Triple P forADHD Children's Mothers, Education of Behavioral Problems, and Change in Mothers' Attitude: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Triple P forADHD Children's Mothers, Education of Behavioral Problems, and Change in Mothers' Attitude (NCT07069621), a randomized na study. The primary outcome is SDQ: Strengths and Difficulties Questionnaire SDQ.

2. Clinical Question

The trial asks whether a Triple P parenting program is associated with changes in child behavior problems and mothers’ perspectives and competence. Its registry summary also identifies feasibility and cultural acceptability in the Palestinian context as questions of interest. The primary outcome is the Strengths and Difficulties Questionnaire (SDQ), assessed before the intervention and at post-intervention follow-up described as 12 months.

The listed secondary outcomes are the Parenting Scale and the Parenting Sense of Competence (PSOC) Scale. The trial summary frames these outcomes around mothers’ attitudes toward managing ADHD and their sense of competency. Although the record describes the intended questions, it does not report numerical findings for the primary or secondary outcomes. It also does not report a result for feasibility or cultural acceptability. The clinical question can therefore be described, but the registry record does not establish what changes were observed or how precisely any change was estimated.

3. Trial Design

The registry identifies this as a randomized, double-masked, parallel-group trial, with an enrollment of 67. It is marked completed. The sponsor is Palestine Polytechnic University. The registry lists the study start as 2023-07-25 and primary completion as 2024-08-30. The trial has no applicable phase designation.

The intervention was the Triple P level parenting program, classified as behavioral. Mothers assigned to the intervention had Triple P sessions; the control group did not receive Triple P. The record does not describe other control-arm care or activities. It identifies the population as mothers of children with ADHD, with an arm description specifying children aged 6-12 years for the intervention group.

Randomized allocation means assignment to the study arms was described as random. The registry labels masking as double, but does not state which participants, assessors, or other people were masked, or how masking was maintained. A parallel design means the arms are separate groups rather than a sequence of treatments received by the same participants; this is a general description of the design label, not an additional protocol detail.

The primary outcome timeframe is pre-intervention baseline and post-intervention at 12 months. The brief summary says outcomes would be evaluated pre- and post-intervention. The record does not provide a detailed visit schedule, explain whether all outcomes shared the same timing, or describe any deviations from the planned assessments. It also does not report the randomization procedure, allocation concealment, eligibility criteria in detail, or the planned statistical analysis. These details are not reported in the registry record.

Enrollment describes the trial’s stated enrollment, not necessarily the number with observed outcome data or included in an analysis. The record provides no primary-outcome analysis, and its analysis count is 0. Consequently, the enrollment figure cannot be treated as the denominator for an outcome estimate. The adverse-event entries list their own at-risk counts for the intervention and control groups, but the record does not explain how those counts relate to outcome follow-up or analysis populations.

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: files were searched for possible matched inclusion criteria

Intervention

13 Months

Analysis population for the primary outcome, as defined in the registry: mothers of ADHD children

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: Mothers of ADHD children

6. Primary Endpoint

The registry lists the primary outcome as SDQ: Strengths and Difficulties Questionnaire SDQ, measured over Pre (Baseline) intervention and Post (12 months).

The primary endpoint is the Strengths and Difficulties Questionnaire (SDQ), reported as a mean with standard deviation on a score scale. The registry describes the SDQ as a behavioral screening tool covering children’s emotional and behavioral difficulties through 25 items grouped into five subscales: Emotional Symptoms, Conduct Problems, Hyperactivity/Inattention, Peer Relationship Problems, and Prosocial Behavior.

Each subscale contains five items scored from 0 to 2, producing subscale scores from 0 to 10. The Total Difficulties Score combines the four difficulties subscales and ranges from 0 to 40. Higher values on the difficulties subscales and Total Difficulties Score indicate more difficulties; higher values on the Prosocial Behavior subscale indicate better social functioning. This direction differs across the prosocial and difficulties measures, so a score must be interpreted with its subscale in mind.

The SDQ is used to assess child behavior in relation to the trial’s question about whether the parenting program affects children’s ADHD behavioral symptoms. The registry specifies measurement at pre-intervention baseline and post-intervention at 12 months. It does not identify a single SDQ subscale or a single change score as the reported primary comparison. The registry notes that the primary outcome has several categories or time points and is not reduced to one comparison. No group means, standard deviations, changes, or uncertainty estimates for the SDQ are reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The methods that can be described from the registry are limited to the design labels, the named outcome measure, and the planned assessment timing. Randomized allocation, double masking, and a parallel model are recorded. The intervention is the Triple P level parenting program, and the control group did not receive Triple P. The record does not explain the randomization method, who was masked, or the statistical model used for any outcome.

What does a mean and standard deviation describe?

For a continuous outcome such as an SDQ score, a mean summarizes the group’s average score. A standard deviation summarizes how dispersed individual scores are around that average. These quantities answer different questions: a group mean describes its center, whereas the standard deviation describes variability among scores. A mean alone does not show whether most participants had similar scores or whether scores varied substantially. The registry says the SDQ is to be reported as mean ± standard deviation, but it does not provide those results.

The SDQ includes subscales with different interpretations. Higher scores on the four difficulties subscales and the Total Difficulties Score indicate greater difficulties, while higher Prosocial Behavior scores indicate better social functioning. An analysis that combines or compares scores must retain this distinction. For example, the direction that would be considered more favorable for a difficulties score is not the same as the direction for the prosocial score. This is a general point about interpreting the stated scoring system; it does not describe an observed trial result.

How would a group comparison be interpreted?

A between-group estimate would describe the difference in outcome between the intervention and control groups under a specified analysis. A change-from-baseline analysis would instead use each group’s follow-up score in relation to baseline, and then compare those changes or otherwise account for baseline. These approaches are not interchangeable in every setting. The registry record does not state which contrast was selected, whether baseline values were incorporated, or whether the reported endpoint was a post-intervention score, a change score, or another measure.

A confidence interval is a statistical expression of uncertainty around an estimate. A narrower interval generally indicates greater precision under the analysis assumptions, while a wider interval indicates less precision. A confidence interval also helps readers assess which effect sizes remain compatible with the data. It is not reported for the primary outcome in this record. A p-value, if used, would address evidence against a specified null hypothesis under an analysis model; it would not replace the estimate and its interval. No p-value for an outcome is reported.

Why can repeated assessments matter?

Baseline and follow-up scores from the same participant are related because they come from the same person. General statistical methods for repeated measures account for that relationship rather than treating all observations as unrelated. The choice of approach can affect the estimate and its uncertainty, particularly if follow-up availability differs or if the relationship between baseline and later scores matters. The record identifies the pre-intervention and post-intervention assessments but does not describe a repeated-measures model, a baseline-adjusted method, or any other analysis strategy.

The registry also flags multiple SDQ categories and time points without reducing them to a single comparison. When an analysis considers several outcomes or contrasts, multiplicity can arise: the chance of at least one apparently notable result can increase as more hypotheses are examined. Statistical approaches may address this in different ways, or a trial may designate a primary contrast in advance. The registry record does not report a multiplicity strategy or specify how the various SDQ subscales and assessment times were prioritized. This general concern does not establish that any particular adjustment was required or used.

What can the planning assumptions tell readers?

The record describes sample-size planning assumptions based on an observed effect, using a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation; the effect to detect is described as a stated fraction of the observed effect. These are planning assumptions, not evidence that the trial achieved a particular power. Planning illustrations concern sample sizes under stated assumptions and must not be interpreted as observed power or as outcome findings. The registry does not report the trial’s own design justification, the source or estimate of the observed effect used for any illustration, or a numerical planning result in the available record.

For any sample-size illustration, participants per arm for a stated power target would describe a hypothetical design under its assumptions, not the number of participants who actually experienced an outcome. Such calculations depend on the effect size, variability, allocation, statistical test, and assumptions about the data. They cannot fill the gap left by absent trial outcome estimates. The record does not provide enough detail to evaluate the assumptions behind the trial’s original design.

What does the registry report about the analysis?

The registry lists 0 analyses and does not supply numerical outcome results. It does not report analysis populations, handling of missing measurements, model diagnostics, covariate adjustment, or sensitivity analyses. These are not minor labels that can be reconstructed from the design alone: different choices may change what an estimate means and how much uncertainty it carries. Thus, the design and endpoint description support an explanation of the intended statistical questions, but not a reconstruction or appraisal of an actual primary analysis.

10. Multiplicity, Missing Data and Analysis Populations

The primary outcome is described across multiple SDQ categories and assessment times. The registry explicitly notes that the primary outcome has several categories or time points and is not reduced to one comparison. When multiple outcome dimensions or contrasts are examined, multiplicity is a statistical consideration because repeated testing can increase the chance of a result that appears unusual under a null model. A prespecified primary contrast or an adjustment method can help define how such results should be interpreted. The registry does not report a hierarchy among the SDQ scores, an adjustment for multiplicity, or a plan for selecting among time points.

The record does not report missing-data counts for the SDQ, completion at each assessment, reasons for missingness, or an imputation or other missing-data method. It also does not describe the analysis population, such as whether analyses were intended to follow randomized assignment or include only participants with observed outcome data. Enrollment of 67 does not establish how many observations were available for a particular endpoint or time point.

These gaps matter because missing measurements can affect both the group estimates and their uncertainty. General methods make different assumptions about why data are missing and may produce different results. Without counts, reasons, and an analysis description, readers cannot assess whether missingness might have introduced bias or how sensitive the findings are to the method used. Since no outcome analysis is reported, the registry record also provides no estimates on which to judge the impact of multiplicity or missing-data handling. The relevant analysis plan and results are not reported in 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 event figures separately for the intervention and control groups. For the intervention group, 33 participants are listed as at risk, with 0 serious adverse events and 0 deaths. For the control group, 31 participants are listed as at risk, with 0 serious adverse events and 0 deaths. The record also lists 0 other adverse events in each group.

These entries describe the counts recorded in the registry; they do not establish that no adverse events occurred outside the registry’s reporting scope. The record does not provide event definitions, the safety observation period, how adverse events were collected, or whether all enrolled participants contributed to these at-risk figures. It also does not explain the relation between these safety counts and the enrollment of 67.

Zero recorded events should not be read as proof that an intervention has no risks. In general, the interpretation of an absence of reported events depends on the size and duration of safety observation, the completeness of reporting, and the event definitions used. Here, no uncertainty estimate or additional safety analysis is reported. The figures are therefore best read narrowly as the adverse-event counts entered in the registry record, not as a comprehensive estimate of safety.

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

The record establishes that a randomized, double-masked, parallel-group trial of the Triple P level parenting program was completed and that the SDQ was identified as the primary outcome. It describes the intended comparison between mothers whose children received the Triple P sessions and a control group that did not receive Triple P. The outcome timeframe is pre-intervention baseline and post-intervention at 12 months. These details convey the study question and framework.

They do not establish whether the intervention changed child behavior, mothers’ attitudes, or mothers’ sense of competence. The registry does not report numerical SDQ results, results for the Parenting Scale or PSOC Scale, or findings on feasibility and cultural acceptability. Without estimates and uncertainty measures, it is not possible to determine the direction, magnitude, or precision of any effect from this record. The completion status indicates the trial is marked completed, not that its outcome analyses are available in the registry.

The SDQ’s score direction also matters. Higher values on the difficulties scales indicate more difficulties, while higher Prosocial Behavior scores indicate better social functioning. Even if scores were available, their meaning would depend on which subscale or total score was analyzed and how the intervention and control groups were compared. The registry does not identify a single primary contrast across its multiple categories and time points.

More generally, a study’s design can support a causal comparison when assignment, follow-up, analysis, and assumptions are appropriate, but the design label alone does not demonstrate that these conditions were met. The record does not describe masking procedures, outcome missingness, or the analysis model. No conclusion about efficacy or lack of efficacy follows from the absence of posted analyses. The defensible conclusion is limited: the registry describes the trial’s intended outcomes and records no numerical primary or secondary outcome analysis.

13. Why This Trial Matters Statistically

This trial is statistically noteworthy as a study with a clearly named continuous behavioral endpoint but no posted numerical analysis in the registry record. The SDQ is described with several subscales, a Total Difficulties Score, and both baseline and post-intervention assessments. That breadth makes the choice of estimand and primary contrast important: readers need to know which outcome dimension and time comparison represent the central question. The registry itself signals that the primary outcome has several categories or time points and does not reduce them to one comparison.

The case also illustrates why a design description and an outcome result are different kinds of information. Randomized allocation, masking, and a parallel model describe intended trial structure. They do not give the effect estimate, its uncertainty, the data included in analysis, or the handling of missing measurements. Those details are needed to judge how strongly the observed data address the clinical question.

The listed sample-size assumptions provide context for planning illustrations, but planning is not a substitute for an observed estimate. A planning calculation depends on assumptions about the effect and variability; it does not reveal what the trial found. Likewise, the adverse-event counts are a separate registry entry and cannot be used to infer the unreported behavioral outcomes.

For biostatisticians and clinical researchers, the main lesson is interpretive discipline: distinguish the protocol-level question from the results available for evaluation. Here, the registry gives the population, intervention, comparator, endpoint definition, and assessment timing, while leaving the actual outcome analysis unreported. That boundary prevents claims about treatment effects, but it also identifies what reporting would be needed for meaningful appraisal: a defined contrast, group estimates, uncertainty, analysis population, and transparent handling of missing data and multiple outcomes.

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.

A central limitation of interpretation is that no numerical primary or secondary outcome results are reported. The record lists 0 analyses, so there is no estimate to assess for size, direction, or precision. The trial’s completed status does not resolve this information gap.

The primary outcome spans multiple SDQ subscales, a Total Difficulties Score, and the stated baseline and post-intervention timing. The registry notes that it is not reduced to a single comparison. It does not specify which score or contrast was designated as primary for inference, or how multiple outcomes and time points were handled. This makes it difficult to identify the exact estimand that would answer the central question.

Important design and analysis details are not reported in the registry record. These include the randomization procedure, allocation concealment, identities of those masked, detailed eligibility criteria, the statistical model, baseline adjustment, the analysis population, missing-data methods, and sensitivity analyses. The record also does not report outcome completion by assessment or explain how the adverse-event at-risk counts relate to endpoint follow-up.

The registry’s brief description identifies questions about feasibility, cultural acceptability, attitudes, competence, and child behavior, but does not report methods or results for those questions beyond the named outcomes. The secondary outcomes are listed without numerical findings. No conclusion can therefore be drawn about their observed patterns or precision.

Finally, adverse-event entries are limited to the recorded counts and lack details on definitions, observation periods, and ascertainment. The sample-size assumptions describe planning illustrations but do not disclose the original design justification or observed endpoint data. Together, these limitations mean the record supports a description of the trial’s structure and intended measurements, but not a complete statistical appraisal of its findings.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Triple P forADHD Children's Mothers, Education of Behavioral Problems, and Change in Mothers' Attitude — NCT07069621.
• Registry record last updated 2026-01-29; status last verified 2026-01.
• Results first posted 2026-01-29.
• 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

NCT07069621 is a completed randomized, double-masked, parallel-group trial sponsored by Palestine Polytechnic University, with an enrollment of 67. The intervention was the Triple P level parenting program; the control group did not receive Triple P. The primary outcome was the SDQ, described as a mean with standard deviation and assessed at pre-intervention baseline and post-intervention at 12 months.

The registry lists the Parenting Scale and PSOC Scale as secondary outcomes and raises questions about child behavior, maternal competence and attitudes, feasibility, and cultural acceptability. It reports 0 analyses and does not provide numerical outcome results or a single primary comparison. Serious adverse event entries list 0 serious events and 0 deaths in both groups. The record therefore describes the trial’s question and design but does not permit interpretation of its outcome effects or their precision.