Biosignatures for the Development of Attention Deficit Hyperactivity Disorder

NCT07381855 | Completed

• 2 other identifiers: IRB-14-0158-CR11R01MH112588
• Study Type: interventional
• Target: 323
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

ADHD; Disruptive Behaviours

Keywords

ADHD; callous-unemotional behaviors; summer treatment program; young children; school readiness; emotion dysregulation; parenting

Outcome Measures

Primary Outcomes (40)

• 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 Outcomes (2)

• Intervetion Attendance

  Through study completion, an average of 1 year

• Daily Report Card

  Through study completion, an average of 1 year

Study Arms (1)

Summer Treatment Program for children transitioning to and from kindergarten (STP-K)

EXPERIMENTAL

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)

Interventions

Summer treatment program for children transitioning to and from kindergarten (STP-K) BEHAVIORAL

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.

Also known as: Summer Treatment Program, Summer Treatment Program for Prekindergarteners (STP-PreK)

Summer Treatment Program for children transitioning to and from kindergarten (STP-K)

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Florida International University: lead
• National Institute of Mental Health (NIMH): collaborator

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: February 2, 2026
• Study Start: January 1, 2017
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share