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 A Pilot Study Using Facebook to Support Opioid Recovery Among American Indian Women (NCT05340855), a na na study. The primary outcome is The Feasibility of Developing a Culturally Relevant Facebook Intervention.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05340855 |
| Phase | NA |
| Condition | Opioid Use |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 10 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Mayo Clinic |
| Results posted | Yes |
2. Clinical Question
Population
American Indian and Alaska Native women in Minnesota recovering from illicit opioid use. The registry record lists Opioid Use as the condition and describes the study as a pilot preparatory study.
Intervention
The Wiidookaage'win Facebook Group, a behavioral intervention intended to support opioid recovery. The stated purpose is to develop a culturally relevant Facebook intervention.
Comparator
No like-for-like control group is described. The record identifies a single-group model and says that all participants receive the same intervention.
Primary question
How feasible is it to develop and use a culturally relevant Facebook intervention, as assessed by participants’ engagement with the Facebook page over 30 days?
This is a feasibility and preparation question, not a randomized estimate of whether the intervention reduces opioid use or prevents relapse. The primary outcome counts viewing, reacting, posting, commenting, and voting on Facebook posts. The record also lists feasibility of using Facebook as an opioid intervention platform and treatment satisfaction as secondary outcomes, but their numerical results are not reported in the registry record.
The population and intervention are described in the study purpose and intervention record. The record does not provide additional eligibility details, such as how recovery was defined or what criteria were used to determine participation. Those details are not reported in the registry record. Consequently, the question should be read as concerning the population described in the record, rather than as a result applicable to every person with opioid use or every setting.
3. Trial Design
This completed study is identified as a pilot preparatory study, with the official title describing Aim 1. The registry record gives an enrollment of 10 and classifies the model as single-group. It lists allocation as not applicable and masking as none. The record therefore does not describe a randomized comparison or a blinded assessment. The intervention listed is the Wiidookaage'win Facebook Group, classified as behavioral; the arm description says participants receive the same intervention.
The study purpose is to develop a culturally relevant Facebook intervention for American Indian and Alaska Native women in Minnesota recovering from illicit opioid use. The primary outcome is engagement with the Facebook page during a 30-day timeframe. Secondary outcomes listed in the record concern feasibility of Facebook as an opioid intervention platform and treatment satisfaction. This design can describe engagement and feasibility within the study setting, but it does not provide a concurrent control comparison from which to estimate an intervention effect.
The registry record lists the study start as 2022-05-05, primary completion as 2023-06-08, and status as completed. It lists phase as not applicable. The record does not state a randomized assignment procedure, a control intervention, or an allocation ratio. Details such as recruitment procedures, the intervention’s specific content, duration of participants’ access, and how engagement information was captured are not reported in the registry record.
Because the study is single-group, any observed engagement would be descriptive of participants in this intervention setting. It cannot separate the contribution of the Facebook group from other influences, nor can it establish what would have happened to similar participants without the group. The registry record lists zero analyses, and numerical outcome results are not reported in the registry record. The design and stated outcome therefore support a feasibility-focused reading, not a comparative efficacy conclusion.
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 | Facebook Intervention |
|---|---|
| STARTED | 10 |
| COMPLETED | 10 |
| NOT COMPLETED | 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 | Facebook Intervention |
|---|---|---|
| Participants analysed | 10 | |
| Age, Continuous | years | 42.2 (SD 12.82) |
| Sex: Female, Male: Female | Participants | 10 |
| Sex: Female, Male: Male | Participants | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 10 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 8 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 0 |
| Race (NIH/OMB): More than one race | Participants | 2 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 10 |
6. Primary Endpoint
The registry lists the primary outcome as The Feasibility of Developing a Culturally Relevant Facebook Intervention, measured over 30 days.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Full Range |
| Unit | engagement events |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is engagement with the Facebook page over 30 days. The record defines engagement events as viewing, reacting, posting, commenting, and voting on any Facebook post, and states that the measure is the number of times participants engaged with the page. It specifies engagement events as the unit, the median as the summary measure, and the full range as the dispersion measure.
Engagement is used as a feasibility indicator: it describes whether and how participants interact with the platform. This is relevant to a study developing a Facebook intervention because a platform-based intervention requires participants to encounter or interact with its content. The endpoint is a measure of platform activity, however, not a direct measure of opioid use, relapse, recovery, or clinical benefit. The record does not report how individual event types were counted, whether events were verified, or how engagement was handled when participants had different opportunities to use the group; those details are not reported in the registry record.
A median describes the middle of a set of observations, while the full range describes its observed spread from the lowest to the highest value. In general, these summaries can help convey typical engagement and variation without assuming that activity is evenly distributed. Here, the numerical median and range are not reported in the registry record. The endpoint definition alone does not establish how much engagement occurred or whether participants found the intervention useful.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a completed single-group study focused on developing a culturally relevant Facebook intervention. Its primary outcome is engagement activity during 30 days, not a treatment contrast or a clinical outcome. Although the record describes the endpoint and its intended summaries, it does not report a numerical median or full range. The registry also lists zero analyses. Thus, the available record does not support a numerical account of engagement or a statistical estimate of intervention effect.
The absence of a comparator is central to interpretation. A single-group study can document what happened among people who received the same intervention, but it cannot compare that experience with a control condition. Even if engagement values were available, those values alone would not show that the Facebook group caused engagement, changed opioid use, or prevented relapse. The title and purpose refer to opioid recovery and relapse prevention, but the listed primary endpoint measures activity on Facebook. The distinction between a behavioral process measure and a clinical outcome should remain explicit.
The record lists an enrollment of 10. That enrollment describes the study record; it does not substitute for an outcome result, demonstrate precision, or establish how representative the participants were. The record does not report a confidence interval or other uncertainty estimate for the primary outcome. It also does not report an analysis plan or analysis results. Accordingly, the magnitude and uncertainty of the observed engagement cannot be assessed from the registry record.
The secondary outcomes are feasibility of using Facebook as an opioid intervention platform and treatment satisfaction. Their names indicate what the study intended to assess, but their numerical findings and measurement details are not reported in the registry record. No conclusion about acceptability or satisfaction can be drawn from outcome labels alone.
The sample-size assumptions describe planning illustrations based on an observed effect, with two-sided significance level 0.05, equal allocation between two arms, and a normal approximation. Time-to-event illustrations use a total number of events; other illustrations use participants per arm. These are planning assumptions, not evidence that this study used a two-arm design: the registry identifies a single-group model and no allocation. The numerical illustration results and the observed effect value are not reported in the registry record. They should not be interpreted as observed power, as the trial’s own design rationale, or as a substitute for results.
The record reports no serious adverse events, no other adverse events in the stated category, and no deaths, with 10 at risk for each adverse-event category. These counts are descriptive registry entries. Without further information about ascertainment and follow-up, they should not be read as proof that no harm occurred or as a comparative safety finding.
9. Statistical Methods Explained
The statistical information in this record is limited. It identifies the primary outcome’s summary measure and spread, describes planning-illustration assumptions, and lists zero analyses. It does not report a numerical primary outcome, inferential test, confidence interval, adjusted estimate, or analysis population. The concepts below explain how such methods are generally interpreted; they do not imply that any unreported method was used in this study.
What does the median describe?
In general, the median is the midpoint of ordered observations: values on either side are at least as common in the distribution. It is less influenced by unusually high or low observations than the mean. That feature can be useful for measures such as engagement, where a small number of participants might account for much of the activity. A median does not show the shape of the distribution or reveal whether most observations cluster near it. The record specifies the median, but its numerical value is not reported in the registry record.
What does the full range add?
In general, a full range reports the lowest and highest observed values. It communicates the extent of observed variation, but it is sensitive to extreme observations and does not describe how values are distributed between the endpoints. A range can be broad because of a single unusual value, or it can conceal substantial clustering. Reading a median alongside a range gives more context than either summary alone, but it is not a complete account of the data. The numerical range is not reported in the registry record.
Why is an engagement count a feasibility measure?
In general, interaction counts can indicate whether participants use a digital platform and which kinds of platform activity occur. They are process measures: they describe activity during delivery rather than directly measuring a clinical state. Counts can be affected by access, opportunity to interact, how activity is captured, and participants’ differing habits. Unless the record describes these factors and how the data were collected, the count cannot by itself distinguish among them. The registry record defines the engagement actions included, but further measurement details are not reported in the registry record.
What would a confidence interval mean?
In general, a confidence interval expresses uncertainty around an estimated quantity under specified statistical assumptions. A narrow interval indicates greater precision than a wide interval, while an interval does not by itself establish that an effect is clinically important or causal. Interpretation also depends on the estimand, study design, and method used to calculate the interval. The registry record does not report a confidence interval for the primary outcome. No precision claim about the engagement estimate can therefore be made from the available results.
Why does the single-group structure matter?
In general, a control group helps distinguish changes associated with an intervention from changes that might occur over time or for other reasons. A single-group study has no such concurrent comparison. It can still provide descriptive information useful to intervention development, but it cannot estimate a between-group effect. The record identifies a single-group model, no allocation, and a common intervention for participants. Consequently, a contrast between intervention and control is not part of the described design.
What do the planning assumptions represent?
The record characterizes its sample-size figures as planning illustrations computed from an observed effect, rather than as the study’s own design. The stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The record says time-to-event illustrations give total events using the Schoenfeld method, while other illustrations give participants per arm. In general, such calculations estimate the amount of information a hypothetical design would need to detect a specified effect under stated assumptions. Their results depend on the assumed effect and model.
These illustrations do not change the registry’s classification of this study as single-group. They are not evidence that participants were assigned equally between two arms, and they are not observed power. An illustration based on an effect also depends on how that effect was estimated; the observed effect value and numerical illustration results are not reported in the registry record. The registry record does not report a sample-size justification for the study itself.
What can be concluded from the listed analysis count?
The record lists zero analyses. That means no analysis entries are listed in the registry record; it does not establish that all underlying data are unavailable or describe any unregistered work. It does mean that there is no reported analysis result to interpret. The record does not specify an inferential model, covariate adjustment, missing-data method, or analysis population. Those methods are not reported in the registry record, so they should not be inferred from the outcome summary type or planning assumptions.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists three outcome measures and identifies feasibility of developing a culturally relevant Facebook intervention as the primary outcome. It also names feasibility of Facebook as an opioid intervention platform and treatment satisfaction as secondary outcomes. It does not report how the outcomes were measured beyond the primary endpoint description, or whether any formal procedure was used to address multiple outcomes. Multiplicity methods are not reported in the registry record.
In general, when several outcomes are examined, the chance of a nominally unusual result can increase if each is tested separately without an agreed strategy. A prespecified hierarchy, adjusted testing procedure, or emphasis on estimation can help clarify interpretation. The record does not state whether outcomes were prioritized beyond the primary and secondary labels, whether analyses were exploratory, or whether any adjustment was planned. Because it lists zero analyses and reports no numerical outcome findings, there are no posted test results on which to assess multiplicity.
Missing-data handling is also not described. The record does not say whether all participants contributed engagement data throughout the 30-day timeframe, how unavailable or incomplete platform activity was treated, or whether any imputation or sensitivity analysis was conducted. These details are not reported in the registry record. In general, missingness can affect a summary if participants with incomplete records differ from those with complete records.
The analysis population is not specified. The enrollment entry does not establish which participants were included in any particular outcome analysis, and the record lists no analysis results. It is therefore not possible to determine whether the primary outcome was analyzed for all enrolled participants or for a subset. No assumptions about intention-to-treat analysis, per-protocol analysis, or complete-case analysis are supported by the registry record.
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 |
|---|---|---|---|
| Facebook Intervention | 0 | 10 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Facebook Intervention | 0 of 10 |
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 |
|---|---|
| Facebook Intervention | 0 of 10 |
The adverse-event entries list 10 participants at risk for serious adverse events and zero affected, 10 at risk for other adverse events and zero affected, and zero deaths. The registry record does not list serious adverse-event terms. These are descriptive counts for the Facebook Intervention group; they are not comparisons against a control group.
Zero reported events should be read as the registry’s recorded count, not as proof that risk was absent. The record does not provide further details about how adverse events were solicited, defined, reviewed, or followed over time. Those details are not reported in the registry record. In general, an event count is most informative when its ascertainment method and observation period are clear, and when the study design supports the comparison being made.
Because this is a single-group study, the safety entries cannot estimate a relative risk versus another intervention or usual care. The counts also do not establish that the intervention caused or prevented any event. They describe only what the registry records for the stated categories and at-risk groups.
12. What the Result Does, and Does Not, Mean
The registry record describes a completed pilot preparatory study of the Wiidookaage'win Facebook Group for American Indian and Alaska Native women in Minnesota recovering from illicit opioid use. Its primary outcome is engagement with Facebook content during 30 days, summarized by a median and full range. This focus is consistent with assessing platform use as part of intervention development.
The record does not report the numerical primary outcome, the full range, or results for the secondary outcomes. It lists zero analyses. Consequently, the record does not establish how much participants engaged, how engagement varied, or how participants rated treatment satisfaction. Outcome names and definitions describe what was to be assessed; they are not evidence of the findings.
The design is single-group, with no like-for-like control comparison. Therefore, the registry entry cannot establish that the Facebook group changed opioid use, prevented relapse, or caused any observed activity. The title refers to relapse prevention, but the stated primary endpoint is engagement rather than relapse. The record also does not report a clinical effect estimate or uncertainty interval.
The safety entries report zero serious adverse events, zero other adverse events in the stated category, and zero deaths. These counts do not establish comparative safety or the absence of risk. Further details about event ascertainment are not reported in the registry record.
The study can be understood as preparation for developing an intervention in the population described, not as a controlled test of clinical effectiveness. Its potential contribution is the feasibility question it sets out to address. The posted registry information does not give the outcome results needed to judge how that question was answered.
13. Why This Trial Matters Statistically
Digital interventions depend in part on whether people interact with the platform and its content. Measuring views, reactions, posts, comments, and votes can therefore provide a practical description of engagement during intervention development. For a culturally relevant intervention intended for American Indian and Alaska Native women, engagement is a distinct question from clinical effectiveness: it concerns interaction with the delivery platform, not whether opioid use or relapse changes.
The single-group design also matters statistically. It is suited to describing activity among participants receiving the intervention, but it does not create a control-based estimate of what the intervention changed. Keeping that distinction clear prevents a process measure from being read as a clinical effect. The record’s primary endpoint and study purpose should be interpreted at their stated level: developing an intervention and assessing engagement and feasibility.
Precision is another important issue. A median and full range are appropriate descriptive summaries for an activity measure, but the registry record does not report their numerical values. Without those values, readers cannot assess the amount or spread of engagement. The record also lists zero analyses, so it does not offer a statistical estimate that could support claims about uncertainty or an intervention effect.
Finally, planning calculations must be separated from observed findings. The record describes sample-size figures as illustrations under assumptions, not as the trial’s design or observed power. This distinction is important because an illustrative calculation does not replace reported outcomes, an analysis plan, or a comparison group. In this record, the design, endpoint definition, and missing numerical results set clear limits on the statistical conclusions that can be drawn.
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 a brief description of the study purpose, intervention, design, and outcomes, but limited detail on implementation and measurement. Eligibility criteria, recruitment procedures, participant characteristics beyond the target population, and intervention content are not reported in the registry record. It is therefore difficult to assess how closely the enrolled group reflects the broader population described in the study purpose.
The primary outcome is defined through several types of Facebook activity, but the record does not explain how activity was captured, whether each type was counted in the same way, or how participants’ differing opportunities to engage were addressed. It also does not report the numerical median or full range. Without these results and measurement details, the extent and distribution of engagement cannot be evaluated.
The single-group design lacks a control comparison, limiting conclusions to description rather than a comparative effect. The record does not report outcome results for the stated secondary measures of platform feasibility and treatment satisfaction. It also does not describe an analysis plan, missing-data procedures, or analysis populations; these details are not reported in the registry record.
Finally, the adverse-event entries are limited to counts and at-risk groups. Further information about ascertainment and follow-up is not reported in the registry record. The planning illustrations use assumptions that include two-arm allocation, whereas the trial is identified as single-group; those illustrations should not be mistaken for the actual design or a justification for its enrollment.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Pilot Study Using Facebook to Support Opioid Recovery Among American Indian Women — NCT05340855.
- Registry record last updated 2024-06-20; status last verified 2024-05.
- Results first posted 2024-06-20.
- 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
NCT05340855 is a completed, single-group pilot preparatory study of the Wiidookaage'win Facebook Group. The stated purpose is to develop a culturally relevant Facebook intervention for American Indian and Alaska Native women in Minnesota recovering from illicit opioid use. The registry lists an enrollment of 10, a start date of 2022-05-05, and a primary completion date of 2023-06-08.
The primary outcome concerns Facebook engagement over 30 days, defined through viewing, reacting, posting, commenting, and voting. It is specified as a median with full range. The numerical primary outcome and secondary outcome results are not reported in the registry record, which lists zero analyses. The design has no control comparison. The adverse-event entries list zero serious adverse events, zero other adverse events in the stated category, and zero deaths.