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

Part of paid clinical trials in Amherst, New York.

Sponsor
Florida International University
Study ID
NCT05142826
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
4 Years - 5 Years
Healthy Volunteers
Not accepted

Interventions

  • Relative Age Effect Intervention — BEHAVIORAL
    School-based consultation to establish a developmentally appropriate daily behavior report; teacher education regarding developmentally appropriate behaviors; teacher consultation to promote positive behavior supports.
  • School as Usual — OTHER
    Interventions and supports as provided through usual care

Study Details

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.

Key Dates

Start date
Jun 1, 2022
Status verified
Nov 2025
Primary completion
Nov 30, 2024
Completion
Jun 1, 2025

Study Design

Enrollment
62 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: School as Usual
    School procedures as typically used and implemented.
  • Experimental: Immediate Relative Age Effect Intervention
    Relative age effect intervention administered in the Fall in school.
  • Experimental: Delayed Relative Age Effect Intervention
    Relative age effect intervention administered after the Winter break in school.

Primary Outcome Measure

Disruptive Behavior Disorders Rating Scale [ Time Frame: Baseline (Fall), 3 Months (Winter), 6 Months (Spring) and 12 Months (First Grade Follow-up) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Center for Children and FamiliesAmherstNew York14226-

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