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

Florida International University (FIU)

Status: Completed

Conditions: ADHD; Disruptive Behaviours

Treatments: Behavioral: Summer treatment program for children transitioning to and from kindergarten (STP-K)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07381855

IRB-14-0158-CR11

R01MH112588 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 323 patients

Sex: All

Ages: 4 to 7 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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323 participants in 1 patient group

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

Experimental group

Description:

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.

Treatment:

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