Biosignatures for the Development of Attention Deficit Hyperactivity Disorder (AHEAD)

As an exploratory aim of this grant, we examined the extent to which a comprehensive psychosocial intervention conducted in the summer can improve young children with disruptive behavior challenges as it relates to their social-emotional and academic functioning.

Study Overview

• Status: Completed
• Conditions: ADHD; Disruptive Behaviours
• Intervention / Treatment: Behavioral: Summer treatment program for children transitioning to and from kindergarten (STP-K)

Detailed Description

Due to the high prevalence rates and significant impairments associated with ADHD and comorbid disruptive behavior disorders, it is not surprising that a great deal of research has focused on psychosocial interventions, with the Summer Treatment Program (STP) emerging as one of the most widely regarded and effective multimodal psychosocial treatments for children with ADHD and comorbid disruptive behavior disorders. Over the last 15 years, the STP has been adapted for preschoolers transitioning into kindergarten, with similar success in not only improving general externalizing behavior problems (EBP), but also other school readiness outcomes.

Part of the STP for pre-kindergarteners' (STP-PreK) successful adaption is due to the recognition of the importance of addressing children's emotion dysregulation, which has not only been identified as a core impairment among children with ADHD but also a contributing factor in the development of DBDs. Callous-unemotional traits (CU) is one emotion dysregulation domain that amplifies impairments associated with ADHD and DBDs, and can attenuate the response to evidence-based treatments. The current study examines the extent to which the STP-PreK can improve these emotion dysregulation outcomes along with other school readiness outcomes (i.e., academic functioning and social skills) in a sample of young children with ADHD and co-occurring DBDs, compared to their TD peers.

• Study Type: Interventional
• Enrollment (Actual): 323
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Children had to be attending school and between the ages of 4 and 7
• Children in the typically developing (TD) group had to have their parents and/or their teachers endorse them as having less than four ADHD symptoms (across either Inattention or Hyperactivity/Impulsivity), less than four ODD symptoms, less than three CD symptoms, and indicated no clinically significant impairment (score below 3 on the IRS).
• Children in the ADHD group had to have endorsed at least 6 ADHD symptoms of Inattention and/or Hyperactivity/Impulsivity, land indicated clinically significant impairment (score above 3 on the IRS) across parent and/or teacher report.
• Children in the ADHD group also had to attend the STP-K.

Exclusion Criteria:

• Diagnosis of Autism Spectrum Disorder
• Full scale IQ below 70
• Currently taking any psychotropic medication

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Summer Treatment Program for children transitioning to and from kindergarten (STP-K); Participants in the STP-K included children ages 4 to 7 who attended a school readiness class during the summer, Monday-Friday from 8 a..m to 4:00 p.m. for 7 to 8 weeks. Parents received feedback everyday in the form of daily report card regarding how their children performed during the day. Parents also attended a weekly parenting program lasting between 1.5 to 2 hours.

Behavioral: Summer treatment program for children transitioning to and from kindergarten (STP-K); The STP-K is a multimodal intervention including a school readiness class, which consists of a behavior modification program as well as an academic and social-emotional curriculum, along with a parenting program. Throughout the day children participate in activities designed to promote a) behavioral and social-emotional skills consistent with the expectations of kindergarten and first grade, b) academic skills, c) physical activity, good sportsmanship, basic sports skills, and c) a positive attitude towards learning and school. Fifteen children are assigned to a classroom, staffed by one lead teacher, one lead counselor, and four paraprofessional developmental aides, yielding a 2:5 staff to student ratio. A behavior modification program is used across activities to promote positive behaviors. Parents then receive feedback everyday on how their child is doing and also attend a weekly parenting program lasting between 1.5 to 2 hours.; Other Names: Summer Treatment Program; Summer Treatment Program for Prekindergarteners (STP-PreK)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Emotion Regulation as measured by the Emotion Regulation Checklist	The average score on the emotion regulation subscale of the 24-item Emotion Regulation Checklist was used with higher scores indicating better emotion regulation skills.	Baseline
Overall Emotion Regulation as measures by the Emotion regulation Checklist	The average score on the emotion regulation subscale of the 24-item Emotion Regulation Checklist was used with higher scores indicating better emotion regulation skills.	6 months after enrollment (post treatment)
Overall Emotion Regulation as measured by the Emotion regulation Checklist	The average score on the emotion regulation subscale of the 24-item Emotion Regulation Checklist was used with higher scores indicating better emotion regulation skills.	1 year after enrollment
ADHD symptoms as assesed by the Disruptive Behavior Disorders Rating Scale	Average symptom severity of the ADHD items of the Disruptive Behavior Disorders Rating Scale with higher scores indicating worse ADHD severity.	Baseline
ADHD symptoms as assessed by the Disruptive Behavior Disorders Rating Scale	Average symptom severity of the ADHD items of the Disruptive Behavior Disorders Rating Scale with higher scores indicating worse ADHD severity.	6 months after enrollment (post-treatment)
ADHD symptoms as assessed by the Disruptive Behavior Disorders Rating Scale	Average symptom severity of the ADHD items of the Disruptive Behavior Disorders Rating Scale with higher scores indicating worse ADHD severity.	Completed 1 year after enrollment
Overall Adaptive Functioning as assessed by the Behavior Assessment System for Children	T-score on the adaptive functioning subscale of the Behavior Assessment System for Children with higher scores indicating better adaptive functioning skills	baseline
Overall adaptive functioning as measured by the Behavior Assessment System for Children	T-score on the adaptive functioning subscale of the Behavior Assessment System for Children with higher scores indicating better adaptive functionining skills	6 months after enrollment (post-treatment)
Overall adaptive functioning as assessed by the Behavior Assessment System for Children	t-score on the adaptive functioning subscale of the Behavior Assessment System for Children with higher scores indicating better adaptive functionining skills	Completed 1 year after enrollment
Severity of Disruptive Behaviors as assessed by the Disruptive Behavior Disorders Rating Scale	Average symptom severity of the ODD and CDD items of the Disruptive Behavior Disorders Rating Scale with higher scores indicating worse disruptive behaviors.	baseline
Severity of Disruptive behaviors as assessed by the Disruptive Behavior Disorders Rating Scale	Average symptom severity of the ODD and CDD items of the Disruptive Behavior Disorders Rating Scale with higher scores indicating worse disruptive behaviors.	6 months after enrollment (post-treatment)
Severity of Disruptive Behaviors as assessed by the Disruptive Behavior Disorders Rating Scale	Average symptom severity of the ODD and CDD items of the Disruptive Behavior Disorders Rating Scale with higher scores indicating worse disruptive behaviors.	1 year after enrollment
Severity of callous-unemotional behaviors as assessed by the abbreviated version of the Inventory of Callous-Unemotional Traits.	Average frequency of callous-unemotional behaviors across the 12 items of the questionnaire with higher scores indicating more severe behaviors.	baseline
Severity of callous-unemotional behaviors as assessed by the abbreviated version of the Inventory of Callous-Unemotional Traits	Average frequency of callous-unemotional behaviors across the 12 items of the questionnaire with higher scores indicating more severe behaviors.	6 months after enrollment (post-treatment)
Severity of callous-unemotional behaviors as assessed by the abbreviated version of the Inventory of Callous-unemotional traits.	Average frequency of callous-unemotional behaviors across the 12 items of the questionnaire with higher scores indicating more severe behaviors.	1 year after enrollment
Social Skills as assessed via the Behavior Assessment System for Children	T-score on the social skills subtest of the Behavior Assessment System for Children with higher scores indicating better social skills.	baseline
Social Skills as assessed by the Behavior Assessment System for Children	T-score on the social skills subtest of the Behavior Assessment System for Children with higher scores indicating better social skills.	6 months after enrollment (post-treatment)
Social Skills as assessed by the Behavior Assessment System for Children	T-test on the social skills subtest of the Behavior Assessment System for Children with higher scores indicating better social skills	1 year after enrollment
Overall social problem solving as assessed by the Challenging Situations Task	Total prosocial score across the six hypothetical peer situations from the Challenging Situations task with higher scores indicating better social-problem solving.	baseline
Overall social problem solving as assessed by the Challenging Situations Task	Total prosocial score across the six hypothetical peer situations from the Challenging Situations task with higher scores indicating better social-problem solving.	6 months after enrollment (post-treatment)
Overall social problem solving as assessed by the Challenging Situations Task	Total prosocial score across the six hypothetical peer situations from the Challenging Situations task with higher scores indicating better social-problem solving.	1 year after enrollment
Overall Academic Achievement as measured by the Woodcock Johnson Test of Achievement	The current study examined the mean raw scores of the derived composite scores on the Woodcock-Johnson Test of Achievement: Brief Reading (letter-word identification, passage comprehension), Brief Math (applied problems, calculation), and Brief Writing (spelling, writing samples). However, given the high correlations among these composites, an overall achievement composite was used with higher scores indicating better academic functioning.	baseline
Overall Academic Achievement as measured by the Woodcock Johnson Test of Achievement	The current study examined the mean raw scores of the derived composite scores on the Woodcock-Johnson Test of Achievement: Brief Reading (letter-word identification, passage comprehension), Brief Math (applied problems, calculation), and Brief Writing (spelling, writing samples). However, given the high correlations among these composites, an overall achievement composite was used with higher scores indicating better academic functioning.	6-months after enrollment (post-treatment)
Overall Academic Achievement as measured by the Woodcock Johnson Test of Achievement	The current study examined the mean raw scores of the derived composite scores on the Woodcock-Johnson Test of Achievement: Brief Reading (letter-word identification, passage comprehension), Brief Math (applied problems, calculation), and Brief Writing (spelling, writing samples). However, given the high correlations among these composites, an overall achievement composite was used with higher scores indicating better academic functioning.	1 year after enrollment
Overall readiness for kindergarten as assessed by the Kindergarten Behavior and Academic Competency Scale	An overall score from the 23-items of the Kindergarten Behavior and Academic Competency Scale, which measures kindergarten readiness across domains (following clasroom rules, completing academic work) was derived by averaging across all items (along a 5-point scale) with higher scores indicating greater kindergarten readiness	baseline
Overall readiness for kindergarten as assessed by the Kindergarten Behavior and Academic Competency Scale	An overall score from the 23-items of the Kindergarten Behavior and Academic Competency Scale, which measures kindergarten readiness across domains (following clasroom rules, completing academic work) was derived by averaging across all items (along a 5-point scale) with higher scores indicating greater kindergarten readiness	6 months after enrollment
Overall readiness for kindergarten as assessed by the Kindergarten Behavior and Academic Competency Scale	An overall score from the 23-items of the Kindergarten Behavior and Academic Competency Scale, which measures kindergarten readiness across domains (following clasroom rules, completing academic work) was derived by averaging across all items (along a 5-point scale) with higher scores indicating greater kindergarten readiness	1 year after enrollment
Overall academic readiness for kindergarten as assessed by the Bracken School Readiness Assessment	The Bracken School Readiness Assessment is a widely-used and psychometrically sound test consisting of five subtests assessing children's receptive knowledge of colors, letters, numbers/counting, sizes/comparisons, and shapes. For this study, the overall school readiness composite raw score was used with higher scores indicating better academic skills.	baseline
Overall academic readiness for kindergarten as assessed by the Bracken School Readiness Assessment	The Bracken School Readiness Assessment is a widely-used and psychometrically sound test consisting of five subtests assessing children's receptive knowledge of colors, letters, numbers/counting, sizes/comparisons, and shapes. For this study, the overall school readiness composite raw score was used with higher scores indicating better academic skills.	Completed 6 months after enrollment
Overall academic readiness for kindergarten as assessed by the Bracken School Readiness Assessment	The Bracken School Readiness Assessment is a widely-used and psychometrically sound test consisting of five subtests assessing children's receptive knowledge of colors, letters, numbers/counting, sizes/comparisons, and shapes. For this study, the overall school readiness composite raw score was used with higher scores indicating better academic skills.	Completed 1 year after enrollment
Observed Emotion Regulation as assessed via the Laboratory Temperament Assessment Battery	A global measure of emotion regulation was coded (on a scale of 0 to 4) from two frustration tasks from the Laboratory Temperament Assessment Battery with higher average scores indicating better emotion regulation skills.	baseline
Observed Emotion Regulation as assessed via the Laboratory Temperament Assessment Battery	A global measure of emotion regulation was coded (on a scale of 0 to 4) from two frustration tasks from the Laboratory Temperament Assessment Battery with higher average scores indicating better emotion regulation skills.	6 months after enrollment (post treatment)
Observed Emotion Regulation as assessed via the Laboratory Temperament Assessment Battery	A global measure of emotion regulation was coded (on a scale of 0 to 4) from two frustration tasks from the Laboratory Temperament Assessment Battery with higher average scores indicating better emotion regulation skills.	1 year after enrollment
Overall Executive functioning as measured by the Behavior Rating Inventory of Executive Function	T-score of the emergent metacognitive index of the Behavior Rating Inventory of Executive Function was used (items are rated on a three point liker scale) with higher scores indicating poorer executive functioning	baseline
Overall Executive functioning as measured by the Behavior Rating Inventory of Executive Function	T-score of the emergent metacognitive index of the Behavior Rating Inventory of Executive Function was used (items are rated on a three point liker scale) with higher scores indicating poorer executive functioning	6 months after enrollment
Overall Executive functioning as measured by the Behavior Rating Inventory of Executive Function	T-score of the emergent metacognitive index of the Behavior Rating Inventory of Executive Function was used (items are rated on a three point liker scale) with higher scores indicating poorer executive functioning	1 year after enrollment
Overall Executive Functioning Performance as measured by the Head-Toes-Knees-Shoulders task	Total score on the Head-Toes-Knees-Shoulders task, which consists of 10 test trials. Scores range from 0 to 40 with higher scores indicative of better executive functioning.	baseline
Overall Executive Functioning Performance as measured by the Head-Toes-Knees-Shoulders task	Total score on the Head-Toes-Knees-Shoulders task, which consists of 10 test trials. Scores range from 0 to 40 with higher scores indicative of better executive functioning.	6 months after enrollment
Overall Executive Functioning Performance as measured by the Head-Toes-Knees-Shoulders task	Total score on the Head-Toes-Knees-Shoulders task, which consists of 10 test trials. Scores range from 0 to 40 with higher scores indicative of better executive functioning.	1 year after enrollment
Peer status as assessed by sociometrics ratings during the intervention	A Social Preference Index score capturing overall peer status within the classroom was derived by subtracting the child's "like least" nominations from their peers from their standardized "like most" nominations from their peers, then re-standardized, as is commonly done in sociometric analyses. Higher social preference scores indicate higher peer status relative to other children in their class.	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervetion Attendance	As part of the intervention (STP-K), children attend the summer camp and parents attend weekly parent training. The overall number of days attended will be used with higher numbers indicating greater participation in the intervention.	Through study completion, an average of 1 year
Daily Report Card	Children's daily report card performance defined by percentage of days in which their behavior and academic goals were achieved leading to a "green" (75% or better) "yellow (50-74%)" or "red (below 50%)" day across the STP-K.	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Florida International University
• Collaborators: National Institute of Mental Health (NIMH)

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: January 20, 2026
• First Submitted That Met QC Criteria: January 26, 2026
• First Posted (Actual): February 2, 2026

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: ADHD; parenting; young children; emotion dysregulation; school readiness; callous-unemotional behaviors; summer treatment program
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Attention Deficit and Disruptive Behavior Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: IRB-14-0158-CR11; R01MH112588 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We already have our data in the National Institute of Mental Health Data Archive (NDA)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No