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Attention Deficit Hyperactivity DisorderNCT05142826

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

A study testing Relative Age Effect Intervention and School as Usual in people with Attention Deficit Hyperactivity Disorder, run by Florida International University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 to 5 years
Conditions the study is for
Attention Deficit Hyperactivity Disorder
What is being tested?
Relative Age Effect Intervention and School as Usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteUnited States
Study dates
1 Jun 2022to 1 Jun 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 5 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Center for Children and Families

    Amherst, New York, 14226

Other trials in United States

About this study

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.

Read the detailed description

The entry to kindergarten is one of the most memorable and important milestones in a child's school career. Positive and quality kindergarten experiences have been associated with meaningful outcomes sustained into adulthood including greater rates of college attendance/higher earnings. Kindergarten entry is one of the first educational transitions made by a family, and it may cause stress and present new challenges for children and families. Given the increased demands that are associated with school entry and the concerns parents may have about this developmental milestone, there are numerous popular press and policy recommendations (e.g., National Association for the Education of Young Children), as well as empirical papers, that weigh in on the appropriate age to start kindergarten.

The transition to kindergarten is of particular concern for parents of children with ADHD, especially those relatively young for the grade. There is converging evidence suggesting that children who are young for their kindergarten class (e.g., they have a birthdate that falls within the months immediately preceding the cut-off date, typically August through November) are at increased risk for a range of negative educational outcomes including lower academic achievement, grade retention, social impairments, and ADHD diagnosis . These risks appear to be related to age of entry when other explanatory variables are controlled. Thus, these studies suggest that the robust evidence that children closest to an arbitrary cut-off date are disproportionally at-risk for negative social, behavioral, and educational outcomes is solely a consequence of educational policy - a phenomenon called the Relative Age Effect (RAE). Together, the consequence of these risks are 1.5x increased ADHD diagnostic rates and increased ADHD treatment with psychoactive medication for children relatively younger for their kindergarten grade .

There are prominent, candidate mechanisms that may explain the differential risk for children with ADHD who are also young for the grade. First, if a teacher is basing behavioral expectations for children in the classroom based on the relatively older children in the class, children who are relatively younger and have behaviors that are attributed to having considerable delays, even in situations where the child is acting in a manner consistent with their chronological age. Over time, if teachers are issuing frequent commands/reprimands, a coercive process may develop. Second, given expected variability in neurocognitive processing at this age level, inappropriate demands may fail to facilitate, and potentially even slow, the development of executive functions. The present proposal aims to reduce functional impairments and ADHD symptom levels by investigating whether evidence-based school treatment for ADHD (e.g., positive behavior supports) coupled with teacher training on the RAE results in improved school functioning for children with elevated ADHD symptoms prior to the kindergarten year. Further, the potential mechanism for the impairment experienced by children with ADHD will be explored, by investigating whether the impairments are due to characteristics of the child (e.g., deficits in neurocognitive development), the classroom (e.g., teacher classroom management strategies), or both.

Being tested
Relative Age Effect Intervention, School as Usual
Keywords
ADHD, kindergarten, relative age effect
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Relative Age Effect InterventionBehavioural

    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 UsualOther

    Interventions and supports as provided through usual care

Study groups in NCT05142826
Study groupRoleWhat they receive
School as UsualActive comparatorSchool procedures as typically used and implemented.
Receives: Other: School as Usual
Immediate Relative Age Effect InterventionExperimentalRelative age effect intervention administered in the Fall in school.
Receives: Behavioral: Relative Age Effect Intervention
Delayed Relative Age Effect InterventionExperimentalRelative age effect intervention administered after the Winter break in school.
Receives: Behavioral: Relative Age Effect Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. Impairment Rating Scale

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

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

  3. Student Behavior Teacher Response Observation Code

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

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

  4. Academic Performance Rating Scale

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2021
  2. Study start1 Jun 2022
  3. Primary completion30 Nov 2024
  4. Study completion1 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05142826
Sponsor's protocol ID
IRB-20-0389
Other IDs
R34MH122212
Status last verified
Nov 2025
First submitted
8 Nov 2021
Last updated
19 Nov 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified, anonymous data will be shared for the main outcome measures of the Disruptive Behavior Disorders Rating Scale and Impairment Rating Scale

Questions about this trial

What is this clinical trial studying?

A study testing Relative Age Effect Intervention and School as Usual in people with Attention Deficit Hyperactivity Disorder, run by Florida International University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.

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