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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 belowSelect...
I am enrolling in Kindergarten.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change between baseline, three month, six, month, nine month, and 12 month assessments.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change between baseline, three month, six, month, nine month, and 12 month assessments.
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 moreOther 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.
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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
2,813 Previous Clinical Trials
2,667,659 Total Patients Enrolled
95 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
20,030 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on medication for mood, behavior, or attention issues.I was born within 4 months before the school entry deadline in my state.I am enrolling in Kindergarten.My birthdate does not fall within the required range.
Research Study Groups:
This trial has the following groups:- Group 1: School as Usual
- Group 2: Delayed Relative Age Effect Intervention
- Group 3: Immediate Relative Age Effect Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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