Social Support and Stress Reduction for Caregivers of Young Adults With IDD: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Social Support and Stress Reduction for Caregivers of Young Adults With IDD (NCT05938998), a na na study. The primary outcome is Recruitment.

2. Clinical Question

The clinical question is therefore primarily whether caregivers could be recruited to participate in the combined program, rather than whether the program outperformed another treatment or usual care. The registry describes several measures that relate to stress, social support, caregiver strain, empowerment, sleep, physical activity, and body mass index. Those measures could address different aspects of participant experience and health, but the record does not give their results.

Because there is no control group, any change measured during participation would not, by itself, establish that the program caused that change. Other influences over time could also contribute. The recruitment result addresses an important practical part of feasibility, while leaving questions about acceptability, adherence, and changes in stress unanswered by the reported outcome data.

3. Trial Design

This was a completed, single-group behavioral study sponsored by the University of Kansas Medical Center. The registry lists the study as completed, with a start date of 2023-03-31 and a primary completion date of 2023-12-30. The enrollment figure is 20. The phase is listed as NA, allocation as NA, and masking as NONE. A single-group design means participants received the program without a separate control arm described in the record.

The arm, named Social Support and Yoga, combined a guided social support group with yoga. Each activity was scheduled for one hour weekly for 12 total weeks. The brief study description states that the objective was to evaluate feasibility and stress reduction impacts for caregivers of people with intellectual and developmental disabilities.

The registry identifies recruitment as the primary outcome, measured at baseline. Its description defines the recruitment rate using the number who enrolled relative to those found eligible by questionnaire. The record says 25 participants completed the eligibility questionnaire, all 25 were eligible, the study team was unable to reach 3, and 2 decided not to participate; it reports a recruitment rate of 80%.

The registry also lists secondary measures covering perceived stress, salivary cortisol, perceived social support, caregiver strain, family empowerment, sleep quality, physical activity, and body mass index. The presence of these measures does not mean results are available. Their numerical results and analysis details are not reported in the registry record. Without a randomized or concurrent comparison group, the design can describe recruitment and observed changes among participants, but cannot isolate the program's effect from other explanations for change.

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: This was a single-arm pilot trial, therefore all participants were assigned to the intervention arm.

Overall Study

Analysis population for the primary outcome, as defined in the registry: 25 participants completed the eligibility questionnaire. All 25 were eligible, however the study team was unable to reach 3 participants and 2 more decided not to participate, resulting in a recruitment rate of 80%.

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 Recruitment, measured over Baseline.

The primary endpoint is recruitment, expressed as a rate. The registry defines this measure as the number of participants who enroll divided by the number found eligible on the questionnaire. It reports that 25 participants completed the eligibility questionnaire and all were eligible. The team was unable to reach 3 participants, and 2 decided not to participate. The reported recruitment rate is 80%.

Recruitment is used as a feasibility measure because it describes whether eligible people proceed to enrollment. For an intervention intended for caregivers, this can inform whether the study was able to engage the population it sought to reach. It is distinct from an outcome such as stress reduction: enrollment does not measure stress, symptom change, or benefit from the program.

The record identifies the endpoint timeframe as baseline. It does not report a confidence interval, a target recruitment rate, or a criterion for deciding whether recruitment was adequate. It also does not report a recruitment estimate for a different setting or population. As a result, the rate describes the recruitment experience recorded for this study; its precision and its relevance to other recruitment efforts cannot be determined from the registry record alone.

Although the study objective mentions stress reduction impacts, the primary endpoint is recruitment, not a stress score. The Perceived Stress Scale Score is listed among secondary outcomes, but its result is not reported in the registry record. The endpoint therefore supports interpretation of recruitment feasibility only, and should not be treated as evidence about the program's effects on stress.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record supports a limited statistical interpretation because it reports a recruitment result but no outcome analysis records. The concepts below explain how such results are generally understood; they do not describe analyses confirmed to have been conducted for this study.

What does the recruitment rate represent?

In general, a rate expresses an event count relative to a defined group or opportunity. Here, the registry defines recruitment using those who enrolled relative to those found eligible through the questionnaire. The denominator definition matters: people who were never assessed, or people found ineligible, are not interchangeable with those eligible for enrollment. The record gives the eligibility and recruitment details and reports 80%. It does not report a confidence interval or a prespecified recruitment threshold.

In general, a point estimate does not show all the uncertainty associated with a result. A confidence interval provides a range of values compatible with the observed data under specified assumptions. Its width depends on the amount of information and the method used. Since no interval is reported for the recruitment rate, readers should not infer that the reported value is highly precise or that it would necessarily recur in another setting.

Why does the single-group design matter?

A single-group study measures participants who receive the program without a concurrent comparison group. This can be useful for describing feasibility and participant outcomes, but it cannot directly compare outcomes under the program with outcomes under an alternative. General influences such as changes over time or differences in who participates may offer competing explanations for observed changes. Randomization and a suitable control condition are common design tools for reducing some of these concerns, but neither a randomized allocation nor a comparator is described in this record.

The posted endpoint is recruitment, not a contrast in stress scores. No test of an intervention effect should be inferred from a recruitment percentage. The registry lists secondary measures, but reports no numeric results or analyses for them. Consequently, it is not possible to interpret estimated change, uncertainty, or statistical evidence for those measures from the record.

What do analysis and planning quantities mean?

In general, an analysis plan states how outcomes will be summarized or compared, how uncertainty will be quantified, and how issues such as incomplete observations will be handled. The record lists 0 analysis records. It does not report the statistical plan, the handling of repeated measurements, or any model used for secondary outcomes.

The record's sample-size assumptions describe a planning illustration based on an observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The stated fraction of the observed effect is the target effect for that illustration. Those assumptions describe a hypothetical planning exercise, not the single-group trial's allocation. Any resulting sample sizes are planning illustrations, not observed power, and do not establish that the study had a particular probability of detecting an effect. The numerical planning results and the underlying observed effect are not reported in the registry record.

In general, power is a design-stage probability calculated under stated assumptions about an effect, variability, sample size, and analysis. It is not a measure of how likely a finding is true after data have been collected. A post hoc power value based on an observed result does not replace an effect estimate and its confidence interval. No observed power or outcome effect estimate is reported for the measures listed in this study.

What would a confidence interval add?

In general, confidence intervals help readers judge both the range of plausible effects and the degree of precision. A narrow interval indicates greater precision under the model assumptions; a wide interval indicates greater uncertainty. A statistically significant result and a practically important result are not the same thing, and an interval helps assess the range of magnitudes consistent with the data. For this registry record, no such interval is reported for recruitment or the secondary outcomes.

Statistical methods should be interpreted alongside study design and outcome definitions. A method cannot compensate for the absence of a comparison group when the question is causal, and a listed measure cannot establish an outcome without its observed values and analysis. The record's recruitment result can therefore be read as a descriptive feasibility measure, while broader inference about program effects is not supported by the reported statistical information.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Arm 1")
n      <- c(25)
events <- c(20)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Arm 1  25  20  80.0  59.3  93.2  60.9  91.1  60.6  91.0

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 13 outcome measures and 0 analysis records. It identifies recruitment as the primary outcome and lists secondary outcomes relating to perceived stress, salivary cortisol, perceived social support, caregiver strain, family empowerment, sleep quality, physical activity, and body mass index. Results for these secondary measures are not reported in the registry record.

Multiplicity arises when several outcomes or statistical tests are considered. In general, the more tests performed, the greater the chance that at least one result may appear unusual just by chance. Statistical plans may identify a primary outcome, define a limited set of confirmatory tests, or use an adjustment for multiple comparisons. The approach used for this study is not reported in the registry record, so the risk of selective emphasis or chance findings across outcomes cannot be evaluated from the record.

The registry does not report how missing measurements were handled, whether participants completed follow-up assessments, or which analysis population was used for any secondary outcome. These details matter because missing observations can affect estimates, particularly if the likelihood of missingness is related to participant experience or outcome values. No assumptions about the amount or pattern of missing data can be made from the record.

The record also does not report a statistical analysis plan or explain whether analyses were adjusted for baseline values or other variables. These methods are not interchangeable, and their appropriateness depends on the study question and data structure. Without the analysis details and results, the listed secondary measures indicate what the study intended to assess, not what it found.

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.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: pneumonia hospitalization (5.0%).

The registry reports one serious adverse event among 20 participants at risk, with a serious-event figure of 5.0%. It lists pneumonia hospitalization as the top serious event term, also at 5.0%. It separately reports one other adverse event among 20 participants at risk. The record reports 0 deaths.

These are descriptive safety figures for the study arm. They do not establish whether an event was caused by the intervention. The registry record does not provide a comparison arm, event timing, a detailed assessment of relatedness, or a narrative account of the event. It also does not clarify whether the serious and other adverse event counts refer to the same or different participants or episodes, so they should not be combined.

In general, adverse event counts describe events recorded during a study, while causal attribution requires additional clinical and design information. A small single-group safety record cannot establish how event rates compare with another intervention or with the background rate in a similar population. The figures should therefore be read as the adverse-event information posted for this arm, not as an estimate of comparative risk.

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

The result establishes that the registry reports a recruitment rate of 80% for eligible people in this study. It documents the recruitment pathway, including questionnaire completion, eligibility, unsuccessful contact, and decisions not to participate. That information can help readers understand the feasibility of enrolling caregivers under the study's recruitment process.

The result does not establish that the yoga and support group program reduced stress. The study objective refers to stress reduction impacts, and the Perceived Stress Scale Score is listed as a secondary outcome, but a result for that measure is not reported in the registry record. Numerical findings for the other listed secondary outcomes are also not reported. Recruitment is an implementation measure; it is not a clinical outcome or a measure of intervention effectiveness.

The result also does not show whether the program is more effective than another option. There is no separate comparator arm, and allocation is listed as NA. A single-group study cannot directly estimate a between-group treatment effect. Even if a change in a participant's score were reported, change alone would not show what would have happened in the absence of the program.

In general, a statistical result is most informative when its estimate, uncertainty, outcome definition, and analysis method are available together. For this record, the recruitment rate is reported without a confidence interval or a stated feasibility threshold. The degree of precision and the basis for judging recruitment as adequate are therefore not reported.

The completion status and enrollment figure describe the study record but do not fill in missing outcome results. The appropriate interpretation is narrow: recruitment was reported at 80%, while evidence about stress outcomes, other secondary measures, and comparative effects is not reported in the registry record.

14. Why This Trial Matters Statistically

Feasibility studies address whether a research program can be carried out in the population it intends to study. Recruitment is one practical component: eligible people must be identified, contacted, and willing to enroll. The reported recruitment rate of 80%, together with the registry's account of eligibility and nonparticipation, offers information about that process for caregivers of young adults with intellectual and developmental disabilities.

That information is distinct from an estimate of treatment effect. A program may be feasible to recruit for without having demonstrated a change in stress, and outcome change cannot be inferred from participation alone. Keeping feasibility and effectiveness questions separate helps prevent a recruitment result from being interpreted as clinical evidence.

The single-group design also illustrates why a clear estimand matters. The recruitment endpoint describes enrollment, while the study objective also names stress reduction. Those questions require different outcomes and different interpretations. A controlled design would be needed to make a direct comparison of outcomes under the program versus a comparator; the registry does not describe such a comparison.

The listed secondary measures span psychological, social, and physical domains. Their inclusion reflects the range of questions the study sought to examine, but without posted estimates and uncertainty, they cannot answer those questions statistically. Reporting outcome values alongside methods and missing-data information would be important for assessing precision and potential bias.

Statistically, this record is useful as an example of how a feasibility result should be kept within its scope. The reported recruitment rate provides a descriptive signal about enrollment in this study. It does not stand in for unreported patient- or caregiver-centered outcomes, and it cannot support a causal conclusion about the intervention.

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 primary limitation is that the registry reports a recruitment result but no numerical results for the listed stress-related or other secondary outcomes. The study objective includes stress reduction impacts, yet the Perceived Stress Scale Score result is not reported in the registry record. This prevents assessment of the main outcome domain beyond recruitment feasibility.

The single-group design has no concurrent comparator. It cannot separate changes associated with program participation from other changes over time, and it does not support a direct estimate of comparative effectiveness. The record also lists allocation as NA and masking as NONE.

The recruitment rate is reported without a confidence interval or a stated threshold for acceptable feasibility. The precision of the estimate and the criterion used to interpret it are therefore not reported. The registry describes questionnaire completion, eligibility, unsuccessful contact, and decisions not to participate, but does not report further information about recruitment at other sites or in other settings.

The record lists multiple outcome measures but no analysis records. The statistical analysis plan, multiplicity approach, missing-data handling, follow-up completion, and analysis populations are not reported in the registry record. Without these details, readers cannot assess how the secondary outcomes would have been analyzed or whether missing observations could influence results.

Safety interpretation is also limited by the absence of a comparator and details on event timing and relatedness. The serious and other adverse-event counts should be read descriptively; the record does not establish attribution to the program. These limitations restrict conclusions to the posted recruitment and safety descriptions.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Social Support and Stress Reduction for Caregivers of Young Adults With IDD — NCT05938998.
• Registry record last updated 2025-09-12; status last verified 2025-08.
• Results first posted 2025-09-12.
• 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

The registry record describes a completed, single-group behavioral study sponsored by the University of Kansas Medical Center. Its objective was to evaluate feasibility and stress reduction impacts of yoga and social support for caregivers of people with intellectual and developmental disabilities. The program combined one hour of guided social support with one hour of yoga weekly for 12 total weeks.

Recruitment is the primary outcome. The record reports a recruitment rate of 80% and describes questionnaire completion, eligibility, unsuccessful contact, and decisions not to participate. It lists secondary measures across stress, social support, caregiver strain, family empowerment, sleep, physical activity, and body mass index, but their results are not reported in the registry record.

The study has no separate comparator arm. Consequently, the reported recruitment result does not establish an effect on stress or any other clinical outcome. The registry also reports adverse-event counts descriptively, with 0 deaths.