60 Participants Needed

RAE Intervention for ADHD in Kindergarten

Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Florida International University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the RAE Intervention treatment for ADHD in kindergarten?

The Preschool First Step (PFS) program, a similar early intervention for children at risk for ADHD, showed significant improvements in social skills and behavior problems, suggesting that early interventions can be effective for young children with ADHD.12345

Is the RAE Intervention for ADHD in Kindergarten safe for children?

There is no specific safety data available for the RAE Intervention for ADHD in Kindergarten, but studies on ADHD treatments in young children suggest that while some medications can have side effects, behavioral interventions are generally considered safe.678910

How is the RAE Intervention for ADHD in Kindergarten different from other treatments?

The RAE Intervention for ADHD in Kindergarten is unique because it focuses on the relative age effect, which considers the impact of a child's age relative to their peers in the same school year. This approach is different from traditional treatments that often involve medication or behavioral therapy, as it addresses the potential misdiagnosis and overmedication of younger children in a classroom setting.4671112

Eligibility Criteria

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.
See 1 more

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.
See 1 more

Timeline

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

Treatment Details

Interventions

  • Relative Age Effect Intervention
Trial OverviewThe 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.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Immediate Relative Age Effect InterventionExperimental Treatment1 Intervention
Relative age effect intervention administered in the Fall in school.
Group II: Delayed Relative Age Effect InterventionExperimental Treatment1 Intervention
Relative age effect intervention administered after the Winter break in school.
Group III: School as UsualActive Control1 Intervention
School procedures as typically used and implemented.

Find a Clinic Near You

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+

Findings from Research

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.
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]

References

The long-term outcomes of interventions for the management of attention-deficit hyperactivity disorder in children and adolescents: a systematic review of randomized controlled trials. [2021]
Factors associated with treatment mode and termination among preschoolers with ADHD in Taiwan. [2015]
Early Intervention for Preschoolers at Risk for Attention-Deficit/Hyperactivity Disorder: Preschool First Step to Success. [2020]
Attention deficit/hyperactivity disorder in preschool-age children: issues and concerns. [2011]
Which kindergarten children are at greatest risk for attention-deficit/hyperactivity and conduct disorder symptomatology as adolescents? [2023]
Academic Outcomes Following a School-Based RCT for ADHD: 6-Year Follow-Up. [2020]
Relative age and ADHD symptoms, diagnosis and medication: a systematic review. [2020]
Treatment of preschoolers with attention-deficit/hyperactivity disorder. [2021]
Two different solicitation methods for obtaining information on adverse events associated with methylphenidate in adolescents: a 12-week multicenter, open-label study. [2015]
10.United Statespubmed.ncbi.nlm.nih.gov
Gastrointestinal adverse events during methylphenidate treatment of children and adolescents with attention deficit hyperactivity disorder: A systematic review with meta-analysis and Trial Sequential Analysis of randomised clinical trials. [2019]
Moderators Influencing the Effectiveness of a Behavioral Teacher Program. [2020]
12.United Statespubmed.ncbi.nlm.nih.gov
Attention deficit hyperactivity disorder in preschool children. [2022]