Me & You-Tech: A Socio-Ecological Solution to Teen Dating Violence for the Digital Age: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Me & You-Tech: A Socio-Ecological Solution to Teen Dating Violence for the Digital Age (NCT05225727), a randomized na study. The primary outcome is Number of Youth Who Perpetrated Any Type of Teen Dating Violence as Assessed by the Conflict in Adolescent Dating Relationships Inventory (CADRI).

2. Clinical Question

The clinical question is therefore about a prevention program and a comparison with usual health education, but the posted primary measure does not answer whether the groups differed after receiving their assigned education. It records baseline status. The registry record does not report a later primary-outcome time point, a between-group estimate, or an analysis of change. Those omissions limit what can be concluded about the intervention from this endpoint record.

3. Trial Design

The registry describes a randomized, parallel-group study with no masking. The intervention was Me & You-Tech, a behavioral program; the comparator was standard health education. The registry lists the study as completed and gives an enrollment of 123. The phase is listed as not applicable. Study start and primary completion are recorded as 2022-10-01 and 2024-12-14.

In a randomized parallel design, participants are assigned to separate groups and the groups receive different conditions. Random allocation is intended to make group assignment independent of participants’ measured and unmeasured characteristics on average. It does not guarantee that groups are identical, especially in a study of limited size; baseline data can help describe the groups. The registry record does not state how randomization was generated, whether allocation was concealed, or how students were assigned within any school or classroom structure.

No masking means the registry does not report blinding of participants or study personnel to assignment. The intervention and usual health education are distinct experiences, so assignment may be apparent to those involved. The record does not explain whether outcome assessors or analysts were masked. Those details are not reported in the registry record.

The intervention is described as operating at youth, parent, and school levels and as internet-based. More detailed information about its content, duration, delivery schedule, or implementation is not reported in the registry record. The comparator is described as usual health education, usually including knowledge-based content on violence prevention taught from the state textbook; the precise curriculum and delivery received by individual students are not described.

The registry’s primary outcome is specified at baseline. It does not present a post-intervention primary endpoint or an analysis comparing the randomized groups. Thus, the design description establishes the intended randomized comparison, but the posted primary outcome information does not provide the result of that comparison.

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

Analysis population for the primary outcome, as defined in the registry: Data were not collected from 5 participants in the Intervention arm because they did not complete the question. Data were not collected from 6 participants in the Control arm because they did not complete the question

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 Number of Youth Who Perpetrated Any Type of Teen Dating Violence as Assessed by the Conflict in Adolescent Dating Relationships Inventory (CADRI), measured over Baseline.

The primary endpoint is the number of youth classified as having perpetrated any type of teen dating violence, assessed with the Conflict in Adolescent Dating Relationships Inventory (CADRI). The registry describes CADRI as a 34-item questionnaire assessing abusive behavior among adolescent dating partners. Its count score ranges from 0-34. A score of 1 or more is categorized as “Yes,” meaning the participant is considered a perpetrator; a score of 0 is categorized as “No.” The “No” category also includes participants who did not report a dating partner, as well as those who reported a dating partner but no perpetration.

This measure turns a questionnaire count into a participant-level binary classification. That can make the outcome easier to describe as the number of participants with a reported event, but it also removes information about how many behaviors were endorsed. The “No” category does not distinguish between having no dating partner and having a dating partner without reported perpetration. These are characteristics of the endpoint definition, not evidence about what occurred in either study group.

The registry lists the timeframe as baseline. A baseline measurement can describe status before the intervention comparison is evaluated, but by itself it does not show whether the intervention changed later behavior. Arm-specific baseline counts and subsequent primary-outcome results are not reported in the registry record. The endpoint is therefore defined, but the posted record does not provide the values needed to assess a group difference.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does randomization contribute?

General statistical explanation: random allocation is a design method for reducing systematic differences between groups at the start of a study. If assignment is implemented as intended, measured and unmeasured characteristics are balanced on average across repeated allocations. A particular trial can still have chance imbalances. Randomization supports a fair comparison, but it does not replace clear reporting of who was analyzed, what outcome was measured, or how missing observations were handled.

This registry describes the study as randomized and parallel, but does not report the sequence-generation method, allocation concealment, or assignment procedures. No masking is reported. These omissions matter when evaluating conduct and possible sources of bias, but they do not justify guessing how the trial was run.

What kind of outcome is the CADRI endpoint?

The primary measure starts with a 34-item questionnaire and a count score from 0-34. The registry then defines a binary participant classification: score 1 or more is “Yes,” while score 0 is “No.” The outcome is therefore analyzed conceptually as a participant having or not having the defined event, rather than as the full range of questionnaire counts. This threshold-based definition can be useful when the research question concerns whether any perpetration was reported. It also means differences in the number of endorsed behaviors among participants above the threshold are not reflected in this binary classification.

The definition of “No” combines participants who did not report a dating partner with those who reported a dating partner but no perpetration. That matters for interpretation because the category does not isolate only participants who had an opportunity to report dating behavior. The registry does not provide a separate category for those circumstances.

Why does the time point matter?

The listed timeframe is baseline. General statistical explanation: in a randomized intervention study, a baseline measure typically describes status before exposure to the assigned intervention. It can be used to characterize the groups or, if specified, to adjust an analysis of a later outcome. A baseline measure alone cannot show an intervention-related change, because it precedes the intervention comparison. The registry record does not state a primary post-intervention time point or report a later analysis of this endpoint.

The statistical target, or estimand, is not reported in the registry record. In general, an estimand specifies the treatment contrast, population, outcome, and time point the analysis is intended to describe, along with how events such as missing measurements are treated. Without those details and without posted results, readers cannot tell whether an intended analysis focused on a difference in proportions, a participant count, or another contrast.

How should uncertainty be assessed?

General statistical explanation: an estimate gives a numerical summary of a group contrast, while a confidence interval communicates its precision under the chosen statistical method. A narrow interval indicates greater precision than a wide interval, but precision does not establish clinical importance. A p-value addresses compatibility of the data with a specified null model; it does not measure the probability that an intervention works. Here, no primary-outcome estimate, interval, or p-value is reported in the registry record, so those concepts cannot be applied to a numerical treatment comparison.

The endpoint is binary at the participant level. General methods for binary outcomes may compare group proportions or model the probability of the event, but the registry record does not identify the statistical model or analysis used. There is no basis to attribute a particular test, adjustment, or covariate strategy to this study.

What do the planning assumptions mean?

The planning description refers to an illustration based on an observed effect, using a two-sided significance level 0.05, equal allocation between arms, and a normal approximation. It also describes considering fractions of the observed effect. This is a planning illustration, not a statement of the trial’s original sample-size justification. The actual sample-size justification and its assumptions are not reported in the registry record. The registry entries do not include the observed effect or numerical planning results, so no sample-size requirement can be evaluated from them.

General statistical explanation: a sample-size calculation depends on the target effect, outcome variability or event frequency, chosen error rates, allocation, and analysis method. Smaller target effects generally require more information to distinguish from random variation. A calculation based on an observed effect is a retrospective planning illustration; it is not observed power and does not establish that the completed study had adequate power. No power conclusion can be drawn from the enrollment figure alone.

The record lists enrollment of 123, but does not report a sample-size justification, interim analyses, a statistical analysis plan, or the analysis populations. These items are not reported in the registry record and should not be inferred from the randomized design or the outcome definitions.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists multiple outcomes, including psychological and physical teen dating violence perpetration and victimization, as well as the primary endpoint for any type of perpetration. Multiple outcomes create a multiplicity issue: when many hypotheses are tested, the chance of at least one apparently unusual result can increase. General statistical explanation: researchers may address this through prespecified outcome hierarchies or adjustments, or may frame analyses as exploratory. The registry entries do not report a multiplicity strategy, outcome hierarchy beyond identifying the primary outcome, or an analysis plan.

The primary outcome description states that data were not collected from 5 participants in the Intervention arm because they did not complete the question, and from 6 participants in the Control arm for the same reason. The registry record does not describe why the question was incomplete, whether these participants completed other measures, or how missing primary-outcome data were handled. It does not report imputation, complete-case analysis, sensitivity analyses, or a missing-data assumption.

General statistical explanation: missing outcome data can affect both the number of participants contributing to an analysis and the interpretation of a group comparison. The consequences depend on why the data are missing and on the analysis approach. Without a reported approach, the direction or size of any possible impact cannot be determined.

The record does not identify an intention-to-treat, per-protocol, or other analysis population. It also does not report whether all randomized participants were included in any outcome analysis. The missing-data counts are therefore important context, but they do not reveal the analysis denominator or establish how the missing responses were treated.

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 serious adverse event counts of 0 in the Intervention group and 0 in the Control group. It also lists other adverse event counts of 0 in both groups and deaths of 0 in both groups. The corresponding numbers listed as at risk are 43 for the Intervention group and 80 for the Control group.

These are event counts as recorded, not a complete description of safety surveillance. The registry record does not report the adverse-event collection timeframe, definitions, ascertainment procedures, or whether events were actively solicited. It also does not explain how the safety denominators relate to the enrollment of 123. Because those details are not reported, the figures should be read as the registry’s posted counts rather than as proof that no adverse events occurred outside the reported monitoring or reporting process.

General statistical explanation: a zero count does not establish zero underlying risk. The precision of a safety estimate depends on the number of people observed, duration of observation, event definition, and completeness of reporting. No risk estimate or confidence interval is reported. The figures do not support a comparison of safety between the groups beyond the recorded counts.

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

The registry record establishes that a randomized, parallel-group study of Me & You-Tech versus usual health education was completed, and it defines a baseline CADRI classification for teen dating violence perpetration. It also documents missing responses for the baseline primary question and lists adverse-event counts by group. Those details describe the design and posted measurements; they do not establish an intervention effect.

The primary endpoint is measured at baseline, and the registry does not report arm-specific baseline outcome values or a later primary-outcome comparison. There is no posted estimate that describes how the groups differed after their assigned education, and no uncertainty interval or test result for such a comparison. A completed study status cannot substitute for those results.

General statistical explanation: a treatment effect is a contrast between outcomes under the intervention and comparator, defined for a particular population and time point. A result is most informative when its estimate, uncertainty, outcome definition, and analysis population are clear. Without those elements, neither the magnitude nor precision of a possible effect can be assessed.

The intervention’s stated purpose is prevention, and the study description identifies youth, parents, and schools as levels of the program. That purpose does not show that the program changed behavior. Likewise, the listed secondary outcome titles do not reveal whether psychological or physical perpetration or victimization differed between groups. No medical or behavioral conclusion about efficacy follows from the information reported.

The record also does not report implementation details, the statistical analysis plan, or the treatment of missing outcome data. These are relevant to judging how closely the reported analysis, if any, answers the intended research question. In the absence of posted comparative results, the appropriate conclusion is limited: the registry describes a trial and a baseline outcome definition, but does not provide evidence from which to estimate an intervention effect.

13. Why This Trial Matters Statistically

This study is statistically interesting because it combines a randomized intervention design with a behavior-prevention question in sixth-grade middle school students. The intervention is described as internet-based and operating at youth, parent, and school levels, while the comparator is usual health education. Such a design raises practical questions about how assignment and implementation work across educational settings, but the registry record does not provide the details needed to assess those processes.

The endpoint also illustrates a common measurement choice: converting a questionnaire score into a binary participant classification. The threshold of 1 or more gives a direct definition of reported perpetration, while the original score ranges from 0-34. That simplification may support a clear event-count question, but it discards variation above the threshold and combines distinct circumstances within the “No” category. These features affect what the outcome can mean, independently of the intervention’s effect.

The primary measure’s baseline timeframe is especially important. A trial can be randomized and completed while its posted primary outcome information still does not answer a post-intervention comparison. Keeping design, measurement timing, and result reporting distinct prevents readers from treating a baseline measure as a treatment effect.

Finally, the record identifies missing responses and lists multiple related outcomes, making analysis populations, missing-data handling, and multiplicity relevant to interpretation. Those methods are not reported in the registry record. The case therefore underscores that a trial’s design description, endpoint definition, and outcome results are separate pieces of evidence; one cannot stand in for another.

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 primary limitation for interpretation is that the registry lists the primary endpoint at baseline and does not report a post-intervention group comparison. Arm-specific outcome values, effect estimates, confidence intervals, and p-values are not reported in the registry record. As a result, the intervention’s effect on the listed primary endpoint cannot be assessed from these registry entries.

The baseline primary question was not completed by 5 participants in the Intervention arm and 6 participants in the Control arm. The registry does not explain the reasons beyond non-completion of the question, the handling of these missing data, or the population included in any analysis. This prevents assessment of whether missing responses could affect the reported outcome distribution.

The CADRI classification also has interpretive limits. It dichotomizes a 0-34 score at 1 or more and groups participants without a dating partner together with those reporting a dating partner but no perpetration. The record provides no further breakdown of these categories. This limits what can be learned from the binary endpoint about the nature or frequency of reported behaviors.

The intervention and comparator descriptions are broad. Content, duration, delivery procedures, adherence, and implementation details are not reported in the registry record. The randomization method, allocation concealment, analysis plan, analysis populations, and any multiplicity or interim-analysis procedures are also not reported. No further participant characteristics or eligibility details are given. These omissions constrain evaluation of conduct, generalizability, and analysis choices; they do not establish that any particular procedure was absent.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Me & You-Tech: A Socio-Ecological Solution to Teen Dating Violence for the Digital Age — NCT05225727.
• Registry record last updated 2025-12-24; status last verified 2025-12.
• Results first posted 2025-12-24.
• 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

NCT05225727 is a completed, randomized, parallel-group study with no masking and enrollment of 123. It evaluates Me & You-Tech, described as an internet-based, multi-level teen dating violence prevention program for sixth-grade middle school students, against usual health education. The primary outcome is the number of youth classified as having perpetrated any type of teen dating violence on the CADRI, with the listed timeframe at baseline.

The CADRI classification is “Yes” for a score of 1 or more on its 0-34 count and “No” for a score of 0; the latter includes participants who did not report a dating partner or reported one without perpetration. The registry reports missing baseline responses from 5 Intervention participants and 6 Control participants. It lists zero serious adverse events, other adverse events, and deaths in each group, with 43 and 80 participants listed as at risk, respectively.

Arm-specific primary-outcome results and statistical analyses are not reported in the registry record. The record therefore describes the trial and endpoint but does not provide a comparative estimate of intervention effect.