Community Health Through Engagement and Environmental Renewal: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Community Health Through Engagement and Environmental Renewal (NCT04362475), a randomized na study. The primary outcome is Problem Behaviors in Children Ages 11 to 16 Years..

2. Clinical Question

The registry frames CHEER as a test of family- and neighborhood-level approaches intended to influence social interaction, cohesion, collective efficacy and wellbeing. Its primary-outcome description focuses more narrowly on a child behavior score within FYI responses. It does not report numerical scores, changes over time, uncertainty estimates or a statistical test result for that outcome. Accordingly, the record does not establish the size or precision of any change, nor does it provide a reported comparison of this outcome against a control group.

3. Trial Design

CHEER, or Community Health Through Engagement and Environmental Renewal, was a randomized, unmasked, factorial trial sponsored by the University of Alabama at Birmingham. The registry lists enrollment of 915, a start date of 2021-05-21, primary completion on 2024-08-10 and status as completed. The listed phase is NA. The trial addressed family relations and blight in resource-poor urban neighborhoods in Birmingham.

The intervention framework included FYI, focused on family strengthening, and ESPI, which addressed social and physical neighborhood conditions through blight elimination and lot recovery. The registry describes an intended FYI sample of 120 parent-child pairs and an ESPI effort to enroll 500 community members. It also describes two of eight neighborhoods receiving both interventions, while two communities were to receive ESPI after study completion as wait-list controls. These are descriptions of the intervention plan; the registry record does not establish the realized number enrolled in each intervention group.

Randomization is recorded, but the allocation sequence, unit of randomization, and allocation proportions are not reported in the registry record. The factorial label indicates the stated design model, but further details of the design and how factors were assigned are not reported in the registry record. Masking is listed as none. The primary outcome was assessed at baseline, 1-week and 6-month follow-up, with a repeated measures ANOVA described for children ages 11 to 16 years in FYI responses who completed the items at all three timepoints.

The registry record does not report the protocol’s sample-size justification, interim-analysis plan, or full statistical analysis plan. Those omissions matter when interpreting the reported design labels: they do not establish how the trial’s planned comparisons were specified or whether the stated primary-outcome analysis represented the entire randomized sample.

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: Children from the FYI intervention responses were analyzed using a repeated measures ANOVA. Data were included for the 11 to 16 years old that completed the items at all three timepoints.

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 Problem Behaviors in Children Ages 11 to 16 Years., measured over Baseline, 1-week and 6-month Follow-up.

The primary endpoint is a continuous score for problem behaviors in children ages 11 to 16 years. It is based on three yes-or-no items coded 1 for yes and 0 for no. At baseline, the questions ask whether the child has ever been suspended from school and whether the child smoked cigarettes or drank alcohol within the 12 months before the baseline survey. At 1-week and 6-month follow-up, the questions ask whether the child has been suspended, smoked cigarettes or drunk alcohol since baseline.

The possible score ranges from 0 to 3, with 3 describing a higher level of problematic behavior. The registry identifies the summary measure as a mean and the dispersion measure as a standard deviation. A mean can describe the average score in the analyzed group, while a standard deviation describes how spread out individual scores are around that mean.

This endpoint combines responses about three behaviors into a single score. It allows the analysis to describe the overall count of affirmative responses rather than treating each item as a separate primary outcome. The registry does not report the observed means, standard deviations or changes at the stated timepoints, so the size and precision of the outcome pattern are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The statistical method named for the primary outcome is repeated measures analysis of variance (ANOVA). The endpoint is continuous in the sense that it is summarized using a mean and standard deviation, although its individual scores are counts on a bounded scale from 0 to 3. The analysis uses repeated observations from the same children at baseline, 1-week follow-up and 6-month follow-up.

What repeated measures ANOVA does

In general, repeated measures ANOVA evaluates whether the average outcome differs across repeated timepoints while accounting for the fact that observations from the same participant are related. Repeated measurements from one child are not independent in the same way as measurements from different children. A method that accounts for this within-person relationship is therefore relevant when assessing average patterns over time.

In general, ANOVA can be used to test whether the means across timepoints are equal under its model assumptions. A test result does not, by itself, explain which timepoints differ or how large any difference is. For interpretation, estimated means and contrasts, together with measures of uncertainty, are useful. The registry record does not report those estimates or the detailed model specification, so it is not possible to assess the actual time pattern or determine which comparisons were tested.

How to read the score

The outcome adds three binary responses. A score of 0 means none of the three responses was yes, and a score of 3 means all three were yes, according to the stated coding and range. In general, a mean score represents the group’s average count of affirmative responses; it does not describe every child’s individual experience. A standard deviation describes the spread of scores around the mean. Because the possible score is bounded and based on a small number of items, the mean and standard deviation should be interpreted alongside the score definition and the population analyzed.

The wording of the items differs by assessment: baseline asks about ever being suspended and smoking or drinking in the prior 12 months, whereas follow-up asks whether these behaviors occurred since baseline. That distinction is part of the endpoint definition and should be kept in mind when interpreting a time trend. The registry does not provide separate item-level results, so it is not possible to determine which behaviors contribute to any overall score pattern.

Planning illustrations and uncertainty

The sample-size planning illustrations use a two-sided significance level of 0.05, equal allocation between two arms and a normal approximation. They consider an effect defined as a stated fraction of the observed effect. For non-time-to-event outcomes, the illustrations express sample size as participants per arm; time-to-event illustrations instead express a total number of events. These are planning illustrations computed from the observed effect, not the trial’s own design justification, and they should not be read as observed power. No numerical illustration is repeated in this explanation.

In general, a confidence interval communicates uncertainty around an estimated effect: wider intervals indicate less precision, while narrower intervals indicate greater precision under the method’s assumptions. The registry record does not report confidence intervals for the primary outcome. It also does not report the distributional checks, model diagnostics, handling of clustering or any adjustment variables used in the repeated measures ANOVA. Those analysis details are not reported in the registry record and should not be inferred from the method name alone.

Over-dispersion is a general concern for count outcomes when observed variability exceeds what a proposed probability model expects. The primary score is described as a mean continuous measure and analyzed using repeated measures ANOVA; the registry does not report a count-model analysis or a dispersion assessment. It would therefore be inappropriate to claim that over-dispersion was found or addressed in this analysis. More generally, statistical methods should match the outcome scale and dependence structure, but the information in the registry record is insufficient to assess all model assumptions for the reported analysis.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 16 outcome measures and 13 analyses, and names several secondary outcomes: parent-adolescent communication, parental nurturance, family functioning, coping, perceived depression, social support, the World Health Organization Quality of Life Brief Scale and the Punitive Discipline Scale. Evaluating multiple outcomes or multiple timepoint comparisons can increase the chance of observing at least one apparently unusual result by chance. In general, multiplicity procedures can control that risk, but the approach depends on the analysis plan and the claims being made. A multiplicity adjustment or hierarchy of outcomes is not reported in the registry record.

The primary endpoint is described at three timepoints, but the record does not specify whether the primary statistical question was an overall time effect, particular pairwise comparisons, or another contrast. It also does not report which of the 13 analyses correspond to which outcomes or whether any analyses were exploratory. The intended treatment of multiple outcomes and comparisons is therefore not reported in the registry record.

The stated primary analysis includes only children ages 11 to 16 years who completed the items at baseline, 1-week follow-up and 6-month follow-up. This is a complete-measurement analysis population as described. The number of children included, the number missing at each timepoint and reasons for missingness are not reported in the registry record. The method used to handle missing data for participants outside this complete set is not reported in the registry record.

In general, analyzing only participants with all repeated measurements can yield a result that differs from one using all randomized participants, particularly if completion is related to the outcome or intervention. That possibility is not evidence that bias occurred in this trial; the missingness pattern and sensitivity analyses are not reported in the registry record. The record also does not specify an intention-to-treat population or describe imputation. Accordingly, the reported analysis population should not be assumed to include all randomized participants.

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 adverse-event entries list three groups: FYI parents, FYI children and ESPI participants. For FYI parents, 237 were at risk for serious adverse events and 0 were affected; 237 were at risk for other adverse events and 0 were affected; deaths were 0. For FYI children, the corresponding at-risk counts were 200 and 200, with 0 affected by serious adverse events, 0 affected by other adverse events and 0 deaths. For ESPI, the at-risk counts were 280 and 280, with 0 affected by serious adverse events, 0 affected by other adverse events and 0 deaths.

These figures describe the registry’s reported counts for those groups. They do not establish that every possible event was actively sought or reported in the same way, and they do not describe groups absent from the adverse-event listing. No serious adverse-event terms are listed. The registry does not provide further detail about event definitions, collection methods, follow-up duration for safety reporting or the handling of missing safety information; those details are not reported in the registry record.

Zero reported events in these entries should be read as a report of zero affected participants in the listed categories, not as proof that an intervention has no risk. These safety counts are separate from the primary behavioral outcome and cannot establish its effect.

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

The record documents a randomized, unmasked, factorial trial of community and family-focused interventions, with enrollment of 915 and completed status. It describes a primary child problem-behavior score and a repeated measures ANOVA among children ages 11 to 16 years in FYI responses who completed the measure at all three specified timepoints. This gives readers a basis for understanding the outcome’s content, its timing and the population named for analysis.

It does not provide numerical primary-outcome findings. Without means, changes, uncertainty intervals or test results, the magnitude and precision of any observed pattern cannot be assessed from the registry record. The listed primary analysis is focused on repeated responses within the described FYI population, and a specific randomized comparator for that endpoint is not reported in the registry record. A within-group time pattern, if reported elsewhere, would not alone show what would have happened to comparable participants without the intervention.

The trial’s broader aims concern family and neighborhood conditions, including social interaction, cohesion and collective efficacy. The primary measure captures a limited set of child behaviors; it is not itself a measure of all those broader concepts. The registry lists secondary outcomes related to family functioning, communication, social support, coping, perceived depression and quality of life, but numerical results for those measures are not reported in the registry record.

Accordingly, the record supports a description of the trial design and outcome method, not a conclusion about the size or certainty of a treatment effect. It also does not support a claim that the trial confirmed or ruled out its broader causal hypotheses. Those judgments require reported estimates, uncertainty, comparator details and analysis information that are not reported in the registry record.

13. Why This Trial Matters Statistically

CHEER is statistically notable for combining family- and neighborhood-level intervention ideas within a randomized, factorial design. Its stated aims encompass social cohesion, collective efficacy, parenting and youth behavior, while the primary outcome described for analysis is a brief score assembled from three child behavior items. That contrast illustrates why a trial’s broad motivation and its operational endpoint need to be distinguished: the endpoint measures a specific construct, not every intended pathway or outcome.

The repeated assessments also raise familiar questions about within-participant dependence and incomplete follow-up. The registry describes a repeated measures ANOVA and restricts the stated primary analysis to children who completed all three measurement occasions. This makes the analysis population and missing-data approach important to interpretation. The record does not provide enough detail to assess how missingness might affect the estimates or how the model addressed the design’s factorial and community features.

Another statistical issue is multiplicity. The registry lists 16 outcome measures and 13 analyses, but does not report a multiplicity strategy or the mapping between analyses and outcomes. When a trial evaluates several outcomes and time comparisons, the prespecified primary question and the treatment of secondary analyses help readers distinguish confirmatory evidence from exploratory patterns. Those details are not reported in the registry record.

Finally, the registry record specifies the outcome and method without numerical outcome estimates. This highlights a central principle of statistical reporting: design and analysis labels do not replace estimates and measures of uncertainty. Without those results, readers can understand what was planned or analyzed, but cannot judge the size or precision of the primary outcome pattern.

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 primary-outcome description does not include numerical results. Means, standard deviations, estimated changes, confidence intervals and p-values are not reported in the registry record. The number of children in the stated analysis population is also not reported in the registry record, limiting the ability to understand how much information contributed to the repeated measures analysis.

The primary population is restricted to children ages 11 to 16 years in FYI responses who completed the outcome at baseline, 1-week follow-up and 6-month follow-up. The record does not report the number who did not complete all timepoints, reasons for missingness, or whether missing data were handled with an additional method. It also does not report a comparator contrast for this primary endpoint, so the described repeated-measures analysis should not be treated as a documented between-group treatment estimate.

The outcome score combines three items, and the item wording differs between baseline and follow-up. Item-level results are not reported in the registry record, so the contribution of each behavior to the overall score cannot be examined. The registry also does not report detailed model specifications, assumption checks, clustering adjustments, or the procedure for handling multiple outcomes and comparisons.

The broader trial has a factorial label and includes family and community interventions, but details of allocation, realized intervention-group sizes and the analysis of factorial effects are not reported in the registry record. The listed intervention aims and planned sample descriptions do not establish which participants completed the primary measure or how the primary analysis relates to each randomized group. These limitations constrain interpretation of both the outcome and its potential generalizability.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Community Health Through Engagement and Environmental Renewal — NCT04362475.
• Registry record last updated 2026-03-13; status last verified 2026-02.
• Results first posted 2026-03-13.
• 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

CHEER (NCT04362475) was a completed, randomized, unmasked, factorial trial sponsored by the University of Alabama at Birmingham, with enrollment of 915. The registry lists a start date of 2021-05-21 and primary completion on 2024-08-10. The interventions included FYI, a family-strengthening approach, and ESPI, addressing social and physical neighborhood conditions.

The primary outcome was a score for problem behaviors in children ages 11 to 16 years, based on three yes-or-no items and measured at baseline, 1-week and 6-month follow-up. A repeated measures ANOVA was described for children in FYI responses who completed all three assessments. Numerical primary-outcome results and key details about missing-data handling, multiplicity and the comparator for this analysis are not reported in the registry record. Adverse-event entries list zero affected participants and zero deaths in the reported FYI parent, FYI child and ESPI groups.