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

NCT05142826 | Completed Results

• 2 other identifiers: IRB-20-0389R34MH122212
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD; kindergarten; relative age effect

Outcome Measures

Primary Outcomes (4)

• Disruptive Behavior Disorders Rating Scale

  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.

  Baseline (Fall), 3 Months (Winter), 6 Months (Spring) and 12 Months (First Grade Follow-up)

• Impairment Rating Scale

  ADHD impairment - teacher rating. Average score ranges from 0.0 to 6.0 with higher scores indicating greater impairment.

  Baseline (Fall), 3 Months (Winter), 6 Months (Spring) and 12 Months (First Grade Follow-up)

• Student Behavior Teacher Response Observation Code

  Number of disruptive behaviors; higher counts equal the presence of more classroom rule violations

  Baseline (Fall), 3 Months (Winter), 6 Months (Spring) and 12 Months (First Grade Follow-up)

• Academic Performance Rating Scale

  Teacher rating of academic productivity. Average scores range from 1.0 to 5.0 with lower scores indicating academic underperformance.

  Baseline (Fall), 3 Months (Winter), 6 Months (Spring) and 12 Months (First Grade Follow-up)

Other Outcomes (3)

• Number of Children Who Were Referred to Special Education

  Collected at the end of the kindergarten school year, approximately 10 months from the start of study procedures.

• Number of Children Who Were Prescribed Stimulant Medication

  Collected at the end of the kindergarten school year, approximately 10 months from the start of study procedures.

• Number of Children Who Were Retained in Kindergarten

  Collected at the end of the kindergarten school year, approximately 10 months from the start of study procedures.

Study Arms (3)

School as Usual

ACTIVE COMPARATOR

School procedures as typically used and implemented.

Other: School as Usual

Immediate Relative Age Effect Intervention

EXPERIMENTAL

Relative age effect intervention administered in the Fall in school.

Behavioral: Relative Age Effect Intervention

Delayed Relative Age Effect Intervention

EXPERIMENTAL

Relative age effect intervention administered after the Winter break in school.

Behavioral: Relative Age Effect Intervention

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.

Delayed Relative Age Effect Intervention; Immediate Relative Age Effect Intervention

School as Usual OTHER

Interventions and supports as provided through usual care

School as Usual

Eligibility Criteria

• Age: 4 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Florida International University: lead
• University at Buffalo: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Center for Children and Families

Amherst, New York, 14226, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Schools

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Non-Medical Public and Private Facilities

Results Point of Contact

• Title: Gregory A. Fabiano, Ph.D.
• Organization: Florida International University

gfabiano@fiu.edu

716-359-7823

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Observers are masked to group assignment of the participants
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: December 3, 2021
• Study Start: June 1, 2022
• Primary Completion: November 30, 2024
• Study Completion: June 1, 2025
• Last Updated: November 19, 2025
• Results First Posted: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Six months after the completion of the project.
• Access Criteria: Data will be shared through the NIMH data-sharing repository.

Locations

US (1)