Altitudes for Caregivers: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Altitudes for Caregivers (NCT06094647), a non-randomized na study. The primary outcome is Qualitative Summaries of Participant Experience in Post-Treatment Feedback.

2. Clinical Question

The broader objective was to assess acceptability and feasibility, including platform engagement and feedback from interviews, while also evaluating caregivers’ psychological status, wellbeing, and social support using self-report questionnaires. These aims are relevant to a pilot because they concern whether an intervention can be used and studied in its intended setting, as well as possible changes in outcomes that could inform later research.

The listed secondary outcomes include changes in loneliness, perceived social support, caregiving experiences, and expressed emotion. The registry record identifies these outcome areas but does not report their results. With no enrolled Treatment as Usual participants reported for the primary outcome, the record cannot support a like-for-like comparison of the platform with usual care.

3. Trial Design

Altitudes for Caregivers is registered as a pilot study, with a parallel model, non-randomized allocation, and no masking. The study evaluated Altitudes USA, a digital intervention intended for caregivers and supporters of people experiencing first episode psychosis. The intervention was described as an adjunct to services at the relevant clinic over 6 months. The Treatment as Usual arm was described as receiving care offered by its respective clinic.

The registry lists enrollment of 24. Its study summary describes evaluating up to 30 caregivers and supporters over 6 months. The arm descriptions refer to recruitment from separate clinic groups: the Altitudes arm from OASIS and SHORE, and the Treatment as Usual arm from Encompass, Eagle, and AEGIS. These arm descriptions are not evidence that the intended participants enrolled. In particular, the primary-outcome population states that no participants were enrolled into the Treatment as Usual arm. The registry does not report the number enrolled in each clinic or the reasons for the difference between the intended recruitment and the enrolled population.

Because allocation was non-randomized, the arms were not assigned by chance. The registry record also explicitly cautions that they are not a like-for-like control comparison. Separate clinic settings could be associated with differences in participants or services, and this design does not isolate the intervention from such differences. With no Treatment as Usual participants reported for the primary outcome, there is no enrolled comparison group for a comparative estimate in that outcome population.

The primary outcome was qualitative summaries of participant experience in post-treatment feedback, with a timeframe of up to 6 months. Individual interviews were intended to address platform use and participant feedback. The registry states that two participants elected not to complete the post-treatment interview, but it does not report the resulting themes. The study status is completed. The start date is 2024-01-15 and the primary completion date is 2024-11-01.

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: The research team attempted to recruit participants for a treatment as usual condition, but the coordinated specialty care (CSC) programs that were encouraged to refer caregivers indicated that family members of young people with first episode psychosis (FEP) were not interested in completing assessments without the option of joining the Altitudes program (treatment condition). Therefore, no participants were enrolled into the Treatment as Usual Arm.

Overall Study

Analysis population for the primary outcome, as defined in the registry: No participants were enrolled into the Treatment as Usual Arm. Two participants elected not to complete the post-treatment interview.

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: No participants were enrolled into the Treatment as Usual Arm.

6. Primary Endpoint

The registry lists the primary outcome as Qualitative Summaries of Participant Experience in Post-Treatment Feedback, measured over Up to 6 months.

The primary endpoint is qualitative feedback collected after treatment from Altitudes participants. Interviews were intended to discuss use of the platform and participants’ feedback. The planned summaries were to identify common themes about likes and dislikes, implementation in the clinical setting, and ideas for future directions. The registry gives the timeframe as up to 6 months.

A qualitative endpoint is suited to questions about experience and implementation that may not be captured by a single questionnaire score. Interview accounts can describe what participants found useful or difficult and can raise issues for later evaluation. Such findings can help clarify how an intervention is used and what refinements may be worth studying. These are general reasons to use qualitative feedback; they are not findings from this study.

The endpoint is not a numerical measure of treatment effect. Its interpretation depends on the interview material, the approach used to organize or code responses, and the way themes are reported. The registry record says that common themes would be summarized, but it does not report the interview findings, the analytic procedure, or theme frequencies. Those details are not reported in the registry record.

The population note says no participants were enrolled into the Treatment as Usual arm and that two participants elected not to complete the post-treatment interview. As a result, the stated endpoint describes feedback from Altitudes participants rather than a comparison of interview outcomes between arms. Without the reported themes and a fuller account of who contributed interview data, the endpoint cannot establish the overall acceptability of the intervention or show how experiences differed across groups.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a non-randomized parallel design mean?

In a parallel design, participants are considered in separate groups rather than all receiving each condition in sequence. Randomization would allocate participants by chance, helping balance measured and unmeasured characteristics on average. This study is registered as non-randomized, so that protection does not apply. The registry describes different clinics for the Altitudes and Treatment as Usual groups and notes that the arms are not a like-for-like control comparison. Differences between groups could therefore reflect clinic context, participant characteristics, or other factors as well as intervention exposure. This is a general design consideration, not evidence that any particular difference occurred.

The absence of participants in the Treatment as Usual arm for the primary outcome further limits comparative interpretation. Without an enrolled comparison group, a difference between intervention and usual care cannot be estimated for that outcome population. A within-group description of experience, if reported, would answer a different question from a controlled treatment comparison.

What can qualitative summaries show?

Qualitative interviews can capture experiences, explanations, and suggestions in participants’ own accounts. Researchers commonly organize interview material into themes, but the credibility and meaning of a summary depend on how interviews were conducted, how material was reviewed, and how themes were selected and presented. A theme is not automatically a measure of how common an experience is in the full target population. If the registry reports only that themes were intended to be summarized, without the themes or methods, readers cannot assess the content or interpret how representative it may be. The interview analysis approach is not reported in the registry record.

How should questionnaire changes be interpreted?

A change score describes how a measured outcome differs between assessment occasions. To interpret one, readers need the actual group summaries, the timing and completeness of assessments, and an account of how the change was calculated. A comparison between groups also requires a defined analysis and an appropriate treatment of the group structure. None of these outcome results or analysis details is reported for the listed secondary measures in the registry record.

Even when a numerical change is available, its size should be considered alongside uncertainty. A confidence interval is a general statistical tool that describes a range of values compatible with the data and the model used. A narrow interval indicates greater precision than a wide interval, while an interval that includes values representing little or no difference can leave the direction or magnitude uncertain. No confidence intervals or effect estimates are reported in this record, so this framework explains how such results would generally be read rather than describing study findings.

Why does over-dispersion matter?

Over-dispersion is a general issue for count outcomes when observed variability exceeds what a statistical model assumes. If a model underestimates variability, standard errors may be too small and confidence intervals may be too narrow. The primary outcome in this record is described as qualitative summaries, not as an inferential count comparison, and no dispersion estimate is reported. The general concept should not be taken as evidence that over-dispersion was assessed or present in this study.

What do the planning assumptions mean?

The registry’s sample-size assumptions describe a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. Such illustrations address how many participants might be needed under specified assumptions to detect an effect of a chosen fraction of an observed effect. They are not observed power, and they do not establish the study’s original design rationale. The sample-size justification and the statistical plan are not reported in the registry record. Since no observed effect estimate is reported for the outcomes, the planning assumptions alone do not show that the study could detect a particular result.

What is not available for evaluating the analysis?

The registry record does not report the statistical methods for questionnaire outcomes, adjustment for baseline values, handling of missing questionnaire data, or a detailed analysis population. It lists 0 analyses. This means there is no posted analysis from which to assess model choice, uncertainty, or sensitivity to assumptions. General statistical methods can clarify what information matters, but they cannot substitute for the study’s unreported results or analysis plan.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 34 outcome measures, including multiple secondary measures and subscales concerning loneliness, perceived social support, caregiving experience, and expressed emotion. When a study examines many outcomes, the chance of finding at least one apparently notable result by chance can increase if each is tested separately. Statistical approaches to multiplicity can control or describe that issue, but the appropriate approach depends on the study’s prespecified questions and analysis plan. A multiplicity strategy is not reported in the registry record.

The record identifies the primary outcome as qualitative interview summaries, while questionnaire changes appear among the secondary outcomes. It does not report a hierarchy of confirmatory hypotheses, specify which comparisons were intended to be primary for each questionnaire, or describe any adjustment for multiple testing. The listed analysis count is 0, and no outcome estimates or significance tests are posted. Consequently, there are no inferential findings on which to judge multiplicity-adjusted or unadjusted conclusions.

Missing-data interpretation is also limited. The primary-outcome population notes that two participants elected not to complete the post-treatment interview. The registry does not report why they did not complete it, whether their interview information was unavailable in full, or how their absence was reflected in the qualitative summary. Missing questionnaire data, assessment completion, and methods for handling missing values are not reported in the registry record.

The record does not define a detailed analysis population for the questionnaire outcomes or state whether all enrolled participants, only participants with follow-up data, or another group would be analyzed. Without these details, readers cannot assess how selection into the analyzed data may affect representativeness. These are reporting gaps, not evidence that a particular method was or was not used outside the registry record.

11. 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 adverse-event entries list the Altitudes Condition with 24 participants at risk, zero serious adverse events, zero other adverse events, and zero deaths. The Treatment as Usual group lists zero participants at risk and zero counts for those event categories. These are registry counts, not estimates of comparative risk.

A count of zero recorded events does not establish that an intervention has no risk. It means that no events were entered for that category in the record during the reported observation. The interpretation depends on how events were collected, the length and completeness of follow-up, and the definitions used. Those details are not reported in the registry record. The zero count in the Treatment as Usual group must be read alongside its zero participants at risk; it is not evidence that usual care had no events among an enrolled comparison population.

The record does not list serious adverse-event terms. That absence should not be read as a detailed description of the safety-monitoring procedures or as proof that every possible event was assessed in the same way. The posted counts are descriptive safety reporting for this pilot and do not support a comparative safety conclusion.

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

The registry record documents a completed pilot study designed to explore use of Altitudes by caregivers and supporters of people experiencing first episode psychosis. It describes a digital behavioral health and psychoeducational intervention, a 6-month period, planned interviews, and self-report measures covering psychological status, wellbeing, social support, and caregiving-related outcomes. This information clarifies the study’s aims and the types of questions it was designed to address.

What the posted record does not establish is whether participants found the platform acceptable, whether it was feasible to implement, or whether questionnaire outcomes changed. The qualitative outcome is described as a plan to summarize common themes, but the themes themselves are not reported in the registry record. The listed secondary outcomes likewise have no posted estimates or analyses. Absence of results in the record should not be mistaken for a finding of no change or no benefit.

The design also does not support a comparative conclusion. Allocation was non-randomized, the registry cautions that the arms are not a like-for-like control comparison, and the primary-outcome population states that no participants were enrolled into Treatment as Usual. Therefore, the record does not show how outcomes under Altitudes compare with outcomes under usual care.

For safety, the registry reports zero serious adverse events, zero other adverse events, and zero deaths among 24 participants listed at risk in the Altitudes Condition. These counts are descriptive and do not prove absence of risk or provide a comparison with usual care. The usual-care group has zero participants listed at risk.

In general, a pilot can provide information useful for planning later research, such as whether recruitment, measurement, intervention delivery, and data collection can be carried out. The registry record does not report enough findings to assess those aspects in detail. Any claims about the intervention’s effects or wider applicability would go beyond the results posted in this record.

13. Why This Trial Matters Statistically

This study raises several statistical issues that matter when interpreting early-stage intervention research. First, the question is primarily one of acceptability and feasibility, with qualitative interviews as the primary outcome. Those aims differ from estimating a treatment effect. A successful description of participant experience would not by itself demonstrate comparative effectiveness, while a questionnaire change would not necessarily explain how participants experienced the platform.

Second, the design is non-randomized and the registry cautions that the arms are not like-for-like. The arm descriptions place the intervention and usual-care groups at different clinics, so a comparison could be entangled with clinic-level context. The primary-outcome population also reports no enrollment into Treatment as Usual. These features illustrate why a comparator must be present and suitably comparable before a treatment contrast can be interpreted.

Third, missingness and reporting shape what readers can learn. The registry notes that two participants elected not to complete the post-treatment interview, but does not give the resulting themes or describe how absent interviews were handled. It lists a broad set of secondary outcomes, but reports no outcome analyses. A clear account of completed assessments, analysis populations, and missing-data methods would help readers judge how well the observed data represent the intended participant group.

Finally, planning calculations are conditional illustrations, not evidence of study power or of an effect. Their interpretation depends on assumptions about the effect to detect, allocation, and statistical model. The registry’s stated planning assumptions do not replace a reported design justification or outcome analysis. These distinctions are important because the study’s pilot aims, its actual enrolled population, and its unreported results each constrain the claims that can be made from the registry record.

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 most consequential limitation for interpreting results is that the registry record does not report the qualitative themes or the results of the secondary questionnaire outcomes. It also lists 0 analyses. Thus, the aims and measures are described, but readers cannot assess the observed acceptability, feasibility, or outcome changes from the posted results.

The registry states that no participants were enrolled into the Treatment as Usual arm for the primary outcome. This leaves no enrolled usual-care comparison for interpreting that endpoint, and the record cautions that the non-randomized arms are not a like-for-like control comparison. The arm descriptions identify different clinic groups, so even a comparison, if reported, would require careful consideration of clinic and participant differences.

The registry lists enrollment of 24, while the study summary describes an objective of evaluating up to 30 caregivers and supporters. The record does not explain the difference between that stated objective and the enrollment figure, nor does it provide a breakdown of enrollment by arm or clinic. The primary-outcome population reports that two participants elected not to complete the post-treatment interview, but reasons and handling of those missing interviews are not described.

Additional limitations are that the statistical analysis plan, sample-size justification, interview analysis procedures, questionnaire analysis methods, and handling of missing questionnaire data are not reported in the registry record. The record also does not provide enough information to assess the completeness of follow-up or how broadly the participants’ experiences might apply to caregivers and supporters outside the participating clinics.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Altitudes for Caregivers — NCT06094647.
• Registry record last updated 2025-08-14; status last verified 2025-02.
• Results first posted 2025-08-14.
• 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.

18. Record Summary

Altitudes for Caregivers is a completed, non-randomized pilot study of the Altitudes USA digital intervention for caregivers and supporters of people experiencing first episode psychosis. The registry lists 24 enrolled participants and describes an intended intervention period of 6 months. The primary outcome is qualitative post-treatment feedback about platform use, likes and dislikes, clinical implementation, and future directions.

The primary-outcome population states that no participants were enrolled into the Treatment as Usual arm and that two participants elected not to complete the post-treatment interview. The record does not report the interview themes or results for the listed secondary measures, and it lists 0 analyses. The arms are explicitly not described as a like-for-like control comparison.

For adverse events, the Altitudes Condition lists 24 participants at risk and zero serious adverse events, zero other adverse events, and zero deaths. The Treatment as Usual group lists zero participants at risk. These figures are descriptive and do not establish comparative safety or effectiveness.