Computer Assisted Family Intervention to Treat Self-Harm Disparities in Latinas and Sexual/Gender Minority Youth: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Computer Assisted Family Intervention to Treat Self-Harm Disparities in Latinas and Sexual/Gender Minority Youth (NCT03709472), a randomized na study. The primary outcome is Columbia Suicide Severity Rating Scale (CSSRS) Suicide Ideation.

2. Clinical Question

3. Trial Design

The registry identifies this as a randomized, parallel-group trial with no masking. The study status is completed, and the listed enrollment is 172. The phase is recorded as not applicable. The sponsor is the University of Miami. The study start date is 2018-11-12, and the primary completion date is 2023-08-23.

The trial compares Computer Assisted CIFFTA with traditional face-to-face treatment without technology. CIFFTA is described as a hybrid, culturally informed and flexible family-based intervention, combining office-based treatment and technology-delivered material. The comparison group receives Treatment-As-Usual through a community agency during a 16-week period; participants may receive individual or family treatment. The registry says the team coordinates with agencies to minimize overlap of collected data, but does not explain how this was implemented or evaluated.

The primary outcome is assessed at baseline and at follow-up points listed as 4 months post baseline and 12 months post baseline. The registry also lists secondary outcomes concerning reported self-harm behavior, emotional dysregulation, depression, and family connectedness. It names five outcome measures overall, but does not provide a complete account of their analysis in the registry record for this explanation.

Randomization can help make treatment groups comparable at assignment, but the record does not state the sequence-generation method, allocation concealment procedures, or whether any stratification was used. Masking is listed as none. The registry record does not report the protocol details, a statistical analysis plan, or arm-specific outcome results. Accordingly, the design description establishes what was planned and how the comparison was organized, not what the primary outcome showed.

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: Four families declined to participate after enrollment (consent and intake assessment) and before randomization.

Baseline

4 Month Assessment (Post Treatment)

Reasons for not completing this period:

Assessment (12-month Post Baseline)

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Only data from adolescents was collected. Missing data is because they did not provide sufficient item responses to calculate a score. Participants can respond with "don't know" or "refuse". This interferes with scoring.

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 Columbia Suicide Severity Rating Scale (CSSRS) Suicide Ideation, measured over Baseline, 4 months post baseline, 12 months post baseline.

The primary endpoint is the number of adolescent participants who reported suicidal ideation in the last month, as assessed with the Columbia Suicide Severity Rating Scale. The registry describes the scale as yielding information on suicidal ideation and ideation with intent. Youth are categorized as having or not having ideation and as having or not having intent; endorsing any of the relevant items as “yes” is described as a worse outcome. The primary outcome’s stated number refers specifically to participants answering “yes” to experiencing suicidal ideation in the last month.

A binary classification can make an outcome easier to describe as the presence or absence of a reported experience. It also omits variation in frequency, intensity, or context if those are not represented in the yes/no classification. The registry’s description does not give further scoring rules or explain how answers about intent are incorporated into the primary count. The listed assessment schedule is baseline, 4 months post baseline, and 12 months post baseline, allowing outcome measurement at the start and at follow-up. However, no arm-specific counts or treatment comparison are reported in the registry record, so the endpoint definition alone does not show whether reported ideation changed or differed between groups.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a randomized, parallel-group study with no masking. These design labels describe how the comparison was organized: participants were assigned at random, groups were followed in parallel, and masking was not used. They do not supply an analysis method or a result. The registry record does not report the randomization procedure, allocation concealment, prespecified statistical plan, or model used for the primary outcome.

What does a binary outcome represent?

The primary outcome is described as a participant count based on a yes/no classification of suicidal ideation in the last month. A binary outcome separates observations into categories rather than measuring a continuously varying quantity. A count of participants meeting the category can be useful for describing how many people were classified as having the outcome. To compare randomized groups statistically, an analysis would also need to define the comparison, the relevant denominator, and how observations are handled across assessment times. The registry record does not report those details or the arm-specific counts.

The outcome description also refers to ideation with intent and says that endorsing any of the relevant items as “yes” is a worse outcome. The primary number is nevertheless specified as the number reporting suicidal ideation in the last month. The record does not explain whether intent is analyzed separately, combined with ideation for any analysis, or treated in another way. This distinction matters because different scoring or classification choices can produce different interpretations.

Why do the assessment times matter?

The primary endpoint is listed at baseline, 4 months post baseline, and 12 months post baseline. Repeated assessment means the same trial question can be framed in more than one way: an analysis might compare groups at a particular follow-up, examine change from baseline, or model the pattern over time. These approaches answer related but not identical questions. A statistical model for repeated measurements may account for the fact that observations from the same participant are related. The registry record does not state which approach was planned or used.

The entry specifically notes that the primary outcome has several categories or time points and is not reduced to one comparison. Consequently, it does not present a single effect estimate that can be read as the primary treatment contrast. Without an identified estimand and analysis, a reader cannot know which assessment time or summary was intended to carry the main inference.

What does a confidence interval add?

In general, a confidence interval describes the range of effect estimates compatible with the data under a specified statistical method and its assumptions. It communicates precision as well as the estimated direction and size of an effect. A narrow interval generally indicates greater precision than a wide interval, while an interval spanning values in different directions may leave the direction uncertain. The registry record does not report a confidence interval for the primary outcome, and no interval can be inferred from the endpoint definition alone.

A p-value, in general, describes how unusual data at least as incompatible with a specified null hypothesis would be under the assumptions of a statistical test. It is not the probability that the null hypothesis is true, and it does not measure clinical importance. No primary-outcome p-value or test is reported in the registry record. Without the underlying result and the test specification, significance cannot be assessed from the recorded outcome description.

How should planning assumptions be understood?

The study information describes a sample-size planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. It says that the effect to detect is a stated fraction of the observed effect. Such illustrations are planning calculations, not observed trial outcomes and not observed power. The registry record does not report the numerical planning results or the details needed to reconstruct them. Because arm-specific primary-outcome results are also not reported, the illustration cannot be used as a substitute for an analysis of the trial.

In general, a planning calculation depends on the assumed effect, outcome variability or event frequency, allocation, significance threshold, and desired power. If an assumed effect is smaller, detecting it generally requires more information, all else being equal. This general relationship does not provide a trial-specific estimate. The registry record does not report a sample-size justification or explain whether the planning illustration reflects the study’s original design.

What can be inferred from the statistical record?

The record names five outcome measures and identifies secondary outcomes concerning self-harm behavior, emotional dysregulation, depression, and family connectedness. It reports zero analyses in the registry record for this explanation. It does not provide outcome estimates, uncertainty intervals, or analysis methods. The appropriate statistical reading is therefore descriptive: the design and measurement plan are identifiable, but the primary treatment effect and its precision are not reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

Multiplicity arises when a study examines several outcomes, assessment times, or statistical comparisons. The registry lists five outcome measures overall and gives the primary outcome at baseline, 4 months post baseline, and 12 months post baseline. It also lists secondary outcomes concerning reported self-harm behavior, emotional dysregulation, depression, and family connectedness. Considering several endpoints or time points can create more than one opportunity to observe an apparently notable result. In general, a statistical plan may identify a primary comparison or use methods to address multiple testing. The registry record does not report such a plan, any multiplicity adjustment, or a hierarchy among the follow-up comparisons.

The entry notes that the primary outcome has several categories or time points and is not reduced to one comparison. This means the record does not identify a single reported estimate or test as the primary result. Without a prespecified analysis description, readers cannot determine how results across time points would be combined or which comparison would be emphasized.

Missingness is relevant to this outcome because the registry says that insufficient item responses can prevent a score from being calculated. Participants may answer “don’t know” or “refuse,” which interferes with scoring. The record does not report the number of missing observations, missingness by arm or assessment time, or the method used to handle missing data. It also does not state whether sensitivity analyses were performed.

In general, missing data can affect estimates when the participants with observed outcomes differ systematically from those without observed outcomes. The impact depends on why responses are missing and on the assumptions made by an analysis. The primary-outcome description alone does not establish those reasons or assumptions. The population description says that only adolescent data were collected, but the analysis population, eligibility for each analysis, and handling of participants with incomplete follow-up are not reported in 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 registry’s adverse-event entry lists Computer Assisted CIFFTA and traditional face-to-face treatment without technology. For each arm, the record lists 42 participants at risk, 0 serious adverse events, 0 other adverse events, and 0 deaths. No serious adverse-event terms are listed.

These are the counts recorded in the safety entry. They should be read as registry-reported observations, not as proof that no events occurred beyond what was recorded. The record does not provide further definitions of serious or other adverse events, the method or duration of safety monitoring, or an explanation of how the at-risk population was selected. It also does not explain how these safety counts relate to the listed enrollment of 172. The figures do not establish a comparative safety effect, because no statistical comparison or uncertainty estimate is reported.

In general, a zero count is most informative when the event definitions, observation period, surveillance procedures, and completeness of follow-up are clear. Those details are not reported in the registry record. The absence of listed events should therefore be described narrowly: the registry reports 0 serious events, 0 other events, and 0 deaths in each listed arm.

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

The record establishes that a randomized study compared Computer Assisted CIFFTA with traditional face-to-face Treatment-As-Usual, and that its primary outcome concerned adolescent reports of suicidal ideation in the last month. The outcome was scheduled for assessment at baseline, 4 months post baseline, and 12 months post baseline. The entry also describes the target population and the broad features of each treatment condition.

What the record does not establish is the result of that comparison. It does not report the primary outcome count by arm, an estimated between-group effect, a confidence interval, or a statistical test. It therefore cannot show whether reported suicidal ideation was more common in either group, whether there was a difference at a particular follow-up, or how precisely any difference was estimated. A completed study status is not itself an outcome finding.

The registry’s description of the endpoint also limits what can be inferred from the measure alone. A yes/no report captures whether a participant endorsed the specified experience, but does not by itself describe its intensity or circumstances. The record does not give additional scoring details for the related ideation-with-intent information, so the relationship between that information and the primary count should not be assumed.

The listed secondary measures indicate that the study also considered self-harm behavior, emotional dysregulation, depression, and family connectedness. Their inclusion does not show that those outcomes changed, nor does it establish how they were analyzed. The registry record does not report results or analytic details for these outcomes.

Accordingly, the sound conclusion is about the scope and reporting status of the study: the intervention comparison and outcomes are described, but the treatment effects are not. Any claim that the intervention did or did not alter suicidal ideation, self-harm, or other outcomes would go beyond what the registry record reports. Interpreting efficacy or comparative safety would require the arm-level results, an analysis plan, and information on missing data and follow-up.

13. Why This Trial Matters Statistically

This trial’s statistical question matters because it combines a randomized treatment comparison with an outcome that is both important to the study’s stated purpose and measured repeatedly. The registry focuses on Latino adolescents, specifically Latinas and sexual/gender minority youth, and describes self-harm as a health disparity motivating the intervention. Assessing whether a culturally informed, family-based approach can be compared with community agency Treatment-As-Usual is therefore a question about both intervention evaluation and the population the study intends to serve.

The design also illustrates why outcome definitions and analysis choices need to be explicit. The primary measure is a yes/no report of suicidal ideation, recorded as a participant count at baseline and follow-up. A count is straightforward to describe, but a complete comparison requires clear denominators, a prespecified time point or longitudinal summary, and a method for handling incomplete responses. The registry notes that insufficient item responses can prevent scoring, including responses of “don’t know” or “refuse.” Those details can affect how a result should be interpreted.

Multiplicity is another relevant statistical issue. The record includes several outcome measures and multiple primary-outcome assessment times, but does not identify a single comparison or report an analysis plan. In general, decisions about which outcome and time point carry the main inference help readers distinguish a confirmatory result from other analyses.

The record’s value is consequently strongest as a description of the study design and measurement plan. Its lack of reported arm-specific outcomes means it cannot answer the efficacy question statistically. That distinction matters: a clear research question and completed trial status are not substitutes for effect estimates and their uncertainty.

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 main trial-specific limitation of the available registry record is that it does not report arm-specific results for the primary outcome. There is no stated treatment contrast, confidence interval, or test result to evaluate. The record also indicates that the primary outcome has multiple categories or time points and has not been reduced to one comparison, leaving the intended primary analysis unclear.

The endpoint description gives a yes/no classification based on adolescent reports of suicidal ideation in the last month, but does not provide full scoring rules for how ideation and ideation with intent relate to the reported primary count. The listed assessment schedule is baseline, 4 months post baseline, and 12 months post baseline, yet no statistical method for repeated observations is reported. It is therefore not possible to determine whether an analysis would compare follow-up values, changes from baseline, or the overall course across assessments.

Missing data are acknowledged: insufficient item responses can prevent calculation of a score, and participants may answer “don’t know” or “refuse.” The record does not report the extent or distribution of missingness, the assumptions used to address it, or sensitivity analyses. These omissions limit interpretation of any potential comparison.

The intervention and comparator descriptions are also incomplete. The CIFFTA description ends after approximately 45, and the Treatment-As-Usual description does not fully specify services or intensity. The record does not report randomization procedures, allocation concealment, adherence, treatment exposure, or details of the statistical analysis plan. These are limitations of what can be learned from the registry record and should not be taken as proof that the trial did not collect or analyze such information elsewhere.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Computer Assisted Family Intervention to Treat Self-Harm Disparities in Latinas and Sexual/Gender Minority Youth — NCT03709472.
• Registry record last updated 2024-11-05; status last verified 2024-10.
• Results first posted 2024-11-05.
• 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

NCT03709472 is a completed randomized, parallel-group study with no masking. The registry lists enrollment of 172 and compares Computer Assisted CIFFTA with traditional face-to-face Treatment-As-Usual. The study concerns adolescents, with a focus on Latinas and sexual/gender minority youth.

The primary outcome is the number of adolescents reporting suicidal ideation in the last month, assessed at baseline, 4 months post baseline, and 12 months post baseline. The registry also lists outcomes related to self-harm behavior, emotional dysregulation, depression, and family connectedness. It describes missing responses that can prevent outcome scoring.

Arm-specific primary-outcome results, a statistical comparison, and the analysis plan are not reported in the registry record. Safety entries list 0 serious adverse events, 0 other adverse events, and 0 deaths in each arm. The record therefore describes the trial’s design and outcome definitions but does not provide evidence from which to estimate the primary treatment effect.