Trial Outcomes & Findings for Investigation of Strategies to Reduce the Impact of the Relative Age Effect in Kindergarten (NCT NCT05142826)
NCT ID: NCT05142826
Last Updated: 2025-11-19
Results Overview
Average score for ADHD symptom ratings on the Disruptive Behavior Disorders rating scale Average score ranges from 0.0 to 3.0 with higher scores indicating greater impairment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
62 participants
Primary outcome timeframe
Baseline (Fall), 3 Months (Winter), 6 Months (Spring) and 12 Months (First Grade Follow-up)
Results posted on
2025-11-19
Participant Flow
Participant milestones
| Measure |
School as Usual
School procedures as typically used and implemented.
School as Usual: Interventions and supports as provided through usual care
|
Immediate Relative Age Effect Intervention
Relative age effect intervention administered in the Fall in school.
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.
|
Delayed Relative Age Effect Intervention
Relative age effect intervention administered after the Winter break in school.
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
21
|
21
|
|
Overall Study
COMPLETED
|
9
|
16
|
14
|
|
Overall Study
NOT COMPLETED
|
11
|
5
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Investigation of Strategies to Reduce the Impact of the Relative Age Effect in Kindergarten
Baseline characteristics by cohort
| Measure |
School as Usual
n=20 Participants
School procedures as typically used and implemented.
School as Usual: Interventions and supports as provided through usual care
|
Immediate Relative Age Effect Intervention
n=21 Participants
Relative age effect intervention administered in the Fall in school.
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.
|
Delayed Relative Age Effect Intervention
n=21 Participants
Relative age effect intervention administered after the Winter break in school.
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.
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
20 Participants
n=39 Participants
|
21 Participants
n=29 Participants
|
21 Participants
n=60 Participants
|
62 Participants
n=185 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=185 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=185 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=39 Participants
|
8 Participants
n=29 Participants
|
13 Participants
n=60 Participants
|
28 Participants
n=185 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=39 Participants
|
13 Participants
n=29 Participants
|
8 Participants
n=60 Participants
|
34 Participants
n=185 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=185 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
1 Participants
n=29 Participants
|
1 Participants
n=60 Participants
|
2 Participants
n=185 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=185 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=39 Participants
|
3 Participants
n=29 Participants
|
6 Participants
n=60 Participants
|
11 Participants
n=185 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=39 Participants
|
15 Participants
n=29 Participants
|
10 Participants
n=60 Participants
|
34 Participants
n=185 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
1 Participants
n=60 Participants
|
2 Participants
n=185 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=39 Participants
|
2 Participants
n=29 Participants
|
3 Participants
n=60 Participants
|
13 Participants
n=185 Participants
|
PRIMARY outcome
Timeframe: Baseline (Fall), 3 Months (Winter), 6 Months (Spring) and 12 Months (First Grade Follow-up)Average score for ADHD symptom ratings on the Disruptive Behavior Disorders rating scale Average score ranges from 0.0 to 3.0 with higher scores indicating greater impairment.
Outcome measures
| Measure |
School as Usual
n=20 Participants
School procedures as typically used and implemented.
School as Usual: Interventions and supports as provided through usual care
|
Immediate Relative Age Effect Intervention
n=21 Participants
Relative age effect intervention administered in the Fall in school.
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.
|
Delayed Relative Age Effect Intervention
n=21 Participants
Relative age effect intervention administered after the Winter break in school.
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.
|
|---|---|---|---|
|
Disruptive Behavior Disorders Rating Scale
Baseline Fall Assessment
|
.8 score on the scale
Standard Deviation .51
|
1.12 score on the scale
Standard Deviation .8
|
1.03 score on the scale
Standard Deviation .72
|
|
Disruptive Behavior Disorders Rating Scale
Winter Assessment
|
1.33 score on the scale
Standard Deviation .83
|
1.15 score on the scale
Standard Deviation .70
|
1.28 score on the scale
Standard Deviation .85
|
|
Disruptive Behavior Disorders Rating Scale
Spring Assessment
|
1.34 score on the scale
Standard Deviation .91
|
1.13 score on the scale
Standard Deviation .80
|
1.00 score on the scale
Standard Deviation .65
|
|
Disruptive Behavior Disorders Rating Scale
First Grade Follow-up
|
1.19 score on the scale
Standard Deviation .58
|
1.12 score on the scale
Standard Deviation .83
|
1.05 score on the scale
Standard Deviation 1.03
|
PRIMARY outcome
Timeframe: Baseline (Fall), 3 Months (Winter), 6 Months (Spring) and 12 Months (First Grade Follow-up)ADHD impairment - teacher rating. Average score ranges from 0.0 to 6.0 with higher scores indicating greater impairment.
Outcome measures
| Measure |
School as Usual
n=20 Participants
School procedures as typically used and implemented.
School as Usual: Interventions and supports as provided through usual care
|
Immediate Relative Age Effect Intervention
n=21 Participants
Relative age effect intervention administered in the Fall in school.
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.
|
Delayed Relative Age Effect Intervention
n=21 Participants
Relative age effect intervention administered after the Winter break in school.
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.
|
|---|---|---|---|
|
Impairment Rating Scale
Fall (First Grade Follow-up)
|
2.22 Score on the scale
Standard Deviation 2.40
|
2.44 Score on the scale
Standard Deviation 2.06
|
1.86 Score on the scale
Standard Deviation 1.94
|
|
Impairment Rating Scale
Spring
|
3.24 Score on the scale
Standard Deviation 2.30
|
2.19 Score on the scale
Standard Deviation 1.58
|
1.57 Score on the scale
Standard Deviation 1.55
|
|
Impairment Rating Scale
Fall (Baseline
|
1.48 Score on the scale
Standard Deviation 2.01
|
2.25 Score on the scale
Standard Deviation 1.84
|
1.84 Score on the scale
Standard Deviation 1.71
|
|
Impairment Rating Scale
Winter
|
2.48 Score on the scale
Standard Deviation 2.15
|
2.43 Score on the scale
Standard Deviation 1.43
|
1.7 Score on the scale
Standard Deviation 1.66
|
PRIMARY outcome
Timeframe: Baseline (Fall), 3 Months (Winter), 6 Months (Spring) and 12 Months (First Grade Follow-up)Number of disruptive behaviors; higher counts equal the presence of more classroom rule violations
Outcome measures
| Measure |
School as Usual
n=20 Participants
School procedures as typically used and implemented.
School as Usual: Interventions and supports as provided through usual care
|
Immediate Relative Age Effect Intervention
n=21 Participants
Relative age effect intervention administered in the Fall in school.
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.
|
Delayed Relative Age Effect Intervention
n=21 Participants
Relative age effect intervention administered after the Winter break in school.
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.
|
|---|---|---|---|
|
Student Behavior Teacher Response Observation Code
Fall (Baseline
|
5 Frequency count of behaviors
Standard Deviation 4.27
|
5.67 Frequency count of behaviors
Standard Deviation 6.2
|
7 Frequency count of behaviors
Standard Deviation 6.7
|
|
Student Behavior Teacher Response Observation Code
Winter
|
5.56 Frequency count of behaviors
Standard Deviation 8.12
|
5.21 Frequency count of behaviors
Standard Deviation 7.77
|
5.75 Frequency count of behaviors
Standard Deviation 4.9
|
|
Student Behavior Teacher Response Observation Code
Spring
|
4.22 Frequency count of behaviors
Standard Deviation 4.02
|
4.36 Frequency count of behaviors
Standard Deviation 5.51
|
4.17 Frequency count of behaviors
Standard Deviation 3.74
|
|
Student Behavior Teacher Response Observation Code
First grade follow-up (Fall)
|
3 Frequency count of behaviors
Standard Deviation 2.39
|
3.88 Frequency count of behaviors
Standard Deviation 3.74
|
2.6 Frequency count of behaviors
Standard Deviation 3.53
|
PRIMARY outcome
Timeframe: Baseline (Fall), 3 Months (Winter), 6 Months (Spring) and 12 Months (First Grade Follow-up)Teacher rating of academic productivity. Average scores range from 1.0 to 5.0 with lower scores indicating academic underperformance.
Outcome measures
| Measure |
School as Usual
n=20 Participants
School procedures as typically used and implemented.
School as Usual: Interventions and supports as provided through usual care
|
Immediate Relative Age Effect Intervention
n=21 Participants
Relative age effect intervention administered in the Fall in school.
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.
|
Delayed Relative Age Effect Intervention
n=21 Participants
Relative age effect intervention administered after the Winter break in school.
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.
|
|---|---|---|---|
|
Academic Performance Rating Scale
Fall (Baseline)
|
3.51 Score on the scale
Standard Deviation .83
|
3.22 Score on the scale
Standard Deviation .97
|
3.36 Score on the scale
Standard Deviation .97
|
|
Academic Performance Rating Scale
Winter
|
3.17 Score on the scale
Standard Deviation .55
|
3.36 Score on the scale
Standard Deviation .83
|
3.34 Score on the scale
Standard Deviation .94
|
|
Academic Performance Rating Scale
Spring
|
3.15 Score on the scale
Standard Deviation 1.03
|
3.5 Score on the scale
Standard Deviation .81
|
3.49 Score on the scale
Standard Deviation .84
|
|
Academic Performance Rating Scale
First Grade Follow-up (Fall)
|
3.7 Score on the scale
Standard Deviation .87
|
3.49 Score on the scale
Standard Deviation .8
|
3.01 Score on the scale
Standard Deviation 1.09
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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
Outcome measures
| Measure |
School as Usual
n=20 Participants
School procedures as typically used and implemented.
School as Usual: Interventions and supports as provided through usual care
|
Immediate Relative Age Effect Intervention
n=21 Participants
Relative age effect intervention administered in the Fall in school.
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.
|
Delayed Relative Age Effect Intervention
n=21 Participants
Relative age effect intervention administered after the Winter break in school.
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.
|
|---|---|---|---|
|
Number of Children Who Were Referred to Special Education
|
1 Participants
|
2 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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
Outcome measures
| Measure |
School as Usual
n=20 Participants
School procedures as typically used and implemented.
School as Usual: Interventions and supports as provided through usual care
|
Immediate Relative Age Effect Intervention
n=21 Participants
Relative age effect intervention administered in the Fall in school.
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.
|
Delayed Relative Age Effect Intervention
n=21 Participants
Relative age effect intervention administered after the Winter break in school.
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.
|
|---|---|---|---|
|
Number of Children Who Were Prescribed Stimulant Medication
|
0 Participants
|
0 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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
Outcome measures
| Measure |
School as Usual
n=20 Participants
School procedures as typically used and implemented.
School as Usual: Interventions and supports as provided through usual care
|
Immediate Relative Age Effect Intervention
n=21 Participants
Relative age effect intervention administered in the Fall in school.
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.
|
Delayed Relative Age Effect Intervention
n=21 Participants
Relative age effect intervention administered after the Winter break in school.
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.
|
|---|---|---|---|
|
Number of Children Who Were Retained in Kindergarten
|
0 Participants
|
3 Participants
|
0 Participants
|
Adverse Events
School as Usual
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Immediate Relative Age Effect Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Delayed Relative Age Effect Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Gregory A. Fabiano, Ph.D.
Florida International University
Phone: 716-359-7823
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place