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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05142826
• Other study ID #: IRB-20-0389
• Secondary ID: R34MH122212
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: October 31, 2024

Study information

• Verified date: June 2024
• Source: Florida International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder

Intervention

Behavioral:
• Relative Age Effect Intervention
School-based consultation to establish a developmentally appropriate daily behavior report; teacher education regarding developmentally appropriate behaviors; teacher consultation to promote positive behavior supports.

Other:
• School as Usual
Interventions and supports as provided through usual care

Locations

Country	Name	City	State
United States	Center for Children and Families	Amherst	New York

Sponsors (3)

Lead Sponsor	Collaborator
Florida International University	National Institute of Mental Health (NIMH), University at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of referral for special education	Dichotomous parent rating of yes or no for referral for special education at the end of kindergarten	Collected at the end of the kindergarten school year, approximately 10 months from the start of study procedures.
Other	Incidence of stimulant medication use	Dichotomous parent rating of yes or no for initiation of stimulant medication at the end of kindergarten	Collected at the end of the kindergarten school year, approximately 10 months from the start of study procedures.
Other	Incidence of grade retention	Dichotomous parent rating of yes or no for retained in kindergarten at the end of kindergarten	Collected at the end of the kindergarten school year, approximately 10 months from the start of study procedures.
Primary	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	Change between baseline, three month, six, month, nine month, and 12 month assessments.
Primary	Impairment Rating Scale	ADHD impairment - teacher rating. Average score ranges from 0.0 to 6.0 with higher scores indicating greater impairment.	Change between baseline, three month, six, month, nine month, and 12 month assessments.
Primary	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.	Change between baseline, three month, six, month, nine month, and 12 month assessments.
Primary	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.	Change between baseline, three month, six, month, nine month, and 12 month assessments.