ADHDAHEADNCT07381855
Biosignatures for the Development of Attention Deficit Hyperactivity Disorder
A study testing Summer treatment program for children transitioning to and from kindergarten (STP-K) in people with ADHD and Disruptive Behaviours, run by Florida International University.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD, Disruptive Behaviours
- What is being tested?
- Summer treatment program for children transitioning to and from kindergarten (STP-K)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 323 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Diagnosis of Autism Spectrum Disorder
- Full scale IQ below 70
- Currently taking any psychotropic medication
About this study
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.
Read the 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.
- Conditions
- ADHD, Disruptive Behaviours
- Being tested
- Summer treatment program for children transitioning to and from kindergarten (STP-K)
- Keywords
- ADHD, callous-unemotional behaviors, summer treatment program, young children, school readiness, emotion dysregulation, parenting
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Summer treatment program for children transitioning to and from kindergarten (STP-K)Behavioural
Also called Summer Treatment Program, Summer Treatment Program for Prekindergarteners (STP-PreK)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Summer treatment program for children transitioning to and from kindergarten (STP-K) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
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.
Measured: 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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start1 Jan 2017
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07381855
- Sponsor's protocol ID
- IRB-14-0158-CR11
- Other IDs
- R01MH112588
- Acronym
- AHEAD
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We already have our data in the National Institute of Mental Health Data Archive (NDA)
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biosignatures for the Development of Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT07381855
- Acronym / sponsor ID
- AHEAD / IRB-14-0158-CR11
- Conditions
- ADHD, Disruptive Behaviours
- Keywords
- ADHD, callous-unemotional behaviors, summer treatment program, young children, school readiness, emotion dysregulation, parenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Summer Treatment Program for children transitioning to and from kindergarten (STP-K) | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Diagnosis of Autism Spectrum Disorder
- Full scale IQ below 70
- Currently taking any psychotropic medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Summer treatment program for children transitioning to and from kindergarten (STP-K)Also: Summer Treatment Program, Summer Treatment Program for Prekindergarteners (STP-PreK)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. | Behavioural | Summer Treatment Program for children transitioning to and from kindergarten (STP-K) |
Primary outcome
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.
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.
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.
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.
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.
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.
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
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
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
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
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
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.
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.
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.
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.
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.
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.
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
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
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
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.
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.
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.
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.
2 secondary outcomes
Intervetion Attendance
Time frame: Through study completion, an average of 1 year
Daily Report Card
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: No. We already have our data in the National Institute of Mental Health Data Archive (NDA)
Related trials for ADHD
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
RecruitingPhase 2
A Study to Evaluate Safety and Efficacy of ALKS 7290 Compared With Placebo in Adult Participants With Attention Deficit Hyperactivity Disorder (ALKS 7290-201)
Attention Deficit Disorder With Hyperactivity (ADHD)
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
RecruitingObservational study
Pharmacogenomics of Stimulant Treatment Response
Attention-Deficit/ Hyperactivity Disorder (ADHD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Summer treatment program for children transitioning to and from kindergarten (STP-K) in people with ADHD and Disruptive Behaviours, run by Florida International University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Emotion Regulation as measured by the Emotion Regulation Checklist (time frame: Baseline). The study lists 40 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.