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 Coaching for Caregivers of Children With Spinal Cord Injury (NCT03898700), a na na study. The primary outcome is Change in Canadian Occupational Performance Measure (COPM).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03898700 |
| Phase | NA |
| Condition | Spinal Cord Injuries |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 9 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Thomas Jefferson University |
| Results posted | Yes |
2. Clinical Question
Population
Caregivers of youth with spinal cord injury. The completed study enrolled 9 participants; the registry record does not report further eligibility details or describe the enrolled caregivers’ characteristics.
Intervention
Strength-based coaching in the Coaching in Context program. The arm description specifies 10, 1 hour sessions, delivered face to face or over the phone.
Comparator
There was no separate control group. The registry records a single-group model and no allocation, so the study does not provide a like-for-like comparison with usual care, another intervention, or no coaching.
Primary question
The pilot’s first aim was to establish the feasibility of coaching for caregivers of youth with spinal cord injury. Its second aim was to establish methodological procedures for a future multi-center study of coaching effectiveness. The primary outcome was change in the Canadian Occupational Performance Measure (COPM), which rates self-perceived performance and satisfaction with self-identified goals. Although the record specifies measurement before coaching and after the 10 sessions, at 12 weeks from baseline, it does not report the resulting score changes. The listed measure therefore identifies what the study intended to assess, but the posted record does not establish whether scores changed or whether coaching caused any change.
3. Trial Design
This was a completed pilot study of strength-based coaching for caregivers of children with spinal cord injury, registered as NCT03898700 and sponsored by Thomas Jefferson University. The registry lists the study phase as NA, allocation as NA, masking as none, and the model as single group. Enrollment was 9. The study began on 2018-09-28, reached primary completion on 2019-11-16, and has a status of completed.
The intervention is named strength-based coaching. Its arm description calls the program Coaching in Context and specifies 10, 1 hour sessions, delivered face to face or over the phone. Because the study had one group rather than a randomized comparison, the observed change from baseline, if reported, would describe change among participants over time. It would not by itself separate an intervention effect from other explanations for change, such as time, participant expectations, or events occurring during the study.
The registry describes two aims: to establish feasibility of coaching for caregivers of youth with spinal cord injury, and to establish methodological procedures for a future multi-center study on coaching effectiveness. These aims frame the study as preparatory rather than as a controlled test of effectiveness. The record does not report operational definitions or thresholds for feasibility, nor does it describe the methodological procedures established. It also does not report how participants were recruited, how many were screened or eligible, or how the delivery format was chosen.
The primary completion timeframe is described as baseline before coaching and repeated at the end of the 10 coaching sessions, 12 weeks from baseline. The registry record does not report detailed visit procedures, adherence, or whether all enrolled participants completed the intervention and follow-up assessment.
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 | Coaching in Context |
|---|---|
| STARTED | 9 |
| COMPLETED | 7 |
| NOT COMPLETED | 2 |
Reasons for not completing this period:
| Reason | Coaching in Context |
|---|---|
| Withdrawal by Subject | 2 |
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 | Coaching in Context |
|---|---|---|
| Participants analysed | 9 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 9 |
| Age, Categorical: >=65 years | Participants | 0 |
| Age, Continuous | years | 37.14 (SD 5.15) |
| Sex: Female, Male: Female | Participants | 9 |
| Sex: Female, Male: Male | Participants | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 8 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| 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 | 3 |
| Race (NIH/OMB): White | Participants | 6 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Canadian Occupational Performance Measure: Performance Score | units on a scale | 4.23 (1 to 8) |
| Canadian Occupational Performance Measure: Satisfaction Score | units on a scale | 3.97 (1 to 8) |
6. Primary Endpoint
The registry lists the primary outcome as Change in Canadian Occupational Performance Measure (COPM), measured over Baseline - before coaching and repeated at end of 10 coaching sessions (12 weeks from baseline).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change in the Canadian Occupational Performance Measure (COPM). The measure rates self-perceived performance and satisfaction with goals identified by the caregiver. The registry describes a 10 point Likert scale, where 1 means cannot do and not satisfied, and 10 means can do without a problem and very satisfied. It also states that a 2-point change is considered clinically meaningful.
The measure is relevant to a coaching program because it centers on participants’ own goals and their perceptions of performance and satisfaction in relation to those goals. Tracking scores before and after coaching can describe whether participants’ ratings changed during the study period. The registry specifies baseline assessment before coaching and repeat assessment at the end of the 10 coaching sessions, 12 weeks from baseline.
These endpoint details explain what was intended to be measured and how the record characterizes the scale. They do not show the actual baseline or follow-up scores, the average change, variability, or how many participants met the stated threshold for a clinically meaningful change. Those results are not reported in the registry record. Without them, the size and precision of any observed change cannot be evaluated.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a primary outcome and its assessment schedule, but it does not report COPM results. In particular, it does not report baseline and follow-up means, the mean change, a standard deviation for change, or a confidence interval. As a result, the direction, magnitude, and precision of change in caregiver-rated performance and satisfaction cannot be described from this record. The stated 2-point threshold provides context for interpreting an individual change, but no participant-level changes or count of participants reaching that threshold are reported.
The study enrolled 9 participants and used a single-group design. Enrollment describes the study size, not the number who completed coaching or contributed endpoint data; those counts are not reported in the registry record. With no comparison group, even a reported before-and-after change would be an observation over time rather than an estimate that isolates the effect of coaching. The design is consistent with the stated pilot aims of assessing feasibility and establishing procedures for a future multi-center study, rather than supporting a controlled effectiveness comparison.
The record lists one outcome measure and 2 analyses, but it does not describe what those analyses were, which analysis was primary, or whether the reported analyses used adjusted or unadjusted methods. No test statistics, p-values, confidence intervals, or analysis estimates are available in the registry record. Consequently, statistical significance and the precision of any outcome estimate cannot be assessed.
The registry also does not report feasibility results such as recruitment, retention, session attendance, or acceptability. The study’s stated aim cannot substitute for those results: describing an aim does not show whether it was achieved. Similarly, completion status indicates the trial is recorded as completed, but it does not establish that every planned assessment was completed or that all intended methods were established.
For safety, the record lists 9 participants at risk in the Coaching in Context group and 0 affected by serious adverse events, 0 affected by other adverse events, and 0 deaths. These entries describe the event counts recorded for this group. They do not establish that no unrecorded or unreported events occurred, and the record does not provide event definitions, collection procedures, or follow-up details.
Overall, the registry record supports a description of the study’s design, planned coaching program, outcome measure, and recorded safety counts. It does not provide outcome estimates or feasibility findings. Conclusions about changes in COPM ratings or the success of the pilot’s aims therefore cannot be drawn from the posted results.
9. Statistical Methods Explained
The registry identifies the COPM as a continuous outcome summarized by a mean and standard deviation. These are ways of describing a set of numerical scores. A mean represents the average score or average change in the analyzed participants, while a standard deviation describes how spread out individual values are around that average. Neither quantity is reported for the primary endpoint in the registry record, so no numerical summary of the outcome can be interpreted.
What does a change score represent?
A change score compares a participant’s measurement at follow-up with that participant’s measurement at baseline. Across participants, the mean change describes the average movement in scores over the assessment period. The variability in individual changes matters: participants may have different experiences even when the group average is stable. The registry specifies measurements before coaching and at the end of the 10 coaching sessions, 12 weeks from baseline, but it does not report individual scores or a group change estimate.
A change in a single group is not the same as a treatment effect estimated against a control group. Without a concurrent comparison group, a before-and-after analysis cannot distinguish the intervention from other influences on scores over time. This is a design limitation, not a defect that can be remedied simply by applying a more complex statistical test. The single-group model and lack of allocation to a comparator are explicit features of this trial.
How should the stated clinical threshold be used?
The registry states that a 2-point change is considered clinically meaningful. This provides a benchmark for interpreting the scale, distinct from a test of statistical significance. A group average, if reported, would not reveal how many individuals crossed that benchmark; that requires participant-level information or an explicit count. Neither an average change nor the number of participants meeting the benchmark is reported in the registry record. The threshold alone is not evidence that participants experienced such a change.
What can a confidence interval tell a reader?
In general, a confidence interval describes the uncertainty around an estimate under the assumptions of the analysis. A narrower interval indicates greater precision, while a wider interval indicates less precision. An interval for a mean change would help readers judge which changes are compatible with the observed data, and whether the estimate is precise enough to distinguish small from larger changes. No confidence interval for COPM change is reported in the registry record, so the precision of the endpoint estimate cannot be judged.
Statistical significance and practical importance are different questions. A p-value, if reported, would address compatibility of the data with a specified statistical null model under the analysis assumptions. It would not by itself quantify the size of the change or establish that it met the stated clinical threshold. The record does not report p-values or the analyses underlying them, so no significance assessment is available.
What do the analysis and planning entries establish?
The registry lists 2 analyses but does not describe their methods, populations, or relationship to the primary outcome. It does not report whether the analyses accounted for baseline values, how incomplete observations were handled, or whether any covariates were used. Those choices can affect how an estimate is interpreted, and they cannot be inferred from a count of analyses.
The record’s sample-size assumptions describe planning illustrations based on an observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is expressed as a stated fraction of the observed effect. These are planning assumptions, not evidence that this single-group pilot was designed or powered according to that illustration. The registry does not report a trial-specific sample-size justification. Planning illustrations are not observed power and should not be read as a measure of the certainty or validity of the study’s findings.
For a future comparison, general statistical planning would need to define the outcome, target effect, variability, analysis, and design assumptions in advance. The registry states that establishing methodological procedures for a future multi-center study was an aim, but the procedures and their results are not reported. Accordingly, the posted record permits an explanation of the outcome and design, but not an independent reconstruction of the statistical analysis.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one outcome measure and 2 analyses. It does not specify what the analyses were, whether they addressed the same endpoint or different questions, or which result was designated as primary. The record also does not describe a multiplicity strategy. When several outcomes, time points, or statistical tests are examined, the chance of at least one apparently unusual result can increase; methods such as prespecifying a primary analysis or adjusting for multiple testing can help address that issue. This is general statistical context, not a description of methods used in this trial.
The registry record does not report missing-data counts, reasons for missingness, or the method used to handle missing observations. It does not state how many participants completed the follow-up COPM assessment. Enrollment of 9 participants should therefore not be treated as the number analyzed. In general, incomplete follow-up can affect both the amount and the representativeness of the information available, particularly if participants with missing measurements differ from those with observed measurements.
The record also does not define an analysis population, such as all enrolled participants or only participants with complete endpoint data. It does not report whether any sensitivity analyses were conducted. These omissions limit assessment of how the analysis population was formed and whether conclusions might depend on assumptions about missing outcomes. No missing-data or analysis-population method can be inferred from the number of analyses or from the completed status.
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 |
|---|---|---|---|
| Coaching in Context | 0 | 9 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Coaching in Context | 0 of 9 |
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 |
|---|---|
| Coaching in Context | 0 of 9 |
For the Coaching in Context group, the registry records 9 participants at risk for serious adverse events and 0 affected. It records 9 participants at risk for other adverse events and 0 affected, and 0 deaths. These are the posted counts for the group; the record lists no serious adverse event terms.
Zero events in the registry entry means that no affected participants or deaths are recorded in these fields. It is not proof that the intervention has no risks. The registry record does not describe how adverse events were defined, collected, or adjudicated, nor does it report detailed follow-up duration for safety monitoring. The small enrollment also means these counts should be read as descriptive information from this pilot, not as a precise estimate of event frequency in a broader population.
The entries do not identify whether all participants completed safety follow-up or whether events outside the specified reporting categories were collected. No causal comparison is possible because the study had no separate control group. The counts therefore characterize recorded events in the single group; they do not establish comparative safety.
12. What the Result Does, and Does Not, Mean
The study record describes a completed pilot of strength-based coaching for caregivers of youth with spinal cord injury. It specifies the program, the COPM outcome, and the timing of assessments. It also states that feasibility and the development of procedures for a future multi-center study were the aims. These details clarify the questions the investigators intended to address, but the registry record does not report the outcome estimates or feasibility findings needed to determine what the study observed.
In particular, no COPM score changes are reported. The available record therefore cannot show whether caregivers’ self-ratings increased, decreased, or remained similar between baseline and follow-up. It also cannot indicate how precise a change estimate would be or how many participants experienced a change meeting the stated 2-point threshold. The stated threshold is a guide to interpretation, not a result.
The single-group design also limits what a change, if it were reported, could establish. Without a comparator, a change over time would not isolate the contribution of coaching from other possible influences. This matters when interpreting any pre-post result and is especially relevant when considering a future study intended to evaluate effectiveness.
Nor does the completed status establish that the feasibility aims were met. Recruitment, retention, participation in sessions, acceptability, and methodological outputs are not reported in the registry record. The safety entries record no affected participants and no deaths, but do not establish the absence of all possible adverse events or estimate comparative risk.
The appropriate reading is therefore limited: the registry documents a small, single-group pilot and its intended measures, but does not provide the results needed to judge outcome change, feasibility, or effectiveness. The record may inform readers about the design of a preparatory study; it does not support a conclusion about the effect of coaching.
13. Why This Trial Matters Statistically
This trial is statistically informative in part because its design and aims make the distinction between feasibility work and effectiveness testing important. It enrolled 9 participants in a single group, with no randomized allocation or comparator. The study’s stated focus was to establish feasibility and procedures for a future multi-center investigation. These features place emphasis on whether the intervention and study processes can be evaluated, rather than on a controlled estimate of treatment effect.
The COPM is a participant-centered continuous measure, and the registry gives its scale interpretation and a clinical-meaningfulness benchmark. That information helps clarify what a future analysis might need to report: group summaries, variability, changes over time, and the distribution of individual changes in relation to the stated threshold. However, the registry does not report those results. A well-described endpoint is not a substitute for its observed estimates.
The record also illustrates why enrollment and completion status alone are not enough to assess feasibility. Readers would need information such as recruitment, follow-up completion, session attendance, and acceptability to judge the feasibility aim, but these outcomes are not reported. Likewise, the entry for 2 analyses does not reveal the analytic methods or the handling of incomplete data.
For statistical interpretation, the central lesson is to separate what the design intended to measure from what the posted results actually establish. A pre-post measure can describe within-group change, while a comparator is needed to make a stronger comparative effectiveness assessment. The registry identifies a potential next step in a future multi-center study, but the results and procedures from this pilot that would guide that work are not reported in the registry record.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
Several trial-specific limitations constrain interpretation. The study enrolled 9 participants and used a single-group design, so the registry record provides no like-for-like control comparison. Any pre-post change, if available, could not by itself distinguish coaching from other influences over time. The record does not report COPM scores or change estimates, making it impossible to assess the endpoint’s direction, magnitude, or precision.
The registry does not report participant characteristics beyond the condition and caregiver population description. It also does not report recruitment details, eligibility counts, intervention completion, session attendance, or follow-up completion. These omissions prevent assessment of who participated, how many contributed endpoint data, and how representative the recorded group might be.
The registry lists 2 analyses but does not describe the statistical methods, analysis population, missing-data approach, or multiplicity handling. The reasons for missing data and any sensitivity analyses are also not reported. No trial-specific sample-size justification is reported, and the planning assumptions described in the record should not be mistaken for the trial’s own design rationale.
Finally, the safety fields record zero affected participants for serious and other adverse events and zero deaths, but event definitions, collection methods, and follow-up details are not described. These limitations are specific to what the registry record reports; they do not establish that the underlying study lacked procedures or information, only that those details are not reported in the record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Coaching for Caregivers of Children With Spinal Cord Injury — NCT03898700.
- Registry record last updated 2023-04-18; status last verified 2023-04.
- Results first posted 2023-04-18.
- 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
NCT03898700 is a completed, single-group pilot study sponsored by Thomas Jefferson University. It enrolled 9 participants and evaluated strength-based coaching for caregivers of youth with spinal cord injury. The program description specifies 10, 1 hour sessions delivered face to face or over the phone.
The stated aims were to establish feasibility and methodological procedures for a future multi-center study. The primary measure was change in COPM scores, assessed before coaching and at the end of the 10 sessions, 12 weeks from baseline. The registry describes the measure’s 10 point scale and states that a 2-point change is considered clinically meaningful.
The registry record does not report COPM results, feasibility findings, or detailed analysis methods. It records 0 serious adverse events, 0 other adverse events, and 0 deaths among the group. The single-group design does not provide a control comparison.