This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Parenting Support for Justice Involved Families (NCT06329336), a na na study. The primary outcome is Parenting Behavior Inventory - Very Short Form.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06329336 |
| Phase | NA |
| Condition | Parenting, Well-Being, Psychological, Mental Health Wellness 1 |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 13 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Washington |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns parents re-entering the community after incarceration and their families, including children’s primary caregivers. The stated goal is to support parent and caregiver well-being and effective parenting, with attention to children’s development. The registry record lists an enrollment of 13, but does not describe the characteristics of the enrolled participants or identify how many contributed assessments.
Intervention
The intervention is described as a preventive parenting program combining behavioral parenting and mindfulness-based well-being practices. The study evaluates a task-sharing approach in which re-entry navigators are trained to deliver parenting interventions. The registry names the intervention Social Emotional Competence for Children and Parents and describes the program as intended to support effective parenting.
Comparator
There is no separate control group in the registry design. The study is single-group, with pretest and posttest assessments around a 6-week program. Those measurements permit description of outcomes before and after participation, but they do not provide a like-for-like comparison with families who did not receive the intervention.
Primary question
The primary measure is the Parenting Behavior Inventory - Very Short Form, which assesses parental warmth and consistency on a scale from 0 to 4, with higher scores reflecting more warmth and consistency. The question is whether the measure differs between pretest and posttest assessments in this single group. The registry record does not report the numerical scores, the amount of change, or an inferential analysis, so it does not establish whether a change was observed.
3. Trial Design
NCT06329336, titled “Parenting Support for Justice Involved Families,” is listed as completed and has no applicable phase. The registry describes a single-group behavioral study with no masking. Allocation is not applicable, and no randomized control comparison is described. The listed enrollment is 13. The study start date is 2024-06-01, and the primary completion date is 2025-03-30.
The project is framed around adapting and delivering parenting support for parents re-entering the community and their families. The summary describes collaboration with the Community Care Team of King County Community Partnership for Transition Solutions. Re-entry navigators with lived experience are to contribute to intervention adaptation and delivery, with the stated aim of making the program more feasible and accessible through trusted connections. The intervention named in the record is Social Emotional Competence for Children and Parents; its arm description identifies a preventive parenting program combining behavioral parenting and mindfulness-based well-being practices.
The primary outcome assessments are described as pretest measurements conducted 2-3 weeks before the start of the 6-week program and posttest measurements conducted within 2-3 weeks of completion. This is a before-and-after structure within one group, rather than a comparison between intervention and control groups. It can describe measurements at two time points, but without a control group it cannot separate a program-associated pattern from other changes over time or differences in who completed each assessment.
The registry record does not report a randomization method, a masking procedure beyond NONE, or a statistical analysis plan. It also does not report a sample-size justification. The posted design information therefore supports a descriptive account of the planned setting and measurement schedule, but not an assessment of comparative effectiveness or causal effects.
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
| Stage | Intervention |
|---|---|
| STARTED | 13 |
| COMPLETED | 13 |
| NOT COMPLETED | 0 |
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.
| Characteristic | Unit | Intervention |
|---|---|---|
| Participants analysed | 13 | |
| Age, Continuous | Years | 32.18 (SD 9.18) |
| Sex: Female, Male: Female | Participants | 10 |
| Sex: Female, Male: Male | Participants | 3 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 1 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 6 |
| Race (NIH/OMB): White | Participants | 3 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 3 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 10 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 2 |
| Region of Enrollment: United States | Participants | 13 |
6. Primary Endpoint
The registry lists the primary outcome as Parenting Behavior Inventory - Very Short Form, measured over Pretest assessments were conducted 2-3 weeks prior to the start of the 6-week program, and posttest assessments were conducted within 2-3 weeks of completion of the program..
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Units on a Scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the Parenting Behavior Inventory - Very Short Form, a questionnaire measuring parental warmth and consistency. Its scores range from 0 to 4; higher scores reflect higher warmth and consistency. The registry expresses the outcome as a mean with standard deviation, in units on the scale. The stated assessment schedule places the pretest 2-3 weeks before the 6-week program and the posttest within 2-3 weeks after completion.
This measure is relevant to the stated intervention aims because the program is intended to support effective parenting. A continuous scale can describe the average level of measured warmth and consistency and the spread of scores among assessed participants. A mean alone does not show whether individuals changed in the same way, and a standard deviation describes variability rather than precision of the mean. Interpreting a pretest-to-posttest contrast also requires knowing which participants contributed data at each time and how the contrast was analyzed.
The registry record does not report the observed pretest or posttest means, their standard deviations, a change estimate, or a confidence interval. It consequently does not establish the direction, size, or precision of any change on this endpoint. The measure captures the questionnaire construct described in the registry; it should not be treated as a direct measure of every aspect of parenting, caregiver well-being, or child development.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a primary outcome and assessment schedule but does not include numerical outcome results for the Parenting Behavior Inventory - Very Short Form. There are no posted means, standard deviations, estimates of pretest-to-posttest change, confidence intervals, or p-values in the record information. Accordingly, the primary endpoint cannot be interpreted as showing an increase, a decrease, or no change. The absence of a posted estimate is not evidence that the measure remained unchanged.
The design is single-group. Pretest and posttest measurements can reveal how scores in the assessed group compare across time, but such a comparison by itself does not establish that the intervention caused any difference. Other influences during the interval, measurement variation, regression toward typical scores, and changes in who completed follow-up could contribute to an observed pattern. A separate comparison group would be needed for a direct contrast against a concurrent group not receiving the intervention; no such group is described in the registry design.
The enrollment listed in the record is 13. That figure does not establish how many participants completed the program, completed either assessment, or were included in an analysis. Those analysis counts are not reported in the registry record. Without them, it is not possible to assess the completeness of outcome data or whether assessment availability differed between time points.
The registry marks the study completed and lists three outcome measures, but it reports no analyses. Completion status indicates the record’s study status; it is not itself evidence of an outcome or of successful implementation. Nor does the number of listed measures tell readers whether every measure was collected or analyzed.
The intervention’s goals include supporting parents and caregivers and promoting positive child development. The primary measure, however, is a questionnaire focused on parental warmth and consistency. Even if numerical findings were available, this one endpoint would not alone establish effects on all the broader goals described in the study summary. The registry record does not provide results for those broader aims in the information available for this analysis.
Planning calculations should also be distinguished from observed findings. The stated sample-size assumptions describe an illustration based on an observed effect, with two-sided significance level 0.05, equal allocation between two arms, and a normal approximation. The study itself is single-group, and the assumptions explicitly describe a planning illustration rather than the trial’s own design. No numerical planning results or observed endpoint effect are reported in the registry record. Such illustrations are not observed power and cannot fill the gap in reported outcome findings.
9. Statistical Methods Explained
The primary endpoint is continuous: it is a questionnaire score summarized as a mean and standard deviation. A mean gives the arithmetic average of observed scores, while a standard deviation describes how dispersed individual scores are around that average. They answer different questions. The mean describes the group’s average measured level; the standard deviation describes variability among scores. Neither statistic, on its own, gives the precision of an estimated mean or the uncertainty in a comparison over time.
What does a pretest-to-posttest comparison describe?
In a single-group study, a pretest-to-posttest analysis compares measurements collected from the same study group at two time points. If the same individuals contribute both observations, an analysis can use the within-person pairing to characterize changes. If different participants contribute at the two time points, a comparison of group summaries instead reflects both the score patterns and the composition of the assessed groups. The registry record does not report which participants contributed each assessment or specify the analytic approach, so it is not possible to determine how any contrast would have been constructed.
For a paired analysis, the variability of individual changes matters; it cannot generally be recovered from separate means and standard deviations alone. For a comparison of group averages without pairing, the uncertainty depends on the variability and number of observations in each group of measurements. In either case, an estimate of change should be presented with a measure of uncertainty, such as a confidence interval, when available. The registry record does not report a change estimate or its uncertainty.
How should a confidence interval be understood?
As a general statistical explanation, a confidence interval describes the range of estimates compatible with the data and the method used, under the assumptions of that method. A narrow interval indicates greater statistical precision than a wide interval, but precision is not the same as importance or freedom from bias. An interval for change would help readers assess which magnitudes of change remain plausible. No confidence interval for this endpoint is reported in the registry record.
A p-value, if reported, would address compatibility between the data and a specified statistical model or null hypothesis. It would not measure the size of an effect, the probability that the intervention works, or whether an observed result is important. The registry information for this analysis reports no endpoint p-value and no analysis. It is therefore inappropriate to infer statistical significance or lack of significance.
Why does the single-group design matter?
A before-and-after measurement can describe temporal change in participants who are assessed, but it does not isolate the intervention as the cause. Participants may change over time for reasons unrelated to program participation, and the act of measurement can itself produce variability. A concurrent control group can help account for shared changes over time, though the design and analysis still determine what causal conclusions are justified. Here, the registry explicitly characterizes the study as single-group, so there is no like-for-like control comparison in the listed design.
Regression toward typical values is a general concern when participants enter a study at a time when their measured scores are unusually high or low. On reassessment, some movement toward more typical values may occur even without an intervention effect. The registry record does not describe selection based on baseline scores, so this is a general interpretive consideration, not a claim about how participants were selected in this study.
What does the planning illustration mean?
The sample-size assumptions describe a planning illustration based on an observed effect, not the study’s own design. They specify a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the target effect expressed as a stated fraction of the observed effect. General sample-size planning asks how much information a future design might need to detect a chosen effect under specified assumptions. Its outputs depend on the effect size used, variability, design, allocation, and analysis assumptions.
Those assumptions do not turn this single-group study into a two-arm comparison. The illustration is not observed power, which should not be presented as a retrospective measure of whether the completed study could detect an effect. The registry record does not report a sample-size justification or numerical planning results in the information available for this analysis. It also does not report the observed effect needed to independently assess the illustration.
What role does the standard deviation play?
As a general matter, the standard deviation describes score dispersion, whereas the standard error describes uncertainty in an estimated mean and depends on the data and analysis. They are not interchangeable. A larger spread can make an estimate less precise when other features are held constant, but the actual precision cannot be determined without the relevant sample and analysis information. Since the endpoint summaries and analysis results are not reported, neither outcome variability nor precision can be evaluated for this study.
Finally, statistical methods cannot address missingness or measurement quality without information about data collection and analysis. The record specifies the questionnaire and timing but does not explain how incomplete questionnaires were handled, whether scores were calculated under a particular rule, or whether analyses adjusted for participant characteristics. These details are not reported in the registry record, so conclusions should remain limited to the design and outcome definition that are documented.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists three outcome measures and identifies the Parenting Behavior Inventory - Very Short Form as the primary outcome. It reports no analyses in the information available for this account. The record does not state whether the other outcome measures were designated secondary or exploratory, how their results were analyzed, or whether any adjustment for multiple comparisons was planned or used. Multiplicity concerns arise when several outcomes or analyses are examined, because the chance of at least one apparently notable finding can increase as the number of tests grows. Whether and how that concern was addressed is not reported in the registry record.
Missing-data methods are not reported. The record does not state how incomplete questionnaires, missed posttests, or participants without paired assessments were handled. It also does not provide assessment completion counts, so the extent or pattern of missing outcome information cannot be evaluated. In general, missingness can affect a pretest-to-posttest estimate if the participants with observed follow-up differ systematically from those without it. The direction and magnitude of any such effect cannot be determined without data and a documented analysis.
The analysis population is not reported. It is not stated whether analyses were intended to include all enrolled participants, only those who began or completed the program, or those with specific outcome data. No per-analysis denominator is reported. The enrollment figure alone should not be treated as the number analyzed.
The statistical plan, including any adjustment for covariates, handling of repeated measurements, and criteria for excluding observations, is not reported in the registry record. These omissions limit reproducibility and make it difficult to assess whether the posted analysis, if any, followed a prespecified approach. No conclusion about multiplicity control, missing-data bias, or the analysis population is justified from the available record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Intervention | 0 | 13 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Intervention | 0 of 13 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Intervention | 0 of 13 |
The registry lists one intervention group for adverse events, with 13 participants at risk for serious events and 13 at risk for other events. The listed counts of serious events, other events, and deaths are all 0. These are the recorded figures for the intervention group in the registry record; they do not provide a comparison with a separate control group, because the study is single-group.
An at-risk count describes the participants included in the relevant safety denominator, while an event count describes events recorded under the registry’s categories. A zero event count means that none are listed in that category in this record. It should not be broadened to mean that no participant experienced any possible unwanted effect, that all safety information was captured, or that the intervention is free of risk. The record does not report additional details about event collection, follow-up completeness, event severity beyond the serious-event category, or causal attribution.
The record lists no top serious-event terms. That is a reporting detail, not a detailed account of surveillance procedures. With no control group and no further safety-analysis information reported, these figures are descriptive registry counts only. They do not support a comparative estimate of safety or a conclusion about risks outside the recorded categories and period.
12. What the Result Does, and Does Not, Mean
The registry record documents a completed, single-group study of a parenting support approach for justice-involved families. It names a primary measure focused on parental warmth and consistency and describes pretest and posttest timing around a 6-week program. These details establish what the primary outcome was intended to measure and how the assessments were scheduled.
The record does not report numerical primary outcome results or analyses. As a result, it is not possible to say whether scores increased, decreased, or remained similar, or to describe the size or precision of any change. No inferential conclusion can be drawn from the endpoint information. A lack of posted numerical results should not be interpreted as a null result.
Even if a pretest-to-posttest difference were reported, the single-group design would support a description of change over time rather than a direct comparison with a control group. It would not by itself establish that participation caused the change. Interpretation would also depend on which participants completed the assessments, how missing data were handled, and what analysis was conducted; these details are not reported in the registry record.
The stated aims extend beyond the primary questionnaire, including caregiver well-being and children’s development. The Parenting Behavior Inventory - Very Short Form is described as measuring parental warmth and consistency, so it does not encompass every stated aim. The record information analyzed does not report findings for broader outcomes either.
The safety counts are likewise limited: the registry lists zero serious events, zero other events, and zero deaths in the intervention group, with 13 at risk in each event category. Those entries are descriptive and should not be read as proof that no possible adverse effects occurred. Overall, the record defines the intended study and endpoint, but does not establish an outcome effect, a causal effect, or a comprehensive safety conclusion.
13. Why This Trial Matters Statistically
This study is statistically notable for the question it sets out to address and the design used to address it. Parenting support for parents re-entering the community is delivered through a task-sharing approach in which re-entry navigators are trained to deliver parenting interventions. The study summary emphasizes the navigators’ lived experience and trusted connections as relevant to accessibility and adaptation. Evaluating implementation in this setting can be important, but the registry record’s single-group design and absent numerical outcome results limit the statistical claims that can be made.
The primary measure gives the study a defined quantitative focus: parental warmth and consistency assessed with a continuous questionnaire. A clear scale and specified measurement schedule help readers understand the intended endpoint. At the same time, the broader aims involve caregiver well-being and children’s development, which cannot be represented fully by this one measure. The registry lists three outcome measures, but does not report analyses or numerical findings in the record information available for this analysis.
Statistically, the key distinction is between observing change and attributing change. Repeated assessment within one group can be informative about measured scores over time, but it does not supply the counterfactual comparison needed to distinguish intervention-associated change from other temporal influences. That distinction matters for clinical and community research because an appealing program rationale does not substitute for an identified contrast and reported estimates.
The record also illustrates why outcome reporting matters. Without means, variability, change estimates, uncertainty intervals, and analysis counts, readers cannot judge the amount or precision of a measured change. Completion status and enrollment do not fill those gaps. A transparent report of assessment completeness, analysis population, and methods would help readers evaluate both results and limitations.
The project’s focus on adaptation and task-sharing may be relevant to how future evaluations are designed. This record, however, supports no conclusion about efficacy or broader impact. Its statistical value lies in the documented aims, outcome definition, and limitations that readers should consider when interpreting any eventual or separately reported findings.
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 central limitation is that the registry record does not report numerical results for the primary endpoint or analyses. Without observed summaries and an estimate of change, the direction, magnitude, and precision of the measured outcome cannot be evaluated. The record’s completed status does not resolve this absence.
The study is single-group, with no like-for-like control comparison. Any pretest-to-posttest pattern, if reported elsewhere, would be difficult to distinguish from changes over time unrelated to the intervention. The design therefore does not provide a direct comparative estimate of intervention effect. The registry information also does not describe an analytic strategy that might address repeated observations or other sources of bias.
The enrollment listed is 13, but the registry record does not report how many participants completed the program, completed each assessment, or entered the analysis. Participant characteristics and the representativeness of the enrolled group are also not described in the information available for this analysis. These omissions limit assessment of generalizability and follow-up completeness.
The primary measure is a questionnaire about parental warmth and consistency. It does not directly capture every broader aim in the summary, including caregiver well-being and child development. The registry record does not provide results for those broader aims. Nor does it report details of questionnaire scoring, missing-item handling, or measurement quality in this population.
Finally, the registry does not report the statistical plan, multiplicity handling, missing-data methods, or analysis population. The adverse-event entries are descriptive and lack a control group. These limitations do not imply that the study was conducted improperly; they identify information not reported in the registry record and constrain what can be concluded from it.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Parenting Support for Justice Involved Families — NCT06329336.
- Registry record last updated 2026-05-20; status last verified 2026-04.
- Results first posted 2026-05-20.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT06329336 is a completed, single-group behavioral study titled “Parenting Support for Justice Involved Families,” sponsored by the University of Washington. The record lists enrollment of 13, no masking, and no applicable phase. Its intervention is named Social Emotional Competence for Children and Parents and is described as a preventive parenting program combining behavioral parenting and mindfulness-based well-being practices.
The primary outcome is the Parenting Behavior Inventory - Very Short Form, measuring parental warmth and consistency on a scale from 0 to 4. Assessments were scheduled 2-3 weeks before and within 2-3 weeks after a 6-week program. The record lists three outcome measures and no analyses. Numerical results for the primary endpoint are not reported in the registry record. The listed safety counts are zero for serious events, other events, and deaths in the intervention group; these are descriptive counts, not a controlled safety comparison.