Central Executive Training for ADHD: Efficacy Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Florida State University
- Enrollment
- 251
- Locations
- 1
- Primary Endpoint
- ADHD symptoms
Study Overview
Brief Summary
The goal of the current project is to assess the efficacy of Central Executive Training (CET) for youth with ADHD. CET is a new, computerized training intervention that targets specific components of the working memory system. Two versions of CET were developed as part of our R34, each targeting a different combinations of executive functions. The final CET protocol reflects the contributions and feedback of a diverse group of caregivers, children with ADHD, and recognized experts in human cognition, ADHD treatment research, randomized control trial (RCT) intervention design methods, serious game theory and task design, cognitive training, and the role of executive dysfunction in ADHD.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 8 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Children ages 8-12 with principal ADHD diagnoses (via Kiddie Schedule for Affective Disorders semi-structured clinical interviewing (K-SADS)
- •Parent AND teacher ratings in clinical/borderline range based on age and gender on ADHD-RS-5 or BASC-3 Attention Problems/Hyperactivity subscales
- •Below average or lower working memory on at least one pre-treatment WM test. All ADHD presentations will be eligible.
Exclusion Criteria
- •gross neurological, sensory, or motor impairment
- •history of seizure disorder, psychosis, bipolar, or severe dysregulation disorders that may interfere with study participation (substance use, disruptive mood dysregulation, intermittent explosive, reactive attachment)
- •intellectual disability or Wechsler Intelligence Scale for Children (WISC-V) short-form intelligence quotient (FSIQ) < 78 (1.5 standard deviations (SD) below mean)
- •conditions requiring acute intervention, e.g., active suicidality
- •non-English speaking child or parent.
Arms & Interventions
CET-Working Memory (WM)
Central Executive Training: Working Memory
Intervention: Central Executive Training: Working Memory (Behavioral)
CET-Behavioral Inhibition (BI)
Central Executive Training: Inhibitory Control
Intervention: Central Executive Training: Inhibitory Control (Behavioral)
Outcomes
Primary Outcomes
ADHD symptoms
Time Frame: Immediate post-treatment (within 2 weeks of final treatment session)
Average of T-scores on parent-report ADHD symptoms questionnaires (Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-5) Inattention and Hyperactivity subscales, Behavioral Assessment System for Children (BASC-3) Inattention and Hyperactivity subscales)
Secondary Outcomes
- Inhibitory control(Immediate post-treatment (within 2 weeks of final treatment session))
- Actigraph-measured hyperactivity during working memory testing(Immediate post-treatment (within 2 weeks of final treatment session))
- Working Memory(Immediate post-treatment (within 2 weeks of final treatment session))
- Actigraph-measured hyperactivity during baseline(Immediate post-treatment (within 2 weeks of final treatment session))
Investigators
Michael J. Kofler
Associate Professor
Florida State University