Integrated Treatment for Adolescents With ADHD: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Integrated Treatment for Adolescents With ADHD (NCT02420990), a randomized na study. The primary outcome is Change From Baseline in Symptoms: ADHD Symptoms (Inattention, Hyperactivity/Impulsivity) and Comorbid Problems (Conduct and Mood Problems, Substance Use)..

2. Clinical Question

3. Trial Design

This is a randomized, parallel-group trial with a single-masking designation in the registry record. The record does not identify who was masked or describe how the randomization sequence was generated, how allocation was concealed, or how treatment assignment was implemented. Those design details are not reported in the registry record.

The comparison is between behavioral-only treatment and integrated treatment. The behavioral intervention is CASH-AA, described as combining ADHD psychoeducation, family-based motivational interventions, and academic training. The integrated arm adds medication decision-making support through MIP. Its description includes medication psychoeducation and family decision-making, and coordinated medication management for participants who elect to start medication. These descriptions concern the interventions as registered; the record does not state how much treatment each participant actually received.

The registry lists enrollment as 145, identifies the trial phase as NA, and gives the status as completed. The recorded start date is 2015-03-01 and the primary completion date is 2018-08-31. The sponsor is The National Center on Addiction and Substance Abuse at Columbia University. The record does not report the rationale for the enrollment target, a sample-size justification, or whether enrollment matched the number included in each outcome analysis.

The primary outcome timeframe is baseline to one year. Details about assessment visits, adherence, treatment crossover, or other post-randomization care are not reported in the registry record. The single-masking label alone does not establish which trial personnel or participants were unaware of assignment.

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.

Baseline

3-Month Follow-up

6-Month Follow-up

12-Month Follow-up

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 Symptoms: ADHD Symptoms (Inattention, Hyperactivity/Impulsivity) and Comorbid Problems (Conduct and Mood Problems, Substance Use)., measured over Baseline to One Year.

The primary outcome is described as change from baseline in ADHD symptoms and comorbid problems from baseline to one year. The registry characterizes the measure as a mean with standard deviation, in units on a scale. It includes symptom and behavior domains rather than a single common clinical event.

ADHD symptoms were assessed with the Mini International Neuropsychiatric Interview, Version 5.0. The registry describes a symptom count with a range of 0-14, with higher values representing more symptoms. Delinquency was assessed using the National Youth Survey Self-Report Delinquency Scale; the count of delinquent acts has a range of 0-68, with higher values representing more acts. Substance use was measured with the Comprehensive Addiction Severity Index for Adolescents, using a total score with a range of 0-60; higher values indicate greater substance use.

Externalizing and internalizing symptoms were measured with the Child Behavior Checklist. Higher scores correspond to more symptoms. Items range from 0 to 2, and the study variables sum items within each scale. The externalizing scale range is 0 - 62 units on a scale, and the internalizing scale range is 0-64 units on a scale.

These measures can describe change across several relevant domains. Their interpretation depends on the specific scale and direction of scoring; a change in one domain cannot automatically stand in for change in another.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes the primary outcome using means and standard deviations for continuous measures. A mean represents the average observed score in a group. A standard deviation describes how spread out individual scores are around that group mean; it is not the uncertainty in the estimated mean and is not a confidence interval. The measures listed for this trial include both symptom counts and scale totals, so the units and interpretation of an average depend on the measure.

What does change from baseline mean?

Change from baseline expresses the difference between a participant’s later measurement and their baseline measurement, according to the direction and coding used for that outcome. Comparing change between randomized groups can account for where participants started, but it does not by itself resolve missing follow-up data or other analysis choices. The registry identifies baseline to one year as the primary timeframe; the exact calculation and model used to analyze change are not reported in the registry record.

The descriptions identify the direction of higher scores for the listed measures. Higher ADHD symptom counts, delinquency counts, and substance-use scores indicate more symptoms, acts, or substance use, respectively. Higher Child Behavior Checklist scores correspond to more symptoms. These descriptions make score direction interpretable, but the registry does not give the actual group means, changes, or variability needed to quantify the results.

How would an effect estimate be interpreted?

In general, an effect estimate for a two-group comparison states the size and direction of the observed contrast on the scale being analyzed. Its units must be retained: a contrast in a symptom count is not directly interchangeable with a contrast in a behavior checklist scale. A confidence interval gives a range of values compatible with the data and analysis assumptions at the stated confidence level. A narrow interval indicates greater precision than a wide interval, but neither interval width nor statistical significance alone establishes practical importance. These are general principles; the registry record does not report a primary-outcome effect estimate or confidence interval.

In general, an analysis may use a model to account for baseline values, repeated measurements, or other design features. The model, covariates, and handling of repeated observations are not reported in the registry record. It would therefore be inappropriate to attribute an adjusted or unadjusted method to this trial. The registry also does not report whether the primary comparison used a model-based test, a direct comparison of change scores, or another approach.

Why do the planning assumptions matter?

The registry describes planning illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. It also states that the effect to detect is a specified fraction of the observed effect. These are assumptions for planning illustrations, not a report of the trial’s analysis procedure. The illustrations should not be interpreted as observed power, nor as proof that a particular effect was or was not detected. Sample-size illustrations depend on the effect and assumptions used; the registry record does not supply a trial-specific sample-size justification.

In general, over-dispersion occurs when count data vary more than a model assumes. If relevant, accounting for that extra variability can affect standard errors and uncertainty estimates. The listed delinquency and ADHD symptom outcomes are counts, but the registry record does not say that over-dispersion was assessed or describe a count-data model. This is a general consideration, not a claim about the trial’s analysis.

How should multiple outcomes be considered?

The primary outcome description includes multiple domains and the record lists three outcome measures and 11 analyses. Those registry counts do not establish how many tests were designated as primary, how analyses relate to each other, or whether the tests were statistically independent. In general, testing multiple outcomes can increase the chance of obtaining at least one apparently unusual result when all null hypotheses hold. Methods such as prespecifying a hierarchy or adjusting for multiplicity can address that issue, but the registry record does not report whether either approach was used.

Precision also depends on the number of observations contributing to each analysis and on the variability of the measure. The enrollment figure is not enough to establish the effective sample for a one-year outcome, because follow-up completion and analysis inclusion are not reported. The registry record does not provide the outcome-analysis denominators or a description of missing-data methods. Without those details and the numerical outcome results, the statistical interpretation remains limited to the stated design, measures, and reporting structure.

10. Multiplicity, Missing Data and Analysis Populations

The primary outcome encompasses multiple domains: ADHD symptoms, delinquency, substance use, and internalizing and externalizing symptoms. The registry also lists three outcome measures and 11 analyses. These descriptions indicate that the study reports more than one outcome analysis, but do not identify which comparisons were prespecified as primary, how the analyses map to the listed measures, or whether a multiplicity strategy was used. A correction, testing hierarchy, or other control of type I error is not reported in the registry record.

In general, when several hypotheses are tested, the chance of at least one apparently significant result can rise unless the analysis plan accounts for multiple testing. This general concern does not establish that the trial’s findings are false or that any particular adjustment was required. Interpretation would need the prespecified analysis plan and the actual results for each outcome. Those details are not reported in the registry record.

Missing-data procedures and analysis populations are also not reported in the registry record. The overall enrollment is 145, but the record does not state how many participants contributed baseline and one-year values for each measure, whether participants were analyzed according to randomized assignment, or how incomplete follow-up was handled. It does not describe imputation, sensitivity analyses, or reasons for missing outcome measurements. Consequently, the extent to which missing observations could affect the outcome comparisons cannot be assessed from the registry record.

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 serious adverse events and other adverse events separately for the two treatment groups. For Behavioral Only- Treatment, the serious-adverse-event count is 0 among 53 at risk, and the other-adverse-event count is 0 among 53 at risk. For Integrated Treatment, the serious-adverse-event count is 0 among 92 at risk, and the other-adverse-event count is 0 among 92 at risk. The recorded number of deaths is 0 in each group.

These figures describe events recorded in the registry, not proof that no event occurred outside the recorded collection and reporting process. The record does not provide event-term detail for serious adverse events, and no top serious-event terms are listed. It also does not describe the adverse-event collection period, definitions, monitoring procedures, or how events were judged in relation to treatment. The at-risk figures are safety denominators and should not be assumed to match the number contributing data to the primary outcome.

Zero recorded events in these groups does not by itself establish that the interventions have no risks. It indicates only that the registry reports no affected participants in the listed event categories for the stated at-risk groups.

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

The registry record describes a randomized comparison of behavioral-only care with an integrated intervention that adds medication decision-making support for adolescents with ADHD in outpatient behavioral services. Its primary outcome covers change from baseline to one year across ADHD symptoms and comorbid problems. The record also describes the assessment instruments and the direction of higher scores, which helps explain what the measures are intended to capture.

The result information available for this analysis does not include numerical outcome values or a single reported comparison between the groups. It therefore cannot establish the magnitude or direction of any difference, the precision of a difference, or whether an analysis found evidence against a null hypothesis. No claim that one intervention was better, worse, or equivalent to the other follows from the available outcome information.

The design also does not answer every possible question about treatment. The integrated intervention includes medication decision-making support, and medication management is described for participants who elect to start medication. The record does not report how many elected to do so, the medication exposure received, or the outcomes within that subset. The comparison therefore should not be recast as a direct test of medication versus no medication.

In general, randomized assignment supports a comparison of assigned intervention strategies, subject to the analysis and follow-up available. It does not automatically establish that every participant received the intended treatment or that missing follow-up had no effect. Those implementation and analysis details are not reported in the registry record. The adverse-event record lists zero events in the stated categories, but those entries do not demonstrate an absence of all possible harms.

The appropriate conclusion is descriptive: the registry records a completed randomized, parallel-group trial with a one-year, multi-domain primary outcome and the stated intervention contrast. The posted information does not provide the numerical results needed for an efficacy or precision judgment.

13. Why This Trial Matters Statistically

This trial is statistically notable for treating behavioral support and medication decision-making as components of competing intervention strategies rather than presenting medication exposure alone as the contrast. The registry describes CASH-AA in both arms and MIP as an added decision-making intervention in the integrated arm. That distinction matters when defining the estimand: a group comparison would concern assignment to these intervention strategies, not simply medication use versus non-use.

The primary outcome also spans several domains measured on different scales. ADHD symptom counts, delinquency counts, substance-use scores, and behavior checklist scores do not share one unit or one interpretation. Reporting each outcome with its scale, direction, and time point is important for statistical interpretation. A single summary can obscure domain-specific patterns, while multiple separate analyses raise questions about prespecification and multiplicity.

The registry identifies a baseline-to-one-year timeframe, but the available record does not give the outcome estimates, their uncertainty, or analysis populations. This is a useful reminder that a randomized design and a completed status do not, by themselves, communicate the size or precision of a result. Readers need group-level outcome data and a clear analysis description to assess how informative a comparison is.

The safety entries likewise illustrate the need to read counts alongside their at-risk groups and reporting context. Zero recorded events in the listed categories is not equivalent to a comprehensive demonstration of no risk. More broadly, this record highlights how conclusions depend on transparent outcome reporting, follow-up denominators, missing-data handling, and statistical methods, as well as on the intervention design.

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 is broad and includes several distinct measures. The registry does not reduce these categories or time points to one comparison, and the available record does not give individual measure results. This prevents assessment of whether the intervention groups had consistent patterns across ADHD symptoms, delinquency, substance use, and internalizing or externalizing symptoms.

The registry record does not report the statistical analysis plan, the method used to compare groups, adjustment for baseline values, or multiplicity handling. It also does not give arm-level outcome values, effect estimates, confidence intervals, or p-values. As a result, neither the magnitude of a group contrast nor its precision can be evaluated.

Although enrollment is listed as 145, the record does not provide the number analyzed for each outcome or the extent of one-year follow-up. Missing-data methods, analysis populations, and reasons for missing observations are not reported in the registry record. The available information therefore does not show how attrition or incomplete measurements were addressed.

Further details that could clarify interpretation are also absent: the randomization and allocation-concealment procedures, the identity of the masked parties, treatment duration and frequency, intervention adherence, and how medication decisions unfolded in practice. The record does not report the number who elected medication in the integrated arm. The adverse-event entries lack event-term detail and information about collection procedures. These limitations concern what can be learned from the registry record and do not establish flaws in trial conduct.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Integrated Treatment for Adolescents With ADHD — NCT02420990.
• Registry record last updated 2022-10-14; status last verified 2022-10.
• Results first posted 2022-07-18.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

The registry identifies NCT02420990 as a completed, randomized, single-masked, parallel-group trial titled Integrated Treatment for Adolescents With ADHD. The comparison is behavioral-only CASH-AA versus integrated behavioral and medication decision-making interventions, including MIP. Enrollment is listed as 145; the phase is NA.

The primary outcome is change from baseline to one year in ADHD symptoms and comorbid problems, measured across several symptom and behavior domains. The record provides measure descriptions and score directions but does not report a single numerical primary-outcome comparison or its uncertainty. Analysis methods, missing-data procedures, multiplicity handling, and analysis populations are not reported in the registry record.

For serious adverse events and other adverse events, the record lists 0 affected in the Behavioral Only- Treatment group among 53 at risk and 0 affected in the Integrated Treatment group among 92 at risk. Deaths are recorded as 0 in both groups. These safety entries should be interpreted within the event categories and reporting details available in the registry.