Mechanisms of Active Music Engagement to Improve Health Outcomes of Children With Cancer and Parents: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Mechanisms of Active Music Engagement to Improve Health Outcomes of Children With Cancer and Parents (NCT03085927), a randomized na study. The primary outcome is Family Normalcy Perspective - Family Management Measure (FaMM).

2. Clinical Question

3. Trial Design

The registry record describes a randomized, parallel-group study with no masking. It lists Active Music Engagement and audio-storybooks as the behavioral interventions. The study enrolled 137 participants and is marked completed. Its phase is listed as NA. Indiana University is identified as the sponsor. The recorded start date is 2016-09-26, and the primary completion date is 2020-04-06.

Participants were enrolled as parent-child dyads. Both conditions involved three 45-minute sessions with a board-certified music therapist, delivered over three days in a private setting during in-patient hospitalization. The Active Music Engagement condition is described as interactive, music-based play. Its arm description includes an account of information given during the first visit, but that description ends mid-sentence. The audio-storybook condition involved choosing and listening to illustrated children’s books with recorded narration during sessions.

Random assignment is intended to make comparisons between groups less vulnerable to systematic differences at baseline. It does not guarantee that the groups are identical in every characteristic, and the registry record does not provide baseline comparisons or details of the randomization procedure. With no masking, participants and the people delivering sessions were not masked to condition, as indicated by the design entry. The registry record does not report additional details about outcome-assessor masking.

The primary outcome was measured at two stated follow-up times, but the registry does not report a single analyzed comparison, an analysis population, or outcome estimates. The record lists eight outcome measures and zero analyses. It does not report the planned statistical model or the basis for the enrollment target. The design information therefore establishes the broad randomized comparison, but not how the trial’s outcome data were ultimately analyzed.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: Participants in this study were enrolled as a dyad (child/parent). Totals listed below represent the numbers of dyads enrolled. One dyad of the 137 total dyads enrolled came off study prior to completing baseline measures due to the child's toxicity/side effects of cancer treatment.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Parent and child participants were enrolled as a dyad. Parents completed all outcome measures for self and for their child as proxy. Arm 1 had 2 parents who did not complete Time 3 measures leaving only 63 participants for analysis. Arm 2 had one parent who did not complete T2 measures leaving 60 participants for analysis.

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: Parents and Children were enrolled as dyads and engaged in sessions together. Some of the outcome measures reflect the children, some the parents, and some both members of the dyad.

6. Primary Endpoint

The registry lists the primary outcome as Family Normalcy Perspective - Family Management Measure (FaMM), measured over Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days).

The primary endpoint is titled Family Normalcy Perspective and uses the Family Management Measure’s Family Life Difficulty Subscale. The subscale contains 14 items rated on a 5-point Likert-type scale. Its items ask about parents’ perceptions of how much having a child with a chronic condition makes family life difficult. The score range is 14 - 70, and higher values indicate more difficulty managing the condition. The registry describes the endpoint as a mean with standard deviation.

This measure focuses on family experience rather than a clinical event. In principle, measuring perceived family difficulty can help describe how families experience the demands associated with a child’s chronic condition. That is the rationale for using such a measure as an outcome; it does not establish that a particular intervention changes family experience.

The stated assessment times were Time 2, after session 3 on day 3, and Time 3, 30 days after session 3, approximately 33 days. The registry record does not provide the mean scores, standard deviations, between-condition estimates, confidence intervals, or tests for either time. It also notes that the primary outcome has several categories or time points and was not reduced to one comparison. Consequently, the endpoint definition is available, but the comparative result is not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies a continuous primary measure summarized by a mean and standard deviation, but does not report the model used to analyze it. The explanations below describe general statistical ideas relevant to this kind of outcome; they do not assert that the trial used a particular analysis.

What does a mean and standard deviation describe?

For a continuous score, the mean is the arithmetic average across participants with measured scores. It provides a compact description of the group’s average reported family difficulty. The standard deviation describes how dispersed individual scores are around that average. A small spread would indicate that scores are relatively clustered, while a larger spread would indicate more variability. Neither quantity alone compares the randomized conditions or shows whether an observed contrast is precise.

The Family Life Difficulty Subscale has a stated range of 14 - 70, with higher values indicating more difficulty managing the condition. That direction helps interpret a reported score: a higher mean would correspond to greater reported difficulty on this scale. But the registry record contains no group means or standard deviations, so no direction of an observed comparison can be stated.

What would a group comparison estimate?

In general, a comparison of group means estimates how far apart the average scores are between conditions. The estimate should be read alongside uncertainty. A confidence interval gives a range of values compatible with the data and the analysis assumptions at its stated confidence level. A narrower interval indicates greater precision than a wider interval, although precision does not by itself determine whether an effect is important. No confidence interval or mean comparison is reported in the registry record.

A p-value, when reported, describes how incompatible the observed data are with a specified null model, under the assumptions of the analysis. It is not the probability that the null hypothesis is true, nor a measure of the magnitude or practical importance of a difference. The registry record does not report a p-value or a hypothesis test for the primary outcome. Its planning illustration specifies a two-sided significance level of 0.05, but that assumption is not an outcome result and does not identify the test actually used.

Why do the assessment times matter?

The endpoint is specified at Time 2, after session 3 on day 3, and Time 3, 30 days after session 3, approximately 33 days. Repeated observations from the same participant are related: a person’s later score is not generally independent of that person’s earlier score. In general, an analysis that uses both assessments can account for this within-participant relationship and estimate time-specific differences or differences in change. Separate comparisons at each time can answer a different question and may have different precision. The registry record does not state which approach was planned or used.

Because the primary outcome includes several categories or time points and is not reduced to one comparison, the exact estimand is not clear from the record. An estimand is the specific quantity a study intends to estimate, such as a condition contrast at a particular assessment time or a contrast in change over time. Without a designated contrast, model, or reported results, the assessment schedule does not establish which of these quantities was the principal basis for interpretation.

What role does randomization play?

Random allocation can support a fair comparison by making assignment independent of participant characteristics on average. In any one trial, chance differences between groups can still occur. Statistical adjustment may be used to account for selected characteristics or improve precision, but the registry record does not report covariates, adjusted estimates, or an adjustment plan. It is therefore not possible to characterize the primary outcome comparison as adjusted or unadjusted from this record.

The trial is listed as parallel and unmasked. A parallel design assigns participants to a condition that is compared with the other condition; it differs from a design in which participants switch between conditions. General concerns with unmasked behavioral interventions include the possibility that awareness of assignment affects responses or measurement. The record does not describe procedures intended to address such effects, and the available information does not establish whether they affected the outcome.

How should the planning illustrations be read?

In general, a sample-size calculation estimates how many participants would be needed under specified assumptions to detect an effect of a chosen size with a chosen statistical design. The registry’s planning illustration uses the observed effect as its reference and considers stated fractions of that effect. It assumes a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. These calculations are planning illustrations, not observed power and not evidence that the study detected an effect. The registry record does not report the study’s own design justification, and the observed effect and analyses are not reported there.

Planning calculations depend on the assumed effect, outcome variability, allocation, and analysis. If those assumptions differ from the actual data or intended analysis, the illustrative participant requirement may not describe the achieved precision. A planned sample size also does not guarantee a particular result. The enrollment of 137 is reported, but the record does not provide enough outcome information to evaluate achieved precision for the primary endpoint.

Does over-dispersion apply to this outcome?

Over-dispersion is a general concern for some count outcomes when observed variability exceeds what a simple count model assumes. The primary measure in this record is a continuous scale score summarized by mean and standard deviation, not a count outcome. Over-dispersion is therefore not the central issue identified by the reported endpoint description. More relevant general considerations include the distribution of scores, within-participant correlation across assessment times, missing measurements, and the selected comparison. The registry record does not report the data distributions or model diagnostics needed to assess those considerations.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists eight outcome measures and identifies the primary outcome as having several categories or time points, rather than reducing it to one comparison. It also lists zero analyses. The record does not specify which outcome contrasts were planned as primary tests, how multiple outcomes or assessment times were handled, or whether any multiplicity adjustment was used. These details are not reported in the registry record.

In general, testing several outcomes or time-specific contrasts can increase the chance of finding at least one apparently unusual result by chance. A prespecified hierarchy, a clearly identified primary contrast, or an adjustment method can help make interpretation more transparent. None of those procedures can be attributed to this trial from the available record. The presence of multiple measurements does not itself imply that an adjustment was or was not applied.

The outcome description reports incomplete measurements in both conditions. In the Active Music Engagement arm, two parents did not complete Time 3 measures, leaving 63 participants for analysis, as stated in the record. In the audio-storybook arm, one parent did not complete Time 2 measures; the accompanying population sentence is truncated after “60 pa,” so the resulting analysis count is not fully reported in the registry record. These details do not establish how missing observations were handled, whether other measurements were missing, or which participants were included in any analysis.

In general, missing-data methods matter because conclusions can depend on why measurements are absent and on assumptions made about unobserved scores. Possible approaches include analyzing available observations or using a model or imputation method, but the record does not identify an approach used in this trial. It also does not report an intention-to-treat population, a per-protocol population, or a sensitivity analysis. The enrollment total of 137 should therefore not be treated as the number contributing to every endpoint assessment.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry lists adverse-event groups separately for parents and children in each condition. For parents, 69 participants were at risk in the Active Music Engagement group and 67 in the audio-storybook group. For children, the corresponding at-risk counts were 69 and 67. The record lists zero participants with serious adverse events and zero with other adverse events in each of those groups.

The deaths field lists one death in the Active Music Engagement child group and zero in the other parent and child groups. These are registry counts; the record does not establish a relationship between the death and an intervention. It also does not provide a narrative account, cause, timing, or further context for the death. No serious adverse-event terms are listed.

These figures describe what the registry reports for the listed groups. They should not be interpreted as proof that an intervention caused or prevented an event, and they do not by themselves establish comparative safety. The record does not give additional follow-up context or explain how adverse events were collected. The event figures should be read alongside those reporting limitations, rather than as a complete account of all possible harms.

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

The record establishes that the completed study was designed to compare Active Music Engagement with audio-storybooks among parent-child dyads during a child’s cancer treatment. It identifies family difficulty as the primary outcome, measured using the Family Life Difficulty Subscale, and specifies two assessment times. These design details explain what the researchers intended to examine.

The record does not report the primary outcome results. There are no group means, standard deviations, contrasts, confidence intervals, or p-values for that endpoint, and the record lists zero analyses. Consequently, it is not possible to determine from the registry whether reported family difficulty differed between the conditions, what direction a difference might have taken, or how precise an estimate would be.

This absence does not show that there was no difference. It also does not support a conclusion that either intervention improved or worsened family outcomes. A conclusion about a comparison requires outcome estimates and their uncertainty, together with information about the analysis population and methods. The endpoint’s scoring direction—higher values indicate more difficulty—explains how future reported values would be read, but it cannot stand in for missing results.

The stated follow-up times represent assessments after the session series and at a later follow-up. Without estimates at those times and a description of the planned contrast, the record cannot establish whether any difference was immediate, persisted, or changed over time. Nor does a completed status guarantee that the results are posted in this registry record.

The planning illustrations are not a substitute for results or an assessment of observed power. Enrollment of 137 participants describes the study’s enrolled sample, while incomplete measures are noted for some parents. Neither fact determines the magnitude or statistical reliability of a comparison without the outcome data and analysis. The defensible reading is therefore limited to the study question, its design, endpoint, and the data-reporting gaps.

13. Why This Trial Matters Statistically

Statistically, this trial is useful as an example of the difference between a registered design and a reported analysis. The record describes random allocation, a parallel comparison, the two behavioral conditions, and a specific parent-reported continuous endpoint. Those details allow readers to understand the intended comparison and the construct being measured. Yet the primary outcome analyses and their results are not reported in the registry record.

The endpoint also illustrates why a clear estimand matters. It was measured at Time 2 and Time 3, while the record indicates that the primary outcome has several categories or time points rather than one reduced comparison. A reader needs to know which time-specific or longitudinal contrast was intended before interpreting an estimate. A defined question, analysis population, and method for handling repeated measures and missing observations would help make the eventual result interpretable.

Randomization is a valuable design feature, but it does not remove the need for transparent outcome reporting. Estimates, uncertainty intervals, and a clear account of the analysis are necessary to understand what the randomized comparison shows. The incomplete description of one arm and the truncated population text further limit detail about intervention delivery and endpoint availability.

The record’s planning assumptions also demonstrate why a sample-size illustration should not be mistaken for evidence about results. Illustrations based on an observed effect and specified design assumptions address planning questions; they do not establish what the trial found or how precise its estimates were. Without the outcome estimates and analyses, the central statistical contribution cannot be evaluated from this record alone.

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 in the registry record restrict interpretation. Most importantly, the record lists zero analyses and does not report primary outcome estimates, uncertainty, or tests. The randomized design therefore cannot be connected to a quantitative comparison on the stated family-difficulty measure using the registry information alone.

The primary outcome was assessed at two stated times, and the record says the outcome has several categories or time points rather than a single comparison. It does not identify a target contrast, statistical model, adjustment strategy, or method for handling repeated measurements. Without these details, the estimand and intended interpretation of a result are not reported in the registry record.

The record notes missing measures in both arms, but does not describe the missing-data method or any sensitivity analysis. The audio-storybook population statement is truncated after “60 pa,” leaving the analysis count unclear. The Active Music Engagement description is also cut off mid-sentence, which limits understanding of the full session content. The listed enrollment is not necessarily the number with complete outcome data.

The study is listed as unmasked. The record does not explain whether outcome assessment was conducted by masked personnel or describe methods to reduce possible effects of awareness of assignment on parent-reported measures. Further eligibility, baseline, and randomization details are not reported in the registry record. The registry does not report the trial’s own sample-size justification or a statistical analysis plan. These omissions do not establish that the procedures were absent; they mean that they cannot be assessed from this record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Mechanisms of Active Music Engagement to Improve Health Outcomes of Children With Cancer and Parents — NCT03085927.
• Registry record last updated 2021-11-11; status last verified 2021-10.
• Results first posted 2021-11-11.
• 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

NCT03085927 is a completed randomized, parallel-group study sponsored by Indiana University. The registry lists no masking and a phase of NA. It reports enrollment of 137 participants, a start date of 2016-09-26, and a primary completion date of 2020-04-06.

The study compared Active Music Engagement with audio-storybooks among parent-child dyads affected by childhood cancer. The primary outcome was the Family Normalcy Perspective, assessed with the Family Management Measure’s Family Life Difficulty Subscale at Time 2 and Time 3. Higher scores indicate more difficulty managing the condition, and the score range is 14 - 70.

The registry record lists eight outcome measures and zero analyses. It does not report the primary outcome estimates or statistical comparisons. It also records incomplete measures in both arms and adverse-event counts, including one death in the Active Music Engagement child group. The available record supports a description of the study design and outcome, but not a conclusion about the comparative outcome results.