Sexual and Gender Minority Emerging Adults Eliciting Narratives: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Sexual and Gender Minority Emerging Adults Eliciting Narratives (NCT05899218), a randomized na study. The primary outcome is Patient Health Questionnaire (PHQ-9).

2. Clinical Question

3. Trial Design

The registry describes Sexual and Gender Minority Emerging Adults Eliciting Narratives (SEEN) as a randomized, parallel-group behavioral study. Its listed intervention is Critical Narrative Development, delivered in one of two formats: Photo-Novella or Digital Storytelling. Masking is listed as none. The study is marked completed, with enrollment of 20. Its recorded start date is 2023-07-17 and its primary completion date is 2024-04-01. Phase is listed as NA.

The study summary describes an online survey followed by an interview about everyday experiences as a sexual or gender minority person of color and experiences seeking mental health services. After the interview, participants were to have one month to tell their stories in response to prompts about times when they felt seen and unseen. Assignment to photographs or videos was randomized. The registry describes the photo format as 12 photographs with captions and the video format as two short videos.

The posted primary outcome is PHQ-9 score at 1 month. The outcome measure is continuous, and the record specifies a mean and standard deviation. The primary outcome summaries list 7 participants for Photo-Novella and 8 for Digital Storytelling. These arm counts do not match the enrollment figure, and the registry record does not explain the difference. It does not report the analysis population or explain whether the arm counts reflect missing outcome data, exclusions, or another reason.

The record lists 14 outcome measures, including seven secondary outcomes. It reports no posted analyses, and the registry record does not provide an inferential comparison for the primary outcome. Detailed statistical methods, allocation procedures beyond randomization, and the basis for the enrollment target are not reported in the registry 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.

Overall Study

Reasons for not completing this period:

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 Patient Health Questionnaire (PHQ-9), measured over 1 month.

The primary endpoint is the Patient Health Questionnaire (PHQ-9), reported as a mean score at 1 month. The registry describes scores ranging from 0 to 27, with higher scores indicating higher levels of depression severity. This makes the endpoint a continuous measure: its summaries describe average scores and their dispersion, rather than counts of participants in categories.

A depression symptom measure is relevant to the study’s stated purpose because the study summary describes an interest in psychological outcomes among sexual and gender minority emerging adults of color. The registry also notes that the intervention is intended to examine whether telling a story through photographs or video can affect mental health and well-being. That rationale does not establish that the endpoint changed or that either format caused a change.

The posted summaries give a mean of 14.29 with a standard deviation of 4.72 for Photo-Novella, based on 7 participants, and a mean of 11.5 with a standard deviation of 0.93 for Digital Storytelling, based on 8 participants. These are descriptive arm summaries. The registry record does not report an estimable two-arm comparison for this continuous endpoint, a confidence interval, or a statistical test. It also does not report additional detail on the timing or method of endpoint assessment beyond the stated 1-month timeframe.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the design as randomized and parallel-group, with no masking. Randomization is a method for assigning participants to study arms by chance. In general, it is intended to reduce systematic differences between groups at assignment, although it does not guarantee that groups will be alike in every characteristic, especially in a pilot study. A parallel-group design assigns participants to one format rather than describing a crossover between formats. The record does not report details of sequence generation, concealment, or implementation of randomization.

What do the reported means and standard deviations describe?

For a continuous endpoint, the mean is the arithmetic average of observed scores in an arm. The standard deviation describes how dispersed those scores are around the mean. The primary measure is the PHQ-9, described as ranging from 0 to 27, with higher scores indicating higher depression severity. The reported mean and standard deviation are descriptive summaries; neither supplies a direct estimate of the difference between study arms.

An inferential comparison would ordinarily estimate the contrast between the arms and quantify uncertainty around that estimate. A confidence interval is a range of values compatible with the data and the statistical assumptions used to calculate it. Its width conveys precision: a wider interval indicates less precision than a narrower interval. A p-value addresses how compatible the observed data are with a specified null hypothesis under a statistical model. Neither quantity is reported for the primary two-arm comparison in the registry record. The registry indicates that the comparison is not estimable from the posted results, so a comparative estimate and its uncertainty should not be inferred from the arm summaries.

Why does the comparison matter more than comparing two means by eye?

Comparing two observed means by inspection does not account for variability or uncertainty. In general, the amount of information available depends on the distribution of scores and the number of observations contributing to each estimate. The posted standard deviations describe within-arm dispersion, but without an estimable contrast, an inferential procedure, and its uncertainty, the registry does not establish how compatible the arm summaries are with no difference or with effects of other sizes. No new contrast should be calculated from the posted summaries.

What does “not estimable” mean in this record?

The registry’s note says values are missing or not estimable for a two-arm comparison of the continuous endpoint. This is a limitation of the posted comparative result, not an explanation of its cause. The record does not say whether the issue arose from missing observations, the analysis procedure, data structure, or another reason. Those possibilities should not be treated as details about this study. The record also does not report a sponsor analysis that resolves the comparison.

The posted sample sizes for the primary outcome are 7 participants in Photo-Novella and 8 in Digital Storytelling. Enrollment is listed as 20, but the registry does not explain why the reported endpoint counts differ from enrollment. In general, an analysis population defines which randomized or enrolled participants contribute to a particular result. It can vary by endpoint if observations are unavailable or if eligibility rules are applied, but the specific population used is not reported. The difference between counts cannot be assigned to a particular cause based on this record.

How should planning calculations be understood?

In general, sample-size calculations are prospective planning tools: they estimate how many participants per arm might be needed under stated assumptions to detect an effect at a chosen significance level and power. They are not results from the completed study and should not be described as observed power. The registry’s planning assumptions refer to a two-sided significance level of 0.05, equal allocation, a normal approximation, and effects expressed as fractions of an observed effect. No numerical planning results are reported in the registry record. These assumptions do not establish that the trial was designed around them, and the record does not report its own sample-size justification.

Effect-based planning can be sensitive to the effect estimate used as a reference. In general, an observed effect from a small pilot sample may be imprecise, so planning illustrations based on it should be interpreted cautiously. Such calculations address hypothetical future design choices; they cannot repair the absence of an estimable comparison in the posted primary results. The registry’s stated distinction between planning illustrations and the trial’s own design is important.

Why can over-dispersion matter?

Over-dispersion is a general issue when observed variability exceeds what a statistical model assumes. It can make model-based standard errors too small and uncertainty appear narrower than warranted if the model does not account for the extra variability. The PHQ-9 endpoint is summarized with means and standard deviations, but the registry does not report a model or an over-dispersion assessment for the primary comparison. This is a general statistical consideration, not a finding about this trial.

The record also does not report covariate adjustment, interim analyses, a prespecified testing hierarchy, or a detailed statistical analysis plan. Those details cannot be reconstructed from the outcome summaries. The most defensible statistical reading is therefore limited: the registry reports arm-level descriptive summaries for PHQ-9 at 1 month and does not report an estimable comparative analysis.

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("Photo-Novella", "Digital Storytelling")
n   <- c(7, 8)
m   <- c(14.29, 11.5)
sp  <- c(4.72, 0.93)
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  Photo-Novella  7  14.290  4.720  9.925  18.655
CARM  Digital Storytelling  8  11.500  0.930  10.723  12.277

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 14 outcome measures, including 7 secondary outcomes. Multiple outcomes can create a multiplicity issue because, in general, testing many hypotheses increases the chance of obtaining at least one apparently noteworthy result by chance. Common approaches include prespecifying a primary hypothesis, adjusting statistical thresholds, or defining a testing hierarchy. The registry record does not report a multiplicity strategy, a hierarchy among the secondary measures, or inferential results for those outcomes. The primary endpoint is identified, but the record does not show how the other measures were handled analytically.

Missing-data methods are also not reported. The primary outcome summaries include 7 participants in Photo-Novella and 8 in Digital Storytelling, whereas enrollment is 20. The registry does not explain the difference or state whether the outcome data were incomplete, whether participants were excluded from an analysis, or whether another population definition was used. It does not report imputation, a complete-case approach, sensitivity analyses, or the assumptions used to handle missing outcomes. Those methods should not be presumed.

The analysis population is not reported in the registry record. In general, results may be defined for all randomized participants, for participants who received an assigned intervention, or for those with available outcome measurements. Each definition answers a different question and can yield different results. The record does not identify which definition applies to the posted means. It also does not report a participant flow explaining the transition from enrollment to the primary outcome counts. As a result, the scope and potential influence of missing or excluded observations cannot be evaluated from the posted results.

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 safety record lists 0 serious adverse events, 0 other adverse events, and 0 deaths in each arm. For both Photo-Novella and Digital Storytelling, the registry lists 10 participants at risk for serious adverse events and 10 at risk for other adverse events. No serious adverse event terms are listed.

These are event counts and risk denominators recorded in the safety fields. They are not the same counts as the primary outcome arm summaries, which list 7 participants for Photo-Novella and 8 for Digital Storytelling. The registry record does not explain this difference or describe the safety population, the observation period for adverse events, or how events were collected. The safety denominators should therefore be read as reported rather than reconciled with the primary outcome counts.

A zero count means that no events of the specified kind were recorded in the listed group in the registry results. In general, zero observed events do not establish that an event is impossible or that a larger study would also observe none. The registry record does not provide additional detail with which to assess the completeness or duration of safety surveillance. These figures describe the posted safety data and do not, on their own, establish a comparative safety profile.

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

The record documents a randomized pilot study comparing two ways of developing a critical narrative: photographs with captions and short videos. It gives descriptive PHQ-9 summaries at 1 month for the two arms and reports no serious adverse events, other adverse events, or deaths in the safety groups listed. Those details describe the posted results; they do not establish that one format is better, that either format changes depression scores, or that the formats are equivalent.

The primary comparison is not estimable in the registry results. There is no reported comparative effect estimate, confidence interval, or p-value. The arm means alone cannot show whether an apparent difference is precise, likely to reflect chance variation, or attributable to the assigned format. A lack of a reported comparison should not be recast as evidence of no effect. It means that the registry record does not provide a usable inferential result for the primary two-arm question.

The study is marked completed, but the record does not describe the sample-size rationale, analysis population, handling of missing data, or detailed statistical plan. The reported primary outcome counts also differ from the enrollment figure without explanation. These omissions limit assessment of how representative the endpoint summaries are of all enrolled participants and how much uncertainty surrounds the comparison.

As a pilot, the study’s stated focus is to examine critical narrative interventions in a population for which the summary says these interventions had not been examined for psychological outcomes. That context identifies the research question; it does not determine the result. The posted data should be understood as limited descriptive evidence from this study, not as a definitive test of the intervention concept or a basis for conclusions about mental health outcomes beyond the reported sample.

14. Why This Trial Matters Statistically

This study is statistically notable for asking a comparative question in a population and intervention context that the registry summary describes as not previously examined for psychological outcomes. It randomizes participants between two narrative formats rather than comparing a narrative format with no intervention. That distinction determines the question the design can address: the relative results of photo-based and video-based storytelling, not the effect of either format against an untreated or usual-care group.

The primary measure is continuous, and the registry reports arm-specific means and standard deviations. Such summaries can describe observed data, but the comparative question requires an estimated contrast and an account of its uncertainty. Because the registry says the two-arm comparison is not estimable, the results illustrate the difference between having descriptive summaries and having an interpretable inferential result. The record gives no reported p-value or confidence interval to support a comparative conclusion.

Reporting the outcome counts alongside the enrollment figure also matters for interpretation. The registry lists 20 enrolled participants but reports primary outcome summaries based on 7 in one arm and 8 in the other. Since the reason is not documented, readers cannot judge from the record whether the available summaries represent the intended analysis population or how missing outcomes may have affected them.

The registry also lists several secondary measures, raising a general need for clear prespecification and transparent multiplicity handling. Those methods are not reported. Together, the unestimable primary comparison, unexplained outcome counts, and absent analytical details show why a completed study status and descriptive statistics are not substitutes for a transparent analysis. The record identifies a meaningful research question but does not provide enough inferential information to answer it statistically.

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 most direct limitation is that the registry does not report an estimable two-arm comparison for the primary continuous outcome. The posted arm means and standard deviations therefore cannot establish the size or precision of a comparative effect. No confidence interval, p-value, or treatment-effect estimate is reported.

The reported primary outcome counts, 7 for Photo-Novella and 8 for Digital Storytelling, do not match the enrollment figure of 20. The registry record does not explain this discrepancy. It does not report a participant flow, analysis population, or reason for unavailable observations. Missing-data methods and sensitivity analyses are not reported, so the effect of incomplete data cannot be assessed.

The study is a pilot with a listed enrollment of 20, and the record does not report a sample-size justification or the study’s statistical analysis plan. The fact that it is randomized does not fill in unreported details about sequence generation or allocation concealment. Masking is listed as none. The record also does not report baseline outcome summaries, so the status of baseline PHQ-9 measurements cannot be determined from the posted results.

Although the registry lists 14 outcome measures and 7 secondary outcomes, it does not report how multiplicity was addressed or provide inferential results for them. Safety denominators are 10 in each arm, unlike the reported primary outcome counts, and the record does not explain the safety population or adverse-event observation period. These limitations constrain interpretation of both efficacy-related summaries and safety counts.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Sexual and Gender Minority Emerging Adults Eliciting Narratives — NCT05899218.
• Registry record last updated 2024-11-25; status last verified 2024-10.
• Results first posted 2024-11-25.
• 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.

19. Record Summary

SEEN is a completed, randomized, parallel-group behavioral study with no masking, sponsored by the University of Pennsylvania. Enrollment is listed as 20. Participants were assigned to Photo-Novella or Digital Storytelling, two formats for responding to prompts about feeling seen and unseen. The primary outcome is mean PHQ-9 score at 1 month.

The registry reports a Photo-Novella mean of 14.29 with standard deviation 4.72, based on 7 participants, and a Digital Storytelling mean of 11.5 with standard deviation 0.93, based on 8 participants. It states that the two-arm comparison is not estimable. No comparative effect estimate, confidence interval, or p-value is reported. The registry lists 14 outcome measures and 7 secondary outcomes, but no posted analyses. It records 0 serious adverse events, 0 other adverse events, and 0 deaths in each arm. The differences between enrollment, outcome counts, and safety denominators are not explained in the registry record.