Tx for Child Sexual Behavior Problems: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Tx for Child Sexual Behavior Problems (NCT02625571), a na na study. The primary outcome is Child Sexual Behavior on the Child Sexual Behavior Inventory (CSBI).

2. Clinical Question

3. Trial Design

This is a completed, single-group behavioral intervention study registered as NCT02625571. The intervention is named Phase-based treatment of sexual behavior problems of children. The registry identifies Milton S. Hershey Medical Center as the sponsor. The study began in 2015-12, had a primary completion date of 2017-06-30, and is listed as completed. Its phase is recorded as not applicable.

The registered enrollment is 13. Allocation is listed as not applicable, masking is listed as none, and the model is single group. These features mean the record does not describe a randomized, masked comparison of the intervention against a control. The intervention arm has no further description in the registry record. Details such as how participants entered the study, whether all enrolled participants received the same treatment, and how treatment delivery was monitored are not reported in the registry record.

The project summary frames the work as a definition and pilot test of an intervention intended to be usable in settings where group treatment may not be feasible. It also describes the project as an early step toward validation in larger clinical trials. This stated purpose is consistent with interpreting the study as preliminary: a single-group pilot can describe treatment implementation and observed outcome patterns, but it cannot by itself separate treatment effects from other changes over time or establish comparative effectiveness.

The registry lists two outcome measures and zero analyses. The primary outcome is CSBI score; the listed secondary outcome concerns child sexual concerns on the Trauma Symptom Checklist for Young Children. Numerical outcome findings, analysis methods, and details about follow-up completion 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.

Before assignment: No details to provide. All recruited participants were enrolled.

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 Child Sexual Behavior on the Child Sexual Behavior Inventory (CSBI), measured over 4-6 months.

The primary endpoint is child sexual behavior measured by the Child Sexual Behavior Inventory (CSBI). The registry specifies a total raw score on a scale with a potential range of 0-138. Higher scores indicate a greater number and frequency of reported problematic sexual behavior. The outcome is recorded as a mean with standard deviation, and its timeframe is 4-6 months.

A continuous score can describe variation in reported behavior across participants and can be summarized by a mean and standard deviation. In general, the mean represents the average score in the group, while the standard deviation describes how dispersed individual scores are around that average. Looking at scores over time can be useful in a pilot study because it describes whether measured outcomes changed during the study period. However, the registry record does not give the CSBI mean, standard deviation, baseline score, follow-up score, or an estimated change.

The CSBI is used as the primary measure of the behavior the intervention is intended to address. Its score reflects reported number and frequency, rather than every aspect of a child’s circumstances or treatment experience. The record does not describe who completed the inventory, how missing questionnaire items were handled, or the specific assessment schedule within the 4-6 months. The measure’s stated range and direction help explain the scale, but without recorded results they do not establish whether participants’ scores changed.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Statistical methods are easiest to interpret when the design, outcome scale, and reported estimates are considered together. This registry describes a single-group study, a continuous primary outcome, and a mean with standard deviation as the summary form. It does not report outcome estimates or an analysis. The general explanations below clarify what these methods mean; they do not describe analyses that the registry confirms were performed.

What does a mean and standard deviation describe?

For a continuous outcome such as CSBI score, the mean describes the group’s average score. The standard deviation describes how much individual scores vary around that average. A mean alone can conceal substantial variation between participants, while a standard deviation alone does not show the average score. Together they give a basic description of the group’s outcome distribution, though they do not show the full distribution or explain why participants differ.

The CSBI score has a potential range of 0-138, with higher scores representing a greater number and frequency of reported problematic sexual behavior. This scale direction helps interpret a score if one is reported. It does not, by itself, tell whether a particular score is clinically important or whether a change is meaningful. The registry record does not report a threshold for meaningful change or other criteria for interpreting individual scores.

What would a confidence interval add?

In general, a confidence interval expresses the uncertainty around an estimate. For example, an interval around a group mean or an estimated change indicates a range of values compatible with the data and the method used to calculate the interval. A narrower interval represents greater precision than a wider interval, all else being equal. An interval’s interpretation depends on the analysis and assumptions behind it. No confidence interval for the primary or secondary outcome is reported in the registry record, so the precision of any outcome estimate cannot be assessed.

Why does a single-group design matter?

In a randomized comparison, the contrast between groups can help distinguish an intervention-related difference from changes that would also occur without that intervention, subject to the design and analysis. Here the registry describes one group and no randomized allocation. A within-group comparison over time, if one were reported, would describe how scores changed among those assessed. It would not provide a concurrent estimate of what would have happened without treatment. General influences on repeated measurements, such as maturation, changes in the surrounding environment, and regression to the mean, can also affect observed change.

The record does not specify whether the primary analysis was intended to compare baseline and follow-up scores, use another approach, or adjust for any covariates. It also does not give the exact assessment schedule beyond the primary timeframe of 4-6 months. These analysis details are not reported in the registry record and should not be inferred from the outcome’s summary format.

What does over-dispersion mean in general?

Over-dispersion occurs when observed variability is greater than a statistical model expects. It is particularly relevant to some count outcomes and models that assume a particular relationship between the mean and variance. If over-dispersion is ignored, standard errors can be too small and uncertainty can be understated. The primary endpoint in this record is described as a continuous CSBI score summarized by a mean and standard deviation; the registry does not specify a count model or report an over-dispersion assessment. Therefore, over-dispersion should not be presented as a finding of this study.

How should the planning illustration be read?

The sample-size assumptions describe a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is defined as a stated fraction of the observed effect. In general, a sample-size calculation estimates how many participants per arm a hypothetical comparative study might require under specified assumptions. It is not a count of participants observed in this single-group study, and it is not observed power.

The registry record does not report numerical planning outputs or the observed effect used in the illustration. The assumed two-arm design is distinct from the registered single-group design. Consequently, the planning assumptions should not be read as a description of the actual allocation or as evidence that the study was designed with those assumptions. Nor can the illustration establish whether the completed study had adequate precision for its pilot objectives.

Finally, statistical significance and clinical importance are different ideas. In general, a p-value evaluates compatibility between data and a statistical null model under specified assumptions; it does not quantify the size or importance of an effect. An estimate and its uncertainty are needed to understand the magnitude and precision of a result. Since outcome estimates and inferential results are not reported in the registry record, these distinctions cannot be applied to a numerical treatment finding for this study.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists two outcome measures: the CSBI primary outcome and child sexual concerns on the Trauma Symptom Checklist for Young Children as a secondary outcome. It reports zero analyses. The numerical findings and analysis details for both outcomes are not reported in the registry record. A multiplicity strategy, such as prioritizing one confirmatory test or adjusting interpretation across multiple tests, is also not reported.

In general, testing several outcomes or several versions of an outcome can increase the chance of finding an apparently unusual result by chance. How this concern should be handled depends on whether outcomes are confirmatory or exploratory, the analysis plan, and the intended interpretation. The record identifies a primary and a secondary measure, but does not state whether formal hypothesis tests were planned or how multiplicity would be addressed. No correction or absence of correction should be inferred.

Missing-data handling and analysis populations are not reported in the registry record. It does not state how many participants completed each assessment, whether any outcome data were missing, why data might be missing, or whether an analysis included all enrolled participants or a subset. There is also no stated approach for imputation, complete-case analysis, or sensitivity analysis. These are important details because missingness can affect both the estimate and how representative the analyzed participants are of those enrolled.

For a single-group pilot, clarity about who contributed baseline and follow-up measurements is especially useful for interpreting change over time. The registry’s enrollment figure does not establish how many observations were available for a particular outcome or assessment. Without outcome-specific denominators and missing-data methods, the completeness and potential selection effects of any analysis cannot be evaluated.

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 reports no serious adverse events among the 13 participants listed as at risk for serious events, and no other adverse events among the 13 listed as at risk for other events. Deaths are recorded as 0. No serious adverse event terms are listed. These are the safety figures recorded for this single-group study.

Zero reported events should be read as a description of what the registry record reports, not as proof that the intervention carries no risk. The record does not provide event definitions, severity grading procedures, collection methods, timing, relatedness assessments, or a narrative explaining the safety monitoring process. It also does not describe whether adverse events were actively solicited or how long participants were monitored for safety.

The number at risk indicates the group size used for the registry’s event reporting; it does not establish that all possible events were captured or that follow-up was complete. With no comparator group, the record cannot support a comparative safety estimate. The figures do not establish whether an event was caused by treatment, and they should not be interpreted as a broad safety guarantee. They describe only the adverse-event counts recorded in this registry entry.

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

The record establishes that a completed, single-group pilot of a phase-based behavioral treatment was registered, with 13 participants and a primary outcome focused on child sexual behavior. It identifies a measure, its score direction, and a primary timeframe. It also records the listed secondary outcome and adverse-event counts. These details describe the study’s scope and the information available in the registration.

The record does not report numerical CSBI results, secondary outcome results, or statistical analyses. It therefore does not show whether scores changed, how large any change was, how variable the scores were, or how precisely a change was estimated. The absence of reported results is not evidence that there was no change, just as it is not evidence that there was a change. It permits neither a favorable nor an unfavorable efficacy conclusion.

Even if a within-group change were reported, the design would not provide a randomized concurrent control comparison. In general, changes observed in one group over time can reflect treatment and other influences. A single-group pilot can offer descriptive information and support further study, but comparative claims require an appropriate comparison and an analysis suited to the study question.

The project summary describes an aim to develop and pilot test an intervention applicable in a range of treatment settings, as an early step toward validation in larger clinical trials. This is a stated development purpose, not a demonstration of validation. The registry record does not report implementation outcomes, treatment fidelity, acceptability measures, or detailed feasibility criteria. Those features cannot be assumed from the study’s pilot designation.

The safety entry records zero serious and other adverse events and zero deaths, but the absence of recorded events in this entry does not establish that there is no risk. Overall, the registry record supplies a design description and limited outcome reporting, but it is insufficient to establish treatment effectiveness, comparative benefit, or a full safety profile.

13. Why This Trial Matters Statistically

This study is statistically relevant because it illustrates the difference between a pilot’s developmental purpose and the evidence needed for a comparative treatment conclusion. A single-group design may be useful for early work, but it cannot distinguish an intervention-related change from time trends and other influences as effectively as a well-designed comparison. Recognizing that design boundary prevents a descriptive observation from being overstated as causal evidence.

The primary outcome is a continuous behavioral measure summarized by a mean and standard deviation. This makes the meaning of the estimand important: an average score describes a group, while individual experiences may vary. Interpretation also depends on the assessment schedule, completeness of repeated measurements, and the method used to estimate change. The registry identifies the outcome and timeframe but does not report these analytic details or the resulting values.

The entry also illustrates why registration and results reporting are distinct. Registration describes the planned study and its outcomes; interpreting evidence requires numerical findings, uncertainty estimates, analysis populations, and transparent handling of missing data. Those results are not reported in this registry record. Without them, readers cannot evaluate precision, assess whether the observed data align with the stated question, or judge the role of multiple outcomes.

Finally, the project summary places the intervention in a treatment context where group delivery may not be feasible and frames the work as a step toward later validation. That context matters for study development, but it does not substitute for outcome evidence. Statistically, the key lesson is to distinguish an intervention’s rationale and intended applicability from measured effects and from evidence that a treatment caused those effects.

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 limitations affect interpretation. The study is single group, with no randomized allocation or concurrent control. Any reported within-group changes would therefore have limited ability to distinguish treatment effects from other changes over time. The registry record does not report numerical primary or secondary outcome results, so the direction, magnitude, and precision of the measured outcomes cannot be assessed.

Although the record specifies enrollment of 13, it does not report outcome-specific participant counts, assessment completion, or the handling of missing data. It also does not describe participant characteristics, eligibility criteria in detail, recruitment, or whether the enrolled group reflects the broader population the project intends to serve. Generalizability cannot be assessed from the information recorded.

The intervention is identified as phase-based, but the registry record does not describe its components, duration, delivery, adherence, or provider qualifications. The record also does not explain the exact timing of assessments within the 4-6 month primary timeframe. These omissions limit assessment of treatment reproducibility and of how consistently participants received the intervention.

Analysis methods, analysis populations, multiplicity handling, and confidence intervals are not reported. The record lists two outcomes and zero analyses, leaving no inferential results to evaluate. The safety entry records no events, but does not provide detail on event collection or monitoring. Together, these limitations mean the registry record supports a basic description of the pilot’s design and registered measures, not a full evaluation of its findings or conduct.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Tx for Child Sexual Behavior Problems — NCT02625571.
• Registry record last updated 2019-10-21; status last verified 2019-09.
• Results first posted 2019-10-21.
• 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

NCT02625571 is a completed, single-group behavioral study sponsored by Milton S. Hershey Medical Center. It enrolled 13 participants and evaluated a phase-based treatment for children with sexual behavior problems. The primary outcome was CSBI total raw score, with a timeframe of 4-6 months; a secondary outcome concerned child sexual concerns on the Trauma Symptom Checklist for Young Children.

The registry record reports no numerical outcome results and lists zero analyses. It records zero serious adverse events, zero other adverse events, and zero deaths. Without outcome estimates, analysis details, or a control group, the record does not establish the direction or size of change, its precision, or whether any change was caused by treatment.