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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- 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 group | Role | What they receive |
|---|---|---|
| School as Usual | Active comparator | School procedures as typically used and implemented. Receives: Other: School as Usual |
| Immediate Relative Age Effect Intervention | Experimental | Relative age effect intervention administered in the Fall in school. Receives: Behavioral: Relative Age Effect Intervention |
| Delayed Relative Age Effect Intervention | Experimental | Relative 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.
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)
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)
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)
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.
- First posted3 Dec 2021
- Study start1 Jun 2022
- Primary completion30 Nov 2024
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Collaborators
- University at Buffalo, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Strategies to Reduce the Impact of the Relative Age Effect in Kindergarten
- ClinicalTrials.gov ID
- NCT05142826
- Acronym / sponsor ID
- IRB-20-0389
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, kindergarten, relative age effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Collaborators
- University at Buffalo, National Institute of Mental Health (NIMH)
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 3 Dec 2021 (actual)
- Results
- Posted 19 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| School as Usual | Active comparator | Other: School as UsualSchool procedures as typically used and implemented. |
| Immediate Relative Age Effect Intervention | Experimental | Behavioral: Relative Age Effect InterventionRelative age effect intervention administered in the Fall in school. |
| Delayed Relative Age Effect Intervention | Experimental | Behavioral: Relative Age Effect InterventionRelative age effect intervention administered after the Winter break in school. |
Who may qualify
- Ages
- 4 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relative Age Effect InterventionSchool-based consultation to establish a developmentally appropriate daily behavior report; teacher education regarding developmentally appropriate behaviors; teacher consultation to promote positive behavior supports. | Behavioural | Delayed Relative Age Effect Intervention, Immediate Relative Age Effect Intervention |
| School as UsualInterventions and supports as provided through usual care | Other | School as Usual |
Primary outcome
Disruptive Behavior Disorders Rating Scale
Time frame: Baseline (Fall), 3 Months (Winter), 6 Months (Spring) and 12 Months (First Grade Follow-up)
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.
Impairment Rating Scale
Time frame: Baseline (Fall), 3 Months (Winter), 6 Months (Spring) and 12 Months (First Grade Follow-up)
ADHD impairment - teacher rating. Average score ranges from 0.0 to 6.0 with higher scores indicating greater impairment.
Student Behavior Teacher Response Observation Code
Time frame: Baseline (Fall), 3 Months (Winter), 6 Months (Spring) and 12 Months (First Grade Follow-up)
Number of disruptive behaviors; higher counts equal the presence of more classroom rule violations
Academic Performance Rating Scale
Time frame: Baseline (Fall), 3 Months (Winter), 6 Months (Spring) and 12 Months (First Grade Follow-up)
Teacher rating of academic productivity. Average scores range from 1.0 to 5.0 with lower scores indicating academic underperformance.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified, anonymous data will be shared for the main outcome measures of the Disruptive Behavior Disorders Rating Scale and Impairment Rating Scale
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.