Supporting Our Caregivers In ADRD Learning (SOCIAL): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Supporting Our Caregivers In ADRD Learning (SOCIAL) (NCT06276023), a randomized na study. The primary outcome is Feasibility of Randomization.

2. Clinical Question

3. Trial Design

SOCIAL is a completed pilot randomized trial comparing MASC with HEP among caregivers of people with ADRD. The registry lists randomized allocation, single masking, an enrollment of 82, and a completed study status. The study dates recorded are 2024-03-22 for start and 2025-05-28 for primary completion. The phase is listed as NA, and Massachusetts General Hospital is the sponsor.

The intervention and control descriptions each specify six virtual group sessions and at-home activities. MASC focuses on mindfulness, self-compassion, and behavioral management. HEP covers caregiver stress, sleep hygiene, nutrition, and physical activity. The stated main aim is to demonstrate feasibility, acceptability, credibility, fidelity, preliminary efficacy, and evidence for the proposed mechanism of MASC through a pilot randomized controlled trial. The posted primary outcome, however, is feasibility of randomization measured by post-test completion.

Some design entries do not align: the record lists randomized allocation and two interventions, but also identifies the model as single group. It reports 82 enrolled while the primary outcome gives group counts of 45 and 23. The registry record does not reconcile these entries or explain the relationship between enrollment and the group counts used for this result. The single-masking entry does not identify who was masked. Details of sequence generation, allocation concealment, or the conduct of masking are not reported in the registry record. The record identifies this as a pilot; it does not report a sample-size justification or the intended precision of the primary estimate.

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: 82 participants provided informed consent and were enrolled in the study. 14 enrolled participants did not proceed to intervention assignment/start due to withdrawal, loss to follow-up prior to intervention/randomization. Therefore, 68 participants were randomized and started the intervention.

Overall Study

Analysis population for the primary outcome, as defined in the registry: 119 participants were eligible and 82 chose to enroll.

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 Feasibility of Randomization, measured over Baseline, Post intervention (6-8 weeks post baseline).

The primary endpoint is feasibility of randomization, defined in the record as the percentage randomized who complete the post-test. The measurement window is baseline and post-intervention, with the post-test scheduled 6-8 weeks after baseline. In the intervention group, the description notes that 1 participant did not complete the post-test. The posted outcome counts are 44 of 45 for the intervention group and 23 of 23 for the control group.

This endpoint is useful in a pilot because completion indicates whether participants can be followed through the planned assessment period. Completion information can inform the practical design of a later study, including the effort needed to obtain outcome measurements. It is not itself a measure of caregiver stress, quality of life, or the proposed mechanisms of MASC. High completion, if observed, does not establish that the program changes those outcomes or that participants found the program acceptable. The registry lists those broader aims, but separate results for them are not reported in the registry record.

Because the endpoint is a binary event—completion or non-completion—the result can be expressed as the proportion completing in each group and as a between-group risk difference. The registry's primary question is feasibility; interpretation should therefore stay focused on assessment completion rather than treating this endpoint as a clinical effect.

7. Results Posted in the Registry

• Intervention: 97.8% (44/45) versus 100.0% (23/23) on control; risk difference -2.2 percentage points (95% CI -6.5 to 2.1), risk ratio 0.98 (0.94–1.02); unadjusted two-proportion z-test p = 0.471.

8. Statistical Interpretation

9. Statistical Methods Explained

What does the risk difference describe?

The risk difference compares the proportion experiencing an event in one group with the proportion in another. Here, the event is completing the post-test, and the comparison is intervention minus control. A value below zero means that the observed completion proportion was lower in the intervention group; a value above zero would mean it was higher. The posted estimate is -0.022. This is an unadjusted comparison based on the reported group counts, rather than an estimate adjusted for participant characteristics or other covariates. Such adjustment is not reported in the registry record.

How should the confidence interval be read?

In general, a confidence interval describes the statistical uncertainty around an estimate under the assumptions of the method used. It gives a range of values compatible with the observed data and the method, rather than a guarantee that the true effect lies in that range. The posted 95% interval for the risk difference runs from -0.065 to 0.021. Since it includes zero, the data do not distinguish clearly between no difference and a difference in either direction at the corresponding conventional threshold. The interval does not prove that the groups are equivalent. An equivalence conclusion would require a prespecified margin and an analysis designed for that question; neither is reported in the registry record.

What does the p-value add?

The unadjusted p-value is 0.471. In general, a p-value measures how unusual data at least as discrepant as those observed would be under a specified null hypothesis and statistical model. It is not the probability that the null hypothesis is true, and it does not measure the size or importance of an effect. The p-value is consistent with the confidence interval's inclusion of zero. The statistical test used to produce it is not reported in the registry record, so its specific assumptions cannot be assessed from the posted entry.

Why use a binary endpoint?

Post-test completion is recorded as a count of participants with the event. A binary endpoint gives a direct account of how many participants reached the scheduled assessment in each group. For a feasibility question, that can describe whether outcome collection occurred as planned. It does not capture why an assessment was missed, the time or effort required to retain participants, or whether the intervention was acceptable. Those details are not reported in the registry record. General statistical caution is warranted when interpreting proportions from small groups: a single event can noticeably change the observed proportion, and estimates may remain imprecise even when the displayed proportions look high.

What is and is not adjusted?

The posted comparison is labeled unadjusted. In general, an unadjusted estimate compares group outcomes without accounting for other variables. Randomization is intended to support a fair comparison, but the registry entry alone does not show how randomization was generated or implemented. No adjusted model, covariate set, or analysis population is reported in the registry record. It is therefore not possible to describe adjustment procedures or verify how participants were handled in an analysis beyond the reported counts.

What is the role of the planning illustration?

The record describes a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation; the target effect is a stated fraction of the observed effect. In general, such calculations explore the sample size that a future study might need under chosen assumptions. They are not observed power and do not show the probability that this completed trial detected an effect. The specific planning values are not reported in the registry record summarized by the primary result. More broadly, a planning calculation based on an observed pilot effect may be uncertain because the pilot estimate itself has sampling uncertainty. The record does not report a separate original sample-size justification.

Several design and analysis details needed for a fuller statistical appraisal are not reported in the registry record, including the precise test, prespecified analysis plan, handling of missing outcome data, and whether any interim analyses occurred. These should not be inferred from the reported estimate or p-value.

10. Confidence Intervals and Precision

The primary estimate is a risk difference of -0.022. Its 95% confidence interval extends from -0.065 to 0.021. The interval crosses zero, which is the value corresponding to no difference in completion proportions. In general, this means the posted data do not identify a single direction of difference with much certainty. Values favoring either group remain compatible with the interval.

The interval is important alongside the point estimate. The estimate alone is a single summary of the observed group contrast, while the interval conveys uncertainty about that contrast. A confidence interval is not a statement that every value inside it is equally likely, nor does it guarantee that the underlying value is contained within the interval. Its interpretation depends on the statistical method and assumptions. The method is not identified in the registry record.

The event counts are 44 of 45 in the intervention group and 23 of 23 in the control group. The smaller group contributes less information to a between-group comparison than a group with more observations, all else being equal; this is a general statistical principle, not a separate trial result. The record's enrollment of 82 is not reconciled with the group counts reported for the primary outcome, so the precision of this particular comparison should be understood using the posted outcome counts.

The interval does not establish equivalence or rule out a meaningful difference. The registry record does not state a feasibility threshold or a margin for an acceptable between-group difference. Without such a benchmark, the interval can be described statistically but cannot be classified against a prespecified criterion for success. The result is most appropriately read as a pilot estimate of post-test completion with uncertainty, not as a definitive comparison of clinical benefit.

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 25 outcome measures, but zero secondary outcomes are posted and zero analyses are listed. The primary result concerns post-test completion. Although the study's stated aims include preliminary efficacy and proposed mechanisms, separate results for caregiver stress, quality of life, or other outcomes are not reported in the registry record. The number of listed outcomes makes it important to know which analyses were prespecified and how multiple comparisons were to be handled; those details are not reported in the registry record.

In general, when many outcomes or comparisons are tested, the chance of at least one apparently notable result can increase. Statistical approaches can address this issue, but the appropriate approach depends on the study's questions and analysis plan. No multiplicity adjustment or hierarchy of outcomes is reported in the registry record. The single posted primary comparison should therefore not be taken as evidence that all other planned questions were tested and found null.

For missingness in the primary outcome, the record states that 1 participant in the intervention group did not complete the post-test. The posted counts are 44 of 45 for intervention and 23 of 23 for control. The record does not explain why the assessment was missing, how the missing participant was handled in the analysis, or whether the reported denominators represent all randomized participants in each group. No imputation or sensitivity analysis is reported in the registry record.

The analysis population is not specified beyond the reported outcome groups. The record does not state whether participants were analyzed according to randomized assignment, whether exclusions occurred, or how participants who did not complete the assessment were treated in the inferential comparison. Interim analyses, a protocol-specific statistical analysis plan, and a prespecified missing-data strategy are not reported in the registry record. These omissions limit assessment of how closely the reported analysis followed the intended plan.

12. 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 posted adverse-event entries report zero serious adverse events in the MASC group among 45 participants at risk and zero in the HEP group among 23 participants at risk. The record also reports zero other adverse events in both groups and zero deaths in both groups. No serious adverse event terms are listed.

These entries mean that no events are recorded in the posted adverse-event fields for the groups and counts shown. They should not be read as proof that the programs have no risks. A zero count in a trial does not rule out events that are uncommon, events not captured by the collection process, or events occurring outside the reported observation and reporting framework. The registry entry does not describe adverse-event definitions, collection procedures, monitoring duration, or whether event ascertainment differed by group. Those details are not reported in the registry record.

Safety counts also answer a different question from the primary endpoint. The primary result concerns post-test completion, while adverse-event entries describe recorded harms. Neither result alone establishes overall safety or clinical benefit. The counts should be interpreted as the posted event record, with the stated group sizes at risk, rather than as a comprehensive assessment of every possible harm.

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

The posted result gives a focused account of assessment completion in a pilot randomized comparison. Post-test completion was reported for 44 of 45 participants assigned to the intervention group and 23 of 23 in the control group. The risk difference is -0.022, and its 95% confidence interval ranges from -0.065 to 0.021. This provides a description of the observed feasibility outcome and its statistical uncertainty.

It does not show whether MASC reduces caregiver stress, improves quality of life, changes responses to challenging behaviors, or affects any other clinical outcome. The study's broad aims include preliminary efficacy and evidence for a proposed mechanism, but those results are not reported in the registry record. Completion is a process measure, not a substitute for an outcome measuring caregiver experience.

The result also does not demonstrate equivalence between MASC and HEP. The confidence interval includes zero, but the registry record does not report a prespecified equivalence margin or a non-inferiority framework. A non-significant p-value is not evidence that two programs are the same. Conversely, the negative point estimate alone does not establish a reliable disadvantage for MASC; the interval includes values on both sides of zero.

The record describes a randomized trial, but it also labels the model single group and does not reconcile the reported enrollment of 82 with the primary outcome group counts of 45 and 23. This limits a reader's ability to trace the full participant flow from enrollment through analysis. The posted counts remain interpretable as the counts associated with the primary outcome, but broader conclusions require details not reported in the registry record.

Overall, the result is evidence about completion in the listed outcome groups, with uncertainty. It is not a definitive assessment of efficacy, acceptability, fidelity, mechanism, or generalizability. The registry record does not report the benchmarks or supporting analyses needed to resolve those broader questions.

14. Why This Trial Matters Statistically

Feasibility outcomes matter statistically because a future comparison depends on being able to retain participants and measure the outcomes of interest. If assessments are not completed, estimates of clinical outcomes can become less precise and may be biased when missingness is related to participants' outcomes or circumstances. Completion is therefore a useful practical part of evaluating a pilot, even though it is not a clinical effect.

The SOCIAL primary endpoint makes this distinction visible: it asks whether randomized participants complete the post-test, not whether MASC changes stress. The posted result can inform discussion of assessment follow-up in the reported groups, while the confidence interval communicates that the between-group estimate remains uncertain. A feasibility threshold would help translate that estimate into a prespecified decision, but no such threshold is reported in the registry record.

The record also illustrates why transparent participant accounting is important. It lists enrollment of 82 and reports primary-outcome groups of 45 and 23, without explaining their relationship. Clear flow information would help readers understand who entered the study, who was randomized, who completed follow-up, and who contributed to each analysis. Those details are not reported in the registry record.

Finally, a pilot's stated aims can be broader than its posted results. Here, the registry describes acceptability, credibility, fidelity, preliminary efficacy, and proposed mechanisms, while the posted primary finding addresses completion. Keeping those questions distinct prevents a process outcome from being mistaken for evidence of treatment effect. It also clarifies what further reporting would be needed to assess the intervention's other objectives.

15. 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 principal limitation of the posted result is that it addresses completion of a post-test rather than a clinical endpoint. The broader aims include preliminary efficacy and proposed mechanisms, but results for those aims are not reported in the registry record. The number of secondary outcomes posted is zero, and no analyses are listed.

The enrollment and group-count entries are not reconciled: the study lists enrollment of 82, while the primary result reports 45 in the intervention group and 23 in the control group. The registry model is also identified as single group even though allocation is randomized and two interventions are described. These inconsistencies make participant flow and the analysis population difficult to establish from the record alone.

The record notes one intervention participant who did not complete the post-test, but does not state why the assessment was missing or describe any missing-data method. The inferential test, analysis plan, randomization procedure, allocation concealment, and identity of the party masked are not reported in the registry record. No feasibility success threshold is stated, so the observed completion cannot be judged against a documented decision criterion.

The adverse-event entries report no events, but the record does not describe event definitions, collection methods, or the duration of safety monitoring. The record also does not report an original sample-size justification or interim-analysis procedures. These limitations are specific to what is documented for this trial and restrict interpretation beyond the posted completion counts and comparison.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Supporting Our Caregivers In ADRD Learning (SOCIAL) — NCT06276023.
• Registry record last updated 2026-09-02; status last verified 2026-08.
• Results first posted 2026-09-02.
• 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.

19. Record Summary

NCT06276023, titled Supporting Our Caregivers In ADRD Learning (SOCIAL), is listed as a completed randomized pilot trial sponsored by Massachusetts General Hospital. It compares the Mindful and Self-Compassionate Care Program (MASC) with the Health Education Program (HEP) for caregivers of people with ADRD. The stated primary outcome is feasibility of randomization, measured by completion of the post-test 6-8 weeks after baseline.

The posted primary counts are 44 of 45 in the intervention group and 23 of 23 in the control group. The risk difference is -0.022, with a 95% confidence interval from -0.065 to 0.021 and an unadjusted p-value of 0.471. No serious or other adverse events, or deaths, are recorded in either group. Clinical efficacy results and secondary analyses are not reported in the registry record. The listed enrollment, group counts, and single-group model designation are not reconciled in the record.