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 African American Knowledge Optimized for Mindfully Healthy Adolescents (NCT00578318), a randomized na study. The primary outcome is Attendance at First Depression Treatment Appointment.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00578318 |
| Phase | NA |
| Condition | Depression |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 16 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Georgetown University |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns African American adolescents with depression and their families. Its stated purpose was to understand how families identify and address emotional and behavioral concerns associated with depression in adolescent youth, and to identify factors related to participation in psychiatric research and treatment. The registry does not give further eligibility criteria or a more detailed description of the analyzed population.
Intervention
Patients in the active group received a stepped progression of talk-based treatment using Motivational Interviewing as its basis. The primary outcome was assessed after completion of the 2 session Motivational Interviewing intervention. The registry describes the interval to the appointment as approximately 3-4 weeks on average, during which study staff followed all patients.
Comparator
The delayed control group received treatment as usual, described as no specific intervention and supportive check-ins from study staff. Patients in both groups were followed during the interval before the first available depression treatment appointment after completion of the AAKOMA protocol.
Primary question
The primary question was whether patients attended the first available depression treatment appointment scheduled after completing the AAKOMA protocol. Attendance was recorded as a yes-or-no outcome. The registry reports attendance counts for each group, but the posted record does not give an estimable two-arm comparison. The results therefore describe the observed counts without establishing the size or precision of a comparative effect.
3. Trial Design
The registry describes a randomized, parallel-group study with no masking. It lists Georgetown University as the sponsor and records the trial as completed. The study began in 2007-06, and primary completion was recorded as 2010-01. The phase is listed as NA. The registry enrollment is 16.
The two groups were Motivational Interviewing Active and Delayed Control. The active group received a stepped progression of talk-based treatment based on Motivational Interviewing. The delayed control group received treatment as usual, defined in the record as no specific intervention and supportive check-ins from study staff. The record does not describe further details of treatment delivery or how treatment as usual was organized outside those check-ins.
The primary outcome was attendance at the first available depression treatment appointment scheduled after the patient completed the AAKOMA protocol. The outcome description places assessment after completion of the 2 session Motivational Interviewing intervention. It states that the average time to attendance was approximately 3-4 weeks and that study staff followed all patients during this interval.
The arm-level results list 8 participants in the Motivational Interviewing Active group and 8 in the Delayed Control group. The recorded attendance counts are 5 and 6, respectively. Random allocation describes how the registry characterizes group assignment; it does not by itself provide information about allocation concealment or the implementation of the randomization. Those details, as well as further protocol information, 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
| Stage | Motivational Interviewing Active | Delayed Control |
|---|---|---|
| STARTED | 8 | 8 |
| COMPLETED | 5 | 8 |
| NOT COMPLETED | 3 | 0 |
Reasons for not completing this period:
| Reason | Motivational Interviewing Active | Delayed Control |
|---|---|---|
| Lost to Follow-up | 2 | 0 |
| Physician Decision | 1 | 0 |
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.
| Characteristic | Unit | Motivational Interviewing Active | Delayed Control | Total |
|---|---|---|---|---|
| Participants analysed | 8 | 8 | 16 | |
| Age, Categorical: <=18 years | Participants | 8 | 8 | 16 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 | 0 | 0 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Female | Participants | 6 | 7 | 13 |
| Sex: Female, Male: Male | Participants | 2 | 1 | 3 |
| Region of Enrollment: United States | participants | 8 | 8 | 16 |
6. Primary Endpoint
The registry lists the primary outcome as Attendance at First Depression Treatment Appointment, measured over Post completion of 2 session Motivational Interviewing (MI) intervention (approximately 3-4 weeks on average during which time study staff followed all patients).
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is attendance at the first available depression treatment appointment scheduled after completion of the AAKOMA protocol. It is recorded as a binary outcome: a patient either attended or did not attend. The registry reports the number of participants with attendance in each group, rather than a continuous measure or a time-to-event estimate.
This endpoint captures whether a patient reached the first scheduled treatment appointment. In general, a binary attendance outcome can provide a direct description of an observed behavior at a defined point in a care pathway. It does not, by itself, describe the quality or duration of subsequent care, improvement in depression, or other clinical outcomes. Those questions are distinct from the endpoint recorded in this trial.
The registry places the outcome after completion of the protocol and notes an average interval of approximately 3-4 weeks to attendance. It also states that study staff followed all patients during that intermediate period. The record does not provide additional operational details about how attendance was verified or how patients without a scheduled appointment were handled. Such details matter when interpreting a binary endpoint because its meaning depends on the outcome definition and the availability of the event being measured.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted results report 5 participants with attendance in the Motivational Interviewing Active group and 6 in the Delayed Control group. Each arm lists 8 participants. These are descriptive counts for the binary primary outcome; they are not accompanied by a reported comparative estimate or uncertainty interval.
The registry flags the two-arm comparison values as missing or not estimable for this binary endpoint. It lists no analyses. Consequently, the record does not provide a sponsor-reported effect estimate, confidence interval, or p-value for the comparison. The counts alone do not establish whether an observed difference is compatible with chance variation or indicate the precision of a group contrast. No statistical significance conclusion can be drawn from the registry results.
In general, a confidence interval expresses the range of values compatible with the observed data under a specified statistical model and conveys uncertainty around an estimate. No such interval is reported for this comparison. Likewise, a p-value would summarize how unusual the data would be under a specified null model; it is not reported, and the registry does not provide a test result to interpret.
The design is randomized, but the registry entry does not provide enough analysis information to assess how the randomization was reflected in a formal comparison. The results do not report an adjusted analysis, analysis population, or handling of missing outcome data. The record also does not give baseline group characteristics that would help describe the groups at the start of follow-up. These omissions limit what can be said about comparability and the analysis of the endpoint.
The arm counts should therefore be read as a limited description of attendance recorded in this trial, not as a precise estimate of an intervention effect. The registry record also does not establish whether any difference was due to the intervention, to other features of care, or to chance. The active and delayed-control descriptions identify the intended group conditions, but further implementation details are not reported.
9. Statistical Methods Explained
The primary endpoint is binary: attendance at the first available depression treatment appointment was classified as yes or no. For a binary outcome, the most direct descriptive summaries are the number of participants with the event and the number assessed in each group. The registry reports the event counts and arm sizes. It does not report a formal two-group effect estimate, such as a difference in event probabilities or a relative measure.
What does a comparison estimate represent?
In general, a comparison estimate quantifies how outcome frequency differs between groups according to a chosen statistical scale. Different scales answer different questions and can convey different magnitudes even when based on the same outcome data. A confidence interval adds information about uncertainty around the estimate. In this record, a two-arm comparison is flagged as missing or not estimable, so no comparative effect or confidence interval is available to interpret. The reported counts should not be converted into an unreported estimate.
Why does the registry say the comparison is not estimable?
The registry's note identifies values as missing or not estimable for a two-arm comparison of this binary endpoint. It does not explain the reason for that status. The record therefore does not establish whether the issue reflects a particular modeling choice, data limitation, or another analytic concern. The presence of arm-level counts does not supply the missing analysis specification or validate a reconstructed test. No recalculated comparison is reported.
What does randomization contribute?
In general, random allocation is intended to make group assignment independent of participants' characteristics, on average, and can support a causal comparison when the study is implemented and analyzed appropriately. Randomization does not guarantee that groups will be similar in every characteristic, particularly in a small study, and it does not replace reporting of the analysis. The registry identifies the allocation as randomized but does not report the sequence-generation procedure, concealment, or other implementation details. It also does not report baseline characteristics or a defined analysis population.
What is the role of the planning illustration?
The registry describes a planning illustration based on the observed effect, with equal allocation, a two-sided significance level of 0.05, and a normal approximation. The illustration is described as considering an effect that is a stated fraction of the observed effect. No resulting sample-size figures or fractions are available in the registry record described for this analysis, so none can be interpreted or restated. In general, such a calculation explores the sample size that might be needed under specified assumptions; it is not a measure of the probability that this completed trial detected an effect. It should not be confused with observed power.
The normal approximation is a general method for approximating the distribution of a test statistic or estimator. Its suitability depends on the data and assumptions. With a binary outcome, the amount of information depends in part on the number of observed events and non-events in each group. Sparse data can make approximations less reliable and estimates imprecise. This general consideration does not identify the reason that the registry marks the comparison not estimable, and the record does not report which method, if any, was attempted.
How should uncertainty be described?
Uncertainty should be conveyed using an estimate and an appropriate interval or other explicitly reported inferential result. Here, only the group-level attendance counts are available, while the registry does not report a two-arm comparison or interval. General statistical reasoning cannot fill in those missing trial results. A reader should distinguish the observed counts from conclusions about the underlying effect, and should not treat the planning illustration as an inferential result from the completed trial.
10. Exact Estimates for Each Arm
No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.
| Arm | Participants | Events | Observed % | Clopper-Pearson 95% CI | Wilson 95% CI | Bayesian 95% credible interval |
|---|---|---|---|---|---|---|
| Motivational Interviewing Active | 8 | 5 | 62.5% | 24.5% to 91.5% | 30.6% to 86.3% | 29.9% to 86.3% |
| Delayed Control | 8 | 6 | 75.0% | 34.9% to 96.8% | 40.9% to 92.9% | 40.0% to 92.5% |
R code and output
arm <- c("Motivational Interviewing Active", "Delayed Control")
n <- c(8, 8)
events <- c(5, 6)
for (i in seq_along(n)) {
ci <- binom.test(events[i], n[i])$conf.int # Clopper-Pearson exact interval
cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i]) # Bayesian, uniform Beta(1,1) prior
wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}
ARM Motivational Interviewing Active 8 5 62.5 24.5 91.5 30.6 86.3 29.9 86.3
ARM Delayed Control 8 6 75.0 34.9 96.8 40.9 92.9 40.0 92.511. Multiplicity, Missing Data and Analysis Populations
The registry lists one outcome measure and no secondary outcomes posted. It also lists no analyses. The record does not report a statistical analysis plan, a hierarchy of hypotheses, or an approach to multiplicity. Multiplicity concerns arise in general when several outcomes, time points, or comparisons are tested, because repeated testing can increase the chance of false-positive findings. The registry does not provide enough analysis information to determine how this issue was handled.
Missing outcome data and the analysis population are also not described. The arm-level results give an arm size and attendance count, but the record does not explain whether all randomized patients were assessed, how patients without an available appointment were classified, or how any incomplete records were handled. It does not report an intention-to-treat or per-protocol analysis population. These are not details that can be inferred from the attendance counts.
The registry states that study staff followed all patients during the interval between protocol completion and treatment initiation. That description provides context for follow-up, but it does not specify whether follow-up was complete for the endpoint or how attendance was verified. No imputation procedure, sensitivity analysis, or missing-data assumption is reported in the registry record. These limitations restrict assessment of whether the posted counts represent complete outcome ascertainment.
12. What the Result Does, and Does Not, Mean
The results describe attendance at the first available depression treatment appointment after completion of the AAKOMA protocol. The registry reports 5 attendees in the Motivational Interviewing Active group and 6 in the Delayed Control group, with 8 participants listed in each arm. The record does not report an estimable two-arm comparison or an uncertainty interval, so the observed counts do not quantify the precision of an intervention contrast.
In general, an observed difference between group counts is not, by itself, evidence that the groups differ in the broader population. Statistical interpretation requires an explicit estimate, an appropriate measure of uncertainty, and an understanding of the design and analysis. Those comparative results are not reported in the registry record. The counts also do not establish why participants attended or did not attend, or whether the intervention changed other aspects of treatment engagement.
The endpoint is specifically first-appointment attendance. It does not measure depression symptoms, continuing engagement in treatment, treatment quality, or longer-term outcomes. The registry summary describes broader goals of understanding participation and developing an intervention, but the posted primary outcome addresses appointment attendance only.
The record therefore supports a narrow descriptive statement about the reported attendance counts. It does not support a claim that Motivational Interviewing increased or decreased attendance, nor does it establish equivalence between the groups. The randomized design is relevant context, but it cannot replace the missing comparative analysis and reporting needed to assess the effect and its uncertainty.
13. Why This Trial Matters Statistically
This study raises statistical questions that are common in clinical and behavioral research: how to define engagement as an outcome, how to compare randomized groups on a binary endpoint, and how to communicate uncertainty when event counts are limited. The registry gives a clearly named primary outcome—attendance at the first available depression treatment appointment—and describes the timing relative to completion of the protocol. That specificity helps distinguish the measured outcome from broader concepts such as ongoing treatment engagement or clinical improvement.
The record also illustrates the difference between descriptive results and an inferential comparison. Group-level counts can tell readers what the registry reports, while a comparative estimate and uncertainty interval are needed to evaluate the size and precision of a group contrast. The entry flags the two-arm comparison as missing or not estimable, leaving that inferential question unresolved. This is an important reporting distinction: a randomized design does not alone communicate the result of an analysis.
Finally, the study's stated purpose includes understanding factors associated with participation and developing an intervention to increase participation in psychiatric research and treatment. The posted primary endpoint addresses a specific step in treatment engagement. Interpreting it carefully avoids extending a narrow attendance result to broader outcomes that were not reported. The registry record offers a useful example of why outcome definition, analysis reporting, and transparent limits all matter when reading a clinical trial.
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 for statistical interpretation is that the registry reports arm-level attendance counts but no estimable two-arm comparison. It lists no analyses, and no effect estimate, confidence interval, or p-value is reported. As a result, the magnitude and precision of any group contrast cannot be assessed from the registry record.
The entry provides limited information about the study population beyond its focus on African American adolescents with depression and their families. Further eligibility criteria, baseline characteristics, and analysis-population definitions are not reported. Although allocation is recorded as randomized, details of sequence generation and concealment are not reported. The registry also identifies no masking.
Outcome ascertainment and missing data are not fully described. The record states that study staff followed all patients during the interval before treatment and reports the group sizes and attendance counts, but does not explain how attendance was verified, how unavailable appointments were handled, or whether any endpoint data were missing. It reports no imputation or sensitivity analysis.
The endpoint is limited to attendance at the first available depression treatment appointment. The record does not provide results for continued treatment engagement or clinical outcomes. Adverse-event fields list 0 at risk and 0 affected for serious and other adverse events in both groups; those entries do not establish that adverse events were comprehensively assessed or that there were no risks. The registry does not report further safety-monitoring details. These limitations constrain interpretation of both the effectiveness comparison and the completeness of the trial record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: African American Knowledge Optimized for Mindfully Healthy Adolescents — NCT00578318.
- Registry record last updated 2013-05-17; status last verified 2013-05.
- Results first posted 2013-05-17.
- 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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Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry record identifies NCT00578318, titled African American Knowledge Optimized for Mindfully Healthy Adolescents. It describes a randomized, parallel-group study with no masking, sponsored by Georgetown University and recorded as completed. The study began in 2007-06, with primary completion in 2010-01. Enrollment is listed as 16, and phase is recorded as NA.
The groups were Motivational Interviewing Active and Delayed Control. The primary outcome was attendance at the first available depression treatment appointment after completion of the AAKOMA protocol. The registry reports 5 attendees among 8 participants in the active group and 6 among 8 in delayed control. It lists one outcome measure, no secondary outcomes posted, and no analyses. A two-arm comparison for the binary endpoint is marked missing or not estimable. The registry record does not report a comparative effect estimate or its uncertainty.