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

• ClinicalTrials.gov Identifier: NCT05142826
• Recruitment Status: Recruiting
• First Posted: December 3, 2021
• Last Update Posted: June 6, 2022
• Sponsor: Florida International University
• Collaborators: University at Buffalo; National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Florida International University

Tracking Information

• First Submitted Date: November 8, 2021
• First Posted Date: December 3, 2021
• Last Update Posted Date: June 6, 2022
• Actual Study Start Date: June 1, 2022
• Estimated Primary Completion Date: October 31, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 1, 2021)

• Disruptive Behavior Disorders rating scale [ Time Frame: Change between baseline, three month, six, month, nine month, and 12 month assessments. ]
  ADHD symptoms - teacher rating. Scores range from an average of 0.0-3.0 with higher scores meaning more symptoms
• Impairment Rating Scale [ Time Frame: Change between baseline, three month, six, month, nine month, and 12 month assessments. ]
  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 [ Time Frame: Change between baseline, three month, six, month, nine month, and 12 month assessments. ]
  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 [ Time Frame: Change between baseline, three month, six, month, nine month, and 12 month assessments. ]
  Teacher rating of academic performance and productivity. Average scores range from 1.0 to 5.0 with lower scores indicating academic underperformance.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided

Current Other Pre-specified Outcome Measures (submitted: December 1, 2021)

• Incidence of referral for special education [ Time Frame: Collected at the end of the kindergarten school year, approximately 10 months from the start of study procedures. ]
  Dichotomous parent rating of yes or no for referral for special education at the end of kindergarten
• Incidence of stimulant medication use [ Time Frame: Collected at the end of the kindergarten school year, approximately 10 months from the start of study procedures. ]
  Dichotomous parent rating of yes or no for initiation of stimulant medication at the end of kindergarten
• Incidence of grade retention [ Time Frame: Collected at the end of the kindergarten school year, approximately 10 months from the start of study procedures. ]
  Dichotomous parent rating of yes or no for retained in kindergarten at the end of kindergarten

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• 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

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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:

Observers are masked to group assignment of the participants

Primary Purpose: Treatment

• Condition: 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

Study Arms

• Active Comparator: School as Usual
  Intervention: Other: School as Usual
• Experimental: Immediate Relative Age Effect Intervention
  Intervention: Behavioral: Relative Age Effect Intervention
• Experimental: Delayed Relative Age Effect Intervention
  Intervention: Behavioral: Relative Age Effect Intervention

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 1, 2021): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2025
• Estimated Primary Completion Date: October 31, 2025 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 4 Years to 5 Years (Child)
• Accepts Healthy Volunteers: No
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05142826
• Other Study ID Numbers: IRB-20-0389; R34MH122212 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Florida International University
• Original Responsible Party: Same as current
• Current Study Sponsor: Florida International University
• Original Study Sponsor: Same as current

Collaborators

• University at Buffalo
• National Institute of Mental Health (NIMH)

• Investigators: Not Provided
• PRS Account: Florida International University
• Verification Date: June 2022