NCT07381855

Biosignatures for the Development of Attention Deficit Hyperactivity Disorder

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 323 (actual)
• Sponsor: Florida International University · Academic / Other
• Sex: All
• Age: 4 Years – 7 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-01-01
• Primary completion: 2023-01-01
• Completion: 2023-01-01
• First posted: 2026-02-02
• Last updated: 2026-02-02