RAE Intervention for ADHD in Kindergarten
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?
Is the RAE Intervention for ADHD in Kindergarten safe for children?
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
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
Immediate Intervention
Relative Age Effect prevention intervention administered immediately in the Fall
Delayed Intervention
Relative Age Effect prevention intervention administered after the Winter break
Follow-up
Participants are monitored for safety and effectiveness after intervention
Treatment Details
Interventions
- Relative Age Effect Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Florida International University
Lead Sponsor
University at Buffalo
Collaborator
National Institute of Mental Health (NIMH)
Collaborator