Enhancing Quality Interventions Promoting Healthy Sexuality: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Enhancing Quality Interventions Promoting Healthy Sexuality (NCT01818791), a randomized na study. The primary outcome is Abstinence Attitudes.

2. Clinical Question

3. Trial Design

The registry describes a randomized, parallel-group study with no masking. One group received Making Proud Choices training, while the other received Making Proud Choices training plus Getting To Outcomes. The study is listed as completed. Its recorded start is 2012-07, and its primary completion is 2014-12. The phase entry is NA.

The study’s stated purpose was to examine whether capacity building through Getting To Outcomes could augment the quality of implementation of Making Proud Choices, a research-based intervention addressing teen sexual health. The brief summary explains the rationale in terms of the challenges community organizations can face when implementing established programs. It also describes collecting primary data from middle school youth and program staff at cooperating Boys and Girls Clubs.

The registry enrollment entry is 909. The brief summary separately refers to 960 youth and 32 Clubs. The record does not explain how these entries relate, whether enrollment refers to a particular analysis population, or how many participants contributed data at each assessment. It also does not report the allocation unit or the number assigned to each group as a trial-design result. The adverse-event record lists group-specific at-risk counts, but those entries should not be treated as a complete account of the study’s participant flow.

The primary outcome is a continuous score measured at baseline and post-intervention, with the post assessment scheduled 8 weeks later. The registry lists three outcome measures and one secondary outcome named Interview About Change in Capacity. It lists no analysis records. Details such as the randomization method, masking procedures beyond the NONE entry, analysis population, handling of repeated measurements, and adjustment for the Club structure are not reported in the registry record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

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 Abstinence Attitudes, measured over Baseline, Post (8 weeks later).

Abstinence Attitudes is the registered primary endpoint. It measures attitudes about abstinence using a score on a scale. Responses use a 5-point format, where 5 means strongly agree and 1 means strongly disagree; higher scores are described as indicating more prosocial attitudes. The outcome is recorded at baseline and post-intervention, with the latter assessment scheduled 8 weeks later.

A continuous attitude score can describe variation in participants’ responses and can be compared between study groups or across assessment times, provided the analysis specifies which comparison is intended. In general, an outcome measure is useful when it captures a construct relevant to the study question in a consistent way. The registry’s description identifies the response range and direction of scoring, but does not report information about scale validation, reliability, scoring rules for incomplete responses, or a threshold for interpreting the size of a difference.

The registry lists Abstinence Attitudes as the primary outcome, but the available record does not provide a single numerical comparison for it. The record flags that the primary outcome has several categories or time points and was not reduced to one comparison. Consequently, no group means, estimated difference, confidence interval, or significance result for a specific primary contrast is reported in the registry record. The outcome definition alone describes what was intended to be measured; it does not establish what the study found.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

General statistical context: a randomized comparison aims to make the study groups comparable in expectation, so that differences in outcomes can be interpreted in relation to the assigned study conditions. Randomization does not guarantee that all observed characteristics will be identical, and the registry entry alone does not show how allocation was generated or concealed. The record labels the study randomized, but the randomization procedure and allocation unit are not reported in the registry record.

What does a continuous outcome comparison represent?

Abstinence Attitudes is recorded as a score on a scale, and the registry identifies the summary parameter as a mean with standard deviation as the dispersion measure. In general, a mean describes the average score in a group, while a standard deviation describes variation among scores around that mean. A comparison of means can summarize a difference in average scores, but its interpretation depends on the specified time point, target population, and analysis method. The registry does not report a single primary contrast or the group summaries needed to interpret one.

Because the outcome is recorded at baseline and post-intervention, an analysis could in principle focus on post-intervention scores, change from baseline, or a model that uses both assessments. These approaches answer related but not identical statistical questions. The registry record does not say which approach was prespecified or used. It would therefore be inappropriate to infer a change score, baseline adjustment, or repeated-measures model from the assessment schedule alone.

What does uncertainty mean?

General statistical context: a confidence interval gives a range of values compatible with the observed data under the assumptions of the analysis procedure. It expresses statistical uncertainty about an effect estimate; it is not a guarantee that the true effect lies in that particular interval. A p-value measures how incompatible the observed data are with a specified null model, under the test’s assumptions. Neither quantity describes the size or practical importance of an effect on its own. The registry record does not report a primary-outcome estimate, confidence interval, or p-value for a single comparison.

The registry’s planning assumptions include a two-sided significance level of 0.05. In general, a significance level is a decision threshold used in a testing procedure; it does not state the probability that a study conclusion is true. A planning assumption is not a reported test result. The record also refers to equal allocation, a normal approximation, and planning effects defined as fractions of the observed effect. Those entries do not establish the actual allocation or analysis method used in the trial.

Why can the Club structure matter?

General statistical context: when participants are grouped within sites or organizations, outcomes from people in the same group may be more similar than outcomes from people in different groups. This dependence is often called clustering. If a design or analysis ignores meaningful clustering, standard errors and confidence intervals may not reflect the true uncertainty. The brief summary describes cooperating Boys and Girls Clubs, but the record does not report the allocation unit, the statistical handling of clustering, or an intracluster correlation estimate. No conclusion about the adequacy of a clustering adjustment can be drawn from the available record.

What do the planning illustrations mean?

General statistical context: a sample-size calculation asks how much information a future study might need to detect a specified effect under stated assumptions. Such a calculation is prospective; it is not an observed outcome and does not describe the probability that this completed trial detected an effect. The registry characterizes its sample-size assumptions as planning illustrations based on the observed effect, using a two-sided significance level of 0.05, equal allocation, and a normal approximation. It also defines the target effect in relation to the observed effect. The numerical planning estimates are not reported in the registry record, and these assumptions should not be confused with the trial’s own design justification or an observed-power calculation.

For time-to-event outcomes, general methods may express a planning requirement as a total number of events; for other outcomes, a planning requirement may be expressed as participants per arm. The registry’s assumptions distinguish these formats. Abstinence Attitudes is a continuous outcome, not a time-to-event endpoint. No event-time analysis for this primary outcome is reported.

Finally, a prespecified analysis plan helps identify the principal contrast, the treatment of missing observations, and the handling of multiple outcomes. Those details influence how confidently a reader can interpret the estimate and whether it reflects the original study question. The registry record does not report the statistical analysis plan, interim analyses, or a sample-size justification. No assumptions about those procedures should be made from the study design label alone.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists three outcome measures, identifies Abstinence Attitudes as primary, and names Interview About Change in Capacity as a secondary outcome. It also indicates that the primary outcome has several categories or time points and was not reduced to one comparison. The record therefore does not identify a single reported primary contrast whose estimate can be interpreted. The statistical plan for selecting among outcomes, time points, or possible comparisons is not reported in the registry record.

General statistical context: when many outcomes or comparisons are tested, the chance of obtaining at least one apparently notable result can increase. Prespecified outcome hierarchies or adjustment procedures can address some multiplicity concerns, but the registry does not report whether any such procedure was planned or used. No multiplicity adjustment should be inferred from the designation of one outcome as primary.

The registry does not report the number of participants with outcome data at baseline or post-intervention, the amount or pattern of missing data, or how missing observations were handled. General statistical context: missingness can affect an estimate when the probability of an observation being absent is related to participant characteristics or outcomes. Complete-case analysis, imputation, and model-based approaches require assumptions, and their appropriateness depends on the data and analysis plan. No particular approach can be attributed to this trial from the record.

The registry also does not identify an intention-to-treat population, a per-protocol population, or another analysis population for the primary outcome. It lists no analysis records. As a result, the available record does not establish which participants were included in any outcome analysis or whether analyses followed randomized assignment. These omissions limit assessment of multiplicity, missing-data bias, and the population to which any result would apply.

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 adverse-event record gives group-specific counts of participants at risk and counts affected. For Making Proud Choices Alone, the registry lists 433 at risk for serious adverse events and 433 at risk for other adverse events, with 0 affected in each category. For Making Proud Choices+Getting To Outcomes, it lists 476 at risk for serious adverse events and 476 at risk for other adverse events, again with 0 affected in each category. The record lists 0 deaths in each group.

These are registry entries, not a detailed account of how safety information was collected or assessed. The record lists no serious adverse-event terms. It does not describe event definitions, reporting windows, ascertainment methods, follow-up completeness, or whether the at-risk counts represent everyone enrolled or only a safety population. Those details are not reported in the registry record.

General statistical context: a recorded count of zero is not the same as proof that no event could occur or that all events were observed. Interpretation depends on how events were defined, how actively they were sought, and how complete the follow-up was. The registry entries support the limited statement that no affected participants or deaths are recorded in these categories for the listed groups; they do not support a broader safety conclusion.

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

The registry record describes a study comparing Making Proud Choices alone with Making Proud Choices plus Getting To Outcomes among middle school youth connected with Boys and Girls Clubs. It identifies abstinence attitudes as the primary outcome, measured at baseline and post-intervention, with the post assessment 8 weeks later. It also describes the study’s rationale: to assess whether capacity-building support could augment the implementation of a research-based sexual-health program.

What the record does not establish is the result of the primary comparison. It reports no single numerical comparison for Abstinence Attitudes and gives no group means, effect estimate, confidence interval, or p-value for that comparison. Therefore, the direction, size, and precision of a difference between groups cannot be judged from the registry record. The study’s purpose and intervention descriptions are not evidence of an observed effect.

The record likewise does not report a numerical result for implementation quality or the named secondary outcome, Interview About Change in Capacity. No analysis records are listed. The relationship between implementation measures and youth outcomes is not reported. The record also does not explain the difference between the enrollment entry of 909 and the brief summary’s reference to 960 youth, or describe outcome-specific participant counts.

General statistical context: an estimate should be considered alongside its uncertainty, outcome definition, analysis population, missing-data handling, and design. A statistically precise estimate may still have limited practical meaning if its scale is difficult to interpret, while an imprecise estimate can leave several possibilities consistent with the data. Since the registry does not report the primary estimate or its uncertainty, neither type of interpretation is possible.

The reported adverse-event entries record zero affected participants in the listed serious and other adverse-event categories and zero deaths in each group. This does not demonstrate that all possible events were captured or establish an overall safety profile. The record lacks the event definitions and ascertainment details needed for a broader conclusion.

13. Why This Trial Matters Statistically

This trial addresses a statistical question that extends beyond whether a behavioral program is assigned. Its stated aim is to examine whether adding capacity-building support can augment implementation of Making Proud Choices. That distinction matters because an implementation strategy may affect how consistently a program is delivered, while participant outcomes represent a separate level of evaluation. Interpreting one type of outcome does not automatically answer the other.

The record also illustrates why an outcome label is not a complete analysis result. Abstinence Attitudes is defined as a continuous scale score, with its direction and assessment schedule specified. But without a clearly reported comparison, group summaries, an effect estimate, and uncertainty, readers cannot assess how the groups differed. Naming a primary outcome is useful, but it does not replace reporting its analysis.

The study includes cooperating Clubs, making the design’s organizational structure potentially relevant to statistical uncertainty. General statistical context: participants within a site may have correlated outcomes, and the analysis may need to account for that dependence. The registry does not report whether assignment occurred by Club or how clustering was addressed. This makes the design and analysis details important for evaluating any future reported estimate.

Several record entries also require careful separation. The enrollment entry is 909, while the brief summary refers to 960 youth and 32 Clubs. The adverse-event counts are group-specific safety entries, not a substitute for a participant-flow account or outcome-analysis denominators. Keeping these quantities distinct helps prevent unsupported totals or assumptions about who contributed data.

Finally, planning assumptions are not study findings. The record’s description of a two-sided significance level of 0.05, equal allocation, and normal approximation concerns planning illustrations. It does not provide evidence of statistical power, prove that the study met a target, or replace results from an analysis. Clear reporting of the prespecified comparison, analysis population, missing-data approach, and uncertainty would be needed to assess the primary statistical question.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The most direct limitation of the registry information is that it does not report a single primary-outcome comparison. Although the record defines Abstinence Attitudes and gives its assessment schedule, it supplies no numerical result for a specific contrast. Effect size and precision are therefore unavailable for interpretation.

The participant counts are not fully reconciled. The enrollment entry is 909, while the brief summary refers to 960 youth and 32 cooperating Clubs. The registry does not explain the distinction, provide a participant-flow account, or report the number contributing to each outcome and assessment. The group-specific adverse-event at-risk entries do not resolve these questions.

Important design and analysis details are not reported in the registry record. These include the allocation unit and procedure, the handling of the Club structure, the analysis population, the statistical model, the treatment of baseline scores, and the handling of missing outcomes. The record does not report the statistical analysis plan, sample-size justification, or interim analyses. These omissions prevent assessment of whether the analysis matched a prespecified plan.

The registry identifies three outcome measures but does not describe a multiplicity strategy or provide a single primary comparison. It does not report scale validation or reliability for Abstinence Attitudes, rules for incomplete scale responses, or a threshold for judging the meaning of a score difference. The named secondary outcome is listed without a numerical result.

Safety information is also limited: the record lists zero affected participants in the reported event categories and zero deaths, but no event terms or ascertainment details. These limitations concern the registry record and do not establish whether additional study information exists outside it.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Enhancing Quality Interventions Promoting Healthy Sexuality — NCT01818791.
• Registry record last updated 2026-03-11; status last verified 2026-02.
• Results first posted 2026-03-11.
• 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

NCT01818791, titled Enhancing Quality Interventions Promoting Healthy Sexuality, is listed as a completed, randomized, unmasked, parallel-group study. The intervention comparison is Making Proud Choices alone versus Making Proud Choices plus Getting To Outcomes. The registry enrollment entry is 909; the brief summary separately refers to 960 youth and 32 Boys and Girls Clubs. The record does not explain the relationship between these entries.

The primary outcome is Abstinence Attitudes, a scale score assessed at baseline and post-intervention, 8 weeks later. Higher scores indicate more prosocial attitudes on the described 5-point response scale. The registry flags that the primary outcome has several categories or time points and was not reduced to one comparison. No primary-outcome estimate or analysis record is reported.

The registry lists Interview About Change in Capacity as a secondary outcome and reports zero affected participants in the listed serious and other adverse-event categories in both groups, with zero deaths in each group. Further analysis, missing-data, participant-flow, and safety-ascertainment details are not reported in the registry record.