not the probability of future events or a guarantee that no event occurred outside the reporting period or definitions used. The record does not include serious-event terms, so it provides no event descriptions. It also does not explain the adverse-event collection period, definitions, ascertainment procedures, or whether every randomized participant was included in safety monitoring. The at-risk counts differ from the feasibility outcome counts, and the record does not explain the distinction.

Zero recorded events should be read as a descriptive count in the reported groups. It is not evidence that the interventions have identical safety profiles, nor does it establish the absence of risk. With no event counts recorded, a comparative safety analysis is not reported. No medical conclusion should be drawn beyond the registry’s stated counts and the limits of the reporting detail.

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

The registry record describes a feasibility trial in which both groups received motivational interviewing-enhanced counseling and a clinic referral, while the multi-level intervention added an offer of immediate emergency-department contraception and a warm referral. The posted feasibility scores are 4.5 for the multi-level intervention and 4.7 for enhanced standard of care. They are ratings on a scale where higher values indicate greater feasibility. The record’s listed bounds are 4.2 to 4.8 and 4.6 to 5.0, respectively, but their statistical meaning is not identified.

The results do not establish whether the median-based feasibility criterion was met as defined, because that criterion uses the median across all items and the posted arm values are identified as means. The record does not provide the overall median or explain the relationship between the mean values and the threshold. It also does not report a formal statistical comparison between groups. The closeness and ordering of the posted values are descriptive, not evidence of a statistically significant difference.

The registry does not report a pregnancy outcome or other clinical outcome demonstrating whether the intervention changed pregnancy risk. The feasibility ratings cannot be interpreted as evidence that contraception was used, that referrals resulted in care, or that a particular method was effective. The record reports no secondary outcomes and no analyses.

The study can therefore be understood as documenting participant feasibility ratings for two approaches in an emergency-department setting, with limited detail about score construction, missing data, and inferential methods. Its record does not support conclusions about comparative effectiveness, the size or precision of a between-group effect, or generalizability beyond the enrolled trial population. Those questions require outcome definitions and analysis details that are not reported in the registry record.

13. Why This Trial Matters Statistically

Feasibility trials address an important statistical question that differs from whether an intervention changes a clinical outcome. Before a larger evaluation can be interpreted, researchers may need to know whether an intervention can be delivered in the setting under study and whether participants can assess its acceptability or feasibility. In this trial, the primary outcome is an investigator-created feasibility assessment, collected during a visit on day 1. The registry’s outcome definition makes the measurement and its threshold central to interpretation.

The record also illustrates why the summary statistic must match the decision rule. Feasibility is defined through a median across all items, while the posted arm values are labeled as means. Without the overall median, item-level scoring details, or a clear account of how the posted values were calculated, readers cannot directly connect the numerical summaries to the stated criterion. This is a measurement and reporting issue, not merely a question of whether the values appear high on the scale.

Small feasibility studies can be valuable for learning about intervention delivery, but descriptive scores should not be mistaken for a definitive comparison of outcomes. The registry lists an enrollment of 37, yet the outcome counts differ by arm and the record does not explain those counts. It also lists no analyses. These details matter because readers need to understand who contributed data and what analysis supports any comparison.

The record is therefore statistically informative as an example of the distinction between a feasibility endpoint and a clinical outcome, and between descriptive summaries and inferential evidence. Its value for interpretation depends on transparency about the endpoint’s construction, missing data, and analysis methods. Those elements are not reported in the registry record.

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.

Several trial-specific details needed to interpret the feasibility result are absent. The registry does not describe the individual assessment items, their wording, or how responses were combined. It defines feasibility using a median across all items but reports arm values as means. The overall median and an explicit determination against the threshold are not reported. This leaves uncertainty about whether the posted values answer the endpoint question as defined.

The record identifies the inter-quartile range as the dispersion measure, but does not post the spread values. It gives bounds for each arm without saying what they represent or how they were calculated. Consequently, the bounds cannot be used as a documented measure of precision. No formal between-group analysis, test statistic, p-value, or adjusted estimate is reported.

The listed outcome counts are 16 for the multi-level intervention and 9 for enhanced standard of care, while the enrollment and safety reporting use different counts. The registry does not explain the relationship among these values, the number of participants with missing scores, or the analysis population. It does not describe how missing data were handled. This prevents assessment of whether the outcome summaries reflect all assigned participants or a subset.

Design details are also limited. The record does not report eligibility criteria, participant characteristics, random-sequence generation, allocation concealment, the identity of the masked party, or baseline comparability. It does not give site-level information or explain how implementation varied across sites. Details about intervention uptake, contraception selection, and referral completion are not reported.

Finally, no pregnancy outcome or secondary outcome is posted, and no analyses are listed. The registry does not provide the trial’s statistical plan, sample-size justification, or interim-analysis information. These omissions constrain conclusions to the recorded feasibility summaries and safety counts; they do not support a comparative clinical-effect estimate.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Reducing Adolescent Pregnancy in the Emergency Department — NCT04744155.
• Registry record last updated 2023-09-28; status last verified 2023-09.
• Results first posted 2023-09-28.
• 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.

18. Record Summary

NCT04744155, titled “Reducing Adolescent Pregnancy in the Emergency Department,” is a completed, randomized, parallel-group, multi-site feasibility trial sponsored by Children’s Mercy Hospital Kansas City. The record lists an enrollment of 37, a start date of 2021-05-12, and a primary completion date of 2022-10-31. Masking is listed as single, but the masked party is not identified.

The multi-level intervention added an offer of immediate emergency-department contraception and a warm referral to motivational interviewing-enhanced counseling and a clinic referral. The enhanced standard-of-care group received the counseling and clinic referral, with contraception available only at the referral.

The primary outcome is adolescent feasibility, assessed during a visit on day 1. The registry defines feasibility using a median score across all items of at least 3 on a scale from 1 through 5. Posted arm values are 4.5 and 4.7, identified as means; the record does not explain how they relate to the median-based criterion. No analyses or secondary outcomes are posted. Serious adverse-event counts and deaths are listed as 0 in both groups, with no serious-event terms reported.