RAE Intervention for ADHD in Kindergarten

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Florida International University

Must not be taking: Psychoactive medications

Disqualifiers: Autism, Psychosis, Disruptive mood, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist kindergarteners who are young for their grade and exhibit signs of ADHD. The study will test a new approach called the Relative Age Effect Intervention, where teachers learn to better support these children, aiming to reduce unnecessary ADHD diagnoses and medication. Children will either continue with their usual school routine or receive this new support immediately or after the winter break. The trial seeks kids starting kindergarten who are born just before the school cut-off date and lack an educational plan for behavior. This research aims to improve school life and support for these young students. As an unphased trial, this study offers a unique opportunity to contribute to educational strategies that could enhance learning environments for young children.

Will I have to stop taking my current medications?

The trial excludes children who are currently taking psychoactive medication for mood, behavior, or inattention, so participants cannot be on these medications to join the study.

What prior data suggests that this intervention is safe for kindergarten children?

Research has shown that younger children in a class are more often diagnosed with ADHD and are more likely to receive medication for it. The Relative Age Effect intervention under testing aims to help by training teachers to better recognize and support these younger students.

Regarding safety, this intervention involves training teachers and altering how they support students in the classroom. It does not involve drugs or medical procedures, significantly reducing the risk of physical side effects. The main concerns might involve privacy or the possibility that a child's symptoms could initially appear worse when the intervention begins. However, these risks are considered minor compared to the potential benefits of reducing unnecessary ADHD diagnoses and medication in young children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Relative Age Effect Intervention because it's a fresh approach to managing ADHD in kindergarten-aged children. Unlike typical treatments like medication or behavioral therapy, this intervention focuses on the concept that a child's age relative to their peers can impact their development and behavior. The intervention is unique because it aims to adjust educational strategies based on the child's relative age, potentially reducing ADHD symptoms by addressing these developmental differences. This approach could provide a non-pharmacological option that aligns educational methods with a child's individual needs, offering a new avenue for early intervention.

What evidence suggests that this trial's interventions could be effective for reducing ADHD symptoms in young kindergarteners?

Research has shown that younger children in a grade are more likely to be diagnosed with ADHD and given medication, a phenomenon known as the Relative Age Effect. Studies have found that younger kids in a class often exhibit more ADHD symptoms than their older classmates. This trial will test the Relative Age Effect Intervention in two different arms: the Immediate Intervention, administered in the Fall, and the Delayed Intervention, administered after the Winter break. The new program aims to help teachers support these younger students by understanding normal development and using positive behavior strategies. This approach is expected to reduce ADHD symptoms and improve behavior by focusing on the specific challenges younger students face. Early results suggest that these strategies can help level the playing field for younger children in the classroom. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for children entering kindergarten who are young for their grade, born within 4 months of the state cut-off date. They should not have an Individualized Education Program for behavior, haven't been held back a year or 'red-shirted', and aren't on psychoactive medication or diagnosed with autism, psychosis, or disruptive mood dysregulation disorder.

Inclusion Criteria

I was born within 4 months before the school entry deadline in my state.

Has not been retained in school or 'red-shirted' by parents.

I am enrolling in Kindergarten.

Exclusion Criteria

I am on medication for mood, behavior, or attention issues.

My birthdate does not fall within the required range.

In a classroom with an already enrolled study participant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Development and Refinement

Development and refinement of the teacher intervention to attenuate the impact of the relative age effect on young kindergarteners with elevated ADHD symptoms

2 months

Immediate Intervention

Relative Age Effect prevention intervention administered immediately in the Fall

3 months

Monthly assessments

Delayed Intervention

Relative Age Effect prevention intervention administered after the Winter break

3 months

Monthly assessments

Follow-up

Participants are monitored for safety and effectiveness after intervention

4 months

Assessments at 9 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Relative Age Effect Intervention

Trial Overview The study tests a teacher-led intervention designed to reduce ADHD diagnosis risks due to age-related entry into kindergarten versus usual school experience. It involves educating teachers about relative age effects and using positive behavioral supports throughout the school year.

How Is the Trial Designed?

Group I: Immediate Relative Age Effect Intervention Experimental Treatment 1 Intervention

Relative age effect intervention administered in the Fall in school.

Group II: Delayed Relative Age Effect Intervention Experimental Treatment 1 Intervention

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

Group III: School as Usual Active Control 1 Intervention

School procedures as typically used and implemented.

Who Is Running the Clinical Trial?

Florida International University

Lead Sponsor

Trials

114

Recruited

19,400+

University at Buffalo

Collaborator

Trials

139

Recruited

105,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

In a 12-week study involving 55 adolescents treated with osmotic-release oral system methylphenidate (MPH) for ADHD, both patients and parents reported similar adverse events (AEs), but clinicians identified more AEs, especially at week 6, suggesting the need for comprehensive reporting methods.

The study highlights the importance of using a drug-specific checklist for clinicians to better capture AEs, as differences in reported AEs between patients and parents indicate that gathering information from both sources can provide a fuller picture of the treatment's safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two different solicitation methods for obtaining information on adverse events associated with methylphenidate in adolescents: a 12-week multicenter, open-label study. Lee, MS., Lee, SI., Hong, SD., et al.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9221667/

Relative Age Effect in Attention Deficit/Hyperactivity Disorder ... Parents' reports of ADHD behaviors are not consistently associated with relative age. Whereas two studies have shown a weak association with ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2949732924000115

Relative Age Effects on Attention-Deficit/Hyperactivity ... We investigated this “relative age effect” on educational achievement at age 15 to 16 years and on ADHD symptoms from age 7 to age 21 years.

3. link.springer.com link.springer.com/article/10.1007/s00787-024-02459-x

Systematic review and meta-analysis: relative age in ... One study found an association between younger relative age and higher scores for ADHD symptoms for both teacher and parent ratings (75% and 54% ...

4. pharmacytimes.com pharmacytimes.com/view/study-finds-relative-age-effect-on-adhd-diagnosis-and-prescription-of-medication-in-children

Study Finds Relative Age Effect on ADHD Diagnosis and ... One of the 2 studies took the effect of relative age on multiple neurodevelopment disorders and reported there was a highly pronounced drop in ...

5. thelancet.com thelancet.com/journals/lanpsy/article/PIIS2215-0366(23)00272-9/fulltext

an individual participant data meta-analysis One interpretation is that the relative age effect decreases the likelihood of children of older relative age receiving a diagnosis of ADHD, and ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2215036623002729

Association between relative age at school and ... We found that younger relative age was not statistically significantly associated with ADHD persistence at follow-up (odds ratio 1·02, 95% CI 0·99–1·06; p=0·19 ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39552820/

Relative Age Effects on Attention-Deficit/Hyperactivity ... Results showed that young-in-class children are more likely to be rated with ADHD symptoms by both parents and teachers, especially in middle childhood, and ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3328520/

Influence of relative age on diagnosis and treatment ... These studies found that children who were relatively younger than their peers within the same grade were more likely to receive a diagnosis or a prescription ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT05142826

Study Details | NCT05142826 | Investigation of Strategies ... The present proposal aims to develop a teacher intervention to attenuate the impact of the relative age effect on young kindergarteners with elevated ADHD ...