Central Executive Training (CET) for ADHD

NCT03324464 | Completed

• 1 other identifier: R01MH115048
• Study Type: interventional
• Target: 251
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD

Outcome Measures

Primary Outcomes (1)

• ADHD symptoms

  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)

  Immediate post-treatment (within 2 weeks of final treatment session)

Secondary Outcomes (4)

• Working Memory

  Immediate post-treatment (within 2 weeks of final treatment session)

• 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)

• Actigraph-measured hyperactivity during baseline

  Immediate post-treatment (within 2 weeks of final treatment session)

Other Outcomes (12)

• NIH List Sorting

  Follow-up testing: 2-4 months after the post-treatment evaluation (variable time frame to account for school breaks)

• Teacher-reported ADHD symptoms

  Immediate post-treatment (within 2 weeks of final treatment session)

• Academic performance rating scale (APRS)

  Immediate post-treatment (within 2 weeks of final treatment session)

Study Arms (2)

CET-Working Memory (WM)

EXPERIMENTAL

Central Executive Training: Working Memory

Behavioral: Central Executive Training: Working Memory

CET-Behavioral Inhibition (BI)

ACTIVE COMPARATOR

Central Executive Training: Inhibitory Control

Behavioral: Central Executive Training: Inhibitory Control

Interventions

Central Executive Training: Working Memory BEHAVIORAL

Computerized working memory training

CET-Working Memory (WM)

Central Executive Training: Inhibitory Control BEHAVIORAL

Computerized inhibitory control training

CET-Behavioral Inhibition (BI)

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

Location

Related Publications (1)

• Groves NB, Chan ESM, Marsh CL, Gaye F, Jaisle EM, Kofler MJ. Does central executive training and/or inhibitory control training improve emotion regulation for children with attention-deficit/hyperactivity disorder? A randomized controlled trial. Front Psychiatry. 2022 Dec 6;13:1034722. doi: 10.3389/fpsyt.2022.1034722. eCollection 2022.

  PMID: 36561637 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 9, 2017
• First Posted: October 27, 2017
• Study Start: January 1, 2018
• Primary Completion: December 31, 2023
• Study Completion: January 5, 2024
• Last Updated: March 7, 2025

Record last verified: 2025-03

Locations

US (1)