N/A
N=62
Investigation of Strategies to Reduce the Impact of the Relative Age Effect in Kindergarten
Attention Deficit Hyperactivity Disorder
Bottom Line
View on ClinicalTrials.gov: NCT05142826 ↗Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Disruptive Behavior Disorders Rating Scale — .8; 1.12; 1.03; 1.33 score on the scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Relative Age Effect Intervention (Behavioral); School as Usual (Other)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- Florida International University
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disruptive Behavior Disorders Rating Scale |
.8; 1.12; 1.03; 1.33; 1.15; 1.28 | — |
| PRIMARY Impairment Rating Scale |
1.48; 2.25; 1.84; 2.48; 2.43; 1.7 | — |
| PRIMARY Student Behavior Teacher Response Observation Code |
5; 5.67; 7; 5.56; 5.21; 5.75 | — |
| PRIMARY Academic Performance Rating Scale |
3.51; 3.22; 3.36; 3.17; 3.36; 3.34 | — |
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 negative effects for children who receive intervention, and risks include breach of confidentiality and worsening of symptoms initially if an intervention is instituted. The knowledge to be gained is important as it could reduce untoward outcomes for the relatively youngest children in the grade.
Eligibility Criteria
Inclusion Criteria
- enrolling in Kindergarten
- has a date of birth 4 months prior to the respective state cut-off for school entry
- does not have an Individualized Education program for behavioral concerns
- has not been retained in school or "red-shirted" by parents.
Exclusion Criteria
- outside of the targeted birthdate range
- diagnosed with autism, psychosis, or disruptive mood dysregulation disorder
- taking psychoactive medication for mood, behavior, or inattention,
- in a classroom with an already enrolled study participant.
Data sourced from ClinicalTrials.gov (NCT05142826). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.