Examining the Impact of Family Connectors: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Examining the Impact of Family Connectors (NCT05195489), a randomized na study. The primary outcome is Change in Perceived Social Support.

2. Clinical Question

The question concerns a self-reported measure of perceived social support, not a direct assessment of participants’ caregiving behavior or the health of the adolescents and young adults who participated in OnTrackNY. The questionnaire asks respondents to rate statements about social support. Higher scores indicate stronger perceived social support.

The key inferential question in a randomized study is whether outcomes differed between groups, rather than whether one group’s change considered alone is distinguishable from no change. The registry record does not post a between-group estimate, confidence interval, or p-value for this primary outcome. The group-level summaries therefore describe the recorded results but do not establish the precision or statistical evidence for a comparative effect.

3. Trial Design

The registry describes a randomized, parallel-group study with no masking. Its title is “Examining the Impact of Family Connectors,” and NYU Langone Health is listed as the sponsor. The registry status is completed. The study start date is 2022-03-07, and the primary completion date is 2024-10-31.

The two groups differed in the support package described in the registry. Family members in the active intervention group participated in Family Connectors by phone and received a packet of resources. Family members in the comparison group received a pack of resources. The registry does not give further details about the frequency or duration of phone contact, how the program was delivered, or how adherence was assessed.

Random allocation is intended to make groups comparable, on average, at the start of a trial. A parallel design means participants are assigned to a group and the groups are followed during the same study period. The registry identifies the allocation as randomized, but does not report the sequence-generation method, allocation concealment, or other implementation details. Masking is listed as none; the record does not describe whether outcome assessment involved any procedures intended to limit awareness of group assignment.

Enrollment was 28. For the primary outcome, the posted group summaries are based on 8 participants in the active intervention group and 11 in the comparison group. The record says that the measure was not completed in full by two comparison participants and one Family Connectors participant. It does not explain all differences between enrollment and the numbers contributing to the outcome summaries.

The registry does not report a sample-size justification, a detailed statistical analysis plan, interim analyses, or a definition of the primary analysis population. The record lists no posted statistical analyses. These absences limit assessment of how the study was planned and how the reported summaries relate to the intended analysis.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: The measure was not completed in full by two participants in the comparison group and one participant in the FC group.

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 Change in Perceived Social Support, measured over Month 1, Month 7.

The primary endpoint is change in perceived social support, reported in units on a scale. The measure is a 13-item self-reported questionnaire. For each statement, respondents rate their agreement on a scale from 1, very strongly disagree, to 7, very strongly agree. Total scores range from 13 to 91, and higher scores indicate stronger perceived social support.

Social support is relevant to a program built around peer-to-peer support and education for family members. A questionnaire provides a structured way to measure participants’ perceptions, rather than relying only on a general description of their experience. Using the same measure at Month 1 and Month 7 allows change over time to be described.

The registry gives the endpoint timeframe as Month 1 and Month 7. It does not report the precise formula used to calculate the change score, such as which visit’s score was subtracted from the other. That matters when interpreting the sign of a change value. The scale description establishes that higher scores represent stronger perceived support, but the change-score convention is not reported in the registry record.

The endpoint is a self-report measure, so it reflects respondents’ reported perceptions. The record does not report information about questionnaire completion procedures, measurement properties in this study, or how incomplete questionnaires were handled beyond noting the participants who did not complete the measure in full.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is continuous: it is a numerical change score on a questionnaire scale. The registry reports the mean and standard deviation for each group. It does not report a confidence interval, p-value, or formal analysis comparing the groups.

What does a mean change describe?

A mean is the arithmetic average of the recorded change scores among the participants included in a group summary. It gives a concise description of the group’s central result, but it does not show the full distribution of individual scores. Participants may have changes close to the mean or much farther from it, and the mean alone does not reveal that pattern.

The posted mean change is -5.06 for the active intervention group and 2.91 for the comparison group. The record does not define the subtraction order used for the change score. The questionnaire’s scoring direction is clear—higher total scores indicate stronger perceived social support—but interpreting a positive or negative change requires knowing the change formula. The score range and item response scale also describe the questionnaire, not a threshold for a meaningful change; no such threshold is reported.

What does the standard deviation describe?

A standard deviation describes the spread of individual observations around their group mean. The posted standard deviations are 7.39 for the active intervention group and 8.18 for the comparison group. A larger standard deviation indicates more dispersion in the recorded change scores relative to the mean. It is not the standard error of the mean, a confidence interval, or a measure of the comparative effect.

General statistical explanation: the standard error reflects uncertainty in an estimated mean and depends on both the variability of observations and the amount of information available. A confidence interval uses an estimate and its uncertainty to express a range of values compatible with the data under the analysis assumptions. Neither can be read directly from a standard deviation alone without additional information and a specified method. The registry does not post confidence intervals for these outcomes.

Why is a between-group estimate important?

In a randomized parallel-group study, the central comparison is usually the outcome contrast between the assigned groups. Separate group means describe each group, but do not by themselves provide a fully reported estimate of the comparative effect or its uncertainty. A comparative analysis can account for the design and the outcome definition, and its confidence interval can show the precision of the estimate. The registry does not post that estimate, its confidence interval, or a test result for this primary endpoint.

General statistical explanation: a p-value, when reported, measures how unusual data at least as extreme as those observed would be under a stated statistical model and null hypothesis. It does not measure the probability that the null hypothesis is true, and it does not describe the size or practical importance of an effect. No p-value for the primary comparison is reported in this record, so no such interpretation is available.

What can randomization contribute?

Random allocation is intended to make assigned groups comparable in expectation, including for factors that were not measured. It does not guarantee that every characteristic will be balanced in a particular study, especially when the study is small. A clear analysis should still describe the groups, define the analysis population, and account for the trial’s design. The registry identifies randomization but does not report sequence generation, concealment, or the statistical model used for the endpoint.

General statistical explanation: over-dispersion refers to variability greater than a statistical model expects. It is especially relevant when a model assumes a particular variance structure, because underestimated variability can make uncertainty look smaller than it is. The registry reports standard deviations for this continuous endpoint but does not report a fitted model or an over-dispersion assessment. There is therefore no basis for saying that over-dispersion was present or that a particular adjustment was used.

What do planning illustrations mean?

General statistical explanation: sample-size planning uses assumptions about a target effect, variability, allocation, significance level, and power to illustrate how many participants might be needed for a future or planned comparison. Such figures are planning illustrations, not observed results, and they are not “observed power.” The registry record does not report the trial’s own sample-size justification.

The planning assumptions described for the posted illustrations use a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the target effect expressed as a fraction of the observed effect. Those assumptions describe the illustrations, not necessarily the trial’s original design. No specific planning sample-size values are reported in the registry record summarized in the results. These calculations cannot replace a trial-specific design rationale or a comparative analysis of the observed outcome.

Overall, the available statistical information supports a descriptive reading of two group means and standard deviations. It does not support reconstructing the sponsor’s inferential analysis, because that analysis is not posted. Any additional statistical conclusion would require methods and results that the registry record does not report.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Active Intervention", "Comparison")
n   <- c(8, 11)
m   <- c(-5.06, 2.91)
sp  <- c(7.39, 8.18)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Active Intervention  8  -5.060  7.390  -11.238  1.118
CARM  Comparison  11  2.910  8.180  -2.585  8.405

11. Multiplicity, Missing Data and Analysis Populations

The record lists three outcome measures, but no secondary outcomes are posted in the results. It reports zero posted analyses. The registry does not describe a multiplicity procedure, such as adjustment of significance levels or a hierarchy for interpreting several outcomes. Without posted secondary results or a reported analysis plan, the handling of multiple outcomes or tests is not reported in the registry record.

For the primary measure, the record says that two participants in the comparison group and one participant in the Family Connectors group did not complete the questionnaire in full. The endpoint summaries include 11 comparison participants and 8 active intervention participants. The record does not state whether incomplete questionnaires were excluded, partly scored, or handled by another method, nor does it describe imputation or sensitivity analyses.

General statistical explanation: missing outcomes can affect an estimate when the chance of missingness is related to participants’ characteristics or their unobserved outcomes. The amount and pattern of missingness matter, but a count alone cannot establish whether the missing data are likely to bias a comparison. The registry does not report reasons for incomplete questionnaires or an analysis of how missingness may have affected the results.

The analysis populations are also not defined. The record does not state whether results were analyzed according to randomized assignment, according to participation in the intervention, or under another rule. It does not report how deviations from assigned group or incomplete follow-up were treated. Those choices are important for interpreting a randomized comparison, but they are not reported in the registry record.

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 registry reports no serious adverse events among the participants listed as at risk in either group. For the active intervention group, 11 participants were at risk and zero were reported with a serious adverse event; for the comparison group, 17 were at risk and zero were reported with a serious adverse event. The registry also reports zero other adverse events in both groups, with 11 and 17 participants at risk, respectively, and zero deaths in each group.

These figures describe events recorded in the registry, not proof that no event occurred outside the registry’s reporting definitions or observation procedures. The record does not specify the safety-monitoring period, definitions used for serious and other adverse events, or the process for collecting events. It lists no serious adverse event terms.

The numbers at risk for these safety summaries differ from the numbers contributing to the primary outcome summaries. Safety counts and outcome counts therefore refer to different reported denominators and should not be treated as interchangeable. The absence of reported events in these summaries does not resolve the uncertainty in the primary outcome comparison.

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

The result does show that the registry contains group-level summaries for change in perceived social support at Month 1 and Month 7. The active intervention group’s posted mean change is -5.06 units, with a standard deviation of 7.39; the comparison group’s posted mean change is 2.91 units, with a standard deviation of 8.18. These summaries describe the recorded outcomes for the participants included in each group summary.

The result does not establish a statistically significant or nonsignificant difference between the groups. No comparative estimate, confidence interval, or p-value is posted for the primary outcome. The registry also does not report the change-score formula, so the signs should not be given a directional interpretation beyond the values as recorded.

The result does not show whether the group summaries represent all randomized participants, because the primary endpoint summaries include 8 participants in the active intervention group and 11 in the comparison group, while enrollment is 28. The record notes three incomplete questionnaires across the groups but does not fully account for the difference between enrollment and the endpoint denominators. It also does not describe the missing-data method or define the analysis population.

General statistical explanation: an estimate is more informative when accompanied by an uncertainty interval and a transparent account of the analysis. The standard deviations describe dispersion among individual changes; they do not provide the uncertainty interval for a group comparison. Consequently, the posted numbers do not establish how precisely any comparative effect has been estimated.

These data should not be treated as a complete evaluation of the program’s impact on family members or on the adolescents and young adults associated with OnTrackNY. The measured endpoint is perceived social support, and the registry does not post additional outcome analyses or a detailed statistical report. The record permits a cautious description of the endpoint summaries, but not a definitive claim about the comparative effect or its broader meaning.

14. Why This Trial Matters Statistically

This trial raises several important statistical questions in a compact randomized study. First, a randomized design makes the between-group comparison central. Group-level means are useful descriptions, but the registry does not report the comparative estimate or its uncertainty. That distinction helps readers separate observed summaries from evidence about a difference between assigned groups.

Second, the endpoint is a self-reported scale measured at Month 1 and Month 7. The instrument has an explicit scoring direction, with higher scores indicating stronger perceived support, but the record does not state how the change score was formed. A clear definition of change is essential for interpreting the sign and for reproducing an analysis.

Third, the outcome summaries are based on fewer participants than the enrollment figure, and the registry notes incomplete questionnaires. This makes the analysis population and missing-data approach especially relevant. Without reasons for noncompletion, a stated handling method, or sensitivity analyses, readers cannot assess how incomplete measurement may influence the observed summaries.

Fourth, the posted means and standard deviations do not supply the precision of a between-group result. Confidence intervals and a defined analysis would help readers understand the range of comparative effects compatible with the data. The record lists no posted analyses, making it important not to infer a formal conclusion from descriptive values alone.

Finally, planning illustrations should be distinguished from the trial’s original design and from observed evidence. The registry does not report a sample-size justification. These distinctions are useful well beyond this study: they clarify what randomized summaries can describe, what additional statistical reporting is needed, and where uncertainty remains.

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 registry record leaves several trial-specific questions unresolved. It does not state the formula used for the primary change score, so the direction represented by a positive or negative value cannot be confirmed from the endpoint description alone. It also does not report baseline questionnaire scores, which limits assessment of initial perceived social support by group.

The primary outcome summaries use 8 participants in the active intervention group and 11 in the comparison group, while the record lists enrollment of 28. It notes that one active intervention participant and two comparison participants did not complete the measure in full, but does not explain all differences between enrollment and the summary denominators. Reasons for incomplete measurement, the treatment of partial responses, and any sensitivity analysis are not reported.

There is no posted comparative analysis, confidence interval, or p-value for the primary endpoint. The record also does not define the analysis population or report the statistical model. The randomization method, concealment procedures, intervention duration and contact schedule, and approach to adherence are not reported. These omissions limit evaluation of both the conduct and interpretation of the comparison.

The registry identifies no masking, but does not detail any procedures for outcome collection or assessment. It does not report a sample-size justification or statistical analysis plan. For safety, it does not specify event definitions or the monitoring period. These limitations do not invalidate the recorded summaries, but they constrain what can be concluded from them and prevent a fuller assessment of bias, precision, and reproducibility.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Examining the Impact of Family Connectors — NCT05195489.
• Registry record last updated 2025-10-09; status last verified 2025-09.
• Results first posted 2025-10-09.
• 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

NCT05195489 is a completed randomized, unmasked, parallel-group study sponsored by NYU Langone Health. The registry lists enrollment of 28 and describes Family Connectors, a phone-based peer support and education program with a packet of resources, compared with a group receiving a pack of resources.

The primary endpoint is change in perceived social support between Month 1 and Month 7, measured with a 13-item questionnaire. The posted mean changes are -5.06 units for the active intervention group and 2.91 units for the comparison group, with standard deviations of 7.39 and 8.18, respectively. The registry does not post a comparative analysis, confidence interval, or p-value. It notes incomplete primary questionnaires for one active intervention participant and two comparison participants.

The record lists zero posted statistical analyses and no posted secondary outcomes. It reports zero serious adverse events, zero other adverse events, and zero deaths in both groups. Sample-size justification, analysis-population definitions, missing-data methods, and several trial conduct details are not reported in the registry record.