AVANCE-Houston FRAMEWorks Program Evaluation: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for AVANCE-Houston FRAMEWorks Program Evaluation (NCT05261802), a na na study. The primary outcome is Parenting Behavior Measurement #1.

2. Clinical Question

3. Trial Design

This is the AVANCE-Houston FRAMEWorks Program Evaluation, a completed, single-group program evaluation. The registry classifies the phase as NA, allocation as NA, and masking as none. The enrollment listed in the record is 1403. The evaluation began on 2021-04-01, had a primary completion date of 2025-03-31, and is marked completed.

The program summary describes an interest in whether a standard or compressed schedule for the Survival Skills for Healthy Families curriculum better meets the needs of low-income adults. However, the registered model is single group, and the listed group covers all formats of delivery. That structure should not be read as a randomized head-to-head comparison. The record does not identify a separate concurrent control group or describe allocation to distinct schedule arms. It therefore does not, on its own, support a causal comparison of the schedule formats.

The intervention is classified as descriptive and of type other. The arm description identifies workshops delivered by a trained facilitator with support from Career and Family Coaches, and mentions recurring weekly workshops and intensive weekend retreats. It does not provide a complete account of the program activities in this discussion recorded for that arm. Details about participant exposure, adherence, or how each participant received a particular format are not reported in the registry record.

The listed primary outcome is a mean score on a continuous scale, with standard deviation as the stated measure of dispersion. Its timeframe is change from baseline in parenting behavior at 12 months from enrollment. The registry lists five outcome measures, but records no analyses. Thus the design and target outcome can be described, while an estimated outcome change and its statistical uncertainty cannot be recovered from the registry record. The record also does not report a protocol-based sample-size justification or a statistical analysis plan.

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: All types of workshop completions (virtually completing across 7 weeks, completing in person across 7 weeks, completing the weekend format in person, completing the weekend format virtually) were analyzed as one arm. Originally, the study was designed to be an RCT where researchers would look for differences among groups. But funding was downgraded to a descriptive study, mostly due to COVID highly affecting the program when it started out.

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 Parenting Behavior Measurement #1, measured over Change from baseline in parenting behavior (frequency of support for child) at 12 months from enrollment..

The primary endpoint is Parenting Behavior Measurement #1, a score intended to capture the frequency of support for a child. It combines four items, each rated on a four-point scale: 1 = Never, 2 = Hardly ever, 3 = Sometimes, and 4 = Often. The four items are combined by adding them and dividing by 4. The resulting construct score ranges from a minimum score of 1.0 to a maximum score of 4.0, and higher scores indicate better outcomes.

The endpoint is framed as change from baseline to 12 months after enrollment. A repeated measure of this kind can describe whether participants’ reported behavior differs over time, while retaining the meaning of the scale as frequency of support. It is a continuous measure, so a mean is the registered summary parameter and standard deviation is the registered dispersion measure. The mean describes the average score, while the standard deviation describes variability among the scores.

The registry record does not report the baseline mean, 12-month mean, change estimate, standard deviation values, or an analysis of change. The endpoint definition explains what was intended to be measured, but the record does not establish the magnitude or precision of any observed change.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The outcome is defined as a mean on a continuous scale, and the registered dispersion measure is the standard deviation. These summaries answer different questions. A mean locates the center of the observed scores; a standard deviation describes how spread out individual scores are around that center. Reporting both can help readers understand the average score as well as variation across participants. The registry record supplies the intended summaries but does not report their values for the primary endpoint.

What would a change estimate mean?

A change-from-baseline endpoint compares a participant’s or group’s score at follow-up with its baseline score, according to the analysis method used. A group mean change describes average movement on the scale; it does not imply that every participant changed in the same way. Here the intended follow-up is 12 months from enrollment. The record does not state how change was calculated in an analysis, and it lists no analyses, so a particular calculation method should not be assumed.

The scale ranges from 1.0 to 4.0, and higher scores represent more frequent reported support for a child. This direction helps interpret a reported score or change if one is available. The score is a construct derived from four items, rather than a direct count of events. Its interpretation is consequently tied to the item wording, rating choices, and combination rule recorded for the measure. The registry record does not report additional information about validation, reliability, or how the items were handled when a response was missing.

What does a confidence interval add?

In general, a confidence interval expresses the uncertainty around an estimated quantity under the method’s assumptions. A narrower interval indicates greater statistical precision than a wider one, but precision is not the same as freedom from bias. An interval cannot correct a non-comparable design, systematic measurement error, or informative loss to follow-up. No confidence interval for the primary endpoint is reported in the registry record, so the precision of an estimated change cannot be assessed.

Why does the single-group structure matter?

In general, observing a change over time in one group is not the same as estimating the difference that would have occurred under an alternative program or no program. Participants may change for reasons other than the program, and the record does not identify a separate concurrent comparison group. The stated interest in schedule formats does not change the registered single-group model. Without a reported controlled comparison, an outcome change could not be attributed to one format over another solely from the design information in the registry record.

What do the planning assumptions represent?

The stated sample-size assumptions describe a planning illustration based on an observed effect, not the trial’s own design. The illustration uses a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is expressed as a stated fraction of the observed effect. The record specifies that time-to-event illustrations would report total events, while other illustrations would report participants per arm. These are planning conventions, not observed findings, and they do not establish that the evaluation was designed or conducted as a two-arm trial.

In general, a planning calculation asks how much information a future comparison might require under specified assumptions. It is not observed power, and it is not evidence that a comparison was actually made. The registry does not report its own sample-size justification or a formal design comparison. Moreover, the primary effect estimate that would anchor such an illustration is not reported in the registry record. The planning assumptions therefore should not be used as a substitute for outcome results or as proof that the evaluation had a particular level of power.

What can be concluded from the analysis record?

The registry lists zero analyses. It does not report a model, test, adjustment strategy, confidence interval, or handling of repeated measurements for the primary outcome. General descriptions of statistical methods explain how such analyses might be interpreted, but they cannot establish which method was used in this evaluation. The appropriate reading is that the record defines a continuous primary measure and its follow-up timeframe, while the analysis and numerical results are not reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists five outcome measures, including the primary parenting behavior measure and secondary measures concerning parenting attitudes and partner relationship attitudes. However, it records no analyses. The registry record does not report whether outcomes were tested, whether any multiplicity adjustment was planned, or how the primary outcome was prioritized in an analysis plan. Without reported tests or a statistical plan, the risk of selective emphasis across multiple outcomes cannot be assessed from this record.

Missing-data methods are also not reported in the registry record. The record does not explain how incomplete item responses, missing baseline scores, or unavailable 12-month measurements were handled. It does not report the number of outcome observations analyzed or whether any imputation, weighting, or other method was used. These details can affect both the estimate and its precision, especially when the likelihood of missing data is related to participant characteristics or outcomes.

The analysis population is not reported in the registry record. There is no stated rule defining who was included in the primary analysis, whether inclusion required having both baseline and follow-up data, or how participants with partial data were treated. No intention-to-treat, per-protocol, or other analysis population is specified. These approaches answer different questions and can yield different estimates; none should be attributed to this evaluation without a report of the method used.

Because the registry reports zero analyses, it is not possible to assess how multiplicity, missing outcomes, or analysis-population choices affected the primary result. This absence does not establish that the investigators did not address these issues elsewhere; it means they are not reported in the registry record.

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 information is recorded for the all-formats delivery group. For serious adverse events, the registry lists 1403 at risk and 0 affected. For other adverse events, it also lists 1403 at risk and 0 affected. The number of deaths recorded is 0, and no top serious-event terms are listed.

These figures describe what the registry record reports; they should not be read as proof that no adverse experiences occurred outside the record’s definitions or reporting process. The record does not provide further detail about event definitions, surveillance procedures, duration of safety follow-up, or completeness of reporting. It also does not explain the relationship between adverse-event follow-up and the 12-month primary outcome timeframe. Those details are not reported in the registry record.

The safety counts do not provide a comparison with an untreated or alternative-format group, because the listed design is single group. The counts therefore describe the recorded events in the listed group, not a comparative safety estimate. They are separate from the parenting behavior endpoint and do not supply evidence about program effectiveness.

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

The record establishes what the evaluation set out to measure: change from baseline in a parenting behavior score at 12 months from enrollment. It also defines the score, its range, and its direction. It describes a program that uses the Survival Skills for Healthy Families curriculum and identifies several delivery formats. These details clarify the intended evaluation question and the measurement framework.

The record does not report the primary outcome’s estimate, uncertainty, or analysis. It therefore cannot establish whether parenting behavior increased, decreased, or remained similar over the evaluation period. It also cannot establish whether any observed change, if one was calculated, was precise or compatible with no change. The absence of reported results is not itself evidence of no effect.

Nor does the registry structure establish whether a standard or compressed schedule is better. Although comparing those formats is part of the stated program interest, the registered evaluation is single group and the listed group includes all formats. The record does not describe a separate randomized schedule comparison. A before-and-after description, even if reported, would not by itself show that the program or a particular format caused the change.

In general, evidence about program impact depends on the design, outcome measurement, completeness of follow-up, and analysis as well as the observed estimate. The registry record does not report enough information about analysis methods or missing data to assess those features for the primary endpoint. The result is a meaningful account of the intended measure and evaluation structure, but not a report of outcome findings. No conclusion about the program’s effects on family relationships, economic stability, or skill retention can be drawn from the primary endpoint information alone.

13. Why This Trial Matters Statistically

This evaluation is statistically useful to examine because its stated program question concerns delivery format, while its registered design is a single group covering all formats. That distinction illustrates why a program’s aim and a design’s capacity to answer a comparison question are not interchangeable. A question about which schedule works better calls for a comparison that can distinguish schedule-related differences from other explanations. The registry record does not describe such a separate comparison.

The primary endpoint also demonstrates the importance of defining an outcome precisely. The record specifies the behavior of interest, the response scale, the construction of the score, its range, its direction, and the follow-up timeframe. These details make the intended measurement more interpretable than a broad label alone. At the same time, a well-described measure does not replace a reported estimate, uncertainty interval, or analysis.

The record’s completed status and enrollment figure might otherwise invite readers to expect results. Yet completion and enrollment describe the evaluation’s status and scale, not its findings. The registry lists five outcome measures but zero analyses. Statistically, that gap matters: without results, readers cannot judge the direction, size, or precision of change, and without a reported analysis plan they cannot assess how missing outcomes or multiple measures were handled.

Finally, the planning assumptions are distinct from the evaluation’s reported design. A planning illustration based on an observed effect does not demonstrate that a two-arm comparison occurred, and it is not observed power. Keeping these categories separate helps prevent a planning calculation from being mistaken for an outcome finding. The case underscores a broader principle: clear interpretation requires matching claims to the design and results actually reported.

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.

A central limitation of the registry record is that it does not report a primary outcome estimate or analysis. Although the endpoint and follow-up time are defined, the baseline and follow-up means, mean change, variability values, and uncertainty are not reported in the registry record. The magnitude and precision of change therefore cannot be evaluated.

The registered model is single group, and the listed group includes all delivery formats. The record does not identify a separate comparison group or a direct comparison between standard and compressed schedules. As a result, the registered design information does not support attributing change to the program or determining which schedule format is preferable.

Further limitations concern incomplete methodological detail. The registry record does not report the analysis population, missing-data methods, outcome observation counts, multiplicity procedures, or a statistical analysis plan. It also does not give enough detail to determine how participants were exposed to particular formats, whether delivery differed from what was intended, or how workshop participation was measured. These details are not reported in the registry record and should not be inferred from the program description.

The primary measure is a construct score based on four self-reported frequency items. The record explains its scoring, but does not report additional measurement properties or how incomplete item responses were handled. The reported adverse-event figures are also limited by the absence of further information on event definitions and monitoring. Finally, the planning assumptions are illustrations rather than evidence of the evaluation’s own design or observed power. Together, these gaps limit what can be concluded from the registry record, even though it identifies the program, target measure, and intended timeframe.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: AVANCE-Houston FRAMEWorks Program Evaluation — NCT05261802.
• Registry record last updated 2026-03-06; status last verified 2026-02.
• Results first posted 2026-03-06.
• 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

The AVANCE-Houston FRAMEWorks Program Evaluation is registered as a completed, single-group evaluation with enrollment of 1403. Its listed primary outcome is change from baseline in parenting behavior at 12 months from enrollment, measured by a continuous score for frequency of support for a child.

The registry describes weekly workshops and intensive weekend retreats and states an interest in standard versus compressed schedule formats. It does not report a separate schedule comparison, a primary outcome estimate, or any analysis. Missing-data methods, analysis populations, and multiplicity procedures are also not reported in the registry record.

The adverse-event listing records 0 serious events, 0 other events, and 0 deaths. These counts describe the registry’s recorded safety information and do not provide a comparative estimate. Overall, the record defines the evaluation question and measurement, but does not report findings that establish the direction or precision of change.