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 Feasibility of an Early Detection Program for Early Psychosis on a College Campus (NCT03983421), a registered phase not stated study. The primary outcome is Duration of Untreated Psychosis.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03983421 |
| Phase | Phase not stated |
| Condition | Psychosis, First Episode Psychosis, Clinical High Risk for Psychosis |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 25 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of New Mexico |
| Results posted | Yes |
2. Clinical Question
Population
College students screened through the PQ-B at a college counseling center, with the program aiming to identify students at clinical high risk of psychosis or experiencing first episode psychosis. The registry description also refers to students determined eligible for coordinated specialty care.
Intervention
An early detection program intended to identify students and link them to coordinated specialty care for a second-stage screen, clinical assessment, and appropriate treatment. The registry also describes collecting information on pathways to care and perceived barriers among students enrolled in coordinated specialty care.
Comparator
No control group or comparator is described. The registry identifies a single group of students enrolled in coordinated specialty care; it does not describe a randomized, like-for-like comparison.
Primary question
The primary outcome is duration of untreated psychosis, assessed upon admission to coordinated specialty care. The broader study objective is feasibility: identifying students at clinical high risk or with first episode psychosis and linking them with specialty care.
This is a feasibility question rather than a conventional treatment-effect question. The study aims to examine whether a campus-based detection and referral pathway can connect students to specialty services, and to describe pathways and perceived barriers to seeking help. Duration of untreated psychosis is listed as the primary outcome, but it applies only to participants experiencing first episode psychosis: the registry says it cannot be determined for participants at clinical high risk of psychosis.
The record does not report a comparator or an outcome estimate for the primary measure. It therefore cannot establish whether the program changed duration of untreated psychosis relative to another approach. Nor does the stated objective alone establish how many students were identified, linked to care, or completed each step. Those findings are not reported in the registry record.
3. Trial Design
The study, titled “Feasibility of an Early Detection Program for Early Psychosis on a College Campus,” is registered as NCT03983421 and sponsored by the University of New Mexico. The registry lists the study as completed, with a start date of 2019-10-01 and a primary completion date of 2022-12-31. Enrollment is listed as 25.
The stated objective was to assess a program for identifying college students at clinical high risk of psychosis or experiencing first episode psychosis, and linking them to coordinated specialty care. The described pathway included a second-stage screen, clinical assessment, and appropriate treatment. The study also aimed to examine pathways to care and perceived barriers among students enrolled in coordinated specialty care.
The registry describes one group: students determined eligible for coordinated specialty care who were originally screened through the PQ-B at a college counseling center. It does not describe a control group. The record characterizes the study as not being a randomized comparison, and allocation is not stated. There is no basis for interpreting the group as a treatment arm compared with a like-for-like control group.
The listed outcomes include duration of untreated psychosis as the primary outcome, along with number of steps to coordinated specialty care and perceived barriers to seeking psychological help. The registry lists 3 outcome measures and 0 analyses. It does not report the statistical analysis plan, participant flow, or numerical results for these outcomes.
The record does not report details such as eligibility criteria, how screening or referral was conducted in practice, or how feasibility was defined. These omissions matter when judging what the completed study can establish: a stated aim is not itself evidence that each part of the intended pathway was completed or successful.
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
| Stage | Students Enrolled In Coordinated Specialty Care |
|---|---|
| STARTED | 25 |
| COMPLETED | 24 |
| NOT COMPLETED | 1 |
Reasons for not completing this period:
| Reason | Students Enrolled In Coordinated Specialty Care |
|---|---|
| Lost to Follow-up | 1 |
Analysis population for the primary outcome, as defined in the registry: 17 of the participants were determined to be at clinical high risk of psychosis rather than experiencing first episode psychosis. Duration of untreated psychosis can not be determined for participants at clinical high risk of psychosis. The other seven participants were determined to be experiencing their first episode of psychosis however were missing data on duration of psychosis.
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.
Population: Data are only available for 24 participants because after one participant was consented to participate in the study, they needed to reschedule and then did not show up for their interview
| Characteristic | Unit | Students Enrolled in Coordinated Specialty Care |
|---|---|---|
| Participants analysed | 24 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 24 |
| Age, Categorical: >=65 years | Participants | 0 |
| Age, Continuous | Years | 21.4 (SD 2.3) |
| Sex: Female, Male: Female | Participants | 16 |
| Sex: Female, Male: Male | Participants | 8 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 10 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 13 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 1 |
| Region of Enrollment: United States | participants | 24 |
6. Primary Endpoint
The registry lists the primary outcome as Duration of Untreated Psychosis, measured over Measured upon admission (baseline) to coordinated specialty care (CSC).
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
Duration of untreated psychosis is the time during which psychosis is present before the person enters care. The registry lists the outcome as measured upon admission to coordinated specialty care, at baseline, and describes it as determined upon enrollment to that service. As a general statistical concept, this endpoint can describe how long people with first episode psychosis have gone without treatment before reaching specialty care. It is relevant to an early detection program because the program aims to identify people and connect them with care.
The endpoint does not apply to every enrolled participant. The registry says 17 participants were determined to be at clinical high risk of psychosis rather than experiencing first episode psychosis, and that duration of untreated psychosis cannot be determined for them. It says the other seven participants were experiencing first episode psychosis. The description does not account for all of the listed enrollment of 25, and the registry record does not explain this difference.
No unit, summary statistic, or numerical result for duration of untreated psychosis is reported in the registry record. The endpoint's timing and target population are described, but the actual observed duration and its variability cannot be assessed from the record. This limits interpretation of the primary outcome; it does not imply that the measure was zero or that no participants experienced untreated psychosis.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes a completed feasibility study with a campus-based early detection and referral objective. Its aims were to identify students at clinical high risk of psychosis or with first episode psychosis and connect them to coordinated specialty care. It also intended to describe routes into care and perceived barriers. These aims address how a pathway is organized and used, rather than establishing a comparative treatment effect.
The record lists duration of untreated psychosis as the primary outcome, measured upon admission to coordinated specialty care. It does not report a numerical result for that endpoint. The endpoint is not applicable to participants at clinical high risk of psychosis, according to the registry. The record identifies 17 participants in that category and says the other seven were experiencing first episode psychosis, but does not account for all of the listed enrollment of 25. It does not explain whether the difference reflects missing outcome classification, incomplete information, or another reason, so none should be inferred.
The registry lists 3 outcome measures and 0 analyses. The secondary outcomes are number of steps to coordinated specialty care and perceived barriers to seeking psychological help. Their numerical results are not reported in the registry record. Without outcome estimates, distributions, or uncertainty measures, readers cannot judge the observed levels of these outcomes or how precisely they were measured.
The record describes a single group and no control comparison. That design can describe experiences among the students included, if results are reported, but it cannot by itself separate program effects from other influences or show what would have happened under another referral approach. No comparative effect estimate is reported, and there is no basis for claiming that the program increased or decreased any outcome.
The registry's completed status indicates that the study is listed as completed; it does not substitute for outcome reporting. A feasibility aim also does not guarantee that feasibility criteria were met. The criteria used to define feasibility and the results against those criteria are not reported in the registry record.
Accordingly, the record supports a description of the study's purpose, setting, planned care pathway, and listed outcomes. It does not support conclusions about the size or precision of the primary outcome, the frequency of successful linkage to care, the barriers participants experienced, or the effect of the program compared with an alternative. Those questions require results and analysis details that are not reported in the registry record.
9. Statistical Methods Explained
The registry record identifies duration of untreated psychosis as the primary outcome, but does not report an analysis for it. It lists 0 analyses. Statistical methods can help explain what would be needed to interpret such an endpoint, but they cannot replace missing results or establish which methods were actually used.
What does an outcome estimate tell the reader?
An estimate is a summary of observed data, such as a mean or median for a measured duration. The choice depends on the outcome's distribution and the analysis plan. A mean is sensitive to unusually large values, while a median describes the middle of an ordered set of observations. For a duration measure, the distribution may be skewed, so a single average may not fully describe participants' experiences. These are general statistical considerations, not methods reported for this study.
The registry record does not state a unit, summary measure, or numerical estimate for duration of untreated psychosis. It also does not report the underlying participant-level values or a distributional summary. Without those elements, readers cannot assess the typical duration, the range of durations, or whether a small number of longer durations influenced a summary.
Why does the endpoint population matter?
An outcome should be interpreted only among people for whom it is defined. The registry says duration of untreated psychosis cannot be determined for participants at clinical high risk of psychosis, and identifies 17 participants in that category. It says the other seven were experiencing first episode psychosis. The record does not account for all of the listed enrollment of 25. It does not explain how participants were assigned to outcome populations or whether any further outcome data were unavailable.
This distinction affects both the estimand—the specific quantity an analysis is intended to describe—and the denominator for any summary. A result among participants with first episode psychosis would not automatically describe the full enrolled group. The registry does not report a numerical result or the analysis population, so the intended estimand cannot be reconstructed from the record.
What would a confidence interval add?
As a general concept, a confidence interval describes the uncertainty around an estimated quantity under a specified statistical model and sampling process. A narrower interval indicates greater precision under those assumptions; a wider interval indicates less precision. An interval does not correct bias, missing data, or a mismatch between the analyzed group and the question of interest. No confidence interval for the primary outcome is reported in the registry record, so its precision cannot be evaluated.
What does the planning illustration mean?
The planning illustration is described as a calculation based on an observed effect, not the trial's own design. Its stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. For time-to-event outcomes, the illustration uses a total number of events under the Schoenfeld approach; for other outcomes, it gives participants per arm.
Those assumptions describe a planning exercise, not observed evidence about this study. The registry does not describe a randomized two-arm comparison, and the listed study group is not a like-for-like control comparison. Planning values cannot be read as the number enrolled, the number analyzed, or evidence that the study had a particular level of power. They are not observed power. Numerical planning targets are not reported in the registry record.
Why is over-dispersion sometimes relevant?
As a general explanation, count outcomes can vary more than a simple statistical model expects. This is called over-dispersion. If it is ignored, standard errors can be too small and uncertainty can appear less than it is. Models for count outcomes can allow for extra variability, but model choice depends on the outcome distribution and design. The registry lists number of steps to coordinated specialty care as a secondary outcome, but does not report its distribution, model, or analysis. It is therefore not possible to say whether over-dispersion was present or addressed.
Likewise, methods for handling incomplete observations, selecting covariates, or adjusting for repeated observations depend on information about the data and prespecified plan. Those methods are not reported in the registry record. General statistical principles can guide interpretation, but they do not establish what analyses were performed in this study.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 3 outcome measures: duration of untreated psychosis, number of steps to coordinated specialty care, and perceived barriers to seeking psychological help. It lists 0 analyses. The record does not describe a statistical analysis plan, the order in which outcomes were to be assessed, or whether any outcome was designated as confirmatory beyond identifying duration of untreated psychosis as primary.
When several outcomes are tested, the chance of at least one apparently unusual result can increase. As a general statistical principle, multiplicity procedures can control that risk, but they may also affect precision and interpretation. The registry record does not report whether any adjustment was planned or applied. With no reported analyses or outcome estimates, there are no test results to interpret in relation to multiplicity.
Missing-data handling is also not reported in the registry record. The record does not state how incomplete questionnaires, unavailable endpoint measurements, or loss to follow-up were addressed, nor does it provide a participant flow accounting. The primary endpoint is inapplicable to the clinical-high-risk group, according to the registry; that is distinct from a missing measurement. The record identifies 17 participants at clinical high risk and the other seven as experiencing first episode psychosis, but does not explain how this classification relates to the listed enrollment of 25.
Analysis populations are not reported in the registry record. It is therefore unclear which participants contributed to each outcome, whether analyses used all enrolled participants or a subset, and how the outcome population was defined. These gaps limit reproducibility and make it difficult to judge whether any results would apply to the full enrolled group.
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 |
|---|---|---|---|
| Number of Students Enrolled in Coordinated Specialty Care | 0 | 25 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Number of Students Enrolled in Coordinated Specialty Care | 0 of 25 |
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 |
|---|---|
| Number of Students Enrolled in Coordinated Specialty Care | 0 of 25 |
The registry reports a single group titled “Number of Students Enrolled in Coordinated Specialty Care.” For that group, it lists 25 at risk for serious adverse events and 0 serious adverse events. It also lists 25 at risk for other adverse events and 0 other adverse events, with 0 deaths. No top serious adverse event terms are listed.
These are the adverse-event figures recorded for this study, not evidence that the program is free of risk. The record does not describe how adverse events were collected, how long participants were monitored, or how events were defined. It also does not provide details about completeness of reporting. A zero count in a registry entry should therefore be read as no events reported in these fields, rather than proof that no event could have occurred.
The at-risk counts are registry entries for the group and event categories; they should not be treated as separate group sizes or as a comparator. Because the study does not describe a control group, these figures do not support a comparative safety assessment.
12. What the Result Does, and Does Not, Mean
The study addresses a practical research question: whether a college-based process can identify students who may need early psychosis services and connect them with coordinated specialty care. The registry also identifies pathways to care and perceived barriers as study interests. These aims make the work relevant to evaluating how detection and referral processes are organized.
The record does not report numerical results for the primary endpoint or the secondary outcomes. It therefore cannot establish the observed duration of untreated psychosis, the number of steps involved in reaching specialty care, or the perceived barriers reported by participants. The stated goal of assessing feasibility is not itself a result; feasibility criteria and findings are not reported in the registry record.
The study is not described as a randomized comparison, and no control group is reported. Consequently, the record does not show whether the program performed differently from usual care or another approach. It cannot support a causal conclusion about the program's effect on detection, referral, treatment, or clinical outcomes.
The endpoint also has a restricted population. The registry says duration of untreated psychosis cannot be determined for participants at clinical high risk of psychosis. It identifies 17 participants in that category and the other seven as experiencing first episode psychosis, but does not account for all of the listed enrollment of 25. This makes the outcome population unclear from the record.
The adverse-event fields list 0 serious events, 0 other events, and 0 deaths, alongside 25 at risk in each adverse-event category. These entries describe what the registry reports; they do not establish that the intervention has no risks. Overall, the registry supports understanding the study's intended purpose and broad design, but not conclusions about outcome magnitude, precision, comparative effect, or the success of the referral pathway.
13. Why This Trial Matters Statistically
Feasibility studies can be statistically important even when they are not designed to estimate a treatment effect. They can examine whether recruitment, screening, referral, and outcome measurement are workable, and identify where a larger or more detailed study may need clearer procedures. In this study, those questions are particularly relevant because the proposed pathway connects campus screening with specialty care.
The registry's outcome choices reflect different parts of that pathway. Duration of untreated psychosis concerns the time before specialty care among people with first episode psychosis. Number of steps to coordinated specialty care and perceived barriers concern access and navigation. Interpreting those measures requires clear definitions of the eligible population, how each measure was collected, and which participants contributed data. Those details and the numerical results are not reported in the registry record.
The record also illustrates why a single enrollment figure does not answer every analysis question. The primary endpoint is not defined for the clinical-high-risk group, and the registry's description of participant categories does not account for all of the listed enrollment. A well-specified analysis population and participant flow are essential for understanding which group an estimate represents.
Finally, statistical interpretation depends on more than whether a study is marked completed. Estimates, uncertainty intervals, outcome definitions, and analysis methods help readers distinguish a measured finding from an objective. The registry lists 0 analyses and does not report numerical outcome results, so it leaves those distinctions unresolved. That limitation is important for researchers assessing both the promise of a campus detection pathway and the evidence needed to evaluate it.
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 registry record provides limited detail for evaluating the study's findings. Although the study is listed as completed, it reports no numerical results for the primary or secondary outcomes and lists 0 analyses. The criteria used to define feasibility are not reported, so the record does not allow readers to determine whether the study met its feasibility objectives.
The primary outcome is duration of untreated psychosis, but the record says it cannot be determined for participants at clinical high risk of psychosis. It identifies 17 participants in that category and the other seven as experiencing first episode psychosis, while the listed enrollment is 25. The record does not explain the difference or identify the analysis population. As a result, the relation between enrollment and the endpoint population is unclear.
The study description identifies a group of students enrolled in coordinated specialty care, with no control group described. Without a comparison, the registry cannot establish what outcomes would have been under another screening or referral process. The record also does not report how long participants were followed, how outcomes were measured beyond the stated endpoint timing, or how missing information was handled.
Further details that would assist interpretation—including eligibility criteria, screening and referral procedures as implemented, outcome definitions, and the statistical analysis plan—are not reported in the registry record. These omissions do not establish that the study was conducted poorly; they limit what can be concluded from the available record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Feasibility of an Early Detection Program for Early Psychosis on a College Campus — NCT03983421.
- Registry record last updated 2024-04-01; status last verified 2024-03.
- Results first posted 2024-04-01.
- 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
NCT03983421 is a completed study sponsored by the University of New Mexico, titled “Feasibility of an Early Detection Program for Early Psychosis on a College Campus.” The registry lists enrollment of 25, a start date of 2019-10-01, and a primary completion date of 2022-12-31.
The stated aim was to identify college students at clinical high risk of psychosis or with first episode psychosis and link them to coordinated specialty care. The primary outcome is duration of untreated psychosis upon admission to coordinated specialty care. Secondary outcomes are number of steps to coordinated specialty care and perceived barriers to seeking psychological help.
The registry lists 3 outcome measures and 0 analyses. Numerical outcome results and statistical methods are not reported in the registry record. The adverse-event fields list 0 serious events, 0 other events, and 0 deaths. The study is not described as a randomized comparison, and no control group is reported.