Improving Delay Discounting to Decrease Harsh Parenting Among Parents Receiving Substance Use Treatment: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Improving Delay Discounting to Decrease Harsh Parenting Among Parents Receiving Substance Use Treatment (NCT05229120), a na na study. The primary outcome is Change in Delay Discounting 5 Trial Adjusted Measure.

2. Clinical Question

The clinical question is whether this brief, low-cost intervention can be implemented with parents receiving substance use treatment and whether delay-discounting scores change over the stated assessment period. The study rationale links immediate-reward preference with parenting choices, describing physical punishment as an immediate response and shaping adaptive child behaviors as a benefit that may emerge over time. That rationale explains why delay discounting is of interest; it does not establish that a change in the measured score leads to a change in parenting behavior.

The registry lists change in Dyadic Parent-Child Interaction Coding System Scores and change in Alabama Parenting Questionnaire Scores as secondary outcomes. Their numerical results are not reported in the registry record. Consequently, the record does not establish whether scores on the primary measure or the parenting measures changed, how large any change was, or how precisely it was estimated. The single-group design also means that any observed within-participant change, if reported elsewhere, would not by itself distinguish an intervention effect from changes associated with time, treatment, repeated assessment, or other factors.

3. Trial Design

This completed study, NCT05229120, is titled “Improving Delay Discounting to Decrease Harsh Parenting Among Parents Receiving Substance Use Treatment.” Its official title specifies parents receiving substance use treatment in a low income community. The listed condition is Behavioral Health, and the sponsor is Henry Ford Health System. The study began on 2022-04-07, had primary completion on 2023-02-10, and is recorded as COMPLETED.

The registry describes the model as SINGLE GROUP, with allocation listed as NA and masking as NONE. Phase is listed as NA. Enrollment is 38. These details describe a study without a randomized comparator condition in the registry record. The intervention is Episodic Future Thinking, categorized as behavioral. Parents receiving residential substance use disorder treatment were to meet with peer recovery coaches who administered an adapted intervention focused on generating pleasant future events with their children.

The primary outcome is a continuous measure: change in the Delay Discounting 5 Trial Adjusted Measure, reported in log (k), with the timeframe stated as baseline and 4 weeks. The registry description also refers to an intervention assessment approximately 1 week after baseline and a post-intervention assessment approximately 4 weeks after baseline. For the stated primary analysis population, participants had to complete the measure at baseline and 4 weeks post. How many participants met that criterion is not reported in the registry record.

The listed secondary outcomes concern change in Dyadic Parent-Child Interaction Coding System Scores and change in Alabama Parenting Questionnaire Scores. The registry record lists four outcome measures and nine analyses, but does not report their statistical methods or numerical results. The record also does not report the protocol’s sample-size justification, an interim analysis plan, or a detailed statistical analysis plan. The sample-size assumptions associated with planning illustrations are not the trial’s own design assumptions or evidence of a randomized two-group trial. A design-based interpretation should therefore remain focused on a single-group intervention study with repeated assessment and no concurrent control comparison.

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: Participants included in analyses were those who completed the measure at both baseline and 4 weeks post.

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: Analyses of self-reported outcomes include only (n=15) parents who completed baseline and post-intervention. Additionally, only a subset of parents received the 5-trial adjusting measure. Only parent-child dyads that completed both the baseline and post-intervention parent-child interactions (n=6) were included in DPICS analyses.

6. Primary Endpoint

The registry lists the primary outcome as Change in Delay Discounting 5 Trial Adjusted Measure, measured over Baseline and 4 weeks.

The primary endpoint is change in the Delay Discounting 5 Trial Adjusted Measure, reported as log (k), between baseline and 4 weeks. The task uses a computer-based adjusting procedure to estimate the amount of immediately available money considered equivalent to a larger delayed sum. Delays are presented in randomized order, and the amount is adjusted in response to the participant’s earlier choices to identify an indifference point: the point at which the two monetary options are perceived as equivalent.

The resulting estimate is converted to a k-value and logarithmically transformed. According to the registry description, the transformation is intended to make the values normally distributed and leaves them unbounded by minimum and maximum values. Higher k-values indicate greater preference for immediate rewards. A change in this measure is therefore interpreted as a change in the measured tendency to discount delayed rewards, not as a direct count of parenting behaviors or a clinical outcome for a child.

The task is used because the study rationale treats parental delay discounting as a possible mechanism linking substance use and maladaptive parenting strategies. The registry describes a contrast between an immediately available outcome, such as stopping misbehavior through physical punishment, and a delayed benefit, such as shaping adaptive behavior over time. This conceptual framing supplies a reason to measure delay discounting, but does not show that the score is a validated proxy for harsh parenting in this study.

The registry specifies baseline and 4 weeks for the primary outcome and states that the analysis population consists of participants with both measurements. The numerical change, its variability, and the number of participants analyzed are not reported in the registry record. The endpoint’s direction and precision therefore cannot be assessed from the posted results.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a continuous primary outcome measured repeatedly in a single group. Statistical interpretation requires distinguishing the outcome definition, the change being estimated, the variability around that estimate, and the study design that determines what conclusions are justified. The registry record supplies the outcome description and broad design, but does not report a numerical primary result or detailed analytic procedure.

What does a change score represent?

In general, a change score compares a participant’s later measurement with that participant’s earlier measurement. A group summary of change describes the average pattern among those included in the analysis. It is not the same as comparing two independently assigned treatment groups. For this study, the primary timeframe is baseline and 4 weeks, and the analysis population is described as participants who completed both measurements. The exact calculation and aggregation method used for the posted endpoint are not reported in the registry record.

Because the measure is a logarithmically transformed k-value, its scale differs from the untransformed k-value. The registry states that higher k-values indicate greater preference for immediate rewards and that the logarithmic transformation is intended to support normally distributed values. A change in the transformed score should therefore be interpreted on the stated log (k) scale. The numerical estimate is not reported, so its direction and size cannot be described.

Why does variability matter?

General statistical explanation: a mean describes the center of a set of measurements, while a standard deviation describes how spread out the measurements are around that center. The registry identifies standard deviation as the dispersion measure for the primary continuous outcome, but the value is not reported in the registry record. Without the estimate and its variability, readers cannot judge whether participants’ changes were similar or widely dispersed.

General statistical explanation: a confidence interval conveys uncertainty around an estimated quantity. A narrower interval indicates greater precision under the model used; a wider interval indicates more uncertainty. The interval is not a guarantee about the true value, and its interpretation depends on the analysis assumptions. No confidence interval for the primary endpoint is reported in the registry record. A significance test, if available, would answer a different question from the confidence interval: it assesses how compatible the data are with a specified null hypothesis under the test assumptions, while the interval helps show the range of effect sizes compatible with the data.

What can a single-group design establish?

The registry identifies the model as single-group and lists allocation as NA. In general, repeated measurements within a group can describe whether the observed outcome differs across assessment times. Without a concurrent control group, however, that difference cannot by itself identify the cause. Secular change, treatment received outside the study intervention, assessment familiarity, and other influences may coincide with the intervention period. These are general alternative explanations; the registry record does not state that any particular one occurred.

A single-group result also cannot provide the same direct contrast as a randomized comparison. Random allocation, when used, supports balancing measured and unmeasured characteristics on average between assigned groups, subject to the study’s conduct and analysis. This registry record does not describe randomized allocation or a like-for-like control condition. The intervention’s effect relative to usual care or another intervention is therefore not estimated by the design as recorded.

How should planning estimates be separated from results?

General statistical explanation: sample-size planning asks how many participants might be needed to detect an assumed effect with specified error rates and analysis assumptions. A planning illustration based on an observed effect is conditional on that effect estimate and the stated assumptions. It does not describe the number actually analyzed, does not add a control group to the completed study, and is not observed power. The record’s planning assumptions describe a two-arm scenario with equal allocation and a normal approximation, although the study itself is single-group. These assumptions should not be mistaken for a protocol justification or the trial’s actual design.

The record states a two-sided significance level of 0.05 for the planning illustration. This does not establish that the trial’s primary analysis used that significance level; the inferential analysis plan is not reported in the registry record. The record also does not report a sample-size justification for the completed study. Consequently, no conclusion about whether enrollment was selected to achieve a particular precision or statistical power is warranted.

Why might over-dispersion matter in other outcome types?

General statistical explanation: for count outcomes, some models assume that variability follows a particular relationship to the mean. Over-dispersion occurs when observed variability exceeds that model’s assumption. If ignored, standard errors may be too small and confidence intervals or tests may appear more certain than justified. This concern is not a description of the stated primary endpoint, which is continuous. The registry record does not identify the specific statistical models used for the secondary outcomes or analyses, so it is not possible to say whether over-dispersion was relevant to any analysis in this study.

Likewise, time-to-event methods and their assumptions should not be attributed to this primary endpoint. The listed primary measure is a continuous delay-discounting score assessed at specified timepoints, not a time-to-event outcome. The registry record does not provide enough detail to reconstruct analysis choices, model diagnostics, covariate adjustment, handling of repeated measurements, or sensitivity analyses.

In general, a transparent analysis report would identify the participants analyzed, the change estimate, its standard deviation or other uncertainty measure, the confidence interval, and the statistical procedure. For this study, the numerical result and those analysis details are not reported in the registry record. The measure description supports understanding what was intended to be measured, but does not substitute for the observed estimate or the analysis method.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists four outcome measures and nine analyses. It names the primary change in delay discounting and two secondary measures: change in Dyadic Parent-Child Interaction Coding System Scores and change in Alabama Parenting Questionnaire Scores. The record does not provide numerical results for these outcomes or explain how the analyses were organized in relation to one another.

Multiplicity arises when several outcomes, timepoints, or statistical tests are examined. In general, more tests create more opportunities for a nominally unusual result to occur by chance, so a prespecified strategy may be used to control or interpret that risk. Whether the study used a multiplicity adjustment, a hierarchy of outcomes, or another strategy is not reported in the registry record. The count of listed analyses alone does not reveal which tests were planned, which were primary, or whether any adjustment was applied.

The primary analysis population includes participants who completed the measure at both baseline and 4 weeks post. The number meeting this criterion is not reported in the registry record. Enrollment is 38, but the record does not state how many participants contributed data at each assessment, how missing measurements were handled, or whether any imputation or sensitivity analysis was performed. The reasons for missing outcome data are also not reported in the registry record.

General statistical explanation: restricting an analysis to participants with complete measurements can be straightforward to describe, but the resulting estimate may be affected if completion is related to participants’ outcomes or other characteristics. That possibility cannot be assessed without information about follow-up completion and the missing-data process. The record also does not report whether analysis populations differed across outcomes.

The registry record does not state whether the outcome plan was prespecified in a protocol or statistical analysis plan, nor does it describe interim analyses. It is therefore not possible to assess selective reporting, deviations from a planned analysis, or the handling of multiple comparisons. No conclusion should be drawn about those practices from the outcome list alone.

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 38 participants at risk for serious adverse events and 0 affected in the Episodic Future Thinking group. For other adverse events, it also lists 38 at risk and 0 affected. Deaths are listed as 0, and no serious adverse event terms are listed.

These counts are a registry summary of the recorded safety information. They do not provide event-level descriptions, timing, severity categories beyond the serious-event grouping, or an explanation of how events were collected and classified. Such details are not reported in the registry record. The figures also do not show how long each participant was observed for safety reporting or whether every enrolled participant contributed equally to the reporting period.

General statistical explanation: a count of zero observed events means none were recorded in the stated group and reporting category; it does not establish that an event is impossible or that risk is absent. The interpretation depends on the number observed, the duration and completeness of follow-up, and the event definitions and ascertainment process. The registry’s 38 participants at risk provide context for the listed zero counts, but the record does not give further detail needed to characterize safety surveillance.

These adverse-event figures should be kept separate from the primary outcome. They do not indicate whether delay-discounting scores changed, and they do not establish an intervention effect. They describe only the adverse-event counts recorded for the stated group.

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

The study addresses a behavioral mechanism that the registry rationale connects with parenting choices: preference for smaller immediate rewards over larger delayed rewards. Its intervention uses episodic future thinking focused on pleasant events with children, administered by peer recovery coaches to parents receiving residential substance use disorder treatment. The primary measure is designed to quantify delay discounting rather than directly measure harsh parenting.

The registry record does not report the numerical primary outcome, so it cannot establish whether the measured delay-discounting score changed from baseline to 4 weeks, in which direction it changed, or how precisely it was estimated. The registry also names parenting-related secondary outcomes, but their results are not reported in the registry record. Thus, the available information cannot establish a change in parent-child interaction or parenting questionnaire scores.

Even if changes were reported, the design matters to what they mean. A single-group study can describe the course of measurements among observed participants, but a before-and-after change does not show that the intervention caused it. The design has no concurrent control condition recorded for comparison, so it cannot separate an intervention-related change from other changes over time, concurrent treatment, or effects of repeated measurement. These are limitations of causal interpretation, not evidence that any particular alternative explanation occurred.

The endpoint is also a measure of a proposed mechanism, not proof of a downstream clinical or family outcome. A change in delay discounting would not by itself demonstrate a change in harsh parenting, child maltreatment, or the intergenerational transmission of addictive disorders. Conversely, the registry rationale does not establish that a delay-discounting measure fully captures parenting behavior. The outcomes and results needed to evaluate those links are not reported in the registry record.

The study’s stated context and intervention may inform future research questions about behavioral approaches in substance use treatment settings. However, the result, precision, analyzed sample, and detailed analysis methods are not reported in the registry record. The appropriate interpretation is therefore limited to the registered design and measurement plan, without a claim that the intervention did or did not produce benefit.

13. Why This Trial Matters Statistically

Statistically, this study is notable for measuring a proposed behavioral mechanism in a setting where the registry rationale connects immediate-reward preference with parenting strategies. The task operationalizes delay discounting through choices between immediately available money and larger delayed sums. Describing the measure clearly matters because a score is an operational indicator of a construct, not the construct itself and not a direct measure of parenting behavior.

The repeated-assessment design also illustrates the distinction between describing change and attributing change. A single-group study can follow a measure over time, but without a concurrent comparison its observed trajectory cannot isolate the intervention’s contribution. This distinction is especially important when participants are also receiving residential substance use disorder treatment and the endpoint is measured across a period of time. The registry record does not identify which influences account for any potential change.

Outcome completeness is another statistical concern. The primary population is defined by completion of baseline and 4 weeks post measurements, but the number of participants meeting that definition is not reported in the registry record. Without that count and information about missing assessments, readers cannot assess how representative the analyzed group may be of those enrolled or how much uncertainty arises from incomplete follow-up.

Finally, the registry record lists several outcome measures and analyses, while detailed multiplicity and analysis plans are not reported. Clear reporting of prespecified outcomes, analysis populations, estimates, uncertainty, and missing-data handling would help readers distinguish confirmatory findings from exploratory ones. In this record, the primary endpoint result and its precision are not reported, so the statistical contribution is primarily the description of a research question and measurement approach rather than an interpretable effect estimate.

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 most direct limitation for interpreting the primary question is that its numerical result is not reported in the registry record. The record does not give the mean change, standard deviation, confidence interval, p-value, or number of participants included in the primary analysis. The direction, magnitude, and precision of any measured change therefore cannot be evaluated.

The design is recorded as single-group, with allocation listed as NA and masking as NONE. A comparator condition is not reported in the registry record. This prevents a direct estimate of how outcomes would have differed under a concurrent alternative condition and limits causal interpretation of any within-group change.

The intervention is described as an adapted episodic future thinking condition administered by peer recovery coaches and focused on pleasant future events with children. The registry record does not report implementation fidelity, participant engagement, intervention exposure, or variation in delivery. The extent to which the intervention was delivered as intended therefore cannot be assessed from the record.

Participants included in the primary analysis had to complete the measure at baseline and 4 weeks post. The number who did so, the reasons for any missing assessments, and the statistical handling of missing data are not reported in the registry record. This prevents evaluation of follow-up completeness and potential differences between participants with and without complete measurements.

The endpoint is a transformed delay-discounting measure, not a direct parenting outcome. Although the registry lists parenting-related secondary measures, their numerical results and analysis details are not reported. The relationship between change in the proposed mechanism and change in parenting behavior therefore cannot be assessed.

The registry record does not report the protocol’s sample-size justification, the detailed statistical analysis plan, interim analyses, multiplicity handling, or model diagnostics. It also does not describe adverse-event definitions or ascertainment beyond the summary counts. These reporting gaps limit assessment of the robustness and completeness of the study’s statistical and safety findings.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Improving Delay Discounting to Decrease Harsh Parenting Among Parents Receiving Substance Use Treatment — NCT05229120.
• Registry record last updated 2025-03-14; status last verified 2025-02.
• Results first posted 2025-03-14.
• 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

NCT05229120 is a completed, single-group behavioral study sponsored by Henry Ford Health System, with enrollment of 38. It examined Episodic Future Thinking for parents receiving residential substance use disorder treatment. Peer recovery coaches administered an adapted intervention focused on generating pleasant future events with children.

The primary outcome was change in the Delay Discounting 5 Trial Adjusted Measure, expressed as log (k), from baseline to 4 weeks. The primary analysis population comprised participants who completed the measure at both assessments. The registry also lists changes in Dyadic Parent-Child Interaction Coding System Scores and Alabama Parenting Questionnaire Scores.

The numerical primary and secondary outcome results, primary analysis sample count, and detailed statistical plan are not reported in the registry record. The design is single-group, with no comparator condition reported. Accordingly, the record describes the intervention and outcome framework but does not provide the estimates needed to assess observed change or its precision.