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Completed

NCT Number: NCT07381855

Biosignatures for the Development of Attention Deficit Hyperactivity Disorder

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.

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Disruptive Behaviours Mental Disorders Neurodevelopmental Disorders

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Summer Treatment Program, Summer Treatment Program for Prekindergarteners (STP-PreK)

Primary outcomes

  1. Overall Emotion Regulation as measured by the Emotion Regulation Checklist

    Time frame: Baseline

    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.

  2. Overall Emotion Regulation as measures by the Emotion regulation Checklist

    Time frame: 6 months after enrollment (post treatment)

    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.

  3. Overall Emotion Regulation as measured by the Emotion regulation Checklist

    Time frame: 1 year after enrollment

    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.

  4. ADHD symptoms as assesed by the Disruptive Behavior Disorders Rating Scale

    Time frame: Baseline

    Average symptom severity of the ADHD items of the Disruptive Behavior Disorders Rating Scale with higher scores indicating worse ADHD severity.

  5. ADHD symptoms as assessed by the Disruptive Behavior Disorders Rating Scale

    Time frame: 6 months after enrollment (post-treatment)

    Average symptom severity of the ADHD items of the Disruptive Behavior Disorders Rating Scale with higher scores indicating worse ADHD severity.

  6. ADHD symptoms as assessed by the Disruptive Behavior Disorders Rating Scale

    Time frame: Completed 1 year after enrollment

    Average symptom severity of the ADHD items of the Disruptive Behavior Disorders Rating Scale with higher scores indicating worse ADHD severity.

  7. Overall Adaptive Functioning as assessed by the Behavior Assessment System for Children

    Time frame: baseline

    T-score on the adaptive functioning subscale of the Behavior Assessment System for Children with higher scores indicating better adaptive functioning skills

  8. Overall adaptive functioning as measured by the Behavior Assessment System for Children

    Time frame: 6 months after enrollment (post-treatment)

    T-score on the adaptive functioning subscale of the Behavior Assessment System for Children with higher scores indicating better adaptive functionining skills

  9. Overall adaptive functioning as assessed by the Behavior Assessment System for Children

    Time frame: Completed 1 year after enrollment

    t-score on the adaptive functioning subscale of the Behavior Assessment System for Children with higher scores indicating better adaptive functionining skills

  10. Severity of Disruptive Behaviors as assessed by the Disruptive Behavior Disorders Rating Scale

    Time frame: baseline

    Average symptom severity of the ODD and CDD items of the Disruptive Behavior Disorders Rating Scale with higher scores indicating worse disruptive behaviors.

  11. Severity of Disruptive behaviors as assessed by the Disruptive Behavior Disorders Rating Scale

    Time frame: 6 months after enrollment (post-treatment)

    Average symptom severity of the ODD and CDD items of the Disruptive Behavior Disorders Rating Scale with higher scores indicating worse disruptive behaviors.

  12. Severity of Disruptive Behaviors as assessed by the Disruptive Behavior Disorders Rating Scale

    Time frame: 1 year after enrollment

    Average symptom severity of the ODD and CDD items of the Disruptive Behavior Disorders Rating Scale with higher scores indicating worse disruptive behaviors.

  13. Severity of callous-unemotional behaviors as assessed by the abbreviated version of the Inventory of Callous-Unemotional Traits.

    Time frame: baseline

    Average frequency of callous-unemotional behaviors across the 12 items of the questionnaire with higher scores indicating more severe behaviors.

  14. Severity of callous-unemotional behaviors as assessed by the abbreviated version of the Inventory of Callous-Unemotional Traits

    Time frame: 6 months after enrollment (post-treatment)

    Average frequency of callous-unemotional behaviors across the 12 items of the questionnaire with higher scores indicating more severe behaviors.

  15. Severity of callous-unemotional behaviors as assessed by the abbreviated version of the Inventory of Callous-unemotional traits.

    Time frame: 1 year after enrollment

    Average frequency of callous-unemotional behaviors across the 12 items of the questionnaire with higher scores indicating more severe behaviors.

  16. Social Skills as assessed via the Behavior Assessment System for Children

    Time frame: baseline

    T-score on the social skills subtest of the Behavior Assessment System for Children with higher scores indicating better social skills.

  17. Social Skills as assessed by the Behavior Assessment System for Children

    Time frame: 6 months after enrollment (post-treatment)

    T-score on the social skills subtest of the Behavior Assessment System for Children with higher scores indicating better social skills.

  18. Social Skills as assessed by the Behavior Assessment System for Children

    Time frame: 1 year after enrollment

    T-test on the social skills subtest of the Behavior Assessment System for Children with higher scores indicating better social skills

  19. Overall social problem solving as assessed by the Challenging Situations Task

    Time frame: baseline

    Total prosocial score across the six hypothetical peer situations from the Challenging Situations task with higher scores indicating better social-problem solving.

  20. Overall social problem solving as assessed by the Challenging Situations Task

    Time frame: 6 months after enrollment (post-treatment)

    Total prosocial score across the six hypothetical peer situations from the Challenging Situations task with higher scores indicating better social-problem solving.

  21. Overall social problem solving as assessed by the Challenging Situations Task

    Time frame: 1 year after enrollment

    Total prosocial score across the six hypothetical peer situations from the Challenging Situations task with higher scores indicating better social-problem solving.

  22. Overall Academic Achievement as measured by the Woodcock Johnson Test of Achievement

    Time frame: baseline

    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.

  23. Overall Academic Achievement as measured by the Woodcock Johnson Test of Achievement

    Time frame: 6-months after enrollment (post-treatment)

    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.

  24. Overall Academic Achievement as measured by the Woodcock Johnson Test of Achievement

    Time frame: 1 year after enrollment

    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.

  25. Overall readiness for kindergarten as assessed by the Kindergarten Behavior and Academic Competency Scale

    Time frame: baseline

    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

  26. Overall readiness for kindergarten as assessed by the Kindergarten Behavior and Academic Competency Scale

    Time frame: 6 months after enrollment

    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

  27. Overall readiness for kindergarten as assessed by the Kindergarten Behavior and Academic Competency Scale

    Time frame: 1 year after enrollment

    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

  28. Overall academic readiness for kindergarten as assessed by the Bracken School Readiness Assessment

    Time frame: baseline

    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.

  29. Overall academic readiness for kindergarten as assessed by the Bracken School Readiness Assessment

    Time frame: Completed 6 months after enrollment

    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.

  30. Overall academic readiness for kindergarten as assessed by the Bracken School Readiness Assessment

    Time frame: Completed 1 year after enrollment

    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.

  31. Observed Emotion Regulation as assessed via the Laboratory Temperament Assessment Battery

    Time frame: baseline

    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.

  32. Observed Emotion Regulation as assessed via the Laboratory Temperament Assessment Battery

    Time frame: 6 months after enrollment (post treatment)

    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.

  33. Observed Emotion Regulation as assessed via the Laboratory Temperament Assessment Battery

    Time frame: 1 year after enrollment

    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.

  34. Overall Executive functioning as measured by the Behavior Rating Inventory of Executive Function

    Time frame: baseline

    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

  35. Overall Executive functioning as measured by the Behavior Rating Inventory of Executive Function

    Time frame: 6 months after enrollment

    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

  36. Overall Executive functioning as measured by the Behavior Rating Inventory of Executive Function

    Time frame: 1 year after enrollment

    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

  37. Overall Executive Functioning Performance as measured by the Head-Toes-Knees-Shoulders task

    Time frame: baseline

    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.

  38. Overall Executive Functioning Performance as measured by the Head-Toes-Knees-Shoulders task

    Time frame: 6 months after enrollment

    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.

  39. Overall Executive Functioning Performance as measured by the Head-Toes-Knees-Shoulders task

    Time frame: 1 year after enrollment

    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.

  40. Peer status as assessed by sociometrics ratings during the intervention

    Time frame: Through study completion, an average of 1 year

    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.

Secondary outcomes

  1. Intervetion Attendance

    Time frame: Through study completion, an average of 1 year

    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.

  2. Daily Report Card

    Time frame: Through study completion, an average of 1 year

    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.

Sponsors and collaborators

Lead sponsor

Florida International University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Acronym: AHEAD

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Feb 2, 2026
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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