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 Joyful Parenting Pilot Project RCT Study (NCT03282071), a randomized na study. The primary outcome is Sharing (Praise), Mind (Appreciation) and Enjoyment (SME) Related Behaviours.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03282071 |
| Phase | NA |
| Condition | Mental Well-being, Happiness |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 144 |
| Arms in the primary outcome | n/a |
| Lead sponsor | The University of Hong Kong |
| Results posted | Yes |
2. Clinical Question
Population
Parents aged 12–59 and their family members in Hong Kong were the intended target population. The registry record lists 144 enrolled participants. It does not report further eligibility details or the characteristics of those enrolled.
Intervention
The Joyful Parenting Intervention consisted of two-session interactive talks on joyful parenting, described as a core session and a booster intervention, plus a family gathering activity. Questionnaire evaluations were planned at baseline, after the session, and at follow-up.
Comparator
The control group received no intervention during the study period. The record does not describe an attention control or another active comparison programme.
Primary question
The primary outcome concerned participants’ reported frequency of Sharing, Mind and Enjoyment behaviours. The intended assessment followed these scores from baseline to the 1-month and 3-month follow-ups. The registry record does not report the comparative outcome estimates, so it does not establish the size or precision of any difference between groups.
3. Trial Design
This was a completed, randomized, parallel-group pilot project sponsored by The University of Hong Kong. The registry lists the allocation as randomized and the masking as none. It also identifies the design as cluster-randomized. The cluster structure matters for interpreting analyses: measurements from people in the same cluster may be statistically related, so an analysis that treats every participant as independent could give misleading uncertainty. The registry record does not report the cluster definition, the number of clusters, or details of how clusters were assigned.
The enrollment was 144. The study start date was 2017-09-21, and primary completion was recorded as 2018-06-30. The status is completed, and the phase is listed as NA. These administrative details do not supply evidence about the outcome: the registry record does not report primary outcome estimates, standard deviations, confidence intervals, or hypothesis-test results.
The intervention was a community-based, family-focused programme. Its stated activities were interactive joyful-parenting talks and a family gathering. The control group received no intervention during the study period. The intervention-group description specifies questionnaires at baseline, post-session, 1 month, and 3 months after the core session; the primary outcome timeframe describes baseline, 1-month follow-up after baseline, and 3-month follow-up after baseline. The record does not explain how these timing descriptions were reconciled in the analysis.
The project description refers to both qualitative and quantitative evaluation, including focus groups and a randomized controlled trial. The registry record does not report qualitative findings or a detailed quantitative analysis plan. Because the study is identified as cluster-randomized, simple individual-level recalculation would be misleading; the registry record indicates that only the sponsor’s own analysis is appropriate. No sponsor analysis results are reported in the 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: 8 parents excluded (not meeting inclusion criteria 18-59 years)
Overall Study
| Stage | Joyful Parenting Intervention | Control |
|---|---|---|
| STARTED | 75 | 69 |
| COMPLETED | 65 | 60 |
| NOT COMPLETED | 10 | 9 |
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 | Joyful Parenting Intervention | Control | Total |
|---|---|---|---|---|
| Participants analysed | 75 | 69 | 144 | |
| Age, Continuous: Age | years | 41.8 (SD 5.51) | 43.3 (SD 6.19) | 42.5 (SD 5.87) |
| Sex: Female, Male: Female | Participants | 58 | 64 | 122 |
| Sex: Female, Male: Male | Participants | 17 | 5 | 22 |
| Race and Ethnicity Not Collected | Participants | — | — | 0 |
| Birthplace: Hong Kong | participants | 28 | 27 | 55 |
| Birthplace: Guangdong Province | participants | 29 | 27 | 56 |
| Birthplace: Other places | participants | 18 | 15 | 33 |
6. Primary Endpoint
The registry lists the primary outcome as Sharing (Praise), Mind (Appreciation) and Enjoyment (SME) Related Behaviours, measured over T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow-up after baseline.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary outcome was Sharing (Praise), Mind (Appreciation) and Enjoyment (SME) related behaviours, measured with an outcome-based questionnaire. It was intended to capture how frequently participants performed the suggested behaviours from baseline through the 3-month follow-up. A behaviour-frequency measure is relevant to the programme’s stated aims because the intervention focused on sharing, appreciation and enjoyment, rather than only on general mental well-being.
The questionnaire description gives three scores. Praise is a 3-item score with a range of 0-21; Appreciation is a 2-item score with a range of 0-14; and Enjoyment is a 2-item score with a range of 0-14. Higher scores mean a better outcome for each. The registry describes the outcome as a mean of a continuous measure, with standard deviation as the dispersion measure.
The record does not explain whether the three scores were analyzed separately, combined into a single summary, or used in another prespecified way. It also does not report the questionnaire’s measurement properties or the primary outcome values by group and time. Without those results, the endpoint definition can be described, but the observed change and its uncertainty cannot be evaluated.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central interpretive limitation is that the registry record contains no posted primary outcome results. It describes the SME behaviour outcome and its planned assessment times, but does not report group means, changes from baseline, a between-group estimate, a confidence interval, or a p-value. Consequently, the record does not show how the intervention and control groups compared on the primary outcome, or how precisely any comparison was estimated.
The study is a pilot project, and the registry lists enrollment of 144. That context identifies the scale and purpose of the project as described in its title, but it does not substitute for an effect estimate. Enrollment alone cannot show whether an observed difference was large, small, or compatible with a range of possibilities. It also cannot indicate whether a finding would be reproducible in a larger or different study.
The cluster-randomized design is important to statistical interpretation. In a cluster design, outcomes within a cluster may be more alike than outcomes from unrelated clusters. As a general statistical point, an analysis that ignores such dependence can understate uncertainty. The registry record itself flags that simple individual-level re-analysis would be misleading and indicates that only the sponsor’s own analysis should be used. However, sponsor analysis results are not reported in the record, and details of the cluster-adjusted method are not reported either. No alternative recalculation should be treated as a substitute.
The record lists nine outcome measures overall and names secondary measures addressing subjective happiness, mental well-being, family relationships, personal and family health, family happiness and harmony, knowledge and perception of mixed anxiety and depressive disorders, and satisfaction with the programme. Multiple outcomes can raise interpretation questions about which findings were primary and how chance findings were handled. Here, the registry record does not report outcome results or a multiplicity procedure, so no pattern of positive or negative findings can be assessed.
The posted information therefore supports a description of the trial’s design, intervention, comparator, endpoint and planned follow-up. It does not support a conclusion about the direction, size, statistical uncertainty, or robustness of the primary outcome comparison. Any sample-size planning illustration should be read as a planning exercise based on an observed effect, not as observed power or evidence of a treatment effect. Numerical sample-size illustrations and the effect estimate on which they rely are not reported in the registry record.
9. Statistical Methods Explained
The registry identifies the study as randomized, parallel-group and cluster-randomized, with no masking. It describes a continuous primary outcome reported as a mean with standard deviation. These labels indicate the broad design and measurement scale, but they do not provide the analysis specification or the results. The registry record lists no analyses and does not report an estimate of the intervention-control contrast.
Why does cluster randomization matter?
In cluster-randomized studies, assignment is made at the cluster level rather than independently for every person. People within a cluster can share settings or experiences, which may make their outcomes correlated. This is a general statistical feature of cluster designs. When that correlation is ignored, the analysis may treat correlated observations as though they contributed fully independent information and may report uncertainty that is too small.
The registry’s own note cautions that a simple individual-level re-analysis would be misleading and says that only the sponsor’s own analysis is shown. The record does not describe the clusters, give the cluster-level allocation details, or report the sponsor analysis. Therefore, a valid interpretation of the primary comparison would require the sponsor’s cluster-aware results and enough methodological detail to understand the analysis. Recalculating an individual-level comparison from group summaries would not resolve that limitation.
What do means and standard deviations describe?
For a continuous measure, a mean describes the group’s average score, while a standard deviation describes how spread out individual scores are around that average. These are descriptive summaries, not a comparison by themselves. To assess the intervention-control contrast, readers would need a clearly defined estimate of the difference, together with an uncertainty measure such as a confidence interval. A confidence interval is a statistical range that expresses the uncertainty around an estimate under the assumptions of the analysis; it is not a guarantee that the true value lies within that range.
The registry record states that the primary measure is treated as a mean and that standard deviation is the dispersion measure. It does not report those values at the relevant assessment times, a change score, or a between-group estimate. It also does not clarify whether Praise, Appreciation and Enjoyment were analyzed as separate continuous outcomes or combined. The outcome description alone cannot answer those questions.
What can a p-value establish?
A p-value, when reported, measures how compatible the observed data are with a specified null model under the assumptions of the statistical test. It does not measure the size or practical importance of an effect, and it is not the probability that the null hypothesis is true. Interpretation usually benefits from an effect estimate and confidence interval as well as any p-value. No p-value or confidence interval for the primary comparison is reported in the registry record, so statistical evidence against a null model cannot be assessed from this record.
How should the planning calculations be read?
The registry’s planning assumptions describe an illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. For outcomes other than time-to-event outcomes, the stated planning quantity is participants per arm for a selected power target; for time-to-event outcomes, it is the total number of events. This study’s primary outcome is continuous, not a time-to-event measure.
Such calculations are planning illustrations, not observed power. They do not show the probability that this completed study detected an effect, and they do not establish that the trial was adequately powered. They depend on the assumed effect and other assumptions. The registry record does not report the numerical planning outputs or the observed effect estimate needed to interpret them. It also does not report the trial’s own sample-size justification, so the planning illustration should not be mistaken for the design rationale.
What is not available for methodological review?
The registry record does not report the detailed statistical plan, the model used for the cluster structure, the handling of repeated measurements, or the analysis population. It does not state how missing measurements were handled, whether there were interim analyses, or how outcome multiplicity was addressed. These details affect how estimates and uncertainty should be interpreted. Their absence does not establish that a particular method was or was not used; it means the method is not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists nine outcome measures overall. The named secondary outcomes cover subjective happiness, mental well-being, family relationship, personal and family health, personal and family happiness, family harmony, knowledge and perception of mixed anxiety and depressive disorders, and satisfaction with the Joyful Parenting programme. These outcomes span several domains and are measured on different concepts. The registry record does not report their results or specify how the primary and secondary outcomes were prioritized in the statistical analysis.
When a study evaluates multiple outcomes or time points, the chance of obtaining at least one seemingly unusual result can increase. As a general statistical principle, an analysis plan may address this through prespecification or an adjustment strategy, depending on the scientific aims. The registry record does not report a multiplicity adjustment or other approach to this issue. It would be inappropriate to assume that an adjustment was used, or that none was used in the sponsor’s analysis.
The record lists no analyses and does not report an analysis population, such as whether the primary comparison included all randomized participants or a subset. It does not report the amount or pattern of missing outcome data, reasons for missingness, or a method for handling missing measurements. Nor does it report whether the repeated questionnaire assessments were modeled jointly or analyzed at separate times. These omissions prevent assessment of how exclusions, incomplete follow-up, and repeated measures may have affected the reported estimates.
The intervention description names baseline, post-session, 1-month and 3-month questionnaire evaluations, while the primary outcome timeframe names baseline, 1-month and 3-month follow-up. The registry record does not explain the analysis’s use of these time points. Results and analysis details for multiplicity, missing data and analysis populations are not reported in the registry 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 |
|---|---|---|---|
| Joyful Parenting Intervention | 0 | 75 | 0.0% |
| Control | 0 | 69 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Joyful Parenting Intervention | 0 of 75 |
| Control | 0 of 69 |
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 |
|---|---|
| Joyful Parenting Intervention | 0 of 75 |
| Control | 0 of 69 |
The registry’s adverse-event figures are counts, not rates or comparative risk estimates. For the Joyful Parenting Intervention group, the record lists 75 at risk for serious adverse events and 75 at risk for other adverse events; it records 0 affected for each category and 0 deaths. For the control group, it lists 69 at risk for serious adverse events and 69 at risk for other adverse events; it records 0 affected for each category and 0 deaths.
These entries mean that the registry reports no serious or other adverse events and no deaths in either group for the categories shown. They do not, by themselves, establish that no events occurred outside the registry’s reporting definitions, observation period, or recorded data. The record does not provide serious-event terms, because no top serious terms are listed, and it does not describe the event-collection procedures, exposure time, or event adjudication. The figures should therefore be read as registry-recorded counts, not as a comprehensive estimate of safety or as evidence that the groups had equivalent risk.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a completed, cluster-randomized pilot trial was designed to evaluate a community-based Joyful Parenting programme against a no-intervention control. It identifies the intended population, intervention activities, primary behaviour outcome, follow-up time points and some safety counts. These details describe what the study set out to examine.
They do not establish the effect of the intervention. No primary outcome estimates, group summaries, confidence intervals or hypothesis-test results are reported in the registry record. The direction and magnitude of any between-group difference are therefore unknown from the posted results, as is the precision of an estimate. The absence of outcome results in the record is not evidence that the intervention had no effect, nor is it evidence that an effect was present.
The cluster-randomized design further limits what can be inferred without the sponsor’s analysis. As a general statistical consideration, accounting for cluster-level dependence is important when estimating uncertainty. The record cautions against simple individual-level re-analysis, but does not report the sponsor’s results or the analysis details needed to appraise them. A comparison reconstructed without those details could give misleading precision.
The planned sample-size material is described as an illustration based on the observed effect. Such planning calculations are not observed power, and they cannot replace the actual outcome estimate and its uncertainty. The registry record does not report the numerical planning outputs or the effect estimate used for them.
The listed secondary outcomes broaden the project’s scope, but their results and the approach to multiplicity are not reported. Missing-data handling and analysis populations are also not reported. Thus, the record supports a careful description of the intended evaluation, but not a conclusion about efficacy, practical importance, reproducibility, or the balance of benefits and harms.
13. Why This Trial Matters Statistically
This trial is statistically notable because its randomized design is cluster-based. That design can be suitable when an intervention is delivered in community or group settings, but it changes the analysis: outcomes from people within the same cluster may be correlated. As a general statistical principle, the analysis needs to account for that dependence when estimating uncertainty. The registry itself warns that a simple individual-level re-analysis would be misleading, making access to the sponsor’s analysis especially important.
The trial also measures a behaviour-focused outcome through three named domains: Praise, Appreciation and Enjoyment. This choice links the measurement to the programme’s stated emphasis on Sharing, Mind and Enjoyment. Clear definitions of the individual scores, their ranges and the direction of better scores help readers understand what was intended to be measured. However, the record does not report whether the domains were treated separately or combined, or how their repeated assessments entered the primary analysis.
The project description places the randomized evaluation within a wider community and family-focused programme. Statistically, that context makes it important to distinguish a programme’s aims from measured trial evidence. A completed status and an enrollment of 144 do not disclose the estimated effect or its precision. The absence of posted results also means the secondary outcome domains and safety counts cannot be interpreted alongside the primary comparison.
The record is therefore useful for understanding the design and the questions the pilot was intended to address. Its main statistical lesson is that the cluster structure and missing analysis results matter: without cluster-aware sponsor estimates, uncertainty intervals, and details on missing data and multiplicity, the record cannot support a quantitative conclusion about the primary outcome.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The most direct limitation is that the registry record does not report the primary outcome results or the sponsor’s analysis. There are no group means, standard deviations, between-group estimates, confidence intervals or p-values with which to assess the outcome. The study’s completed status does not fill this evidence gap.
The cluster-randomized design is identified, but the cluster definition, cluster allocation details and analysis method are not reported. The registry cautions that an individual-level re-analysis would be misleading and indicates that only the sponsor’s own analysis is appropriate. Without the sponsor’s estimates and methods, the primary comparison cannot be independently appraised from this record.
The endpoint description does not clarify whether Praise, Appreciation and Enjoyment were analyzed separately or as a combined measure. Although the registry describes questionnaire assessments at baseline and follow-up, the intervention description also includes a post-session assessment, and the record does not state how those measurements were incorporated. The record does not report measurement validation information.
Analysis populations, missing-data amounts and handling, multiplicity procedures, and the detailed statistical plan are not reported in the registry record. The secondary outcomes are listed, but their results are absent. The adverse-event entries report zero affected in the recorded categories, but the record does not describe ascertainment methods, observation time, or event definitions in detail. These limits mean that the record allows a description of study intent and design, but not a full assessment of outcome validity, uncertainty, or safety.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Joyful Parenting Pilot Project RCT Study — NCT03282071.
- Registry record last updated 2020-11-25; status last verified 2020-11.
- Results first posted 2020-11-25.
- 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.
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18. Record Summary
The Joyful Parenting Pilot Project RCT Study is a completed, randomized, parallel, cluster-randomized study sponsored by The University of Hong Kong. The registry lists enrollment of 144, no masking, a start date of 2017-09-21 and primary completion on 2018-06-30.
The intervention involved interactive joyful-parenting talks and a family gathering; the control group received no intervention during the study period. The primary outcome concerned reported Sharing, Mind and Enjoyment behaviours, assessed by questionnaire. The record describes Praise, Appreciation and Enjoyment scores, with higher scores indicating a better outcome.
Serious adverse events, other adverse events and deaths are recorded as 0 in both groups. The primary and secondary outcome results, sponsor analysis, statistical plan, missing-data methods and analysis populations are not reported in the registry record. As a result, the posted record describes the trial but does not permit assessment of the estimated intervention effect or its precision.