Improving ADHD Behavioral Care: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Improving ADHD Behavioral Care (NCT03628781), a randomized na study. The primary outcome is Rates of Behavioral Treatment.

2. Clinical Question

The study addresses a service-delivery question: whether putting behavioral resources into a web-based ADHD care portal is associated with greater use of behavioral treatment. Its focus is on access and implementation, rather than on a direct comparison of medication strategies. The registry's study description says the investigators aimed to increase behavioral-treatment rates and improve the integrity of behavioral interventions; the primary outcome listed is the parent report of implementation.

The reported comparison is an odds ratio of .384 with p = .535. The record does not give a confidence interval, event counts for the primary outcome, or enough information about the order of the comparison groups to assign a direction to the odds ratio. Thus, the posted result does not establish which group had higher odds from the number alone, nor how large the absolute difference in reported implementation may have been. It records a statistical comparison, not a complete account of the outcome in each group.

3. Trial Design

The registry identifies this as a randomized, single-masked, parallel trial and describes the study as cluster randomized in community pediatric settings. The listed enrollment is 169, and the status is completed. The study began on 2018-09-17, with primary completion on 2020-08-31. The registry does not identify which individuals were masked, or give further detail about the clusters, how they were formed, or how randomization was carried out.

Both groups used the mehealth for ADHD web-based software. In the intervention group, the portal included behavioral tools that parents and teachers could use to develop and implement interventions, including daily report cards. The comparator group used the portal without those integrated tools and was to wait one year before access to the behavioral features. This design therefore compares access to the added behavioral module within the same broader software platform.

The primary outcome was assessed 12 months after randomization. It was parent-reported implementation of behavioral interventions on the Services Use in Children and Adolescents Parent Interview, recorded as a count of participants. The record also lists three secondary outcomes: parent ratings of school performance, teacher ratings of academic performance, and teacher ratings of classroom performance, each on the Impairment Rating Scale.

The planned cluster structure matters when interpreting the reported analysis. People within a cluster may have more similar outcomes than people in different clusters, so analyses generally need to account for that dependence. The record notes that a simple individual-level re-analysis would be misleading and presents only the sponsor's analysis. Cluster size, number of clusters, and the specific adjustment used by the sponsor are 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:

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 Rates of Behavioral Treatment, measured over 12 months after randomization.

The primary endpoint is the number of participants whose parent reported implementation of behavioral interventions on the Services Use in Children and Adolescents Parent Interview. The assessment time is 12 months after randomization. The measure is about whether behavioral strategies were put into practice, rather than a direct measurement of symptoms or a clinical outcome.

This kind of endpoint is relevant to a study intended to improve access to behavioral treatment: a resource can only influence care if families and teachers use or implement it. Parent report also captures information about treatment use that may not be available from a clinical record. As a general measurement consideration, reports of behavior and treatment use can depend on recall, understanding of the questions, and what respondents consider an intervention to be. The registry does not report further details about the interview's scoring, validation, or the threshold used to classify implementation.

The posted primary result is an odds ratio of .384 with p = .535. No group-specific primary-outcome counts, percentages, confidence interval, or absolute difference are reported in the registry record. Consequently, the odds ratio cannot be translated from the record into the observed number or proportion of participants reporting implementation, and its direction cannot be assigned without knowing the comparison's numerator and reference group.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does the odds ratio describe?

As a general statistical explanation, an odds ratio compares the odds of an outcome between two groups. Odds are not the same as probability: they express the chance that an event occurs relative to the chance it does not. An odds ratio of 1 corresponds to equal odds in the two groups under the comparison's specified ordering. Values below or above 1 indicate lower or higher odds for the numerator group relative to the reference group. That interpretation depends on knowing which group is placed first. The registry reports .384, but the analysis entry does not identify the group ordering in terms of the intervention descriptions, so the direction should not be inferred.

What does the p-value say?

As a general explanation, a p-value measures how unusual data at least as discordant with a specified null model would be if that model and the analysis assumptions held. It is not a measure of effect size, and it does not state the probability that a result happened by chance or that the null is true. Here, the reported p-value is .535. This is not a small p-value under common statistical conventions, but the registry does not state a decision threshold. The p-value alone cannot show whether the estimate is precise, because that also depends on the uncertainty around the estimate and the analysis structure.

Why is the confidence interval important?

As a general explanation, a confidence interval presents a range of estimates that are reasonably compatible with the observed data and the statistical model, at a stated confidence level. It shows uncertainty and can make clear whether the data allow a range of materially different effects. No confidence interval or confidence level is reported for this comparison. Without one, readers cannot assess the precision of the odds ratio from the registry entry. The absence of a confidence interval does not mean the effect is known exactly; it means the record does not give that uncertainty measure.

How does clustering affect analysis?

As a general statistical consideration, cluster randomization assigns groups of people or settings, rather than each participant independently. Outcomes among people in the same cluster can be correlated because they share a setting or other features. Treating all participants as independent may then overstate the information in the data and make uncertainty estimates too narrow. Appropriate methods account for clustering, but the details depend on the design and data. The registry describes this trial as cluster randomized and explicitly states that a simple individual-level re-analysis would be misleading. It does not report the number of clusters, their sizes, or the sponsor's specific method for accounting for clustering.

What can be inferred from the posted analysis?

The registry lists a chi-squared method and reports an odds ratio of .384 with p = .535. It does not report the primary-outcome counts by arm or a confidence interval. The primary endpoint is a count of participants, but the posted analysis is expressed as an odds ratio; the record does not give further details about the outcome coding or analysis specification. Because the comparison order is not mapped to the arm descriptions, the direction of the odds ratio is unclear from this entry. No simple recalculation is appropriate: the registry's cluster-randomization warning states that an individual-level re-analysis would be misleading, and only the sponsor's analysis is presented.

As a general principle, a non-small p-value does not establish that two approaches are equivalent. Equivalence or non-inferiority requires a prespecified margin and an analysis designed to evaluate that question. Such a margin and such an analysis are not reported in the registry record. Likewise, a sample-size calculation based on an observed effect would be a planning illustration, not observed power or evidence that the trial could reliably detect a particular effect. No sample-size justification or power calculation for the trial is reported in the registry record.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Mehealth Portal With Integrated Behavioral Tools", "Mehealth Portal With no Integrated Behavioral Tool")
n      <- c(85, 84)
events <- c(44, 64)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Mehealth Portal With Integrated Behavioral Tools  85  44  51.8  40.7  62.7  41.3  62.1  41.3  62.1
ARM  Mehealth Portal With no Integrated Behavioral Tool  84  64  76.2  65.7  84.8  66.1  84.0  66.0  84.0

11. Analyses Reported by the Sponsor

The sponsor's own analysis is the only primary comparison presented: a chi-squared analysis reporting an odds ratio of .384 and p = .535. The registry describes the trial as cluster randomized and cautions that a simple individual-level re-analysis would be misleading. Accordingly, there is no independent recalculated estimate to compare with the sponsor's result. This preserves the analysis structure stated in the record rather than treating participants as independent observations.

The record does not report the details of how the sponsor accounted for clustering, the confidence interval, or the primary-outcome counts by group. It also does not map the reported analysis-group ordering to the arm descriptions. These omissions limit independent appraisal of the estimate's direction, precision, and modeling assumptions. The result should therefore be read as the sponsor-reported comparison, not as a fully reproducible analysis from the registry entry.

The p-value of .535 does not provide strong evidence against a null comparison under common conventions, but the registry does not state a decision threshold. Nor does the result establish that the groups are equivalent. That conclusion would need an appropriate design and an uncertainty assessment, neither of which is documented in the posted primary result.

12. Multiplicity, Missing Data and Analysis Populations

The registry lists one primary outcome and three secondary outcomes, and reports four analyses overall. The secondary measures are parent rating of school performance, teacher rating of academic performance, and teacher rating of classroom performance, all on the Impairment Rating Scale. The registry record does not describe how the analyses correspond to the outcomes, whether additional analyses were conducted, or whether any multiplicity adjustment was used.

As a general statistical consideration, evaluating several outcomes or comparisons can increase the chance of finding at least one apparently notable result even when there is no underlying effect. A prespecified hierarchy, adjustment, or clear distinction between confirmatory and exploratory analyses can help readers interpret multiple tests. The record does not report such a plan, so the implications of multiple testing cannot be assessed. No results for the secondary outcomes are included in the registry record reported for this analysis.

Missing-data methods are not reported in the registry record. The entry does not state how incomplete parent interviews or missing ratings were handled, whether participants were excluded from particular analyses, or whether any sensitivity analyses were performed. The analysis population is also not described: it is not clear from the entry whether the primary analysis included all randomized participants or used another population definition. These details matter because missingness and exclusions can affect both the estimate and its precision.

The sample-size justification, interim-analysis plan, and statistical analysis plan are not reported in the registry record. The stated enrollment is 169, but that figure alone does not establish the number included in the primary analysis or the precision of the comparison. In a cluster-randomized study, information about the number and size of clusters and the method for handling within-cluster dependence would also help readers assess the analysis; those details are not reported.

13. 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 reports zero serious adverse events among 85 participants at risk in the group with integrated behavioral tools and zero among 84 at risk in the group without integrated tools. It also reports zero other adverse events and zero deaths in each group. These figures describe the safety entries recorded in the registry; they do not show that no events of any kind occurred outside the reported categories or observation procedures.

As a general statistical consideration, when no events are recorded, the data provide limited information about how uncommon events may be. The number of participants at risk is not the same as a comprehensive estimate of event risk over a defined period unless the follow-up and collection methods are known. The registry does not report the safety observation timeframe, event-collection procedures, or further detail on adverse-event ascertainment. No serious adverse-event terms are listed.

These figures should be read as registry-reported counts, not as proof of the absence of risk. They also do not address the primary endpoint, which concerns parent-reported implementation of behavioral interventions.

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

The result records a comparison of parent-reported behavioral-treatment implementation at 12 months after randomization. The sponsor reported an odds ratio of .384 and p = .535 using a chi-squared method. The entry does not report a confidence interval or the numbers of participants with the primary outcome in each group. It also does not identify the group order for the odds ratio in a way that connects it to the intervention and comparator descriptions. The posted result therefore does not establish the direction or absolute size of any difference.

It does not demonstrate that adding online behavioral tools increased implementation, nor does it demonstrate that the portal groups were equivalent. A p-value of .535 is not strong evidence against a null comparison under common conventions, but a result that is not statistically compelling is not proof of no effect. Assessing which effects remain compatible with the data requires an uncertainty interval, which is not reported in the registry record.

The result is specific to the registered primary measure, its parent-report source, and its stated assessment time. It should not be treated as a result about symptom change, academic achievement, or the effectiveness of any individual behavioral technique. Although the registry lists ratings of school, academic, and classroom performance as secondary outcomes, results for those measures are not included in the reported analysis information.

The trial's cluster-randomized design also constrains interpretation. The registry says an individual-level re-analysis would be misleading and presents only the sponsor's analysis. The record does not provide enough detail to independently evaluate how clustering was handled. These limitations leave uncertainty about precision and analytic assumptions, while the unavailable group-specific counts prevent assessment of the absolute outcome pattern.

15. Why This Trial Matters Statistically

This trial is statistically notable because it evaluates a service-delivery intervention through a randomized comparison while using a cluster-randomized design. The intervention adds behavioral tools to an existing ADHD care portal, so the primary question concerns whether those features are associated with reported implementation of behavioral treatment. Such an endpoint captures an important step between making a resource available and its use in care.

The design also illustrates why the unit of randomization matters. In cluster-randomized studies, participants from the same setting may have related outcomes. Analyses that ignore that dependence can misstate uncertainty. The registry explicitly cautions against a simple individual-level re-analysis, a useful reminder that methods must reflect how allocation occurred rather than only the number of participants.

The result further highlights the difference between a point estimate and a complete account of evidence. An odds ratio and p-value give some information about a comparison, but without a confidence interval, group-specific outcome counts, and a clear mapping of comparison order, readers cannot determine the direction and precision of the primary result from the registry entry. The reported p-value alone cannot establish equivalence or rule out meaningful effects.

Finally, the registry's outcome list and analysis count make multiplicity and reporting context relevant. Without a documented analysis plan, missing-data approach, or account of how secondary outcomes were handled, it is difficult to know how the primary result fits into the full set of planned analyses. These are general lessons in interpreting pragmatic, cluster-based evaluations of changes to care processes.

16. 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 entry leaves important design and analysis details unspecified. Although the study is described as cluster randomized, the cluster unit, number of clusters, cluster sizes, and allocation procedures are not reported. The masked party is not identified despite the single-masked designation. The sponsor's specific approach to accounting for clustering is also not reported, limiting independent assessment of the primary analysis.

For the primary outcome, the registry reports an odds ratio of .384 and p = .535 but no confidence interval or group-specific counts. The comparison order is not mapped to the intervention descriptions, so the direction of the estimate cannot be determined from the entry alone. Absolute outcome rates and differences also cannot be assessed. The record does not state the outcome coding details or provide enough information to reproduce the sponsor's analysis.

The registry does not report a sample-size justification, interim-analysis plan, statistical analysis plan, missing-data methods, or analysis-population definition. It lists three secondary outcomes and four analyses but does not explain any multiplicity strategy or report the secondary results in the information. The status is completed, but completion does not fill in those analytic details.

The primary endpoint relies on parent report. The registry does not describe the interview's scoring, validation, or classification criteria. The follow-up point is stated as 12 months after randomization, but the safety observation period and procedures for collecting adverse events are not reported. These limits restrict interpretation of both efficacy-related outcomes and safety counts.

17. Related Tutorials

18. Related Statistical Calculators

19. Sources

• ClinicalTrials.gov: Improving ADHD Behavioral Care — NCT03628781.
• Registry record last updated 2022-02-25; status last verified 2021-12.
• Results first posted 2022-02-25.
• 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.

20. Record Summary

This completed randomized, single-masked, parallel study evaluated integrated behavioral tools in the mehealth for ADHD portal in community-based pediatric settings. The registry describes the design as cluster randomized and lists enrollment of 169. The intervention portal included tools for parents and teachers to develop and implement behavioral strategies; the comparator portal did not include those features during the comparison period.

The primary outcome was parent-reported implementation of behavioral interventions on the Services Use in Children and Adolescents Parent Interview at 12 months after randomization. The sponsor reported an odds ratio of .384 and p = .535 using a chi-squared method. No confidence interval or primary-outcome counts by group are reported, and the comparison order is not mapped to the arm descriptions.

The registry cautions that a simple individual-level re-analysis would be misleading because of the cluster-randomized design; only the sponsor's analysis is presented. It reports zero serious adverse events, zero other adverse events, and zero deaths in both groups. Details on clustering, missing data, multiplicity, and the statistical analysis plan are not reported in the registry record.