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Investigation of Strategies to Reduce the Impact of the Relative Age Effect in Kindergarten

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Relative Age Effect Intervention
School as Usual
Sponsored by
Florida International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring ADHD, kindergarten, relative age effect

Eligibility Criteria

4 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • enrolling in Kindergarten
  • has a date of birth 4 months prior to the respective state cut-off for school entry
  • does not have an Individualized Education program for behavioral concerns
  • has not been retained in school or "red-shirted" by parents.

Exclusion Criteria:

  • outside of the targeted birthdate range
  • diagnosed with autism, psychosis, or disruptive mood dysregulation disorder
  • taking psychoactive medication for mood, behavior, or inattention,
  • in a classroom with an already enrolled study participant.

Sites / Locations

  • Center for Children and FamiliesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

School as Usual

Immediate Relative Age Effect Intervention

Delayed Relative Age Effect Intervention

Arm Description

School procedures as typically used and implemented.

Relative age effect intervention administered in the Fall in school.

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

Outcomes

Primary Outcome Measures

Disruptive Behavior Disorders rating scale
ADHD symptoms - teacher rating. Scores range from an average of 0.0-3.0 with higher scores meaning more symptoms
Impairment Rating Scale
ADHD impairment - teacher rating. Average score ranges from 0.0 to 6.0 with higher scores indicating greater impairment.
Student Behavior Teacher Response Observation code
Observations of ADHD behaviors and impairment. Frequency counts of disruptive behaviors; higher frequencies equal the presence of more classroom rule violations.
Academic Performance Rating Scale
Teacher rating of academic performance and productivity. Average scores range from 1.0 to 5.0 with lower scores indicating academic underperformance.

Secondary Outcome Measures

Full Information

First Posted
November 8, 2021
Last Updated
June 8, 2023
Sponsor
Florida International University
Collaborators
University at Buffalo, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05142826
Brief Title
Investigation of Strategies to Reduce the Impact of the Relative Age Effect in Kindergarten
Official Title
Investigation of Strategies to Reduce the Impact of the Relative Age Effect in Kindergarten
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
October 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Florida International University
Collaborators
University at Buffalo, National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
The entry to kindergarten is one of the most memorable and important milestones in a child's school career. Positive and quality kindergarten experiences have been associated with meaningful outcomes sustained into adulthood including greater rates of college attendance/higher earnings. Kindergarten entry is one of the first educational transitions made by a family, and it may cause stress and present new challenges for children and families. Given the increased demands that are associated with school entry and the concerns parents may have about this developmental milestone, there are numerous popular press and policy recommendations (e.g., National Association for the Education of Young Children), as well as empirical papers, that weigh in on the appropriate age to start kindergarten. The transition to kindergarten is of particular concern for parents of children with ADHD, especially those relatively young for the grade. There is converging evidence suggesting that children who are young for their kindergarten class (e.g., they have a birthdate that falls within the months immediately preceding the cut-off date, typically August through November) are at increased risk for a range of negative educational outcomes including lower academic achievement, grade retention, social impairments, and ADHD diagnosis . These risks appear to be related to age of entry when other explanatory variables are controlled. Thus, these studies suggest that the robust evidence that children closest to an arbitrary cut-off date are disproportionally at-risk for negative social, behavioral, and educational outcomes is solely a consequence of educational policy - a phenomenon called the Relative Age Effect (RAE). Together, the consequence of these risks are 1.5x increased ADHD diagnostic rates and increased ADHD treatment with psychoactive medication for children relatively younger for their kindergarten grade . There are prominent, candidate mechanisms that may explain the differential risk for children with ADHD who are also young for the grade. First, if a teacher is basing behavioral expectations for children in the classroom based on the relatively older children in the class, children who are relatively younger and have behaviors that are attributed to having considerable delays, even in situations where the child is acting in a manner consistent with their chronological age. Over time, if teachers are issuing frequent commands/reprimands, a coercive process may develop. Second, given expected variability in neurocognitive processing at this age level, inappropriate demands may fail to facilitate, and potentially even slow, the development of executive functions. The present proposal aims to reduce functional impairments and ADHD symptom levels by investigating whether evidence-based school treatment for ADHD (e.g., positive behavior supports) coupled with teacher training on the RAE results in improved school functioning for children with elevated ADHD symptoms prior to the kindergarten year. Further, the potential mechanism for the impairment experienced by children with ADHD will be explored, by investigating whether the impairments are due to characteristics of the child (e.g., deficits in neurocognitive development), the classroom (e.g., teacher classroom management strategies), or both.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
ADHD, kindergarten, relative age effect

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Observers are masked to group assignment of the participants
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
School as Usual
Arm Type
Active Comparator
Arm Description
School procedures as typically used and implemented.
Arm Title
Immediate Relative Age Effect Intervention
Arm Type
Experimental
Arm Description
Relative age effect intervention administered in the Fall in school.
Arm Title
Delayed Relative Age Effect Intervention
Arm Type
Experimental
Arm Description
Relative age effect intervention administered after the Winter break in school.
Intervention Type
Behavioral
Intervention Name(s)
Relative Age Effect Intervention
Intervention Description
School-based consultation to establish a developmentally appropriate daily behavior report; teacher education regarding developmentally appropriate behaviors; teacher consultation to promote positive behavior supports.
Intervention Type
Other
Intervention Name(s)
School as Usual
Intervention Description
Interventions and supports as provided through usual care
Primary Outcome Measure Information:
Title
Disruptive Behavior Disorders rating scale
Description
ADHD symptoms - teacher rating. Scores range from an average of 0.0-3.0 with higher scores meaning more symptoms
Time Frame
Change between baseline, three month, six, month, nine month, and 12 month assessments.
Title
Impairment Rating Scale
Description
ADHD impairment - teacher rating. Average score ranges from 0.0 to 6.0 with higher scores indicating greater impairment.
Time Frame
Change between baseline, three month, six, month, nine month, and 12 month assessments.
Title
Student Behavior Teacher Response Observation code
Description
Observations of ADHD behaviors and impairment. Frequency counts of disruptive behaviors; higher frequencies equal the presence of more classroom rule violations.
Time Frame
Change between baseline, three month, six, month, nine month, and 12 month assessments.
Title
Academic Performance Rating Scale
Description
Teacher rating of academic performance and productivity. Average scores range from 1.0 to 5.0 with lower scores indicating academic underperformance.
Time Frame
Change between baseline, three month, six, month, nine month, and 12 month assessments.
Other Pre-specified Outcome Measures:
Title
Incidence of referral for special education
Description
Dichotomous parent rating of yes or no for referral for special education at the end of kindergarten
Time Frame
Collected at the end of the kindergarten school year, approximately 10 months from the start of study procedures.
Title
Incidence of stimulant medication use
Description
Dichotomous parent rating of yes or no for initiation of stimulant medication at the end of kindergarten
Time Frame
Collected at the end of the kindergarten school year, approximately 10 months from the start of study procedures.
Title
Incidence of grade retention
Description
Dichotomous parent rating of yes or no for retained in kindergarten at the end of kindergarten
Time Frame
Collected at the end of the kindergarten school year, approximately 10 months from the start of study procedures.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: enrolling in Kindergarten has a date of birth 4 months prior to the respective state cut-off for school entry does not have an Individualized Education program for behavioral concerns has not been retained in school or "red-shirted" by parents. Exclusion Criteria: outside of the targeted birthdate range diagnosed with autism, psychosis, or disruptive mood dysregulation disorder taking psychoactive medication for mood, behavior, or inattention, in a classroom with an already enrolled study participant.
Facility Information:
Facility Name
Center for Children and Families
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gregory A Fabiano, PhD
Phone
716-359-7823
Email
gfabiano@fiu.edu
First Name & Middle Initial & Last Name & Degree
Devon Tower
Phone
716-359-7500
Email
dtower@fiu.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified, anonymous data will be shared for the main outcome measures of the Disruptive Behavior Disorders Rating Scale and Impairment Rating Scale
IPD Sharing Time Frame
Six months after the completion of the project.
IPD Sharing Access Criteria
Data will be shared through the NIMH data-sharing repository.

Learn more about this trial

Investigation of Strategies to Reduce the Impact of the Relative Age Effect in Kindergarten

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