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 — BEHAVIORALSchool-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 — OTHERInterventions 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 UsualSchool procedures as typically used and implemented.
- Experimental: Immediate Relative Age Effect InterventionRelative age effect intervention administered in the Fall in school.
- Experimental: Delayed Relative Age Effect InterventionRelative 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Center for Children and Families | Amherst | New York | 14226 | - |
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