Central Executive Training (CET) for ADHD

Not Applicable

Completed

• Conditions: ADHD

• Registration Number: NCT03324464
• Lead Sponsor: Florida State University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-09
• Study First Submitted QC: 2017-10-24
• Study First Posted: 2017-10-27
• Study Start: 2018-01-01
• Primary Completion: 2023-12-31
• Study Completion: 2024-01-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 251

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
ADHD symptoms	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 Outcome Measures

Name	Time	Method
Actigraph-measured hyperactivity during working memory testing	Immediate post-treatment (within 2 weeks of final treatment session)	Proportional integrating measure (PIM) units from autographs worn on non dominant wrist, left ankle, and right ankle during Rapport working memory tests. PIM units from each actigraph will be aggregated by summing them to create a Total Hyperactivity Score.
Working Memory	Immediate post-treatment (within 2 weeks of final treatment session)	Average of stimuli correct per trial on the Rapport phonological and visuospatial working memory tests
Inhibitory control	Immediate post-treatment (within 2 weeks of final treatment session)	Average of performance on the stop-signal (stop-signal delay metric) and go/no-go tests (commission errors)
Actigraph-measured hyperactivity during baseline	Immediate post-treatment (within 2 weeks of final treatment session)	Proportional integrating measure (PIM) units from autographs worn on non dominant wrist, left ankle, and right ankle. During beginning and end of session baseline painting tasks (described in Rapport et al., 2009). PIM units from each actigraph will be aggregated by summing them to create a Total Hyperactivity Score.

Trial Locations

Locations (1)

Florida State University; 🇺🇸 Tallahassee, Florida, United States