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RAE Intervention for ADHD in Kindergarten

N/A
Recruiting
Research Sponsored by Florida International University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Enrolling in Kindergarten
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change between baseline, three month, six, month, nine month, and 12 month assessments.
Awards & highlights

Study Summary

This trial aims to develop a teacher intervention to reduce the impact of the relative age effect (RAE) on young kindergarteners with elevated ADHD symptoms. RAE is when children entering kindergarten who 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. The intervention will be administered immediately or mid-year. Aims include demonstrating the feasibility and acceptability of the intervention approach, and the ability of the team to retain young children in a longitudinal trial.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects include initial worsening of ADHD symptoms if interventions are applied incorrectly and privacy concerns. However, benefits may include reduced negative impacts associated with being younger in the grade.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am enrolling in Kindergarten.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change between baseline, three month, six, month, nine month, and 12 month assessments.
This trial's timeline: 3 weeks for screening, Varies for treatment, and change between baseline, three month, six, month, nine month, and 12 month assessments. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Academic Performance Rating Scale
Disruptive Behavior Disorders rating scale
Impairment Rating Scale
+1 more
Other outcome measures
Incidence of grade retention
Incidence of referral for special education
Incidence of stimulant medication use

Trial Design

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 Location

Who is running the clinical trial?

Florida International UniversityLead Sponsor
100 Previous Clinical Trials
17,495 Total Patients Enrolled
16 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
2,261 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
University at BuffaloOTHER
132 Previous Clinical Trials
98,919 Total Patients Enrolled
1 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
300 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,707 Total Patients Enrolled
94 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
19,985 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)

Media Library

Relative Age Effect Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05142826 — N/A
Attention Deficit Hyperactivity Disorder (ADHD) Research Study Groups: School as Usual, Delayed Relative Age Effect Intervention, Immediate Relative Age Effect Intervention
Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial 2023: Relative Age Effect Intervention Highlights & Side Effects. Trial Name: NCT05142826 — N/A
Relative Age Effect Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05142826 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor taking on new participants?

"This experimental research is still seeking participants, according to the clinicaltrials.gov listing posted on June 1st 2022 and amended three days later."

Answered by AI

How many participants are included in this clinical experiment?

"Yes, the information on clinicaltrials.gov indicate that this research is actively recruiting participants. The trial was first posted in June 1st 2022 and has been updated as recently as June 3rd 2022. In total, 60 patients are needed for the study at a single location."

Answered by AI

Who meets the criteria for enrolment in this clinical research?

"This study is recruiting 60 children, between four and five years of age, diagnosed with Attention Deficit Disorder. Additionally, all participants must be enrolled in Kindergarten prior to the respective state cut-off for school entry; have no IEP (Individualized Education Program) related to behavior issues; nor has been held back a grade or delayed enrollment by parents ("red-shirted")."

Answered by AI

Does the research team accept participants below 25 years old for this project?

"This clinical trial has specified that the age range for participants is between 4 and 5 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Investigation of Strategies to Reduce the Impact of the Relative Age Effect in Kindergarten
2022. "Investigation of Strategies to Reduce the Impact of the Relative Age Effect in Kindergarten". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05142826.
~27 spots leftby Oct 2025
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