Intervention to Reduce Stress in 0-5 Year Olds With Burns: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Intervention to Reduce Stress in 0-5 Year Olds With Burns (NCT00844896), a randomized na study. The primary outcome is Change From Baseline in Burn Outcomes Questionnaire Short Form (0-4 Year Old Version) at Six Months.

2. Clinical Question

The trial was intended to evaluate whether adding COPE to DEF was associated with different changes in child and parent outcomes than DEF alone. The study summary also describes hypotheses about pain, anxiety, heart rate, and post-traumatic stress symptoms. Those hypotheses are not themselves results. The posted primary outcome is specifically the change in the Burn Outcomes Questionnaire Short Form score, not a direct measurement of every outcome named in the study rationale.

The main interpretive question is therefore narrower than whether the overall intervention strategy reduces stress. The recorded group means describe change on one parent-rated measure over the stated follow-up period. They do not, on their own, establish whether the group changes differ beyond sampling uncertainty, whether any difference is attributable to the added COPE component, or whether other outcomes changed in a similar way.

3. Trial Design

The registry describes a completed, randomized, double-masked, parallel-group trial sponsored by Massachusetts General Hospital. The listed study dates are start in 2008-05 and primary completion in 2010-08. The enrollment field reports 57. The trial compared two behavioral interventions: DEF-only and DEF + COPE. The record does not state who was masked, how randomization was generated or concealed, or how participants were recruited.

DEF-only is described as Distress Emotional Support and Family Assessment Treatment. DEF + COPE combines that treatment with Creating Opportunities for Parent Empowerment Treatment. The study summary characterizes the approach as an early post-burn psychosocial assessment and intervention for young children and their parents. It refers to a DEF protocol and a burn-specific version of COPE. Details such as session length, delivery schedule, staff training, adherence monitoring, and whether families received other care are not reported in the registry record.

The primary outcome is a mean change from baseline to six-month follow-up on the Burn Outcomes Questionnaire Short Form, 0-4 year old version. The outcome population is identified as intention-to-treat. Posted group summaries are available for 13 participants in DEF-only and 6 in DEF + COPE. The enrollment figure and these endpoint-specific group counts describe different record fields; the registry record does not explain the relationship between them or why the posted endpoint counts are smaller.

The study description sets out a broader set of hypothesized child and parent outcomes, but the registry record lists no posted secondary results. It also lists nine outcome measures and no analyses. This means the available record supports a limited account of design and the primary descriptive result, rather than a full reconstruction of the prespecified analysis plan or the complete trial results.

The record does not report a formal sample-size justification, allocation ratio, planned analysis model, covariate adjustments, interim analyses, or protocol deviations. The absence of those details should not be interpreted as evidence that such procedures were or were not used. They are simply not reported in the registry record.

4. Participant Flow and Accounting

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

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Intention to Treat (ITT)

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.

6. Primary Endpoint

The registry lists the primary outcome as Change From Baseline in Burn Outcomes Questionnaire Short Form (0-4 Year Old Version) at Six Months, measured over Baseline and six month follow-up.

The primary endpoint is change from baseline to six-month follow-up in the Burn Outcomes Questionnaire Short Form, 0-4 year old version. The record identifies the outcome as a mean with standard deviation and gives the unit as units on a scale. It describes the questionnaire as parent-rated and focused on the child’s pain and the parent’s worry. Scores range from 5-24, with a higher score indicating worse outcomes.

Change scores express how a participant’s recorded score at follow-up differs from the baseline score. The posted negative group means indicate decreases in questionnaire scores over the measurement period. Given the stated direction of the scale, a decrease is in the direction of lower scores. That description does not establish why the score changed or whether a decrease represents a reliable change for an individual family.

This measure is relevant to the trial’s psychosocial focus because it captures reported aspects of the child’s experience and the parent’s concern. A parent-rated measure can reflect outcomes meaningful to families, while also depending on the parent’s observations and reporting. It is not an objective measure of every symptom named in the study summary, and it should not be treated as a substitute for separately measured pain, anxiety, physiological responses, or post-traumatic stress symptoms.

The registry record does not report a threshold for clinically important change, measurement reliability, or a rationale for selecting this endpoint as primary. Without such information, the group means can be described on the questionnaire’s scale, but their practical importance cannot be determined from the record alone.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Interpreting a trial result involves separating the outcome definition, the summary statistic, the comparison between groups, and the uncertainty around that comparison. The registry record supplies descriptive group summaries for the primary endpoint, but it does not report a formal inferential comparison. The statistical concepts below explain what the posted quantities mean in general and what additional information would ordinarily help assess a treatment contrast.

What does a mean change describe?

A mean change is the average of the recorded changes for participants included in the summary. In this trial, change is defined from baseline to six-month follow-up on the Burn Outcomes Questionnaire Short Form. A negative mean indicates a downward average change on the score, and the registry specifies that higher scores indicate worse outcomes. The mean alone does not show whether most participants changed in the same direction, whether a few larger changes influenced the average, or how the changes were distributed.

A change score also differs from a follow-up score. It uses both baseline and follow-up measurements for each participant and summarizes the change between them. How change scores behave statistically can depend on baseline variation, measurement reliability, and the association between baseline and follow-up. The registry record does not provide group-level baseline or follow-up means, correlations between measurements, or an analysis description that would clarify how these features were handled.

What does the standard deviation describe?

The standard deviation describes the spread of individual measurements around their group mean. Here it refers to variability in change scores, not uncertainty in the estimated mean. A larger standard deviation indicates more variation among observed changes relative to the mean; a smaller one indicates less observed variation. A standard deviation does not show whether a difference between groups is statistically persuasive.

Precision of a group mean depends on both the variability of observations and the amount of information available. A confidence interval is a range of values calculated by a statistical procedure that expresses uncertainty about an estimate under that procedure’s assumptions. It helps readers judge which values remain compatible with the data. The registry record does not report confidence intervals for the means or a between-group effect, so the precision of the primary comparison cannot be assessed from the posted summaries alone.

Why is the between-group comparison central?

In a randomized trial, the primary causal comparison is generally between the groups assigned to different interventions, rather than whether a group changed from its own baseline. Both groups can change over time because of many influences, including recovery, other care, measurement effects, or the passage of time. A within-group decrease does not show that the intervention caused the decrease. The randomized comparison is intended to estimate how outcomes differ between assigned groups, subject to the conduct of the trial and the analysis.

The registry record does not report a tested contrast, its uncertainty, or a model. It is therefore inappropriate to infer statistical significance from the reported means and standard deviations alone. A p-value, when reported, assesses how compatible data are with a specified null hypothesis under a statistical model; it is not the probability that a treatment works or that the null hypothesis is true. A confidence interval for the group contrast would also help assess the range of effects compatible with the data. Neither is reported for the primary comparison.

Why can spread and unequal endpoint counts matter?

Group summaries based on fewer observations tend to be less precise, all else equal. Different sample sizes and different observed variability can affect the uncertainty of a group comparison. The registry’s endpoint summaries include 13 participants in DEF-only and 6 in DEF + COPE, and the reported standard deviations are 4.6 and 1.4, respectively. These quantities describe the available summaries but are not enough to reconstruct a valid inferential analysis without knowing the method, missing-data handling, and analysis population details.

In general, over-dispersion means that observed variability is greater than a statistical model expects. If a model fails to account for extra variability, its uncertainty estimates can be too small and its conclusions too confident. The posted endpoint uses a continuous score with a mean and standard deviation; the record does not report a model or indicate that over-dispersion was assessed. This is a general consideration, not a claim that over-dispersion occurred in this trial.

What does intention-to-treat imply?

In general, intention-to-treat analysis aims to compare participants according to their randomized assignment, regardless of the intervention actually received. Its purpose is to preserve the benefits of random assignment and estimate the effect of assignment to an intervention strategy. In practice, outcome data can be missing, and an intention-to-treat label does not itself explain how missing measurements were handled. The registry identifies the primary outcome population as intention-to-treat but does not describe the operational definition, exclusions, imputation, or sensitivity analyses.

For this trial, the enrollment field reports 57, while the primary outcome summaries have group counts of 13 and 6. The record does not explain the difference. Without a participant-flow account and outcome availability by assigned group, it is not possible to determine how much missingness occurred, why it occurred, or whether the endpoint summaries include every randomized participant under the stated analysis population.

Can the summaries establish clinical importance?

Statistical evidence and clinical importance are related but distinct. A small estimated difference can be precise yet not important to families, while an estimate that might matter can remain uncertain if the data are limited. To interpret the importance of this questionnaire change, readers would benefit from a clinically meaningful threshold or other evidence linking score changes to meaningful differences in children’s or parents’ experiences. That information is not reported in the registry record. Consequently, the posted means and standard deviations describe the observed scores but do not establish clinical importance.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("DEF-only", "DEF + COPE")
n   <- c(13, 6)
m   <- c(-4.9, -4.5)
sp  <- c(4.6, 1.4)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  DEF-only  13  -4.900  4.600  -7.680  -2.120
CARM  DEF + COPE  6  -4.500  1.400  -5.969  -3.031

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists nine outcome measures, but no secondary results are posted. It also records no analyses. The study summary names multiple hypothesized outcomes, including pain, anxiety, heart rate, and post-traumatic stress symptoms. The record does not identify which outcomes were formally designated as secondary, how they were timed or scored, or whether the listed outcomes correspond to the study summary’s hypotheses.

When a study evaluates multiple outcomes or multiple statistical comparisons, the chance of observing at least one apparently notable result can increase. Statistical approaches can address this issue, for example by controlling the family-wise error rate or using a prespecified hierarchy. These are general methods; the registry record does not report whether multiplicity was considered, whether any adjustment was planned, or what inferential criteria were used. Since secondary outcome results are not posted, no conclusion about those outcomes is possible from this record.

The record labels the primary outcome population intention-to-treat, but does not describe missing-data procedures. It does not report how many participants had baseline or follow-up measurements, reasons for missingness, whether missingness differed by group, or whether any values were imputed. Missing-data methods depend on assumptions about why observations are absent. A complete-case summary, an imputation method, and a model using available observations can yield different estimates when data are missing. The registry record does not identify which approach, if any, produced the posted means.

The enrollment field and endpoint counts do not by themselves establish attrition or explain exclusions. The record does not provide a participant-flow description, protocol deviations, or details about adherence and treatment receipt. These omissions limit assessment of the analysis population and the potential for bias. They should not be filled in by assuming that missing outcomes were random or that all randomized participants contributed to the endpoint summaries.

12. Safety Results

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

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 serious adverse event figures for both intervention groups. In DEF-only, 0 serious events affected participants, with 29 at risk. In DEF + COPE, 0 serious events affected participants, with 28 at risk. For other adverse events, the record likewise reports 0 affected participants in each group, with 29 and 28 at risk, respectively. The deaths fields are null for both groups, so death counts are not reported in the registry record.

These entries describe what is recorded in the adverse-event fields; they do not establish that no adverse events occurred outside the registry’s definitions, observation period, or reporting process. The record does not give the safety observation window, event collection procedures, severity criteria, or details about how events were attributed. It also does not describe whether participants stopped treatment or follow-up for safety reasons.

Zero affected participants in the posted fields should therefore be interpreted narrowly. It is not a demonstration that either intervention has no safety risks. The available safety figures also do not support a reliable comparative safety conclusion. The endpoint group counts and adverse-event risk counts are different record fields, and the registry does not explain their relationship. Safety interpretation requires the definitions and completeness of event ascertainment as well as the observed counts.

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

The posted primary result shows that the mean Burn Outcomes Questionnaire score decreased from baseline to six-month follow-up in both groups. The recorded mean change was -4.9 units for DEF-only and -4.5 units for DEF + COPE. The record also gives standard deviations of 4.6 and 1.4, and endpoint counts of 13 and 6, respectively. These are descriptive summaries of the observed change scores.

The result does not establish that adding COPE caused a greater or smaller change than DEF-only. The registry record does not report a statistical comparison, confidence interval, or p-value for the primary outcome. Similar-looking means do not establish equivalence, and the absence of a reported test does not mean that a difference was absent. The uncertainty around the comparison is not quantified in the posted result.

The result also does not establish that either intervention caused the decreases seen in its group. A randomized between-group contrast is needed to separate differences associated with assignment from change over time shared by both groups. Even a reported randomized comparison would need interpretation in light of missing data, adherence, outcome measurement, and the analysis plan. The record’s intention-to-treat label is useful context, but the procedures behind that label are not reported.

The result does not answer every question raised in the study summary. The record lists nine outcome measures but posts no secondary results. It therefore does not establish effects on pain, anxiety, heart rate, physiological symptoms, or post-traumatic stress symptoms. Nor does it provide a clinically meaningful threshold for interpreting change on the questionnaire.

The safest statistical reading is limited: the registry records negative mean changes for the primary parent-rated outcome in both groups, with the stated standard deviations and group counts. The clinical importance, comparative effect, and precision of that pattern cannot be established from the information reported.

14. Why This Trial Matters Statistically

This trial is statistically important as an example of the difference between descriptive change and comparative evidence. A randomized design is intended to support comparisons between assigned groups, but the registry record’s primary result gives group means and standard deviations without a reported inferential contrast. Readers can see the direction of the recorded average changes, but cannot determine how uncertain a between-group estimate would be from the record alone.

The contrast between the enrollment field and the endpoint-specific counts also highlights why participant flow matters. An intention-to-treat label does not explain which observations contributed to a result or how missing outcomes were treated. Transparent reporting of randomized group counts, follow-up availability, exclusions, and missing-data methods helps readers judge whether a posted endpoint summary represents the intended analysis population.

The trial’s broader hypotheses make outcome reporting important as well. The registry lists nine outcome measures and no analyses, while posting no secondary results. When many outcomes are considered, prespecified priorities and multiplicity methods help distinguish confirmatory questions from exploratory ones. Without those details and results, the record does not permit an overall statistical assessment of the intervention’s hypothesized effects.

Finally, an outcome’s statistical interpretation depends on more than a mean. The score’s direction is described, but no threshold for meaningful change, uncertainty interval, or tested group contrast is reported. This leaves open both how precisely the group results are estimated and what a given score change means to children and parents. Clear reporting of those elements would make the evidence easier to evaluate without overstating what descriptive summaries can establish.

15. 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 gives limited detail about how the trial was conducted. It identifies randomization, double masking, and a parallel model, but does not state how the random sequence was generated, how allocation was concealed, or who was masked. It does not describe recruitment, eligibility criteria, intervention delivery, adherence, treatment fidelity, or receipt of other care. Those details are important for judging the risk of bias and the applicability of the results.

The available primary endpoint report is incomplete for comparative interpretation. It provides group means, standard deviations, and endpoint counts, but no confidence interval, p-value, analysis model, or adjusted or unadjusted comparison. The record does not report baseline and follow-up summaries separately, so the underlying score distributions and group balance at baseline cannot be assessed from the posted result. No clinically meaningful change threshold is listed.

The enrollment figure is 57, while the endpoint summaries report 13 and 6 participants. The registry record does not explain why these counts differ, how many randomized participants contributed data, or how missing outcomes were handled. It also does not provide participant flow, reasons for missingness, or sensitivity analyses. These omissions limit assessment of attrition and the stated intention-to-treat population.

The record describes several outcome hypotheses, lists nine outcome measures, and posts no secondary results. It does not report the full statistical plan, multiplicity approach, interim analyses, or sample-size justification. The study’s status is completed, but a completed status alone does not clarify the completeness of outcome reporting. These gaps constrain interpretation of both the primary comparison and the broader study aims.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Intervention to Reduce Stress in 0-5 Year Olds With Burns — NCT00844896.
• Registry record last updated 2014-10-16; status last verified 2014-10.
• Results first posted 2014-10-16.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

19. Record Summary

The registry describes a completed, randomized, double-masked, parallel-group behavioral trial sponsored by Massachusetts General Hospital. The study compared DEF-only with DEF + COPE for young children with burns and their parents. The enrollment field reports 57, and the primary endpoint is mean change from baseline to six-month follow-up on the parent-rated Burn Outcomes Questionnaire Short Form, 0-4 year old version.

The posted primary summaries report mean changes of -4.9 units with a standard deviation of 4.6 for DEF-only, and -4.5 units with a standard deviation of 1.4 for DEF + COPE. The endpoint counts are 13 and 6, respectively. The registry does not report a primary between-group test or confidence interval, and it does not post secondary results despite listing nine outcome measures. Missing-data methods, participant flow, and the relationship between enrollment and endpoint counts are not reported in the registry record.