Testing the Effectiveness of Telephone-based Early Childhood Developmental Screening: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Testing the Effectiveness of Telephone-based Early Childhood Developmental Screening (NCT02495025), a randomized na study. The primary outcome is Number of Participants Screened With a Validated Tool.

2. Clinical Question

The clinical question concerns the delivery of developmental screening through a telephone-based model compared with the clinic-based usual-care approach described in the registry. It is a question about whether screening with a validated instrument took place, not about whether children’s developmental outcomes changed or whether a particular referral led to a service or benefit.

The registry’s primary-outcome description names the Parental Evaluation of Developmental Status (PEDS), PEDS: Developmental Milestones (PEDS:DM), the Ages and Stages Questionnaires (ASQ), and the Modified Checklist for Autism in Toddlers (MCHAT), Revised version, as instruments that could meet its definition. It does not report which specific instruments were used for each participant. The study also lists referral for evaluation or services and primary-care experiences as secondary outcomes, but those address different questions from the primary screening outcome.

3. Trial Design

The registry describes a randomized, parallel-group trial with no masking. It lists an enrollment of 152 participants and two arms: Telephone-based Screening and Usual Care. The reported arm sizes are 77 and 75 participants, respectively. The record labels the study completed and gives its start as 2015-02-01 and primary completion as 2016-12-31.

In the telephone arm, families were to be connected with 211 Los Angeles to complete developmental screening by phone. The intervention description refers to three structured, validated parent-report tools, though the record’s arm description is truncated and does not give a complete account of the intervention procedures. The primary-outcome description names several instruments that could be used to establish whether validated screening occurred, but it does not identify the instruments actually used for each family.

The comparator was usual care in a primary care pediatrics clinic. The registry describes scheduled well-child visits, clinic-based developmental screening and care coordination, and referral of developmental or behavioral concerns to the child’s pediatrician. The brief summary also describes the control group as receiving usual care with their pediatricians.

The primary outcome was assessed at 6 months and counted participants screened with a validated tool. The record also lists referral for evaluation or services and primary-care experiences as secondary outcomes. It does not report the number of sites, detailed recruitment procedures, eligibility criteria, participant baseline characteristics, allocation-concealment procedures, or the exact timing of every assessment. A planned allocation ratio or detailed protocol is 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 Number of Participants Screened With a Validated Tool, measured over 6 months.

The primary endpoint is the number of participants screened with a validated tool by 6 months. It is a count of participants for whom the screening event was recorded, rather than a measurement of developmental ability, a screening score, or a diagnosis. The registry defines the event by whether developmental screening was done using an instrument recommended by the American Academy of Pediatrics and lists PEDS, PEDS:DM, ASQ, and the revised MCHAT among possible instruments.

This endpoint is relevant to the trial’s delivery question because the intervention changes how screening is offered: by telephone and care coordination rather than through the clinic-based usual-care approach. Counting participants who received validated screening therefore describes implementation of the intended screening process. It does not by itself establish the accuracy of screening, whether a concern was correctly identified, whether families completed a recommended evaluation, or whether a child’s later developmental status changed.

The reported arm values are 57 participants in the telephone-based screening group and 0 in usual care. The denominators are 77 and 75 participants. Those counts describe what was recorded for this endpoint; they should not be treated as evidence about unreported developmental outcomes or about the effect of screening on health. The registry does not report details of how outcome ascertainment was conducted, how missing endpoint data were handled, or whether assessors were masked.

7. Results Posted in the Registry

• Telephone-based Screening: 74.0% (57/77) versus 0.0% (0/75) on control; risk difference 74.0 percentage points (95% CI 64.2 to 83.8); unadjusted two-proportion z-test p = <0.001.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Number of Participants Referred for Evaluation/Services (Early Intervention or Early Childhood Special Education)

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Telephone-based Screening: 32.5% (25/77) versus 9.3% (7/75) on control; risk difference 23.1 percentage points (95% CI 10.8 to 35.5), risk ratio 3.48 (1.60–7.55); unadjusted two-proportion z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the proportion with the event is statistically higher for Telephone-based Screening than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The secondary outcomes address steps and experiences beyond the primary question of whether validated screening took place. The registry lists referral for evaluation or services, including Early Intervention or Early Childhood Special Education, and primary-care experiences involving anticipatory guidance and family-centered care. The posted referral comparison follows the same general direction as the primary screening result: referrals were more frequent in the telephone arm than in usual care. This pattern is compatible with a pathway in which more screening is accompanied by more identification or referral, but the registry does not report the reasons for individual referrals or their subsequent completion.

Referral is not interchangeable with screening. A referral records a decision or process step; it does not establish that an evaluation occurred, that a child received a service, or that a participant benefited. Similarly, the primary-care-experience outcome concerns reported discussions and experiences, rather than screening completion itself. Numerical results for that experience outcome are not reported in the registry record, so its relationship to the primary result cannot be assessed from the posted data.

The referral comparison is unadjusted. General statistical explanation: when investigators examine multiple outcomes, the chance of at least one apparently notable result can increase if each is tested without accounting for the family of comparisons. The registry does not report a multiplicity plan or adjusted secondary analyses. Secondary findings therefore deserve less weight than a prespecified primary outcome, especially where the analysis plan and missing-data handling are not described. The registry does not report whether the secondary outcomes were designated in advance as confirmatory or exploratory.

As a whole, the available secondary information is consistent with a difference in care processes, but it does not complete the chain from screening to evaluation, service receipt, or developmental outcome. It should be interpreted as supporting context rather than as independent proof of broader effects.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Number of Participants Referred for Evaluation/Services (Early Intervention or Early Childhood Special Education)
• Primary Care Experiences: Percent of Anticipatory Guidance Topics Discussed & Percentage of Family-Centered Care Items That Participants Report as Usually or Always

9. Statistical Interpretation

10. Statistical Methods Explained

What kind of outcome was analyzed?

The primary outcome is binary at the participant level: a participant either had validated developmental screening recorded or did not. The registry displays the number of participants with the event and the number in each arm. A count of events alone is not sufficient to compare groups, because the groups may have different sizes; the denominators put those counts in context. Here, the posted arm sizes are 77 and 75.

General statistical explanation: for a binary outcome, a risk is the proportion of participants who experience the event. A risk difference compares the two group risks by subtracting one from the other. A positive difference for the intervention-versus-control direction means the event was more common in the intervention group. This is an absolute contrast, not a relative measure. The registry reports the primary comparison as a risk difference and provides its confidence interval and an unadjusted p-value.

How should the p-value be read?

The primary comparison has a reported unadjusted p-value of <0.001. General statistical explanation: a p-value assesses how unusual data at least as incompatible with a null comparison would be if the null model and the test assumptions held. It is not the chance that the observed result is due to chance, and it does not give the probability that the intervention is effective. A small p-value also does not establish that an outcome is important to participants or that the result applies beyond the study setting.

The label unadjusted matters. It indicates that the posted p-value is not presented as corrected for testing multiple outcomes or comparisons. The registry does not identify the exact test, its assumptions, whether an adjusted analysis was performed elsewhere, or whether the p-value accounts for any design features beyond the randomized groups.

What does the confidence interval add?

General statistical explanation: a confidence interval describes a range of values compatible with the data and the method used, under repeated-sampling assumptions. It shows uncertainty around an estimate and should be read alongside the estimate itself. The posted interval for the primary risk difference lies above zero. That is consistent with the direction of the observed group contrast. The interval does not cover uncertainty arising from unreported procedures, possible missingness, measurement error, or limitations in generalizability.

The record gives a numeric interval, but the exact confidence-interval method is not reported in the registry record. No adjustment for baseline variables is stated. The primary comparison therefore should not be described as an adjusted treatment effect.

What can the secondary comparison contribute?

The registry also posts an unadjusted comparison for referral to evaluation or services. This outcome is binary as recorded in the arm counts. The posted estimate is a risk difference, and relative measures are also listed. General statistical explanation: an absolute contrast and a relative contrast answer different questions. The risk difference describes separation between group risks on an absolute scale; a relative measure expresses one group’s risk in relation to another. Relative measures can be sensitive to the baseline risk, and neither measure establishes that referred participants received services.

The registry does not list reported analyses for the secondary outcomes. The comparison values should therefore be treated as posted numerical results rather than as a fully described analysis plan. There is no reported adjustment for multiple testing, and the number of outcomes considered makes selective emphasis a concern. The additional primary-care-experience outcome has no numerical result in the record.

How should the planning illustration be understood?

The registry includes a planning illustration based on the observed referral effect. Its assumptions are a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. The listed rows plan for 100%, 75%, and 50% of the observed effect. For 100% of the observed effect, the illustration gives 48 participants per arm for 80% power and 63 participants per arm for 90% power. For 75%, the corresponding figures are 76 and 101 participants per arm. For 50%, they are 150 and 200 participants per arm.

These are planning illustrations, not the trial’s original sample-size justification and not observed power. They depend on the observed referral effect and the stated assumptions. The registry does not report the trial’s own sample-size assumptions, target effect, or justification. The illustration is associated with the referral comparison; it should not be taken as evidence that the trial was planned or sized for the primary screening outcome.

11. Confidence Intervals and Precision

The primary comparison is reported with a confidence interval whose limits are both above zero. This indicates that the interval generated by the reported method does not include no difference and is consistent with the direction of the observed contrast. The reported p-value is <0.001. Together, the interval and p-value indicate that the posted data provide strong evidence of a difference in recorded screening between the randomized groups under the analysis used.

Precision is not the same as validity. A confidence interval quantifies sampling uncertainty under a statistical method; it does not account for systematic differences in how outcomes were recorded, unreported missing data, deviations from the intended intervention, or limitations in participant selection. The registry does not describe these issues in enough detail to evaluate their impact. The lack of masking is relevant because participants and care teams knew the assigned group, but the record does not report whether outcome recording could have been influenced by that knowledge.

The arm counts give a useful sense of the amount of information behind the primary outcome, but the outcome is highly imbalanced in the posted results: there were no recorded screening events in usual care. The registry provides an interval for the risk difference, but does not describe the interval construction or the specific statistical test. That missing methodological detail limits independent assessment of how the uncertainty was estimated, particularly given the zero-event control group.

For the secondary referral outcome, the posted confidence interval also lies above zero and the unadjusted p-value is <0.001. This supports a difference in referrals as recorded, while leaving uncertainty about what happened after referral. Precision for the primary-care-experience outcome cannot be assessed because numerical results and corresponding intervals are not reported in the registry record. Overall, the reported intervals describe statistical uncertainty in the comparisons that have numerical results, not certainty about broader clinical consequences.

12. Multiplicity, Missing Data and Analysis Populations

The registry lists one primary outcome and several secondary outcome topics, including referrals and primary-care experiences. It does not report a multiplicity strategy, such as a hierarchy of testing, a correction for multiple comparisons, or a rule for interpreting secondary results. The posted primary p-value is identified as unadjusted, and the referral comparison is also unadjusted. Without a prespecified approach to multiple testing, secondary p-values should not be treated as confirmatory evidence on their own.

Missing-data procedures are not reported in the registry record. The posted arm denominators are 77 for telephone-based screening and 75 for usual care, but the record does not state whether these are all randomized participants for each outcome, whether any participants lacked outcome data, or how missing observations were classified. It also does not describe imputation, complete-case analysis, sensitivity analyses, or reasons for missingness. The zero recorded screening events in usual care should therefore be read as the posted outcome count, not as proof that no participant had unrecorded or unavailable data.

The analysis population is not specified. The record does not say whether results follow an intention-to-treat principle, include only participants who completed follow-up, or use another population definition. It also does not report exclusions after randomization, crossover, or adherence to the assigned approach. These details matter because analyses that omit participants or classify outcome availability differently can change the interpretation of a randomized comparison.

Although the study is described as randomized, the methods for sequence generation and allocation concealment are not reported. Masking is listed as none. The record does not specify whether outcome assessors were masked or whether assessment procedures were standardized across groups. These omissions do not establish that bias occurred, but they limit assessment of the protections against bias, the role of missing data, and the strength of inference from the posted comparisons.

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 no serious adverse events in either arm and no deaths. It also reports no other adverse events in either arm. The at-risk counts are 77 for telephone-based screening and 75 for usual care. These figures describe the adverse-event entries recorded in the registry; they do not show that every possible harm was systematically assessed or that no unrecorded events occurred.

The intervention is described as telephone-based screening and care coordination, but the record does not give details of adverse-event definitions, collection methods, monitoring duration, or how events were attributed to an intervention. It also does not report whether participants withdrew because of an adverse event. Consequently, the absence of recorded events should be interpreted as an absence of events listed in the posted safety data, not as proof of zero risk.

These safety figures are separate from the primary outcome. They do not alter the interpretation of screening completion, and they do not provide evidence about effectiveness. The small number of participants represented by the arm counts also means that event-free registry entries cannot rule out uncommon harms.

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

The primary result describes a difference between randomized groups in whether validated developmental screening was recorded by 6 months. The telephone-based group had 57 participants with the event among 77, while usual care had 0 among 75. The posted risk-difference comparison has a confidence interval above zero and an unadjusted p-value of <0.001. This is evidence of a difference in the recorded screening process in this trial.

It does not show that the intervention improved children’s development, prevented developmental disabilities, or improved the accuracy of screening. Those are distinct outcomes, and the primary endpoint counts screening rather than developmental status or diagnostic performance. The result also does not establish that families completed referred evaluations or received early-intervention or special-education services. The registry’s referral outcome records referrals, not completion or subsequent benefit.

The trial compares a telephone-based model with the usual-care approach described in the record. It does not isolate the contribution of any single component, such as the telephone contact, care coordination, the screening instruments, or connection with 211 Los Angeles. The registry does not report enough procedural detail to identify which elements drove the observed contrast.

The estimate applies to the participants and setting represented in this trial. Detailed participant characteristics, recruitment details, and information about the number of sites are not reported in the registry record, so the extent to which the results apply to other populations or health-care settings cannot be established from the record alone. The absence of masking, unspecified outcome ascertainment, and unreported missing-data procedures also limit how completely the comparison can be evaluated.

The appropriate interpretation is therefore focused: the posted results show substantially different recorded screening completion between the study arms. They do not, by themselves, answer whether the model changes developmental outcomes, improves the quality of care, or produces lasting benefits.

15. Why This Trial Matters Statistically

Statistically, this trial asks a practical implementation question rather than measuring a developmental score: whether participants received validated screening through one care-delivery approach or another. That distinction matters because process outcomes can show whether a service was delivered, but they are not substitutes for patient or child outcomes. The primary endpoint is directly connected to the intervention’s purpose while remaining limited to the occurrence of screening.

Randomization provides a framework for comparing the two approaches, and the posted outcome counts show a clear separation in recorded screening. The confidence interval and p-value describe sampling uncertainty for the comparison under the method used. Their interpretation still depends on information that the registry does not report, including outcome ascertainment, analysis population, missing-data handling, and the statistical test.

The trial also illustrates why absolute measures are useful. A risk difference describes the contrast in event frequency between groups on an absolute scale, which is often more directly interpretable for a care-delivery outcome than a relative measure alone. The secondary referral comparison adds context about a related care process, but it does not demonstrate service receipt or developmental change. Unadjusted secondary findings should not be elevated above the primary outcome without a clear multiplicity plan.

Finally, the registry’s sample-size illustration is based on the observed secondary referral effect and explicit planning assumptions. It is not the original trial design justification and does not represent observed power. Distinguishing those concepts is important: a planning calculation can illustrate what sample sizes correspond to assumed effects, but it cannot retroactively establish the design intent or the certainty of the trial’s result. The registry record leaves the original sample-size rationale and formal analysis plan unreported.

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 record leaves several trial-specific details unavailable. It does not give detailed eligibility criteria, participant characteristics, recruitment procedures, or the number of clinical sites. Although the study is described in relation to vulnerable populations and a primary care pediatrics clinic, those descriptions are not enough to characterize who participated or how representative the sample was.

The intervention description is incomplete in the registry, and the usual-care description is also truncated. The record does not fully specify how telephone screening and care coordination were delivered, how many contacts were attempted, or how completion was documented. It names possible validated instruments but does not identify which tools were used for individual participants. As a result, the precise distinction between intervention delivery and outcome measurement cannot be fully evaluated.

The primary endpoint measures whether screening occurred, not whether a screen was positive, whether a concern was accurately identified, or whether subsequent evaluation or services were completed. The registry does not provide numerical results for the listed primary-care-experience outcome. The referral endpoint offers information about another care process, but not about service uptake or later developmental status.

Masking is listed as none, and the record does not state whether outcome assessors were masked. The registry also does not report the analysis population, missing-data methods, protocol deviations, or a multiplicity strategy. These omissions constrain assessment of bias and uncertainty. They do not establish that the results are biased, but they prevent a complete review of how participants and outcomes were handled.

Finally, the posted comparison is not accompanied by a reported statistical-analysis plan or a description of the exact test used. The planning illustration concerns the secondary referral effect and is not the study’s stated sample-size justification. These limitations mean that the result is best read as a comparison of recorded screening within the trial, rather than a complete account of all effects or of the intervention’s broader performance.

17. Related Tutorials

18. Related Statistical Calculators

19. Sources

• ClinicalTrials.gov: Testing the Effectiveness of Telephone-based Early Childhood Developmental Screening — NCT02495025.
• Registry record last updated 2019-10-14; status last verified 2019-09.
• Results first posted 2019-10-14.
• 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.

20. Record Summary

NCT02495025 is a completed randomized, parallel-group study titled “Testing the Effectiveness of Telephone-based Early Childhood Developmental Screening.” The official title describes developing and testing a telephone-based screening and care-coordination model in vulnerable populations. The registry lists 152 enrolled participants and no masking.

The intervention arm received telephone-based developmental screening and care coordination, with families connected to 211 Los Angeles. The comparator was usual care with clinic-based screening and care coordination. The primary outcome counted participants screened with a validated tool at 6 months. The posted counts were 57 of 77 in the telephone arm and 0 of 75 in usual care; the comparison has an unadjusted p-value of <0.001.

The registry also posts a referral comparison, but does not provide numerical results for the listed primary-care-experience outcome. It reports no serious adverse events, other adverse events, or deaths in either group. Detailed analysis methods, missing-data procedures, analysis populations, and the trial’s own sample-size justification are not reported in the registry record.