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NCT05142826 · ClinicalTrials.gov registry record · NA

Investigation of Strategies to Reduce the Impact of the Relative Age Effect in Kindergarten

A NA study, sponsored by Florida International University.

Completed
Registry status
NA
Development phase
62
Enrollment target

NCT05142826: Completed NA study, sponsored by Florida International University.

NCT05142826 is a NA study that has completed, run by Florida International University. The registered enrollment target is 62 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05142826, a NA study, has completed, sponsored by Florida International University.

COMPLETED
Registry status
NA
Development phase
62 participants
Enrollment target

Study Summary

There is now clear evidence that children entering kindergarten, that are relatively young for the grade (e.g., born in the months immediately preceding the school entry cut-off) are at significantly more risk for receiving an ADHD diagnosis and being prescribed stimulant medication. These risks appear to be related solely to age of entry when other explanatory variables are controlled. This situation, termed the "Relative Age Effect"has potentially serious consequences for kindergarten children (e.g., greater likelihood of being prescribed psychoactive medication to control behavior). The present proposal aims to develop a teacher intervention to attenuate the impact of the relative age effect on young kindergarteners with elevated ADHD symptoms, and test the correspondence between the hypothesized mechanisms and treatment outcomes related to ADHD (e.g., symptoms, impairment). Following intervention development and refinement, 60 children entering kindergarten in the fall, and young for the grade, will be randomly assigned to (1) Kindergarten as Usual (KAU); (2) a Relative Age Effect prevention intervention administered immediately; or (3) a Relative Age Effect prevention intervention administered mid-year. In the intervention groups, teachers will be introduced to the relative age effect, receive information on how to anchor behavioral ratings in developmental norms, and implement a positive behavioral support to support growth in the child across the kindergarten school year. Primary aims will be to demonstrate the feasibility and acceptability of the intervention approach as well as the ability of the team to retain young children in a longitudinal trial. Further, the hypothesized mechanisms (e.g., improved neurocognitive functioning; improved teacher use of positive behavioral supports) will be measured and correspondence to hypothesized outcomes (e.g., reduced ADHD symptoms and impairment) will be evaluated. Anticipated benefits include attenuation of any ne

Primary Outcome

Average score for ADHD symptom ratings on the Disruptive Behavior Disorders rating scale Average score ranges from 0.0 to 3.0 with higher scores indicating greater impairment.

Interventions

  • OTHER School as Usual
  • BEHAVIORAL Relative Age Effect Intervention

Trial Details

FieldValue
Enrollment Target 62 participants
Start Date 2022-06-01
Est. Completion 2025-06-01
Phase NA
Florida International University

89 total trials

What the finished NCT05142826 record still lists

NCT05142826 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 2 interventions - of which School as Usual is the first listed.

NCT05142826 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05142826 about?

NCT05142826 is a clinical study titled "Investigation of Strategies to Reduce the Impact of the Relative Age Effect in Kindergarten". There is now clear evidence that children entering kindergarten, that are relatively young for the grade (e.g., born in the months immediately preceding the school entry cut-off) are at significantly more risk for receiving an ADHD diagnosis and being prescribed stimulant medication. These risks app...

What is the current status of trial NCT05142826?

This trial is currently completed. It is a NA study. The enrollment target is 62 participants. The study started on 2022-06-01. Estimated completion is 2025-06-01.

What interventions are being tested in trial NCT05142826?

The interventions under investigation include: School as Usual (OTHER), Relative Age Effect Intervention (BEHAVIORAL).

Who is sponsoring clinical trial NCT05142826?

This trial is sponsored by Florida International University, which has 89 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05142826's enrollment target sits among peer trials

62 1157th of 2000 higher than 837 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05142826, the US trial registry maintained by the National Library of Medicine. NCT05142826 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.