Video-visit Behavior Therapy for Anxiety and Depression in Youth: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Video-visit Behavior Therapy for Anxiety and Depression in Youth (NCT05417412), a na na study. The primary outcome is Minimum Attendance.

2. Clinical Question

3. Trial Design

This was a completed, open, single-group trial sponsored by San Diego State University. The registry record lists enrollment of 12 and identifies the intervention as Brief Behavioral Therapy, specifically STEP-UP. The project description focuses on adapting and pilot testing telehealth delivery for youths with anxiety or depression in low-resource community health centers.

The record gives a study start date of 2021-08-02 and a primary completion date of 2022-08-30. It does not report a randomized allocation scheme, and the design is not a randomized comparison. Masking is listed as none. Trial phase is not reported in the registry record.

In a single-group study, participants are observed in one intervention group rather than compared with a separately assigned control group. That design can describe delivery and participant outcomes within the group, but by itself it cannot separate changes associated with the intervention from other explanations, such as changes over time or differences in who completed follow-up.

The primary outcome was a count of participants who received at least the defined minimum dose. The registry record also names secondary symptom, impairment, and avoidance measures for parents and children. It reports 13 outcome measures overall, but does not provide outcome analysis results. A statistical analysis plan, details of follow-up beyond the primary outcome, and the rationale 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:

Analysis population for the primary outcome, as defined in the registry: Receipt of a minimum dose of intervention was coded from electronic medical records for all 12 enrolled youths. Families who were lost to follow-up were included in these analyses.

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: Youths with significant symptoms of anxiety and depression were recruited through electronic medical record screening and clinican referral. Youths were the target of treatment and the enrolled participants. As youth are minors, consent for youth participation was sought from parents, and information on youths obatined from parents / guardians in addition to youth self-report.

6. Primary Endpoint

The registry lists the primary outcome as Minimum Attendance, measured over Week 16 (post-intervention).

The primary endpoint, “Minimum Attendance,” counts participants who received a minimum dose of intervention. The registry definition sets that threshold at 8 or more sessions and specifies assessment at Week 16 (post-intervention). This is an attendance or intervention-receipt measure, not a direct measure of anxiety or depression symptoms.

The record says attendance was coded from electronic medical records for all 12 enrolled youths. It also says families lost to follow-up were included in these analyses. However, the number who met the attendance threshold is not reported in the registry record. Therefore, the endpoint’s observed result cannot be described from this record.

As a general implementation principle, an attendance threshold can help characterize whether participants received a planned minimum exposure to an intervention. It does not, on its own, establish whether symptoms changed or whether the intervention caused any change. Those questions require outcome results and an appropriate basis for interpreting them. Although the registry lists secondary measures for anxiety, mood, impairment, and avoidance, their results are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a single-group design estimate?

A single-group study observes participants receiving an intervention without a concurrently assigned comparison group. Its outcomes can describe what was recorded among participants in that group. They do not by themselves estimate what would have happened to the same participants without the intervention. That distinction matters because time, outside care, changes in circumstances, and participant selection can also relate to observed outcomes. These are general considerations for single-group designs, not additional findings about this trial.

This record identifies the model as single-group and the trial as open, with masking listed as none. Allocation is not reported as a randomized scheme. Consequently, no randomized treatment contrast is available in the registry record. The primary measure is a count of participants meeting an attendance criterion, rather than a comparison of symptom scores between assigned groups.

How should the attendance endpoint be understood?

The endpoint defines a participant as having received a minimum dose when they attended 8 or more sessions. In general, converting attendance into a threshold produces an easy-to-interpret indicator: whether a specified minimum was reached. But a threshold also compresses information. It does not show the full distribution of session attendance, and participants just below and well below the threshold are grouped together. This is a general property of threshold-based outcomes; the registry record does not report the attendance distribution.

The endpoint is recorded as a count of participants, and the record specifies electronic medical records as its source. The result count itself is not reported in the registry record. Although the record says all 12 enrolled youths were included in outcome coding, including families lost to follow-up, it does not describe how missing attendance entries, if any, were treated.

What do estimates and confidence intervals contribute?

In general, an estimate describes the observed quantity of interest, while a confidence interval conveys uncertainty around that estimate under the statistical method used. A wider interval indicates less precision than a narrower interval. For a count or proportion, interpretation also depends on the denominator and on whether the analysis accounts for the study design. No confidence interval or other uncertainty estimate for minimum attendance is reported in the registry record, so its precision cannot be assessed.

There are no outcome analyses listed in the registry record. No statistical test, model, adjustment, or interval method is specified for the primary outcome. The record does not report an analysis plan, so it is not possible to determine whether a particular inferential method was intended or whether outcomes were analyzed in a way different from their registry descriptions.

What would over-dispersion mean in general?

For count data, a statistical model may assume a particular level of variability. Over-dispersion means the observed variability exceeds what the model assumes. If it is ignored, standard errors can be too small and confidence intervals or tests can appear more certain than warranted. This is a general statistical issue, not a reported feature of this trial. The primary endpoint is described as a count of participants meeting a binary attendance definition, but the registry record does not report a model or dispersion assessment.

How should planning illustrations be read?

Sample-size planning calculations are prospective illustrations of the enrollment that might be needed under stated assumptions; they are not observed outcomes. The planning assumptions described for this study use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a fraction of an observed effect. Time-to-event illustrations use total events; other illustrations use participants per arm.

These are planning assumptions, not a description of the actual single-group design, which has no randomized two-arm comparison. A planning illustration also does not establish observed power. The registry record does not report the observed effect needed to evaluate such illustrations, nor does it report that these assumptions were the basis of the trial’s enrollment target. The sample-size rationale for the trial is not reported in the registry record.

What statistical results are available?

The registry record lists 13 outcome measures and names secondary measures for child and parent reports of anxiety, mood, impairment, and avoidance. It does not report the outcome estimates, their uncertainty, or analysis results. Without those elements, readers cannot evaluate the magnitude or precision of symptom findings or compare them with the attendance outcome. No recalculated estimates are reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry record names multiple secondary measures: parent and child versions of anxiety and mood questionnaires, parent and child impairment measures, and parent and child avoidance measures. It states that there are 13 outcome measures overall, but provides no analysis results for the named secondary outcomes. A statistical analysis plan describing which outcomes were primary for inference, or how multiple outcome tests would be handled, is not reported in the registry record.

Multiplicity is a general concern when many outcomes or tests are examined. The more analyses considered, the greater the chance that at least one result may appear notable by chance if each test is interpreted separately. Methods such as prespecifying a small set of confirmatory outcomes or adjusting inference can address that concern, but the registry record does not report whether such methods were used. It would not be appropriate to assume an adjustment or infer which results were emphasized.

For the primary attendance outcome, the record says all 12 enrolled youths were included in coding from electronic medical records and that families lost to follow-up were included. It does not report the number meeting the threshold, explain how missing attendance data were handled, or describe missing-data methods for secondary measures. The analysis population for the symptom outcomes is not reported in the registry record.

Including families lost to follow-up in primary outcome coding is useful information about the stated population, but it does not clarify whether all records contained attendance information or how incomplete records were classified. No imputation approach, sensitivity analysis, or missingness assumption is reported. These gaps limit assessment of how robust any outcome conclusion would be to incomplete data.

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 5% reporting threshold.

The safety record lists 0 serious adverse events among 12 participants at risk in the STEP-UP group. It also lists 0 other adverse events among 12 at risk and 0 deaths. These are the recorded counts in the registry record; no serious adverse-event terms are listed.

A zero count means that no events of the listed type were recorded for this group in this registry entry. It does not establish that the true risk is zero. In general, safety estimates from a small group can be imprecise, and an event not recorded in the registry entry cannot be ruled out on that basis. The record does not describe event definitions, collection procedures, duration of safety monitoring, or a detailed assessment of event severity or relatedness.

The safety counts do not compare the intervention with another treatment or with usual care, because the trial is single-group. They should therefore be read as descriptive records rather than evidence of a comparative safety difference.

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

The registry record describes a pilot project to adapt and test telehealth delivery of STEP-UP brief behavioral therapy for youths with anxiety or depression in low-resource community health centers. Its primary endpoint was whether participants reached a defined minimum attendance level of 8 or more sessions by Week 16 (post-intervention). The outcome was coded from electronic medical records for all 12 enrolled youths, including families lost to follow-up.

The count meeting the attendance threshold is not reported in the registry record. Secondary outcome measures are named, but their results are not reported either. As a result, the record does not permit a quantitative conclusion about attendance, symptom changes, impairment, avoidance, or the precision of any such outcomes.

Even if within-group changes were available, this open, single-group design would not by itself show that the intervention caused them. There is no randomized comparator in the record. A within-group description and a causal treatment comparison answer different questions; the latter requires a suitable comparison and analysis.

The safety entry reports no serious adverse events, other adverse events, or deaths in the listed group. These recorded counts do not demonstrate absence of risk. They are descriptive and cannot establish comparative safety.

Overall, the record documents the project’s intended setting, intervention, and attendance definition, but not the primary outcome result or analyses of the named secondary measures. It can therefore characterize the study’s focus and design, but it cannot establish whether minimum attendance was achieved or whether clinical outcomes changed.

13. Why This Trial Matters Statistically

This trial raises several important statistical issues that are common in early-stage intervention research. First, the primary outcome is an implementation measure: whether participants received a minimum amount of intervention. Such a measure can help describe delivery, but it is distinct from symptom benefit. Keeping those questions separate avoids treating attendance as if it were evidence of clinical change.

Second, the open, single-group design is suited to describing experience within the intervention group, but it does not provide a randomized contrast. Recognizing that limit is essential when interpreting any future within-group outcome estimates. An observed change alone cannot identify what would have happened without the intervention.

Third, outcome completeness and reporting matter. The registry states that attendance was coded for all enrolled youths, including families lost to follow-up, but does not give the number reaching the threshold or explain handling of incomplete records. It names a range of parent- and child-reported measures, yet their analysis results are not reported. These omissions prevent assessment of both outcome magnitude and uncertainty.

Finally, the safety counts are descriptive, and the enrollment is limited. Zero recorded events in the registry should not be interpreted as a precise estimate of risk. The project’s focus on adapting telehealth delivery in community health centers makes transparent reporting of attendance, missingness, outcome estimates, and uncertainty especially useful for understanding what the pilot can and cannot establish.

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 central limitation is incomplete outcome reporting. The primary attendance endpoint is clearly defined, and the record says it was coded for all 12 enrolled youths, but the number meeting the threshold is not reported in the registry record. The listed secondary outcome measures also have no reported results. This prevents evaluation of the observed attendance level, symptom outcomes, or their precision.

The single-group, open design does not include a randomized control comparison. Any outcome description from the intervention group would therefore be unable, on its own, to distinguish intervention-associated change from other influences. Masking is listed as none. The record does not report details of participant selection, baseline characteristics, intervention delivery fidelity, or the amount of follow-up completed for secondary outcomes.

Although families lost to follow-up were included in primary outcome coding, the record does not explain how incomplete electronic medical records or missing questionnaire responses were handled. The statistical analysis plan, methods for handling multiplicity, and rationale for enrollment are not reported in the registry record. There are no outcome analysis results listed.

The safety entry gives zero recorded events in the listed group, but does not describe monitoring procedures or the detail of event ascertainment. These reporting and design limitations mean the registry record supports a description of the study’s purpose and outcome definitions, but not a conclusion about intervention effects or a precise safety assessment.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Video-visit Behavior Therapy for Anxiety and Depression in Youth — NCT05417412.
• Registry record last updated 2024-05-16; status last verified 2024-05.
• Results first posted 2024-05-16.
• 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

NCT05417412 is a completed, open, single-group pilot sponsored by San Diego State University. It studied STEP-UP brief behavioral therapy, adapted for telehealth delivery by clinic staff in low-resource community health centers for youths with anxiety or depression. Enrollment was 12; the registry lists a start date of 2021-08-02 and a primary completion date of 2022-08-30.

The primary outcome was minimum attendance by Week 16 (post-intervention), defined as 8 or more sessions. The registry says electronic medical records were used to code this outcome for all enrolled youths, including families lost to follow-up, but the result is not reported. Secondary symptom and functioning measures are named, with no analysis results reported. The safety entry lists 0 serious adverse events, 0 other adverse events, and 0 deaths.